Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)
Spectra Medical Deviecs, LLC
SODIUM CHLORIDE
SODIUM CHLORIDE 9 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
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. The pH range is 4.5 to 7.0. The glass ampules made up of Type I glass are used as a primary container for the drug product. Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water.
0.9% Sodium Chloride Injection, USP is supplied in the following: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured for: Spectra Medical Devices, LLC Wilmington, MA 01887 (978) 657-0889 By: Huons Co., Ltd. 100 Bio valley-ro Jecheon-si Chungcheongbuk-do, 27159 Republic of Korea XX#### Rev. # MM/YY
Abbreviated New Drug Application
SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION, SOLUTION SPECTRA MEDICAL DEVIECS, LLC ---------- SODIUM CHLORIDE INJECTION 0.9% Sodium Chloride Injection, USP 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. The pH range is 4.5 to 7.0. The glass ampules made up of Type I glass are used as a primary container for the drug product. Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. 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. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production Baca dokumen lengkapnya