Exjade tablets dispersible

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

deferasirox

Available from:

Novartis Pharma Stein AG

ATC code:

V03AC03

INN (International Name):

deferasirox

Dosage:

500mg

Pharmaceutical form:

tablets dispersible

Units in package:

(28/4x7/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-02-02

Patient Information leaflet

INSTRUCTION
FOR MEDICAL USE OF THE MEDICINAL PRODUCT
EXJADE
This medicinal product is subject to additional monitoring. This will
allow quick identification of new safety
information. Healthcare professionals are asked to report any
suspected adverse reactions. See section 4.8 for how to
report adverse reactions.
COMPOSITION:
_ACTIVE SUBSTANCE_:
Deferasirox;
Exjade 250 mg dispersible tablets:
each dispersible tablet contains 250 mg deferasirox;
excipient with known effect:
each dispersible tablet contains 272 mg lactose.
Exjade 500 mg dispersible tablets:
each dispersible tablet contains 500 mg deferasirox;
excipient with known effect:
each dispersible tablet contains 544 mg lactose.
_EXCIPIENTS_:
lactose monohydrate, crospovidone type A, cellulose, microcrystalline,
povidone, sodium
laurilsulfate, silica, colloidal anhydrous, magnesium stearate.
PHARMACEUTICAL FORM:
dispersible tablets.
PHARMACOTHERAPEUTIC GROUP.
Iron chelating agents.
ATC CODE:
V03AC03.
CLINICAL PARTICULARS._ _
_INDICATIONS_
_. _
Exjade 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.
Exjade 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.
Exjade 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
thal

Summary of Product characteristics

1
ANNEX I
BRIEF DESCRIPTION OF THE MEDICINAL PRODUCT
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF MEDICAL PRODUCT
Exjade 250 mg dispersible tablets.
Exjade 500 mg dispersible tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_active substance:_
deferasirox;
Exjade 250 mg dispersible tablets:
each dispersible tablet contains 250 mg deferasirox;
excipient with known effect:
each dispersible tablet contains 272 mg lactose.
Exjade 500 mg dispersible tablets:
each dispersible tablet contains 500 mg deferasirox;
excipient with known effect:
each dispersible tablet contains 544 mg lactose;
_excipients:_
For a complete list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Dispersible tablets.
Exjade 250 mg dispersible tablets
White to slightly yellow, round, flat tablets with bevelled edges and
imprints (NVR on one
face and J 250 on the other). Approximate tablet dimensions 15 mm x
4.7 mm.
Exjade 500 mg dispersible tablets
White to slightly yellow, round, flat tablets with bevelled edges and
imprints (NVR on one
face and J 500 on the other). Approximate tablet dimensions 20 mm x
5.6 mm.
4.
CLINICAL DATA
4.1
INDICATIONS.
Exjade
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.
Exjade 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