IMURAN TABLET 50 mg

Country: Сингапур

Језик: Енглески

Извор: HSA (Health Sciences Authority)

Активни састојак:

AZATHIOPRINE

Доступно од:

DCH AURIGA SINGAPORE

АТЦ код:

L04AX01

Дозирање:

50 mg

Фармацеутски облик:

TABLET, FILM COATED

Састав:

AZATHIOPRINE 50 mg

Пут администрације:

ORAL

Тип рецептора:

Prescription Only

Произведен од:

Excella GmbH & Co. KG

Статус ауторизације:

ACTIVE

Датум одобрења:

1988-06-24

Информативни летак

IMURAN™ 
AZATHIOPRINE 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each tablet contains 25 mg or 50 mg of the active
ingredient azathioprine._ _
Each vial contains 50 mg of the active ingredient azathioprine
as the sodium salt. 
PHARMACEUTICAL FORM 
Tablet or film-coated tablet. 
Powder for solution for injection/infusion. 
CLINICAL PARTICULARS 
INDICATIONS 
_IMURAN_ is used as an immunosuppressant antimetabolite
either alone or, more 
commonly, in combination with other agents (usually corticosteroids) and procedures 
which influence the immune response. Therapeutic effect may be
evident only after weeks 
or months and can include a
steroid-sparing effect, thereby reducing the toxicity 
associated with high dosage and prolonged usage
of corticosteroids. 
_IMURAN_, in combination with corticosteroids and/or other immunosuppressive
agents 
and procedures, is indicated to enhance the
survival of organ transplants, such as renal 
transplants, cardiac transplants and hepatic transplants. 
It also reduces the corticosteroid 
requirements of renal transplant recipients. 
_IMURAN_, either alone or more
usually in combination with corticosteroids and/or other 
drugs and procedures, has been used with clinical benefit (which may include
reduction of 
dosage or discontinuation of corticosteroids) in a proportion
of patients suffering from the 
following: 

severe rheumatoid arthritis 
           systemic lupus erythematosus 

dermatomyositis and polymyositis 

auto-immune chronic active hepatitis 

pemphigus vulgaris 

polyarteritis nodosa 

auto-immune haemolytic anaemia 

chronic refractory idiopathic thrombocytopenic purpura 

DOSAGE AND ADMINISTRATION 
_IMURAN_ tablets should be administered at least 1 hour
before or 3 hours after food or 
milk (see
Pharmacological Properties: Pharm

Карактеристике производа

PROJECT:
CR_00009871_COMP_5700759 – Aspen Port Elizabeth
DOCUMENT:
5700759 – Aspen Port Elizabeth.pdf
DOCUMENT DESCRIPTION:
VERSION:
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VERSION ID:
00002_0000180056
DOWNLOADED:
Feb 5, 2024 at 10:42 AM GMT+08:00
BY:
LEUNG, JOE ([e-mail])
APPROVAL STATE:
DRAFT
IMURAN
Azathioprine
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg or 50 mg of the active ingredient
azathioprine.
Each vial contains 50 mg of the active ingredient azathioprine as the
sodium salt.
PHARMACEUTICAL FORM
Tablet or film-coated tablet.
Powder for solution for injection/infusion.
CLINICAL PARTICULARS
Indications
_IMURAN_ is used as an immunosuppressant antimetabolite either alone
or, more commonly, in
combination with other agents (usually corticosteroids) and procedures
which influence the
immune response. Therapeutic effect may be evident only after weeks or
months and can include
a steroid-sparing effect, thereby reducing the toxicity associated
with high dosage and prolonged
usage of corticosteroids.
_IMURAN_, in combination with corticosteroids and/or other
immunosuppressive agents and
procedures, is indicated to enhance the survival of organ transplants,
such as renal transplants,
cardiac transplants and hepatic transplants. It also reduces the
corticosteroid requirements of renal
transplant recipients.
_IMURAN_, either alone or more usually in combination with
corticosteroids and/or other drugs
and procedures, has been used with clinical benefit (which may include
reduction of dosage or
discontinuation of corticosteroids) in a proportion of patients
suffering from the following:
severe rheumatoid arthritis
systemic lupus erythematosus
dermatomyositis and polymyositis
auto-immune chronic active hepatitis
pemphigus vulgaris
polyarteritis nodosa
auto-immune haemolytic anaemia
chronic refractory idiopathic thrombocytopenic purpura
Dosage and Administration
_IMURAN_ tablets should be administered at least 1 hour before or 3
hours after food or milk (see
Pharmacological Properties: Pharmacokinetics; Abso