Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Ledipasvir; Sofosbuvir
UNIMED SDN BHD
Ledipasvir; Sofosbuvir
28 Tablets
Strides Shasun Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ VIRPAS - LEDIPASVIR & SOFOSBUVIR TABLETS 90MG/400MG Ledipasvir/Sofosbuvir (90/400 mg) 1 WHAT IS IN THIS LEAFLET 1. What Virpas is used for 2. How Virpas works 3. Before you use Virpas 4. How to use Virpas 5. While you are using it 6. Side effects 7. Storage and Disposal of _ _ Virpas 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT VIRPAS IS USED FOR Virpas is used for the treatment of chronic Hepatitis C (CHC) in adults. It is also used for Hepatitis C virus (HCV) genotype- specific activity. HOW VIRPAS WORKS Hepatitis C is a virus that infects the liver. This medicine works by blocking two different proteins that the Hepatitis C virus needs to grow and reproduce itself. BEFORE YOU USE VIRPAS - _When you must not use it _ Do not take Virpas if: - You are allergic (hypersensitive) to sofosbuvir, ledipasvir or to any one of the ingredients of this medicine. - You are taking any of the following medicine: • Other medicinal product containing sofosbuvir • Rosuvastatin (a medicine used to treat high cholesterol). • Rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis) • St. John’s wort (Hypericum perforatum – herbal medicine used to treat depression) • Carbamazepine, phenytoin, phenobarbital (medicines used to treat epilepsy and prevent seizures). _ _ _ _ _ _ _ _ _Pregnancy and lactation _ When Virpas is used in combination with ribavirin, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Women of childbearing potential or their male partners must use an effective form of contraception during treatment and for a period of time after the treatment has concluded. Do not take this medicine if you are pregnant. The effects during pregnancy are not known. If you are thinking you may be pregnant or are planning to get pregnant, ask your doctor for advice before taking this medicine. Do not breast-feed during treatment with V Soma hati kamili
VIRPAS - LEDIPASVIR & SOFOSBUVIR TABLETS 90MG/400MG COMPOSITION Ledipasvir & Sofosbuvir Tablets 90mg/400mg Each tablet contains:- Ledipasvir…………90 mg Sofosbuvir……….400 mg DOSAGE FORM Oral film-coated tablet PRODUCT DESCRIPTION VIRPAS (Ledipasvir & Sofosbuvir 90mg/400mg) is Brown coloured oval shaped bevelled edge film coated tablets debossed with “SL” on one side and plain on other side. Each film coated tablet contains 90mg of Ledipasvir and 400mg of Sofosbuvir. PHARMACODYNAMICS Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AX65 MECHANISM OF ACTION: Ledipasvir is a HCV inhibitor targeting the HCV NS5A protein, which is essential for both RNA replication and the assembly of HCV virions. Biochemical confirmation of NS5A inhibition by Ledipasvir is not currently possible as NS5A has no enzymatic function. _In vitro_ resistance selection and cross-resistance studies indicate Ledipasvir targets NS5A as its mode 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 analogue triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator. GS-461203 (the active metabolite of Sofosbuvir) is neither an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase. Antiviral activity The EC50 values of ledipasvir and sofosbuvir against full-length or chimeric replicons encoding NS5A and NS5B sequences from clinical isolates are detailed in below table. The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir but reduced the anti-HCV activity of ledipasvir by 12-fold against genotype 1a HCV replicons. Activity of ledipasvir and sofosbuvir against chimeric replicons Genotype replicons Ledipasvir activity (EC50, nM) Sofosbuvir activity (EC50, nM) Stable replicons NS5A transient Soma hati kamili