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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.

tainer. 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.

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 container in series connections.

3 DOSAGE FORMS AND STRENGTHS 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 Injection: 10% (0.1 grams/mL): 10 grams of dextrose hydrous per 100 mL in flexible containers: 250 mL, 500 mL, and 1000 mL. ( 3 )

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 )

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.

lebitis 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 characterized by headache, nausea, seizures, lethargy and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury. Patients at increased risk for developing complications of hyponatremia, such as hyponatremic encephalopathy include pediatric patients; women, in particular, premenopausal women; patients with hypoxemia; and in patients with underlying central nervous system disease [see Use in Specific Populations ( 8.4 , 8.5 )]. Avoid Dextrose Injection in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations. Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications. Brain adaptations reducing risk of cerebral edema make the brain vulnerable to injury when chronic hyponatremia is too rapidly corrected, which is known as osmotic demyelination syndrome (ODS). To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications. High volume infusion must be used with close monitoring in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatremia. 5.5 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 patient's underlying clinical condition and capability to metabolize dextrose, intravenous administration of Dextrose Injection can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, (including hypoosmotic hyponatremia), 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. Avoid Dextrose Injection in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, blood electrolyte levels, concentration of glucose, acid-base balance, correct fluid and electrolyte imbalances during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation and acid-base balance as needed and especially during prolonged use.

alance, blood electrolyte levels, concentration of glucose, acid-base balance, correct fluid and electrolyte imbalances during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation and acid-base balance as needed and especially during prolonged use. Additional monitoring is recommended for patients with water and electrolyte disturbances that could be aggravated by increased glucose, insulin administration and/or free water load. Patients at increased risk for developing hyponatremic encephalopathy include pediatric patients; elderly patients, women, in particular premenopausal women; patients with hypoxemia; and patients with underlying CNS disease [see Use in Specific Populations ( 8.4 , 8.5 )]. 5.6 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 intake.

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.

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 USE IN SPECIFIC POPULATIONS Pediatric Use : Increased risk of hypoglycemia/hyperglycemia; monitor serum glucose concentrations. ( 8.4 ) 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. 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 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 Dextrose Injection and any potential adverse effects on the breastfed infant from Dextrose Injection or from the underlying maternal condition. 8.4 Pediatric Use The safety profile of 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 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 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.

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.

8.4 Pediatric Use The safety profile of 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 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 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.

10 OVERDOSAGE An increased infusion rate of 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.

11 DESCRIPTION 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) Table 1. Contents and Characteristics of Dextrose Injection 10%, USP *Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous Strength Fill Volume Amount of Dextrose Hydrous per Container kcal* per Container Osmolarity (mOsmol per liter) Dextrose Injection 10%, USP (0.1 grams/mL) 250 mL 25 grams 85 505 500 mL 50 grams 170 505 1000 mL 100 grams 340 505 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: Water for Injection, USP is chemically designated H 2 O. 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. Structural Formula

<table ID="t1" width="100%"><caption>Table 1. Contents and Characteristics of Dextrose Injection 10%, USP </caption><col width="20.280%" align="left"/><col width="15.460%" align="left"/><col width="27.840%" align="left"/><col width="16.260%" align="left"/><col width="20.160%" align="left"/><tfoot><tr><td colspan="5" align="left" valign="top"><paragraph styleCode="footnote">*Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous </paragraph></td></tr></tfoot><tbody><tr><td align="center" valign="top" styleCode="Toprule Botrule Lrule Rrule"><content styleCode="bold">Strength</content></td><td align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Fill Volume</content></td><td align="center" valign="bottom" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Amount of Dextrose Hydrous per Container</content></td><td align="center" valign="bottom" styleCode="Toprule Botrule Rrule"><content styleCode="bold">kcal* per Container</content></td><td align="center" valign="bottom" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Osmolarity (mOsmol per liter)</content></td></tr><tr><td rowspan="3" align="center" valign="top" styleCode="Botrule Lrule Rrule">Dextrose Injection 10%, USP (0.1 grams/mL) </td><td align="center" valign="bottom" styleCode="Botrule Rrule">250 mL </td><td align="center" valign="bottom" styleCode="Botrule Rrule">25 grams </td><td align="center" valign="bottom" styleCode="Botrule Rrule">85 </td><td align="center" valign="bottom" styleCode="Botrule Rrule">505 </td></tr><tr><td align="center" valign="top" styleCode="Botrule Rrule">500 mL </td><td align="center" valign="top" styleCode="Botrule Rrule">50 grams </td><td align="center" valign="top" styleCode="Botrule Rrule">170 </td><td align="center" valign="top" styleCode="Botrule Rrule">505 </td></tr><tr><td align="center" valign="top" styleCode="Botrule Rrule">1000 mL </td><td align="center" valign="top" styleCode="Botrule Rrule">100 grams </td><td align="center" valign="top" styleCode="Botrule Rrule">340 </td><td align="center" valign="top" styleCode="Botrule Rrule">505 </td></tr></tbody></table>

