Imuran 50mg powder for solution for injection vials

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Azathioprine

Prieinama:

Aspen Pharma Trading Ltd

ATC kodas:

L04AX01

INN (Tarptautinis Pavadinimas):

Azathioprine

Dozė:

50mg

Vaisto forma:

Powder for solution for injection

Vartojimo būdas:

Intravenous

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 08020100; GTIN: 5010706001992

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
IMURAN
® INJECTION
AZATHIOPRINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, nurse or
pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor, nurse or pharmacist.
IN THIS LEAFLET:
1.
What Imuran is and what it is used for
2.
Before you have Imuran
3.
How to have Imuran
4.
Possible side effects
5.
How to store Imuran
6.
Further information
1 WHAT IMURAN IS AND WHAT IT IS USED FOR
Imuran injection contains a medicine called azathioprine. This belongs
to a group of
medicines called immunosuppressants. These medicines reduce the
activity of your body's
immune system.
Imuran is used to:

stop your body rejecting an organ transplant

treat diseases where your immune system reacts against your own body
(called
autoimmune diseases, such as rheumatoid arthritis).
Ask your doctor, nurse or pharmacist if you would like any further
explanation about these
uses.
2 BEFORE YOU HAVE IMURAN
DO NOT HAVE IMURAN IF:

you are allergic (hypersensitive) to azathioprine, mercaptopurine or
any of the other
ingredients of Imuran (listed in section 6).
If you are not sure, talk to your doctor, nurse or pharmacist before
having Imuran.
TAKE SPECIAL CARE WITH IMURAN
Check with your doctor, nurse or pharmacist before having Imuran if:

you have liver or kidney disease

you have 'Lesch-Nyhan Syndrome'. This is a rare condition that runs in
families
caused by a lack of something called HPRT or 'hypoxanthine-guanine-
phosphoribosyltransferase'

you have a condition where your body produces too little of something
called TPMT
or 'thiopurine methyltransferase'

you have ever suffered from chickenpox or shingles.
_NUDT15-gene m

Prekės savybės

OBJECT 1
IMURAN INJECTION
Summary of Product Characteristics Updated 28-Mar-2018 | Aspen
1. Name of the medicinal product
Imuran Injection.
2. Qualitative and quantitative composition
Azathioprine EP 50 mg/vial.
3. Pharmaceutical form
Injection.
4. Clinical particulars
4.1 Therapeutic 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, and to reduce the corticosteroid requirement 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.
4.2 Posology and method of administration
Imuran Injection should be used ONLY when the oral route is
impractical, and should be discontinued as
soon as oral therapy is tolerated. It must be administered only by the
intravenous route.
Specialist medical literature should be consulted for guidance as to
clinical experience in particular
conditions.
Dosage in transplantation - adults and children
Depending on the immunosuppressive regimen employed, a dosage of up to
5 mg/kg bodyweight/day
may be given