Țară: Armenia
Limbă: engleză
Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
tenofovir (tenofovir disoproxil fumarate)
Emcure Pharmaceuticals Ltd.
J05AF07
tenofovir (tenofovir disoproxil fumarate)
300mg
tablets film-coated
(30) in plastic container
Prescription
Registered
2022-12-06
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TAVIN 300 MG FILM-COATED TABLETS Tenofovir disoproxil fumarate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Tavin is and what it is used for 2. What you need to know before you take Tavin 3. How to use Tavin 4. Possible side effects 5. How to store Tavin 6. Contents of the pack and other information IF TAVIN HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL THE INFORMATION IN THIS LEAFLET IS ADDRESSED TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR CHILD” INSTEAD OF “YOU”). 1. WHAT TAVIN IS AND WHAT IT IS USED FOR Tavin contains the active substance tenofovir disoproxil fumarate. This active substance is an antiretroviral or antiviral medicine which is used to treat HIV or HBV infection or both. Tenofovir is a nucleotide reverse transcriptase inhibitor, generally known as an NRTI and works by interfering with the normal working of enzymes (in HIV reverse transcriptase; in hepatitis B DNA polymerase) that are essential for the viruses to reproduce themselves. In HIV Tavin should always be used combined with other medicines to treat HIV infection. TAVIN 300 MG TABLETS ARE A TREATMENT FOR HIV (Human Immunodeficiency Virus) infection. The tablets are suitable for:ADULTS - ADOLESCENTS AGED 12 TO LESS THAN 18 YEARS WHO HAVE ALREADY BEEN TREATED with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects. TAVIN 300 MG TABLETS ARE ALSO A TREATMENT FOR CHRONIC HEPATITIS B, AN I Citiți documentul complet
1 SUMMARY OF PRODUCT CHARACTERISTICS TAVIN (Tenofovir Disoproxil Fumarate tablets) 2 1. NAME OF THE MEDICINAL PRODUCT Tavin 300mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains: Tenofovir Disoproxil Fumarate ..................... 300 mg Excipient with known effect Each tablet contains 153.66 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). White coloured, modified capsule shaped, film-coated tablets debossed with “EM” on one side and “143” on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HIV-1 INFECTION Tavin 300 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults. Tavin 300 mg film-coated tablets are also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years. The choice of Tavin to treat antiretroviral-experienced patients with HIV-1 infection should be based on individual viral resistance testing and/or treatment history of patients. HEPATITIS B INFECTION: Tavin 300 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in adults with: • compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis (see section 5.1). • evidence of lamivudine-resistant hepatitis B virus (see sections 4.8 and 5.1). • decompensated liver disease (see sections 4.4, 4.8 and 5.1). Tavin 300 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with: • compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis (see sections 4 Citiți documentul complet