16 HOW SUPPLIED/STORAGE AND HANDLING 10% Dextrose Injection, USP is supplied in single dose flexible plastic containers as follows: Product Number Unit of Sale Strength (Concentration) Each 1727172105 NDC 17271-721-05 Package of 30 free flex ® bag 25 grams per 250 mL (100 mg per mL) NDC 17271-721-05 One 250 mL free flex ® bag 1727172106 NDC 17271-721-06 Package of 20 free flex ® bag 50 grams per 500 mL (100 mg per mL) NDC 17271-721-06 One 500 mL free flex ® bag 1727172107 NDC 17271-721-07 Package of 10 free flex ® bag 100 grams per 1,000 mL (100 mg per mL) NDC 17271-721-07 One 1000 mL free flex ® bag Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.

<table width="100%"><col width="22.525%" align="left"/><col width="21.475%" align="left"/><col width="28.050%" align="left"/><col width="27.950%" align="left"/><tbody><tr><td align="left" valign="top" styleCode="Toprule Botrule Lrule Rrule"><content styleCode="bold">Product Number</content></td><td align="left" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Unit of Sale</content></td><td align="left" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Strength (Concentration)</content></td><td align="left" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Each</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">1727172105 </td><td align="left" valign="top" styleCode="Botrule Rrule">NDC 17271-721-05 Package of 30 <content styleCode="bold">free</content><content styleCode="italics">flex</content>^&#xAE; bag </td><td align="left" valign="top" styleCode="Botrule Rrule">25 grams per 250 mL (100 mg per mL) </td><td align="left" valign="top" styleCode="Botrule Rrule">NDC 17271-721-05 One 250 mL <content styleCode="bold">free</content><content styleCode="italics">flex</content>^&#xAE; bag </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">1727172106 </td><td align="left" valign="top" styleCode="Botrule Rrule">NDC 17271-721-06 Package of 20 <content styleCode="bold">free</content><content styleCode="italics">flex</content>^&#xAE; bag </td><td align="left" valign="top" styleCode="Botrule Rrule">50 grams per 500 mL (100 mg per mL) </td><td align="left" valign="top" styleCode="Botrule Rrule">NDC 17271-721-06 One 500 mL <content styleCode="bold">free</content><content styleCode="italics">flex</content>^&#xAE; bag </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">1727172107 </td><td align="left" valign="top" styleCode="Botrule Rrule">NDC 17271-721-07 Package of 10 <content styleCode="bold">free</content><content styleCode="italics">flex</content>^&#xAE; bag </td><td align="left" valign="top" styleCode="Botrule Rrule">100 grams per 1,000 mL (100 mg per mL) </td><td align="left" valign="top" styleCode="Botrule Rrule">NDC 17271-721-07 One 1000 mL <content styleCode="bold">free</content><content styleCode="italics">flex</content>^&#xAE; bag </td></tr></tbody></table>

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

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 )] 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 )] 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. BD Logo

