देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)
US MedSource, LLC
SODIUM CHLORIDE
SODIUM CHLORIDE 9 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
This parenteral preparation is 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.
0.9% Sodium Chloride Injection, USP is supplied in the following: NDC No. Container Size 0409-4888-10 Fliptop Plastic Vial 10 mL 0409-4888-20 Fliptop Plastic Vial 20 mL 0409-4888-50 Fliptop Plastic Vial 50 mL Intended for use with the LifeShield™ blunt cannula: 0409-4888-12 LifeShield™ Fliptop Plastic Vial 10 mL Store at 20 to 25o C (68 to 77o F) [See USP Controlled Room Temperature.] Revised: November, 2009 Printed in USA EN-2319 Hospira, Inc., Lake Forest, IL 60045 USA
New Drug Application
SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION, SOLUTION US MEDSOURCE, LLC ---------- 0.9% SODIUM CHLORIDE INJECTION, USP Fliptop Plastic Vial LifeShield Fliptop Plastic Vial _PRESERVATIVE-FREE_ Rx only DESCRIPTION This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each mL contains sodium chloride 9 mg. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. 0.308 mOsmol/mL (calc.). 0.9% Sodium Chloride Injection, USP contains no preservatives. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH 5.3 (4.5 to 7.0). Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration. CLINICAL PHARMACOLOGY Sodium chloride in water dissociates to provide sodium (Na ) and chloride (Cl¯) ions. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance. The distribution and excretion of sodium (Na ) and chloride (Cl¯) are largely under the control of the kidney which maintains a balance between intake and output. The small volume of fluid and amount of sodium chloride provided by 0.9% Sodium Chloride Injection, USP when used only as an isotonic vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in neonates and very small infants. Wate पूरा दस्तावेज़ पढ़ें