Irosix 90mg Film Coated Tablets

Ülke: Malezya

Dil: İngilizce

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

Aktif bileşen:

DEFERASIROX

Mevcut itibaren:

NOVUGEN PHARMA SDN. BHD.

INN (International Adı):

DEFERASIROX

Paketteki üniteler:

3x10 Tablets; 1x10 Tablets; 6x10 Tablets; 10x10 Tablets; 50x10 Tablets; 100x10 Tablets

Tarafından üretildi:

NOVUGEN PHARMA SDN. BHD.

Bilgilendirme broşürü

_Consumer Medication Information Leaflet (RiMUP) _
1
IROSIX FILM COATED TABLETS
DEFERASIROX
90 mg, 180 mg and 360 mg Film Coated Tablets
WHAT IS IN THIS LEAFLET
1.
WHAT IROSIX IS USED FOR
2.
HOW IROSIX WORKS
3.
BEFORE YOU USE IROSIX
4.
HOW TO USE IROSIX
5.
WHILE YOU ARE USING
IROSIX
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF
IROSIX
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
11.
SERIAL NUMBER
WHAT IROSIX IS USED FOR
Irosix 90 mg, 180 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)
Irosix 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)
Irosix 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

Ürün özellikleri

1. NAME OF THE MEDICINAL PRODUCT
Irosix 90mg Film Coated Tablets
Irosix 180mg Film Coated Tablets
Irosix 360mg Film Coated Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
IROSIX 90MG FILM COATED TABLETS: Each tablet contains 90mg of
Deferasirox.
IROSIX 180MG FILM COATED TABLETS: Each tablet contains 180mg of
Deferasirox.
IROSIX 360MG FILM COATED TABLETS: Each tablet contains 360mg of
Deferasirox.
For the full list of excipients, see section List of excipients.
3. PHARMACEUTICAL FORM
Film Coated Tablets.
IROSIX 90MG: Light blue color, oval, biconvex film coated tablet with
bevelled edges, debossed with “N55” on one side
and plain on other side.
IROSIX 180MG: Medium blue color, oval, biconvex film coated tablet
with bevelled edges, debossed with “N54” on one
side and plain on other side.
IROSIX 360MG: Dark blue color, oval, biconvex film coated tablet with
bevelled edges, debossed with “N53” on one side
and plain on other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Irosix Film Coated Tablets are indicated for the treatment of chronic
iron overload due to blood transfusions
(transfusional hemosiderosis) in adult and pediatric patients (aged 2
years and over).
Irosix
Film
Coated
Tablets
are
also
indicated
for
the
treatment
of
chronic
iron
overload
in
patients
with
non-transfusion-dependent thalassemia syndromes aged 10 years and
over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
TRANSFUSIONAL IRON OVERLOAD
DOSAGE REGIMEN
It is recommended that therapy with Irosix Film Coated Tablets be
started after the transfusion of approximately 20 units
(about 100 mL/kg) of packed red blood cells or when there is evidence
from clinical monitoring that chronic iron overload
is present (e.g. serum ferritin >1,000 µg/L). Doses (in mg/kg) must
be calculated and rounded to the nearest whole tablet
size.
The goals of iron chelation therapy are to remove the amount of iron
administered in transfusions and, as required, to
reduce the existing iron burden. The decision to remove accumulated
iron should be indiv