Land: Israel
Språk: engelska
Källa: Ministry of Health
AZATHIOPRINE
PADAGIS ISRAEL AGENCIES LTD, ISRAEL
L04AX01
FILM COATED TABLETS
AZATHIOPRINE 25 MG
PER OS
Required
ASPEN PHARMA TRADING LTD, IRELAND
AZATHIOPRINE
AZATHIOPRINE
Immunosuppressive agent used in transplantation surgery for suppression of graft rejection. For special cases of rheumatoid arthritis- not responsive to other agents- and only by rheumatology experts in hospitals or rheumatic clinics.
2023-06-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only IMURAN TABLETS 25 MG, 50 MG Each tablet contains: 25 mg or 50 mg Azathioprine. For the list of inactive ingredients and allergens in the preparation – see section 2 “IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF THIS MEDICINE” and section 6 in the leaflet “ADDITIONAL INFORMATION”. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, refer to the doctor or pharmacist. This medicine has been prescribed for your treatment. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Therapeutic activity: Immunosuppression. This effect is important after an organ transplantation, so that the immune system will not reject the transplanted organ. Imuran is also used to treat rheumatoid arthritis that does not respond to other treatments – only by a rheumatologist in a hospital or clinic. THERAPEUTIC GROUP: Immunosuppressants. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive )allergic( to the active ingredient azathioprine or to any of the other ingredients contained in the medicine )see section 6(. • You are sensitive )allergic( to mercaptopurine )a medicine similar to azathioprine, the active ingredient in Imuran(. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE • BEFORE TREATMENT WITH IMURAN, TELL THE DOCTOR IF: ∘ You have recently received or are due to be vaccinated. During treatment with Imuran you should not be vaccinated with live vaccines )such as flu, measles, BCG, etc.( until the doctor confirms that this is safe for you, because some of the vaccines may cause infections during treatment with Imuran. ∘ You have a genetic disorder known as Lesch-Nyhan Syndrome. This is a rare hereditary condition caused by Läs hela dokumentet
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT IMURAN TABLETS 25 MG IMURAN TABLETS 50 MG 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg or 50 mg of the active substance azathioprine. Excipient(s) with known effect Each 25 mg tablet contains 37 mg lactose monohydrate. Each 50 mg tablet contains 74 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. Imuran 25 mg: Orange, round, biconvex, unscored, film-coated tablets branded ‘IM 2’. Imuran 50 mg: Yellow, round, biconvex, scored film-coated tablet, branded 'IM 5'. The scoreline should not be used to break the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Immunosuppressive agent used in transplantation surgery for suppression of Graft rejection. For special cases of rheumatoid arthritis, not responsive to other agents, and only by rheumatology experts in hospitals or rheumatic clinics. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Specialist medical literature should be consulted for guidance as to clinical experience in particular conditions. General When the oral route is impractical azathioprine injection may be administered by the i.v. route only, however, this route should be discontinued as soon as oral therapy can be tolerated once more. Imuran tablets should be administered at least 1 hour before or 3 hours after food or milk (see Section 5.2 Pharmacokinetics: Absorption). Dosage in transplantation - a_dults_ Depending on the immunosuppressive regimen employed, a dosage of up to 5mg/kg bodyweight/day may be given on the first day of therapy, either orally or intravenously. Maintenance dosage should range from 1-4mg/kg bodyweight/day and must be adjusted according to clinical Page 2 of 14 requirements and haematological tolerance. Corticosteroid therapy is usually given concomitantly with Imuran. Evidence indicates that Imuran therapy should be maintained indefinitely, even if only low doses are necessary, because of the risk of Läs hela dokumentet