These Highlights Do Not Include All The Information Needed To Use Prismasol And Phoxillum Safely And Effectively. See Full Prescribing Information For Prismasol And Phoxillum.

These Highlights Do Not Include All The Information Needed To Use Prismasol And Phoxillum Safely And Effectively. See Full Prescribing Information For Prismasol And Phoxillum.
SPL v35
SPL
SPL Set ID 7f675fee-8940-4ece-bb0c-75ac79d8708c
Route
INTRAVENOUS
Published
Effective Date 2025-03-13
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloride Ion (3.68 g) Anhydrous Dextrose (3.05 g) Lactic Acid (20 g) Bicarbonate Ion (5.4 g) Sodium Cation (6.46 g)
Inactive Ingredients
Water Carbon Dioxide Hydrochloric Acid

Identifiers & Packaging

Marketing Status
NDA Active Since 2015-01-13
Description

PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances.

Indications and Usage

PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances.

Dosage and Administration

Therapy must be individualized based on the patient's clinical condition, fluid, electrolyte, acid-base and glucose balance ( 2.2 ) Solution must be mixed prior to use ( 2.2 ) Use only with extracorporeal dialysis equipment appropriate for CRRT ( 2.3 )

Warnings and Precautions

Monitor hemodynamic status and fluid inputs and outputs, potassium, phosphorus, other electrolytes and acid-base balance. Abnormalities may be corrected by the use of appropriate formulations and dosage of PRISMASOL and PHOXILLUM solutions ( 5.1 ) Treatment may affect glucose levels. Monitor blood glucose levels. Antidiabetic therapy adjustment or other corrective measures may be required during treatment ( 5.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Vantive US Healthcare LLC at 1855-857-0003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Contraindications

PHOXILLUM and PRISMASOL replacement solutions are contraindicated in patients with known hypersensitivities to these products.

Adverse Reactions

The following adverse reactions have been identified during postapproval use with these or other similar products and therefore may occur with use of PHOXILLUM or PRISMASOL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Metabolic acidosis Hypotension Acid-base disorders Electrolyte imbalance including calcium ionized increased (reported in PRISMASOL solutions containing calcium), hyperphosphatemia, and hypophosphatemia Fluid imbalance

Drug Interactions

As with the use of other replacement solutions, blood concentrations of dialyzable drugs may be reduced by CRRT due to their removal by the hemofilter or hemodiafilter. The blood concentrations of certain drugs may need to be monitored and appropriate therapy implemented to correct for removal during treatment.

Storage and Handling

PRISMASOL and PHOXILLUM solutions are supplied in a two-compartment bag made of polyolefin. The 5000 mL bag is composed of a small compartment (250 mL) and a large compartment (4750 mL). The two compartments are separated by a peel seal. The bag is overwrapped with a transparent overwrap. See Table 2 for the concentrations of the active ingredients in each compartment for each product [see Description (11) ]. Container Fill Volume NDC PRISMASOL Solutions PRISMASOL BGK0/2.5 5000 mL 24571-108-06 PRISMASOL BGK4/2.5 5000 mL 24571-105-06 PRISMASOL BGK2/3.5 5000 mL 24571-103-06 PRISMASOL BGK2/0 5000 mL 24571-102-06 PRISMASOL B22GK4/0 5000 mL 24571-111-06 PRISMASOL BK0/0/1.2 5000 mL 24571-113-06 PRISMASOL BGK4/0/1.2 5000 mL 24571-114-06 PHOXILLUM Solutions PHOXILLUM BK4/2.5 5000 mL 24571-116-06 PHOXILLUM B22K4/0 5000 mL 24571-117-06 Not all formulations may be marketed.

How Supplied

PRISMASOL and PHOXILLUM solutions are supplied in a two-compartment bag made of polyolefin. The 5000 mL bag is composed of a small compartment (250 mL) and a large compartment (4750 mL). The two compartments are separated by a peel seal. The bag is overwrapped with a transparent overwrap. See Table 2 for the concentrations of the active ingredients in each compartment for each product [see Description (11) ]. Container Fill Volume NDC PRISMASOL Solutions PRISMASOL BGK0/2.5 5000 mL 24571-108-06 PRISMASOL BGK4/2.5 5000 mL 24571-105-06 PRISMASOL BGK2/3.5 5000 mL 24571-103-06 PRISMASOL BGK2/0 5000 mL 24571-102-06 PRISMASOL B22GK4/0 5000 mL 24571-111-06 PRISMASOL BK0/0/1.2 5000 mL 24571-113-06 PRISMASOL BGK4/0/1.2 5000 mL 24571-114-06 PHOXILLUM Solutions PHOXILLUM BK4/2.5 5000 mL 24571-116-06 PHOXILLUM B22K4/0 5000 mL 24571-117-06 Not all formulations may be marketed.

Medication Information

Warnings and Precautions

Monitor hemodynamic status and fluid inputs and outputs, potassium, phosphorus, other electrolytes and acid-base balance. Abnormalities may be corrected by the use of appropriate formulations and dosage of PRISMASOL and PHOXILLUM solutions ( 5.1 ) Treatment may affect glucose levels. Monitor blood glucose levels. Antidiabetic therapy adjustment or other corrective measures may be required during treatment ( 5.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Vantive US Healthcare LLC at 1855-857-0003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Indications and Usage

PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances.

Dosage and Administration

Therapy must be individualized based on the patient's clinical condition, fluid, electrolyte, acid-base and glucose balance ( 2.2 ) Solution must be mixed prior to use ( 2.2 ) Use only with extracorporeal dialysis equipment appropriate for CRRT ( 2.3 )

Contraindications

PHOXILLUM and PRISMASOL replacement solutions are contraindicated in patients with known hypersensitivities to these products.

Adverse Reactions

The following adverse reactions have been identified during postapproval use with these or other similar products and therefore may occur with use of PHOXILLUM or PRISMASOL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Metabolic acidosis Hypotension Acid-base disorders Electrolyte imbalance including calcium ionized increased (reported in PRISMASOL solutions containing calcium), hyperphosphatemia, and hypophosphatemia Fluid imbalance

Drug Interactions

As with the use of other replacement solutions, blood concentrations of dialyzable drugs may be reduced by CRRT due to their removal by the hemofilter or hemodiafilter. The blood concentrations of certain drugs may need to be monitored and appropriate therapy implemented to correct for removal during treatment.

Storage and Handling

PRISMASOL and PHOXILLUM solutions are supplied in a two-compartment bag made of polyolefin. The 5000 mL bag is composed of a small compartment (250 mL) and a large compartment (4750 mL). The two compartments are separated by a peel seal. The bag is overwrapped with a transparent overwrap. See Table 2 for the concentrations of the active ingredients in each compartment for each product [see Description (11) ]. Container Fill Volume NDC PRISMASOL Solutions PRISMASOL BGK0/2.5 5000 mL 24571-108-06 PRISMASOL BGK4/2.5 5000 mL 24571-105-06 PRISMASOL BGK2/3.5 5000 mL 24571-103-06 PRISMASOL BGK2/0 5000 mL 24571-102-06 PRISMASOL B22GK4/0 5000 mL 24571-111-06 PRISMASOL BK0/0/1.2 5000 mL 24571-113-06 PRISMASOL BGK4/0/1.2 5000 mL 24571-114-06 PHOXILLUM Solutions PHOXILLUM BK4/2.5 5000 mL 24571-116-06 PHOXILLUM B22K4/0 5000 mL 24571-117-06 Not all formulations may be marketed.

How Supplied

PRISMASOL and PHOXILLUM solutions are supplied in a two-compartment bag made of polyolefin. The 5000 mL bag is composed of a small compartment (250 mL) and a large compartment (4750 mL). The two compartments are separated by a peel seal. The bag is overwrapped with a transparent overwrap. See Table 2 for the concentrations of the active ingredients in each compartment for each product [see Description (11) ]. Container Fill Volume NDC PRISMASOL Solutions PRISMASOL BGK0/2.5 5000 mL 24571-108-06 PRISMASOL BGK4/2.5 5000 mL 24571-105-06 PRISMASOL BGK2/3.5 5000 mL 24571-103-06 PRISMASOL BGK2/0 5000 mL 24571-102-06 PRISMASOL B22GK4/0 5000 mL 24571-111-06 PRISMASOL BK0/0/1.2 5000 mL 24571-113-06 PRISMASOL BGK4/0/1.2 5000 mL 24571-114-06 PHOXILLUM Solutions PHOXILLUM BK4/2.5 5000 mL 24571-116-06 PHOXILLUM B22K4/0 5000 mL 24571-117-06 Not all formulations may be marketed.

Description

PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances.

Section 42229-5

Instructions for preparing solutions supplied in a two-compartment, polyolefin bag with a peel seal:

Section 44425-7

Storage conditions

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). [See USP Controlled Room Temperature]

Do not freeze or expose to excessive heat. Do not use if precipitate has formed or if container seals have been damaged.

Manufactured for:

Vantive US Healthcare LLC

One Baxter Parkway

Deerfield, Illinois 60015

07-19-00-8247

Vantive, Phoxillum and PrismaSol are trademarks of Vantive Health Inc., or its subsidiaries

7.1 Citrate

When used as an anticoagulant, citrate contributes to the overall buffer load and can reduce plasma calcium levels. Select the PRISMASOL/PHOXILLUM formulation(s) accordingly.

Risk Summary

PRISMASOL and PHOXILLUM are pharmacologically inactive solutions. While there are no adequate and well controlled studies in pregnant women, appropriate administration of PRISMASOL and PHOXILLUM solutions with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to cause fetal harm. Animal reproduction studies have not been conducted with PRISMASOL and PHOXILLUM solutions.

The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

11 Description

PRISMASOL and PHOXILLUM solutions are clear, sterile, free of bacterial endotoxins and contain no bacteriostatic or antimicrobial agents. These solutions are used in Continuous Renal Replacement Therapies (CRRT) as a replacement solution in hemofiltration and hemodiafiltration. Depending on the product (see Table 2), the two compartments contain:

Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 2• 2H 2O).

Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 2• 6H 2O).

Sodium chloride, USP, is chemically designated NaCl.

Potassium chloride, USP, is chemically designated KCl.

Sodium bicarbonate, USP, is chemically designated NaHCO 3.

Dextrose, USP, is chemically designated D-Glucose anhydrous (C 6H 12O 6) or D-Glucose monohydrate (C 6H 12O 6• H 2O).

Lactic acid, USP, is chemically designated CH 3CH(OH)COOH.

Dibasic sodium phosphate, USP, is chemically designated as disodium hydrogen phosphate, dihydrate (Na 2HPO 4• 2H 2O)

Table 2 - Compartment Composition (Before Mixing)
Compartment A (g/L) Compartment B (g/L)
Calcium Chloride ∙ 2H 2O Magnesium Chloride ∙ 6H 2O Dextrose anhydrous (as monohydrate) Lactic Acid Sodium Chloride Sodium bicarbonate Potassium Chloride Sodium Phosphate ∙ 2H 2O

PRISMASOL SOLUTIONS

BGK 0/2.5

3.68

3.05

20 (22)

5.40

6.46

3.09

0

0

BGK 4/2.5

3.68

3.05

20 (22)

5.40

6.46

3.09

0.314

0

BGK 2/3.5

5.15

2.03

20 (22)

5.40

6.46

3.09

0.157

0

BGK 2/0

0

2.03

20 (22)

5.40

6.46

3.09

0.157

0

B22GK 4/0

0

3.05

20 (22)

5.40

7.07

2.21

0.314

0

BK 0/0/1.2

0

2.44

0 (0)

5.40

6.46

3.09

0

0

BGK 4/0/1.2

0

2.44

20 (22)

5.40

6.46

3.09

0.314

0

PHOXILLUM SOLUTIONS

BK 4/2.5

3.68

3.05

0 (0)

0

6.34

3.09

0.314

0.187

B22K 4/0

0

3.05

0 (0)

0

6.95

2.21

0.314

0.187

The pH of the final solution is in the range of 7.0 to 8.5.

8.4 Pediatric Use

Safety and effectiveness have been established based on published clinical data of CRRT replacement solutions with compositions similar to PRISMASOL and PHOXILLUM used in adults and two hemofiltration studies in pediatric patients, including a study of newborns to 17 years old.

8.5 Geriatric Use

The experience with PRISMASOL and PHOXILLUM solutions in geriatric patients has not identified novel concerns.

4 Contraindications

PHOXILLUM and PRISMASOL replacement solutions are contraindicated in patients with known hypersensitivities to these products.

