Kraj: Holandia
Język: niderlandzki
Źródło: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ABACAVIR
Mylan Ireland Limited 35/36 Grange Parade, Baldoyle Industrial Estate DUBLIN 13 (IERLAND)
J05AF06
ABACAVIR
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYSORBAAT 80 (E 433) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLYSORBAAT 80 (E 433) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Abacavir
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POLYSORBAAT 80 (E 433); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
2018-01-04
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ABACAVIR MYLAN 300 MG, FILMOMHULDE TABLETTEN 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 Mylan contains abacavir. 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 Mylan 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 Mylan is and what it is used for 2. What you need to know before you take Abacavir Mylan 3. How to take Abacavir Mylan 4. Possible side effects 5. How to store Abacavir Mylan 6. Contents of the pack and other information 1. WHAT ABACAVIR MYLAN IS AND WHAT IT IS USED FOR Abacavir Mylan is used to treat HIV (human immunodeficiency virus) infection. Abacavir Mylan contains the active substance abacavir. Abacavir belongs to a group of anti-retroviral medicines called _nucleoside analogue reverse transcriptase inhibitors (NRTIs)._ Abacavir 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 infection. Not everyone responds Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Abacavir Mylan 300 mg, filmomhulde tabletten 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 (tablet). Yellow, capsule shaped, biconvex, film-coated tablet (approximately 18.5 x 7.3 mm), debossed with ‘H’ on one side with a score line and ‘A’ and ‘26’ separated by a score line on the other side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Abacavir Mylan 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 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 Posology Abacavir Mylan should be prescribed by physicians experienced in the management of HIV infection. _ _ _Adults, adolescents and children (weighing at least 25 kg): _ The recommended dose of abacavir is 600 mg daily. This may be administered as either 300 mg (one tablet) twice daily or 600 mg (two tablets) once daily (see sections 4.4 and 5.1). _ _ _Children (weighing less than 25 kg):_ Dosing according to weight bands is recommended for abacavir tablets. _ _ _Children weighing ≥ 20 kg to < 25 kg_ : The recommended dose is 450 mg daily. This may be administered as either one 150 mg (one half of a tablet) taken in the morning and 300 mg (one whole tablet) taken in the evening, or 450 mg (one and a half tablets) ta Przeczytaj cały dokument