Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Azathioprine
Tillomed Laboratories Ltd
L04AX01
Azathioprine
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08020100; GTIN: 5024655001637 5024655003761
Azathioprine 25/50 mg FCT Package leaflet 170 mm (w) x 600 mm (L) Till-Rpg-V.9.1/1502677-4 CC19-297 (PRAC) UK All [NA] 382 1 8 points (Reg text) Proof 1 Proof 2 Proof 3 Proof 4 Proof 5 Proof 6 Proof 7 Till-Rpg-V.8/1502677-3 29/08/2019 30/08/2019 04/09/2019 10/09/2019 11/09/2019 09/12/2019 16/01/2020 Black C WHAT AZATHIOPRINE IS AND WHAT IT IS USED FOR 1 Azathioprine belongs to a group of medicines called immunosuppressants. These work by reducing the strength of the body's immune system. Azathioprine may be taken long-term as it can take weeks or months before an effect is seen. Azathioprine is used to treat the following: To prevent the body from rejecting kidney, liver or heart transplants Inflammatory bowel disease (Crohn's disease or ulcerative colitis) Severe inflammatory disease of the joints (rheumatoid arthritis) Long-term inflammation of skin and/or intestines (systemic lupus erythematosus) Inflammation of the skin and muscles (dermatomyositis, polymyositis) Inflammation of the liver (hepatitis) Inflammation of the walls of the arteries (polyarteritis nodosa) Increased breakdown of red blood cells due to the presence of auto-antibodies active at body temperature (warm) causing anaemia (looking pale and feeling tired) Autoimmune disorder where the number of platelets circulating is reduced by the immune system destroying them, causing a rash and an increased tendency to bleed, persisting longer than 6 months without a specific cause and is not responsive to conventional treatment (chronic refractory idiopathic thrombocytopenic purpura) Blistering of the skin (pemphigus vulgaris) WHAT YOU NEED TO KNOW BEFORE YOU TAKE AZATHIOPRINE 2 DO NOT TAKE AZATHIOPRINE IF: You are allergic to Azathioprine, 6-mercaptopurine (a derivative of Azathioprine) or any of the other ingredients of this medicine (see section 6 "Contents of the pack and other information") WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR BEFORE TAKING AZATHIOPRINE: If you are going to have a vaccination Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Azathioprine 50 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg azathioprine. Excipient with known effect: contains 90 mg of lactose (as lactose monohydrate) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to yellowish-white, biconvex film-coated tablet, of diameter 7.9- 8.3mm and height of 3.6-4.2mm with a score-line on one side. The tablet can be divided into equal doses 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Azathioprine 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, 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. Azathioprine 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 therapy, or in patients whose disease is refractory to other standard first line therapy. Azathioprine either alone or more usually in combination with corticosteroids and/or other medicinal products and 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 active rheumatoid arthritis; - Systemic lupus erythematosus; - Dermatomyositis and polymyos Izlasiet visu dokumentu