NANOGEN | Solution for injection FERONSURE (Interferon alfa

Each glass vial of 1 mL contains

Recombinant Human Interferon alfa - 2a ..... 3 MIU

Each prefilled syringe of 0.5 mL contains

Recombinant Human Interferon alfa - 2a ..... 3 MIU

Feronsure (Interferon alfa - 2a, recombinant) is a sterile protein product for use by injection. Feronsure is manufactured by recombinant DNA technology, in which E.coli is genetically manipulated to harbour human DNA sequences. Interferon alfa - 2a, a recombinant protein contains 165 amino acids, and it has an approximate molecular weight of 19.2 kDa.

Pharmacotherapeutic group: Antiviral drug, antineoplastic and immunomodulating agents

INDICATION

Hairy cell leukaemia.
Chronic phase Philadelphia - chromosome positive chronic myelogenous leukaemia.
Cutaneous T-cell lymphoma. Interferon alfa-2a (Feronsure) may be active in patients who have progressive disease and who are refractory to, or unsuitable for, conventional therapy.
Adult patients with histologically proven chronic hepatitis B, who have markers for viral replication, i.e., those who are positive for HBV DNA or HBeAg.
Adult patients with histologically proven chronic hepatitis C, who are positive for HCV antibodies or HCV RNA and have elevated serum alanine aminotransferase ( ALT ) without liver decompensation.
The efficacy of Feronsure in the treatment of hepatitis C enhances with combination of Ribavirin. Feronsure should be prescribed alone in case of intolerance or contraindication to Ribavirin.
Follicular non - Hodgkin's lymphoma.
Advanced renal cell carcinoma.
Patients with AJCC stage II malignant melanoma (Breslow tumour thickness > 1.5 mm, no lymph node involvement or cutaneous spread) who are free of disease after surgery.

CONTRAINDICATION

A history of hypersensitivity to recombinant interferon alfa - 2a or to any of the excipients.
Patients with severe pre - existing cardiac disease or with any history of cardiac illness. No direct cardiotoxic effect has been demonstrated , but it is likely that acute, self - limiting toxicities ( i.e., fever, chills ) frequently associated with administration of Feronsure may exacerbate pre - existing cardiac conditions.
Severe renal , hepatic or myeloid dysfunction.
Uncontrolled seizure disorders and / or compromised central nervous system function.
Chronic hepatitis with advanced, decompensated hepatic disease.
Chronic hepatitis who have been recently treated with immunosuppressive agents.

Benzyl alcohol, which is an excipient in Feronsure has on rare occasions been associated with potentially fatal toxicities and anaphylactoid reactions in children up to 3 years old. Therefore, Feronsure should not be used in premature babies, neonates, infants or children up to 3 years old (Feronsure contains 9 mg of Benzyl alcohol per mL).

STORAGE, SHELF LIFE, PACKING UNITS

Storage: Store in the refrigerator at 2 ° C -8 ° C. Do not freeze. Keep away from light. The solution for injection should be inspected visually for particulates and discoloration before administration.

Shelf Life: 24 months from manufacturing date.

Packing Units:

Box of 01 of solution for injection (1 mL)

Box of 01 prefilled syringe of solution for injection (0.5 mL)

NANOGEN | Solution for injection FERONSURE (Interferon alfa - 2a, recombinant)