国家: 以色列
语言: 英文
来源: Ministry of Health
EMTRICITABINE; RILPIVIRINE AS HYDROCHLORIDE; TENOFOVIR DISOPROXIL AS FUMARATE
J-C HEALTH CARE LTD
J05AG05
FILM COATED TABLETS
TENOFOVIR DISOPROXIL AS FUMARATE 245 MG; RILPIVIRINE AS HYDROCHLORIDE 25 MG; EMTRICITABINE 200 MG
PER OS
Required
JANSSEN CILAG S.P.A., ITALY
RILPIVIRINE
RILPIVIRINE
EVIPLERA, a combination of two nucleoside analog HIV 1 reverse transcriptase inhibitors (emtricitabine and tenofovir disoproxil fumarate) and one non-nucleoside reverse transcriptase inhibitor (rilpivirine), is indicated for use as a complete regimen for the treatment of HIV-1 infection in adult patients with no antiretroviral treatment history and with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy, and in certain virologically-suppressed (HIV-1 RNA <50 copies/mL) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see below).The following points should be considered when initiating therapy with EVIPLERA in adult patients with no antiretroviral treatment history: • More rilpivirine-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to rilpivirine-treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL [See Clinical Studies (14)]. • Regardless of HIV-1 RNA level at the start of therapy, more rilpivirine-treated subjects with CD4+ cell count less than 200 cells/mm3 experienced virologic failure compared to rilpivirine-treated subjects with CD4+ cell count greater than or equal to 200 cells/mm3 [See Clinical Studies (14)]. • The observed virologic failure rate in rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz [See Microbiology (12.4)]• More subjects treated with rilpivirine developed tenofovir and lamivudine/emtricitabine associated resistance compared to efavirenz [See Microbiology (12.4)].
2018-02-28
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only EVIPLERA ® FILM-COATED TABLETS ACTIVE INGREDIENTS AND THEIR QUANTITIES IN EACH FILM-COATED TABLET: Emtricitabine 200 mg / Rilpivirine 25 mg (as hydrochloride) / Tenofovir disoproxil 245 mg (as fumarate) Inactive and allergenic ingredients in the preparation – see section 6 “Further Information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their ailment is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Eviplera contains three active ingredients (emtricitabine, rilpivirine and tenofovir disoproxil) in one tablet intended to treat HIV infection (AIDS). Each of these active ingredients is known as an antiretroviral medicine that interferes with the activity of an enzyme (a protein called reverse transcriptase) that is essential for the virus to multiply. Eviplera reduces the amount of HIV in your body, thus improving the immune system and reducing the risk of developing illnesses linked to HIV infection. Eviplera is a treatment for HIV infection in adults aged 18 years and over who have not been treated before with other medicines for treatment of HIV and whose viral burden before commencement of treatment does not exceed 100,000 copies per ml, and in certain adults with a viral burden below 50 copies per ml at the beginning of treatment in order to replace a current medicinal anti-HIV treatment. THERAPEUTIC GROUP • Emtricitabine, nucleoside reverse transcriptase inhibitors (NRTI) • Rilpivirine, non-nucleoside reverse transcriptase inhibitors (NNRTI) • Tenofovir disoproxil, nucleotide reverse transcriptase inhibitors (NtRTI) 2. BEFORE USING THE MEDICINE 阅读完整的文件
1 1. NAME OF THE MEDICINAL PRODUCT Eviplera 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg of emtricitabine, 25 mg of rilpivirine (as hydrochloride) and 245 mg of tenofovir disoproxil (as fumarate). Excipients with known effect Each film-coated tablet contains 277 mg lactose monohydrate and 4 micrograms sunset yellow aluminium lake (E110). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Purplish-pink, capsule-shaped, film-coated tablet debossed on one side with “GSI” and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EVIPLERA, a combination of two nucleoside analog HIV 1 reverse transcriptase inhibitors (emtricitabine and tenofovir disoproxil) and one non-nucleoside reverse transcriptase inhibitor (rilpivirine), is indicated for use as a complete regimen for the treatment of HIV-1 infection in adult patients with no antiretroviral treatment history and with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy, and in certain virologically-suppressed (HIV-1 RNA <50 copies/mL) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see below). The following points should be considered when initiating therapy with EVIPLERA in adult patients with no antiretroviral treatment history: • More rilpivirine-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to rilpivirine-treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL _[See _ _Pharmacodynamic properties(5.1)]_ . • Regardless of HIV-1 RNA level at the start of therapy, more rilpivirine-treated subjects with CD4+ cell count less than 200 cells/mm 3 experienced virologic failure compared to rilpivirine-treated subjects with CD4+ cell count greater than or equal to 200 cells/mm 3 _[See Pharmacodynamic properties(5.1)]_ . • The obs 阅读完整的文件