Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tenofovir disoproxil fumarate; Emtricitabine
Gilead Sciences International Ltd
J05AR17
Tenofovir disoproxil fumarate; Emtricitabine
245mg ; 200mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05030100; GTIN: 5391507142443
1 B. PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER TRUVADA 200 MG/245 MG FILM-COATED TABLETS Emtricitabine/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 Truvada is and what it is used for 2. What you need to know before you take Truvada 3. How to take Truvada 4. Possible side effects 5. How to store Truvada 6. Contents of the pack and other information 1. WHAT TRUVADA IS AND WHAT IT IS USED FOR TRUVADA CONTAINS TWO ACTIVE SUBSTANCES, _emtricitabine _and _tenofovir disoproxil_. Both of these active substances are _antiretroviral_ medicines which are used to treat HIV infection. Emtricitabine is a _nucleoside reverse transcriptase inhibitor _and tenofovir is a _nucleotide reverse transcriptase _ _inhibitor._ However, both are generally known as NRTIs and they work by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the virus to reproduce itself. TRUVADA IS USED TO TREAT HUMAN IMMUNODEFICIENCY VIRUS 1 (HIV-1) INFECTION IN ADULTS IT IS ALSO USED TO TREAT HIV IN ADOLESCENTS AGED 12 TO LESS THAN 18 YEARS WHO WEIGH AT LEAST 35 KG, and who have already been treated with other HIV medicines that are no longer effective or have caused side effects. Truvada should always be used combined with other medicines to treat HIV infection. Truvada can be administered in place of emtricitabine and tenofovir disoproxil used separately at the same doses. PEOPLE WHO ARE HIV POSITIVE CAN STILL PASS ON HIV when taking this Прочитайте повний документ
OBJECT 1 TRUVADA FILM-COATED TABLETS Summary of Product Characteristics Updated 13-Feb-2018 | Gilead Sciences Ltd 1. Name of the medicinal product Truvada 200 mg/245 mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir). Excipient with known effect Each tablet contains 96 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Blue, capsule-shaped, film-coated tablet, of dimensions 19 mm x 8.5 mm, debossed on one side with “GILEAD” and on the other side with “701”. 4. Clinical particulars 4.1 Therapeutic indications _Treatment of HIV-1 infection:_ Truvada is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1). Truvada is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents (see sections 4.2, 4.4 and 5.1). _Pre-exposure prophylaxis (PrEP):_ Truvada is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk (see sections 4.2, 4.4 and 5.1). 4.2 Posology and method of administration Truvada should be initiated by a physician experienced in the management of HIV infection. Posology Treatment _of HIV in adults and adolescents aged 12 years and older, weighing at least 35 kg:_ One tablet, once daily. _Prevention of HIV in adults and adolescents aged 12 years and older, weighing at least 35 kg:_ One tablet, once daily. Separate preparations of emtricitabine and tenofovir disoproxil fumarate are available for treatment of HIV-1 infection if it becomes necessary to discontinue or modify the dose of one of the components of Truvada. Please refer to the Summary of Product Characteristics for these medicinal products. If Прочитайте повний документ