FERASIRO 180 (Deferasirox Film-Coated Tablets 180mg)

Land: Malaysia

Språk: engelsk

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

Aktiv ingrediens:

DEFERASIROX

Tilgjengelig fra:

Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.

INN (International Name):

DEFERASIROX

Enheter i pakken:

3 x 10 Tablets

Produsert av:

MSN Laboratories Private Limited

Informasjon til brukeren

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

Preparatomtale

1
1. NAME OF THE MEDICINAL PRODUCT
FERASIRO 90 (Deferasirox Film-coated Tablet 90 mg)
FERASIRO 180 (Deferasirox Film-coated Tablet 180 mg)
FERASIRO 360 (Deferasirox Film-Coated Tablets 360 mg)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
FERASIRO 90 (Deferasirox Film-coated Tablet 90 mg)
Each film-coated tablet contains 90 mg deferasirox.
FERASIRO 180 (Deferasirox Film-coated Tablet 180 mg)
Each film-coated tablet contains 180 mg deferasirox.
FERASIRO 360 (Deferasirox Film-Coated Tablets 360 mg)
Each film-coated tablet contains 360 mg deferasirox.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
FERASIRO 90 (Deferasirox Film-Coated Tablets 90 mg)
Yellow colored, film coated oval, biconvex tablets with beveled edges
debossed with ‘D’ on
one side and ‘90’ on another side.
FERASIRO 180 (Deferasirox Film-Coated Tablets 180 mg)
Yellow colored, film coated oval, biconvex tablets with beveled edges
debossed with ‘D’ on
one side and ‘180’ on another side.
FERASIRO 360 (Deferasirox Film-Coated Tablets 360 mg)
Yellow colored, film coated oval, biconvex tablets with beveled edges
debossed with ‘D’ on
one side and ‘360’ on another side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ferasiro 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).
Ferasiro 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Transfusional iron overload _
_Dosage regimen _
It is recommended that therapy with Ferasiro 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 microgram/L). Doses (in mg/kg) must