Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
emtricitabine
Gilead Sciences Ireland UC
J05AF09
emtricitabine
Antivirals for systemic use
HIV Infections
Emtriva is indicated for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents.This indication is based on studies in treatment-naive patients and treatment-experienced patients with stable virological control. There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens.When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient. Where available, resistance testing may be appropriate.
Revision: 33
Authorised
2003-10-24
38 B. PACKAGE LEAFLET 39 PACKAGE LEAFLET: INFORMATION FOR THE USER EMTRIVA 200 MG HARD CAPSULES emtricitabine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Emtriva is and what it is used for 2. What you need to know before you take Emtriva 3. How to take Emtriva 4. Possible side effects 5. How to store Emtriva 6. Contents of the pack and other information 1. WHAT EMTRIVA IS AND WHAT IT IS USED FOR EMTRIVA IS A TREATMENT FOR HUMAN IMMUNODEFICIENCY VIRUS (HIV) infection in adults, children and infants aged 4 months and over. Emtriva 200 mg hard capsules are ONLY SUITABLE FOR PATIENTS WHO WEIGH AT LEAST 33 KG. Emtriva oral solution is available for people who have difficulty in swallowing Emtriva hard capsules. EMTRIVA CONTAINS THE ACTIVE SUBSTANCE _EMTRICITABINE._ This active substance is an _antiretroviral_ medicine which is used to treat HIV infection. Emtricitabine is a _nucleoside reverse transcriptase _ _inhibitor_ (NRTI) which works by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the HIV virus to reproduce itself. Emtriva may lower the amount of HIV in the blood (viral load). It may also help to increase the number of T cells called CD4 cells. Emtriva should always be combined with other medicines to treat HIV infection. THIS MEDICINE IS NOT A CURE FOR HIV INFECTION. While taking Emtriva you may still develop infections or other illnesses associated with HIV infection. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EMTRIVA DO NOT TAKE EMTRIVA • Lue koko asiakirja
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Emtriva 200 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 200 mg of emtricitabine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Each capsule has a white opaque body with a light blue opaque cap, of dimensions 19.4 mm x 6.9 mm. Each capsule is printed with “200 mg” on the cap and “GILEAD” and [Gilead logo] on the body in black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Emtriva is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infected adults and children aged 4 months and over. This indication is based on studies in treatment-naïve patients and treatment-experienced patients with stable virological control. There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens (see section 5.1). When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient. Where available, resistance testing may be appropriate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the management of HIV infection. Posology Emtriva 200 mg hard capsules may be taken with or without food. _Adults:_ The recommended dose of Emtriva is one 200 mg hard capsule, taken orally, once daily. If a patient misses a dose of Emtriva within 12 hours of the time it is usually taken, the patient should take Emtriva with or without food as soon as possible and resume their normal dosing schedule. If a patient misses a dose of Emtriva by more than 12 hours and it is almost time for their next dose, the patient should not take the missed dose and simply resume the usual dosing schedule. If the pat Lue koko asiakirja