These Highlights Do Not Include All The Information Needed To Use 10% Dextrose Injection Safely And Effectively. See Full Prescribing Information For Dextrose Injection.

• 10% Dextrose Injection is intended for intravenous use.
• Peripheral administration of 5% dextrose is generally acceptable, however, consider central vein when administering more than 5% dextrose or with an osmolarity of at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain [see Warnings and Precautions (5.3)].
• Do not administer 10% Dextrose Injection simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis.
• To prevent air embolism, use a non-vented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by a pumping device, turn off pump before the container runs dry.
• Prior to infusion, visually inspect the diluted dextrose solution for particulate matter. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear and container is undamaged.
• Use of a final filter is recommended during administration of parenteral solutions, where possible.

STORE AT: 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; brief exposure up to 40°C/104°F does not adversely affect the product. Keep from freezing.

The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.

PACKAGE LABEL - PRINCIPAL DISPLAY – 10% Dextrose Bag Label

NDC 17271-721-05

free flex^®  250 mL

10% Dextrose Injection, USP

25 grams per 250 mL (100 mg per mL)

For intravenous use. Rx only

Check flexible container solution composition, lot number, and expiry date. Prior to administration, visually inspect for particulate matter and discoloration.

The intact port caps provides visual tamper evidence. Do not use if a port cap is prematurely removed. Do not remove solution container from its overwrap until immediately before use. Use sterile equipment and aseptic technique.

To Open

• Place the solution container on a clean, flat surface. Using the pre-cut corner tabs, peel open the overwrap and remove solution container.
• Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution.
• Do not use if the solution is cloudy or a precipitate is present.

To Add Medication

• Identify WHITE Additive Port with arrow pointing toward container.
• Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container.
• Hold base of WHITE Additive Port horizontally.
• Insert needle (18 to 23 gauge) horizontally through the center of WHITE Additive Port's septum and inject additives.
• Mix container contents thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.

Preparation for Administration

• Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from container.
• Use a non-vented infusion set or close the air-inlet on a vented set.
• Close the roller clamp of the infusion set.
• Hold the base of BLUE Infusion Port.
• Insert spike through BLUE Infusion Port by rotating wrist slightly until the spike is inserted.
• Suspend solution container from hanger hole
• For Single Use Only. Discard unused portion.

NOTE: See full directions accompanying administration set.

WARNING: Do not use flexible container in series connections.

An increased infusion rate of 10% Dextrose Injection or administration of dextrose solutions can cause hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance [see Warnings and Precautions (5.1, 5.5)].

Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. Discontinue infusion, reduce dose and institute appropriate corrective measures such as administration of exogenous insulin.

Discontinue infusion and institute appropriate corrective measures in the event of overhydration or solute overload during therapy, with particular attention to CNS, respiratory and cardiovascular systems.

If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.

10% Dextrose Injection, USP is a sterile, non-pyrogenic solution for fluid replenishment and caloric supply in single dose containers for intravenous administration.

The solution contains no bacteriostatic, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. The pH range is 4.0 (3.2 to 6.5)

Dextrose, USP is chemically designated D-glucose, monohydrate (C₆H₁₂O₆ • H₂O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula:

Water for Injection, USP is chemically designated H₂O.

Dextrose is derived from corn.

The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex^® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.

The flexible container is a closed system, and air is prefilled in the container to facilitate drainage. The container does not require entry of external air during administration.

The container has two ports: one is the administration outlet port for attachment of an intravenous administration set and the other port has a medication site for addition of supplemental medication ([see Instructions for Use (2.3)]). The primary function of the overwrap is to protect the container from the physical environment.

The safety profile of 10% Dextrose Injection in pediatric patients is similar to adults.

Neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose infusions to ensure adequate glycemic control in order to avoid potential long-term adverse effects.

Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of 10% Dextrose Injection may result in increased serum osmolality and risk of intracerebral hemorrhage.

Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions (5.4)].

