Țară: Uniunea Europeană
Limbă: engleză
Sursă: EMA (European Medicines Agency)
emtricitabine, tenofovir alafenamide
Gilead Sciences Ireland UC
J05AR17
emtricitabine, tenofovir alafenamide
Antivirals for systemic use
HIV Infections
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).
Revision: 20
Authorised
2016-04-21
62 B. PACKAGE LEAFLET 63 PACKAGE LEAFLET: INFORMATION FOR THE USER DESCOVY 200 MG/10 MG FILM-COATED TABLETS emtricitabine/tenofovir alafenamide 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 Descovy is and what it is used for 2. What you need to know before you take Descovy 3. How to take Descovy 4. Possible side effects 5. How to store Descovy 6. Contents of the pack and other information 1. WHAT DESCOVY IS AND WHAT IT IS USED FOR Descovy contains two active substances: • EMTRICITABINE, an antiretroviral medicine of a type known as a nucleoside reverse transcriptase inhibitor (NRTI) • TENOFOVIR ALAFENAMIDE, an antiretroviral medicine of a type known as a nucleotide reverse transcriptase inhibitor (NtRTI) 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. 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESCOVY DO NOT TAKE DESCOVY • IF YOU ARE ALLERGIC TO EMTRICITABINE, TENOFOVIR ALAFENAMIDE or any of the other ingredients of this medicine (listed in section 6 of this leaflet). WARNINGS AND PRECAUTIONS You must remain under the care of your doctor while taking Descovy. This medicine is not a cure for HIV infection. While taking Descovy you may still develop infections or other illnesses a Citiți documentul complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Descovy 200 mg/10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide. 3. PHARMACEUTICAL FORM Film-coated tablet. Grey, rectangular-shaped, film-coated tablet of dimensions 12.5 mm x 6.4 mm debossed with “GSI” on one side and “210” 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. 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 studied in treatment-naive subjects, see section 5.1. _Missed doses _ If the patient misses a dose of Descovy within 18 hours of the time it is usually taken, the patient should take Descovy as soon as possible and resume the normal dosing schedule. If a patient misses a dose of Descovy by more than 18 hours, the patient should not take the missed dose and simply resume the usual dosing schedule. If the patient vomits within 1 hour of taking Descovy another tablet should be taken. _Elderly_ No dose adjustment of Descovy is req Citiți documentul complet