These Highlights Do Not Include All The Information Needed To Use Additive Solution Formula 3 (as-3) Safely And Effectively. See Full Prescribing Information For Additive Solution Formula 3 (as-3).

Automated RBC additive solution procedures:

Connect ADDITIVE SOLUTION FORMULA 3 (AS-3) after the collection is over and the donor is disconnected. For automated addition of the product, the system will prompt you to connect the bag.

• Remove the overwrap by pulling down at notch, and remove the AS-3 bag.
• Before use, perform the following checks:
  • Ensure that the solution is the ADDITIVE SOLUTION FORMULA 3 (AS-3) and is within the expiration date.
  • Inspect the bag in good light. Do not use if the container is damaged, leaking or if there is any visible sign of deterioration. Check for leaks by gently squeezing the bag. If leaks are found, discard the bag.
  • Inspect the solution in good light. Use only if solution is clear and free of particulate matter. Bags showing cloudiness, haze, or particulate matter should not be used.
  • Protect from sharp objects.
• Remove the protective cap from the port on the bag.
• Connect the bag to the complementary luer of the apheresis device tubing set using aseptic technique and hang the solution.
• Break the frangible connector. When you break frangible connectors, bend them in both directions to ensure that you break them completely. Failure to do so may result in restricted flow.
• Proceed according to the apheresis device operator's manual.

STORAGE

Up to 25 °C.

Protect from freezing.

ADDITIVE SOLUTION FORMULA 3 (AS-3) is designed to be added to packed RBC collected in apheresis procedures, and acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The solution is intended to be metered by an apheresis device during apheresis procedures or added manually after a collection.

Additive Solution Formula 3 (AS-3) is a clear solution that is steam-sterilized and non-pyrogenic. It does not contain bacteriostatic or antimicrobial agents.

The formulas of the active ingredients are provided in Table 1.

Each 100 mL of ADDITIVE SOLUTION FORMULA 3 (AS-3) contains: Dextrose Monohydrate USP 1.10 g; Trisodium Citrate Dihydrate USP 0.59 g; Sodium Chloride USP 0.41 g; Monobasic Sodium Phosphate Monohydrate USP 0.28 g; Citric Acid Monohydrate USP 0.042 g; Adenine USP 0.03 g; and Water for Injection USP.

ADDITIVE SOLUTION FORMULA 3 is available in three volumes: 100 mL, 200 mL and 350 mL.

The 100 mL bags are individually wrapped with a clear plastic film. Six individually wrapped bags are then vacuum-sealed in a foil pouch, which serves as a vapor barrier to prevent water loss during storage. After you remove the individual solution bags from the foil pouch, you can either leave them in the clear plastic film or remove and discard it. Once the foil pouch has been opened, use all six of the solution bags within 2 weeks.

The 200 mL and 350 mL bags are individually wrapped with a clear plastic film. These larger volumes do not require the additional vapor barrier. Once the clear plastic film has been removed, use the solution within 2 weeks.

The Polyolefin bag is not made with natural rubber latex.

The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration.

Directions for connecting the ADDITIVE SOLUTION FORMULA 3 (AS-3) bag to the apheresis device.

The in vivo and in vitro quality of RBCs stored for 42 days in ADDITIVE SOLUTION FORMULA 3 (AS-3) storage solution has been assessed in three clinical studies.

DO NOT INFUSE ADDITIVE SOLUTION FORMULA 3 (AS-3) DIRECTLY TO THE DONOR.

Citrate reactions or toxicity may occur with the infusion of blood products to patients. The recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity. The signs and symptoms of citrate toxicity begin with paresthesia, a "tingling" sensation around the mouth or in the extremities, followed by severe reactions that are characterized by hypotension and possible cardiac arrhythmia. Citrate toxicity may occur more frequently in patients who are hypothermic, have impaired liver or renal function, or have low calcium levels because of an underlying disease.

Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2).]

ADDITIVE SOLUTION FORMULA 3 acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The following ingredients are key components of the solution:

• Adenine to support adenosine triphosphate (ATP) levels
• Citrate for membrane protection, anticoagulation and pH regulation
• Sodium (Sodium Chloride and Sodium Citrate) and dextrose for isotonicity
• Dextrose for RBC nutrition

This solution has no pharmacological effect.

• Verify that the AS-3 bag has been securely attached to the system tubing set. Use aseptic technique throughout all procedures to ensure product quality.
• Do not reuse. Discard unused or partially used solution bags.