6 Adverse Reactions

The following adverse reactions have been identified during postapproval use with these or other similar products and therefore may occur with use of PHOXILLUM or PRISMASOL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Metabolic acidosis
  • Hypotension
  • Acid-base disorders
  • Electrolyte imbalance including calcium ionized increased (reported in PRISMASOL solutions containing calcium), hyperphosphatemia, and hypophosphatemia
  • Fluid imbalance
7 Drug Interactions

As with the use of other replacement solutions, blood concentrations of dialyzable drugs may be reduced by CRRT due to their removal by the hemofilter or hemodiafilter. The blood concentrations of certain drugs may need to be monitored and appropriate therapy implemented to correct for removal during treatment.

12.3 Pharmacokinetics

The distribution of electrolytes, bicarbonate, and dextrose is determined by the patient's clinical condition, metabolic status, and residual renal function.

The elimination and replacement of water, electrolytes and buffer depend on the patient's electrolyte and acid-base balance, metabolic status, residual renal function and ongoing physiologic losses through intestinal, respiratory and cutaneous routes.

1 Indications and Usage

PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances.

Clinical Considerations

Maintenance of normal acid-base balance is important for fetal well-being.

12.1 Mechanism of Action

PRISMASOL and PHOXILLUM solutions are pharmacologically inactive. The electrolyte concentrations in the solutions are chosen to restore plasma levels to clinically desired concentrations or maintain plasma levels at the desired concentrations.

PRISMASOL and PHOXILLUM solutions are used as replacement solution to replace water and electrolytes removed during hemofiltration and hemodiafiltration. Bicarbonate (or precursor lactate) in the solution is used as an alkalinizing buffer to restore acid-base balance to a clinically desirable level.

2.2 Dosing Considerations

PRISMASOL replacement solutions contain 4 different combinations of active ingredients (7 different products with varying ingredient amounts). PHOXILLUM replacement solutions contain 2 different combinations of active ingredients (2 different products with varying ingredient amounts). PRISMASOL and PHOXILLUM are supplied in a two-compartment bag that must be mixed immediately prior to use [see Dosage and Administration (2.3)]:

  • Small compartment A (250 mL) containing an electrolyte solution, and
  • Large compartment B (4750 mL) containing the buffer solution.

See Table 1for the concentrations of the active ingredients (after mixing) in these 9 different replacement solutions (total volume is 5 Liters).

Table 1: Concentrations of Active Ingredients in the 7 PRISMASOL and 2 PHOXILLUM Replacement Solutions after Mixing
Ca 2+

mEq/L 		HCO 3 -

mEq/L 		K +

mEq/L 		Mg 2+

mEq/L 		Na +

mEq/L 		HPO 4 2-

mmol/L 		Cl -

mEq/L 		Lactate

mEq/L 		Dextrose

mg/dL 		Osmolarity

mOsm/L
Ca 2+= calcium, HCO 3 -= bicarbonate, K += potassium, Mg 2+= magnesium, Na += sodium, HPO 4 2-= phosphate, Cl- = chloride; osmolarity is estimated

PRISMASOL Replacement Solutions

BGK0/2.5

2.5

32

0

1.5

140

0

109

3

100

292

BGK4/2.5

2.5

32

4

1.5

140

0

113

3

100

300

BGK2/3.5

3.5

32

2

1

140

0

111.5

3

100

296

BGK2/0

0

32

2

1

140

0

108

3

100

291

B22GK4/0

0

22

4

1.5

140

0

120.5

3

100

296

BGK4/0/1.2

0

32

4

1.2

140

0

110.2

3

100

295

BK0/0/1.2

0

32

0

1.2

140

0

106.2

3

0

282

PHOXILLUM Replacement Solutions

BK4/2.5

2.5

32

4

1.5

140

1

114.5

0

0

294

B22K4/0

0

22

4

1.5

140

1

122

0

0

290

The mode of therapy, solute formulation, flow rates, and length of PRISMASOL and PHOXILLUM replacement therapy in CRRT should be established by a physician based on the patient’s clinical condition, blood concentration of phosphate and other electrolytes, acid-base and glucose balance. Administer either PRISMASOL or PHOXILLUM into the extracorporeal circuit:

  • Before (pre-dilution) the hemofilter or hemodiafilter,
  • After (post-dilution) the hemofilter or hemodiafilter, or
  • Before and after the hemofilter or hemodiafilter.
2.3 Preparing the Solution

Use only if the overwrap is not damaged, all seals are intact, peel seal is not broken, and the solution is clear.

The solution may be warmed to 37°C/98.6°F prior to removing the overwrap to enhance patient comfort. However, only dry heat should be used. Solutions should not be heated in water or in a microwave oven. After heating, verify that the solution remains clear and contains no particulate matter.

The solutions are supplied in two different two-compartment bags made of polyolefin with a peel seal separating compartment A and B (see Figure 1).

Follow the instructions below when connecting the solution bags for correct use of the access ports.

5 Warnings and Precautions
  • Monitor hemodynamic status and fluid inputs and outputs, potassium, phosphorus, other electrolytes and acid-base balance. Abnormalities may be corrected by the use of appropriate formulations and dosage of PRISMASOL and PHOXILLUM solutions ( 5.1)
  • Treatment may affect glucose levels. Monitor blood glucose levels.
  • Antidiabetic therapy adjustment or other corrective measures may be required during treatment ( 5.2)

To report SUSPECTED ADVERSE REACTIONS, contact Vantive US Healthcare LLC at 1855-857-0003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

2 Dosage and Administration
  • Therapy must be individualized based on the patient's clinical condition, fluid, electrolyte, acid-base and glucose balance ( 2.2)
  • Solution must be mixed prior to use ( 2.2)
  • Use only with extracorporeal dialysis equipment appropriate for CRRT ( 2.3)
Package/label Display Panel

Mixing steps

① SQUEEZE TOPcorners to break seal

②Squeeze BAG SIDESto fully open seal

Barcode

NDC# 24571-108-06

OK +

mEq/L

2.5 Ca 2+

mEq/L

PrismaSol BGK0/2.5

Rx only

Barcode

Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution each 1000 mL contains (g)

A

B

Calcium chloride • 2H 2O

3.68

Magnesium chloride • 6H 2O

3.05

Dextrose anhydrous

20.0

(as dextrose monohydrate)

22.0

Sodium chloride

6.46

Lactic acid

5.40

Sodium bicarbonate

3.09

Water for injections q.s, Carbon dioxide for pH adjustment



A

250 mL

B

4750 mL

After reconstitution, A + B

Calcium

Ca 2+

Magnesium

Mg 2+

Sodium

Na +

Chloride

Cl -

Lactate

C 3H 5O 3 -

Bicarbonate

HCO 3 -

Potassium

K +

Dextrose

mmol/L

1.25

0.75

140

109.0

3.0

32

0

5.5

mEq/L

2.5

1.5

140

109.0

3.0

32

0

(100 mg/dL)

  • Theoretical osmolarity: 292 mOsm/L pH: 7.0 – 8.5

Mix both compartments before use.

See package insert for dosage information and

further instructions.

Sterile and free from bacterial endotoxins.

Confirm the integrity of the packaging. Use only if

solution is clear. For single use only.

DISCARD ANY UNUSED SOLUTION.

Store at +20°C to +25°C (+68°F to +77°F); excursions

permitted to +15°C to +30°C (+59°F to

+86°F). [See USP Controlled room Temperature.]

Do not freeze or expose to excessive heat.

As soon as the overwrap is removed, the reconstitution

of compartments A and B should be done

and the reconstituted solution should be used immediately.

After removal of the overwrap, the solution

is stable for 24 hours including the duration of

the treatment. Mix additives BEFORE connecting

this bag to the extracorporeal circuit. (See insert

for further information.) This product is not made

with natural rubber latex.

5000 mL

EAN-14: 07332414091613

Product # 110240

VANTIVE Logo

Batch No. and expiry date are printed on the back of the bag.

Manufactured for:

Vantive US Healthcare LLC

Deerfield IL 60015 USA

Made in Italy

REPLACEMENT

Solution for Continuous Renal Replacement Therapy

07-25-00-5278

Mixing steps

① SQUEEZE TOPcorners to break seal

②Squeeze BAG SIDESto fully open seal

Barcode

NDC# 24571-105-06

4K +

mEq/L

2.5 Ca 2+

mEq/L

PrismaSol BGK4/2.5

Rx only

Barcode

Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution each 1000 mL contains (g)

A

B

Calcium chloride • 2H 2O

3.68

Magnesium chloride • 6H 2O

3.05

Dextrose anhydrous

20.0

(as dextrose monohydrate)

22.0

Sodium chloride

6.46

Potassium chloride

0.314

Lactic acid

5.40

Sodium bicarbonate

3.09

Water for injections q.s, Carbon dioxide for pH adjustment



A

250 mL

B

4750 mL

After reconstitution, A + B

Calcium

Ca 2+

Magnesium

Mg 2+

Sodium

Na +

Chloride

Cl -

Lactate

C 3H 5O 3 -

Bicarbonate

HCO 3 -

Potassium

K +

Dextrose

mmol/L

1.25

0.75

140

113.0

3.0

32

4.0

5.5

mEq/L

2.5

1.5

140

113.0

3.0

32

4.0

(100 mg/dL)

  • Theoretical osmolarity: 300 mOsm/L pH: 7.0 – 8.5

Mix both compartments before use.

See package insert for dosage information and

further instructions.

Sterile and free from bacterial endotoxins.

Confirm the integrity of the packaging. Use only if

solution is clear. For single use only.

DISCARD ANY UNUSED SOLUTION.

Store at +20°C to +25°C (+68°F to +77°F); excursions

permitted to +15°C to +30°C (+59°F to

+86°F). [See USP Controlled room Temperature.]

Do not freeze or expose to excessive heat.

As soon as the overwrap is removed, the reconstitution

of compartments A and B should be done

and the reconstituted solution should be used immediately.

After removal of the overwrap, the solution

is stable for 24 hours including the duration of

the treatment. Mix additives BEFORE connecting

this bag to the extracorporeal circuit. (See insert

for further information.) This product is not made

with natural rubber latex.

5000 mL

EAN-14: 07332414091637

Product # 110242

VANTIVE Logo

Batch No. and expiry date are printed on the back of the bag.

Manufactured for:

Vantive US Healthcare LLC

Deerfield IL 60015 USA

Made in Italy

REPLACEMENT

Solution for Continuous Renal Replacement Therapy

07-25-00-5280

Mixing steps

① SQUEEZE TOPcorners to break seal

②Squeeze BAG SIDESto fully open seal

Barcode

NDC# 24571-103-06

2K +

mEq/L

3.5 Ca 2+

mEq/L

PrismaSol BGK2/3.5

Rx only

Barcode

Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution each 1000 mL contains (g)

A

B

Calcium chloride • 2H 2O

5.15

Magnesium chloride • 6H 2O

2.03

Dextrose anhydrous

20.0

(as dextrose monohydrate)

22.0

Sodium chloride

6.46

Potassium chloride

0.157

Lactic acid

5.40

Sodium bicarbonate

3.09

Water for injections q.s, Carbon dioxide for pH adjustment

Rx only

A

250 mL

B

4750 mL

After reconstitution, A + B

Calcium

Ca 2+

Magnesium

Mg 2+

Sodium

Na +

Chloride

Cl -

Lactate

C 3H 5O 3 -

Bicarbonate

HCO 3 -

Potassium

K +

Dextrose

mmol/L

1.75

0.5

140

111.5

3.0

32

2.0

5.5

mEq/L

3.5

1.0

140

111.5

3.0

32

2.0

(100 mg/dL)

  • Theoretical osmolarity: 296 mOsm/L pH: 7.0 – 8.5

Mix both compartments before use.

See package insert for dosage information and

further instructions.

Sterile and free from bacterial endotoxins.

Confirm the integrity of the packaging. Use only if

solution is clear. For single use only.

DISCARD ANY UNUSED SOLUTION.

Store at +20°C to +25°C (+68°F to +77°F); excursions

permitted to +15°C to +30°C (+59°F to

+86°F). [See USP Controlled room Temperature.]

Do not freeze or expose to excessive heat.

As soon as the overwrap is removed, the reconstitution

of compartments A and B should be done

and the reconstituted solution should be used immediately.

After removal of the overwrap, the solution

is stable for 24 hours including the duration of

the treatment. Mix additives BEFORE connecting

this bag to the extracorporeal circuit. (See insert

for further information.) This product is not made

with natural rubber latex.

5000 mL

EAN-14: 07332414091644

Product # 110243

VANTIVE Logo

Batch No. and expiry date are printed on the back of the bag.

