Dextrose

1 INDICATIONS AND USAGE Dextrose Injection is indicated as source of water and calories. Dextrose Injection is indicated as a source of water and calories. ( 1 )

2 DOSAGE AND ADMINISTRATION 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 ) 2.1 Important Administration Instructions 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 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. 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 co…

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 ) 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 ) 5.1 Hyperglycemia and Hyperosmolar Hyperglycemic State The use of dextrose infusions in patients with 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. Hyperglycemia is associated with an increase in serum osmolality, resulting in osmotic diuresis, dehydration and electrolyte losses [see Warnings and Precautions ( 5.5 )] . Patients with underlying CNS disease 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 levels within normal limits 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 and infusion reactions, including anaphylaxis, have been reported with Dextrose Injection [see Adverse Reactions ( 6 )]. Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated. 5.3 Vein Damage and Thrombosis 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. 5.4 Hyponatremia Dextrose Injection is a hypertonic solution [see Description, Table 1 ( 11 )]. In the body, however, glucose containing fluids can become extremely physiologically hypotonic due to rapid glucose metabolization. Monitoring of serum sodium is particularly important for hypotonic fluids. Depending on the tonicity of the solution, the volume and rate of infusion, and depending on a patient's underlying clinical condition and capability to metabolize glucose, intravenous administration of glucose can cause electrolyte disturbances, most importantly hypo- or hyperosmotic hyponatremia. Monitor serum sodium to minimize the risk of hyponatremia. The risk for hyponatremia is increased in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as diuretics, certain antiepileptic and psychotropic medications). Close clinical monitoring may be warranted. Acute hyponatremia can lead to acute hyponatremic encephalopathy characterize…

4 CONTRAINDICATIONS 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 )] . Clinically significant hyperglycemia. ( 4 ) Known hypersensitivity to dextrose. ( 4 )

7 DRUG INTERACTIONS 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 ) 7.1 Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance 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.

8.1 Pregnancy Risk Summary Appropriate administration of 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.

6 ADVERSE REACTIONS 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 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.