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TABLE OF CONTENTS FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Important Administration Instructions 2.2 Recommended Dosage 2.3 Instructions for Use 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Hyperglycemia and Hyperosmolar Hyperglycemic State 5.2 Hypersensitivity Reactions 5.3 Vein Damage and Thrombosis 5.4 Hyponatremia 5.5 Electrolyte Imbalance and Fluid Overload 5.6 Refeeding Syndrome 6 ADVERSE REACTIONS 7 DRUG INTERACTIONS 7.1 Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. 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: Lake Zurich, IL 60047 Made in Germany www.fresenius-kabi.com/us 451516B Distributed By: HF Acquisition Co LLC dba HealthFirst 11629 49th PL W, Mukilteo, WA 98275

2.1 Important Administration Instructions 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. 2.2 Recommended Dosage The choice of dextrose concentration, rate and volume depends on the age, weight, clinical and metabolic conditions of the patient and concomitant therapy. Electrolyte supplementation may be indicated according to the clinical needs of the patient. The administration rate should be governed, especially for premature infants with low birth weight, during the first few days of therapy, by the patient's tolerance to dextrose. Increase the infusion rate gradually as indicated by frequent monitoring of blood glucose concentrations [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)]. 2.3 Instructions for Use 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.

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.

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 acidbase balance, as needed and especially during prolonged use. (5.5) Refeeding Syndrome: Monitor severely undernourished patients and slowly increase nutrient intake. (5.6)

The most common adverse reactions are, hyperglycemia, hypersensitivity reactions, hyponatremia, infection both systemic and at the injection site, vein thrombosis or phlebitis, and electrolyte imbalance. (6) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551- 7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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) Pediatric Use: Increased risk of hypoglycemia/hyperglycemia; monitor serum glucose concentrations. (8.4) See 17 for PATIENT COUNSELING INFORMATION. Revised: 12/2021

8.1 Pregnancy Risk Summary Appropriate administration of 10% Dextrose Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with injectable dextrose solutions. The estimated background risk of major birth defects and miscarriage for the indicated population is 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. 8.2 Lactation Risk Summary There are no data on the presence of dextrose in human milk, the effects on a breastfed infant, or the effects on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of 10% Dextrose Injection to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for 10% Dextrose Injection and any potential adverse effects on the breastfed infant from 10% Dextrose Injection or from the underlying maternal condition. 8.4 Pediatric Use 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)]. 8.5 Geriatric Use 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.

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) 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 (freeflex® 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. structure

10% Dextrose Injection, USP is supplied in single dose flexible plastic containers as follows: Product Number Unit of Sale Strength Each NDC 51662-1680-1 250mL BAG Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. 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.

1 INDICATIONS AND USAGE Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient or contraindicated ( 1 )

2 DOSAGE AND ADMINISTRATION • Must be diluted with compatible intravenous fluids or used as admixture, prior to administration. Not for direct intravenous infusion . ( 2.1 ) • Only for slow intravenous infusion only into a: ( 2.1 ) o Central vein , if final dextrose concentration is greater than 5% or osmolality is greater than 900 mOsm/L o Peripheral vein , if final dextrose concentration 5% or less and osmolality is less than 900 mOsm/L • Individualize dosage based on the patient's clinical condition, body weight, nutritional/fluid requirements, as well as additional energy given orally/enterally ( 2.2 ) • Discontinue infusion of concentrated dextrose solutions slowly and/or administer 5% dextrose ( 2.3 ) 2.1 Important Preparation and Administration Instructions Dextrose Injection is supplied in the following five strengths: 20%, 30%, 40%, 50% and 70% [see How Supplied/Storage and Handling ( 16 )] . Prior to administration, Dextrose Injection must be diluted with other compatible intravenous fluids or used as an admixture with amino acids. It is not for direct intravenous infusion . Preparation Prior to Administration • Because additives may be incompatible, evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult with a pharmacist, if available. If it is deemed advisable to introduce additives, use aseptic technique and mix thoroughly. • Inspect Dextrose Injection to ensure precipitates have not formed during the mixing or addition of additives. Discard the bag if precipitates are observed. Some opacity of the plastic container (due to moisture absorption during sterilization process) may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. • Use promptly after admixing or dilution. • For single use only; discard unused portion Important Administration Instructions • Set the vent to the closed position on a vented intravenous administration set to prevent air embolism. • Use a dedicated line without any connections to avoid air embolism. • 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. • The choice of a central or peripheral venous route of infusion should depend on the osmolarity of the final infusate. Solutions with greater than 5% dextrose or with osmolarity of greater than or equal to 900 mOsm/L must be infused through a central catheter [see Warnings and Precautions ( 5.5 )] . 2.2 Dosing Information Caution: Dextrose Injection is not for direct intravenous infusion. Prior to administration, Dextrose Injection must be diluted with other compatible intravenous fluids or used as an admixture with amino acids. Individualize the dosage of Dextrose Injection based on the patient's clinical condition (ability to adequately metabolize dextrose), body weight, nutritional and fluid requirements, as well as additional energy given orally or enterally to the patient. The administration rate should be governed, especially during the first few day of therapy, by the patient's tolerance to dextrose. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of blood glucose levels.

