Country: Ավստրալիա
language: անգլերեն
source: Department of Health (Therapeutic Goods Administration)
azathioprine, Quantity: 25 mg
Arrotex Pharmaceuticals Pty Ltd
Azathioprine
Tablet
Excipient Ingredients: maize starch; lactose monohydrate; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 400
Oral
100s
(S4) Prescription Only Medicine
Azathioprine is used as an immunosuppressant anti-metabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and procedures which influence the immune response. Therapeutic effects 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, in combination with corticosteroids 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: Orange coloured, round, biconvex film coated tablet with "AZA 25" embossed on one side and break line on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-12-03
APO-AZATHIOPRINE TABLETS 1 APO-AZATHIOPRINE _Azathioprine _ CONSUMER MEDICINE INFORMATION FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about azathioprine. 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 using 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 want to read it again. WHAT THIS MEDICINE IS USED FOR Azathioprine is used to help prevent the body from rejecting transplanted organs, such as a heart or kidney. It is also used to treat autoimmune diseases, where your immune system is reacting against your own body. These include: • severe rheumatoid arthritis • systemic lupus erythematosus • chronic active hepatitis • certain skin, muscle, and blood diseases. Azathioprine belongs to a group of medicines called immunosuppressants. It works by supressing the body's immune defence system. Azathioprine is usually taken in combination with other medicines such as corticosteroids or other immunosuppressants. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. This medicine is not addictive. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • azathioprine • 6-mercaptopurine • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue, throat or other parts of the body • rash, itching or hives on the skin DO NOT TAKE THIS MEDICINE IF YOU HAVE RHEUM read_full_document
1 AUSTRALIAN PRODUCT INFORMATION – APO-AZATHIOPRINE (AZATHIOPRINE) TABLETS 1 NAME OF THE MEDICINE Azathioprine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg or 50 mg azathioprine as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Lactose monohydrate For the full list of excipients, see Section 6.1 List of excipients 3 PHARMACEUTICAL FORM APO-AZATHIOPRINE 25 MG TABLETS Orange coloured, round, biconvex film coated tablet with "AZA 25" embossed on one side and break line on other side. APO-AZATHIOPRINE 50 MG TABLETS Pale yellow coloured, round, biconvex film coated tablet with "AZA 50" embossed on one side and break line on other side. Azathioprine tablets should not be divided, crushed or broken. Provided that the film coating is intact, there is no risk in handling film coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Azathioprine is used as an immunosuppressant anti-metabolite 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, in combination with corticosteroids 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. 2 4.2 DOSE AND METHOD OF A read_full_document