Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Efavirenz; Tenofovir disoproxil fumarate; Emtricitabine
Gilead Sciences International Ltd
J05AR06
Efavirenz; Tenofovir disoproxil fumarate; Emtricitabine
600mg ; 245mg ; 200mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05030100; GTIN: 5391507140029
1 B. PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ATRIPLA 600 MG/200 MG/245 MG FILM-COATED TABLETS Efavirenz/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 Atripla is and what it is used for 2. What you need to know before you take Atripla 3. How to take Atripla 4. Possible side effects 5. How to store Atripla 6. Contents of the pack and other information 1. WHAT ATRIPLA IS AND WHAT IT IS USED FOR ATRIPLA CONTAINS THREE ACTIVE SUBSTANCES that are used to treat human immunodeficiency virus (HIV) infection: - Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) - Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) - Tenofovir is a nucleotide reverse transcriptase inhibitor (NtRTI) Each of these active substances, also known as antiretroviral medicines, work by interfering with an enzyme (reverse transcriptase) that is essential for the virus to multiply. ATRIPLA IS A TREATMENT FOR HUMAN IMMUNODEFICIENCY VIRUS (HIV) infection in adults aged 18 years and over who have previously been treated with other antiretroviral medicines and have their HIV-1 infection under control for at least three months. Patients must not have experienced failure of a previous HIV therapy. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATRIPLA DO NOT TAKE ATRIPLA - IF YOU ARE ALLERGIC to efavirenz, emtricitabine, tenofovir, tenofovir disoproxil fumarate or any of the other ingredients of this medicine (listed in section 6). - IF YOU HAVE SEV Lugege kogu dokumenti
OBJECT 1 ATRIPLA 600 MG/200 MG/245 MG FILM COATED TABLETS Summary of Product Characteristics Updated 25-Apr-2018 | Gilead Sciences Ltd 1. Name of the medicinal product Atripla 600 mg/200 mg/245 mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (as fumarate). Excipient with known effect Each film-coated tablet contains 1 mmol (23.6 mg) of sodium. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Pink, capsule-shaped, film-coated tablet, of dimensions 20 mm x 10.4 mm, debossed with “123” on one side, plain on the other side. 4. Clinical particulars 4.1 Therapeutic indications Atripla is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate. It is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Atripla prior to initiation of their first antiretroviral treatment regimen (see sections 4.4 and 5.1). The demonstration of the benefit of Atripla is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to Atripla (see section 5.1). No data are currently available from clinical studies with Atripla in treatment- naïve or in heavily pretreated patients. No data are available to support the combination of Atripla and other antiretroviral agents. 4.2 Posology and method of administration Therapy should be initiated by a physician experienced in the management of HIV infection. Posol Lugege kogu dokumenti