Clinical studies of 10% Dextrose Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions (5.4)]. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Dextrose is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

The use of Dextrose Injection is contraindicated in patients with:

• Clinically significant hyperglycemia [see Warnings and Precautions (5.1)].

• Known hypersensitivity to dextrose [see Warnings and Precautions (5.2)].

The following adverse reactions associated with the use of dextrose injection were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure.

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions (5.1)]
• Hypersensitivity Reactions: anaphylaxis, pruritus, bronchospasm, cyanosis, angioedema, hypotension, pyrexia, chills, and rash [see Warnings and Precautions (5.2)]
• Infusion Site Reactions: infusion site phlebitis, infusion site erythema, vein damage and thrombosis, and infusion site thrombophlebitis [see Warnings and Precautions (5.3)]
• Hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.4)]
• Electrolyte imbalance, fluid overload and hypervolemia [see Warnings and Precautions (5.5)]
• Refeeding syndrome [see Warnings and Precautions (5.6)]
• Pulmonary vascular precipitates

Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance: Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance. (7.1)

10% Dextrose Injection is indicated as source of water and calories.

Dextrose is oxidized to carbon dioxide and water, yielding energy.

• Hyperglycemia or Hyperosmolar Hyperglycemic State: Monitor blood glucose and administer insulin as needed. (5.1)
• Hypersensitivity Reactions: Monitor for signs and symptoms and discontinue infusion if reactions occur. (5.2)
• Vein Damage and Thrombosis: Consider central vein when administering more than 5% dextrose or with an osmolarity of at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain. (2.2, 5.3)
• Hyponatremia: Avoid in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations. (5.4)
• Electrolyte Imbalance and Fluid Overload: Avoid in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor daily fluid balance, electrolyte concentrations, and acid-base balance, as needed and especially during prolonged use. (5.5)
• Refeeding Syndrome: Monitor severely undernourished patients and slowly increase nutrient intake. (5.6)

• Only for intravenous infusion. (2.1)
• See full prescribing information for information on preparation, administration, dosing considerations and instructions for use. (2.1, 2.2, 2.3)

10% Dextrose Injection, USP is a clear, sterile, non-pyrogenic solution of dextrose in single-dose flexible plastic containers

• 10% (0.1 grams/mL): 10 grams of dextrose hydrous per 100 mL in flexible plastic containers: 250 mL, 500 mL, and 1000 mL

Pediatric Use: Increased risk of hypoglycemia/hyperglycemia; monitor serum glucose concentrations. (8.4)

Peripheral administration of 5% Dextrose Injection is generally acceptable, however, consider central vein when administering more than 5% dextrose or with an osmolarity of ≥ at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain [see Dosage and Administration (2.1)]. The infusion of hypertonic solutions into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis. The primary complication of peripheral access is venous thrombophlebitis, which manifests as pain, erythema, tenderness or a palpable cord. Remove the catheter as soon as possible, if thrombophlebitis develops.

Inform patients, caregivers, or home healthcare providers of the following risks of 10% Dextrose Injection:

• Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions (5.1)]
• Hypersensitivity reactions [see Warnings and Precautions (5.2)]
• Vein damage and thrombosis [see Warnings and Precautions (5.3)]
• Hyponatremia [see Warnings and Precautions (5.4)]
• Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.5)]
• Refeeding syndrome [see Warnings and Precautions (5.6)]

Manufactured for:

Becton, Dickinson and Company

1 Becton Drive

Franklin Lakes, NJ 07417 USA

For product inquiry: 1-800-523-0502

Distributed by BD. Manufactured by Fresenius Kabi.

Made in Germany

451636A

10% Dextrose Injection, USP is supplied in single dose flexible plastic containers as follows:

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.

Dextrose Injection can affect glycemic control, vasopressin and fluid and/or electrolyte balance [see Warnings and Precautions (5.1, 5.4, 5.5)]. Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance when using Dextrose Injection in patients treated with other substances that affect glycemic control, vasopressin or fluid and/or electrolyte balance.

