IMURAN TABLETS 50 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

AZATHIOPRINE

متاح من:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC رمز:

L04AX01

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

AZATHIOPRINE 50 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ASPEN PHARMA TRADING LTD, IRELAND

المجموعة العلاجية:

AZATHIOPRINE

المجال العلاجي:

AZATHIOPRINE

الخصائص العلاجية:

Immunosupressive agent used in transplantation surgery for suppression of Graft rejection. For special cases of rheumatoid artritis, not responsive to other agents, and only by rheumatology experts in hospitals or rheumatic clinics.

تاريخ الترخيص:

2020-06-30

نشرة المعلومات

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

خصائص المنتج

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