Concentrated Dextrose for Intravenous Administration NOTE: This solution is hypertonic - See WARNINGS and PRECAUTIONS. LifeShield® Abboject® Syringe Fliptop Container Ansyr™ II Plastic Syringe Rx only Distributedbb by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1027-7.0 Revised: July 2024

Descprition 50% Dextrose Injection, USP is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for injection for intravenous injection as a fluid and nutrient replenisher. Each mL of fluid contains 0.5 g dextrose, hydrous which delivers 3.4 kcal/gram. The solution has an osmolarity of 2.53 mOsmol/mL (calc.), pH 3.2 to 6.5 and may contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required, the unused portion should be discarded with the entire unit. Dextrose, USP is chemically designated C 6 H 12 O 6 ∙ H 2 O (D-glucose monohydrate), a hexose sugar freely soluble in water. Dextrose, hydrous has the following structural formula: Water for Injection, USP is chemically designated H 2 O. The syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material. Formula1.jpg

Clinical Pharmacolgy When administered intravenously this solution restores blood glucose levels in hypoglycemia and provides a source of carbohydrate calories. Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein-sparing action. Dextrose injection undergoes oxidation to carbon dioxide and water. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na + ) plays a major role in maintaining physiologic equilibrium.

Indications and Usage 50% Dextrose Injection is indicated in the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels. The solution is also indicated, after dilution, for intravenous infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements. Slow infusion of hypertonic solutions is essential to insure proper utilization of dextrose and avoid production of hyperglycemia.

Contraindications A concentrated dextrose solution should not be used when intracranial or intraspinal hemorrhage is present, nor in the presence of delirium tremens if the patient is already dehydrated. Dextrose injection without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur.

Warnings 50% Dextrose Injection is hypertonic and may cause phlebitis and thrombosis at the site of injection. Significant hyperglycemia and possible hyperosmolar syndrome may result from too rapid administration. The physician should be aware of the symptoms of hyperosmolar syndrome, such as mental confusion and loss of consciousness, especially in patients with chronic uremia and those with known carbohydrate intolerance. The intravenous administration of this solution can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. Additives may be incompatible. Consult with pharmacist if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. For peripheral vein administration: The solution should be given slowly, preferably through a small bore needle into a large vein, to minimize venous irritation. For central venous administration: Concentrated dextrose should be administered via central vein only after suitable dilution.

Precautions Do not use unless the solution is clear and seal is intact. Discard unused portion. Electrolyte deficits, particularly in serum potassium and phosphate, may occur during prolonged use of concentrated dextrose solutions. Blood electrolyte monitoring is essential and fluid and electrolyte imbalances should be corrected. Essential vitamins and minerals also should be provided as needed. To minimize hyperglycemia and consequent glycosuria, it is desirable to monitor blood and urine glucose and if necessary, add insulin. When a concentrated dextrose infusion is abruptly withdrawn, it is advisable to follow with the administration of 5% or 10% dextrose injection to avoid rebound hypoglycemia. Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus. Care should be exercised to insure that the needle is well within the lumen of the vein and that extravasation does not occur. If thrombosis should occur during administration, the injection should be stopped and corrective measures instituted. Concentrated dextrose solutions should not be administered subcutaneously or intramuscularly. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with solutions in polypropylene syringes have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility. Pregnancy : Animal reproduction studies have not been conducted with dextrose. It is also not known whether dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 50% Dextrose Injection, USP is administered to a nursing mother.

Adverse Reactions Hyperosmolar syndrome, resulting from excessively rapid administration of concentrated dextrose may cause mental confusion and/or loss of consciousness. 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. 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 For peripheral vein administration: Injection of the solution should be made slowly . The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight/hour. About 95% of the dextrose is retained when infused ata rate of 0.8 g/kg/hr. In insulin-induced hypoglycemia, intravenous injection of 10 to 25 grams of dextrose (20 to 50 mL of 50% dextrose) is usually adequate. Repeated doses and supportive treatment may be required in severe cases. A specimen for blood glucose determination should be taken before injecting the dextrose. In such emergencies, dextrose should be administered promptly without awaiting pretreatment test results. For central venous administration: For total parenteral nutrition 50% Dextrose Injection, USP is administered by slow intravenous infusion (a) after admixture with amino acid solutions via an indwelling catheter with the tip positioned in a large central vein, preferably the superior vena cava, or (b) after dilution with sterile water for injection. Dosage should be adjusted to meet individual patient requirements. 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. The maximum rate of dextrose administration which does not result in glycosuria is the same as cited above. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See CONTRAINDICATIONS .

