Nazione: Armenia
Lingua: inglese
Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
peginterferon alfa-2b
Schering-Plough Labo N.V.
peginterferon alfa-2b
80mcg/0,5ml
powder lyophilized for solution for injection
Prescription
1 SUMMARY OF PRODUCT CHARACTERISTICS IN ARMENIA 1. NAME OF THE MEDICINAL PRODUCT PEGINTRON ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 vial of PegIntron contains: _active ingredient_: a sufficient amount of powder of peginterferon alfa-2b to provide after reconstitution of vial (with the solvent provided) 0.7 ml of solution with peginterferon alfa-2b concentrations 50 mcg/0.5 ml, 80 mcg/0.5 ml, 100 mcg/0.5 ml, 120 mcg/0.5 ml, 150 mcg/0.5 ml respectively. The active substance is a covalent conjugate of recombinant interferon alfa-2b* with monomethoxy polyethylene glycol. The potency of this product should not be compared to that of another pegylated or nonpegylated protein of the same therapeutic class (see section 5.1). *produced by rDNA technology in E. coli cells harbouring a genetically engineered plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes. Excipients with known effect: Each vial contains 40 mg of sucrose per 0.5 ml For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilized powder for solution for injection in vial and the solvent. White to off-white liophilized powder free of particulate matter; prepared solution – clear and colorless solution free of visible matter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults (tritherapy) _ PegIntron in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. Please refer to the ribavirin and boceprevir instructions for medical use when PegIntron is to be used in combination with these medicines. _Adults (bitherapy and monotherapy) _ PegIntron is indicated for the treatment of adult patients (18 years of age and older) with CHC who are positive for hepatitis C virus RNA (HCV-RNA), including patients with compensated cirrhosis and/or co-infected with clinically stable HIV. Peg Leggi il documento completo