Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
abacavir
ViiV Healthcare B.V.
J05AF06
abacavir
Antivirals for systemic use
HIV Infections
Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children.The demonstration of the benefit of Ziagen is mainly based on results of studies performed with a twice daily regimen, in treatment-naïve adult patients on combination therapy.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: 47
Authorised
1999-07-08
51 B. PACKAGE LEAFLET 52 PACKAGE LEAFLET: INFORMATION FOR THE USER ZIAGEN 300 MG FILM-COATED TABLETS abacavir 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 ZIAGEN CONTAINS ABACAVIR (which is also an active substance in medicines such as KIVEXA, TRIUMEQ and TRIZIVIR ). 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 Ziagen 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 Ziagen is and what it is used for 2. What you need to know before you take Ziagen 3. How to take Ziagen 4. Possible side effects 5. How to store Ziagen 6. Contents of the pack and other information 1. WHAT ZIAGEN IS AND WHAT IT IS USED FOR ZIAGEN IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION. Ziagen contains the active ingredient abacavir. Abacavir belongs to a group of anti-retroviral medicines called _nucleoside analogue reverse transcriptase inhibitors (NRTIs)_ . Ziagen does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. It also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cell that are important in helping your body to fight infect Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ 2 1. NAME OF THE MEDICINAL PRODUCT Ziagen 300 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of abacavir (as sulfate). For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablets) The scored tablets are yellow, biconvex, capsule shaped and are engraved with ‘GX 623’ on both sides. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children (see sections 4.4 and 5.1). The demonstration of the benefit of Ziagen is mainly based on results of studies performed with a twice daily regimen, in treatment-naïve adult patients on combination therapy (see section 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 Ziagen should be prescribed by physicians experienced in the management of HIV infection. Ziagen can be taken with or without food. To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing. Ziagen is also available as an oral solution for use in children over three months of age and weighing less than 14 kg and for those patients for whom the tablets are inappropriate. Alternatively, for patients who are unable to swallow tablets, the tablet(s) may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately (see section 5.2). _Adults, adolescents and children (weighing at least 25 kg): _ 3 The recommended dose of Ziagen is 600 mg daily. This may be administered as either 300 mg (one tablet) twice daily or 600 mg (tw Pročitajte cijeli dokument