Manufactured for:

Vantive US Healthcare LLC

Deerfield IL 60015 USA

Made in Italy

REPLACEMENT

Solution for Continuous Renal Replacement Therapy

07-25-00-5281

Mixing steps

① SQUEEZE TOPcorners to break seal

②Squeeze BAG SIDESto fully open seal

Barcode

NDC# 24571-102-06

2K +

mEq/L

0Ca 2+

mEq/L

PrismaSol BGK2/0

Rx only

Barcode

Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution each 1000 mL contains (g)

A

B

Magnesium chloride • 6H 2O

2.03

Dextrose anhydrous

20.0

(as dextrose monohydrate)

22.0

Sodium chloride

6.46

Potassium chloride

0.157

Lactic acid

5.40

Sodium bicarbonate

3.09

Water for injections q.s, Carbon dioxide for pH adjustment



A

250 mL

B

4750 mL

After reconstitution, A + B

Calcium

Ca 2+

Magnesium

Mg 2+

Sodium

Na +

Chloride

Cl -

Lactate

C 3H 5O 3 -

Bicarbonate

HCO 3 -

Potassium

K +

Dextrose

mmol/L

0

0.5

140

108.0

3.0

32

2.0

5.5

mEq/L

0

1.0

140

108.0

3.0

32

2.0

(100 mg/dL)
  • Theoretical osmolarity: 291 mOsm/L pH: 7.0 – 8.5

Mix both compartments before use.

See package insert for dosage information and

further instructions.

Sterile and free from bacterial endotoxins.

Confirm the integrity of the packaging. Use only if

solution is clear. For single use only.

DISCARD ANY UNUSED SOLUTION.

Store at +20°C to +25°C (+68°F to +77°F); excursions

permitted to +15°C to +30°C (+59°F to

+86°F). [See USP Controlled room Temperature.]

Do not freeze or expose to excessive heat.

As soon as the overwrap is removed, the reconstitution

of compartments A and B should be done

and the reconstituted solution should be used immediately.

After removal of the overwrap, the solution

is stable for 24 hours including the duration of

the treatment. Mix additives BEFORE connecting

this bag to the extracorporeal circuit. (See insert

for further information.) This product is not made

with natural rubber latex.

5000 mL

EAN-14: 07332414091651

Product # 110244

VANTIVE Logo

Batch No. and expiry date are printed on the back of the bag.

Manufactured for:

Vantive US Healthcare LLC

Deerfield IL 60015 USA

Made in Italy

REPLACEMENT

Solution for Continuous Renal Replacement Therapy

07-25-00-5282

Mixing steps

① SQUEEZE TOPcorners to break seal

②Squeeze BAG SIDESto fully open seal

Barcode

NDC# 24571-111-06

4K +

mEq/L

Bicarbonate 22

0Ca 2+

mEq/L

PrismaSol B22GK4/0

Rx only

Barcode

Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution each 1000 mL contains (g)

A

B

Magnesium chloride • 6H 2O

3.05

Dextrose anhydrous

20.0

(as dextrose monohydrate)

22.0

Sodium chloride

7.07

Potassium chloride

0.314

Lactic acid

5.40

Sodium bicarbonate

2.21

Water for injections q.s, Carbon dioxide for pH adjustment



A

250 mL

B

4750 mL

After reconstitution, A + B

Calcium

Ca 2+

Magnesium

Mg 2+

Sodium

Na +

Chloride

Cl -

Lactate

C 3H 5O 3 -

Bicarbonate

HCO 3 -

Potassium

K +

Dextrose

mmol/L

0

0.75

140

120.5

3.0

22

4.0

5.5

mEq/L

0

1.5

140

120.5

3.0

22

4.0

(100 mg/dL)

  • Theoretical osmolarity: 296 mOsm/L pH: 7.0 – 8.5

Mix both compartments before use.

See package insert for dosage information and

further instructions.

Sterile and free from bacterial endotoxins.

Confirm the integrity of the packaging. Use only if

solution is clear. For single use only.

DISCARD ANY UNUSED SOLUTION.

Store at +20°C to +25°C (+68°F to +77°F); excursions

permitted to +15°C to +30°C (+59°F to

+86°F). [See USP Controlled room Temperature.]

Do not freeze or expose to excessive heat.

As soon as the overwrap is removed, the reconstitution

of compartments A and B should be done

and the reconstituted solution should be used immediately.

After removal of the overwrap, the solution

is stable for 24 hours including the duration of

the treatment. Mix additives BEFORE connecting

this bag to the extracorporeal circuit. (See insert

for further information.) This product is not made

with natural rubber latex.

5000 mL

EAN-14: 07332414116781

Product # 115001

VANTIVE Logo

Batch No. and expiry date are printed on the back of the bag.

Manufactured for:

Vantive US Healthcare LLC

Deerfield IL 60015 USA

Made in Italy

REPLACEMENT

Solution for Continuous Renal Replacement Therapy

07-25-00-5285

Mixing steps

① SQUEEZE TOPcorners to break seal

②Squeeze BAG SIDESto fully open seal

Barcode

NDC# 24571-113-06

0K +

mEq/L

0Ca 2+

mEq/L

PrismaSol BK0/0/1.2

Rx only

Barcode

Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution each 1000 mL contains (g)

A

B

Magnesium chloride • 6H 2O

2.44

Sodium chloride

6.46

Lactic acid

5.40

Sodium bicarbonate

3.09

Water for injections q.s, Carbon dioxide for pH adjustment



A

250 mL

B

4750 mL

After reconstitution, A + B

Calcium

Ca 2+

Magnesium

Mg 2+

Sodium

Na +

Chloride

Cl -

Lactate

C 3H 5O 3 -

Bicarbonate

HCO 3 -

Potassium

K +

Dextrose

mmol/L

0

0.6

140

106.2

3.0

32

0

0

mEq/L

0

1.2

140

106.2

3.0

32

0

(0 mg/dL)

  • Theoretical osmolarity: 282 mOsm/L pH: 7.0 – 8.5

Mix both compartments before use.

See package insert for dosage information and

further instructions.

Sterile and free from bacterial endotoxins.

Confirm the integrity of the packaging. Use only if

solution is clear. For single use only.

DISCARD ANY UNUSED SOLUTION.

Store at +20°C to +25°C (+68°F to +77°F); excursions

permitted to +15°C to +30°C (+59°F to

+86°F). [See USP Controlled room Temperature.]

Do not freeze or expose to excessive heat.

As soon as the overwrap is removed, the reconstitution

of compartments A and B should be done

and the reconstituted solution should be used immediately.

After removal of the overwrap, the solution

is stable for 24 hours including the duration of

the treatment. Mix additives BEFORE connecting

this bag to the extracorporeal circuit. (See insert

for further information.) This product is not made

with natural rubber latex.

5000 mL

EAN-14: 07332414091309

Product # 110239

VANTIVE Logo

Batch No. and expiry date are printed on the back of the bag.

Manufactured for:

Vantive US Healthcare LLC

Deerfield IL 60015 USA

Made in Italy

REPLACEMENT

Solution for Continuous Renal Replacement Therapy

07-25-00-5277

Mixing steps

① SQUEEZE TOPcorners to break seal

②Squeeze BAG SIDESto fully open seal

Barcode

NDC# 24571-114-06

4K +

mEq/L

0Ca 2+

mEq/L

PrismaSol BGK4/0/1.2

Rx only

Barcode

Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution each 1000 mL contains (g)

A

B

Magnesium chloride • 6H 2O

2.44

Dextrose anhydrous

20.0

(as dextrose monohydrate)

22.0

Sodium chloride

6.46

Potassium chloride

0.314

Lactic acid

5.40

Sodium bicarbonate

3.09

Water for injections q.s, Carbon dioxide for pH adjustment



A

250 mL

B

4750 mL

After reconstitution, A + B

Calcium

Ca 2+

Magnesium

Mg 2+

Sodium

Na +

Chloride

Cl -

Lactate

C 3H 5O 3 -

Bicarbonate

HCO 3 -

Potassium

K +

Dextrose

mmol/L

0

0.6

140

110.2

3.0

32

4.0

5.5

mEq/L

0

1.2

140

110.2

3.0

32

4.0

(100 mg/dL)

  • Theoretical osmolarity: 295 mOsm/L pH: 7.0 – 8.5

Mix both compartments before use.

See package insert for dosage information and

further instructions.

Sterile and free from bacterial endotoxins.

Confirm the integrity of the packaging. Use only if

solution is clear. For single use only.

DISCARD ANY UNUSED SOLUTION.

Store at +20°C to +25°C (+68°F to +77°F); excursions

permitted to +15°C to +30°C (+59°F to

+86°F). [See USP Controlled room Temperature.]

Do not freeze or expose to excessive heat.

As soon as the overwrap is removed, the reconstitution

of compartments A and B should be done

and the reconstituted solution should be used immediately.

After removal of the overwrap, the solution

is stable for 24 hours including the duration of

the treatment. Mix additives BEFORE connecting

this bag to the extracorporeal circuit. (See insert

for further information.) This product is not made

with natural rubber latex.

5000 mL

EAN-14: 07332414091620

Product # 110241

VANTIVE Logo

Batch No. and expiry date are printed on the back of the bag.

Manufactured for:

Vantive US Healthcare LLC

Deerfield IL 60015 USA

Made in Italy

REPLACEMENT

Solution for Continuous Renal Replacement Therapy

07-25-00-5279

Mixing steps

① SQUEEZE TOPcorners to break seal

②Squeeze BAG SIDESto fully open seal

Compartment B

Barcode

NDC# 24571-116-06

4K +

mEq/L

1 Phosphate

mmol/L

2.5 Ca 2+

mEq/L

Phoxillum BK4/2.5

Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution, each 1000 mL contains (g):

A

B

Calcium chloride • 2H 2O

3.68

Magnesium chloride • 6H 2O

3.05

Sodium chloride

6.34

Potassium chloride

0.314

Sodium bicarbonate

3.09

Dibasic sodium phosphate • 2H 2O

0.187

Water for injections q.s

Rx only

A

250 mL

B

4750 mL

After reconstitution, A + B

Calcium

Ca 2+

Magnesium

Mg 2+

Sodium

Na +

Chloride

Cl -

Bicarbonate

HCO 3 -

Potassium

K +

Phosphate

HPO 4 2-

Dextrose

mmol/L

1.25

0.75

140

114.5

32

4.0

1

0

mEq/L

2.5

1.5

140

114.5

32

4.0

(1 mmol/L)

(0 mg/dL)
  • Theoretical osmolarity: 294 mOsm/L pH: 7.0 – 8.5

Mix both compartments before use.

See package insert for dosage information and further instructions. Sterile and free from bacterial endotoxins.

Confirm the integrity of the packaging. Use only if solution is clear. For single use only. DISCARD ANY UN-

USED SOLUTION. Store at +20ºC to +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC - +30ºC (+59ºF

to +86ºF). [See USP Controlled Room Temperature]. Do not freeze or expose to excessive heat. As soon as the

overwrap is removed, the reconstitution of compartments A and B should be done and the reconstituted

solution should be used immediately. After removal of the overwrap, the solution is stable for 24 hours including the duration of the treatment. Mix additives BEFORE connecting this bag to the extracorporeal circuit. (See insert for

further information.) This product is not made with natural rubber latex. Carbon dioxide and diluted hydrochloric

acid added for pH adjustment.

5000 mL

EAN-14: 07332414116040

Product # 114905

VANTIVE Logo

Batch No. and expiry date are printed on the back of the bag.

Manufactured for:

Vantive US Healthcare LLC

Deerfield IL 60015 USA

Made in Italy

REPLACEMENT

Solution for Continuous Renal Replacement Therapy

07-25-00-5283

Mixing steps

① SQUEEZE TOPcorners to break seal

②Squeeze BAG SIDESto fully open seal

Compartment B

Barcode

NDC# 24571-117-06

4K +

mEq/L

0 Ca 2+

mEq/L

22 Bicarbonate

mEq/L

1 Phosphate

mmol/L

Phoxillum B22K4/0

Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution, each 1000 mL contains (g):

A

B

Magnesium chloride • 6H 2O

3.05

Sodium chloride

6.95

Potassium chloride

0.314

Sodium bicarbonate

2.21

Dibasic sodium phosphate • 2H 2O

0.187

Water for injections q.s

Rx only

A

250 mL

B

4750 mL

After reconstitution, A + B

Calcium

Ca 2+

Magnesium

Mg 2+

Sodium

Na +

Chloride

Cl -

Bicarbonate

HCO 3 -

Potassium

K +

Phosphate

HPO 4 2-

Dextrose

mmol/L

0

0.75

140

122.0

22

4.0

1

0

mEq/L

0

1.5

140

122.0

22

4.0

(1 mmol/L)

(0 mg/dL)
  • Theoretical osmolarity: 290 mOsm/L pH: 7.0 – 8.5

Mix both compartments before use.

See package insert for dosage information and further instructions. Sterile and free from bacterial endotoxins.