• 10% Dextrose Injection is intended for intravenous use.
• Peripheral administration of 5% dextrose is generally acceptable, however, consider central vein when administering more than 5% dextrose or with an osmolarity of at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain [see Warnings and Precautions (5.3)].
• Do not administer 10% Dextrose Injection simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis.
• To prevent air embolism, use a non-vented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by a pumping device, turn off pump before the container runs dry.
• Prior to infusion, visually inspect the diluted dextrose solution for particulate matter. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear and container is undamaged.
• Use of a final filter is recommended during administration of parenteral solutions, where possible.

STORE AT: 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; brief exposure up to 40°C/104°F does not adversely affect the product. Keep from freezing.

The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.

PACKAGE LABEL - PRINCIPAL DISPLAY – 10% Dextrose Bag Label

NDC 17271-721-05

free flex^®  250 mL

10% Dextrose Injection, USP

25 grams per 250 mL (100 mg per mL)

For intravenous use. Rx only

Check flexible container solution composition, lot number, and expiry date. Prior to administration, visually inspect for particulate matter and discoloration.

The intact port caps provides visual tamper evidence. Do not use if a port cap is prematurely removed. Do not remove solution container from its overwrap until immediately before use. Use sterile equipment and aseptic technique.

To Open

• Place the solution container on a clean, flat surface. Using the pre-cut corner tabs, peel open the overwrap and remove solution container.
• Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution.
• Do not use if the solution is cloudy or a precipitate is present.

To Add Medication

• Identify WHITE Additive Port with arrow pointing toward container.
• Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container.
• Hold base of WHITE Additive Port horizontally.
• Insert needle (18 to 23 gauge) horizontally through the center of WHITE Additive Port's septum and inject additives.
• Mix container contents thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.

Preparation for Administration

• Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from container.
• Use a non-vented infusion set or close the air-inlet on a vented set.
• Close the roller clamp of the infusion set.
• Hold the base of BLUE Infusion Port.
• Insert spike through BLUE Infusion Port by rotating wrist slightly until the spike is inserted.
• Suspend solution container from hanger hole
• For Single Use Only. Discard unused portion.

NOTE: See full directions accompanying administration set.

WARNING: Do not use flexible container in series connections.

An increased infusion rate of 10% Dextrose Injection or administration of dextrose solutions can cause hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance [see Warnings and Precautions (5.1, 5.5)].

Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. Discontinue infusion, reduce dose and institute appropriate corrective measures such as administration of exogenous insulin.

Discontinue infusion and institute appropriate corrective measures in the event of overhydration or solute overload during therapy, with particular attention to CNS, respiratory and cardiovascular systems.

If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.

10% Dextrose Injection, USP is a sterile, non-pyrogenic solution for fluid replenishment and caloric supply in single dose containers for intravenous administration.

The solution contains no bacteriostatic, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. The pH range is 4.0 (3.2 to 6.5)

Dextrose, USP is chemically designated D-glucose, monohydrate (C₆H₁₂O₆ • H₂O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula:

Water for Injection, USP is chemically designated H₂O.

Dextrose is derived from corn.

The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex^® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.

The flexible container is a closed system, and air is prefilled in the container to facilitate drainage. The container does not require entry of external air during administration.

The container has two ports: one is the administration outlet port for attachment of an intravenous administration set and the other port has a medication site for addition of supplemental medication ([see Instructions for Use (2.3)]). The primary function of the overwrap is to protect the container from the physical environment.

The safety profile of 10% Dextrose Injection in pediatric patients is similar to adults.

Neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose infusions to ensure adequate glycemic control in order to avoid potential long-term adverse effects.

Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of 10% Dextrose Injection may result in increased serum osmolality and risk of intracerebral hemorrhage.

Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions (5.4)].

