Country: Netherlands
Language: Dutch
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
EFAVIRENZ ; EMTRICITABINE ; TENOFOVIRDISOPROXILSUCCINAAT SAMENSTELLING overeenkomend met ; TENOFOVIRDISOPROXIL
Dr. Reddy's Laboratories (UK) Ltd.
J05AR06
EFAVIRENZ ; EMTRICITABINE ; TENOFOVIRDISOPROXILSUCCINAAT COMPOSITION corresponding to ; TENOFOVIRDISOPROXIL
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLOXAMEER 407 ; POLYVINYLALCOHOL (E1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Emtricitabine, Tenofovir Disoproxil And Efavirenz
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROLOSE (E 463); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); POLOXAMEER 407; POLYVINYLALCOHOL (E1203); TALK (E 553 B); TITAANDIOXIDE (E 171);
2017-09-25
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EFAVIRENZ/EMTRICITABINE/TENOFOVIRDISOPROXIL DR. REDDY’S 600 MG/200 MG/245 MG, FILMOMHULDE TABLETTEN 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 Efavirenz/Emtricitabine/Tenofovirdisoproxil Dr. Reddy’s is and what it is used for 2. What you need to know before you take Efavirenz/Emtricitabine/Tenofovirdisoproxil Dr. Reddy’s 3. How to take Efavirenz/Emtricitabine/Tenofovirdisoproxil Dr. Reddy’s 4. Possible side effects 5. How to store Efavirenz/Emtricitabine/Tenofovirdisoproxil Dr. Reddy’s 6. Contents of the pack and other information 1. WHAT EFAVIRENZ/EMTRICITABINE/TENOFOVIRDISOPROXIL DR. REDDY’S IS AND WHAT IT IS USED FOR EFAVIRENZ/EMTRICITABINE/TENOFOVIRDISOPROXIL DR. REDDY’S 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. EFAVIRENZ/EMTRICITABINE/TENOFOVIRDISOPROXIL DR. REDDY’S 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 t Read the complete document
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Efavirenz/Emtricitabine/Tenofovirdisoproxil Dr. Reddy’s 600 mg/200 mg/245 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300.6 mg tenofovir disoproxil succinate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Pink, capsule-shaped film-coated tablets, plain on both sides, with dimensions 11 mm x 22 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Efavirenz/Emtricitabine/Tenofovirdisoproxil Dr. Reddy’s is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. 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 Efavirenz/Emtricitabine/Tenofovirdisoproxil Dr. Reddy’s prior to initiation of their first antiretroviral treatment regimen (see sections 4.4 and 5.1). The demonstration of the benefit of the fixed-dose combination of efavirenz/emtricitabine/tenofovir disoproxil 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 the fixed-dose combination of efavirenz/emtricitabine/tenofovir disoproxil (see section 5.1). No data are currently available from clinical studies with the fixed-dose combination of efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients. No data are available to support the combination of efavirenz, e Read the complete document