How Supplied 50% Dextrose Injection, USP is supplied in single-dose containers as follows: Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Abboject® is a trademark of Abbott Labaratories. LifeShield® is the trademark of ICU Medical, Inc. and is used under license. For Medical Information about 50% Dextrose Injection, please visit www.pfizermedinfo.com or call 1-800-438-1985 Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 0409-6648-02 Tray containing 25 50 mL Single-Dose Fliptop Vials NDC 0404-9847-50 1 Single-Dose Fliptop Vial per bag (Vial bears NDC 0409-6648-16) 25 g/50 mL (0.5 g/mL) NDC 0409-7517-16 Bundle containing 10 Ansyr™ II Plastic Syringe NDC 0404-9845-50 1 Ansyr™ II Plastic Syringe per bag (Syringe bears NDC 0409-7517-66) 25 g/50 mL (0.5mg/mL) Image1.jpg

<table width="100%"><caption>Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 </caption><tbody><tr><td>From Original Manufacturer/Distributor&apos;s NDC and Unit of Sale</td><td>To Henry Schein Repackaged Product NDC and Unit of Sale</td><td>Total Strength/Total Volume (Concentration) per unit </td></tr><tr><td>NDC 0409-6648-02 Tray containing 25 50 mL Single-Dose Fliptop Vials</td><td>NDC 0404-9847-50 1 Single-Dose Fliptop Vial per bag (Vial bears NDC 0409-6648-16)</td><td>25 g/50 mL (0.5 g/mL)</td></tr><tr><td>NDC 0409-7517-16 Bundle containing 10 Ansyr&#x2122; II Plastic Syringe</td><td>NDC 0404-9845-50 1 Ansyr&#x2122; II Plastic Syringe per bag (Syringe bears NDC 0409-7517-66)</td><td>25 g/50 mL (0.5mg/mL)</td></tr></tbody></table>

DESCRIPTION: 5% Dextrose Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose monohydrate, 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. The solution pH is 4.3 (3.2 to 6.5). This solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. 5% Dextrose Injection, USP is a parenteral fluid and nutrient replenisher. Dextrose, USP is chemically designated D-glucose monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. It has the following structural formula: Water for Injection, USP is chemically designated H 2 O. 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. Structural Formula

CLINICAL PHARMACOLOGY: When administered intravenously, these solutions provide a source of water and carbohydrate. Isotonic and hypertonic concentrations of dextrose are suitable for parenteral maintenance of water requirements when salt is not needed or should be avoided. Solutions containing carbohydrate in the form of dextrose restore blood glucose levels and provide calories. Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein-sparing action. Dextrose injected parenterally undergoes oxidation to carbon dioxide and water. 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 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na + ) plays a major role in maintaining physiologic equilibrium.

INDICATIONS AND USAGE: Intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient.

CONTRAINDICATIONS: 5% Dextrose Injection, USP without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur.

WARNINGS: Excessive administration of potassium-free solutions may result in significant hypokalemia. The intravenous administration of these 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 of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

PRECAUTIONS: 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. Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus. Do not administer unless solution is clear and container is undamaged. Discard unused portion. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with 5% Dextrose Injection, USP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility. Pregnancy Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with dextrose. It is also not known whether dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose should be given to a pregnant woman only if clearly needed. Nursing Mothers Caution should be exercised when 5% Dextrose Injection, USP is administered to a nursing mother. Pediatric Use The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolarity and possible intracerebral hemorrhage. Geriatric Use An evaluation of current literature revealed no clinical experience identifying differences in response between 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.

