Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: 0.45% Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers as follows: Product Code Unit of Sale Strength Each 626050 63323-626-50 Package of 60 0.225 grams per 50 mL (4.5 mg per mL) 63323-626-01 50 mL in a 100 mL free flex ® bag 626100 63323-626-00 Package of 50 0.45 grams per 100 mL (4.5 mg per mL) 63323-626-02 100 mL in a 100 mL free flex ® bag 626250 63323-626-25 Package of 30 1.125 grams per 250 mL (4.5 mg per mL) 63323-626-03 250 mL in a 250 mL free flex ® bag 626500 63323-626-55 Package of 20 2.25 grams per 500 mL (4.5 mg per mL) 63323-626-04 500 mL in a 500 mL free flex ® bag 626010 63323-626-10 Package of 10 4.5 grams per 1,000 mL (4.5 mg per mL) 63323-626-05 1,000 mL in a 1,000 mL free flex ® bag STORE AT: 20 ° to 25 °C ( 68 ° to 77 °F) [see USP Controlled Room Temperature]. Protect from freezing. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.; PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Sodium Chloride 1,000 mL Bag Label NDC 63323-626-05 1,000 mL 0.45% Sodium Chloride Injection, USP 4.5 grams per 1,000 mL (4.5 mg per mL) For intravenous use. Rx only fflogo sodium bag
- HOW SUPPLIED: 0.45% Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers as follows: Product Code Unit of Sale Strength Each 626050 63323-626-50 Package of 60 0.225 grams per 50 mL (4.5 mg per mL) 63323-626-01 50 mL in a 100 mL free flex ® bag 626100 63323-626-00 Package of 50 0.45 grams per 100 mL (4.5 mg per mL) 63323-626-02 100 mL in a 100 mL free flex ® bag 626250 63323-626-25 Package of 30 1.125 grams per 250 mL (4.5 mg per mL) 63323-626-03 250 mL in a 250 mL free flex ® bag 626500 63323-626-55 Package of 20 2.25 grams per 500 mL (4.5 mg per mL) 63323-626-04 500 mL in a 500 mL free flex ® bag 626010 63323-626-10 Package of 10 4.5 grams per 1,000 mL (4.5 mg per mL) 63323-626-05 1,000 mL in a 1,000 mL free flex ® bag STORE AT: 20 ° to 25 °C ( 68 ° to 77 °F) [see USP Controlled Room Temperature]. Protect from freezing. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Sodium Chloride 1,000 mL Bag Label NDC 63323-626-05 1,000 mL 0.45% Sodium Chloride Injection, USP 4.5 grams per 1,000 mL (4.5 mg per mL) For intravenous use. Rx only fflogo sodium bag
Overview
0.45% Sodium Chloride Injection, USP solution is a sterile and nonpyrogenic solution intended for intravenous administration. Each 100 mL of 0.45% Sodium Chloride Injection, USP contains 450 mg sodium chloride in water for injection. Electrolytes per 1,000 mL: sodium 77 mEq; chloride 77 mEq. The osmolarity is 154 mOsmol/L (calc.). The pH in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The 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. 0.45% Sodium Chloride Injection, USP is a parenteral fluid and electrolyte replenisher. 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 plastic 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.
Indications & Usage
: Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid 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. 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 ).
Warnings & Precautions
WARNINGS: 0.45% Sodium chloride injection 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. The intravenous administration of 0.45% Sodium chloride injection can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutive states is inversely proportional to the electrolyte concentration of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections. In patients with diminished renal function, administration of 0.45% Sodium chloride injection may result in sodium retention.
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. In addition to the above listed adverse reactions hyponatremia has been reported for 0.45% Sodium chloride injection (see Pediatric Use ).
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