BACTERIOSTATIC SODIUM CHLORIDE

Bacteriostatic Sodium Chloride Injection, USP, 0.9% is a sterile, nonpyrogenic, isotonic solution. Each mL contains: Sodium chloride 9 mg; benzyl alcohol 0.9%; Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (pH 4.5-7.0). Sodium chloride occurs as colorless cubic crystals or white crystalline powder and has a saline taste. Sodium chloride is freely soluble in water. It is soluble in glycerin and slightly soluble in alcohol. The empirical formula for sodium chloride is NaCl and the molecular weight is 58.44.

These parenteral preparations are indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. NOT FOR INHALATION .

NOT FOR INHALATION . Before Bacteriostatic Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug, specific references should be checked for any possible incompatibility with sodium chloride or benzyl alcohol. The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. Isotonic solutions may be given subcutaneously, intravenously, and occasionally, intramuscularly. Use Bacteriostatic Sodium Chloride Injection, USP, 0.9% with due regard for the compatibility of the benzyl alcohol it contains with the particular medicinal substance that is to be dissolved or diluted. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Due to potential toxicity of benzyl alcohol in newborns, Bacteriostatic Sodium Chloride Injection, USP, 0.9% containing benzyl alcohol must not be used in this patient population. Bacteriostatic Sodium Chloride Injection, USP, 0.9% should not be used for fluid or sodium chloride replacement.

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. Reactions which may occur because of Bacteriostatic Sodium Chloride Injection, USP, 0.9%, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures and if possible, retrieve and save the remainder of the unused vehicle for examination. Although adverse reactions to intravenous, intramuscular or subcutaneous injection of 0.9% benzyl alcohol are not known to occur in man, experimental studies of small volume parenteral preparations containing 0.9% benzyl alcohol in several species of animals have indicated that an estimated intravenous dose up to 30 mL may be safely given to an adult without toxic effects. Administration of an estimated 9 mL to a 6 kg infant is potentially capable of producing blood pressure changes.