Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
emtricitabine, Quantity: 200 mg; tenofovir alafenamide fumarate, Quantity: 11.2 mg (Equivalent: tenofovir alafenamide, Qty 10 mg)
Gilead Sciences Pty Ltd
Emtricitabine,tenofovir alafenamide fumarate
Tablet, film coated
Excipient Ingredients: croscarmellose sodium; magnesium stearate; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; iron oxide black
Oral
30 tablets
(S4) Prescription Only Medicine
Treatment of HIV-1 Infection: DESCOVY is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and paediatric patients weighing at least 25kg. The patients must not have a history of treatment failure or known mutations associated with resistance to the individual components of DESCOVY (see section 5.1 Pharmacodynamic properties).,HIV-1 Pre-Exposure Prophylaxis: DESCOVY is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg, excluding individuals at risk from receptive vaginal sex.
Visual Identification: DESCOVY 200 mg/10 mg tablets are gray, rectangular-shaped, film-coated tablets with 'GSI' debossed on one side and '210' on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2016-07-01
DESCOVY Consumer Medicine Information v4.0 – (23 January 2020) Page 1 of 5 DESCOVY ® TABLETS (200 MG EMTRICITABINE / 25 MG TENOFOVIR ALAFENAMIDE AND 200 MG EMTRICITABINE / 10 MG TENOFOVIR ALAFENAMIDE) _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 DESCOVY 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 DESCOVY MEDICINE. You may need to read it again. WHAT IS DESCOVY _HOW _ _DESCOVY WORKS_ _ _ DESCOVY tablets consist of the following medicines: • emtricitabine • tenofovir alafenamide These are combined in one tablet to help control Human Immunodeficiency Virus (HIV) infection. DESCOVY helps block HIV-1 reverse transcriptase, a viral chemical in your body (enzyme) that is needed for HIV-1 to multiply. DESCOVY lowers the amount of HIV in the blood (viral load). DESCOVY 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. DESCOVY is for people who do not have a resistant HIV virus to DESCOVY. Emtricitabine and tenofovir alafenamide belong to a group Прочитайте повний документ
DESCOVY Product Information v-4.0– (14 February 2020) 1 AUSTRALIAN PI – DESCOVY ® (EMTRICITABINE/TENOFOVIR ALAFENAMIDE) TABLETS 1 NAME OF THE MEDICINE DESCOVY (200 mg emtricitabine/25 mg tenofovir alafenamide) and DESCOVY 200 mg emtricitabine/10 mg tenofovir alafenamide ) tablets. The drug substances in DESCOVY tablets are emtricitabine (FTC) and tenofovir alafenamide (TAF) fumarate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DESCOVY is available as tablets. DESCOVY 200/25 mg tablets contain 200 mg of FTC and TAF fumarate equivalent to 25 mg tenofovir alafenamide. For the full list of excipients, see section 6.1 List of excipients. DESCOVY 200/10 mg tablets contain 200 mg of FTC and TAF fumarate equivalent to 10 mg tenofovir alafenamide. For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Each 200/25 mg DESCOVY tablet is rectangular shaped, film-coated and blue in colour. Each tablet is debossed with ‘GSI’ on one side and the number “225” on the other side. Each 200/10 mg DESCOVY tablet is rectangular shaped, film-coated and gray in colour. Each tablet is debossed with ‘GSI’ on one side and the number “210” on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS DESCOVY is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older with body weight at least 35 kg. The patients must not have a history of treatment failure or known mutations associated with resistance to the individual components of DESCOVY (see section 5.1 Pharmacodynamic properties). DESCOVY is not indicated for use in Pre ‐ Exposure Prophylaxis (PrEP). 4.2 D OSE AND METHOD OF ADMINISTRATION In adults and adolescent patients aged 12 years and older and weighing ≥ 35 kg, DESCOVY is taken orally once daily with or without food. The recommended dose of DESCOVY is 200/25 mg. DESCOVY Product Information v-4.0– (14 February 2020) 2 If DESCOVY is used in combination with an HIV-1 protease i Прочитайте повний документ