Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
tenofovir disoproxil fumarate, Quantity: 300 mg; emtricitabine, Quantity: 200 mg; elvitegravir, Quantity: 150 mg; cobicistat, Quantity: 150 mg
Gilead Sciences Pty Ltd
Cobicistat,Elvitegravir,Emtricitabine,Tenofovir disoproxil fumarate
Tablet, film coated
Excipient Ingredients: hyprolose; lactose monohydrate; microcrystalline cellulose; silicon dioxide; croscarmellose sodium; magnesium stearate; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake
Oral
30
(S4) Prescription Only Medicine
STRIBILD is indicated as a single tablet regimen for the treatment of HIV infection in treatment-na?ve adults. STRIBILD is also indicated in certain virologically suppressed (HIV1 RNA <50 copies/mL) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see Clinical Trials). Patients must not have a history of treatment failure or known mutations associated with resistance to the antiretroviral components of STRIBILD (tenofovir DF, emtricitabine or elvitegravir). STRIBILD is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide HIV-1 reverse transcriptase inhibitors.
Visual Identification: Film coated, green, capsule-shaped tablets, debossed with 'GSI' on one side and '1' in a square box on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2013-02-22
STRIBILD Consumer Medicine Information v12.0 – (15 July 2020) Page 1 of 5 STRIBILD ® TABLETS _300_ _ _ _mg tenofovir disoproxil fumarate / 200 mg emtricitabine / 150 mg of elvitegravir / 150 mg of cobicistat _ 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 STRIBILD 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. Keep this leaflet with your STRIBILD medicine. You may need to read it again. 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. WHAT IS STRIBILD STRIBILD is used to treat HIV infection. STRIBILD is for people who have NEVER taken HIV medicines before, or who do not have a resistant HIV virus to STRIBILD. STRIBILD consists of four medicines: • tenofovir disoproxil fumarate, also called tenofovir DF (VIREAD ® ) • emtricitabine or FTC (EMTRIVA ® ) • elvitegravir • cobicistat (TYBOST ® ) These are combined in one tablet to help control Human Immunodeficiency Virus (HIV) infection. VIREAD and EMTRIVA belong to a group of antiviral medicines known as nucleoside and nucleotide reverse transcriptase inhibitors (NRTI). Elvitegravir belongs to a class of antiviral medicines known as integrase inhibitors. Cobicistat is a “booster”, to help increase the levels of elvitegravir. _HOW STRIBILD WORKS _ 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. STRIBILD helps block HIV-1 reverse transcriptase, a viral chemical in your body (enzyme) that is needed for HIV-1 to multiply. STRIBILD lowers the amo Baca dokumen lengkapnya
STRIBILD Product Information v17.0 – (24 August 2021) Page 1 AUSTRALIAN PRODUCT INFORMATION STRIBILD ® (TENOFOVIR DISOPROXIL FUMARATE/EMTRICITABINE/ELVITEGRAVIR/COBICISTAT) TABLETS 1 NAME OF THE MEDICINE STRIBILD (tenofovir disoproxil fumarate/emtricitabine/elvitegravir/cobicistat). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active substances in STRIBILD tablets are tenofovir disoproxil fumarate (tenofovir DF), emtricitabine, elvitegravir and cobicistat. Each tablet contains 300 mg tenofovir DF (which is equivalent to 245 mg of tenofovir disoproxil), 200 mg emtricitabine, 150 mg of elvitegravir and 150 mg of cobicistat. Tenofovir DF is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in water at 25 ° C. The partition coefficient ( _log p_ ) for tenofovir disoproxil is 1.25 and the pKa is 3.75. Emtricitabine is a white to off-white crystalline powder with a solubility of approximately 112 mg/mL in water at 25 ° C. The partition coefficient ( _log_ _ _ _p_ ) for emtricitabine is -0.43 and the pKa is 2.65. Elvitegravir is a white to pale yellow powder with a solubility of less than 0.5 µg/mL in water at 20 °C. The partition coefficient ( _log p_ ) for elvitegravir is 4.5 and the pKa is 6.6. Cobicistat is a white to pale yellow solid with a solubility of 0.1 mg/mL in water with pH 6.8 phosphate buffer at 20 °C. The partition coefficient ( _log p_ ) for cobicistat is 4.3 and the pKa is 6.4. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM STRIBILD is available as tablets. The tablets are film-coated, capsule shaped and green in colour. Each tablet is debossed with ‘GSI’ on one side and the number “1” surrounded by a square box ( 1 ) on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS STRIBILD is indicated as a single tablet regimen for the treatment of HIV infection in treatment- naive adults. STRIBILD is also indicated in certain virologically suppressed (HIV1 RNA <50 copies/mL) adult patients on a stable antiretrov Baca dokumen lengkapnya