IMURAN

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

AZATHIOPRINE

Tersedia dari:

GLAXO WELLCOME INDONESIA - Indonesia

INN (Nama Internasional):

AZATHIOPRINE

Dosis:

50 MG

Bentuk farmasi:

TABLET SALUT SELAPUT

Unit dalam paket:

DUS, 4 BLISTER @ 25 TABLET SALUT SELAPUT

Diproduksi oleh:

EXCELLA Gmbh - Germany

Tanggal Otorisasi:

2017-02-27

Karakteristik produk

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