Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Dasabuvir Sodium Monohydrate
ABBVIE SDN BHD
Dasabuvir Sodium Monohydrate
56 Tablets
Abbvie Ireland NL B.V
_Consumer Medication Information Leaflet (RiMUP)_ EXVIERA™ FILM-COATED TABLETS Dasabuvir 250 mg _____________________________________________________________________________________ WHAT IS IN THIS LEAFLET 1. What Exviera™ is used for 2. How Exviera™ works 3. Before you take Exviera™ 4. How to take Exviera™ 5. While you are using Exviera™ 6. Side effects of Exviera™ 7. Storage and disposal of Exviera™ 8. Product description 9. Manufacturer and Product Registratin H older 10. Date of revision 11. Serial number WHAT EXVIERA™ IS USED FOR Exviera™ is an antiviral medicine used to treat adults with chronic (long-term) Hepatitis C (an infectious disease that affects the liver, caused by the Hepatitis C virus). It is very important that you also read the package leaflets for the other antiviral medicines that you take with Exviera™. If you have any questions about your medicines, please ask your doctor or pharmacist. HOW EXVIERA™ WORKS It contains the active substance dasabuvir. Exviera™ works by stopping the Hepatitis C virus from multiplying and infecting new cells, thus clearing the virus from your blood over a period of time. Exviera™ tablets do not work on their own. They are always taken with another antiviral medicine containing ombitasvir/paritaprevir/ritona vir. Some patients may also take an antiviral medicine called ribavirin. Your doctor will talk with you about which of these medicines to take with Exviera™. BEFORE YOU TAKE EXVIERA™ _When you must not take _ _Exviera™_ • If you are allergic to dasabuvir or any of the other ingredients of this medicine (refer to list of ingredients). • If you have moderate to severe liver problems other than Hepatitis C. • If you are taking any of the medicines listed in the following table. This is because serious or life- threatening effects can occur when Exviera and ombitasvir/paritaprevir/riton avir are taken with these medicines. These medicines can affect the way Exviera and ombitasvir/paritaprevir/ritonav ir work and Exviera an Baca dokumen lengkap
1 Product Package Insert Product Name Dasabuvir 250mg Trade Name Exviera 250 mg film-coated tablets Description and Composition Each film-coated tablet contains 250 mg of dasabuvir (as sodium monohydrate). The tablet is beige, ovaloid, film-coated tablets with dimensions of 14.0 mm x 8.0 mm, debossed on one side with ‘AV2’. Excipients for tablet : Microcrystalline cellulose, Lactose monohydrate, Copovidone, Croscarmellose sodium, Colloidal anhydrous silica, Magnesium stearate. Excipients for film-coating : Polyvinyl alcohol , Titanium dioxide, Polyethylene glycol 3350, Talc, Iron oxide yellow, Iron oxide red, Iron oxide black. Excipient with known effect : each film-coated tablet contains 44.94 mg lactose (as monohydrate). This product does not contain gluten. Indication and Usage Exviera is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections Dosage and Administration, Special Warnings and Precautions and Pharmacodynamic Properties). For hepatitis C virus (HCV) genotype specific activity, see sections Special Warnings and Precautions and Pharmacodynamic Properties. Dosage and Administration Treatment with Exviera should be initiated and monitored by a physician experienced in the management of chronic hepatitis C. Posology The recommended dose of dasabuvir is 250 mg (one tablet) twice daily (morning and evening). Exviera must not be administered as monotherapy. Exviera should be used in combination with other medicinal products for the treatment of HCV (see section Pharmacodynamic properties). Refer to the package insert of the medicinal products that are used in combination with Exviera. The recommended co-administered medicinal product(s) and treatment duration for Exviera combination therapy are provided in table 1. Baca dokumen lengkap