Страна: Нидерландия
Език: нидерландски
Източник: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ABACAVIR ; LAMIVUDINE 0-WATER
DOC Generici S.r.l. Via Filippo Turati 40 20121 MILANO (ITALIË)
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
Apr 2016: MA in NL; Dec 2016: approval var. 03; proposed var. 10 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ ABACAVIR/LAMIVUDINE DOC GENERICI 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 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/LAMIVUDINE DOC GENERICI 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 Abacavir/Lamivudine DOC Generici 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 DOC Generici is and what it is used for 2. What you need to know before you take Abacavir/Lamivudine DOC Generici 3. How to take Abacavir/Lamivudine DOC Generici 4. Possible side effects 5. How to store Abacavir/Lamivudine DOC Generici 6. Contents of the pack and other information 1. WHAT ABACAVIR/LAMIVUDINE DOC GENERICI IS AND WHAT IT IS USED FOR ABACAVIR/LAMIVUDINE DOC GENERICI IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION IN ADULTS, ADOLESCENTS AND IN CHILDREN WEIGHING AT LEAST 25 KG. Abacavir/Lamivudine DOC Generici contains two active ingredients that are us Прочетете целия документ
Apr 2016: MA in NL; Dec 2016: approval var. 03; Set 2017: approval var. 06; proposed var. 11 1 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Abacavir/Lamivudine DOC Generici, 600 mg/300 mg filmomhulde tabletten 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg of abacavir and 300 mg lamivudine Excipient(s) 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 (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 DOC Generici 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 DOC Generici is one tablet once daily. _Children Under 25 kg: _ Abacavir/Lamivudine DOC Generici 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 DOC Generici 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 Apr 2016: MA in NL; Dec 2016: approval var. 03; Set 2017: approval var. 06; proposed var. 11 2 in Прочетете целия документ