PRODUCTS > THERAPEUTIC PRODUCTS

Hepatitis B/C, Cirrhosis

PEGNANO

DESCRIPTION

 

Peginterferon alfa-2a is  a  covalent  conjugate of  protein recombinant interferon alfa-2a, (approximate molecular weight [MW] 19,2 KDa), with a branched PEG-CHO chain (approximate molecular weight MW 40,000 daltons). Peginterferon alfa – 2a has an approximate molecular weight of 59 KDa. Interferon alfa – 2a is produced using recombinant DNA technology in which a cloned human leukocyte interferon gene is inserted into and expressed in Escherichia coli.

Pegnano 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.

Pegnano is supplied as an injectable solution in vials and prefilled syringes.  Injectable solution is sterile, clear, and colorless.

Peginterferon alfa-2a is  a  covalent  conjugate of  protein recombinant interferon alfa-2a, (approximate molecular weight [MW] 19,2 KDa), with a branched PEG-CHO chain (approximate molecular weight MW 40,000 daltons). Peginterferon alfa – 2a has an approximate molecular weight of 59 KDa. Interferon alfa – 2a is produced using recombinant DNA technology in which a cloned human leukocyte interferon gene is inserted into and expressed in Escherichia coli.

Pegnano 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.

Pegnano is supplied as an injectable solution in vials and prefilled syringes.  Injectable solution is sterile, clear, and colorless.

COMPOSITION

Each vial of lyophilized powder contains: Peginterferon alfa-2a 180 mcg and 1 vial  solvent (1 mL)

Each glass vial of 1 mL contains : Peginterferon alfa-2a 180 mcg

Each prefilled syringe of 0.5 mL contains: Peginterferon alfa-2a 180 mcg

THERAPEUTIC INDICATIONS

- Chronic hepatitis B

Pegnano is indicated for the treatment of HBeAg-positive or HBeAg-negative-chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, increased ALT and histologically verified liver inflammation and/or fibrosis.

 - Chronic hepatitis C 

Pegnano is indicated for the treatment of chronic hepatitis C in adult patients who are positive for serum HCV-RNA, including patients with compensated cirrhosis and/or co-infected with clinically stable HIV.

The optimal way to use Pegnano in patients with chronic hepatitis C is in combination with ribavirin. The combination of Pegnano and ribavirin is indicated in naive patients and patients who have failed previous treatments with interferon alpha (PEGylated or non-PEGylated) alone or in combination with ribavirin.

Monotherapy is indicated mainly in case of intolerance or contradication to ribavirin.

Administration route: SC injection

CONTRAINDICATIONS

Hypersensitivity to the active substance, to interferon alfa, or to any of the excipients

     - Autoimmune hepatitis

    - Severe hepatic dysfunction or decompensated cirrhosis of the liver

    - Neonates and young children up to 3 years old, because of the excipient benzyl alcohol

    - A history of severe pre-existing cardiac diseases, including unstable or uncontrolled cardiac diseases in the previous six months

    - Initiation of Pegnano is contraindicated in HIV-HCV patients with cirrhosis and a Child-Pugh

STORAGE, SHELF-LIFE AND PACKING UNITS

Storage: Store at 2°C - 8°C. Do not freeze. Protect 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 2°C - 8°C.

Packing units:

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

Box of  01 or 06 prefilled syringe(s) (0,5 mL)

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

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