Clinical studies of 10% Dextrose Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions (5.4)]. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Dextrose is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

The use of Dextrose Injection is contraindicated in patients with:

• Clinically significant hyperglycemia [see Warnings and Precautions (5.1)].

• Known hypersensitivity to dextrose [see Warnings and Precautions (5.2)].

The following adverse reactions associated with the use of dextrose injection were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure.

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions (5.1)]
• Hypersensitivity Reactions: anaphylaxis, pruritus, bronchospasm, cyanosis, angioedema, hypotension, pyrexia, chills, and rash [see Warnings and Precautions (5.2)]
• Infusion Site Reactions: infusion site phlebitis, infusion site erythema, vein damage and thrombosis, and infusion site thrombophlebitis [see Warnings and Precautions (5.3)]
• Hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.4)]
• Electrolyte imbalance, fluid overload and hypervolemia [see Warnings and Precautions (5.5)]
• Refeeding syndrome [see Warnings and Precautions (5.6)]
• Pulmonary vascular precipitates

Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance: Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance. (7.1)

10% Dextrose Injection is indicated as source of water and calories.

Dextrose is oxidized to carbon dioxide and water, yielding energy.

• Hyperglycemia or Hyperosmolar Hyperglycemic State: Monitor blood glucose and administer insulin as needed. (5.1)
• Hypersensitivity Reactions: Monitor for signs and symptoms and discontinue infusion if reactions occur. (5.2)
• Vein Damage and Thrombosis: Consider central vein when administering more than 5% dextrose or with an osmolarity of at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain. (2.2, 5.3)
• Hyponatremia: Avoid in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations. (5.4)
• Electrolyte Imbalance and Fluid Overload: Avoid in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor daily fluid balance, electrolyte concentrations, and acid-base balance, as needed and especially during prolonged use. (5.5)
• Refeeding Syndrome: Monitor severely undernourished patients and slowly increase nutrient intake. (5.6)

• Only for intravenous infusion. (2.1)
• See full prescribing information for information on preparation, administration, dosing considerations and instructions for use. (2.1, 2.2, 2.3)

10% Dextrose Injection, USP is a clear, sterile, non-pyrogenic solution of dextrose in single-dose flexible plastic containers

• 10% (0.1 grams/mL): 10 grams of dextrose hydrous per 100 mL in flexible plastic containers: 250 mL, 500 mL, and 1000 mL

Pediatric Use: Increased risk of hypoglycemia/hyperglycemia; monitor serum glucose concentrations. (8.4)

Peripheral administration of 5% Dextrose Injection is generally acceptable, however, consider central vein when administering more than 5% dextrose or with an osmolarity of ≥ at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain [see Dosage and Administration (2.1)]. The infusion of hypertonic solutions into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis. The primary complication of peripheral access is venous thrombophlebitis, which manifests as pain, erythema, tenderness or a palpable cord. Remove the catheter as soon as possible, if thrombophlebitis develops.

Inform patients, caregivers, or home healthcare providers of the following risks of 10% Dextrose Injection:

• Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions (5.1)]
• Hypersensitivity reactions [see Warnings and Precautions (5.2)]
• Vein damage and thrombosis [see Warnings and Precautions (5.3)]
• Hyponatremia [see Warnings and Precautions (5.4)]
• Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.5)]
• Refeeding syndrome [see Warnings and Precautions (5.6)]

Manufactured for:

Becton, Dickinson and Company

1 Becton Drive

Franklin Lakes, NJ 07417 USA

For product inquiry: 1-800-523-0502

Distributed by BD. Manufactured by Fresenius Kabi.

Made in Germany

451636A

10% Dextrose Injection, USP is supplied in single dose flexible plastic containers as follows:

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.

Dextrose Injection can affect glycemic control, vasopressin and fluid and/or electrolyte balance [see Warnings and Precautions (5.1, 5.4, 5.5)]. Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance when using Dextrose Injection in patients treated with other substances that affect glycemic control, vasopressin or fluid and/or electrolyte balance.