terally to the patient. The administration rate should be governed, especially during the first few day of therapy, by the patient's tolerance to dextrose. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of blood glucose levels. 2.3 Discontinuation of Dextrose Injection To reduce the risk of hypoglycemia, a gradual decrease in flow rate in the last hour of infusion should be considered.

3 DOSAGE FORMS AND STRENGTHS Dextrose Injection 20%, 30%, 40%, 50%, and 70% USP are sterile, non-pyrogenic, hypertonic solutions of dextrose in single-dose, partial-fill, flexible containers. 500 mL fill volume in 1000 mL flexible container • 20% (0.2 grams/mL): 20 grams of dextrose hydrous per 100 mL • 30% (0.3 grams/mL): 30 grams of dextrose hydrous per 100 mL • 40% (0.4 grams/mL): 40 grams of dextrose hydrous per 100 mL • 50% (0.5 grams/mL): 50 grams of dextrose hydrous per 100 mL • 70% (0.7 grams/mL): 70 grams of dextrose hydrous per 100 mL Injection: Single-dose, partial-fill, flexible containers with ( 3 ): 500 mL fill volume in 1000 mL flexible container: • 20% (0.2 grams/mL): 20 grams of dextrose hydrous per 100 mL • 30% (0.3 grams/mL): 30 grams of dextrose hydrous per 100 mL • 40% (0.4 grams/mL): 40 grams of dextrose hydrous per 100 mL • 50% (0.5 grams/mL): 50 grams of dextrose hydrous per 100 mL • 70% (0.7 grams/mL): 70 grams of dextrose hydrous per 100 mL

4 CONTRAINDICATIONS The use of Dextrose Injection is contraindicated in patients: • who are severely dehydrated as hypertonic dextrose solution can worsen the patient's hyperosmolar state. • with known hypersensitivity to dextrose [see Warnings and Precautions (5.2) ] . • Severe dehydration ( 4 ) • Known hypersensitivity to dextrose ( 4 )

5 WARNINGS AND PRECAUTIONS • 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 ) • Risk of Infection : Monitor for signs and symptoms and laboratory parameters ( 5.3 ) • Refeeding Syndrome : Monitory laboratory parameters ( 5.4 ) • Vein Damage and Thrombosis : Administer solutions containing more than 5% dextrose as the final concentration or solutions with an osmolarity ≥ 900 mOsm/L through a central vein ( 2.1 , 5.5 ) • Aluminum Toxicity : Dextrose Injection contains aluminum that may be toxic. Patients with impaired renal function, and preterm infants, at higher risk. Limit aluminum to less than 4 mcg/kg/day ( 5.6 , 8.4 ) • Parenteral Nutrition Associated Liver Disease : increased risk in patients who receive parenteral nutrition for extended periods of time, especially preterm infants; monitor liver function tests, if abnormalities occur consider discontinuation or dosage reduction. ( 5.7 , 8.4 ) • Electrolyte Imbalance and Fluid Overload : monitor daily fluid balance, blood electrolyte levels, correct as needed. ( 5.8 , 8.4 ) 5.1 Hyperglycemia and Hyperosmolar Hyperglycemic State The use of dextrose infusions in patients with diabetes mellitus or impaired glucose tolerance may worsen hyperglycemia. Administration of dextrose at a rate exceeding the patient's utilization rate may lead to hyperglycemia, coma, and death. Patients with underlying confusion and renal impairment who receive dextrose infusions, may be at greater risk of developing hyperosmolar hyperglycemic state. Monitor blood glucose levels and treat hyperglycemia to maintain optimum levels while administering Dextrose Injection. Insulin may be administered or adjusted to maintain optimal blood glucose levels during Dextrose Injection administration. 5.2 Hypersensitivity Reactions Hypersensitivity reactions including anaphylaxis have been reported with dextrose infusions. Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity reaction develop. Signs or symptoms may include: tachypnea, dyspnea, hypoxia, bronchospasm, tachycardia, hypotension, cyanosis, vomiting, nausea, headache, sweating, dizziness, altered mentation, flushing, rash, urticaria, erythema, pyrexia, and chills. 5.3 Risk of Infections Patients who require parenteral nutrition are at high risk of infections because the nutritional components of these solutions can support microbial growth. The risk of infection is increased in patients with malnutrition-associated immunosuppression, hyperglycemia exacerbated by dextrose infusion, long-term use and poor maintenance of intravenous catheters, or immunosuppressive effects of other concomitant conditions, drugs, or other components of the parenteral formulation (e.g., lipid emulsion). To decrease the risk of infectious complications, ensure aseptic technique in catheter placement and maintenance, as well as aseptic technique in the preparation and administration of the nutritional formula. Monitor for signs and symptoms (including fever and chills) of early infections, including laboratory test results (including leukocytosis and hyperglycemia) and frequent checks of the parenteral access device and insertion site for edema, redness and discharge.

