Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)
Baxter Healthcare Corporation
SODIUM CHLORIDE
SODIUM CHLORIDE 600 mg in 100 mL
PRESCRIPTION DRUG
New Drug Application
LACTATED RINGERS- SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE INJECTION, SOLUTION BAXTER HEALTHCARE CORPORATION ---------- LACTATED RINGER’S INJECTION, USP IN AVIVA PLASTIC CONTAINER DESCRIPTION Lactated Ringer’s Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. TABLE 1 Size (mL) Composition (g/L) Osmolarity (mOsmol/L) (calc) pH nominal (range) Ionic Concentration (mEq/L) Caloric Content (kcal/L) Sodium Chloride, USP, (NaCl) Sodium Lactate, (C H NaO ) Potassium Chloride, USP, (KCl) Calcium Chloride, USP (CaCl ·2H O) SodiumPOTAS S IUM CalciumChloride Lactate Lactated Ringer’s Injection, USP 250 6 3.1 0.3 0.2 273 6.5 (6.0 to 7.5) 130 4 2.7 109 28 9 500 1000 The flexible container is made with non-latex plastic materials specially designed for a wide range of parenteral drugs including those requiring delivery in containers made of polyolefins or polypropylene. For example, the AVIVA container system is compatible with and appropriate for use in the admixture and administration of paclitaxel. In addition, the AVIVA container system is compatible with and appropriate for use in the admixture and administration of all drugs deemed compatible with existing polyvinyl chloride container systems. The solution contact materials do not contain PVC, DEHP, or other plasticizers. The suitability of the container materials has been established through biological evaluations, which have shown the container passes Class VI U.S. Pharmacopeia (USP) testing for plastic containers. These tests confirm the biological safety of the container system. The flexible container is a closed system, and air is prefilled in the container to facilitate drainage. The container does not require entry of external air during administration. The container has two ports: one is the administration Lire le document complet