• AS-3 is added to tubing sets after apheresis collections, after the donor has been disconnected. (2)
• AS-3 may only be used with the Trima Accel apheresis device. For instructions on the use of the solution see the device operator's manual. (2.1)
• Follow the directions for connecting the AS-3 bag to the tubing set of a blood collection system. (2.2)

100 mL, 200 mL and 350 mL ADDITIVE SOLUTION FORMULA 3 (AS-3) products are sterile solutions in a Polyolefin bag. Each 100 mL contains: Dextrose Monohydrate USP 1.10 g; Trisodium Citrate Dihydrate USP 0.59 g; Sodium Chloride USP 0.41 g; Monobasic Sodium Phosphate Monohydrate USP 0.28 g; Citric Acid Monohydrate USP 0.042 g; Adenine USP 0.03 g; and Water for Injection USP.

ADDITIVE SOLUTION FORMULA 3 (AS-3) has not been studied in controlled clinical trials with specific populations.

ADDITIVE SOLUTION FORMULA 3 (AS-3) is connected to the tubing set used for an apheresis RBC collection procedure after the collection has been completed.

• For automated RBC procedures, the recommended dose is determined by the apheresis device and metered into the tubing set by the apheresis device.
• To add the product manually, refer to the apheresis system operator's manual to determine the recommended dose.

For instructions on the use of the solution with the apheresis device and tubing set, see the device operator's manual.

ADDITIVE SOLUTION FORMULA 3 (AS-3) is a clear solution supplied in sterile and non-pyrogenic Polyolefin bags.

Additive Solution Formula 3 (AS-3)

Catalog # 40833 Polyolefin Bag 30 x 200 mL units

NDC 14537-833-03

Manufactured by TERUMO BCT, INC.

10811 W. Collins Ave.,

Lakewood CO 80215, USA

Made in UK

LPN 1000005752

Use only with Trima Accel red blood cell apheresis collections. See

apheresis device operator's manual for complete instructions. Read the

package insert before use. Sterile. Non-pyrogenic. Sterilized with steam.

Caution: Do not use if the bag is damaged. Use only if solution is clear

and free of particulate matter. Single use bag. Discard any unused

product. Not for direct intravenous infusion. Rx Only.

Recommended storage: Up to 25°C. Protect from freezing.

Each 100 mL contains:

Dextrose Monohydrate USP

1.10 g

Trisodium Citrate Dihydrate USP

0.588 g

Sodium Chloride USP

0.410 g

Monobasic Sodium Phosphate Monohydrate USP

0.276 g

Citric Acid Monohydrate USP

0.042 g

Adenine USP

0.030 g

In Water for Injection USP

Lot

Expiry Date

Additive Solution Formula 3 (AS-3)

Catalog # 40834 Polyolefin Bag 24 x 350 mL units

NDC 14537-834-03

Manufactured by TERUMO BCT, INC.

10811 W. Collins Ave.,

Lakewood CO 80215, USA

Made in UK

LPN 1000005753

Use only with Trima Accel red blood cell apheresis collections. See

apheresis device operator's manual for complete instructions. Read the

package insert before use. Sterile. Non-pyrogenic. Sterilized with steam.

Caution: Do not use if the bag is damaged. Use only if solution is clear

and free of particulate matter. Single use bag. Discard any unused

product. Not for direct intravenous infusion. Rx Only.

Recommended storage: Up to 25°C. Protect from freezing.

Each 100 mL contains:

Dextrose Monohydrate USP

1.10 g

Trisodium Citrate Dihydrate USP

0.588 g

Sodium Chloride USP

0.410 g

Monobasic Sodium Phosphate Monohydrate USP

0.276 g

Citric Acid Monohydrate USP

0.042 g

Adenine USP

0.030 g

In Water for Injection USP

Lot

Expiry Date

Additive Solution Formula 3 (AS-3)

Catalog # 40832 Polyolefin Bag 6 x 6 x 100 mL units

NDC 14537-832-03

Manufactured by TERUMO BCT, INC.

10811 W. Collins Ave.,

Lakewood CO 80215, USA

Made in UK

LPN 1000005747

Use only with Trima Accel red blood cell apheresis collections. See

apheresis device operator's manual for complete instructions. Read the

package insert before use. Sterile. Non-pyrogenic. Sterilized with steam.

Caution: Do not use if the bag is damaged. Use only if solution is clear

and free of particulate matter. Single use bag. Discard any unused

product. Not for direct intravenous infusion. Rx Only.

Recommended storage: Up to 25°C. Protect from freezing.

