Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)
Baxter Healthcare Corporation
SODIUM CHLORIDE
SODIUM CHLORIDE 900 mg in 100 mL
EXTRACORPOREAL
PRESCRIPTION DRUG
0.9% Sodium Chloride Processing Solution is indicated in processing blood cells. See directions accompanying blood cell processing device for complete instructions for use. None known
0.9% Sodium Chloride Processing Solution in Flexible Plastic Container is available as follows: Code Size (mL) NDC 2B7207 3000 0338-0050-47 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25º C); brief exposure up to 40º C does not adversely affect the product. Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.
New Drug Application
SODIUM CHLORIDE- SODIUM CHLORIDE SOLUTION BAXTER HEALTHCARE CORPORATION ---------- 0.9% SODIUM CHLORIDE PROCESSING SOLUTION IN FLEXIBLE PLASTIC CONTAINER NOT FOR INJECTION DESCRIPTION Sodium Chloride Processing Solution is a sterile, nonpyrogenic solution in single dose container for use in blood cell processing devices. It contains no antimicrobial agents. Composition, osmolarity, pH, and ionic concentration are shown in Table 1. TABLE 1 Size (mL) Composition (g/L) Osmolarity (mOsmol/L) (calc) pH Ionic Concentration (mEq/L) Sodium Chloride, USP (NaCl) Sodium Chloride 0.9% Sodium Chloride Processing Solution 3000 9 308 5.5 (4.5 to 7.0) 154 154 The plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2- ethylhexylphthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies. CLINICAL PHARMACOLOGY 0.9% Sodium Chloride Processing Solution has value as a physiological blood cell processing aid. INDICATIONS AND USAGE 0.9% Sodium Chloride Processing Solution is indicated in processing blood cells. See directions accompanying blood cell processing device for complete instructions for use. CONTRAINDICATIONS None known WARNINGS This container should not be connected for direct intravenous administration. The contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard the unused portion of processing solution. PRECAUTIONS Careful review and understanding of the use of this solution in conjunction with blood cell processing equipment is essential. PREGNANCY Terat Przeczytaj cały dokument