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Hepatitis B/C, Cirrhosis

FERONSURE

DESCRIPTION

 

Feronsure (Interferon alfa – 2a, recombinant) is a sterile protein product for use by injection. Feronsure 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 19,200 daltons.

Feronsure is supplied in sterile, white, lyophilized powder. The reconstituted preparation with 1 ml solvent (containing 0.9% benzyl alcohol) results in a clear, colorless solution.

Feronsure is supplied as an injectable solution in vials and prefilled syringes.  Solution for injection is sterile, clear, and colorless.

 

COMPOSITION

 

 

Each vial of lyophilized powder contains: Recombinant Human Interferon alfa -2a           3 MIU  and 1 vial  solvent (1 mL)

 

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

THERAPEUTIC INDICATIONS

 

Feronsure is indicated for the treatment of:

- Hairy cell leukaemia.

- AIDS patients with progressive, asymptomatic Kaposi's sarcoma who have a CD4 count >

250/mm3.

- Chronic phase Philadelphia-chromosome positive chronic myelogenous leukaemia.

- Cutaneous T-cell lymphoma.

- 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 interferon alfa-2a in the treatment of hepatitis C is enhanced when combined

with ribavirin.

- Feronsure should be given alone mainly 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.

 

Administration route: SC or IM injection.

CONTRAINDICATIONS

 

 

- 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.

STORAGE, SHELF-LIFE AND 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

Reconstituted solution is stable for 30 days at temperatures of 2°C - 8°C

Packing Units:

Box of 01 vial of lyophilized powder  and  1 vial  solvent (1 mL)

Box of 01, 05 vial(s) of solution for injection (1 mL)

Box of  01, 06, 12 prefilled syringe(s) of solution for injection (0.5 mL)

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