APO-AZATHIOPRINE azathioprine 50 mg tablet blister pack

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

azathioprine, Quantity: 50 mg

Доступна з:

Arrotex Pharmaceuticals Pty Ltd

ІПН (Міжнародна Ім'я):

Azathioprine

Фармацевтична форма:

Tablet

Склад:

Excipient Ingredients: lactose monohydrate; magnesium stearate; maize starch; microcrystalline cellulose; macrogol 8000; hypromellose; macrogol 400

Адміністрація маршрут:

Oral

Одиниць в упаковці:

100s

Тип рецепту:

(S4) Prescription Only Medicine

Терапевтичні свідчення:

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 effects 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.,Azathioprine, in combination with corticosteroids and/or other immunosuppressive agents and procedures, is indicated in the management of patients receiving organ transplants.,Azathioprine, 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.

Огляд продуктів:

Visual Identification: Pale yellow coloured, round, biconvex film coated tablet with "AZA 50" embossed on one side and break line on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Статус Авторизація:

Licence status A

Дата Авторизація:

2013-12-03

інформаційний буклет

APO-AZATHIOPRINE TABLETS
1
APO-AZATHIOPRINE
_Azathioprine _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about azathioprine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Azathioprine is used to help prevent
the body from rejecting transplanted
organs, such as a heart or kidney.
It is also used to treat autoimmune
diseases, where your immune system
is reacting against your own body.
These include:
•
severe rheumatoid arthritis
•
systemic lupus erythematosus
•
chronic active hepatitis
•
certain skin, muscle, and blood
diseases.
Azathioprine belongs to a group of
medicines called
immunosuppressants. It works by
supressing the body's immune
defence system. Azathioprine is
usually taken in combination with
other medicines such as
corticosteroids or other
immunosuppressants.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
azathioprine
•
6-mercaptopurine
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue,
throat or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE IF YOU
HAVE RHEUM

Характеристики продукта

1
AUSTRALIAN PRODUCT INFORMATION –
APO-AZATHIOPRINE (AZATHIOPRINE) TABLETS
1
NAME OF THE MEDICINE
Azathioprine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg or 50 mg azathioprine as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients
3
PHARMACEUTICAL FORM
APO-AZATHIOPRINE 25 MG TABLETS
Orange coloured, round, biconvex film coated tablet with "AZA 25"
embossed on one side
and break line on other side.
APO-AZATHIOPRINE 50 MG TABLETS
Pale yellow coloured, round, biconvex film coated tablet with "AZA 50"
embossed on one
side and break line on other side.
Azathioprine tablets should not be divided, crushed or broken.
Provided that the film coating is intact, there is no risk in handling
film coated tablets.
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.
Azathioprine, in combination with corticosteroids and/or other
immunosuppressive agents
and procedures, is indicated in the management of patients receiving
organ transplants.
Azathioprine, 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.
2
4.2
DOSE AND METHOD OF A