reparation and administration of the nutritional formula. Monitor for signs and symptoms (including fever and chills) of early infections, including laboratory test results (including leukocytosis and hyperglycemia) and frequent checks of the parenteral access device and insertion site for edema, redness and discharge. 5.4 Refeeding Syndrome Refeeding severely undernourished patients may result in refeeding syndrome, characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. To prevent these complications, monitor severely undernourished patients and slowly increase nutrient intakes. 5.5 Vein Damage and Thrombosis Dextrose Injection is for admixture with amino acids or dilution with other compatible intravenous fluids. It is not for direct intravenous infusion. Administer solutions containing more than 5% dextrose or with an osmolarity of ≥ 900 mOsm/L through a central vein [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. 5.6 Aluminum Toxicity Dextrose Injection contains no more than 25 mcg/L of aluminum. However, with prolonged parenteral administration in patients with renal impairment, the aluminum contained in Dextrose Injection may reach toxic levels. Preterm infants are at greater risk because their kidneys are immature, and they require large amounts of concomitant calcium and phosphate solutions that contain aluminum. Patients with renal impairment, including preterm infants, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day, accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration of total parenteral nutrition products. 5.7 Risk of Parenteral Nutrition Associated Liver Disease Parenteral Nutrition Associated Liver Disease (PNALD) has been reported in patients who receive parenteral nutrition for extended periods of time, especially preterm infants, and can present as cholestasis or steatohepatitis. The exact etiology is not entirely clear and is likely multifactorial. If Dextrose Injection-treated patients develop abnormal liver function tests consider discontinuation or dosage reduction. 5.8 Electrolyte Imbalance and Fluid Overload Electrolyte deficits, particularly in serum potassium and phosphate, may occur during prolonged use of concentrated dextrose solutions. Depending on the volume and rate of infusion, the intravenous administration of concentrated dextrose solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations in the administered solution. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations in the solution. Monitor blood electrolyte levels, correct fluid and electrolyte imbalances, and administer essential vitamins and minerals as needed. Monitor daily fluid balance.

6 ADVERSE REACTIONS The following adverse reactions from voluntary reports or clinical studies have been reported with Dextrose Injection. Because many of these reactions were 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. • Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions ( 5.1 )] . • Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] . • Risk of infections [see Warnings and Precautions ( 5.3 )] . • Refeeding syndrome [see Warnings and Precautions ( 5.4 )] . • Vein damage and thrombosis [see Warnings and Precautions ( 5.5 )] . • Aluminum toxicity [see Warnings and Precautions ( 5.6 )] . • Risk of parenteral nutrition associated liver disease [see Warnings and Precautions ( 5.7 )] . • Electrolyte imbalance and fluid overload [see Warnings and Precautions ( 5.8 )] . The most common adverse reactions are hyperosmolar syndrome, infection both systemic and at the injection site, vein thrombosis or phlebitis, and hypervolemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact ICU Medical, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

