Country: Իսրայել
language: անգլերեն
source: Ministry of Health
EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
GILEAD SCIENCES ISRAEL LTD
J05AR03
FILM COATED TABLETS
TENOFOVIR ALAFENAMIDE FUMARATE 25 MG; EMTRICITABINE 200 MG
PER OS
Required
GILEAD SCIENCES IRELAND UC, IRELAND
TENOFOVIR DISOPROXIL AND EMTRICITABINE
Descovy is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 (HIV 1).בקשה לשינוי התוויה: 14/8/19Addition of new info to posology section: patients undergoing haemodialysis
2018-10-24
1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ (PRODUCTS) REGULATIONS - 1986 This medicine is to be supplied by doctor’s prescription only DESCOVY ® 200 MG/10 MG DESCOVY ® 200 MG/25 MG FILM-COATED TABLETS ACTIVE INGREDIENTS: Each tablet contains – Descovy 200 mg/10 mg: emtricitabine 200mg tenofovir alafenamide 10mg Descovy 200 mg/25 mg: emtricitabine 200mg tenofovir alafenamide 25mg 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 only for the treatment of your disease. 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. This medicine is intended for adults and adolescents 12 years of age and older, who weigh at least 35 kg. 1. WHAT IS THE MEDICINE INTENDED FOR Descovy in combination with other medicines is for the TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS 1 (HIV-1) INFECTION in adults and adolescents 12 years of age and older, who weigh at least 35 kg. Descovy blocks the action of the reverse transcriptase enzyme, which is essential for the virus to multiply. Descovy, therefore, reduces the amount of HIV in your body. THERAPEUTIC GROUP: Descovy contains two active substances: EMTRICITABINE, is a nucleoside with antiretroviral activity which inhibits the reverse transcriptase enzyme (NRTI) TENOFOVIR ALAFENAMIDE, is a nucleotide with antiretroviral activity which inhibits the reverse transcriptase enzyme (NtRTI) 2. BEFORE TAKING THE MEDICINE X. DO NOT TAKE THIS MEDICINE IF YOU ARE ALLERGIC TO EMTRICITABINE, TENOFOVIR ALAF read_full_document
1 DESCOVY ® (EMTRICITABINE/TENOFOVIR ALAFENAMIDE FUMARATE) FILM-COATED TABLETS 1. NAME OF THE MEDICINAL PRODUCT Descovy ® 200 mg/10 mg Descovy ® 200 mg/25 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Descovy 200 mg/10 mg Each tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide. Descovy 200 mg/25 mg Each tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Descovy 200mg/10mg: Grey, rectangular-shaped, film-coated tablet of dimensions approximately 12.5 mm x 6.4 mm debossed with “GSI” on one side and “210” on the other side of the tablet. Descovy 200 mg/25 mg: Blue, rectangular-shaped tablets, film-coated tablet of dimensions approximately 12.5 mm x 6.4 mm debossed on one side with “GSI” and the number “225” on the other side of the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Descovy is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 (HIV-1) (see sections 4.2 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 _ _ Descovy should be administered as shown in Table 1. 2 TABLE 1: DOSE OF DESCOVY ACCORDING TO THIRD AGENT IN THE HIV TREATMENT REGIMEN DOSE OF DESCOVY THIRD AGENT IN HIV TREATMENT REGIMEN (see section 4.5) Descovy 200/10 mg once daily Atazanavir with ritonavir or cobicistat Darunavir with ritonavir or cobicistat 1 Lopinavir with ritonavir Descovy 200/25 mg once daily Dolutegravir, efavirenz, maraviroc, nevirapine, rilpivirine, raltegravir 1 Descovy 200/10 mg in combination with darunavir 800 mg and cobicistat 150 mg, administered as a fixed-dose combination tablet, was stud read_full_document