Confirm the integrity of the packaging. Use only if solution is clear. For single use only. DISCARD ANY UN-

USED SOLUTION. Store at +20°C to +25°C (+68°F to +77°F); excursions permitted to +15°C to +30°C (+59°F

to +86°F). [See USP Controlled Room Temperature]. Do not freeze or expose to excessive heat. As soon as the

overwrap is removed, the reconstitution of compartments A and B should be done and the reconstituted solution

should be used immediately. After removal of the overwrap, the solution is stable for 24 hours including the duration

of the treatment. Mix additives BEFORE connecting this bag to the extracorporeal circuit. (See insert for

further information.) This product is not made with natural rubber latex. Carbon dioxide and diluted hydrochloric

acid added for pH adjustment.

5000 mL

EAN-14: 07332414116057

Product # 114906

VANTIVE Logo

Batch No. and expiry date are printed on the back of the bag.

Manufactured for:

Vantive US Healthcare LLC

Deerfield IL 60015 USA

Made in Italy

REPLACEMENT

Solution for Continuous Renal Replacement Therapy

07-25-00-5284

IFU Label

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PRISMASOL and PHOXILLUM safely and effectively.

See full prescribing information for PRISMASOL and PHOXILLUM.



PRISMASOL renal replacement solution PRISMASOL Initial U.S. Approval: 2006



PHOXILLUM renal replacement solution PHOXILLUM Initial U.S. Approval: 2015



-------------INDICATIONS AND USAGE-------------

PRISMASOL and PHOXILLUM solutions are indicated:

• As a replacement solution in Continuous Renal Replacement Therapy (CRRT) and in case of drug poisoning when CRRT is used to remove dialyzable substances (1)



---------DOSAGE AND ADMINISTRATION---------



• Therapy must be individualized based on the patient’s clinical condition, fluid, electrolyte, acid-base and glucose balance (2.2)

• Solution must be mixed prior to use (2.2)

• Use only with extracorporeal dialysis equipment appropriate for CRRT (2.3)

------------- DOSAGE FORMS AND STRENGTHS----------

PRISMASOL and PHOXILLUM are available in multiple combinations of ingredients and in multiple variations of strengths. See full Prescribing Information for detailed descriptions of each formulation. (2, 3, 11)

-------------- CONTRAINDICATIONS-----------------

• Known hypersensitivities to PRISMASOL and PHOXILLUM solutions (4)

--------- WARNINGS AND PRECAUTIONS--------

• Monitor hemodynamic status and fluid inputs and outputs, potassium, phosphorus, other electrolytes and acid-base balance. Abnormalities may be corrected by the use of appropriate formulations and dosage of PRISMASOL and PHOXILLUM solutions (5.1)

• Treatment may affect glucose levels. Monitor blood glucose levels. Antidiabetic therapy adjustment or other corrective measures may be required during treatment (5.2)

To report SUSPECTED ADVERSE REACTIONS, contact Vantive US Healthcare LLC at 1-855-857-0003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Revised: 10/2024

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

  • 2.1 Administration Instructions
  • 2.2 Dosing Considerations
  • 2.3 Preparing the Solution
  • 2.4 Adding Drugs to the Solutions

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

  • 5.1 Electrolyte and Volume Abnormalities
  • 5.2 Blood Glucose Abnormalities

6 ADVERSE REACTIONS

7 DRUG INTERACTIONS

  • 7.1 Citrate

07-19-00-8247

8 USE IN SPECIFIC POPULATIONS

  • 8.1 Pregnancy
  • 8.2 Lactation
  • 8.4 Pediatric Use
  • 8.5 Geriatric Use

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

  • 12.1 Mechanism of Action
  • 12.3 Pharmacokinetics

16 HOW SUPPLIED/STORAGE AND HANDLING

*Sections or subsections omitted from the full prescribing information are not listed.

  • Vantive Logo

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances.

2 DOSAGE AND ADMINISTRATION

2.1 Administration Instructions

Visually inspect PRISMASOL and PHOXILLUM for particulate matter and discoloration prior to administration. Administration should only be under the direction of a physician competent in intensive care treatment including CRRT. Use only with extracorporeal dialysis equipment appropriate for CRRT. The prepared solution is for single patient use only. Aseptic technique should be used throughout administration to the patient. Discard any unused solution.

2.2 Dosing Considerations

PRISMASOL replacement solutions contain 4 different combinations of active ingredients (7 different products with varying ingredient amounts). PHOXILLUM replacement solutions contain 2 different combinations of active ingredients (2 different products with varying ingredient amounts). PRISMASOL and PHOXILLUM are supplied in a two-compartment bag that must be mixed immediately prior to use [see Dosage and Administration (2.3)]:

  • Small compartment A (250 mL) containing an electrolyte solution, and
  • Large compartment B (4750 mL) containing the buffer solution.

See Table 1for the concentrations of the active ingredients (after mixing) in these 9 different replacement solutions (total volume is 5 Liters).



The mode of therapy, solute formulation, flow rates, and length of PRISMASOL and PHOXILLUM replacement therapy in CRRT should be established by a physician based on the patient’s clinical condition, blood concentration of phosphate and other electrolytes, acid-base and glucose balance. Administer either PRISMASOL or PHOXILLUM into the extracorporeal circuit:

  • Before (pre-dilution) the hemofilter or hemodiafilter,
  • After (post-dilution) the hemofilter or hemodiafilter, or
  • Before and after the hemofilter or hemodiafilter.

2.3 Preparing the Solution

Use only if the overwrap is not damaged, all seals are intact, peel seal is not broken, and the solution is clear. The solution may be warmed to 37°C/98.6°F prior to removing the overwrap to enhance patient comfort. However, only dry heat should be used. Solutions should not be heated in water or in a microwave oven. After heating, verify that the solution remains clear and contains no particulate matter.

The solutions are supplied in two different two-compartment bags made of polyolefin with a peel seal separating compartment A and B ( see Figure 1).

Follow the instructions below when connecting the solution bags for correct use of the access ports.

2.4 Adding Drugs to the Solutions

After mixing, additional drugs may be added to the bag via injection connector (spike connector) in large compartment B. In general, administer drugs other than phosphate through a different access line.

When introducing drugs, use aseptic techniques and mix thoroughly prior to connecting the solution bag to the extracorporeal circuit.

Do not use if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals after addition of medication.

Phosphate:Up to 1.2 mmol/L of phosphate can be added to the bag as potassium phosphate or sodium phosphate. The total potassium concentration of PRISMASOL solution should not exceed 4 mEq/L.

Use sodium phosphate to add phosphate if the total potassium concentration in PRISMASOL solution is 4 mEq/L.

PHOXILLUM Solutions:

Phosphate:Phosphate up to 0.2 mmol/L may be added to the solution. Use sodium phosphate if adding phosphate to bag. The total phosphate concentration should not exceed 1.2 mmol/L.

3 DOSAGE FORMS AND STRENGTHS

See Table 1for the concentrations of the active ingredients (after mixing) in these 9 different replacement solutions [see Dosage and Administration (2.2)].

4 CONTRAINDICATIONS

PHOXILLUM and PRISMASOL replacement solutions are contraindicated in patients with known hypersensitivities to these products.

5 WARNINGS AND PRECAUTIONS

5.1 Electrolyte and Volume Abnormalities

PHOXILLUM and PRISMASOL solutions can affect electrolytes and volume and may result in hyperkalemia or hyperphosphatemia. Monitor hemodynamic status and fluid inputs and outputs, potassium, phosphorous, calcium, other electrolytes and acid-base balance throughout the procedure. Abnormalities may be corrected by changing the formulation of replacement solution and/or dialysate, supplementation, or adjusting flow rates appropriately [see Dosage and Administration (2)].

PHOXILLUM replacement solutions contain hydrogen phosphate, a weak acid that may increase the risk of metabolic acidosis.

5.2 Blood Glucose Abnormalities

The use of PRISMASOL and PHOXILLUM replacement solutions can affect blood glucose levels resulting in hypo- or hyper-glycemia depending upon the dextrose content of the replacement solution. Monitor blood glucose levels regularly. Patients may require initiation of or modification of antidiabetic therapy or othercorrective measures during treatment.

6 ADVERSE REACTIONS

The following adverse reactions have been identified during postapproval use with these or other similar products and therefore may occur with use of PHOXILLUM or PRISMASOL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Metabolic acidosis
  • Hypotension
  • Acid-base disorders
  • Electrolyte imbalance including calcium ionized increased (reported in PRISMASOL solutions containing calcium), hyperphosphatemia, and hypophosphatemia
  • Fluid imbalance

7 DRUG INTERACTIONS

As with the use of other replacement solutions, blood concentrations of dialyzable drugs may be reduced by CRRT due to their removal by the hemofilter or hemodiafilter. The blood concentrations of certain drugs may need to be monitored and appropriate therapy implemented to correct for removal during treatment.

7.1 Citrate

When used as an anticoagulant, citrate contributes to the overall buffer load and can reduce plasma calcium levels. Select the PRISMASOL/PHOXILLUM formulation(s) accordingly.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

PRISMASOL and PHOXILLUM are pharmacologically inactive solutions. While there are no adequate and well controlled studies in pregnant women, appropriate administration of PRISMASOL and PHOXILLUM solutions with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to cause fetal harm. Animal reproduction studies have not been conducted with PRISMASOL and PHOXILLUM solutions.

The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations

Maintenance of normal acid-base balance is important for fetal well-being.

8.2 Lactation

Risk Summary

The components of PRISMASOL and PHOXILLUM solutions are excreted in human milk. Appropriate administration of PRISMASOL and PHOXILLUM solutions with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to harm a nursing infant.

8.4 Pediatric Use

Safety and effectiveness have been established based on published clinical data of CRRT replacement solutions with compositions similar to PRISMASOL and PHOXILLUM used in adults and two hemofiltration studies in pediatric patients, including a study of newborns to 17 years old.

8.5 Geriatric Use

The experience with PRISMASOL and PHOXILLUM solutions in geriatric patients has not identified novel concerns.

11 DESCRIPTION

PRISMASOL and PHOXILLUM solutions are clear, sterile, free of bacterial endotoxins and contain no bacteriostatic or antimicrobial agents. These solutions are used in Continuous Renal Replacement Therapies (CRRT) as a replacement solution in hemofiltration and hemodiafiltration. Depending on the product (see Table 2), the two compartments contain:

Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 2• 2H 2O).

Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 2• 6H 2O).

Sodium chloride, USP, is chemically designated NaCl.

Potassium chloride, USP, is chemically designated KCl.

Sodium bicarbonate, USP, is chemically designated NaHCO 3.

Dextrose, USP, is chemically designated D-Glucose anhydrous (C 6H 12O 6) or D-Glucose monohydrate (C 6H 12O6 • H 2O).

Lactic acid, USP, is chemically designated CH 3CH(OH)COOH.

Dibasic sodium phosphate, USP, is chemically designated as disodium hydrogen phosphate, dihydrate (Na 2HPO 4• 2H 2O)

The pH of the final solution is in the range of 7.0 to 8.5.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

PRISMASOL and PHOXILLUM solutions are pharmacologically inactive. The electrolyte concentrations in the solutions are chosen to restore plasma levels to clinically desired concentrations or maintain plasma levels at the desired concentrations.

PRISMASOL and PHOXILLUM solutions are used as replacement solution to replace water and electrolytes removed during hemofiltration and hemodiafiltration. Bicarbonate (or precursor lactate) in the solution is used as an alkalinizing buffer to restore acid-base balance to a clinically desirable level.

12.3 Pharmacokinetics

The distribution of electrolytes, bicarbonate, and dextrose is determined by the patient’s clinical condition, metabolic status, and residual renal function. The elimination and replacement of water, electrolytes and buffer depend on the patient’s electrolyte and acid-base balance, metabolic status, residual renal function and ongoing physiologic losses through intestinal, respiratory and cutaneous routes.

16 HOW SUPPLIED/STORAGE AND HANDLING

PRISMASOL and PHOXILLUM solutions are supplied in a two-compartment bag made of polyolefin. The 5000 mL bag is composed of a small compartment (250 mL) and a large compartment (4750 mL). The two compartments are separated by a peel seal.

The bag is overwrapped with a transparent overwrap. See Table 2for the concentrations of the active ingredients in each compartment for each product [see Description (11)].

Container

Fill Volume

NDC

PRISMASOL Solutions

PRISMASOL BGK0/2.5

5000 mL

24571-108-06

PRISMASOL BGK4/2.5

5000 mL

24571-105-06

PRISMASOL BGK2/3.5

5000 mL

24571-103-06

PRISMASOL BGK2/0

5000 mL

24571-102-06

PRISMASOL B22GK4/0

5000 mL

24571-111-06

PRISMASOL BK0/0/1.2

5000 mL

24571-113-06

PRISMASOL BGK4/0/1.2

5000 mL

24571-114-06

PHOXILLUM Solutions

PHOXILLUM BK4/2.5

5000 mL

24571-116-06

PHOXILLUM B22K4/0

5000 mL

24571-117-06

Not all formulations may be marketed.

