Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Sofosbuvir
SYNERRV SDN BHD
Sofosbuvir
28 Tablets
Hetero Labs Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ SOFOVIR SOFOSBUVIR TABLETS 400MG Sofosbuvir (400 mg) 1 WHAT IS IN THIS LEAFLET 1. What SOFOVIR is used for 2. How SOFOVIR works 3. Before you use SOFOVIR 4. How to use SOFOVIR 5. While you are using it 6. Side effects 7. Storage and Disposal of SOFOVIR 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT SOFOVIR IS USED FOR SOFOVIR is used in combination with other medicinal products for the treatment of chronic hepatitis C in adults. HOW SOFOVIR WORKS Hepatitis C is a virus that infects the liver. This medicine works by lowering the amount of hepatitis C virus in your body and removing the virus from your blood over a period of time. This product is always taken with other medicines. It will not work on its own. It is commonly taken with either: Ribavirin, or Peginterferon alfa and ribavirin. It is very important that you also read the leaflets for the other medicines that you will be taking with Sofovir. If you have any questions about your medicines, please ask your doctor or pharmacist. BEFORE YOU USE SOFOVIR - _When you must not use it _ Do not take SOFOVIR if you: • You are allergic (hypersensitive) to sofosbuvir or to any one of the ingredients of this medicine. - _Before you start to use it _ Tell your doctor if you have any of the following: a) Have liver problems other than hepatitis C, e.g. if you are awaiting a liver transplantation. b) Have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely. c) Have kidney problems d) Currently take, or have taken in the last few months, the medicine amiodarone to treat irregular heartbeats (your doctor may consider alternative treatments if you have taken this medicine) Tell you doctor immediately if you are taking any medicines for heart problems and during treatment you experience: - Shortness of breath or worsening of any shortness of breath you already have - Light-headedness - Palpitations - Fainting e) Baca dokumen lengkap
1 SOFOVIR SOFOSBUVIR TABLETS 400 MG SOFOVIR (SOFOSBUVIR TABLETS 400 MG) Each film-coated tablet contains Sofosbuvir 400 mg. PRODUCT DESCRIPTION Orange oval, bevel biconvex, film coated tablets debossed with ‘H’ on one side and ‘S14’ on the other side. PHARMACODYNAMICS Pharmacotherapeutic group: Direct-acting antiviral; ATC code: J05AP08 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 (IC 50 ) value ranging from 0.7 to 2.6 μM. GS-461203 (the active metabolite of sofosbuvir) is not an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase. Antiviral activity In HCV replicon assays, the effective concentration (EC 50 ) values of sofosbuvir against full-length replicons from genotype 1a, 1b, 2a, 3a and 4a were 0.04, 0.11, 0.05, 0.05 and 0.04 μM, respectively, and EC 50 values of sofosbuvir against chimeric 1b replicons encoding NS5B from genotype 2b, 5a or 6a were 0.014 to 0.015 μM. The mean ± SD EC 50 of sofosbuvir against chimeric replicons encoding NS5B sequences from clinical isolates was 0.068 ± 0.024 μM for genotype 1a (n = 67), 0.11 ± 0.029 μM for genotype 1b (n = 29), 0.035 ± 0.018 μM for genotype 2 (n = 15) and 0.085 ± 0.034 μM for genotype 3a (n = 106). In these assays, the _in vitro _antiviral activity of sofosbuvir against the less common genotypes 4, 5 and 6 was similar to that observed for genotypes 1, 2 and 3. The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir. Resistance _In cell culture _ HCV replicons with re Baca dokumen lengkap