Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 5% Dextrose and 0.45% Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers in 250 mL, 500 mL and 1000 mL sizes as follows: Product Code Unit of Sale Each 1727173405 NDC 17271-734-05 Package of 30 NDC 17271-734-05 One 250 mL free flex ® bag 1727173406 NDC 17271-734-06 Package of 20 NDC 17271-734-06 One 500 mL free flex ® bag 1727173407 NDC 17271-734-07 Package of 10 NDC 17271-734-07 One 1,000 mL free flex ® bag The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile. 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.] 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. Revised: February 2024 Fresenius Kabi Logo; PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 250mL Bag Label free flex ® NDC 17271-734-05 250 mL 5% Dextrose and 0.45% Sodium Chloride Injection, USP For intravenous use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 250mL Bag Label; PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 250mL Shipper Label NDC 17271-734-05 1727173405 5% Dextrose and 0.45% Sodium Chloride Injection, USP 250 mL x 30 QTY 30 PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 250mL Shipper Label; PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 500mL Bag Label free flex ® NDC 17271-734-06 500 mL 5% Dextrose and 0.45% Sodium Chloride Injection, USP For intravenous use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 500mL Bag Label; PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 500mL Shipper Label NDC 17271-734-06 1727173406 5% Dextrose and 0.45% Sodium Chloride Injection, USP 500 mL x 20 QTY 20 PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 500mL Shipper Label; PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 1,000mL Bag Label free flex ® NDC 17271-734-07 1000 mL 5% Dextrose and 0.45% Sodium Chloride Injection, USP For intravenous use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 1,000mL Bag Label; PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 1000mL Shipper Label NDC 17271-734-07 727173407 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1,000 mL x 10 QTY 10 PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 1000mL Shipper Label
- HOW SUPPLIED 5% Dextrose and 0.45% Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers in 250 mL, 500 mL and 1000 mL sizes as follows: Product Code Unit of Sale Each 1727173405 NDC 17271-734-05 Package of 30 NDC 17271-734-05 One 250 mL free flex ® bag 1727173406 NDC 17271-734-06 Package of 20 NDC 17271-734-06 One 500 mL free flex ® bag 1727173407 NDC 17271-734-07 Package of 10 NDC 17271-734-07 One 1,000 mL free flex ® bag The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile. 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.] 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. Revised: February 2024 Fresenius Kabi Logo
- PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 250mL Bag Label free flex ® NDC 17271-734-05 250 mL 5% Dextrose and 0.45% Sodium Chloride Injection, USP For intravenous use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 250mL Bag Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 250mL Shipper Label NDC 17271-734-05 1727173405 5% Dextrose and 0.45% Sodium Chloride Injection, USP 250 mL x 30 QTY 30 PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 250mL Shipper Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 500mL Bag Label free flex ® NDC 17271-734-06 500 mL 5% Dextrose and 0.45% Sodium Chloride Injection, USP For intravenous use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 500mL Bag Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 500mL Shipper Label NDC 17271-734-06 1727173406 5% Dextrose and 0.45% Sodium Chloride Injection, USP 500 mL x 20 QTY 20 PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 500mL Shipper Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 1,000mL Bag Label free flex ® NDC 17271-734-07 1000 mL 5% Dextrose and 0.45% Sodium Chloride Injection, USP For intravenous use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 1,000mL Bag Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 1000mL Shipper Label NDC 17271-734-07 727173407 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1,000 mL x 10 QTY 10 PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 1000mL Shipper Label
Overview
5% Dextrose and 0.45% Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are large volume parenteral solutions containing 5 grams per 100 mL of Dextrose monohydrate and 0.45 grams per 100 mL of Sodium Chloride in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose and 0.45% Sodium Chloride Injection, USP contains dextrose, hydrous 5 g and sodium chloride 0.45 g in water for injection. Electrolytes per 1000 mL: sodium (Na + ), 77 mEq; chloride (Cl - ) 77 mEq. The osmolarity is 406 mOsmol/L (calc.), which is hypertonic. The caloric value is 170 kcal/L. The pH is 4.3 (3.5 to 6.5). 5% Dextrose and 0.45% Sodium Chloride Injection, USP 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 and 0.45% Sodium Chloride Injection, USP is a parenteral fluid, nutrient and electrolyte 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: Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. 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
Indications & Usage
Intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient.
Dosage & 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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS . Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. 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 1. 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. 2. Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution. 3. Do not use if the solution is cloudy or a precipitate is present. To Add Medication 1. Identify WHITE Additive Port with arrow pointing toward container. 2. Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container. 3. Hold base of WHITE Additive Port horizontally. 4. Insert needle horizontally through the center of WHITE Additive Port's septum and inject additives. 5. Mix container contents thoroughly. Preparation for Administration 1. Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from container. 2. Use a non-vented infusion set or close the air-inlet on a vented set. 3. Close the roller clamp of the infusion set. 4. Hold the base of BLUE Infusion Port. 5. 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.
Warnings & Precautions
WARNINGS Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. Excessive administration of potassium-free solutions may result in significant hypokalemia. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention. 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.
Contraindications
None known.
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.
Drug Interactions
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.
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