Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)
Fresenius Kabi USA, LLC
SODIUM CHLORIDE
SODIUM CHLORIDE 9 mg in 1 mL
SUBCUTANEOUS
PRESCRIPTION DRUG
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 . 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.
Bacteriostatic Sodium Chloride Injection, USP, 0.9%, preserved with benzyl alcohol is available as follows: Use only if solution is clear and seal intact. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
BACTERIOSTATIC SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION FRESENIUS KABI USA, LLC ---------- BACTERIOSTATIC SODIUM CHLORIDE INJECTION, USP 0.9% _NOT FOR USE IN NEWBORNS_ DESCRIPTION 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. 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 Bacteriostatic Sodium Chloride Injection, USP, 0.9%, when used only as a vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in 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 to 1.5 liters each of insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na ) plays a major role in maintaining physiologic equilibrium. INDICATIONS AND USAGE These parenteral preparations are indicated only for diluting o Lue koko asiakirja