Negara: Belanda
Bahasa: Belanda
Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ABACAVIR ; LAMIVUDINE 0-WATER
Pharos Pharmaceutical Oriented Services Ltd
J05AR02
ABACAVIR ; LAMIVUDINE 0-WATER
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 90 (E 1201) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF ALUMINIUMLAK (E 110), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 90 (E 1201) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF ALUMINIUMLAK (E 110),
Oraal gebruik
Lamivudine And Abacavir
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POVIDON K 90 (E 1201); TITAANDIOXIDE (E 171); ZONNEGEEL FCF ALUMINIUMLAK (E 110);
2016-04-07
1 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ ABACAVIR/LAMIVUDINE PHAROS, 600 MG/300 MG FILMOMHULDE TABLETTEN 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. _ _ IMPORTANT — HYPERSENSITIVITY REACTIONS ABACAVIR/LAMIVUDINE PHAROS CONTAINS ABACAVIR (which is also an active substance in other related medicines). 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/Lamivudine PharOS 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/Lamivudine PharOS is and what it is used for 2. What you need to know before you take Abacavir/Lamivudine PharOS 3. How to take Abacavir/Lamivudine PharOS 4. Possible side effects 5. How to store Abacavir/Lamivudine PharOS 6. Contents of the pack and other information 1. WHAT ABACAVIR/LAMIVUDINE PHAROS IS AND WHAT IT IS USED FOR ABACAVIR/LAMIVUDINE PHAROS IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION IN ADULTS, ADOLESCENTS AND IN CHILDREN WEIGHING AT LEAST 25 KG . Abacavir/Lamivudine PharOS 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 Baca dokumen lengkapnya
1 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Abacavir/Lamivudine PharOS 600 mg/300 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg abacavir and 300 mg lamivudine Excipient with known effect: Sunset Yellow FCF Aluminium Lake (E110) 1.86 mg per tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Orange, film-coated, modified capsule shaped tablets. The dimensions of the tablets are 19.4 mm x 10.4 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Abacavir/Lamivudine PharOS 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 Abacavir/Lamivudine PharOS is one tablet once daily. 2 _Children Under 25 kg: _ Abacavir/Lamivudine PharOS should not be administered to children who weigh less than 25 kg because it is a fixed-dose tablet that cannot be dose reduced. Abacavir/Lamivudine PharOS 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. _Special Populations _ _Elderly:_ No pharmacokinetic data are currently available in patients over 65 years of age Baca dokumen lengkapnya