Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Bictegravir sodium 52.45mg equivalent to to 50 mg bictegravir; ; Emtricitabine 200mg; ; ; ; ; Tenofovir alafenamide fumarate 28.04mg equivalent to to 25 mg tenofovir alafenamide;
Gilead Sciences (NZ)
Film coated tablet
Active: Bictegravir sodium 52.45mg equivalent to to 50 mg bictegravir Emtricitabine 200mg Tenofovir alafenamide fumarate 28.04mg equivalent to to 25 mg tenofovir alafenamide Excipient: Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Opadry brown 85F165072
Prescription
BIKTARVY is indicated for the treatment of HIV-1 infection in adults and paediatric patients weighing at least 25 kg who are antiretroviral therapy (ART)-na?ve or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen at the start of therapy with no history of treatment failure, and no known substitutions associated with resistance to the individual components of BIKTARVY.
Package - Contents - Shelf Life: Bottle, HDPE, 100 mL with CRC PP cap, desiccant and aluminium foil liner - 30 tablets - 36 months from date of manufacture stored at or below 30°C
2019-01-07
BIKTARVY® 1 BIKTARVY® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. This medicine is new or being used differently. Please report side effects. See the full CMI for further details. 1. WHY AM I USING BIKTARVY? BIKTARVY contains the active ingredients bictegravir, emtricitabine and tenofovir alafenamide in a single tablet. BIKTARVY is used to help control Human Immunodeficiency Virus 1 (HIV-1) infection in adults and children weighing at least 25 kg. For more information, see Section 1. Why am I using BIKTARVY? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE BIKTARVY? Do not use if you have ever had an allergic reaction to BIKTARVY or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use BIKTARVY? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with BIKTARVY and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE BIKTARVY? The usual dose is one BIKTARVY tablet orally, once daily. BIKTARVY tablets can be taken with or without food. More instructions can be found in Section 4. How do I use BIKTARVY? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING BIKTARVY? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using BIKTARVY. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly. • Do not breastfeed. • Avoid doing things that can spread HIV infection. DRIVING OR USING MACHINES • Be careful driving or operating machinery until you know how BIKTARVY affects you. LOOKING AFTER YOUR MEDICINE • Keep your BIKTARVY tablets in the bottle with the cap tightly closed until you take them. • Keep BIK Đọc toàn bộ tài liệu
NEW ZEALAND DATA SHEET BIKTARVY Data Sheet v 8.0 (24 August 2023) Page 1 1 BIKTARVY ® (BICTEGRAVIR/EMTRICTABINE/TENOFOVIR ALAFENAMIDE 50/200/25 MG) TABLETS 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Bictegravir 50 mg (BIC) / Emtricitabine 200 mg (FTC) / Tenofovir alafenamide 25 mg (TAF). For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. The tablets are film-coated, capsule shaped and purplish-brown in colour. Each tablet is debossed with ‘GSI’ on one side and the number “9883” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BIKTARVY is indicated for the treatment of HIV-1 infection in adults and paediatric patients weighing at least 25kg who are antiretroviral therapy (ART)-naïve or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen at the start of therapy with no history of treatment failure, and no known substitutions associated with resistance to the individual components of BIKTARVY. 4.2 DOSE AND METHOD OF ADMINISTRATION In adults and paediatric patients weighing at least 25 kg, the dose of BIKTARVY is one tablet taken orally once daily with or without food. No data are available on which to make a dose recommendation for paediatric patients weighing less than 25 kg. Special populations: Dosage adjustment _ELDERLY:_ No dose adjustment is required for elderly patients. NEW ZEALAND DATA SHEET BIKTARVY Data Sheet v 8.0 (24 August 2023) Page 2 _RENAL IMPAIRMENT:_ No dose adjustment of BIKTARVY is required in adult patients with estimated creatinine clearance ≥ 30 mL/min or in adult patients with end stage renal disease (ESRD; estimated creatinine clearance < 15 mL/min) who are receiving chronic haemodialysis. On days of haemodialysis, administer the daily dose of BIKTARVY after completion of haemodialysis treatment. Initiation of BIKTARVY is not recommended in patients with estimated creatinine clearance ≥ 15 and < 30 mL/min, or < 15mL/min who Đọc toàn bộ tài liệu