Pregnancy Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with dextrose. It is also not known whether dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose should be given to a pregnant woman only if clearly needed.

Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with dextrose. It is also not known whether dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose should be given to a pregnant woman only if clearly needed.

Pediatric Use The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolarity and possible intracerebral hemorrhage.

Geriatric Use An evaluation of current literature revealed no clinical experience identifying differences in response between 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.

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. 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. 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.

DOSAGE AND ADMINISTRATION: The dose is dependent upon the age, weight and clinical condition of the patient. As reported in the literature, the dosage 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.

Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, 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 and container permit (see PRECAUTIONS ).

INSTRUCTIONS FOR USE: Check flexible container solution composition, lot number, and expiry date. Do not remove solution container from its overwrap until immediately before use. Use sterile equipment and aseptic technique. To Open Turn solution container over so that the text is face down. 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 horizontally through the center of WHITE Additive Port's septum and inject additives. Mix container contents 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. NOTE: See full directions accompanying administration set. WARNING: Do not use flexible container in series connections.

HOW SUPPLIED: 5% Dextrose Injection, USP is supplied in single dose flexible plastic container as follows: Unit of Sale Strength Each NDC 84549-460-20 25 grams per 500 mL (50 mg per mL) One 500 mL free flex® bag Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile. Made in USA

<table width="100%"><colgroup><col align="left" width="15.354%"/><col align="left" width="25.181%"/><col align="left" width="29.482%"/><col align="left" width="29.982%"/></colgroup><tbody><tr><td align="center" styleCode="Toprule Botrule Lrule Rrule" valign="middle"/><td align="center" styleCode="Toprule Botrule Rrule" valign="middle"><content styleCode="bold">Unit of Sale</content></td><td align="center" styleCode="Toprule Botrule Rrule" valign="middle"><content styleCode="bold">Strength</content></td><td align="center" styleCode="Toprule Botrule Rrule" valign="middle"><content styleCode="bold">Each</content></td></tr><tr><td align="center" styleCode="Botrule Lrule Rrule" valign="middle"/><td align="left" styleCode="Botrule Rrule" valign="middle"/><td align="left" styleCode="Botrule Rrule" valign="middle"/><td align="left" styleCode="Botrule Rrule" valign="middle"/></tr><tr><td align="center" styleCode="Botrule Lrule Rrule" valign="middle"/><td align="left" styleCode="Botrule Rrule" valign="middle">NDC 84549-460-20</td><td align="left" styleCode="Botrule Rrule" valign="middle">25 grams per 500 mL (50 mg per mL) </td><td align="left" styleCode="Botrule Rrule" valign="middle">One 500 mL <content styleCode="bold">free</content><content styleCode="italics">flex&#xAE;</content>bag </td></tr><tr><td align="center" styleCode="Botrule Lrule Rrule" valign="middle"/><td align="left" styleCode="Botrule Rrule" valign="middle"/><td align="left" styleCode="Botrule Rrule" valign="middle"/><td align="left" styleCode="Botrule Rrule" valign="middle"/></tr></tbody></table>

DESCRIPTION: 5% Dextrose Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose monohydrate, 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. The solution pH is 4.3 (3.2 to 6.5). This solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. 5% Dextrose Injection, USP is a parenteral fluid and nutrient replenisher. Dextrose, USP is chemically designated D-glucose monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. It has the following structural formula: Water for Injection, USP is chemically designated H 2 O. The flexible container is fabricated from a specially formulated non-plasticized film containing polypropylene and thermoplastic elastomers ( free flex ® bag). The free flex ® + bag has a needle-free injection port and can accept standard luer lock syringes to add medication. 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. Structural Formula

CLINICAL PHARMACOLOGY: When administered intravenously, these solutions provide a source of water and carbohydrate. Isotonic and hypertonic concentrations of dextrose are suitable for parenteral maintenance of water requirements when salt is not needed or should be avoided. Solutions containing carbohydrate in the form of dextrose restore blood glucose levels and provide calories. Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein- sparing action. Dextrose injected parenterally undergoes oxidation to carbon dioxide and water. 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 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na + ) plays a major role in maintaining physiologic equilibrium.

