Deferasirox Stada 900 mg, filmomhulde tabletten

Pays: Pays-Bas

Langue: néerlandais

Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ingrédients actifs:

DEFERASIROX 900 mg/stuk

DCI (Dénomination commune internationale):

DEFERASIROX 900 mg/stuk

forme pharmaceutique:

Filmomhulde tablet

Composition:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; POLOXAMEER 188 ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; POLOXAMEER 188 ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Mode d'administration:

Oraal gebruik

Date de l'autorisation:

1900-01-01

Notice patient

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DEFERASIROX STADA 900 MG, FILMOMHULDE TABLETTEN
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 only for you or your child. 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 Stada 900 mg, filmomhulde tablettenDeferasirox Stada
900 mg, filmomhulde
tabletten is and what it is used for
2.
What you need to know before you take Deferasirox STADA Arzneimittel
AG 900 mg,
filmomhulde tabletten
3.
How to take Deferasirox Stada 900 mg, filmomhulde tabletten
4.
Possible side effects
5.
How to store Deferasirox Stada 900 mg, filmomhulde tabletten
6.
Contents of the pack and other information
1.
WHAT
DEFERASIROX STADA 900 MG, FILMOMHULDE TABLETTEN IS AND WHAT IT IS USED FOR
WHAT DEFERASIROX STADA 900 MG, FILMOMHULDE TABLETTEN IS
Deferasirox Stada 900 mg, filmomhulde tabletten 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 STADA 900 MG, FILMOMHULDE TABLETTEN 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 tha

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Deferasirox Stada 900 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
900 mg film-coated tablets
Each film-coated tablet contains 900 mg deferasirox.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, ovaloid, biconvex, film-coated tablets with
beveled edges, with a break line on one
side and plain on the other side. The dimensions of the tablet are
approximately 21.6 mm x 9.6 mm. The
score line is only to facilitate breaking for ease of swallowing and
not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
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 (<7 ml/kg/month of packed red blood cells) aged 2
years and older,
-
in adult and paediatric patients with other anaemias aged 2 years and
older.
is also indicated for the treatment of chronic iron
overload requiring chelation
therapy when deferoxamine therapy is contraindicated or inadequate in
patients with non-transfusion-
dependent thalassaemia syndromes aged 10 years and older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with should be initiated and maintained by
physicians experienced in
the treatment of chronic iron overload.
Posology
900 mg tablet should not be broken to