THIOPRINE 50 azathioprine 50 mg film-coated tablet blister pack

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

azathioprine, Quantity: 50 mg

Dostupné z:

Sandoz Pty Ltd

INN (Medzinárodný Name):

Azathioprine

Forma lieku:

Tablet, film coated

Zloženie:

Excipient Ingredients: magnesium stearate; colloidal anhydrous silica; titanium dioxide; lactose monohydrate; maize starch; purified talc; povidone; 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 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.

Prehľad produktov:

Visual Identification: Round, biconvex white to yellowish white film-coated tablets, with one-sided breaking notch.; 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:

Licence status A

Dátum Autorizácia:

2014-11-24

Príbalový leták

AZATHIOPRINE ALPHAPHARM
1
THIOPRINE 50
_azathioprine film-coated tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Thioprine 50.
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 THIOPRINE 50 IS
USED FOR
Thioprine 50 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.
Thioprine 50 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.
Thioprine 50 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
THIOPRINE 50
_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 (Puri-
Nethol
®
).
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or dif

Súhrn charakteristických

211027-thioprine-pi
Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION
THIOPRINE 50 (AZATHIOPRINE) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Azathioprine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Thioprine 50 film-coated tablet contains 50 mg azathioprine.
_Excipients with known effect:_
Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Thioprine 50 film-coated tablets are round, biconvex white to
yellowish-white film-coated
tablets, with one-sided breaking notch.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Thioprine 50 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 50, in combination with corticosteroids and/or other
immunosuppressive agents and
procedures, is indicated in the management of patients receiving organ
transplants.
Thioprine 50, 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
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_DOSAGE IN TRANSPLANTATION _
_ADULTS AND CHILDREN_
Depending on the immunosuppressive regimen adopted, a loading dose of
up to 5 mg/kg/day
is usually given.
Maintenance dosage may range from 1 to 4 mg/kg/day and must be
adjusted according to
clinical requirements and haematological tolerance.
Evidence indica