Sodium Chloride

0.9% Sodium Chloride Processing Solution is indicated in processing blood cells. See directions accompanying blood cell processing device for complete instructions for use.

As directed by a physician. See directions accompanying blood cell processing device. Processing Solutions should be inspected visually for particulate matter and discoloration prior to use.

None known

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.

Careful review and understanding of the use of this solution in conjunction with blood cell processing equipment is essential. Pregnancy Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Processing Solution. It is also not known whether 0.9% Sodium Chloride Processing Solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.9% Sodium Chloride Processing Solution should be given to a pregnant woman only if clearly needed. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Do not administer unless solution is clear and seal is intact.

None known

Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Processing Solution. It is also not known whether 0.9% Sodium Chloride Processing Solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.9% Sodium Chloride Processing Solution should be given to a pregnant woman only if clearly needed.

Safety and effectiveness in pediatric patients have not been established. Do not administer unless solution is clear and seal is intact.

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 0.9% Sodium Chloride Processing Solution Size (mL) Composition (g/L) Osmolarity (mOsmol/L) (calc) pH Ionic Concentration (mEq/L) Sodium Chloride, USP (NaCl) Sodium Chloride 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.

0.9% Sodium Chloride Processing Solution has value as a physiological blood cell processing aid.