Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)
Fresenius Medical Care North America
SODIUM CHLORIDE
SODIUM CHLORIDE 900 mg in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient. None known.
0.9% Sodium Chloride Injection, USP is supplied in a 1000 mL single-dose flexible plastic container. (US manufactured NDC number 49230-300-10) (Mexico manufactured DNC number 46163-300-10) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Fresenius Medical Care North America Waltham, MA 02451 1-800-323-5188 89-900-74 Rev. 03/15
Abbreviated New Drug Application
SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION FRESENIUS MEDICAL CARE NORTH AMERICA ---------- 0.9% SODIUM CHLORIDE INJECTION, USP FLEXIBLE PLASTIC CONTAINER DESCRIPTION 0.9% Sodium Chloride Injection, USP is sterile and nonpyrogenic. It is a parenteral solution containing 0.9% sodium chloride in water for injection intended for intravenous administration. Each 100 mL of 0.9% Sodium Chloride Injection, USP contains 900 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.). The pH is 5.6. The pH range is 4.5 - 7.0. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solution is a parenteral fluid and electrolyte replenisher. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designed H O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. CLINICAL PHARMACOLOGY When administered intravenously, this solution provides a source of water and electrolytes. Solutions which provide combinations of hypotonic or isotonic concentrations of sodium chloride are suitable for parenteral maintenance or replacement of water and electrolyte requirements. Belgenin tamamını okuyun