Երկիր: Իսրայել
Լեզու: անգլերեն
Աղբյուրը: Ministry of Health
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL AS
GILEAD SCIENCES ISRAEL LTD
J05AF07
FILM COATED TABLETS
TENOFOVIR DISOPROXIL AS 245 MG; EMTRICITABINE 200 MG; EFAVIRENZ 600 MG
PER OS
Required
GILEAD SCIENCES INTERNATIONAL LTD, UK
TENOFOVIR DISOPROXIL
TENOFOVIR DISOPROXIL
Atripla is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
2015-09-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is to be supplied upon physician’s prescription only ATRIPLA ® FILM-COATED TABLETS COMPOSITION: Active ingredients: Each tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (as fumarate). NON ACTIVE INGREDIENTS AND ALLERGENS: 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). 1. WHAT IS ATRIPLA INTENDED FOR? Atripla can be used alone as a complete regimen, or in combination with other antiretroviral medicines to treat HIV-1 infection in adults. THERAPEUTIC GROUP: Antiviral for systemic use, antivirals for treatment of HIV infections, combinations. 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) develops. Atripla helps block HIV-1 reverse transcriptase enzyme, a viral chemical in your body that is needed for HIV-1 to multiply. Atripla lowers the amount of HIV-1 in the blood (viral load). Atripla may also help to increase the number of T cells (CD4+ cells), allowing your immune system to improve. Lowering the amount of HIV-1 in the blood lowers the chance of death or infections that happen when your immune system is weak (opportunistic infections). Atripla does not cure HIV-1 infection or AIDS a Կարդացեք ամբողջական փաստաթուղթը
1 ATRIPLA ® Film-coated tablets 1. NAME OF THE MEDICINAL PRODUCT Atripla ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (as fumarate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Pink, capsule-shaped, film-coated tablet, of dimensions 20 mm x 10.4 mm, debossed with “123” on one side, plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ATRIPLA ® is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the management of HIV infection. Posology _ _ _Adults_ The recommended dose of Atripla is one tablet taken orally once daily. If a patient misses a dose of Atripla within 12 hours of the time it is usually taken, the patient should take Atripla as soon as possible and resume the normal dosing schedule. If a patient misses a dose of Atripla by more than 12 hours and it is almost time for the next dose, the patient should not take the missed dose and simply resume the usual dosing schedule. If the patient vomits within 1 hour of taking Atripla, another tablet should be taken. If the patient vomits more than 1 hour after taking Atripla he/she does not need to take another dose. It is recommended that Atripla be taken on an empty stomach since food may increase efavirenz exposure and may lead to an increase in the frequency of adverse reactions (see sections 4.4 and 4.8). In order to improve the tolerability to efavirenz with respect to undesirable effects on the nervous system, bedtime dosing is recommended (see section 4.8). It is anticipated that tenofovir exposure (AUC) will be approximately 30% lower following administration of Atripla on an empty stomach as compared to the individual component tenofovir disoproxil when taken with food (se Կարդացեք ամբողջական փաստաթուղթը