8 USE IN SPECIFIC POPULATIONS Pediatric Use: Increased risk of hypoglycemia/hyperglycemia; monitor serum glucose concentrations. ( 8.4 ) 8.1 Pregnancy Risk Summary There are no data with Dextrose Injection in pregnant women. In addition, animal reproduction studies have not been conducted with dextrose. 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 Disease-Associated Maternal and/or Embryo/Fetal Risk Consider parenteral nutrition in cases of severe maternal malnutrition where nutritional requirements cannot be fulfilled by the enteral route because of the risks to the fetus associated with severe malnutrition, including preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations, and perinatal mortality. 8.2 Lactation There are no data regarding the presence of dextrose in human milk, the effects on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Dextrose Injection and any potential adverse effects on the breastfed infant from Dextrose Injection or from the underlying maternal condition. 8.4 Pediatric Use Neonates, especially those born premature and 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. Hypoglycemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death. Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of Dextrose Injection may result in increased serum osmolality and possible intracerebral hemorrhage. Because of immature renal function, preterm infants receiving prolonged treatment with Dextrose Injection, may be at risk aluminum toxicity [see Warnings and Precautions ( 5.6 )] . Patients, including pediatric patients, may be at risk for Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions ( 5.7 )] . 8.5 Geriatric Use Clinical studies of Dextrose Injection did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from other younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

8.1 Pregnancy Risk Summary There are no data with Dextrose Injection in pregnant women. In addition, animal reproduction studies have not been conducted with dextrose. 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 Disease-Associated Maternal and/or Embryo/Fetal Risk Consider parenteral nutrition in cases of severe maternal malnutrition where nutritional requirements cannot be fulfilled by the enteral route because of the risks to the fetus associated with severe malnutrition, including preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations, and perinatal mortality.

8.4 Pediatric Use Neonates, especially those born premature and 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. Hypoglycemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death. Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of Dextrose Injection may result in increased serum osmolality and possible intracerebral hemorrhage. Because of immature renal function, preterm infants receiving prolonged treatment with Dextrose Injection, may be at risk aluminum toxicity [see Warnings and Precautions ( 5.6 )] . Patients, including pediatric patients, may be at risk for Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions ( 5.7 )] .

8.5 Geriatric Use Clinical studies of Dextrose Injection did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from other younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

10 OVERDOSAGE An increased infusion rate of Dextrose Injection or administration of a concentrated dextrose solution can cause hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance [see Warnings and Precautions ( 5.1 , 5.8 )] . Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. Discontinue infusion and institute appropriate corrective measures in the event of overhydration or solute overload during therapy, with particular attention to respiratory and cardiovascular systems . For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org .

11 DESCRIPTION Dextrose Injection, USP 20%, 30%, 40%, 50% and 70% are sterile, nonpyrogenic, hypertonic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after appropriate admixture or dilution [see Dosage and Administration ( 2.1 )] . Partial-fill containers, designed to facilitate admixture or dilution to provide dextrose in various concentrations, are available in various sizes. See Table 1 for the content and characteristics of these concentrated solutions . The solutions contain no bacteriostatic, antimicrobial agent or added buffer and are intended only for use as a single-dose injection following admixture or dilution. The pH is 4.3 (range is 3.2 to 6.5). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Table 1. Contents and Characteristics of Dextrose Injection 20%, 30%, 40%, 50%, and 70% Strength Fill Volume Amount of Dextrose Hydrous per Container kcal Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous. per Container mOsmol per liter 20% (0.2 grams/mL) 500 mL 100 grams 340 1009 30% (0.3 grams/mL) 500 mL 150 grams 510 1514 40% (0.4 grams/mL) 500 mL 200 grams 680 2018 50% (0.5 grams/mL) 500 mL 250 grams 850 2523 70% (0.7 grams/mL) 500 mL 350 grams 1190 3532 Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula: Dextrose may be derived from corn. Water for Injection, USP is chemically designated H 2 O. Dextrose Injection contains no more than 25 mcg/L of aluminum. Structural Formula for Dextrose Injection, USP

