Jadenu tablets film-coated

Maa: Armenia

Kieli: englanti

Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiivinen ainesosa:

deferasirox

Saatavilla:

Sandoz S.R.L.

ATC-koodi:

V03AC03

INN (Kansainvälinen yleisnimi):

deferasirox

Annos:

360mg

Lääkemuoto:

tablets film-coated

Kpl paketissa:

(30/3x10/) in blister

Prescription tyyppi:

Prescription

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2021-07-26

Pakkausseloste

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.
INSTRUCTION
FOR MEDICAL USE OF THE MEDICINAL PRODUCT
JADENU
COMPOSITION:
_ACTIVE SUBSTANCE_:
Deferasirox;
Jadenu 180 mg film-coated tablets:
each film-coated tablet contains 180 mg deferasirox;
Jadenu 360 mg film-coated tablets:
each film-coated tablet contains 360 mg deferasirox.
_EXCIPIENTS_:
cellulose,
microcrystalline;
crospovidone;
povidone;
magnesium
stearate;
silica,
colloidal anhydrous; poloxamer.
COATING:
opadry blue (hypromellose; titanium dioxide (E171), macrogol 4000;
talc; indigo carmine
aluminium lake (E132)).
PHARMACEUTICAL FORM:
film-coated tablets.
PHARMACOTHERAPEUTIC GROUP.
Iron chelating agents.
ATC CODE:
V03AC03.
CLINICAL PARTICULARS._ _
_INDICATIONS_
_. _
Jadenu 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.
Jadenu 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.
Jadenu 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.
CONTRAINDICATIONS.
Hypersensitivity to the active substance or to any of the excipi

Valmisteyhteenveto

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.
1.
NAME OF MEDICAL PRODUCT
Jadenu 180 mg film-coated tablets.
Jadenu 360 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_active substance:_
deferasirox;
Jadenu 180 mg film-coated tablets:
each film-coated tablet contains 180 mg deferasirox;
Jadenu 360 mg film-coated tablets:
each film-coated tablet contains 360 mg deferasirox;
_excipients:_
For a complete list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Jadenu 180 mg film-coated tablets:
Medium blue, ovaloid, biconvex film-coated tablet with bevelled edges
and imprints (NVR on
one face and 180 on the other). Approximate tablet dimensions 14 mm x
5.5 mm.
Jadenu 360 mg film-coated tablets:
Dark blue, ovaloid, biconvex film-coated tablet with bevelled edges
and imprints (NVR on
one face and 360 on the other). Approximate tablet dimensions 17 mm x
6.7 mm.
4.
CLINICAL DATA
4.1
INDICATIONS.
Jadenu
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.
Jadenu 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.
Jadenu is also indicated for the treatment of chronic iron