FERRIPROX deferiprone 50g/500mL oral solution bottle

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

deferiprone, Quantity: 100 mg/mL

Tillgänglig från:

Chiesi Australia Pty Ltd

INN (International namn):

Deferiprone

Läkemedelsform:

Oral Liquid, solution

Sammansättning:

Excipient Ingredients: glycerol; hydrochloric acid; sucralose; sunset yellow FCF; Peppermint Oil; hyetellose; purified water; Flavour

Administreringssätt:

Oral

Enheter i paketet:

1 bottle

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

Indicated for the treatment of iron overload in patients with thalassaemia major who are unable to take desferrioxamine therapy; or in whom desferrioxamine therapy has proven ineffective.

Produktsammanfattning:

Visual Identification: A clear, reddish orange solution; Container Type: Bottle; Container Material: Plastic; Container Life Time: 18 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Bemyndigande status:

Registered

Tillstånd datum:

2008-03-26

Bipacksedel

FERRIPROX Oral Solution
1
FERRIPROX
® ORAL
SOLUTION
_Contains the active ingredient deferiprone _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ferriprox oral
solution. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
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 CONCERNS ABOUT TAKING
FERRIPROX, ASK YOUR DOCTOR.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may want to read it again.
WHAT FERRIPROX IS
USED FOR
Ferriprox contains the active
ingredient deferiprone and is used for
the treatment of iron overload in
patients with thalassaemia major who
are unable to take desferrioxamine or
in whom desferrioxamine therapy has
proven ineffective.
Ferriprox is a medicine that removes
iron from the body.
In a disease such as thalassaemia
major, there is accumulation of iron
in the body in those patients who are
dependent on blood transfusions. If
not removed, the iron levels can
reach a serious level in the body as a
result of the accumulation. By
removing the excess iron from the
body, Ferriprox can reduce the
serious effects of iron overload.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY FERRIPROX HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another use.
Ferriprox is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE FERRIPROX IF YOU OR
YOUR CHILD:
•
have a history of hypersensitivity
(an allergy) to deferipr

Produktens egenskaper

FERRIPROX AU PI v1.0
1
AUSTRALIAN PRODUCT INFORMATION
FERRIPROX
® (DEFERIPRONE)
1
NAME OF THE MEDICINE
Deferiprone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FERRIPROX 500 MG FILM-COATED TABLET
Each film-coated tablet contains 500 mg deferiprone as the active
ingredient.
FERRIPROX 1000 MG FILM-COATED TABLET
Each film-coated tablet contains 1000 mg deferiprone as the active
ingredient.
FERRIPROX 100 MG/ML ORAL SOLUTION
Each mL of oral solution contains 100 mg deferiprone as the active
substance. The 250 mL bottle
contains a total dose of 25 g of deferiprone and the 500 mL bottle
contains a total dose of 50 g of
deferiprone.
EXCIPIENTS WITH KNOWN EFFECT
Sucralose (oral solution only)
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
500 MG FILM-COATED TABLET
Ferriprox tablets are white to off white, capsule-shaped, film-coated,
scored and imprinted “APO”
bisect “500” on one side, and plain on the other side. The tablets
are breakable in half.
1000 MG FILM-COATED TABLET
Ferriprox tablets are white to off-white, capsule-shaped, film-coated,
scored and imprinted “APO”
bisect “1000” on one side, and plain on the other side. The
tablets are breakable in half.
100 MG/ML ORAL SOLUTION
Ferriprox oral solution is a clear, reddish orange solution with a
peppermint and cherry-flavoured
aroma.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Ferriprox is indicated for the treatment of iron overload in patients
with thalassaemia major who are
unable to take desferrioxamine or in whom desferrioxamine therapy has
proven ineffective.
4.2
D
OSE AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
For oral administration.
Therapy with Ferriprox should be initiated and maintained by a
physician experienced in the treatment
of patients with transfusional haemosiderosis.
FERRIPROX AU PI v1.0
2
DOSAGE
The effect of Ferriprox in decreasing the body iron is influenced by
the dose and degree of iron
overload. Ferriprox is given as 25 mg/kg to 33 mg/kg body weight,
orally, three t