Roferon-A Online, Description, Chemistry, Ingredients - Interferon alfa-2a, Recombinant

Roferon-A Online, Description, Chemistry, Ingredients - Interferon alfa-2a, Recombinant

DESCRIPTION

ROFERON^®-A
(Interferon alfa-2a, recombinant)

Roferon-A (Interferon alfa-2a, recombinant) is a sterile protein product for use by injection. Roferon-A is manufactured by recombinant DNA technology that employs a genetically engineered Escherichia coli bacterium containing DNA that codes for the human protein. Interferon alfa-2a, recombinant is a highly purified protein containing 165 amino acids, and it has an approximate molecular weight of 19,000 daltons. Fermentation is carried out in a defined nutrient medium containing the antibiotic tetracycline hydrochloride, 5 mg/L. However, the presence of the antibiotic is not detectable in the final product. Roferon-A is supplied as an injectable solution in a vial or a prefilled syringe. Each glass syringe barrel contains 0.5 mL of product. In addition, there is a needle which is ½ inch in length.

Single Use Injectable Solution

3 million IU (11.1 µg/mL) Roferon-A per vial — The solution is colorless and each mL contains 3 MIU of Interferon alfa-2a, recombinant, 7.21 mg sodium chloride, 0.2 mg polysorbate 80, 10 mg benzyl alcohol as a preservative and 0.77 mg ammonium acetate.

6 million IU (22.2 µg/mL) Roferon-A per vial — The solution is colorless and each mL contains 6 MIU of Interferon alfa-2a, recombinant, 7.21 mg sodium chloride, 0.2 mg polysorbate 80, 10 mg benzyl alcohol as a preservative and 0.77 mg ammonium acetate.

9 million IU (33.3 µg/0.9 mL) Roferon-A per vial — The solution is colorless and each 0.9 mL contains 9 MIU of Interferon alfa-2a, recombinant, 6.49 mg sodium chloride, 0.18 mg polysorbate 80, 9 mg benzyl alcohol as a preservative and 0.69 mg ammonium acetate. For single dose administration, withdraw 0.9 mL using a 1 mL syringe. Also can be used as a multidose vial.

36 million IU (133.3 µg/mL) Roferon-A per vial — The solution is colorless and each mL contains 36 MIU of Interferon alfa-2a, recombinant, 7.21 mg sodium chloride, 0.2 mg polysorbate 80, 10 mg benzyl alcohol as a preservative and 0.77 mg ammonium acetate.

Single Use Prefilled Syringes

3 million IU (11.1 µg/0.5 mL) Roferon-A per syringe — The solution is colorless and each 0.5 mL contains 3 MIU of Interferon alfa-2a, recombinant, 3.605 mg sodium chloride, 0.1 mg polysorbate 80, 5 mg benzyl alcohol as a preservative and 0.385 mg ammonium acetate.

6 million IU (22.2 µg/0.5 mL) Roferon-A per syringe — The solution is colorless and each 0.5 mL contains 6 MIU of Interferon alfa-2a, recombinant, 3.605 mg sodium chloride, 0.1 mg polysorbate 80, 5 mg benzyl alcohol as a preservative and 0.385 mg ammonium acetate.

9 million IU (33.3 µg/0.5 mL) Roferon-A per syringe — The solution is colorless and each 0.5 mL contains 9 MIU of Interferon alfa-2a, recombinant, 3.605 mg sodium chloride, 0.1 mg polysorbate 80, 5 mg benzyl alcohol as a preservative and 0.385 mg ammonium acetate.

Multidose Injectable Solution

9 million IU (33.3 µg/0.9 mL) Roferon-A per vial — The solution is colorless and each 0.9 mL contains 9 MIU of Interferon alfa-2a, recombinant, 6.49 mg sodium chloride, 0.18 mg polysorbate 80, 9 mg benzyl alcohol as a preservative and 0.69 mg ammonium acetate. Also can be used as a single use vial.

18 million IU (66.7 µg/3 mL) Roferon-A per vial — The solution is colorless and each mL contains 6 MIU of Interferon alfa-2a, recombinant, 7.21 mg sodium chloride, 0.2 mg polysorbate 80, 10 mg benzyl alcohol as a preservative and 0.77 mg ammonium acetate. Each 0.5 mL contains 3 MIU of Interferon alfa-2a, recombinant.

Based on the specific activity of 2.7x10⁸IU/mg protein, the corresponding quantities of Interferon alfa-2a, recombinant in the vials described above are approximately 3 MIU (11.1 µg/mL), 6 MIU (22.2 µg/mL), 9 MIU (33.3 µg/0.9 mL), 18 MIU (66.7 µg/3 mL) and 36 MIU (133.3 µg/mL).

The route of administration for the vial is subcutaneous or intramuscular; the route of administration for the prefilled syringe is subcutaneous only.