<table ID="_Reft1" width="100%"><caption>Table 1. Contents and Characteristics of Dextrose Injection 20%, 30%, 40%, 50%, and 70%</caption><col width="30%"/><col width="18%"/><col width="26%"/><col width="14%"/><col width="12%"/><tbody><tr><td align="center" styleCode="Rrule Botrule Toprule " valign="middle"><paragraph><content styleCode="bold">Strength</content></paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph><content styleCode="bold">Fill Volume</content></paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph><content styleCode="bold">Amount of Dextrose Hydrous per Container</content></paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph><content styleCode="bold">kcal</content><footnote ID="_Ref439159195">Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous.</footnote> <content styleCode="bold">per Container</content></paragraph></td><td align="center" styleCode="Botrule Lrule Toprule " valign="middle"><paragraph><content styleCode="bold">mOsmol </content> <content styleCode="bold">per liter</content></paragraph></td></tr><tr><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>20% (0.2 grams/mL)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>500 mL</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>100 grams</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>340</paragraph></td><td align="center" styleCode="Lrule Botrule " valign="middle"><paragraph>1009</paragraph></td></tr><tr><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>30% (0.3 grams/mL)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>500 mL</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>150 grams</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>510</paragraph></td><td align="center" styleCode="Lrule Botrule " valign="middle"><paragraph>1514</paragraph></td></tr><tr><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>40% (0.4 grams/mL)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>500 mL</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>200 grams</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>680</paragraph></td><td align="center" styleCode="Lrule Botrule " valign="middle"><paragraph>2018</paragraph></td></tr><tr><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>50% (0.5 grams/mL)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>500 mL</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>250 grams</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>850</paragraph></td><td align="center" styleCode="Lrule Botrule " valign="middle"><paragraph>2523</paragraph></td></tr><tr><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>70% (0.7 grams/mL)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="middle"><paragraph>500 mL</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valig

gn="middle"><paragraph>2523</paragraph></td></tr><tr><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>70% (0.7 grams/mL)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="middle"><paragraph>500 mL</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valig n="middle"><paragraph>350 grams</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="middle"><paragraph>1190</paragraph></td><td align="center" styleCode="Botrule Lrule " valign="middle"><paragraph>3532</paragraph></td></tr></tbody></table>

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Dextrose Injection is used to supplement nutrition by providing glucose parenterally. Dextrose is oxidized to carbon dioxide and water, yielding energy.

16 HOW SUPPLIED/STORAGE AND HANDLING Dextrose Injection, 20%, 30%, 40%, 50%, and 70% USP are sterile hypertonic solutions of dextrose supplied in single-dose, partial-fill flexible containers (see Tables 1 and 2 ) for intravenous administration after appropriate admixture or dilution [see Dosage and Administration ( 2.1 )] . Do not remove container from the overwrap until intended for use. Table 2: Strengths, Fill Volume, and NDC # of Dextrose Injection 20%, 30%, 40%, 50%, and 70% Strength Fill Volume NDC# 20% (0.2 grams/mL) 500 mL 0409-7935-19 0990-7935-19 30% (0.3 grams/mL) 500 mL 0409-8004-15 0990-8004-15 40% (0.4 grams/mL) 500 mL 0409-7937-19 0990-7937-19 50% (0.5 grams/mL) 500 mL 0409-7936-19 0990-7936-19 70% (0.7 grams/mL) 500 mL 0409-7918-19 0990-7918-19 ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. Use the product immediately after mixing and the introduction of additives. Store between 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.] Do not freeze.

<table ID="_Reft2" width="100%"><caption>Table 2: Strengths, Fill Volume, and NDC # of Dextrose Injection 20%, 30%, 40%, 50%, and 70%</caption><col width="35%"/><col width="35%"/><col width="29%"/><tbody><tr><td align="center" styleCode="Rrule Botrule Toprule " valign="top"><paragraph><content styleCode="bold">Strength</content></paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">Fill Volume</content></paragraph></td><td align="center" styleCode="Botrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">NDC#</content></paragraph></td></tr><tr><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>20% (0.2 grams/mL)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>500 mL</paragraph></td><td align="center" styleCode="Lrule Botrule " valign="top"><paragraph>0409-7935-19 0990-7935-19</paragraph></td></tr><tr><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>30% (0.3 grams/mL)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>500 mL</paragraph></td><td align="center" styleCode="Lrule Botrule " valign="top"><paragraph>0409-8004-15 0990-8004-15</paragraph></td></tr><tr><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>40% (0.4 grams/mL)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>500 mL</paragraph></td><td align="center" styleCode="Lrule Botrule " valign="top"><paragraph>0409-7937-19 0990-7937-19</paragraph></td></tr><tr><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>50% (0.5 grams/mL)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>500 mL</paragraph></td><td align="center" styleCode="Lrule Botrule " valign="top"><paragraph>0409-7936-19 0990-7936-19</paragraph></td></tr><tr><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>70% (0.7 grams/mL)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>500 mL</paragraph></td><td align="center" styleCode="Botrule Lrule " valign="top"><paragraph>0409-7918-19 0990-7918-19</paragraph></td></tr></tbody></table>