Storage conditions

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). [See USP

Controlled Room Temperature]

Do not freeze or expose to excessive heat. Do not use if precipitate has formed or if container seals have

been damaged.

Manufactured for:

Vantive US Healthcare LLC

One Baxter Parkway

Deerfield, Illinois 60015

07-19-00-6103

3 Dosage Forms and Strengths

See Table 1for the concentrations of the active ingredients (after mixing) in these 9 different replacement solutions [see Dosage and Administration (2.2)] .

2.1 Administration Instructions

Visually inspect PRISMASOL and PHOXILLUM for particulate matter and discoloration prior to administration.

Administration should only be under the direction of a physician competent in intensive care treatment including CRRT. Use only with extracorporeal dialysis equipment appropriate for CRRT.

The prepared solution is for single patient use only.

Aseptic technique should be used throughout administration to the patient.

Discard any unused solution.

5.2 Blood Glucose Abnormalities

The use of PRISMASOL and PHOXILLUM replacement solutions can affect blood glucose levels resulting in hypo- or hyper-glycemia depending upon the dextrose content of the replacement solution. Monitor blood glucose levels regularly. Patients may require initiation of or modification of antidiabetic therapy or other corrective measures during treatment.

2.4 Adding Drugs to the Solutions

After mixing, additional drugs may be added to the bag via injection connector (spike connector) in large compartment B. In general, administer drugs other than phosphate through a different access line.

When introducing drugs, use aseptic techniques and mix thoroughly prior to connecting the solution bag to the extracorporeal circuit.

Do not use if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals after addition of medication.

Phosphate: Up to 1.2 mmol/L of phosphate can be added to the bag as potassium phosphate or sodium phosphate. The total potassium concentration of PRISMASOL solution should not exceed 4 mEq/L. Use sodium phosphate to add phosphate if the total potassium concentration in PRISMASOL solution is 4 mEq/L.

16 How Supplied/storage and Handling

PRISMASOL and PHOXILLUM solutions are supplied in a two-compartment bag made of polyolefin. The 5000 mL bag is composed of a small compartment (250 mL) and a large compartment (4750 mL). The two compartments are separated by a peel seal.

The bag is overwrapped with a transparent overwrap. See Table 2for the concentrations of the active ingredients in each compartment for each product [see Description (11)].

Container

Fill Volume

NDC

PRISMASOL Solutions

PRISMASOL BGK0/2.5

5000 mL

24571-108-06

PRISMASOL BGK4/2.5

5000 mL

24571-105-06

PRISMASOL BGK2/3.5

5000 mL

24571-103-06

PRISMASOL BGK2/0

5000 mL

24571-102-06

PRISMASOL B22GK4/0

5000 mL

24571-111-06

PRISMASOL BK0/0/1.2

5000 mL

24571-113-06

PRISMASOL BGK4/0/1.2

5000 mL

24571-114-06

PHOXILLUM Solutions

PHOXILLUM BK4/2.5

5000 mL

24571-116-06

PHOXILLUM B22K4/0

5000 mL

24571-117-06

Not all formulations may be marketed.

5.1 Electrolyte and Volume Abnormalities

PHOXILLUM and PRISMASOL solutions can affect electrolytes and volume and may result in hyperkalemia or hyperphosphatemia. Monitor hemodynamic status and fluid inputs and outputs, potassium, phosphorous, calcium, other electrolytes and acid-base balance throughout the procedure. Abnormalities may be corrected by changing the formulation of replacement solution and/or dialysate, supplementation, or adjusting flow rates appropriately [ see Dosage and Administration (2) ].

PHOXILLUM replacement solutions contain hydrogen phosphate, a weak acid that may increase the risk of metabolic acidosis.

Structured Label Content

Section 42229-5 (42229-5)

Instructions for preparing solutions supplied in a two-compartment, polyolefin bag with a peel seal:

Section 44425-7 (44425-7)

Storage conditions

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). [See USP Controlled Room Temperature]

Do not freeze or expose to excessive heat. Do not use if precipitate has formed or if container seals have been damaged.

Manufactured for:

Vantive US Healthcare LLC

One Baxter Parkway

Deerfield, Illinois 60015

07-19-00-8247

Vantive, Phoxillum and PrismaSol are trademarks of Vantive Health Inc., or its subsidiaries

7.1 Citrate

When used as an anticoagulant, citrate contributes to the overall buffer load and can reduce plasma calcium levels. Select the PRISMASOL/PHOXILLUM formulation(s) accordingly.

Risk Summary

PRISMASOL and PHOXILLUM are pharmacologically inactive solutions. While there are no adequate and well controlled studies in pregnant women, appropriate administration of PRISMASOL and PHOXILLUM solutions with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to cause fetal harm. Animal reproduction studies have not been conducted with PRISMASOL and PHOXILLUM solutions.

The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

11 Description (11 DESCRIPTION)

PRISMASOL and PHOXILLUM solutions are clear, sterile, free of bacterial endotoxins and contain no bacteriostatic or antimicrobial agents. These solutions are used in Continuous Renal Replacement Therapies (CRRT) as a replacement solution in hemofiltration and hemodiafiltration. Depending on the product (see Table 2), the two compartments contain:

Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 2• 2H 2O).

Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 2• 6H 2O).

Sodium chloride, USP, is chemically designated NaCl.

Potassium chloride, USP, is chemically designated KCl.

Sodium bicarbonate, USP, is chemically designated NaHCO 3.

Dextrose, USP, is chemically designated D-Glucose anhydrous (C 6H 12O 6) or D-Glucose monohydrate (C 6H 12O 6• H 2O).

Lactic acid, USP, is chemically designated CH 3CH(OH)COOH.

Dibasic sodium phosphate, USP, is chemically designated as disodium hydrogen phosphate, dihydrate (Na 2HPO 4• 2H 2O)

Table 2 - Compartment Composition (Before Mixing)
Compartment A (g/L) Compartment B (g/L)
Calcium Chloride ∙ 2H 2O Magnesium Chloride ∙ 6H 2O Dextrose anhydrous (as monohydrate) Lactic Acid Sodium Chloride Sodium bicarbonate Potassium Chloride Sodium Phosphate ∙ 2H 2O

PRISMASOL SOLUTIONS

BGK 0/2.5

3.68

3.05

20 (22)

5.40

6.46

3.09

0

0

BGK 4/2.5

3.68

3.05

20 (22)

5.40

6.46

3.09

0.314

0

BGK 2/3.5

5.15

2.03

20 (22)

5.40

6.46

3.09

0.157

0

BGK 2/0

0

2.03

20 (22)

5.40

6.46

3.09

0.157

0

B22GK 4/0

0

3.05

20 (22)

5.40

7.07

2.21

0.314

0

BK 0/0/1.2

0

2.44

0 (0)

5.40

6.46

3.09

0

0

BGK 4/0/1.2

0

2.44

20 (22)

5.40

6.46

3.09

0.314

0

PHOXILLUM SOLUTIONS

BK 4/2.5

3.68

3.05

0 (0)

0

6.34

3.09

0.314

0.187

B22K 4/0

0

3.05

0 (0)

0

6.95

2.21

0.314

0.187

The pH of the final solution is in the range of 7.0 to 8.5.

8.4 Pediatric Use

Safety and effectiveness have been established based on published clinical data of CRRT replacement solutions with compositions similar to PRISMASOL and PHOXILLUM used in adults and two hemofiltration studies in pediatric patients, including a study of newborns to 17 years old.

8.5 Geriatric Use

The experience with PRISMASOL and PHOXILLUM solutions in geriatric patients has not identified novel concerns.

4 Contraindications (4 CONTRAINDICATIONS)

PHOXILLUM and PRISMASOL replacement solutions are contraindicated in patients with known hypersensitivities to these products.

6 Adverse Reactions (6 ADVERSE REACTIONS)

The following adverse reactions have been identified during postapproval use with these or other similar products and therefore may occur with use of PHOXILLUM or PRISMASOL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Metabolic acidosis
  • Hypotension
  • Acid-base disorders
  • Electrolyte imbalance including calcium ionized increased (reported in PRISMASOL solutions containing calcium), hyperphosphatemia, and hypophosphatemia
  • Fluid imbalance
7 Drug Interactions (7 DRUG INTERACTIONS)

As with the use of other replacement solutions, blood concentrations of dialyzable drugs may be reduced by CRRT due to their removal by the hemofilter or hemodiafilter. The blood concentrations of certain drugs may need to be monitored and appropriate therapy implemented to correct for removal during treatment.

12.3 Pharmacokinetics

The distribution of electrolytes, bicarbonate, and dextrose is determined by the patient's clinical condition, metabolic status, and residual renal function.

The elimination and replacement of water, electrolytes and buffer depend on the patient's electrolyte and acid-base balance, metabolic status, residual renal function and ongoing physiologic losses through intestinal, respiratory and cutaneous routes.

1 Indications and Usage (1 INDICATIONS AND USAGE)

PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances.

Clinical Considerations

Maintenance of normal acid-base balance is important for fetal well-being.

12.1 Mechanism of Action

PRISMASOL and PHOXILLUM solutions are pharmacologically inactive. The electrolyte concentrations in the solutions are chosen to restore plasma levels to clinically desired concentrations or maintain plasma levels at the desired concentrations.

PRISMASOL and PHOXILLUM solutions are used as replacement solution to replace water and electrolytes removed during hemofiltration and hemodiafiltration. Bicarbonate (or precursor lactate) in the solution is used as an alkalinizing buffer to restore acid-base balance to a clinically desirable level.

2.2 Dosing Considerations

PRISMASOL replacement solutions contain 4 different combinations of active ingredients (7 different products with varying ingredient amounts). PHOXILLUM replacement solutions contain 2 different combinations of active ingredients (2 different products with varying ingredient amounts). PRISMASOL and PHOXILLUM are supplied in a two-compartment bag that must be mixed immediately prior to use [see Dosage and Administration (2.3)]:

  • Small compartment A (250 mL) containing an electrolyte solution, and
  • Large compartment B (4750 mL) containing the buffer solution.

See Table 1for the concentrations of the active ingredients (after mixing) in these 9 different replacement solutions (total volume is 5 Liters).

Table 1: Concentrations of Active Ingredients in the 7 PRISMASOL and 2 PHOXILLUM Replacement Solutions after Mixing
Ca 2+

mEq/L 		HCO 3 -

mEq/L 		K +

mEq/L 		Mg 2+

mEq/L 		Na +

mEq/L 		HPO 4 2-

mmol/L 		Cl -

mEq/L 		Lactate

mEq/L 		Dextrose

mg/dL 		Osmolarity

mOsm/L
Ca 2+= calcium, HCO 3 -= bicarbonate, K += potassium, Mg 2+= magnesium, Na += sodium, HPO 4 2-= phosphate, Cl- = chloride; osmolarity is estimated

PRISMASOL Replacement Solutions

BGK0/2.5

2.5

32

0

1.5

140

0

109

3

100

292

BGK4/2.5

2.5

32

4

1.5

140

0

113

3

100

300

BGK2/3.5

3.5

32

2

1

140

0

111.5

3

100

296

BGK2/0

0

32

2

1

140

0

108

3

100

291

B22GK4/0

0

22

4

1.5

140

0

120.5

3

100

296

BGK4/0/1.2

0

32

4

1.2

140

0

110.2

3

100

295

BK0/0/1.2

0

32

0

1.2

140

0

106.2

3

0

282

PHOXILLUM Replacement Solutions

BK4/2.5

2.5

32

4

1.5

140

1

114.5

0

0

294

B22K4/0

0

22

4

1.5

140

1

122

0

0

290

The mode of therapy, solute formulation, flow rates, and length of PRISMASOL and PHOXILLUM replacement therapy in CRRT should be established by a physician based on the patient’s clinical condition, blood concentration of phosphate and other electrolytes, acid-base and glucose balance. Administer either PRISMASOL or PHOXILLUM into the extracorporeal circuit:

  • Before (pre-dilution) the hemofilter or hemodiafilter,
  • After (post-dilution) the hemofilter or hemodiafilter, or
  • Before and after the hemofilter or hemodiafilter.
2.3 Preparing the Solution

Use only if the overwrap is not damaged, all seals are intact, peel seal is not broken, and the solution is clear.

The solution may be warmed to 37°C/98.6°F prior to removing the overwrap to enhance patient comfort. However, only dry heat should be used. Solutions should not be heated in water or in a microwave oven. After heating, verify that the solution remains clear and contains no particulate matter.

