Country: Malta
Bahasa: Inggeris
Sumber: Medicines Authority
ABACAVIR
Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland
J05AF06
ABACAVIR 300 mg
FILM-COATED TABLET
ABACAVIR 300 mg
POM
ANTIVIRALS FOR SYSTEMIC USE
Licence number in the source country: NOT APPLICAPABLE
Withdrawn
2020-10-20
PACKAGE LEAFLET: INFORMATION FOR THE USER ABACAVIR ACCORD 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 ABACAVIR ACCORD CONTAINS ABACAVIR (which is also an active substance in medicines such as ABACAVIR+LAMIVUDINE, ABACAVIR+LAMIVUDINE+ZIDOVUDINE and DOLUTEGRAVIR+ABACAVIR+LAMIVUDINE ). 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 Abacavir Accord 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 Abacavir Accord is and what it is used for 2. What you need to know before you take Abacavir Accord 3. How to take Abacavir Accord 4. Possible side effects 5. How to store Abacavir Accord 6. Contents of the pack and other information 1. WHAT ABACAVIR ACCORD IS AND WHAT IT IS USED FOR ABACAVIR ACCORD IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION. Abacavir Accord contains the active ingredient abacavir. Abacavir belongs to a group of anti- retroviral medicines called _nucleoside analogue reverse transcriptase inhibitors (NRTIs)_ . Abacavir Accord does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. It al Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Abacavir Accord 300 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of abacavir. For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablets) The scored tablets are yellow, biconvex, 18.50 x 7.30 mm, capsule shaped and are debossed with ‘H’ on one side and with ‘A’ and ‘26’ on the other side separated by the score line. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Abacavir Accord 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 Abacavir Accord 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 Abacavir Accord should be prescribed by physicians experienced in the management of HIV infection. Abacavir Accord can be taken with or without food. To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing. Abacavir may also be 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): _ The recommended dos Baca dokumen lengkap