Ferriprox 100mgml oral solution

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Deferiprone

Dostupno od:

Swedish Orphan Biovitrum Ltd

ATC koda:

V03AC02

INN (International ime):

Deferiprone

Doziranje:

100mg/1ml

Farmaceutski oblik:

Oral solution

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 09010300; GTIN: 0771313172943

Uputa o lijeku

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FERRIPROX 100 MG/ML ORAL SOLUTION
Deferiprone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor or pharmacist.
−
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
−
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
−
Attached to this leaflet you will find a patient/carer reminder card.
You should detach, complete,
read the card carefully and carry it with you.
WHAT IS IN THIS LEAFLET
1.
What Ferriprox is and what it is used for
2.
What you need to know before you take Ferriprox
3.
How to take Ferriprox
4.
Possible side effects
5.
How to store Ferriprox
6.
Contents of the pack and other information
1.
WHAT FERRIPROX IS AND WHAT IT IS USED FOR
Ferriprox contains the active substance deferiprone. Ferriprox is a
medicine that removes iron from the
body.
Ferriprox is used to treat iron overload caused by frequent blood
transfusions in patients with
thalassaemia major when current chelation therapy is contraindicated
or inadequate.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FERRIPROX
DO NOT TAKE FERRIPROX
−
if you are allergic to deferiprone or any of the other ingredients of
this medicine (listed in
section 6).
−
if you have a history of repeated episodes of neutropenia (low white
blood cell (neutrophil)
count).
−
if you have a history of agranulocytosis (very low white blood cell
(neutrophil) count).
−
if you are currently taking medicines known to cause neutropenia or
agranulocytosis (see “Other
medicines and Ferriprox”).
−
if you are pregnant or breast-feeding.
WARNINGS AND PRECAUTIONS
−
the most serious side effect that may occur while taking Ferriprox is
a very low white blood c

Svojstava lijeka

OBJECT 1
FERRIPROX 100 MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 09-Aug-2017 | Swedish
Orphan Biovitrum Ltd
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 Sunset Yellow (E110).
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 monotherapy is indicated for the treatment of iron overload
in patients with thalassaemia major
when current chelation therapy is contraindicated or inadequate.
Ferriprox in combination with another chelator (see section 4.4) is
indicated in patients with thalassaemia
major when monotherapy with any iron chelator is ineffective, or when
prevention or treatment of life-
threatening consequences of iron overload (mainly cardiac overload)
justifies rapid or intensive correction
(see section 4.2).
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.
_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 tota