- Differential Diagnosis
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Drug Information for 3% and 5% Sodium Chloride Injection, USP in VIAFLEX Plastic Container (Baxter Healthcare Corporation): DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS AND USAGE
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
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3% and 5% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, hypertonic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. The pH may have been adjusted with hydrochloric acid. It contains no antimicrobial agents. Composition, ionic concentration, osmolarity, and pH are shown in Table 1.
Table 1 Size (mL) Composition (g/L) Ionic Concentration (mEq/L) Normal physiological osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (= 600 mOsmol/L) may cause vein damage.Osmolarity (mOsmol/L) (calc) pH Sodium Chloride, USP (NaCl) Sodium Chloride 3% Sodium Chloride Injection, USP 500 30 513 513 1027 5.0 (4.5 to 7.0) 5% Sodium Chloride Injection, USP 500 50 856 856 1711 5.0 (4.5 to 7.0)
The VIAFLEX 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-ethylhexyl phthalate (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.
- Drug Information Provided by National Library of Medicine (NLM).