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.
EPOGEN (r) (Epoetin alfa), a 165 amino acid glycoprotein manufactured by recombinant DNA technology, has the same biological effects as endogenous erythropoietin. 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.
EPOGEN (r) is formulated as a sterile, colorless liquid in an isotonic sodium
chloride/ sodium citrate buffered solution or a sodium chloride/ sodium
phosphate buffered solution for
administration.
Single-dose, Preservative-free Vial:
Each 1 mL of solution contains 2000, 3000, 4000 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), 1.2 mg sodium phosphate monobasic monohydrate, 1.8 mg sodium phosphate dibasic anhydrate, 0.7 mg sodium citrate, 5.8 mg sodium chloride, and 6.8 mg citric acid in Water for Injection, USP (pH 6.9 ± 0.3). This formulation con-tains 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).
EPOGEN (r) (Epoetin alfa)
FOR INJECTION
EPOGEN (r) (Epoetin alfa) 2 EPOGEN (r) (Epoetin alfa) 3 EPOGEN (r) (Epoetin alfa) 4 EPOGEN (r) (Epoetin alfa) 5 EPOGEN (r) (Epoetin alfa) 6 EPOGEN (r) (Epoetin alfa) 7
EPOGEN (r) (E poetin alfa)
FOR INJECTION
3106809
3106809/ P30380B
3106809/ P30380B