17 PATIENT COUNSELING INFORMATION Inform patients, caregivers, or home healthcare providers of the following risks of Dextrose Injection: • Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions ( 5.1 )] • Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] • Risk of infection [see Warnings and Precautions ( 5.3 )] • Vein damage and thrombosis [see Warnings and Precautions ( 5.5 )] • Aluminum toxicity [see Warnings and Precautions ( 5.6 )] • Risk of parenteral nutrition associated liver disease [see Warnings and Precautions ( 5.7 )] • Fluid overload and electrolyte imbalance [see Warnings and Precautions ( 5.8 )] EN-4695 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

Concentrated Dextrose in Water Pharmacy Bulk Package — Not For Direct Infusion. NOTE: This solution is hypertonic — see WARNINGS and PRECAUTIONS. Directions for Use of Pharmacy Bulk Package Container Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration or admixture and final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration, whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions where possible. 70% Dextrose Injection USP in the Pharmacy Bulk Package is intended for use in the preparation of sterile, intravenous admixtures. Refer to standard texts and guidelines on the preparation of parenteral nutritional admixtures. When compounding admixtures, use aseptic technique. Mix thoroughly. Do not store any unused portion of 70% Dextrose Injection USP. TO OPEN: Inspect overwrap. Do not use if overwrap has been damaged. Do not use unless solution is clear and closure is intact. Tear overwrap starting from the tear notches. (Figure 1) Inspect the container for minute leaks by squeezing inner bag firmly. If leaks are found, discard the bag as sterility may be impaired. For compounding only. Do not use for direct infusion. PREPARATION FOR ADMIXING Note: Important Admixing Information The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar air flow hood (or an equivalent clean air compounding area). The contents are restricted to the preparation of admixtures for infusion or, through a sterile transfer device, for the filling of empty sterile syringes. Additives may be incompatible with the fluid withdrawn from this container. When compounding admixtures, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution container permits. (see PRECAUTIONS, General ) Do not use/penetrate blocked port (see Figure 2, left upper corner). Remove aluminum foil of set port at the bottom of container. Attach suitable transfer device or compounding set (Figure 2). Refer to complete directions accompanying device. Hang bag on suitable fixture (Figure 3). Once container closure has been penetrated, withdrawal of content should be completed within 4 hours. Bag Illustration Figure 1 Bag Hanger illustration Figure 2 Figure 3

ach suitable transfer device or compounding set (Figure 2). Refer to complete directions accompanying device. Hang bag on suitable fixture (Figure 3). Once container closure has been penetrated, withdrawal of content should be completed within 4 hours. Bag Illustration Figure 1 Bag Hanger illustration Figure 2 Figure 3 Rx only Revised: May 2019 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y36-002-997 LD-355-4

DESCRIPTION Each 100 mL of 70% Dextrose Injection USP contains: Hydrous Dextrose USP 70 g; Water for Injection USP qs pH: 4.0 (3.2-6.5); Calculated Osmolarity: 3532 mOsmol/liter, hypertonic. Specific gravity 1.233 at 25°C Calories per liter: 2380 calculated on the basis of 3.4 kcal/g of dextrose, hydrous 70% Dextrose Injection USP is sterile, nonpyrogenic and contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration after appropriate admixture or dilution as a caloric source. The formula of the active ingredient is: Ingredient Molecular Formula Molecular Weight Hydrous Dextrose USP 198.17 Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during use. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Dextrose Molecular Formula

<table><col/><col/><col/><tbody><tr><td align="center"> <content styleCode="bold">Ingredient</content></td><td> <content styleCode="bold">Molecular Formula</content></td><td> <content styleCode="bold">Molecular Weight</content></td></tr><tr><td> Hydrous Dextrose USP</td><td> <renderMultiMedia referencedObject="MM1"/></td><td align="center"> 198.17</td></tr></tbody></table>

CLINICAL PHARMACOLOGY 70% Dextrose Injection USP provides calories and is a source of water for hydration. It is capable of inducing diuresis depending on the clinical condition of the patient. Dextrose is readily metabolized, may decrease losses of body protein and nitrogen, promotes glycogen deposition and decreases or prevents ketosis if sufficient doses are provided. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirements range from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

INDICATIONS AND USAGE 70% Dextrose Injection USP is indicated as a caloric component in a parenteral nutrition regimen. 70% Dextrose Injection USP is used with an appropriate protein (nitrogen) source in the prevention of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns.

