Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Efavirenz; Emtricitabine; Tenofovir disoproxil
Teva B.V.
J05AR; J05AR06
Efavirenz; Emtricitabine; Tenofovir disoproxil
600 mg/200 mg/245 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Antivirals for treatment of HIV infections, combinations; emtricitabine, tenofovir disoproxil and efavirenz
Marketed
2017-03-24
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Efavirenz/Emtricitabine/Tenofovir disoproxil Teva 600mg/ 200mg/ 245mg film-coated tablets 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 Efavirenz/Emtricitabine/Tenofovir disoproxil Teva 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 in Efavirenz/Emtricitabine/Tenofovir disoproxil Teva 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 patient Đọc toàn bộ tài liệu
Health Products Regulatory Authority 09 August 2022 CRN00CV48 Page 1 of 39 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Efavirenz/Emtricitabine/Tenofovir disoproxil Teva 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 (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 Efavirenz/Emtricitabine/Tenofovir disoproxil Teva 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 in Efavirenz/Emtricitabine/Tenofovir disoproxil Teva 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/ Đọc toàn bộ tài liệu