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** SOFOLANORK (Sofosbuvir 400 mg) 28 Film-Coated Tablets.
** Composition:
Each film-coated tablet contains:
Sofosbuvir 400 mg
** Indications:
Sofosbuvir is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.
** Pharmacotherapeutic group:
Direct-acting antiviral.
** Mechanism of action:
Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator. In a biochemical assay, GS-461203 inhibited the polymerase activity of the recombinant NS5B from HCV genotype 1b, 2a, 3a and 4a with a 50% inhibitory concentration (IC50) value ranging from 0.7 to 2.6 ?M. GS-461203 (the active metabolite of sofosbuvir) is not an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase.
** Dose:
. The recommended dose is one 400 mg tablet, taken orally, once daily with food.
. Sofosbuvir should be used in combination with other medicinal products. Monotherapy of Sofosbuvir is not recommended.
. Recommended co-administered medicinal product(s) and treatment duration for Sovaldi combination therapy:
Patient population : Treatment # Duration
Patients with genotype 1, 4, 5 or 6 CHC:
Sofosbuvir + ribavirin + peginterferon alfa # 12 weeks
Sofosbuvir + ribavirin (Only for use in patients ineligible or intolerant to peginterferon alfa) # 24 weeks
Patients with genotype 2 CHC:
Sofosbuvir + ribavirin # 12 weeks
Patients with genotype 3 CHC:
Sofosbuvir + ribavirin + peginterferon alfa # 12 weeks
Sofosbuvir + ribavirin # 24 weeks
Patients with CHC awaiting liver transplantation:
Sofosbuvir + ribavirin # Until liver transplantation
** Store at temperature not exceeding 30 degrees C, in dry place.
Keep away from reach of children.
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