The solutions are supplied in two different two-compartment bags made of polyolefin with a peel seal separating compartment A and B (see Figure 1).

Follow the instructions below when connecting the solution bags for correct use of the access ports.

5 Warnings and Precautions (5 WARNINGS AND PRECAUTIONS)
  • Monitor hemodynamic status and fluid inputs and outputs, potassium, phosphorus, other electrolytes and acid-base balance. Abnormalities may be corrected by the use of appropriate formulations and dosage of PRISMASOL and PHOXILLUM solutions ( 5.1)
  • Treatment may affect glucose levels. Monitor blood glucose levels.
  • Antidiabetic therapy adjustment or other corrective measures may be required during treatment ( 5.2)

To report SUSPECTED ADVERSE REACTIONS, contact Vantive US Healthcare LLC at 1855-857-0003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

2 Dosage and Administration (2 DOSAGE AND ADMINISTRATION)
  • Therapy must be individualized based on the patient's clinical condition, fluid, electrolyte, acid-base and glucose balance ( 2.2)
  • Solution must be mixed prior to use ( 2.2)
  • Use only with extracorporeal dialysis equipment appropriate for CRRT ( 2.3)
Package/label Display Panel (Package/Label Display Panel)

Mixing steps

① SQUEEZE TOPcorners to break seal

②Squeeze BAG SIDESto fully open seal

Barcode

NDC# 24571-108-06

OK +

mEq/L

2.5 Ca 2+

mEq/L

PrismaSol BGK0/2.5

Rx only

Barcode

Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution each 1000 mL contains (g)

A

B

Calcium chloride • 2H 2O

3.68

Magnesium chloride • 6H 2O

3.05

Dextrose anhydrous

20.0

(as dextrose monohydrate)

22.0

Sodium chloride

6.46

Lactic acid

5.40

Sodium bicarbonate

3.09

Water for injections q.s, Carbon dioxide for pH adjustment



A

250 mL

B

4750 mL

After reconstitution, A + B

Calcium

Ca 2+

Magnesium

Mg 2+

Sodium

Na +

Chloride

Cl -

Lactate

C 3H 5O 3 -

Bicarbonate

HCO 3 -

Potassium

K +

Dextrose

mmol/L

1.25

0.75

140

109.0

3.0

32

0

5.5

mEq/L

2.5

1.5

140

109.0

3.0

32

0

(100 mg/dL)

  • Theoretical osmolarity: 292 mOsm/L pH: 7.0 – 8.5

Mix both compartments before use.

See package insert for dosage information and

further instructions.

Sterile and free from bacterial endotoxins.

Confirm the integrity of the packaging. Use only if

solution is clear. For single use only.

DISCARD ANY UNUSED SOLUTION.

Store at +20°C to +25°C (+68°F to +77°F); excursions

permitted to +15°C to +30°C (+59°F to

+86°F). [See USP Controlled room Temperature.]

Do not freeze or expose to excessive heat.

As soon as the overwrap is removed, the reconstitution

of compartments A and B should be done

and the reconstituted solution should be used immediately.

After removal of the overwrap, the solution

is stable for 24 hours including the duration of

the treatment. Mix additives BEFORE connecting

this bag to the extracorporeal circuit. (See insert

for further information.) This product is not made

with natural rubber latex.

5000 mL

EAN-14: 07332414091613

Product # 110240

VANTIVE Logo

Batch No. and expiry date are printed on the back of the bag.

Manufactured for:

Vantive US Healthcare LLC

Deerfield IL 60015 USA

Made in Italy

REPLACEMENT

Solution for Continuous Renal Replacement Therapy

07-25-00-5278

Mixing steps

① SQUEEZE TOPcorners to break seal

②Squeeze BAG SIDESto fully open seal

Barcode

NDC# 24571-105-06

4K +

mEq/L

2.5 Ca 2+

mEq/L

PrismaSol BGK4/2.5

Rx only

Barcode

Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution each 1000 mL contains (g)

A

B

Calcium chloride • 2H 2O

3.68

Magnesium chloride • 6H 2O

3.05

Dextrose anhydrous

20.0

(as dextrose monohydrate)

22.0

Sodium chloride

6.46

Potassium chloride

0.314

Lactic acid

5.40

Sodium bicarbonate

3.09

Water for injections q.s, Carbon dioxide for pH adjustment



A

250 mL

B

4750 mL

After reconstitution, A + B

Calcium

Ca 2+

Magnesium

Mg 2+

Sodium

Na +

Chloride

Cl -

Lactate

C 3H 5O 3 -

Bicarbonate

HCO 3 -

Potassium

K +

Dextrose

mmol/L

1.25

0.75

140

113.0

3.0

32

4.0

5.5

mEq/L

2.5

1.5

140

113.0

3.0

32

4.0

(100 mg/dL)

  • Theoretical osmolarity: 300 mOsm/L pH: 7.0 – 8.5

Mix both compartments before use.

See package insert for dosage information and

further instructions.

Sterile and free from bacterial endotoxins.

Confirm the integrity of the packaging. Use only if

solution is clear. For single use only.

DISCARD ANY UNUSED SOLUTION.

Store at +20°C to +25°C (+68°F to +77°F); excursions

permitted to +15°C to +30°C (+59°F to

+86°F). [See USP Controlled room Temperature.]

Do not freeze or expose to excessive heat.

As soon as the overwrap is removed, the reconstitution

of compartments A and B should be done

and the reconstituted solution should be used immediately.

After removal of the overwrap, the solution

is stable for 24 hours including the duration of

the treatment. Mix additives BEFORE connecting

this bag to the extracorporeal circuit. (See insert

for further information.) This product is not made

with natural rubber latex.

5000 mL

EAN-14: 07332414091637

Product # 110242

VANTIVE Logo

Batch No. and expiry date are printed on the back of the bag.

Manufactured for:

Vantive US Healthcare LLC

Deerfield IL 60015 USA

Made in Italy

REPLACEMENT

Solution for Continuous Renal Replacement Therapy

07-25-00-5280

Mixing steps

① SQUEEZE TOPcorners to break seal

②Squeeze BAG SIDESto fully open seal

Barcode

NDC# 24571-103-06

2K +

mEq/L

3.5 Ca 2+

mEq/L

PrismaSol BGK2/3.5

Rx only

Barcode

Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution each 1000 mL contains (g)

A

B

Calcium chloride • 2H 2O

5.15

Magnesium chloride • 6H 2O

2.03

Dextrose anhydrous

20.0

(as dextrose monohydrate)

22.0

Sodium chloride

6.46

Potassium chloride

0.157

Lactic acid

5.40

Sodium bicarbonate

3.09

Water for injections q.s, Carbon dioxide for pH adjustment

Rx only

A

250 mL

B

4750 mL

After reconstitution, A + B

Calcium

Ca 2+

Magnesium

Mg 2+

Sodium

Na +

Chloride

Cl -

Lactate

C 3H 5O 3 -

Bicarbonate

HCO 3 -

Potassium

K +

Dextrose

mmol/L

1.75

0.5

140

111.5

3.0

32

2.0

5.5

mEq/L

3.5

1.0

140

111.5

3.0

32

2.0

(100 mg/dL)

  • Theoretical osmolarity: 296 mOsm/L pH: 7.0 – 8.5

Mix both compartments before use.

See package insert for dosage information and

further instructions.

Sterile and free from bacterial endotoxins.

Confirm the integrity of the packaging. Use only if

solution is clear. For single use only.

DISCARD ANY UNUSED SOLUTION.

Store at +20°C to +25°C (+68°F to +77°F); excursions

permitted to +15°C to +30°C (+59°F to

+86°F). [See USP Controlled room Temperature.]

Do not freeze or expose to excessive heat.

As soon as the overwrap is removed, the reconstitution

of compartments A and B should be done

and the reconstituted solution should be used immediately.

After removal of the overwrap, the solution

is stable for 24 hours including the duration of

the treatment. Mix additives BEFORE connecting

this bag to the extracorporeal circuit. (See insert

for further information.) This product is not made

with natural rubber latex.

5000 mL

EAN-14: 07332414091644

Product # 110243

VANTIVE Logo

Batch No. and expiry date are printed on the back of the bag.

Manufactured for:

Vantive US Healthcare LLC

Deerfield IL 60015 USA

Made in Italy

REPLACEMENT

Solution for Continuous Renal Replacement Therapy

07-25-00-5281

Mixing steps

① SQUEEZE TOPcorners to break seal

②Squeeze BAG SIDESto fully open seal

Barcode

NDC# 24571-102-06

2K +

mEq/L

0Ca 2+

mEq/L

PrismaSol BGK2/0

Rx only

Barcode

Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution each 1000 mL contains (g)

A

B

Magnesium chloride • 6H 2O

2.03

Dextrose anhydrous

20.0

(as dextrose monohydrate)

22.0

Sodium chloride

6.46

Potassium chloride

0.157

Lactic acid

5.40

Sodium bicarbonate

3.09

Water for injections q.s, Carbon dioxide for pH adjustment



A

250 mL

B

4750 mL

After reconstitution, A + B

Calcium

Ca 2+

Magnesium

Mg 2+

Sodium

Na +

Chloride

Cl -

Lactate

C 3H 5O 3 -

Bicarbonate

HCO 3 -

Potassium

K +

Dextrose

mmol/L

0

0.5

140

108.0

3.0

32

2.0

5.5

mEq/L

0

1.0

140

108.0

3.0

32

2.0

(100 mg/dL)
  • Theoretical osmolarity: 291 mOsm/L pH: 7.0 – 8.5

Mix both compartments before use.

See package insert for dosage information and

further instructions.

Sterile and free from bacterial endotoxins.

Confirm the integrity of the packaging. Use only if

solution is clear. For single use only.

DISCARD ANY UNUSED SOLUTION.

Store at +20°C to +25°C (+68°F to +77°F); excursions

permitted to +15°C to +30°C (+59°F to

+86°F). [See USP Controlled room Temperature.]

Do not freeze or expose to excessive heat.

As soon as the overwrap is removed, the reconstitution

of compartments A and B should be done

and the reconstituted solution should be used immediately.

After removal of the overwrap, the solution

is stable for 24 hours including the duration of

the treatment. Mix additives BEFORE connecting

this bag to the extracorporeal circuit. (See insert

for further information.) This product is not made

with natural rubber latex.

5000 mL

EAN-14: 07332414091651

Product # 110244

VANTIVE Logo

Batch No. and expiry date are printed on the back of the bag.

Manufactured for:

Vantive US Healthcare LLC

Deerfield IL 60015 USA

Made in Italy

REPLACEMENT

Solution for Continuous Renal Replacement Therapy

07-25-00-5282

Mixing steps

① SQUEEZE TOPcorners to break seal

②Squeeze BAG SIDESto fully open seal

Barcode

NDC# 24571-111-06

4K +

mEq/L

Bicarbonate 22

0Ca 2+

mEq/L

PrismaSol B22GK4/0

Rx only

Barcode

Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution each 1000 mL contains (g)

A

B

Magnesium chloride • 6H 2O

3.05

Dextrose anhydrous

20.0

(as dextrose monohydrate)

22.0

Sodium chloride

7.07

Potassium chloride

0.314

Lactic acid

5.40

Sodium bicarbonate

2.21

Water for injections q.s, Carbon dioxide for pH adjustment



A

250 mL

B

4750 mL

After reconstitution, A + B

Calcium

Ca 2+

Magnesium

Mg 2+

Sodium

Na +

Chloride

Cl -

Lactate

C 3H 5O 3 -

Bicarbonate

HCO 3 -

Potassium

K +

Dextrose

mmol/L

0

0.75

140

120.5

3.0

22

4.0

5.5

mEq/L

0

1.5

140

120.5

3.0

22

4.0

(100 mg/dL)

  • Theoretical osmolarity: 296 mOsm/L pH: 7.0 – 8.5

Mix both compartments before use.

See package insert for dosage information and

further instructions.

Sterile and free from bacterial endotoxins.

Confirm the integrity of the packaging. Use only if

solution is clear. For single use only.

DISCARD ANY UNUSED SOLUTION.

Store at +20°C to +25°C (+68°F to +77°F); excursions

permitted to +15°C to +30°C (+59°F to

+86°F). [See USP Controlled room Temperature.]

Do not freeze or expose to excessive heat.

As soon as the overwrap is removed, the reconstitution

of compartments A and B should be done

and the reconstituted solution should be used immediately.

After removal of the overwrap, the solution

is stable for 24 hours including the duration of

the treatment. Mix additives BEFORE connecting

this bag to the extracorporeal circuit. (See insert

for further information.) This product is not made

with natural rubber latex.