Each 100 mL contains:

Dextrose Monohydrate USP

1.10 g

Trisodium Citrate Dihydrate USP

0.588 g

Sodium Chloride USP

0.410 g

Monobasic Sodium Phosphate Monohydrate USP

0.276 g

Citric Acid Monohydrate USP

0.042 g

Adenine USP

0.030 g

In Water for Injection USP

Lot

Expiry Date

Automated RBC additive solution procedures:

Connect ADDITIVE SOLUTION FORMULA 3 (AS-3) after the collection is over and the donor is disconnected. For automated addition of the product, the system will prompt you to connect the bag.

• Remove the overwrap by pulling down at notch, and remove the AS-3 bag.
• Before use, perform the following checks:
  • Ensure that the solution is the ADDITIVE SOLUTION FORMULA 3 (AS-3) and is within the expiration date.
  • Inspect the bag in good light. Do not use if the container is damaged, leaking or if there is any visible sign of deterioration. Check for leaks by gently squeezing the bag. If leaks are found, discard the bag.
  • Inspect the solution in good light. Use only if solution is clear and free of particulate matter. Bags showing cloudiness, haze, or particulate matter should not be used.
  • Protect from sharp objects.
• Remove the protective cap from the port on the bag.
• Connect the bag to the complementary luer of the apheresis device tubing set using aseptic technique and hang the solution.
• Break the frangible connector. When you break frangible connectors, bend them in both directions to ensure that you break them completely. Failure to do so may result in restricted flow.
• Proceed according to the apheresis device operator's manual.

STORAGE

Up to 25 °C.

Protect from freezing.

ADDITIVE SOLUTION FORMULA 3 (AS-3) is designed to be added to packed RBC collected in apheresis procedures, and acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The solution is intended to be metered by an apheresis device during apheresis procedures or added manually after a collection.

Additive Solution Formula 3 (AS-3) is a clear solution that is steam-sterilized and non-pyrogenic. It does not contain bacteriostatic or antimicrobial agents.

The formulas of the active ingredients are provided in Table 1.

Each 100 mL of ADDITIVE SOLUTION FORMULA 3 (AS-3) contains: Dextrose Monohydrate USP 1.10 g; Trisodium Citrate Dihydrate USP 0.59 g; Sodium Chloride USP 0.41 g; Monobasic Sodium Phosphate Monohydrate USP 0.28 g; Citric Acid Monohydrate USP 0.042 g; Adenine USP 0.03 g; and Water for Injection USP.

ADDITIVE SOLUTION FORMULA 3 is available in three volumes: 100 mL, 200 mL and 350 mL.

The 100 mL bags are individually wrapped with a clear plastic film. Six individually wrapped bags are then vacuum-sealed in a foil pouch, which serves as a vapor barrier to prevent water loss during storage. After you remove the individual solution bags from the foil pouch, you can either leave them in the clear plastic film or remove and discard it. Once the foil pouch has been opened, use all six of the solution bags within 2 weeks.

The 200 mL and 350 mL bags are individually wrapped with a clear plastic film. These larger volumes do not require the additional vapor barrier. Once the clear plastic film has been removed, use the solution within 2 weeks.

The Polyolefin bag is not made with natural rubber latex.

The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration.

Directions for connecting the ADDITIVE SOLUTION FORMULA 3 (AS-3) bag to the apheresis device.

The in vivo and in vitro quality of RBCs stored for 42 days in ADDITIVE SOLUTION FORMULA 3 (AS-3) storage solution has been assessed in three clinical studies.

DO NOT INFUSE ADDITIVE SOLUTION FORMULA 3 (AS-3) DIRECTLY TO THE DONOR.

Citrate reactions or toxicity may occur with the infusion of blood products to patients. The recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity. The signs and symptoms of citrate toxicity begin with paresthesia, a "tingling" sensation around the mouth or in the extremities, followed by severe reactions that are characterized by hypotension and possible cardiac arrhythmia. Citrate toxicity may occur more frequently in patients who are hypothermic, have impaired liver or renal function, or have low calcium levels because of an underlying disease.

Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2).]

ADDITIVE SOLUTION FORMULA 3 acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The following ingredients are key components of the solution:

• Adenine to support adenosine triphosphate (ATP) levels
• Citrate for membrane protection, anticoagulation and pH regulation
• Sodium (Sodium Chloride and Sodium Citrate) and dextrose for isotonicity
• Dextrose for RBC nutrition

This solution has no pharmacological effect.

• Verify that the AS-3 bag has been securely attached to the system tubing set. Use aseptic technique throughout all procedures to ensure product quality.
• Do not reuse. Discard unused or partially used solution bags.

