Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
azathioprine, Quantity: 25 mg
Sandoz Pty Ltd
Tablet, film coated
Excipient Ingredients: purified talc; lactose monohydrate; magnesium stearate; maize starch; povidone; colloidal anhydrous silica; titanium dioxide; hypromellose; microcrystalline cellulose; PEG-8 stearate
Oral
100 tablets
(S4) Prescription Only Medicine
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 higher dosage and prolonged usage of corticosteroids. Azathioprine, in combination with cortocosteroids and/or other immunosuppressive agents and procedures, is indicated in the management of patients receiving organ transplants. Azathioprine, either alone or more usually in combination with corticosteroids and/or other procedures, has been used with clinical benefit which may include reduction of dosage or discontinuation of corticosteroids, in a proportion of patients suffering from the following: severe rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis/polymyositis, autoimmune chronic active hepatitis, pemphigus vulgaris, polyarteritis nodosa, autoimmune haemolytic anaemia, chronic refractory idiopathic thrombocytopenic purpura.
Visual Identification: Round, biconvex yellowish-white film coated tablets.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2000-05-19
AZATHIOPRINE SANDOZ ® 1 AZATHIOPRINE SANDOZ ® _azathioprine film-coated tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Azathioprine Sandoz. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT AZATHIOPRINE SANDOZ IS USED FOR Azathioprine Sandoz contains azathioprine as the active ingredient. Azathioprine belongs to a group of medicines called immunosuppressants. This medicine is used to help prevent the rejection of a transplanted organ such as a kidney, liver or heart. It works by suppressing the body's immune defence system. Azathioprine Sandoz can also be used to treat other diseases called autoimmune diseases where your immune system is reacting against your own body. These may include: • severe rheumatoid arthritis • systemic lupus erythematosus (SLE) • chronic active hepatitis • certain skin, muscle and blood diseases. Azathioprine Sandoz is usually taken in combination with other medicines such as corticosteroids or other immunosuppressive drugs. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE AZATHIOPRINE SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • azathioprine, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description • any other similar medicines such as 6-mercaptopurine (Puri- Nethol ® ). Some of the symptoms of an allergic reaction may i Lesen Sie das vollständige Dokument
211027-azathioprine-sandoz-pi Page 1 of 15 AUSTRALIAN PRODUCT INFORMATION AZATHIOPRINE SANDOZ ® (AZATHIOPRINE) FILM-COATED TABLET 1 NAME OF THE MEDICINE Azathioprine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Azathioprine Sandoz ® 25 mg film coated tablet contains 25 mg azathioprine. Each Azathioprine Sandoz ® 50 mg film coated tablet contains 50 mg azathioprine. _Not all strengths may be marketed in Australia. _ _Excipient with known effect:_ Lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Azathioprine Sandoz 25 mg film-coated tablets are round, biconvex yellowish-white film- coated tablets. Azathioprine Sandoz 50 mg film-coated tablets are round, biconvex white to yellowish-white film-coated tablets, with one-sided breaking notch. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Azathioprine Sandoz 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. Azathioprine Sandoz, in combination with corticosteroids and/or other immunosuppressive agents and procedures, is indicated in the management of patients receiving organ transplants. Azathioprine Sandoz, either alone or more usually in combination with corticosteroids and/or other procedures, has been used with clinical benefit which may include reduction of dosage or discontinuation of corticosteroids, in a proportion of patients suffering from the following: severe rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis/polymyositis, autoimmune chronic active hepatitis, pemphigus vulgaris, polyarteritis nodosa, autoimmune haemolytic anaemia, chronic refractory idiopathic thrombocytopenic purpura. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE _DOS Lesen Sie das vollständige Dokument