البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
BICTEGRAVIR AS SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE AS FUMARATE
GILEAD SCIENCES ISRAEL LTD
J05AR20
FILM COATED TABLETS
TENOFOVIR ALAFENAMIDE AS FUMARATE 25 MG; EMTRICITABINE 200 MG; BICTEGRAVIR AS SODIUM 50 MG
PER OS
Required
GILEAD SCIENCES IRELAND UC, IRELAND
EMTRICITABINE, TENOFOVIR ALAFENAMIDE AND BICTEGRAVIR
Biktarvy is indicated for the treatment of adults infected with human immunodeficiency virus 1 (HIV 1) without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.
2024-01-31
1 Patient leaflet in accordance with the Pharmacists’ (Products) Regulations - 1986 This medicine is to be supplied by doctor’s prescription only Biktarvy ® Film-coated tablets Active ingredients: Each tablet contains – Bictegravir (as sodium) 50 mg emtricitabine 200 mg tenofovir alafenamide (as fumarate) 25 mg Inactive and allergenic substances: see section 6 _“Additional information_”. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. This leaflet contains essential information about this medicine. If you have any further questions, ask your doctor or pharmacist. Keep this leaflet. You may need to read it again. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if it seems to you that their illness issimilar to yours. If you experience any side effects, talk to your doctor or pharmacist. Even if you experience any side effects that are not listed in this leaflet (see section 4). This medicine is intended for adults aged 18 years and over. 1. What is the medicine intended for Biktarvy is indicated for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir. Therapeutic group: Antiviral for systemic use; antivirals for treatment of HIV infections, combinations. Biktarvy 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. Biktarvy contains three active substances: bictegravir, an antiretroviral medicine known as an integrase strand transfer inhibitor (INSTI) 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) 2. Before taking the medicine . X . Do not take this medicine • If y اقرأ الوثيقة كاملة
1 BIKTARVY ® (Bictegravir/emtricitabine/tenofovir alafenamide fumarate) Film-coated tablets 1. NAME OF THE MEDICINAL PRODUCT Biktarvy ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains bictegravir sodium equivalent to 50 mg of bictegravir, 200 mg of emtricitabine, and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Purplish-brown, capsule-shaped, film-coated tablet debossed with “GSI” on one side and “9883” on the other side of the tablet. Each tablet is approximately 15 mm × 8 mm. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Biktarvy is indicated for the treatment of adults infected with human immunodeficiency virus-1 (HIV-1) without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir _ _ (see section 5.1). 4.2 Posology and method of administration Therapy should be initiated by a physician experienced in the management of HIV infection. Posology One tablet to be taken once daily. _Missed doses _ If the patient misses a dose of Biktarvy within 18 hours of the time it is usually taken, the patient should take Biktarvy as soon as possible and resume the normal dosing schedule. If a patient misses a dose of Biktarvy 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 Biktarvy another tablet should be taken. If a patient vomits more than 1 hour after taking Biktarvy they do not need to take another dose of Biktarvy until the next regularly scheduled dose. _Special populations _ _ _ _Elderly_ 2 No dose adjustment of Biktarvy is required in patients aged ≥ 65 years (see sections 4.8 and 5.2). _ _ _Hepatic impairment _ No dose adjustment of Biktarvy is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. Biktarvy has not been studied i اقرأ الوثيقة كاملة