• AS-3 is added to tubing sets after apheresis collections, after the donor has been disconnected. (2)
• AS-3 may only be used with the Trima Accel apheresis device. For instructions on the use of the solution see the device operator's manual. (2.1)
• Follow the directions for connecting the AS-3 bag to the tubing set of a blood collection system. (2.2)

100 mL, 200 mL and 350 mL ADDITIVE SOLUTION FORMULA 3 (AS-3) products are sterile solutions in a Polyolefin bag. Each 100 mL contains: Dextrose Monohydrate USP 1.10 g; Trisodium Citrate Dihydrate USP 0.59 g; Sodium Chloride USP 0.41 g; Monobasic Sodium Phosphate Monohydrate USP 0.28 g; Citric Acid Monohydrate USP 0.042 g; Adenine USP 0.03 g; and Water for Injection USP.

ADDITIVE SOLUTION FORMULA 3 (AS-3) has not been studied in controlled clinical trials with specific populations.

ADDITIVE SOLUTION FORMULA 3 (AS-3) is connected to the tubing set used for an apheresis RBC collection procedure after the collection has been completed.

• For automated RBC procedures, the recommended dose is determined by the apheresis device and metered into the tubing set by the apheresis device.
• To add the product manually, refer to the apheresis system operator's manual to determine the recommended dose.

For instructions on the use of the solution with the apheresis device and tubing set, see the device operator's manual.

ADDITIVE SOLUTION FORMULA 3 (AS-3) is a clear solution supplied in sterile and non-pyrogenic Polyolefin bags.

Additive Solution Formula 3 (AS-3)

Catalog # 40833 Polyolefin Bag 30 x 200 mL units

NDC 14537-833-03

Manufactured by TERUMO BCT, INC.

10811 W. Collins Ave.,

Lakewood CO 80215, USA

Made in UK

LPN 1000005752

Use only with Trima Accel red blood cell apheresis collections. See

apheresis device operator's manual for complete instructions. Read the

package insert before use. Sterile. Non-pyrogenic. Sterilized with steam.

Caution: Do not use if the bag is damaged. Use only if solution is clear

and free of particulate matter. Single use bag. Discard any unused

product. Not for direct intravenous infusion. Rx Only.

Recommended storage: Up to 25°C. Protect from freezing.

Each 100 mL contains:

Dextrose Monohydrate USP

1.10 g

Trisodium Citrate Dihydrate USP

0.588 g

Sodium Chloride USP

0.410 g

Monobasic Sodium Phosphate Monohydrate USP

0.276 g

Citric Acid Monohydrate USP

0.042 g

Adenine USP

0.030 g

In Water for Injection USP

Lot

Expiry Date

Additive Solution Formula 3 (AS-3)

Catalog # 40834 Polyolefin Bag 24 x 350 mL units

NDC 14537-834-03

Manufactured by TERUMO BCT, INC.

10811 W. Collins Ave.,

Lakewood CO 80215, USA

Made in UK

LPN 1000005753

Use only with Trima Accel red blood cell apheresis collections. See

apheresis device operator's manual for complete instructions. Read the

package insert before use. Sterile. Non-pyrogenic. Sterilized with steam.

Caution: Do not use if the bag is damaged. Use only if solution is clear

and free of particulate matter. Single use bag. Discard any unused

product. Not for direct intravenous infusion. Rx Only.

Recommended storage: Up to 25°C. Protect from freezing.

Each 100 mL contains:

Dextrose Monohydrate USP

1.10 g

Trisodium Citrate Dihydrate USP

0.588 g

Sodium Chloride USP

0.410 g

Monobasic Sodium Phosphate Monohydrate USP

0.276 g

Citric Acid Monohydrate USP

0.042 g

Adenine USP

0.030 g

In Water for Injection USP

Lot

Expiry Date

Additive Solution Formula 3 (AS-3)

Catalog # 40832 Polyolefin Bag 6 x 6 x 100 mL units

NDC 14537-832-03

Manufactured by TERUMO BCT, INC.

10811 W. Collins Ave.,

Lakewood CO 80215, USA

Made in UK

LPN 1000005747

Use only with Trima Accel red blood cell apheresis collections. See

apheresis device operator's manual for complete instructions. Read the

package insert before use. Sterile. Non-pyrogenic. Sterilized with steam.

Caution: Do not use if the bag is damaged. Use only if solution is clear

and free of particulate matter. Single use bag. Discard any unused

product. Not for direct intravenous infusion. Rx Only.

Recommended storage: Up to 25°C. Protect from freezing.

Each 100 mL contains:

Dextrose Monohydrate USP

1.10 g

Trisodium Citrate Dihydrate USP

0.588 g

Sodium Chloride USP

0.410 g

Monobasic Sodium Phosphate Monohydrate USP

0.276 g

Citric Acid Monohydrate USP

0.042 g

Adenine USP

0.030 g

In Water for Injection USP

Lot

Expiry Date