AZAPIN azathioprine 50 mg tablet blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

azathioprine, Quantity: 50 mg

Disponível em:

Arrotex Pharmaceuticals Pty Ltd

Forma farmacêutica:

Tablet, film coated

Composição:

Excipient Ingredients: microcrystalline cellulose; mannitol; maize starch; povidone; croscarmellose sodium; sodium stearylfumarate; hypromellose; macrogol 400

Via de administração:

Oral

Unidades em pacote:

100 tablets

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Azathioprine is used as an immunosuppressant/antimetabolite either alone or, more commonly, in combination with the 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.

Resumo do produto:

Visual Identification: A Light yellow, circular, biconvex tablet engraved "AZA" breakline "50" on one side and plain on the other side.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Status de autorização:

Licence status A

Data de autorização:

2003-04-04

Folheto informativo - Bula

AZAPIN – Consumer Medicine Information Page 1 of 4
_AZAPIN _
azathioprine
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common
questions
about
AZAPIN.
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
AZAPIN
against
the
benefits
the
medicine is expected to 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 AZAPIN IS USED FOR
AZAPIN tablets contain azathioprine. This
belongs
to
a
group
of
medicines
called
immunosuppressants
which
work
by
reducing
the
body’s
own
natural
immunity.
AZAPIN tablets are used to treat patients
who have received an organ transplant to
help prevent their body from rejecting the
transplanted
organs
(e.g.
a
heart
or
kidney).
This medicine is also used to suppress the
body’s immunity to treat “autoimmune”
conditions like rheumatoid arthritis, and
SLE (systemic lupus erythematosus).
AZAPIN tablets may also be used to treat
other
conditions as determined by your
doctor.
AZAPIN is a very powerful medicine.
NEVER LET ANYONE ELSE TAKE YOUR MEDICINE
EVEN IF HIS OR HER CONDITION SEEMS SIMILAR
TO YOURS.
HAVE REGULAR CHECK UPS WITH YOUR DOCTOR.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE AZAPIN IF YOU HAVE EVER
HAD AN ALLERGIC REACTION TO:
•
azathioprine
•
6-mercaptopurine (Puri-Nethol), a
medicine which is similar to AZAPIN
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction may
include shortness of breath, wheezing
or difficulty in breathing; swelling of
the
face,
lips,
tongue
or
any
other
parts
of
the
body;
rash,
itching
or
hives on the skin.
DO NOT TAKE AZAPIN IF YOU ARE PREGNANT,
MAY
BE
PREGNANT,
PLAN
TO
BECOME
PREGNANT OR INTENDING TO FATHER A CHILD.
This medicine may cause birth defects if
either the male

Características técnicas

AZAPIN Product Information
1
AUSTRALIAN PRODUCT INFORMATION – AZAPIN (AZATHIOPRINE)
TABLETS
1
NAME OF THE MEDICINE
Azathioprine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AZAPIN tablets contain 50 mg azathioprine.
Azathioprine is a pale yellow powder.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
AZAPIN 50 mg tablets are pale yellow, round, film coated, biconvex,
tablets engraved with “AZA”,
breakline & “50” on one face. The other face is plain.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Azathioprine is used as an immunosuppressant / antimetabolite either
alone or, more commonly,
in combination with the 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, and chronic refractory idiopathic thrombocytopenic purpura.
4.2
D
OSE AND METHOD OF ADMINISTRATION
AZAPIN tablets are intended for oral administration only.
_ _
_ _
AZAPIN Product Information
2
TRANSPLANTATION – ADULTS AND CHILDREN
Depending on the immunosuppressive regimen employed, a dosage of up to
5 mg / kg bodyweight /
day may be given orally on the first day of therapy.
The maintenance dosage should range from 1 to 4