5000 mL

EAN-14: 07332414116781

Product # 115001

VANTIVE Logo

Batch No. and expiry date are printed on the back of the bag.

Manufactured for:

Vantive US Healthcare LLC

Deerfield IL 60015 USA

Made in Italy

REPLACEMENT

Solution for Continuous Renal Replacement Therapy

07-25-00-5285

Mixing steps

① SQUEEZE TOPcorners to break seal

②Squeeze BAG SIDESto fully open seal

Barcode

NDC# 24571-113-06

0K +

mEq/L

0Ca 2+

mEq/L

PrismaSol BK0/0/1.2

Rx only

Barcode

Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution each 1000 mL contains (g)

A

B

Magnesium chloride • 6H 2O

2.44

Sodium chloride

6.46

Lactic acid

5.40

Sodium bicarbonate

3.09

Water for injections q.s, Carbon dioxide for pH adjustment



A

250 mL

B

4750 mL

After reconstitution, A + B

Calcium

Ca 2+

Magnesium

Mg 2+

Sodium

Na +

Chloride

Cl -

Lactate

C 3H 5O 3 -

Bicarbonate

HCO 3 -

Potassium

K +

Dextrose

mmol/L

0

0.6

140

106.2

3.0

32

0

0

mEq/L

0

1.2

140

106.2

3.0

32

0

(0 mg/dL)

  • Theoretical osmolarity: 282 mOsm/L pH: 7.0 – 8.5

Mix both compartments before use.

See package insert for dosage information and

further instructions.

Sterile and free from bacterial endotoxins.

Confirm the integrity of the packaging. Use only if

solution is clear. For single use only.

DISCARD ANY UNUSED SOLUTION.

Store at +20°C to +25°C (+68°F to +77°F); excursions

permitted to +15°C to +30°C (+59°F to

+86°F). [See USP Controlled room Temperature.]

Do not freeze or expose to excessive heat.

As soon as the overwrap is removed, the reconstitution

of compartments A and B should be done

and the reconstituted solution should be used immediately.

After removal of the overwrap, the solution

is stable for 24 hours including the duration of

the treatment. Mix additives BEFORE connecting

this bag to the extracorporeal circuit. (See insert

for further information.) This product is not made

with natural rubber latex.

5000 mL

EAN-14: 07332414091309

Product # 110239

VANTIVE Logo

Batch No. and expiry date are printed on the back of the bag.

Manufactured for:

Vantive US Healthcare LLC

Deerfield IL 60015 USA

Made in Italy

REPLACEMENT

Solution for Continuous Renal Replacement Therapy

07-25-00-5277

Mixing steps

① SQUEEZE TOPcorners to break seal

②Squeeze BAG SIDESto fully open seal

Barcode

NDC# 24571-114-06

4K +

mEq/L

0Ca 2+

mEq/L

PrismaSol BGK4/0/1.2

Rx only

Barcode

Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution each 1000 mL contains (g)

A

B

Magnesium chloride • 6H 2O

2.44

Dextrose anhydrous

20.0

(as dextrose monohydrate)

22.0

Sodium chloride

6.46

Potassium chloride

0.314

Lactic acid

5.40

Sodium bicarbonate

3.09

Water for injections q.s, Carbon dioxide for pH adjustment



A

250 mL

B

4750 mL

After reconstitution, A + B

Calcium

Ca 2+

Magnesium

Mg 2+

Sodium

Na +

Chloride

Cl -

Lactate

C 3H 5O 3 -

Bicarbonate

HCO 3 -

Potassium

K +

Dextrose

mmol/L

0

0.6

140

110.2

3.0

32

4.0

5.5

mEq/L

0

1.2

140

110.2

3.0

32

4.0

(100 mg/dL)

  • Theoretical osmolarity: 295 mOsm/L pH: 7.0 – 8.5

Mix both compartments before use.

See package insert for dosage information and

further instructions.

Sterile and free from bacterial endotoxins.

Confirm the integrity of the packaging. Use only if

solution is clear. For single use only.

DISCARD ANY UNUSED SOLUTION.

Store at +20°C to +25°C (+68°F to +77°F); excursions

permitted to +15°C to +30°C (+59°F to

+86°F). [See USP Controlled room Temperature.]

Do not freeze or expose to excessive heat.

As soon as the overwrap is removed, the reconstitution

of compartments A and B should be done

and the reconstituted solution should be used immediately.

After removal of the overwrap, the solution

is stable for 24 hours including the duration of

the treatment. Mix additives BEFORE connecting

this bag to the extracorporeal circuit. (See insert

for further information.) This product is not made

with natural rubber latex.

5000 mL

EAN-14: 07332414091620

Product # 110241

VANTIVE Logo

Batch No. and expiry date are printed on the back of the bag.

Manufactured for:

Vantive US Healthcare LLC

Deerfield IL 60015 USA

Made in Italy

REPLACEMENT

Solution for Continuous Renal Replacement Therapy

07-25-00-5279

Mixing steps

① SQUEEZE TOPcorners to break seal

②Squeeze BAG SIDESto fully open seal

Compartment B

Barcode

NDC# 24571-116-06

4K +

mEq/L

1 Phosphate

mmol/L

2.5 Ca 2+

mEq/L

Phoxillum BK4/2.5

Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution, each 1000 mL contains (g):

A

B

Calcium chloride • 2H 2O

3.68

Magnesium chloride • 6H 2O

3.05

Sodium chloride

6.34

Potassium chloride

0.314

Sodium bicarbonate

3.09

Dibasic sodium phosphate • 2H 2O

0.187

Water for injections q.s

Rx only

A

250 mL

B

4750 mL

After reconstitution, A + B

Calcium

Ca 2+

Magnesium

Mg 2+

Sodium

Na +

Chloride

Cl -

Bicarbonate

HCO 3 -

Potassium

K +

Phosphate

HPO 4 2-

Dextrose

mmol/L

1.25

0.75

140

114.5

32

4.0

1

0

mEq/L

2.5

1.5

140

114.5

32

4.0

(1 mmol/L)

(0 mg/dL)
  • Theoretical osmolarity: 294 mOsm/L pH: 7.0 – 8.5

Mix both compartments before use.

See package insert for dosage information and further instructions. Sterile and free from bacterial endotoxins.

Confirm the integrity of the packaging. Use only if solution is clear. For single use only. DISCARD ANY UN-

USED SOLUTION. Store at +20ºC to +25ºC (+68ºF to +77ºF); excursions permitted to +15ºC - +30ºC (+59ºF

to +86ºF). [See USP Controlled Room Temperature]. Do not freeze or expose to excessive heat. As soon as the

overwrap is removed, the reconstitution of compartments A and B should be done and the reconstituted

solution should be used immediately. After removal of the overwrap, the solution is stable for 24 hours including the duration of the treatment. Mix additives BEFORE connecting this bag to the extracorporeal circuit. (See insert for

further information.) This product is not made with natural rubber latex. Carbon dioxide and diluted hydrochloric

acid added for pH adjustment.

5000 mL

EAN-14: 07332414116040

Product # 114905

VANTIVE Logo

Batch No. and expiry date are printed on the back of the bag.

Manufactured for:

Vantive US Healthcare LLC

Deerfield IL 60015 USA

Made in Italy

REPLACEMENT

Solution for Continuous Renal Replacement Therapy

07-25-00-5283

Mixing steps

① SQUEEZE TOPcorners to break seal

②Squeeze BAG SIDESto fully open seal

Compartment B

Barcode

NDC# 24571-117-06

4K +

mEq/L

0 Ca 2+

mEq/L

22 Bicarbonate

mEq/L

1 Phosphate

mmol/L

Phoxillum B22K4/0

Replacement Solution for Continuous Renal Replacement Therapy

Before reconstitution, each 1000 mL contains (g):

A

B

Magnesium chloride • 6H 2O

3.05

Sodium chloride

6.95

Potassium chloride

0.314

Sodium bicarbonate

2.21

Dibasic sodium phosphate • 2H 2O

0.187

Water for injections q.s

Rx only

A

250 mL

B

4750 mL

After reconstitution, A + B

Calcium

Ca 2+

Magnesium

Mg 2+

Sodium

Na +

Chloride

Cl -

Bicarbonate

HCO 3 -

Potassium

K +

Phosphate

HPO 4 2-

Dextrose

mmol/L

0

0.75

140

122.0

22

4.0

1

0

mEq/L

0

1.5

140

122.0

22

4.0

(1 mmol/L)

(0 mg/dL)
  • Theoretical osmolarity: 290 mOsm/L pH: 7.0 – 8.5

Mix both compartments before use.

See package insert for dosage information and further instructions. Sterile and free from bacterial endotoxins.

Confirm the integrity of the packaging. Use only if solution is clear. For single use only. DISCARD ANY UN-

USED SOLUTION. Store at +20°C to +25°C (+68°F to +77°F); excursions permitted to +15°C to +30°C (+59°F

to +86°F). [See USP Controlled Room Temperature]. Do not freeze or expose to excessive heat. As soon as the

overwrap is removed, the reconstitution of compartments A and B should be done and the reconstituted solution

should be used immediately. After removal of the overwrap, the solution is stable for 24 hours including the duration

of the treatment. Mix additives BEFORE connecting this bag to the extracorporeal circuit. (See insert for

further information.) This product is not made with natural rubber latex. Carbon dioxide and diluted hydrochloric

acid added for pH adjustment.

5000 mL

EAN-14: 07332414116057

Product # 114906

VANTIVE Logo

Batch No. and expiry date are printed on the back of the bag.

Manufactured for:

Vantive US Healthcare LLC

Deerfield IL 60015 USA

Made in Italy

REPLACEMENT

Solution for Continuous Renal Replacement Therapy

07-25-00-5284

IFU Label

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PRISMASOL and PHOXILLUM safely and effectively.

See full prescribing information for PRISMASOL and PHOXILLUM.



PRISMASOL renal replacement solution PRISMASOL Initial U.S. Approval: 2006



PHOXILLUM renal replacement solution PHOXILLUM Initial U.S. Approval: 2015



-------------INDICATIONS AND USAGE-------------

PRISMASOL and PHOXILLUM solutions are indicated:

• As a replacement solution in Continuous Renal Replacement Therapy (CRRT) and in case of drug poisoning when CRRT is used to remove dialyzable substances (1)



---------DOSAGE AND ADMINISTRATION---------



• Therapy must be individualized based on the patient’s clinical condition, fluid, electrolyte, acid-base and glucose balance (2.2)

• Solution must be mixed prior to use (2.2)

• Use only with extracorporeal dialysis equipment appropriate for CRRT (2.3)

------------- DOSAGE FORMS AND STRENGTHS----------

PRISMASOL and PHOXILLUM are available in multiple combinations of ingredients and in multiple variations of strengths. See full Prescribing Information for detailed descriptions of each formulation. (2, 3, 11)

-------------- CONTRAINDICATIONS-----------------

• Known hypersensitivities to PRISMASOL and PHOXILLUM solutions (4)

--------- WARNINGS AND PRECAUTIONS--------

• Monitor hemodynamic status and fluid inputs and outputs, potassium, phosphorus, other electrolytes and acid-base balance. Abnormalities may be corrected by the use of appropriate formulations and dosage of PRISMASOL and PHOXILLUM solutions (5.1)

• Treatment may affect glucose levels. Monitor blood glucose levels. Antidiabetic therapy adjustment or other corrective measures may be required during treatment (5.2)

To report SUSPECTED ADVERSE REACTIONS, contact Vantive US Healthcare LLC at 1-855-857-0003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Revised: 10/2024

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

  • 2.1 Administration Instructions
  • 2.2 Dosing Considerations
  • 2.3 Preparing the Solution
  • 2.4 Adding Drugs to the Solutions

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

  • 5.1 Electrolyte and Volume Abnormalities
  • 5.2 Blood Glucose Abnormalities

6 ADVERSE REACTIONS

7 DRUG INTERACTIONS

  • 7.1 Citrate

07-19-00-8247

8 USE IN SPECIFIC POPULATIONS

  • 8.1 Pregnancy
  • 8.2 Lactation
  • 8.4 Pediatric Use
  • 8.5 Geriatric Use

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

  • 12.1 Mechanism of Action
  • 12.3 Pharmacokinetics

16 HOW SUPPLIED/STORAGE AND HANDLING

*Sections or subsections omitted from the full prescribing information are not listed.

  • Vantive Logo

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances.

2 DOSAGE AND ADMINISTRATION

2.1 Administration Instructions

Visually inspect PRISMASOL and PHOXILLUM for particulate matter and discoloration prior to administration. Administration should only be under the direction of a physician competent in intensive care treatment including CRRT. Use only with extracorporeal dialysis equipment appropriate for CRRT. The prepared solution is for single patient use only. Aseptic technique should be used throughout administration to the patient. Discard any unused solution.

