Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
COBICISTATE; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE
GILEAD SCIENCES ISRAEL LTD
J05AR18
FILM COATED TABLETS
TENOFOVIR ALAFENAMIDE 10 MG; EMTRICITABINE 200 MG; COBICISTATE 150 MG; ELVITEGRAVIR 150 MG
PER OS
Required
GILEAD SCIENCES IRELAND UC, IRELAND
EMTRICITABINE, TENOFOVIR ALAFENAMIDE, ELVITEGRAVIR AND COBICISTAT
Gendevra is indicated for the treatment of human immunodeficiency virus 1 (HIV 1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir as follows:• In adults and adolescents aged from 12 years and with body weight at least 35 kg• In children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to toxicities.תוספת התוויה: 2/7/2019Addition of new info to posology section: precaution in pregnant women
2021-11-30
1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ (PRODUCTS) REGULATIONS - 1986 This medicine is to be supplied by doctor’s prescription only GENDEVRA ® 150 MG/150 MG/200 MG/10 MG FILM-COATED TABLETS ACTIVE INGREDIENTS: Each tablet contains – elvitegravir 150 mg cobicistat 150 mg emtricitabine 200 mg tenofovir alafenamide 10 mg Inactive and allergenic substances: see section 6 _“Additional information_ ”. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This leaflet contains essential information about this medicine. If you have any further questions, ask your doctor or pharmacist. Keep this leaflet. You may need to read it again. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if it seems to you that their illness is the same as yours. If you get any side effects, talk to your doctor or pharmacist. Even if you experience any side effects that are not listed in this leaflet (see section 4). This medicine is intended for adults, adolescents and children aged 6 years of age and older, who weigh at least 25 kg. 1. WHAT IS GENDEVRA INTENDED FOR Gendevra is a single tablet for the TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS 1 (HIV-1) INFECTION in adults, adolescents and in children aged 6 years and older who weigh at least 25 kg. IF GENDEVRA HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL THE INFORMATION IN THIS LEAFLET IS ADDRESSED TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR CHILD” INSTEAD OF “YOU”). THERAPEUTIC GROUP: Gendevra contains four active substances: • ELVITEGRAVIR, an antiretroviral medicine known as an integrase inhibitor • COBICISTAT, a booster (enhancer) of the effects of elvitegravir • EMTRICITABINE, an antiretroviral medicine known as a nucleoside reverse transcriptase inhibitor (NRTI) • TENOFOVIR ALAFENAMIDE, an antiretroviral medicine known as a nucleotide reverse transcriptase inhibitor (NtRTI) Gendevra reduces the amount of HIV in yo Olvassa el a teljes dokumentumot
1 GENDEVRA ® (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, TENOFOVIR ALAFENAMIDE (AS FUMARATE)) FILM-COATED TABLETS 1. NAME OF THE MEDICINAL PRODUCT Gendevra ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide. Excipient(s) with known effect Each tablet contains 58 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Green, capsule-shaped, film-coated tablet of dimensions 19 mm x 8.5 mm, debossed with “GSI” on one side of the tablet and “510” on the other side of the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gendevra is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir as follows: • In adults and adolescents aged from 12 years and with body weight at least 35 kg • In children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to toxicities. See sections 4.2, 4.4 and 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the management of HIV infection. Posology _ _ _Adults and paediatric patients aged 6 years and older, weighing at least 25 kg_ One tablet to be taken once daily with food. If the patient misses a dose of Gendevra within 18 hours of the time it is usually taken, the patient should take Gendevra with food as soon as possible and resume the normal dosing schedule. If a patient misses a dose of Gendevra by more than 18 hours, the patient should not take the missed dose and simply resume the usual dosing schedule. 2 If the patient vomits within 1 hour of taking Gendevra another tablet should be taken. Special populations _ _ _Elderly_ No dose adjustment of Gendevra is required in e Olvassa el a teljes dokumentumot