Sovelpak 400/100 mg, 28 tablets

Trade Name:

Sovelpak

Compound:

Properties

Sofosbuvir is a pangenotypic inhibitor of the hepatitis C virus (HCV) NS5B RNA-dependent RNA polymerase, which is necessary for viral replication. Sofosbuvir is a nucleotide prodrug that, as a result of intracellular metabolism, is converted to the pharmacologically active triphosphate (GS-461203), an analogue of uridine, which is inserted into the RNA of the hepatitis C virus using NS5B polymerase and acts as a chain terminator. GS-461203 (the active metabolite of sofosbuvir) is not an inhibitor of human DNA and RNA polymerases, nor is it an inhibitor of mitochondrial RNA polymerase.

Velpatasvir is an HCV inhibitor that acts on the HCV non-structural NS5A protein, which is required for both RNA replication and the formation of HCV virions. Selective resistance and cross-resistance studies in vitro indicate that the mechanism of action of velpatasvir is an effect on NS5A.

Indications

Treatment of chronic hepatitis C (CHC) in adult patients.

Dosage and administration

For oral administration.

Treatment with Sovelpak should be initiated and supervised by a physician experienced in the treatment of chronic hepatitis C.

1 tablet of the drug is recommended to be taken 1 time / day, regardless of the meal. The tablet must be swallowed whole with water. Tablets are not recommended to be chewed or broken due to the bitter taste.

Contraindications

— hypersensitivity to active substances or any other component of the drug;

-pregnancy;

— age up to 18 years (efficacy and safety have not been established in this population);

Side effects

Central and peripheral nervous system: dizziness, fainting, cognitive disorders.

Circulatory system: peripheral edema.

Hematopoietic system: anemia, lymphopenia, thrombocytopenia, leukopenia.

Storage

Store at a temperature not exceeding 30°C.

Package:

The carton box contains 28 tablets, paper leaflet.