Country: Մալայզիա
language: անգլերեն
source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
EFAVIRENZ; TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE
CAMBER LABORATORIES SDN. BHD.
EFAVIRENZ; TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE
30tablet Tablets
Hetero Labs Limited
TRUSTIVA TABLET ® _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate (600mg/200mg/300mg) WHAT IS IN THIS LEAFLET 1. What _TRUSTIVA _ _(Efavirenz, _ _Emtricitabine _ _and _ _Tenofovir _ _Disoproxil Fumarate) _ is used for 2. How _TRUSTIVA _ _(Efavirenz, _ _Emtricitabine _ _and _ _Tenofovir _ _DF) _ works 3. Before you use _TRUSTIVA _ _(Efavirenz, _ _Emtricitabine _ _and _ _Tenofovir DF) _ 4. How to use _TRUSTIVA (Efavirenz, _ _Emtricitabine and Tenofovir DF) _ 5. While you are using it 6. Side effects 7. Storage and Disposal of _TRUSTIVA _ _(Efavirenz, _ _Emtricitabine _ _and _ _Tenofovir DF) _ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _TRUSTIVA _ _(EFAVIRENZ, _ _EMTRICITABINE _ _AND _ _TENOFOVIR _ _DF) _ IS USED FOR TRUSTIVA can be used alone as a complete regimen, or in combination with other anti-HIV-1 medicines to treat people with HIV-1 infection. HOW _TRUSTIVA _ _(EFAVIRENZ, _ _EMTRICITABINE AND TENOFOVIR DF) _WORKS TRUSTIVA helps block HIV-1 reverse transcriptase, a viral chemical in your body (enzyme) that is needed for HIV-1 to multiply, lowers the amount of HIV- 1 in the blood (viral load) and may also help to increase the number of T cells (CD4 + cells), allowing your immune system to improve. BEFORE YOU USE _TRUSTIVA (EFAVIRENZ, _ _EMTRICITABINE AND TENOFOVIR DF) _ - _When you must not use it _ _Pregnancy and lactation _ Do not take _TRUSTIVA (EFAVIRENZ, _ _EMTRICITABINE AND TENOFOVIR DF) _ if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take _TRUSTIVA (EFAVIRENZ, _ _EMTRICITABINE AND TENOFOVIR DF) _ if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. If you are allergic to efavirenz, emtricitabine, tenofovir disoproxil fumarate or any of the other ingredients of this medicine. - _Before you start to use it _ Tell your doctor if you have any heart disorder. Tell your healthcare provider if you: • Have kidney pro read_full_document
TRUSTIVA Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 600 mg / 200 mg / 300 mg NAME OF PRODUCT Trustiva Tablet NAME AND STRENGTH OF ACTIVE INGREDIENT Each film-coated tablet contains: 600 mg of Efavirenz, 200 mg of Emtricitabine and 300 mg of Tenofovir Disoproxil Fumarate is equivalent to 245 mg of Tenofovir Disoproxil. DOSAGE FORM Oral, fixed-dose tablet PRODUCT DESCRIPTION Pink colored, capsule shaped, film coated tablets debossed with 'H' on one side and '128' on the other side. PHARMACODYNAMICS/PHARMACOKINETICS PHARMACODYNAMICS _CARDIAC ELECTROPHYSIOLOGY: _ The effect of TRUSTIVA on the QTc interval was evaluated in an open-label, positive and placebo controlled, fixed single sequence 3-period, 3-treatment crossover QT study in 58 healthy subjects enriched for CYP2B6 polymorphisms. The mean Cmax of efavirenz in subjects with CYP2B6 *6/*6 genotype following the administration of 600 mg daily dose for 14 days was 2.25-fold the mean Cmax observed in subjects with CYP2B6 *1/*1 genotype. A positive relationship between efavirenz concentration and QTc prolongation was observed. Based on the concentration-QTc relationship, the mean QTc prolongation and its upper bound 90% confidence interval are 8.7 ms and 11.3 ms in subjects with CYP2B6*6/*6 genotype following the administration of 600 mg daily dose for 14 days. (see Section Warnings and Precautions & Section Interaction with Other Medicaments). _EFAVIRENZ_ Efavirenz is a non-nucleoside reverse transcriptase (RT) inhibitor of HIV-1. Efavirenz activity is mediated predominantly by the noncompetitive inhibition of HIV-1 reverse transcriptase (RT). HIV-2 RT and human cellular DNA polymerases, α, β, γ and δ are not inhibited by efavirenz. _EMTRICITABINE_ Emtricitabine, a synthetic nucleoside analog of cytidine, is phosphorylated by cellular enzymes to form emtricitabine 5'-triphosphate. Emtricitabine 5'-triphosphate inhibits the activity of the HIV-1 RT by competing with the natural substrate deoxycytidine 5'-triphosphate, and by being in read_full_document