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Procrit

[Epoetin alfa]


Drug Description
DESCRIPTION

Erythropoietin is a glycoprotein which stimulates red blood cell production. It is produced in the kidney and stimulates the division and differentiation of committed erythroid progenitors in the bone marrow. PROCRIT (Epoetin alfa), a 165 amino acid glycoprotein manufactured by recombinant DNA technology, has the same biological effects as endogenous erythropoietin. 1 It has a molecular weight of 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced. The product contains the identical amino acid sequence of isolated natural erythropoietin.

PROCRIT is formulated as a sterile, colorless, liquid in an isotonic sodium chloride/ sodium citrate or a sodium chloride/ sodium phosphate buffered solution for intravenous (IV) or subcutaneous (SC) administration

Text Continues Below



. Single-Dose, Preservative-Free Vial: 1 mL (2,000, 3,000, 4,000 or 10,000 Units/ mL). Each 1 mL of solution contains 2,000, 3,000, 4,000 or 10,000 Units of Epoetin alfa, 2.5 mg Albumin (Human), 5.8 mg sodium citrate, 5.8 mg sodium chloride, and 0.06 mg citric acid in Water for Injection, USP (pH 6.9± 0.3). This formulation contains no preservative.

Single-Dose, Preservative-Free Vial:

1 mL (40,000 Units/ mL). Each 1 mL of solution contains 40,000 Units of Epoetin alfa, 2.5 mg Albumin (Human), 1.164 mg sodium phosphate monobasic monohydrate, 1.766 mg sodium phosphate dibasic anhydrate, 0.696 mg sodium citrate, 5.78 mg sodium chloride, and 6.8 mcg citric acid in Water for Injection, USP (pH 6.9± 0.3). This formulation contains no preservative.

Multidose, Preserved Vial: 2 mL (20,000 Units, 10,000 Units/ mL). Each 1 mL of solution contains 10,000 Units of Epoetin alfa, 2.5 mg Albumin (Human), 1.3 mg sodium citrate, 8.2 mg sodium chloride, 0.11 mg citric acid, and 1% benzyl alcohol as preservative in Water for Injection, USP (pH 6.1± 0.3). Multidose, Preserved Vial: 1 mL (20,000 Units/ mL). Each 1 mL of solution contains 20,000 Units of Epoetin alfa, 2.5 mg Albumin (Human), 1.3 mg sodium citrate, 8.2 mg sodium chloride, 0.11 mg citric acid, and 1% benzyl alcohol as preservative in Water for Injection, USP (pH 6.1± 0.3).









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