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. 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: The dose is dependent upon the age, weight and clinical condition of the patient. As reported in the literature, the dosage 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. Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, 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 and container permit (see PRECAUTIONS ).

INSTRUCTIONS FOR USE: Check flexible container solution composition, lot number, and expiry date. Do not remove solution container from its overwrap until immediately before use. Use sterile equipment and aseptic technique. To Open Turn solution container over so that the text is face down. 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 The Additive port of the free flex ® + container accepts standard luer lock syringes. Do not use a needle for additions. Identify LIGHT BLUE Additive Port with arrow pointing toward solution container. Immediately before injecting additives, break off LIGHT BLUE Additive Port Cap with the arrow pointing toward solution container. Hold base of LIGHT BLUE Additive Port. Attach Luer Lock syringe to the threaded LIGHT BLUE Additive Port. Inject additive. Mix solution container contents 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. NOTE: See full directions accompanying administration set. WARNING: Do not use flexible container in series connections.

HOW SUPPLIED: 5% Dextrose Injection, USP is supplied in single dose flexible plastic containers as follows: Product Code Unit of Sale Strength (Concentration) Each 1727177202 NDC 17271-772-02 Package of 60 free flex ® + bags 2.5 grams per 50 mL (50 mg per mL) NDC 17271-772-02 50 mL in a 100 mL free flex ® + bag 1727177203 NDC 17271-772-03 Package of 50 free flex ® + bags 5 grams per 100 mL (50 mg per mL) NDC 17271-772-03 100 mL free flex ® + bag 1727177205 NDC 17271-772-05 Package of 30 free flex ® + bags 12.5 grams per 250 mL (50 mg per mL) NDC 17271-772-05 250 mL free flex ® + bag Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile. 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. 451834 Issued: August 2024 Figure

<table width="100%"><col width="14.225%" align="left"/><col width="32.700%" align="left"/><col width="28.300%" align="left"/><col width="24.775%" align="left"/><tbody><tr><td align="center" valign="top" styleCode="Toprule Botrule Lrule Rrule"><content styleCode="bold">Product Code</content></td><td align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Unit of Sale</content></td><td align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Strength (Concentration)</content></td><td align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Each</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">1727177202 </td><td align="left" valign="bottom" styleCode="Botrule Rrule">NDC 17271-772-02 Package of 60 <content styleCode="bold">free</content><content styleCode="italics">flex</content>^&#xAE; + bags </td><td align="left" valign="top" styleCode="Botrule Rrule">2.5 grams per 50 mL (50 mg per mL) </td><td align="left" valign="bottom" styleCode="Botrule Rrule">NDC 17271-772-02 50 mL in a 100 mL <content styleCode="bold">free</content><content styleCode="italics">flex</content>^&#xAE; + bag </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">1727177203 </td><td align="left" valign="bottom" styleCode="Botrule Rrule">NDC 17271-772-03 Package of 50 <content styleCode="bold">free</content><content styleCode="italics">flex</content>^&#xAE; + bags </td><td align="left" valign="top" styleCode="Botrule Rrule">5 grams per 100 mL (50 mg per mL) </td><td align="left" valign="top" styleCode="Botrule Rrule">NDC 17271-772-03 100 mL <content styleCode="bold">free</content><content styleCode="italics">flex</content>^&#xAE; + bag </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">1727177205 </td><td align="left" valign="bottom" styleCode="Botrule Rrule">NDC 17271-772-05 Package of 30 <content styleCode="bold">free</content><content styleCode="italics">flex</content>^&#xAE; + bags </td><td align="left" valign="top" styleCode="Botrule Rrule">12.5 grams per 250 mL (50 mg per mL) </td><td align="left" valign="top" styleCode="Botrule Rrule">NDC 17271-772-05 250 mL <content styleCode="bold">free</content><content styleCode="italics">flex</content>^&#xAE; + bag </td></tr></tbody></table>