THIOPRINE azathioprine 50mg tablet blister pack

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

azathioprine, Quantity: 50 mg

Disponible des:

Alphapharm Pty Ltd

formulario farmacéutico:

Tablet, film coated

Composición:

Excipient Ingredients: lactose monohydrate; pregelatinised maize starch; magnesium stearate; maize starch; macrogol 400; stearic acid; hypromellose

Vía de administración:

Oral

Unidades en paquete:

100 tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

INDICATINS AS AT 2 FEBUARY 2005 : THIOPRINE 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. THIOPRINE, in combination with corticosteroids and/or other immunosuppressive agents and procedures, is indicated in the management of patients receiving organ transplants. THIOPRINE, either alone or more usually in combination with corticosteroids and/or other 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/polymyositis; autoimmune chronic active hepatitis; pemphigus vulgaris

Resumen del producto:

Visual Identification: A round biconvex yellow film coated tablet, scored and debossed "GX" above score and "CHI" below the score line on one side and plain on the other.; Container Type: Blister Pack; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Estat d'Autorització:

Registered

Data d'autorització:

1996-09-30

Informació per a l'usuari

THIOPRINE
_contains the active ingredient azathioprine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Thioprine.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Thioprine against
the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT THIOPRINE IS
USED FOR
Thioprine contains azathioprine as
the active ingredient. Azathioprine
belongs to a group of medicines
called immunosuppressants.
These medicines work by blocking
the activity of some parts of the
body's immune system.
Thioprine is used to:
•
prevent rejection after organ
transplants
•
treat autoimmune diseases, such
as rheumatoid arthritis and SLE
(systemic lupus erythematosus)
•
treat certain skin, muscle and
blood disorders.
Thioprine can also be used to treat
other diseased called autoimmune
diseases where your immune system
is reacting against your own body.
These may include:
•
severe rheumatoid arthritis
•
systemic lupus erthematosus
•
chronic active hepatitis
•
certain skin, muscle, and blood
diseases.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIOPRINE HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Thioprine for another reason.
Thioprine is often taken together
with other medicines, such as
corticosteroids.
Thioprine is available only with a
doctor's prescription.
There is no evidence that Thioprine
is addictive.
BEFORE YOU TAKE
THIOPRINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIOPRINE IF YOU ARE
ALLERGIC TO:
•
medicines containing
azathioprine (eg. Imuran,
Azamun) or mercaptopurine
(Puri-Nethol)
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include skin rash,
itching or hives; swelling of the face,
li

Fitxa tècnica

AUSTRALIAN PRODUCT INFORMATION
THIOPRINE
_Azathioprine _
1. NAME OF THE MEDICINE
Azathioprine
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
THIOPRINE tablets contain 50mg of the active azathioprine.
For the list of excipients, see section 6.1 List of excipients.
The tablets are gluten free.
Azathioprine is a pale yellow, odourless powder.
3. PHARMACEUTICAL FORM
The 50 mg film coated tablets are round, yellow, scored and marked
“GX” above the score and “CH1” below
the score on one side, plain on the other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Azathioprine is used as an immunosuppressant anti-metabolite 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.
THIOPRINE, in combination with corticosteroids and/or other
immunosuppressive agents and procedures,
is indicated in the management of patients receiving organ
transplants.
THIOPRINE, either alone or more usually in combination with
corticosteroids and/or other 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/polymyositis,
•
autoimmune chronic active hepatitis,
•
pemphigus vulgaris,
•
polyarteritis nodosa,
•
autoimmune haemolytic anaemia,
•
chronic refractory idiopathic thrombocytopenic purpura.
4.2 DOSE AND METHOD OF ADMINISTRATION
THIOPRINE tablets should be administered at least 1 hour before or 3
hours after food or milk.
Specialist medical literature should be consulted for guidance as to
clinical experience in particular
conditions.
THIOPRINE – PRODUCT INFORMATION
2
DOSAGE IN TRANSPLANTATION
ADULTS AND CHILDREN.
Depending o