CONTRAINDICATIONS The infusion of 70% Dextrose Injection USP is contraindicated in patients having intracranial or intraspinal hemorrhage, in patients who are severely dehydrated, in patients who are anuric, and in patients in hepatic coma. Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.

WARNINGS This injection is for compounding only, not for direct infusion. Dilute before use to a concentration which will, when administered with an amino acid (nitrogen) source, result in an appropriate calorie to gram of nitrogen ratio and which has an osmolarity consistent with the route of administration. Unless appropriately diluted, the infusion of hypertonic dextrose injection into a peripheral vein may result in vein irritation, vein damage, and thrombosis. Strongly hypertonic nutrient solutions should only be administered through an indwelling intravenous catheter with the tip located in a large central vein such as the superior vena cava. Use of 70% Dextrose Injection USP to prepare parenteral nutritional admixtures may be incompatible with other components, especially calcium and phosphate salts and lipid emulsions. Incompatibility of admixed components can produce precipitates which may cause particulate emboli. Use 70% Dextrose Injection USP only to prepare formulations that are known to be stable: refer to standard texts for further information. The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. WARNING: 70% Dextrose Injection USP contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. Prolonged infusion of isotonic or hypotonic dextrose in water may increase the volume of extracellular fluid and cause water intoxication. Solutions containing dextrose without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility of agglomeration. Excessive administration of potassium-free dextrose solutions may result in significant hypokalemia. Serum potassium levels should be maintained and potassium supplemented as required. In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.

PRECAUTIONS General This solution should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation. Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus or carbohydrate intolerance for any reason. Essential electrolytes, minerals, and vitamins should be supplied as needed. Hypokalemia may develop during parenteral administration of hypertonic dextrose solutions. Sufficient amounts of potassium should be added to dextrose solutions administered to fasting patients with good renal function, especially those on digitalis therapy. To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration. See WARNINGS . Do not use plastic container in series connection. If administration of 70% Dextrose Injection USP after admixture or dilution is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container. This solution is intended for intravenous administration after admixture or dilution using sterile equipment. When using an automated compounding device replace all disposable components as recommended by manufacturer and at least every 24 hours. Aseptic technique is essential with the use of sterile preparations for compounding nutritional admixtures. Discard container within 4 hours of entering closure. Administration of hypertonic dextrose and amino acid solutions via central venous catheter may be associated with complications which can be prevented or minimized by careful attention to all aspects of the procedure. This includes attention to solution preparation, administration and patient monitoring. It is essential that a carefully prepared protocol, based upon current medical practice, be followed, preferably by an experienced team . The package insert of the protein (nitrogen) source should be consulted for dosage and all precautionary information. Use only if solution is clear and container and seals are intact. 70% Dextrose Injection USP contains no more than 25 mcg/L of aluminum. Laboratory Tests Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require tailoring of the electrolyte pattern, in these or alternative solutions. Drug Interactions Caution must be exercised in the administration of 70% Dextrose Injection USP to patients receiving corticosteroids or corticotropin. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Dispose of any unused product. See WARNINGS .

ution must be exercised in the administration of 70% Dextrose Injection USP to patients receiving corticosteroids or corticotropin. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Dispose of any unused product. See WARNINGS . Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with Dextrose Injections USP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility. Pregnancy There are no adequate and well controlled studies with Dextrose Injections, USP in pregnant women and animal reproduction studies have not been conducted with this drug. Therefore, it is not known whether Dextrose Injections USP can cause fetal harm when administered to a pregnant woman. Dextrose Injections USP should be given during pregnancy only if the potential benefit justifies the potential risk to the fetus. Labor and Delivery Intrapartum maternal intravenous infusion of glucose-containing solutions may produce maternal hyperglycemia with subsequent fetal hyperglycemia and fetal metabolic acidosis. Fetal hyperglycemia can result in increased fetal insulin levels which may result in neonatal hypoglycemia following delivery. Consider the potential risks and benefits for each specific patient before administering Dextrose Injection, USP. Nursing Mothers It is not known if this drug is present in human milk. Because many drugs are present in human milk, caution should be exercised when Dextrose Injections USP are administered to a nursing woman. Pediatric Use The use of Dextrose in pediatric patients is based on clinical practice (see DOSAGE AND ADMINISTRATION ). Because of their hypertonicity, 70% Dextrose Injections must be diluted prior to administration. Newborns – especially those born premature and with low birth weight - are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Hypoglycemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death. Geriatric Use An evaluation of literature revealed no clinical experience identifying 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. This drug 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. See WARNINGS .

