מדינה: ניו זילנד
שפה: אנגלית
מקור: Medsafe (Medicines Safety Authority)
Efavirenz 600mg; ; ; ; Emtricitabine 200mg; ; ; ; Tenofovir disoproxil fumarate 300mg; ; ;
Gilead Sciences (NZ)
Efavirenz 600 mg
Film coated tablet
Active: Efavirenz 600mg Emtricitabine 200mg Tenofovir disoproxil fumarate 300mg Excipient: Croscarmellose sodium Hyprolose Magnesium stearate Microcrystalline cellulose Opadry pink 85F94172 Purified water Sodium laurilsulfate
Bottle, HDPE white, 30 tablets
Prescription
Prescription
BASF Orgamol Pharma Solutions France SAS
ATRIPLA is indicated for the treatment of HIV infected adults over the age of 18 years, alone or in combination with other antiretroviral agents.
Package - Contents - Shelf Life: Bottle, HDPE white - 30 tablets - 48 months from date of manufacture stored at or below 30°C
2008-09-17
ATRIPLA CMI v14.0 – (05 June 2019) Page 1 ATRIPLA ® TABLETS _300_ _ _ _mg tenofovir disoproxil fumarate / 200 mg emtricitabine/ 600 mg efavirenz _ 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 ATRIPLA 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 ATRIPLA 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 ATRIPLA ATRIPLA is used to treat Human Immunodeficiency Virus (HIV-1) infection in adults. This medicine can be taken alone or in combination with other anti-HIV medicines. ATRIPLA consists of three medicines: VIREAD ® (tenofovir disoproxil fumarate, also called tenofovir DF) EMTRIVA ® (emtricitabine or FTC) STOCRIN ® (efavirenz) These are combined in one tablet to help control Human Immunodeficiency Virus (HIV-1) infection. VIREAD and EMTRIVA belong to a group of antiviral medicines known as nucleoside and nucleotide reverse transcriptase inhibitors (NRTI). STOCRIN belongs to a group of antiviral medicines known as non- nucleoside reverse transcriptase inhibitors (NNRTI). Tenofovir DF and emtricitabine are components of TRUVADA ® and ATRIPLA ® tablets. _HOW ATRIPLA WORKS _ HIV-1 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. ATRIPLA helps block HIV-1 reverse transcriptase, a viral chemical in your body (enzyme) that is needed for HIV-1 to multiply. ATRIPLA lowers the amount of HIV-1 in the blood (viral load). AT קרא את המסמך השלם
ATRIPLA Data Sheet 15.0 (19 May 2020) Page 1 DATA SHEET 1. ATRIPLA ® (TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE AND EFAVIRENZ) TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 300 mg tenofovir disoproxil fumarate/200 mg emtricitabine/600 mg efavirenz tablets. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. ATRIPLA tablets are capsule shaped and pink in colour. Each tablet is debossed with ‘123’ on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ATRIPLA is indicated for the treatment of HIV infected adults over the age of 18 years, alone or in combination with other antiretroviral agents 4.2 DOSE AND METHOD OF ADMINISTRATION _ADULTS:_ The recommended dose of ATRIPLA is one tablet once daily taken orally on an empty stomach. Dosing at bedtime may improve the tolerability of nervous system symptoms. _PAEDIATRIC PATIENTS:_ ATRIPLA is not recommended for use in children below 18 years of age due to insufficient data on safety and efficacy. SPECIAL POPULATIONS _ELDERLY:_ ATRIPLA should be administered with caution to elderly patients (see section 4.4 Special warnings and precautions for use). _RENAL IMPAIRMENT:_ ATRIPLA is not recommended for patients with moderate or severe renal impairment (Creatinine Clearance (Cl Cr ) < 50 mL/min). Patients with moderate or severe renal impairment require dose interval adjustments of tenofovir disoproxil fumarate (tenofovir DF) and emtricitabine that cannot be achieved with the combination tablet (see section 4.4 Special warnings and precautions for use). The safety and efficacy of once daily dosing of tenofovir DF with emtricitabine in patients with mild renal impairment (Cl Cr 50 to 80 mL/min), have been demonstrated in clinical studies. No dosage adjustment is recommended for patients with renal impairment who receive efavirenz. Therefore no dosage adjustment is required for ATRIPLA in patients with mild renal impairment. _ _ ATRIPLA Data Sheet 15.0 (19 May 2020) Page 2 _HEPATIC IMPAIRM קרא את המסמך השלם