Exjade 360mg Film-coated Tablet

国家: 马来西亚

语言: 英文

来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有效成分:

DEFERASIROX

可用日期:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN（国际名称）:

DEFERASIROX

每包单位数:

30tablet Tablets

厂商:

Sandoz S.R.L.

资料单张

_Consumer Medication Information Leaflet (RiMUP) _
EXJADE ®
FILM-COATED TABLETS
DEFERASIROX
90 mg and 360 mg Film-Coated Tablets
1
WHAT IS IN THIS LEAFLET
1.
WHAT EXJADE IS USED FOR
2.
HOW EXJADE WORKS
3.
BEFORE YOU USE EXJADE
4.
HOW TO USE EXJADE
5.
WHILE YOU ARE USING
EXJADE
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF
EXJADE
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
WHAT EXJADE IS USED FOR
EXJADE 90 mg and 360 mg
Film-Coated Tablets contains an
active substance called
deferasirox. This medicine is an
iron chelator which removes the
excess iron from the body (also
called iron overload).
•
Transfusional iron overload
(excess amount of iron in
patients receiving regular
blood transfusions)
EXJADE is used to treat iron
overload caused by repeated
blood transfusions. It can be used
to treat adults, adolescents, and
children aged 2 years and above.
Repeated blood transfusions may
be necessary in patients suffering
from certain types of anemia such
as thalassemia, sickle cell disease
or myelodysplastic syndromes.
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.
•
Non-transfusion-dependent
thalassemia syndromes (
excess amount of iron in
patients with thalassemia not
receiving regular blood
transfusions)
EXJADE is used to treat patients
who have iron overload
associated with their thalassemia
syndromes, but who are not
transfusion dependent. In this
case, it can be used to treat adults,
adolescents, and children aged 10
years and above. In patients with
non-transfusion-dependent
thalassemia syndromes, iron
overload may develop over time
due to increased absorption of
dietary iron in response to low
blood cell counts. In thalassemic
patients not receiving regular
blood transfusions, increased iron
levels are usually only observed
in patients 10 years of age and
above.
Over time, the excess iron can
dama

产品特点

Regulatory Affairs
EXJADE

FILM-COATED TABLETS
(DEFERASIROX)
90 mg and 360 mg film-coated tablets
MALAYSIAN PACKAGE LEAFLET
IPL Author:
Sravanthi Diddi
CDS Author(s):
Julien Lustig, Sandra Navarro-
Carrasco
GLC approval:
25-Jun-2019
Release date:
24-Jul-2019
Safety Label Change (SLC)
Tracking Number:
2019-PSB/GLC-1065-s
Document status:
Final
Number of pages:
26
Novartis
Page 2
Malaysian Package Leaflet
24-Jul-2019 Exjade FCT
EXJADE

FILM-COATED TABLETS
Iron chelating agent.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
Film-coated tablets.
DESCRIPTION
90mg: Light blue unscored ovaloid biconvex film-coated tablet with
beveled edges, debossed
with ‘NVR’ on one side and ‘90’ on a slight upward slope in
between two debossed curved
lines on the other side. Dimensions: Approx. 10.7 x 4.2 mm.
360mg: Dark blue unscored ovaloid biconvex film-coated tablet with
beveled edges, debossed
with ‘NVR’ on one side and ‘360’ on a slight upward slope in
between two debossed curved
lines on the other side. Dimensions: Approx. 17 x 6.7 mm.
ACTIVE SUBSTANCE(S)
Each film-coated tablet contains 90 mg / 360 mg deferasirox as active
substance.
Certain dosage strengths may not be available in all countries.
EXCIPIENTS
Microcrystalline cellulose; crospovidone; povidone (K30); magnesium
stearate; colloidal
silicon dioxide; poloxamer 188; coating material: hypromellose;
titanium dioxide (E171);
polyethylene glycol (4000); talc; FD&C blue #2/Indigo carminine
aluminum lake (E132).
INDICATIONS
Exjade film-coated tablet is indicated for the treatment of chronic
iron overload due to blood
transfusions (transfusional hemosiderosis) in adult and pediatric
patients (aged 2 years and
over).
Exjade film-coated tablet is also indicated for the treatment of
chronic iron overload in patients
with non-transfusion-dependent thalassemia syndromes aged 10 years and
over.
DOSAGE REGIMEN AND ADMINISTRATION
TRANSFUSIONAL IRON OVERLOAD
DOSAGE REGIMEN
It is recommended that therapy with Exjade film-coated tablets be
started after the tr