General This solution should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation. Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus or carbohydrate intolerance for any reason. Essential electrolytes, minerals, and vitamins should be supplied as needed. Hypokalemia may develop during parenteral administration of hypertonic dextrose solutions. Sufficient amounts of potassium should be added to dextrose solutions administered to fasting patients with good renal function, especially those on digitalis therapy. To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration. See WARNINGS . Do not use plastic container in series connection. If administration of 70% Dextrose Injection USP after admixture or dilution is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container. This solution is intended for intravenous administration after admixture or dilution using sterile equipment. When using an automated compounding device replace all disposable components as recommended by manufacturer and at least every 24 hours. Aseptic technique is essential with the use of sterile preparations for compounding nutritional admixtures. Discard container within 4 hours of entering closure. Administration of hypertonic dextrose and amino acid solutions via central venous catheter may be associated with complications which can be prevented or minimized by careful attention to all aspects of the procedure. This includes attention to solution preparation, administration and patient monitoring. It is essential that a carefully prepared protocol, based upon current medical practice, be followed, preferably by an experienced team . The package insert of the protein (nitrogen) source should be consulted for dosage and all precautionary information. Use only if solution is clear and container and seals are intact. 70% Dextrose Injection USP contains no more than 25 mcg/L of aluminum.

Laboratory Tests Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require tailoring of the electrolyte pattern, in these or alternative solutions.

Drug Interactions Caution must be exercised in the administration of 70% Dextrose Injection USP to patients receiving corticosteroids or corticotropin. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Dispose of any unused product. See WARNINGS .

Pregnancy There are no adequate and well controlled studies with Dextrose Injections, USP in pregnant women and animal reproduction studies have not been conducted with this drug. Therefore, it is not known whether Dextrose Injections USP can cause fetal harm when administered to a pregnant woman. Dextrose Injections USP should be given during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labor and Delivery Intrapartum maternal intravenous infusion of glucose-containing solutions may produce maternal hyperglycemia with subsequent fetal hyperglycemia and fetal metabolic acidosis. Fetal hyperglycemia can result in increased fetal insulin levels which may result in neonatal hypoglycemia following delivery. Consider the potential risks and benefits for each specific patient before administering Dextrose Injection, USP.

Nursing Mothers It is not known if this drug is present in human milk. Because many drugs are present in human milk, caution should be exercised when Dextrose Injections USP are administered to a nursing woman.

Pediatric Use The use of Dextrose in pediatric patients is based on clinical practice (see DOSAGE AND ADMINISTRATION ). Because of their hypertonicity, 70% Dextrose Injections must be diluted prior to administration. Newborns – especially those born premature and with low birth weight - are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Hypoglycemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death. Pediatric Use The dosage selection and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician experienced in pediatric intravenous fluid therapy.

Geriatric Use An evaluation of literature revealed no clinical experience identifying 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. This drug 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. See WARNINGS .

ADVERSE REACTIONS Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. Incompatibility of admixed components can produce precipitates which may cause particulate emboli. Hyperosmolar syndrome, resulting from excessively rapid administration of concentrated dextrose may cause hypovolemia, dehydration, mental confusion and/or loss of consciousness. Too rapid infusion of hypertonic solutions may cause local pain and venous irritation. Rate of administration should be adjusted according to tolerance. Use of the largest peripheral vein and a small bore needle is recommended. (See DOSAGE AND ADMINISTRATION .) Hypersensitivity reactions, including anaphylaxis and chills. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

DOSAGE AND ADMINISTRATION This solution is for intravenous use only after admixture or dilution. 70% Dextrose Injection USP is designed for use with automated compounding devices for preparing intravenous nutritional admixtures or for the filling of empty sterile syringes. Dosages will be in accordance with the recommendation of the prescribing physician. 70% Dextrose Injection USP is not intended for direct infusion. Admixtures should be made by, or under the direction of, a pharmacist using strict aseptic technique under a laminar flow hood. Compounded admixtures may be stored under refrigeration for up to 24 hours. Administration of admixtures should be completed within 24 hours after removal from refrigeration. Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy. Fluid Administration should be based on calculated maintenance or replacement fluid requirements for each patient. Pediatric Use The dosage selection and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician experienced in pediatric intravenous fluid therapy.

HOW SUPPLIED 70% Dextrose Injection USP is supplied in 2000 mL Pharmacy Bulk Package containers packaged 4 per case. NDC REF SIZE 0264-7387-50 S8705 2000 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.