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3% and 5% Sodium Chloride Injection, USP
in VIAFLEX Plastic Container
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.
|size (mL)||Composition (g/L)||Ionic Concentration (mEq/L)||*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)
|*Normal physiological osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions ( ≥ 600 mOsmol/L) may cause vein damage.|
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.
Last reviewed on RxList: 10/3/2008
This monograph has been modified to include the generic and brand name in many instances.
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