Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
AZATHIOPRINE 50 mg/stuk
Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)
L04AX01
AZATHIOPRINE 50 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MACROGOLSTEARAAT, TYPE I ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; POVIDON (E 1201) ; SILICA, HYDRATE FORM UNKNOWN (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Azathioprine
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE (E 464); LACTOSE 1-WATER; MACROGOLSTEARAAT, TYPE I; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; POVIDON (E 1201); SILICA, HYDRATE FORM UNKNOWN (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
2002-02-20
Hexal A.G. Page 1/9 Azathioprine 25/50 mg, filmomhulde tablet RVG 27564-5 1313-v15 1.3.1.3 Bijsluiter Juni 2021 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AZATHIOPRINE 25 MG, FILMOMHULDE TABLET AZATHIOPRINE 50 MG, FILMOMHULDE TABLET azathioprine 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. WHAT IS IN THIS LEAFLET 1. What [nationally completed name] is and what it is used for 2. What you need to know before you take [nationally completed name] 3. How to take [nationally completed name] 4. Possible side effects 5. How to store [nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY APPROVED NAME] ARE AND WHAT THEY ARE USED FOR [Nationally approved name] contain the active substance azathioprine. They belong to a group of medicines called immunosuppressives. This means that they reduce the strength of your immune system. [Nationally approved name] may be used to help your body accept an organ transplant, such as a new kidney, heart or liver, or to treat some diseases where your immune system is reacting against your own body (autoimmune diseases). Autoimmune diseases may include: • severe rheumatoid arthritis (a disease where the immune system attacks cells lining the joints causing swelling, pain, stiffness of the joints), • systemic lupus erythematosus (a disease where the immune system attacks many of the body's organs and tissues, including skin, joints, kidneys, brain, and other organs causing severe fatigue, fever, stiffness and joint pain), • dermatomyositis and polymyositis Lees het volledige document
Hexal A.G. Page 1/16 Azathioprine 25/50 mg, filmomhulde tablet RVG 27564-5 1311-v11 1.3.1.1 Samenvatting van de Productkenmerken Juni 2021 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Azathioprine 25 mg, filmomhulde tablet Azathioprine 50 mg, filmomhulde tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 25 mg azathioprine. Excipient(s) with known effect: Each film-coated tablet contains 42.75 mg lactose (as monohydrate) Each film-coated tablet contains 50 mg azathioprine. Excipient(s) with known effect: Each film-coated tablet contains 85.50 mg lactose (as monohydrate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White to yellowish-white film-coated tablet, biconvex, no score-line. White to yellowish-white film-coated tablet, biconvex with a score-line on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Nationally approved name] is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and procedures which influence the immune response. Therapeutic effect may be evident only after weeks or months and can include a steroid-sparing effect, thereby reducing the toxicity associated with high dosage and prolonged usage of corticosteroids. [Nationally approved name] in combination with corticosteroids and/or other immunosuppressive agents and procedures, is indicated to enhance the survival of organ transplants, such as renal transplants, cardiac transplants, and hepatic transplants. It also reduces the corticosteroid requirements of renal transplant recipients. [Nationally approved name] is indicated for the treatment of moderate to severe inflammatory bowel disease (IBD) (Crohn’s disease or ulcerative colitis) in patients in whom corticosteroid therapy is required, in patients who cannot tolerate corticosteroid thera Lees het volledige document