Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
abacavir, lamivudine
ViiV Healthcare BV
J05AR02
abacavir, lamivudine
Antivirals for treatment of HIV infections, combinations, Antivirals for systemic use
HIV Infections
Kivexa is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children weighing at least 25 kg.Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Abacavir should not be used in patients known to carry the HLA-B*5701 allele.
Revision: 37
Authorised
2004-12-16
40 B. PACKAGE LEAFLET 41 PACKAGE LEAFLET: INFORMATION FOR THE USER KIVEXA 600 MG/300 MG FILM-COATED TABLETS abacavir/lamivudine 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. IMPORTANT — HYPERSENSITIVITY REACTIONS KIVEXA CONTAINS ABACAVIR (which is also an active substance in medicines such as TRIZIVIR, TRIUMEQ and ZIAGEN ). Some people who take abacavir may develop a HYPERSENSITIVITY REACTION (a serious allergic reaction), which can be life-threatening if they continue to take abacavir containing products. YOU MUST CAREFULLY READ ALL THE INFORMATION UNDER ‘HYPERSENSITIVITY REACTIONS’ IN THE PANEL IN SECTION 4 . The Kivexa pack includes an ALERT CARD , to remind you and medical staff about abacavir hypersensitivity. DETACH THIS CARD AND KEEP IT WITH YOU AT ALL TIMES . WHAT IS IN THIS LEAFLET 1. What Kivexa is and what it is used for 2. What you need to know before you take Kivexa 3. How to take Kivexa 4. Possible side effects 5. How to store Kivexa 6. Contents of the pack and other information 1. WHAT KIVEXA IS AND WHAT IT IS USED FOR KIVEXA IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION IN ADULTS, ADOLESCENTS AND IN CHILDREN WEIGHING AT LEAST 25 KG. Kivexa contains two active ingredients that are used to treat HIV infection: abacavir and lamivudine. These belong to a group of anti-retroviral medicines called _nucleoside analogue reverse transcriptase _ _inhibitors (NRTIs)_ . Kivexa does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. It also incr Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Kivexa 600 mg/300 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg of abacavir (as sulfate) and 300 mg lamivudine. Excipient(s) with known effect: Each 600 mg/300 mg tablet contains 1.7 mg sunset yellow FCF (E110) and 2.31 mg sodium. For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Orange, film-coated, modified capsule shaped tablets, debossed with GS FC2 on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ Kivexa is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children weighing at least 25 kg (see sections 4.4 and 5.1). Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin (see section 4.4). Abacavir should not be used in patients known to carry the HLA-B*5701 allele. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be prescribed by a physician experienced in the management of HIV infection. Posology _Adults, adolescents and children weighing at least 25 kg_ The recommended dose of Kivexa is one tablet once daily. _Children Under 25 kg _ Kivexa should not be administered to children who weigh less than 25 kg because it is a fixed-dose tablet that cannot be dose reduced. Kivexa is a fixed-dose tablet and should not be prescribed for patients requiring dose adjustments. Separate preparations of abacavir or lamivudine are available in cases where discontinuation or dose adjustment of one of the active substances is indicated. In these cases the physician should refer to the individual product information for these medicinal products. 3 Special Populations _ _ _Elderly_ No pharmacokinetic data are currently available in patients over 65 years of age. Special care is advised in this age group due to Przeczytaj cały dokument