Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
daclatasvir dihydrochloride
SYNERRV SDN BHD
daclatasvir dihydrochloride
28 Tablets
Hetero Labs Limited
DASVIR 30/60 Daclatasvir 30mg and 60mg (as dihydrochloride) Tablet 1 _Consumer Medication Information Leaflet (RiMUP)_ WHAT IS IN THIS LEAFLET 1. What Dasvir is used for 2. How Dasvir works 3. Before you use Dasvir 4. How to use Dasvir 5. While you are using it 6. Side effects 7. Storage and Disposal of Dasvir 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 1.WHAT DASVIR IS USED FOR It is used to treat adults with hepatitis C, an infectious disease that affects the liver, caused by the hepatitis C virus 2.HOW DASVIR WORKS This medicine works by stopping the hepatitis C virus from multiplying and infecting new cells. This lowers the amount of hepatitis C virus in your body and removes the virus from your blood over a period of time. 3. BEFORE YOU USE DASVIR _-When you must not use it _ • Allergic to daclatasvir or any of the other ingredients of this medicine _Pregnancy and lactation _ Do not use Dasvir if you are pregnant, trying to get pregnant or think you may be pregnant. Do not use Dasvir if you are breast- feeding. Ask your doctor or pharmacist for advice before taking any medicine. _-Before you start to use it _ Tell your doctor if any of the following applies: • you 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) • you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely • your liver is damaged and not functioning properly (decompensated liver disease) Tell your doctor immediately if you are taking any medicines for heart problems and during treatment you experience: • Shortness of breath • Light-headedness • Palpitations • Faintings - _Taking other medicines_ Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. This is because Dasvir may af Read the complete document
DASVIR 30/60 (DACLATASVIR TABLETS 30 MG & 60 MG) HETERO NAME AND STRENGTH OF ACTIVE INGREDIENT _Dasvir 30mg _ Each film coated Tablet contains Daclatasvir dihydrochloride equivalent to Daclatasvir 30mg _Dasvir 60 mg _ Each film coated Tablet contains Daclatasvir dihydrochloride equivalent to Daclatasvir 60mg PRODUCT DESCRIPTION _Dasvir 30mg _ Yellow round; bevel edged, biconvex, film coated tablets debossed with 'D 14' on one side and 'H' on the other side. _Dasvir 60 mg _ Light yellow, round, bevel edged, biconvex film coated tablets debossed with ‘D 19’ on one side and ‘H’ on other side. DOSAGE FORM Film coated Tablets PHARMACODYNAMICS Pharmacotherapeutic group: Direct-acting antiviral ATC code, J05AP07 Mechanism of action Daclatasvir is an inhibitor of nonstructural protein 5A (NS5A), a multifunctional protein that is an essential component of the HCV replication complex. Daclatasvir inhibits both viral RNA replication and virion assembly. Antiviral activity in cell culture Daclatasvir is an inhibitor of HCV genotypes 1a and 1b replication in cell-based replicon assays with effective concentration (50% reduction, EC 50 ) values of 0.003-0.050 and 0.001-0.009 nM, respectively, depending on the assay method. The daclatasvir EC 50 values in the replicon system were 0.003-1.25 nM for genotypes 3a, 4a, 5a and 6a, and 0.034-19 nM for genotype 2a as well as 0.020 nM for infectious genotype 2a (JFH-1) virus. Daclatasvir showed additive to synergistic interactions with interferon alfa, HCV nonstructural protein 3 (NS3) PIs, HCV nonstructural protein 5B (NS5B) non-nucleoside inhibitors, and HCV NS5B nucleoside analogues in combination studies using the cell-based HCV replicon system. No antagonism of antiviral activity was observed. No clinically relevant antiviral activity was observed against a variety of RNA and DNA viruses, including HIV, confirming that daclatasvir, which inhibits a HCV-specific target, is highly selective for HCV. Resistance in cell culture Substitutions conferring daclatasvir resistance i Read the complete document