Ferriprox

Država: Novi Zeland

Jezik: engleski

Izvor: Medsafe (Medicines Safety Authority)

Aktivni sastojci:

Deferiprone 500mg;  

Dostupno od:

Chiesi New Zealand Limited t/a Emerge Health

INN (International ime):

Deferiprone 500 mg

Doziranje:

500 mg

Farmaceutski oblik:

Film coated tablet

Sastav:

Active: Deferiprone 500mg   Excipient: Colloidal silicon dioxide Hypromellose Macrogol 3350 Magnesium stearate Microcrystalline cellulose Titanium dioxide

Jedinice u paketu:

Bottle, plastic, 120 mL HDPE bottle child resistant closure with induction seal and foam liner, 100 tablets

Razred:

Prescription

Tip recepta:

Prescription

Proizveden od:

Srini Pharmaceuticals Pvt Ltd

Terapijske indikacije:

Ferriprox is 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.

Proizvod sažetak:

Package - Contents - Shelf Life: Bottle, plastic, 120 mL HDPE bottle child resistant closure with induction seal and foam liner - 100 tablets - 60 months from date of manufacture stored at or below 25°C

Datum autorizacije:

2008-12-05

Uputa o lijeku

FERRIPROX 500 mg Tablets
1
FERRIPROX
®
500 MG TABLETS
Contains the active ingredient deferiprone
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ferriprox. 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 deferiprone or any
of the

Svojstava lijeka

FERRIPROX Data Sheet v2.1
1
NEW ZEALAND DATA SHEET
FERRIPROX
DEFERIPRONE 500 MG TABLET
DEFERIPRONE 1000 MG TABLET
DEFERIPRONE 100 MG/ML ORAL SOLUTION
1. PRODUCT NAME
Ferriprox
®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Deferiprone 500 mg film-coated tablets
Deferiprone 1000 mg film-coated tablets
Deferiprone 100 mg/mL oral solution
Excipient(s) of known effect
Ferriprox tablets and Ferriprox oral solution are lactose and gluten
free.
Ferriprox oral solution contains sucralose and the colorant sunset
yellow FCF.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
500 mg film-coated tablets
Ferriprox 500 mg tablets are white to off white, capsule-shaped,
film-coated, scored and
imprinted “APO” bisect “500” on one side, plain on the other
side.
The tablets are breakable in half.
1000 mg film-coated tablets
Ferriprox 1000 mg tablets are white to off white, capsule-shaped,
film-coated, scored and
imprinted "APO" bisect "1000" on one side, 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 THERAPEUTIC INDICATIONS
Ferriprox is 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.
4.2 DOSE AND METHOD OF ADMINISTRATION
Therapy with Ferriprox should be initiated and maintained by a
physician experienced in
the treatment of patients with thalassaemia.
FERRIPROX Data Sheet v2.1
2
Ferriprox is given as 25 mg/kg body weight, orally, three times a day
for a total daily dose
of 75 mg/kg body weight. The dose was not developed through a formal
dose finding
study, but rather through literature evaluation and assessment of an
effective dose to
produce iron excretion equivalent to the transfusional input. Dosage
per kilogram body
weight should be calculated to the nearest half tablet or to the
nearest 2.5 m