SODIUM CHLORIDE BACTERIOSTATIC INJECTION 0.9% 25X30ML
Generic: SODIUM CHLORIDE
SODIUM CHLORIDE BACTERIOSTATIC INJECTION 0.9% 25X30ML
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Identification
SODIUM CHLORIDE
Bacteriostatic Sodium Chloride
Fresenius Kabi USA, LLC
HUMAN PRESCRIPTION DRUG
Administration
INJECTION
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
ANDA088911
Active Ingredients
| Ingredient | Strength |
|---|---|
| SODIUM CHLORIDE | 9 mg/mL |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Drug Resources
Clinical Drug Information
Indications & Usage
INDICATIONS AND USAGE 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 .
Warnings
WARNINGS Benzyl alcohol as a preservative in Bacteriostatic Sodium Chloride Injection, USP, 0.9% has been associated with toxicity in newborns. Data is unavailable on the toxicity of other preservatives in this age group. Preservative-free Sodium Chloride Injection, USP, 0.9% should be used for flushing intravascular catheters. Where a sodium chloride solution is required for preparing or diluting medications for use in newborns, only preservative-free Sodium Chloride Injection, USP, 0.9% should be used.
Dosage & Administration
DOSAGE AND ADMINISTRATION 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.
Adverse Reactions
ADVERSE REACTIONS 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.
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.