Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
VELPATASVIR; Sofosbuvir
MYLAN HEALTHCARE SDN. BHD.
VELPATASVIR; Sofosbuvir
28 Tablets
Mylan Laboratories Limited
1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ MYHEP ALL (SOFOSBUVIR AND VELPATASVIR FILM COATED TABLETS 400MG/100MG) Sofosbuvir & Velpatasvir (400mg/100mg) WHAT IS IN THIS LEAFLET 1. What _MyHep ALL _ is used for 2. How it works 3. Before you use _MyHep ALL _ 4. How to use _MyHep ALL _ 5. While you are using it 6. Side Effects 7. Storage and disposal of _MyHep _ _ALL _ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT _MYHEP ALL _IS USED FOR _MyHep _ _ALL _ is a medicine that contains the active substances sofosbuvir and velpatasvir in a single tablet. It is given to treat a chronic (long-term) viral infection of the liver called hepatitis C in adults of 18 years and older. HOW MYHEP ALL WORKS The active substances in this medicine work together by blocking two different proteins that the virus needs to grow and reproduce itself, allowing the infection to be permanently eliminated from the body. _MyHep ALL _ is sometimes taken with another medicine, ribavirin. It is very important that you also read the leaflets for the other medicines that you will be taking with _MyHep ALL_ . If you have any questions about your medicines, please ask your doctor or pharmacist. BEFORE YOU USE MYHEP ALL_ _ _ _ _When you must not use it _ DO NOT TAKE _MYHEP ALL _ • If you are allergic to sofosbuvir, velpatasvir or any of the other ingredients of this medicine. • IF YOU ARE CURRENTLY TAKING ANY OF THE FOLLOWING MEDICINES: i. RIFAMPICIN and RIFABUTIN (antibiotics used to treat infections, including tuberculosis); ii. ST. JOHN’S WORT (Hypericum perforatum – herbal medicine used to treat depression); iii. CARBAMAZEPINE, PHENOBARBITAL and PHENYTOIN (medicines used to treat epilepsy and prevent seizures); _Before _ _you _ _start _ _to _ _use _ _it _ WARNING AND PRECAUTIONS Talk to your doctor if you: • HAVE LIVER PROBLEMS other than from hepatitis C, for instance i. IF YOU HAVE A CURRENT OR PREVIOUS INFECTION WITH THE HEPATITIS B VIRUS , since your doctor Read the complete document
Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg 1. NAME OF THE MEDICINAL PRODUCT MYHEP ALL (Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION EACH FILM COATED TABLET CONTAINS: SOFOSBUVIR 400 MG VELPATASVIR 100 MG Excipients with known effects: Each film-coated tablet contains 261.0 mg of lactose monohydrate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablet; Light green to green colored capsule shaped biconvex beveled edge film coated tablet debossed with ‘S and F on either side of score line’ on one side and ‘M and V on either side of Score Line’ on another side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections Posology & Method of Administration, Warning & Precautions, and Pharmacodynamics). 4.2 POSOLOGY The recommended dose of Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg is one tablet, taken orally, once daily with or without food (see section Pharmacokinetics). TABLE 1: RECOMMENDED TREATMENT AND DURATION FOR ALL HCV GENOTYPES PATIENT POPULATION A TREATMENT AND DURATION Patients with genotype 1, 2, 3, 4, 5 or 6 HCV Patients without cirrhosis and patients with compensated cirrhosis Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg for 12 weeks Patients with genotype 1 or 3 HCV PATIENTS WITH DECOMPENSATED CIRRHOSIS Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg + ribavirin b for 12 weeks a. Includes patients co-infected with human immunodeficiency virus (HIV). b. When administered with Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg, the recommended dosage of ribavirin is based on weight (administered with food); 1000 mg per day for patients less than 75kg and 1200 mg for those weighing at least 75kg, divided and administered twice daily. The starting dosage and on-treatment dosage o Read the complete document