Maa: Indonesia
Kieli: indonesia
Lähde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
AZATHIOPRINE
GLAXO WELLCOME INDONESIA - Indonesia
AZATHIOPRINE
50 MG
TABLET SALUT SELAPUT
DUS, 4 BLISTER @ 25 TABLET SALUT SELAPUT
EXCELLA Gmbh - Germany
2017-02-27
Page 1 of 12 IMURAN™ AZATHIOPRINE 1. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of the active ingredient azathioprine. _ _ 2. PHARMACEUTICAL FORM Film-coated tablet. 3. CLINICAL PARTICULARS 3.1 INDICATIONS _IMURAN_ is indicated for the treatment of patients who have received an organ transplant. _IMURAN_ has a significant therapeutic effect in a proportion patient suffering from chronic active hepatitis, severe rheumatoid arthritis, systemic lupus erythematosus (SLE), dermatomyositis, pemphigus vulgaris, polyarteritis nodosa, acquired hemolytic anemia, idiophatic thrombocytophenic purpura. _IMURAN_ is used in conditions other than transplantation when : (a). they are refractory to corticosteroids alone, or (b). they are controlled by corticosteroids in dosages producing or likely to produce severe side effects and the primary aim is to reduce the requirements of steroids, or (c). corticosteroid are contra-indicated. In pemphigus and rheumatoid arthritis _IMURAN_ has been shown to have significant therapeutic activity when used without corticosteroids. In other conditions or where local registration authority approval has not yet been given for a particular condition, the use of _IMURAN_ must be regarded as experimental. The risk as associated with therapy with _IMURAN_ should be consider against the severity of patient’s condition and the prospects of therapeutic benefit. 3.2 DOSAGE AND ADMINISTRATION ADULTS AND CHILDREN _In transplantation: _ In renal transplantation the dose of _IMURAN_ required to prevent rejection and minimize toxicity will vary with individual patients; this necessitates careful management. Initial dose usually 3 to 5 mg/kg daily, beginning at the time of transplant. _IMURAN_ is usually given as a single daily dose on the day of, and in a minority of cases to three days before transplantation. _IMURAN_ is often initiated with the intravenous administration of the sodium salt, with the subsequence use of film-coated tablets (at the same dose level) after post-oper Lue koko asiakirja