Deferasirox Accord

Kraj: Unia Europejska

Język: angielski

Źródło: EMA (European Medicines Agency)

Składnik aktywny:

deferasirox

Dostępny od:

Accord Healthcare S.L.U.

Kod ATC:

V03AC03

INN (International Nazwa):

deferasirox

Grupa terapeutyczna:

All other therapeutic products, Iron chelating agents

Dziedzina terapeutyczna:

Iron Overload; beta-Thalassemia

Wskazania:

Deferasirox Accord is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older.Deferasirox Accord is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years,in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (

Podsumowanie produktu:

Revision: 5

Status autoryzacji:

Authorised

Data autoryzacji:

2020-01-09

Ulotka dla pacjenta

37
B. PACKAGE LEAFLET
38
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEFERASIROX ACCORD 90 MG FILM-COATED TABLETS
DEFERASIROX ACCORD 180 MG FILM-COATED TABLETS
DEFERASIROX ACCORD 360 MG FILM-COATED TABLETS
deferasirox
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.
WHAT IS IN THIS LEAFLET
1.
What Deferasirox Accord is and what it is used for
2.
What you need to know before you take Deferasirox Accord
3.
How to take Deferasirox Accord
4.
Possible side effects
5.
How to store Deferasirox Accord
6.
Contents of the pack and other information
1.
WHAT DEFERASIROX ACCORD IS AND WHAT IT IS USED FOR
WHAT DEFERASIROX ACCORD IS
Deferasirox Accord contains an active substance called deferasirox. It
is an iron chelator which is a
medicine used to remove the excess iron from the body (also called
iron overload). It traps and
removes excess iron which is then excreted mainly in the stools.
WHAT DEFERASIROX ACCORD IS USED FOR
Repeated blood transfusions may be necessary in patients with various
types of anaemia (for example
thalassaemia, sickle cell disease or myelodysplastic syndromes (MDS)).
However, repeated blood
transfusions can cause a build-up of excess iron. This is because
blood contains iron and your body
does not have a natural way to remove the excess iron you get with
your blood transfusions. In patients
with non-transfusion-dependent thalassaemia syndromes, iron overload
may also develop over time,
mainly due to increased absorption of dietary iron in response to low
blood cell counts. Over time, the
excess iron can dama

Charakterystyka produktu

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Deferasirox Accord 90 mg film-coated tablets
Deferasirox Accord 180 mg film-coated tablets
Deferasirox Accord 360 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Deferasirox Accord 90 mg film-coated tablets
Each film-coated tablet contains 90 mg deferasirox.
_Excipients with known effect _
Each 90 mg tablet also contains 27 mg of lactose (as monohydrate) and
2.95 mg of castor oil.
Deferasirox Accord 180 mg film-coated tablets
Each film-coated tablet contains 180 mg deferasirox.
_Excipients with known effect _
Each 180 mg tablet also contains 54 mg of lactose (as monohydrate) and
5.9 mg of castor oil.
Deferasirox Accord 360 mg film-coated tablets
Each film-coated tablet contains 360 mg deferasirox.
_Excipients with known effect _
Each 360 mg tablet also contains 108 mg of lactose (as monohydrate)
and 11.8 mg of castor oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Deferasirox Accord 90 mg film-coated tablets
Yellow colored, film coated oval, biconvex tablets with beveled edges
debossed with ‘D’ on one side
and ‘90’ on another side. Approximate tablet dimensions 11.0 mm x
4.20 mm.
Deferasirox Accord 180 mg film-coated tablets
Yellow colored, film coated oval, biconvex tablets with beveled edges
debossed with ‘D’ on one side
and ‘180’ on another side. Approximate tablet dimensions 14.0 mm x
5.50 mm.
Deferasirox Accord 360 mg film-coated tablets
Yellow colored, film coated oval, biconvex tablets with beveled edges
debossed with ‘D’ on one side
and ‘360’ on another side. Approximate tablet dimensions 17.0 mm x
6.80 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
3
Deferasirox Accord is indicated for the treatment of chronic iron
overload due to frequent blood
transfusions (
_≥_
7 ml/kg/month of packed red blood cells) in patients with beta
thalassaemia major aged
6 years and older.
Deferasirox Accord is also indicated for the treatment of