Երկիր: Նոր Զելանդիա
Լեզու: անգլերեն
Աղբյուրը: Medsafe (Medicines Safety Authority)
Cobicistat 150mg (As a blend with silicon dioxide); ; ; ; Elvitegravir 150mg; ; ; Emtricitabine 200mg; ; ; ; ; Tenofovir alafenamide 10mg (As tenofovir alafenamide fumarate 11.2mg);
Gilead Sciences (NZ)
Cobicistat 150 mg (As a blend with silicon dioxide)
Tablet
Active: Cobicistat 150mg (As a blend with silicon dioxide) Elvitegravir 150mg Emtricitabine 200mg Tenofovir alafenamide 10mg (As tenofovir alafenamide fumarate 11.2mg) Excipient: Colloidal silicon dioxide Croscarmellose sodium Hyprolose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry green 85F110095 Sodium laurilsulfate
Prescription
Esteve Quimica SA
GENVOYA is indicated as a single tablet regimen for the treatment of HIV-1 infection in adults and paediatric patients weighing at least 25 kg who are either treatment-na?ve; or virologically suppressed (HIV-1 RNA GENVOYA is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide HIV-1 reverse transcriptase inhibitors.
Package - Contents - Shelf Life: Bottle, 100mL HDPE bottle with a PP child resistant cap & al foil liner - 30 tablets - 36 months from date of manufacture stored at or below 25°C
2016-01-27
GENVOYA Consumer Medicine Information v4.0 (05 March 2020) Page 1 of 5 GENVOYA ® TABLETS (150 MG ELVITEGRAVIR / 150 MG COBICISTAT / 200 MG EMTRICITABINE / 10 MG TENOFOVIR ALAFENAMIDE) _elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide_ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. This leaflet answers some of the common questions about GENVOYA tablets. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist about your medical condition or treatment. If you have further questions, please ask your doctor or your pharmacist. THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU PERSONALLY AND YOU SHOULD NOT PASS IT ON TO OTHERS. It may harm them, even if their symptoms are the same as yours. MEDICINES ARE SOMETIMES PRESCRIBED FOR CONDITIONS THAT ARE NOT MENTIONED IN THIS LEAFLET. KEEP THIS LEAFLET WITH YOUR GENVOYA MEDICINE. You may need to read it again. WHAT IS GENVOYA _HOW _ _GENVOYA WORKS_ _ _ GENVOYA tablets consist of the following four medicines: • elvitegravir • cobicistat • emtricitabine • tenofovir alafenamide These are combined in one tablet to help control Human Immunodeficiency Virus (HIV) infection. GENVOYA helps block HIV-1 reverse transcriptase, a viral chemical in your body (enzyme) that is needed for HIV-1 to multiply. GENVOYA lowers the amount of HIV in the blood (viral load). GENVOYA may also help to increase the number of T cells (CD4 + cells), allowing your immune system to improve. Lowering the amount of HIV in the blood lowers the chance of death or infections that happen when your immune system is weak (opportunistic infections). HIV infection destroys CD4 T cells, which are important to the immune system. The immune system helps fight infection. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) may develop. GENVOYA is for people who do not have a resistant HIV virus to GENVOYA. Elvitegravir Կարդացեք ամբողջական փաստաթուղթը
NEW ZEALAND DATA SHEET GENVOYA Data Sheet v8.0 (15 March 2022) Page 1 GENVOYA ® (ELVITEGRAVIR/COBICISTAT/EMTRICITABINE/TENOFOVIR ALAFENAMIDE) TABLETS 1 PRODUCT NAME GENVOYA (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION GENVOYA is available as tablets. Each tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide. The tablets are film-coated, capsule shaped and green in colour. Each tablet is debossed with ‘GSI’ on one side and the number “510” on the other side. For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Each GENVOYA tablet is capsule shaped, film-coated and green in colour. Each tablet is debossed with ‘GSI’ on one side and the number ’510’ on the other side. The tablets are supplied in bottles with child resistant closures. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS GENVOYA is indicated as a single tablet regimen for the treatment of HIV-1 infection in adults and paediatric patients weighing at least 25 kg who are either treatment–naïve; or virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see section 5.1 Pharmacodynamic properties, Clinical trials). Patients must not have a history of treatment failure or known mutations associated with resistance to the antiretroviral components of GENVOYA. GENVOYA is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide HIV ‐ 1 reverse transcriptase inhibitors. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS The recommended dose of GENVOYA is one tablet once daily taken with food. _ _ CHILDREN AND ADOLESCENTS UP TO 18 YEARS OF AGE In paediatric patients weighing ≥ 25 kg, the recommended dose of GENVOYA is one tablet once daily taken with food. NEW ZEALAND DATA SHEET Կարդացեք ամբողջական փաստաթուղթը