FERRIPROX ORAL SOLUTION 100 MGML

Kraj: Izrael

Język: angielski

Źródło: Ministry of Health

Składnik aktywny:

DEFERIPRONE

Dostępny od:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

Kod ATC:

V03AC02

Forma farmaceutyczna:

SOLUTION (ORAL)

Skład:

DEFERIPRONE 100 MG / 1 ML

Droga podania:

PER OS

Typ recepty:

Required

Wyprodukowano przez:

APOTEX INC. (RICHMOND HILL SITE), CANADA

Grupa terapeutyczna:

DEFERIPRONE

Dziedzina terapeutyczna:

DEFERIPRONE

Wskazania:

For the treatment of iron overload in patients over 6 years old with thalassaemia major when deferoxamine therapy is contraindicated or inadequate.

Data autoryzacji:

2017-02-28

Ulotka dla pacjenta

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
FERRIPROX ORAL SOLUTION 100 MG/ML
COMPOSITION: Each ml of solution contains Deferiprone 100 mg
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains
concise information about the medicine. If you have further questions,
refer to the doctor or
pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it on to
others. It may harm them even if it seems to you that their medical
condition is similar.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Ferriprox Oral Solution is a medicine for the treatment of iron
overload in patients over 6 years
old who suffer from thalassemia major, when deferoxamine therapy is
contraindicated or
inadequate.
THERAPEUTIC GROUP: Iron-binding agents (chelators)
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
•
You are pregnant or breastfeeding.
•
In children under the age of 6.
•
You suffer from hypersensitivity to deferiprone or to any of this
medicine’s ingredients
(see section 6).
•
You suffer or have suffered in the past from neutropenia (low white
blood cell
(neutrophil) count)
•
You suffer or have suffered in the past from agranulocytosis (very low
white blood cell
(neutrophil) count)
•
You are currently being treated with medicines known to cause
neutropenia or
agranulocytosis
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE:
-
The most serious side effect that may occur due to taking Ferriprox is
a very low white
blood cell (neutrophil) count. This condition, known as severe
neutropenia or
agranulocytosis, has occurred in 1 to 2 out of 100 people who have
taken Ferriprox in
clinical studies. Because white blood cells help to fight infection, a
low neutrophil count
may place the patient at risk of developing a serious and potentially
life-threatening
infection. To monitor for neutropenia, your doctor will ask you to
have a blood test (to

Charakterystyka produktu

1
FERRIPROX ORAL SOLUTION 100 MG/ML– PHYSICIAN LEAFLET
1.
NAME OF THE MEDICINAL PRODUCT
Ferriprox 100 mg/ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 100 mg deferiprone (25 g deferiprone
in 250 ml and 50 g deferiprone
in 500 ml).
Excipient with known effect
Each ml of oral solution contains 0.4 mg FD&C Yellow.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Clear, reddish orange-coloured liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ferriprox is indicated for the treatment of iron overload in patients
over 6 years old
with thalassaemia
major when deferoxamine therapy is contraindicated or inadequate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Deferiprone therapy should be initiated and maintained by a physician
experienced in the treatment of
patients with thalassaemia.
_Posology _
Deferiprone is usually given as 25 mg/kg body weight, orally, three
times a day for a total daily dose
of 75 mg/kg body weight. Dose per kilogram body weight should be
calculated to the nearest 2.5 ml.
See table below for recommended doses for body weights at 10 kg
increments.
2
_Dose table_
To obtain a dose of about 75 mg/kg/day, use the volume of oral
solution suggested in the following
table for the body weight of the patient. Sample body weights at 10 kg
increments are listed.
BODY WEIGHT
(KG)
TOTAL DAILY DOSE
(MG)
DOSE
(MG, THREE TIMES/DAY)
ML OF ORAL SOLUTION
(THREE TIMES/DAY)
20
1500
500
5.0
30
2250
750
7.5
40
3000
1000
10.0
50
3750
1250
12.5
60
4500
1500
15.0
70
5250
1750
17.5
80
6000
2000
20.0
90
6750
2250
22.5
A total daily dose above 100 mg/kg body weight is not recommended
because of the potentially
increased risk of adverse reactions (see sections 4.4, 4.8, and 4.9).
The effect of Ferriprox in decreasing the body iron is directly
influenced by the dose and the degree of
iron overload. After starting Ferriprox therapy, it is recommended
that serum ferritin concentrations,
or other indicators of body iron load, be monitor