2.2 Dosing Considerations

PRISMASOL replacement solutions contain 4 different combinations of active ingredients (7 different products with varying ingredient amounts). PHOXILLUM replacement solutions contain 2 different combinations of active ingredients (2 different products with varying ingredient amounts). PRISMASOL and PHOXILLUM are supplied in a two-compartment bag that must be mixed immediately prior to use [see Dosage and Administration (2.3)]:

  • Small compartment A (250 mL) containing an electrolyte solution, and
  • Large compartment B (4750 mL) containing the buffer solution.

See Table 1for the concentrations of the active ingredients (after mixing) in these 9 different replacement solutions (total volume is 5 Liters).



The mode of therapy, solute formulation, flow rates, and length of PRISMASOL and PHOXILLUM replacement therapy in CRRT should be established by a physician based on the patient’s clinical condition, blood concentration of phosphate and other electrolytes, acid-base and glucose balance. Administer either PRISMASOL or PHOXILLUM into the extracorporeal circuit:

  • Before (pre-dilution) the hemofilter or hemodiafilter,
  • After (post-dilution) the hemofilter or hemodiafilter, or
  • Before and after the hemofilter or hemodiafilter.

2.3 Preparing the Solution

Use only if the overwrap is not damaged, all seals are intact, peel seal is not broken, and the solution is clear. The solution may be warmed to 37°C/98.6°F prior to removing the overwrap to enhance patient comfort. However, only dry heat should be used. Solutions should not be heated in water or in a microwave oven. After heating, verify that the solution remains clear and contains no particulate matter.

The solutions are supplied in two different two-compartment bags made of polyolefin with a peel seal separating compartment A and B ( see Figure 1).

Follow the instructions below when connecting the solution bags for correct use of the access ports.

2.4 Adding Drugs to the Solutions

After mixing, additional drugs may be added to the bag via injection connector (spike connector) in large compartment B. In general, administer drugs other than phosphate through a different access line.

When introducing drugs, use aseptic techniques and mix thoroughly prior to connecting the solution bag to the extracorporeal circuit.

Do not use if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals after addition of medication.

Phosphate:Up to 1.2 mmol/L of phosphate can be added to the bag as potassium phosphate or sodium phosphate. The total potassium concentration of PRISMASOL solution should not exceed 4 mEq/L.

Use sodium phosphate to add phosphate if the total potassium concentration in PRISMASOL solution is 4 mEq/L.

PHOXILLUM Solutions:

Phosphate:Phosphate up to 0.2 mmol/L may be added to the solution. Use sodium phosphate if adding phosphate to bag. The total phosphate concentration should not exceed 1.2 mmol/L.

3 DOSAGE FORMS AND STRENGTHS

See Table 1for the concentrations of the active ingredients (after mixing) in these 9 different replacement solutions [see Dosage and Administration (2.2)].

4 CONTRAINDICATIONS

PHOXILLUM and PRISMASOL replacement solutions are contraindicated in patients with known hypersensitivities to these products.

5 WARNINGS AND PRECAUTIONS

5.1 Electrolyte and Volume Abnormalities

PHOXILLUM and PRISMASOL solutions can affect electrolytes and volume and may result in hyperkalemia or hyperphosphatemia. Monitor hemodynamic status and fluid inputs and outputs, potassium, phosphorous, calcium, other electrolytes and acid-base balance throughout the procedure. Abnormalities may be corrected by changing the formulation of replacement solution and/or dialysate, supplementation, or adjusting flow rates appropriately [see Dosage and Administration (2)].

PHOXILLUM replacement solutions contain hydrogen phosphate, a weak acid that may increase the risk of metabolic acidosis.

5.2 Blood Glucose Abnormalities

The use of PRISMASOL and PHOXILLUM replacement solutions can affect blood glucose levels resulting in hypo- or hyper-glycemia depending upon the dextrose content of the replacement solution. Monitor blood glucose levels regularly. Patients may require initiation of or modification of antidiabetic therapy or othercorrective measures during treatment.

6 ADVERSE REACTIONS

The following adverse reactions have been identified during postapproval use with these or other similar products and therefore may occur with use of PHOXILLUM or PRISMASOL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Metabolic acidosis
  • Hypotension
  • Acid-base disorders
  • Electrolyte imbalance including calcium ionized increased (reported in PRISMASOL solutions containing calcium), hyperphosphatemia, and hypophosphatemia
  • Fluid imbalance

7 DRUG INTERACTIONS

As with the use of other replacement solutions, blood concentrations of dialyzable drugs may be reduced by CRRT due to their removal by the hemofilter or hemodiafilter. The blood concentrations of certain drugs may need to be monitored and appropriate therapy implemented to correct for removal during treatment.

7.1 Citrate

When used as an anticoagulant, citrate contributes to the overall buffer load and can reduce plasma calcium levels. Select the PRISMASOL/PHOXILLUM formulation(s) accordingly.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

PRISMASOL and PHOXILLUM are pharmacologically inactive solutions. While there are no adequate and well controlled studies in pregnant women, appropriate administration of PRISMASOL and PHOXILLUM solutions with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to cause fetal harm. Animal reproduction studies have not been conducted with PRISMASOL and PHOXILLUM solutions.

The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations

Maintenance of normal acid-base balance is important for fetal well-being.

8.2 Lactation

Risk Summary

The components of PRISMASOL and PHOXILLUM solutions are excreted in human milk. Appropriate administration of PRISMASOL and PHOXILLUM solutions with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to harm a nursing infant.

8.4 Pediatric Use

Safety and effectiveness have been established based on published clinical data of CRRT replacement solutions with compositions similar to PRISMASOL and PHOXILLUM used in adults and two hemofiltration studies in pediatric patients, including a study of newborns to 17 years old.

8.5 Geriatric Use

The experience with PRISMASOL and PHOXILLUM solutions in geriatric patients has not identified novel concerns.

11 DESCRIPTION

PRISMASOL and PHOXILLUM solutions are clear, sterile, free of bacterial endotoxins and contain no bacteriostatic or antimicrobial agents. These solutions are used in Continuous Renal Replacement Therapies (CRRT) as a replacement solution in hemofiltration and hemodiafiltration. Depending on the product (see Table 2), the two compartments contain:

Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 2• 2H 2O).

Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 2• 6H 2O).

Sodium chloride, USP, is chemically designated NaCl.

Potassium chloride, USP, is chemically designated KCl.

Sodium bicarbonate, USP, is chemically designated NaHCO 3.

Dextrose, USP, is chemically designated D-Glucose anhydrous (C 6H 12O 6) or D-Glucose monohydrate (C 6H 12O6 • H 2O).

Lactic acid, USP, is chemically designated CH 3CH(OH)COOH.

Dibasic sodium phosphate, USP, is chemically designated as disodium hydrogen phosphate, dihydrate (Na 2HPO 4• 2H 2O)

The pH of the final solution is in the range of 7.0 to 8.5.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

PRISMASOL and PHOXILLUM solutions are pharmacologically inactive. The electrolyte concentrations in the solutions are chosen to restore plasma levels to clinically desired concentrations or maintain plasma levels at the desired concentrations.

PRISMASOL and PHOXILLUM solutions are used as replacement solution to replace water and electrolytes removed during hemofiltration and hemodiafiltration. Bicarbonate (or precursor lactate) in the solution is used as an alkalinizing buffer to restore acid-base balance to a clinically desirable level.

12.3 Pharmacokinetics

The distribution of electrolytes, bicarbonate, and dextrose is determined by the patient’s clinical condition, metabolic status, and residual renal function. The elimination and replacement of water, electrolytes and buffer depend on the patient’s electrolyte and acid-base balance, metabolic status, residual renal function and ongoing physiologic losses through intestinal, respiratory and cutaneous routes.

16 HOW SUPPLIED/STORAGE AND HANDLING

PRISMASOL and PHOXILLUM solutions are supplied in a two-compartment bag made of polyolefin. The 5000 mL bag is composed of a small compartment (250 mL) and a large compartment (4750 mL). The two compartments are separated by a peel seal.

The bag is overwrapped with a transparent overwrap. See Table 2for the concentrations of the active ingredients in each compartment for each product [see Description (11)].

Container

Fill Volume

NDC

PRISMASOL Solutions

PRISMASOL BGK0/2.5

5000 mL

24571-108-06

PRISMASOL BGK4/2.5

5000 mL

24571-105-06

PRISMASOL BGK2/3.5

5000 mL

24571-103-06

PRISMASOL BGK2/0

5000 mL

24571-102-06

PRISMASOL B22GK4/0

5000 mL

24571-111-06

PRISMASOL BK0/0/1.2

5000 mL

24571-113-06

PRISMASOL BGK4/0/1.2

5000 mL

24571-114-06

PHOXILLUM Solutions

PHOXILLUM BK4/2.5

5000 mL

24571-116-06

PHOXILLUM B22K4/0

5000 mL

24571-117-06

Not all formulations may be marketed.

Storage conditions

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). [See USP

Controlled Room Temperature]

Do not freeze or expose to excessive heat. Do not use if precipitate has formed or if container seals have

been damaged.

Manufactured for:

Vantive US Healthcare LLC

One Baxter Parkway

Deerfield, Illinois 60015

07-19-00-6103

3 Dosage Forms and Strengths (3 DOSAGE FORMS AND STRENGTHS)

See Table 1for the concentrations of the active ingredients (after mixing) in these 9 different replacement solutions [see Dosage and Administration (2.2)] .

2.1 Administration Instructions

Visually inspect PRISMASOL and PHOXILLUM for particulate matter and discoloration prior to administration.

Administration should only be under the direction of a physician competent in intensive care treatment including CRRT. Use only with extracorporeal dialysis equipment appropriate for CRRT.

The prepared solution is for single patient use only.

Aseptic technique should be used throughout administration to the patient.

Discard any unused solution.

5.2 Blood Glucose Abnormalities

The use of PRISMASOL and PHOXILLUM replacement solutions can affect blood glucose levels resulting in hypo- or hyper-glycemia depending upon the dextrose content of the replacement solution. Monitor blood glucose levels regularly. Patients may require initiation of or modification of antidiabetic therapy or other corrective measures during treatment.

2.4 Adding Drugs to the Solutions

After mixing, additional drugs may be added to the bag via injection connector (spike connector) in large compartment B. In general, administer drugs other than phosphate through a different access line.

When introducing drugs, use aseptic techniques and mix thoroughly prior to connecting the solution bag to the extracorporeal circuit.

Do not use if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals after addition of medication.

Phosphate: Up to 1.2 mmol/L of phosphate can be added to the bag as potassium phosphate or sodium phosphate. The total potassium concentration of PRISMASOL solution should not exceed 4 mEq/L. Use sodium phosphate to add phosphate if the total potassium concentration in PRISMASOL solution is 4 mEq/L.

16 How Supplied/storage and Handling (16 HOW SUPPLIED/STORAGE AND HANDLING)

PRISMASOL and PHOXILLUM solutions are supplied in a two-compartment bag made of polyolefin. The 5000 mL bag is composed of a small compartment (250 mL) and a large compartment (4750 mL). The two compartments are separated by a peel seal.

The bag is overwrapped with a transparent overwrap. See Table 2for the concentrations of the active ingredients in each compartment for each product [see Description (11)].

Container

Fill Volume

NDC

PRISMASOL Solutions

PRISMASOL BGK0/2.5

5000 mL

24571-108-06

PRISMASOL BGK4/2.5

5000 mL

24571-105-06

PRISMASOL BGK2/3.5

5000 mL

24571-103-06

PRISMASOL BGK2/0

5000 mL

24571-102-06

PRISMASOL B22GK4/0

5000 mL

24571-111-06

PRISMASOL BK0/0/1.2

5000 mL

24571-113-06

PRISMASOL BGK4/0/1.2

5000 mL

24571-114-06

PHOXILLUM Solutions

PHOXILLUM BK4/2.5

5000 mL

24571-116-06

PHOXILLUM B22K4/0

5000 mL

24571-117-06

Not all formulations may be marketed.

5.1 Electrolyte and Volume Abnormalities

PHOXILLUM and PRISMASOL solutions can affect electrolytes and volume and may result in hyperkalemia or hyperphosphatemia. Monitor hemodynamic status and fluid inputs and outputs, potassium, phosphorous, calcium, other electrolytes and acid-base balance throughout the procedure. Abnormalities may be corrected by changing the formulation of replacement solution and/or dialysate, supplementation, or adjusting flow rates appropriately [ see Dosage and Administration (2) ].

PHOXILLUM replacement solutions contain hydrogen phosphate, a weak acid that may increase the risk of metabolic acidosis.

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