AZATHIOPRINE GH azathioprine 25mg tablet blister pack

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

azathioprine, Quantity: 25 mg

Dostupné z:

Sandoz Pty Ltd

Forma lieku:

Tablet, film coated

Zloženie:

Excipient Ingredients: purified talc; lactose monohydrate; magnesium stearate; maize starch; povidone; colloidal anhydrous silica; titanium dioxide; hypromellose; microcrystalline cellulose; PEG-8 stearate

Spôsob podávania:

Oral

Počet v balení:

100 tablets

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

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 higher dosage and prolonged usage of corticosteroids. Azathioprine, in combination with cortocosteroids 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 ana

Prehľad produktov:

Visual Identification: Round, biconvex yellowish-white film coated tablets.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizácia:

Registered

Príbalový leták

CONSUMER MEDICINE INFORMATION
AZATHIOPRINE GH
(AZATHIOPRINE) FILM-COATED TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Azathioprine GH.
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 taking
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 need to read it again.
WHAT AZATHIOPRINE GH IS
USED FOR
Azathioprine GH contains
azathioprine as the active
ingredient. Azathioprine
belongs to a group of medicines
called immunosuppressants.
This medicine is used to help
prevent the rejection of a
transplanted organ such as a
kidney, liver or heart. It works
by suppressing the body's
immune defence system.
Azathioprine GH can also be
used to treat other diseases
called autoimmune diseases
where your immune system is
reacting against your own body.
These may include:
•
severe rheumatoid arthritis;
•
systemic lupus
erythematosus (SLE);
•
chronic active hepatitis;
•
certain skin, muscle and
blood diseases.
Azathioprine GH is usually taken
in combination with other
medicines such as
corticosteroids or other
immunosuppressive drugs
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have
prescribed it for another reason.
This medicine is not addictive.
This medicine is available only
with a doctor's prescription.
BEFORE YOU TAKE
AZATHIOPRINE GH
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF
YOU HAVE AN ALLERGY TO:
•
azathioprine, the active
ingredient, or to any of the
other ingredients listed at the
end of this leaflet under
Product Description;
•
any other similar medicines
such as 6-mercaptopurine
(PuriNethol
®
).
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath;
•
wheezing or difficu

Súhrn charakteristických

AUSTRALIAN PRODUCT INFORMATION – AZATHIOPRINE GH
(AZATHIOPRINE) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Azathioprine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Azathioprine GH 25 mg film-coated tablet contains 25 mg
azathioprine.
Each Azathioprine GH 50 mg film-coated tablet contains 50 mg
azathioprine.
_Not all strengths may be marketed in Australia. _
_ _
List of excipients with known effects: Lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Azathioprine GH 25 mg film-coated tablets are round, biconvex,
yellowish-white film-coated tablets.
Azathioprine GH 50 mg film-coated tablets are round, biconvex, white
to yellowish-white, film-coated
tablets with one-sided breaking notch
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Azathioprine GH 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.
Azathioprine GH, in combination with corticosteroids and/or other
immunosuppressive agents and
procedures, is indicated in the management of patients receiving organ
transplants.
Azathioprine GH, 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.
Azathioprine GH v4.1
Page 2 of 16
(azathioprine) film-coated tablet
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Dosa