Ország: Hollandia
Nyelv: holland
Forrás: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
EFAVIRENZ 600 mg/stuk ; EMTRICITABINE 200 mg/stuk ; TENOFOVIRDISOPROXILFOSFAAT 291,2 mg/stuk SAMENSTELLING overeenkomend met ; TENOFOVIRDISOPROXIL 245 mg/stuk
Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)
J05AR06
EFAVIRENZ 600 mg/stuk ; EMTRICITABINE 200 mg/stuk ; TENOFOVIRDISOPROXILFOSFAAT 291,2 mg/stuk SAMENSTELLING overeenkomend met ; TENOFOVIRDISOPROXIL 245 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463a) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; KARMIJN (E120) ; MACROGOL 3350 ; MANNITOL (D-) (E 421) ; NATRIUMSTEARYLFUMARAAT ; PLANTAARDIGE OLIE, GEHYDREERD ; POLOXAMEER 407 ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; KARMIJN (E120) ; MACROGOL 3350 ; MANNITOL (D-) (E 421) ; NATRIUMSTEARYLFUMARAAT ; PLANTAARDIGE OLIE, GEHYDREERD ; POLOXAMEER 407 ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Emtricitabine, Tenofovir Disoproxil And Efavirenz
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); CROSPOVIDON (E 1202); HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463); HYPROLOSE (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); KARMIJN (E120); MACROGOL 3350; MANNITOL (D-) (E 421); NATRIUMSTEARYLFUMARAAT; PLANTAARDIGE OLIE, GEHYDREERD; POLOXAMEER 407; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); TALK (E 553 B); TITAANDIOXIDE (E 171);
1900-01-01
Efavirenz/Emtricitabine/Tenofovir disoproxil, NL/H/3603/001, 31.01.22 1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER EFAVIRENZ/EMTRICITABINE/TENOFOVIRDISOPROXIL RATIOPHARM 600/200/245 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 [Product name] is and what it is used for 2. What you need to know before you take [Product name] 3. How to take use [Product name] 4. Possible side effects 5. How to store [Product name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR [PRODUCT NAME] 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. [PRODUCT NAME] 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 [PRODUCT NAME] DO NOT TAKE [PRODUCT NAME] - IF YO Olvassa el a teljes dokumentumot
Efavirenz/Emtricitabine/Tenofovir disoproxil, NL/H/3603/001, 31.01.22 1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Efavirenz/Emtricitabine/Tenofovirdisoproxil ratiopharm 600/200/245 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 291.22 mg of tenofovir disoproxil phosphate or 136 mg of tenofovir). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Pink, oval shaped film coated tablet, approximately 23mm x 11mm x 8mm, debossed with “TEE” on one side of the tablet and plain on the other side of the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Product name] is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil phosphate. 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 inprior 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 Olvassa el a teljes dokumentumot