Kraj: Malezja
Język: angielski
Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
EMTRICITABINE; Tenofovir alafenamide fumarate; Elvitegravir; Cobicistat on silicon dioxide
Gilead Sciences Malaysia Sdn. Bhd.
EMTRICITABINE; Tenofovir alafenamide fumarate; Elvitegravir; Cobicistat on silicon dioxide
30tablet Tablets
PATHEON INC
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ GENVOYA ® FILM-COATED TABLETS ELVITEGRAVIR 150MG/COBICISTAT 150MG/EMTRICITABINE 200MG/TENOFOVIR ALAFENAMIDE 10MG 1 WHAT IS IN THIS LEAFLET 1. What Genvoya is used for 2. How Genvoya works 3. Before you use Genvoya 4. How to use Genvoya 5. While you are using Genvoya 6. Side effects 7. Storage and disposal of Genvoya 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT GENVOYA IS USED FOR Genvoya is a single tablet 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. Genvoya reduces the amount of HIV in your body. This will improve your immune system and reduce the risk of developing illnesses linked to HIV infection. HOW GENVOYA WORKS Genvoya 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) BEFORE YOU USE GENVOYA _When you must not use it_ DO NOT TAKE GENVOYA • IF YOU ARE ALLERGIC TO ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, TENOFOVIR ALAFENAMIDE or any of the other ingredients of this medicine (listed in ingredient section of this leaflet). • IF YOU ARE TAKING ONE OF THESE MEDICINES: - ALFUZOSIN (used to treat an enlarged prostate gland) - DABIGATRAN (used to prevent and treat blood clots) - AMIODARONE, QUINIDINE (used to correct irregular heartbeats) - CARBAMAZEPINE, PHENOBARBITAL, PHENYTOIN (used to prevent seizures) - RIFAMPICIN (used to prevent and treat tuberculosis and other infections) - DIHYDROERGOTAMINE, ERGOMETRINE, ERGOTAMINE (used to treat migraine headache) - CISAPRIDE (used to relieve certain stomach problems) - ST. JOHN’S WORT ( _Hypericum perforatum_ , a herb Przeczytaj cały dokument
1 GENVOYA ® (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) For Oral Use Rx Only FULL PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg) Film-Coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 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. Excipients 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 Genvoya is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus-1 (HIV-1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir (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 _Adults and adolescents aged 12 years and older, weighing at least 35 kg_ _ _ One tablet to be taken once daily with food. If the patient misses a dose of Genvoya within 18 hours of the time it is usually taken, the patient should take Genvoya with food as soon as possible and resume the normal dosing schedule. If a patient misses a dose of Genvoya 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 Genvoya another tablet should be taken. 2 _Elderly_ No dose adjustment of Genvoya is required in elderly patients (see sections 5.1 and 5.2). _Renal impairment_ No dose ad Przeczytaj cały dokument