IMURAN

البلد: أندونيسيا

اللغة: الإندونيسية

المصدر: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

العنصر النشط:

AZATHIOPRINE

متاح من:

GLAXO WELLCOME INDONESIA - Indonesia

INN (الاسم الدولي):

AZATHIOPRINE

جرعة:

50.00 MG

الشكل الصيدلاني:

TABLET SALUT SELAPUT

الوحدات في الحزمة:

DUS, 4 BLISTER @ 25 TABLET SALUT SELAPUT

المصنعة من قبل:

ASPEN PORT ELIZABETH (PTY) LTD - South Africa

تاريخ الترخيص:

2021-05-26

خصائص المنتج

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 affect in a proportion patient
suffering from chronic
active
hepatitis,
severe
rheumatoid
arthritis,
systemic
lupus
erythematosus
(SLE),
dermatomyositis, pemphigus vulgaris, polyarteritis nodosa, acquired
haemolytic 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)
corticosteroids 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 POSOLOGY AND METHOD ADMINISTRATION
ADULTS AND CHILDREN
_In Transplants: _
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-operative period. In