Land: Europeiska unionen
Språk: engelska
Källa: EMA (European Medicines Agency)
tenofovir disoproxil
Mylan Pharmaceuticals Limited
J05AF07
tenofovir disoproxil
Antivirals for systemic use
HIV Infections
HIV-1 infectionTenofovir disoproxil 245 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults.In adults, the demonstration of the benefit of tenofovir disoproxil in HIV-1 infection is based on results of one study in treatment-naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which tenofovir disoproxil was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml).Tenofovir disoproxil 245 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 tenofovir disoproxil 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 infectionTenofovir disoproxil 245 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.evidence of lamivudine-resistant hepatitis B virus.decompensated liver disease.Tenofovir disoproxil 245 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.
Revision: 18
Authorised
2016-12-08
62 B. PACKAGE LEAFLET 63 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TENOFOVIR DISOPROXIL MYLAN 245 MG FILM-COATED TABLETS tenofovir disoproxil READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or pharmacist. - 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 Tenofovir disoproxil Mylan is and what it is used for 2. What you need to know before you take Tenofovir disoproxil Mylan 3. How to take Tenofovir disoproxil Mylan 4. Possible side effects 5. How to store Tenofovir disoproxil Mylan 6. Contents of the pack and other information IF THIS MEDICINE 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 TENOFOVIR DISOPROXIL MYLAN IS AND WHAT IT IS USED FOR Tenofovir disoproxil Mylan contains the active substance _tenofovir disoproxil_ . 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 Tenofovir disoproxil Mylan should always be used combined with other medicines to treat HIV infection. TENOFOVIR DISOPROXIL MYLAN 245 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 Läs hela dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Tenofovir disoproxil Mylan 245 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 245 mg of tenofovir disoproxil (as maleate). Excipient with known effect Each tablet contains 155 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Light blue, round, biconvex, film-coated tablets, 12.20 ± 0.20 mm in diameter, debossed with ‘TN245’ on one side and ‘M’ on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HIV-1 infection Tenofovir disoproxil 245 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults. In adults, the demonstration of the benefit of tenofovir disoproxil in HIV-1 infection is based on results of one study in treatment-naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which tenofovir disoproxil was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml). Tenofovir disoproxil 245 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 tenofovir disoproxil 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 Tenofovir disoproxil 245 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) Läs hela dokumentet