Baxter 2B0944 - Heparin Sodium Solution, 0.9% Sodium Chloride

Baxter 2B0944 - Heparin Sodium Solution, 0.9% Sodium Chloride

Baxter 2B0944 Heparin Sodium, 0.9% Sodium Chloride Injection, 2000 USP Heparin Units/ 1000 ml, Viaflex Plastic Container, Liquid Premix

Heparin Sodium 2,000 IU/L in 0.9% w/v Sodium Chloride IV Infusions in VIAFLEX Container. This product is manufactured by Baxters manufacturing facility in the UK and marketed in the UK. At this time, no other entity except Baxter is authorized by the FDA to import or distribute these products in the United States. FDA has not approved Heparin Sodium BP in 0.9% w/v Sodium Chloride IV Infusions in VIAFLEX container.

Injection: 2,000 USP units per 1,000 mL (2 units per mL) clear solution in a single-dose infusion bag.

Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) ?-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-?-D-glucose 6-sulfate, (3) ?-D-glucuronic acid, (4) 2-acetamido-2-deoxy-?-D- glucose, and (5) ?-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2) > (1) > (4) > (3) > (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions.

Heparin Sodium in Sodium Chloride Injection is a buffered, sterile, nonpyrogenic solution of Heparin Sodium, USP derived from porcine intestinal mucosa, standardized for anticoagulant activity supplied in single dose containers for vascular administration. It contains no antimicrobial agents. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram.

This VIAFLEX PLUS plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). VIAFLEX PLUS on the container indicates the presence of a drug additive in a drug vehicle. The VIAFLEX PLUS plastic container system utilizes the same container as the VIAFLEX plastic container system. 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.

Heparin Sodium in Sodium Chloride Injection in VIAFLEX PLUS plastic container is supplied as follows:

Composition, Osmolarity, pH, and Ionic Concentration of Heparin in 0.9% Sodium Chloride Injection