EPOGEN Solution for injection Ref.[50659] Active ingredients: Epoetin alfa

Source: FDA, National Drug Code (US)  Revision Year: 2018 

Product description

Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 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 (epoetin alfa) injection for intravenous or subcutaneous administration is formulated as a sterile, clear, colorless liquid in vials in multiple formulations. Single-dose vials, formulated with an isotonic sodium chloride/sodium citrate-buffered solution, are supplied in multiple strengths. Each single-dose 1 mL vial contains 2,000, 3,000, 4,000, or 10,000 Units of epoetin alfa, Albumin (Human) (2.5 mg), citric acid (0.06 mg), sodium chloride (5.9 mg), and sodium citrate (5.8 mg) in Water for Injection, USP (pH 6.9 ± 0.3). Multiple-dose, 2 mL vials contain 10,000 Units epoetin alfa, albumin (human) (2.5 mg), benzyl alcohol (1%), sodium chloride (8.2 mg), citric acid (0.11 mg), and sodium citrate (1.3 mg) per 1 mL Water for Injection, USP (pH 6.1 ± 0.3). Multiple-dose 1 mL vials contain 20,000 Units epoetin alfa, albumin (human) (2.5 mg), benzyl alcohol (1%), sodium chloride (8.2 mg), citric acid (0.11 mg), and sodium citrate (1.3 mg), per 1 mL in Water for Injection, USP (pH 6.1 ± 0.3).

Dosage Forms and Strengths

Injection:

  • 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, and 10,000 Units/mL of Epogen as a clear and colorless liquid in single-dose vials
  • 20,000 Units/2 mL (10,000 Units/mL) and 20,000 Units/mL of Epogen as a clear and colorless liquid in multiple-dose vials (contains benzyl alcohol).
How Supplied

Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as:

Preservative-free, single-dose vials (in citrate-buffered formulation): 2,000 Units/mL (NDC 55513-126-10), 3,000 Units/mL (NDC 55513-267-10), 4,000 Units/mL (NDC 55513-148-10), or 10,000 Units/mL (NDC 55513-144-10) supplied in dispensing packs containing ten 1 mL single-dose vials.

Preserved, multiple-dose vial: 20,000 Units/2 mL (10,000 Units/mL) (NDC 55513-283-10) supplied in dispensing packs containing ten 2 mL multiple-dose vials.

Preserved, multiple-dose vial: 20,000 Units/mL (NDC 55513-478-10) supplied in dispensing packs containing ten 1 mL multiple-dose vials.

Manufactured by: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320-1799, U.S.A.

Drugs

Drug Countries
EPOGEN Ecuador, United States

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