Interferon alfa-2a how supplied

Interferon alfa-2a
PEGASYS® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

How Supplied

Single Use Prefilled Syringes

(for subcutaneous administration)

3 million IU Roferon-A per syringe — 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. Boxes of 1 (NDC 0004-2015-09); Boxes of 6 (NDC 0004-2015-07).

6 million IU Roferon-A per syringe — 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. Boxes of 1 (NDC 0004-2016-09); Boxes of 6 (NDC 0004-2016-07).

9 million IU Roferon-A per syringe — 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. Boxes of 1 (NDC 0004-2017-09); Boxes of 6 (NDC 0004-2017-07).

Storage

The prefilled syringe should be stored in the refrigerator at 36° to 46°F (2° to 8°C). Do not freeze or shake. Protect Roferon-A from light during storage.

References

Adapted from the FDA Package Insert.