Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 5% Dextrose and 0.225% Sodium Chloride Injection, USP are supplied in single-dose flexible plastic containers in various sizes as shown in the accompanying Table. Content and Characteristics Product Name Size Unit of Sale NDC Product Code 5% Dextrose and 0.225% Sodium Chloride Injection, USP 250 mL 30 bags NDC 63323-873-75 873175 5% Dextrose and 0.225% Sodium Chloride Injection, USP 500 mL 20 bags NDC 63323-873-74 873174 5% Dextrose and 0.225% Sodium Chloride Injection, USP 1000 mL 10 bags NDC 63323-873-10 873110 The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile. Protect from freezing. Store at 20 ° to 25 °C ( 68 ° to 77 °F). [See USP Controlled Room Temperature]. Manufactured for: Lake Zurich, Illinois 60047 Made in Germany 451686 www.fresenius-kabi.com/us Issued: September 2020 Fresenius Kabi Logo; PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 250 mL Bag Label NDC 63323-873-75 250 mL 5% Dextrose and 0.225% Sodium Chloride Injection, USP For intravenous use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 250 mL Bag Label; PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 500 mL Bag Label NDC 63323-873-74 500 mL 5% Dextrose and 0.225% Sodium Chloride Injection, USP For intravenous use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 500 mL Bag Label; PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 1000 mL Bag Label NDC 63323-873-10 1000 mL 5% Dextrose and 0.225% Sodium Chloride Injection, USP For intravenous use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 1000 mL Bag Label
- HOW SUPPLIED 5% Dextrose and 0.225% Sodium Chloride Injection, USP are supplied in single-dose flexible plastic containers in various sizes as shown in the accompanying Table. Content and Characteristics Product Name Size Unit of Sale NDC Product Code 5% Dextrose and 0.225% Sodium Chloride Injection, USP 250 mL 30 bags NDC 63323-873-75 873175 5% Dextrose and 0.225% Sodium Chloride Injection, USP 500 mL 20 bags NDC 63323-873-74 873174 5% Dextrose and 0.225% Sodium Chloride Injection, USP 1000 mL 10 bags NDC 63323-873-10 873110 The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile. Protect from freezing. Store at 20 ° to 25 °C ( 68 ° to 77 °F). [See USP Controlled Room Temperature]. Manufactured for: Lake Zurich, Illinois 60047 Made in Germany 451686 www.fresenius-kabi.com/us Issued: September 2020 Fresenius Kabi Logo
- PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 250 mL Bag Label NDC 63323-873-75 250 mL 5% Dextrose and 0.225% Sodium Chloride Injection, USP For intravenous use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 250 mL Bag Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 500 mL Bag Label NDC 63323-873-74 500 mL 5% Dextrose and 0.225% Sodium Chloride Injection, USP For intravenous use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 500 mL Bag Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 1000 mL Bag Label NDC 63323-873-10 1000 mL 5% Dextrose and 0.225% Sodium Chloride Injection, USP For intravenous use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 1000 mL Bag Label
Overview
Dextrose and 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 0.225 grams per 100 mL of Sodium Chloride in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose and 0.225% Sodium Chloride Injection, USP contains dextrose, hydrous 5g and sodium chloride 0.225g in water for injection. Electrolytes per 1000 mL: sodium (Na+), 38.5 mEq; chloride (Cl-) 38.5 mEq. The osmolarity is 329 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 0.225% Sodium Chloride Injection, USP contains no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. 5% Dextrose and 0.225% Sodium Chloride Injection, USP are parenteral fluid, nutrient and electrolyte replenishers. 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.
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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