JEDOXRED 250 (DEFERASIROX DISPERSIBLE TABLETS 250MG)

Riik: Malaisia

keel: inglise

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

Toimeaine:

DEFERASIROX

Saadav alates:

Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.

INN (Rahvusvaheline Nimetus):

DEFERASIROX

Ühikuid pakis:

1 x 7 Tablets; 4 x 7 Tablets; 12 x 7 Tablets

Valmistatud:

MSN Laboratories Private Limited

Infovoldik

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
JEDOXRED 125 (DEFERASIROX DISPERSIBLE TABLETS 125MG)
JEDOXRED 250 (DEFERASIROX DISPERSIBLE TABLETS 250MG)
JEDOXRED 500 (DEFERASIROX DISPERSIBLE TABLETS 500MG)
_ _
Deferasirox Dispersible Tablets 125mg, 250mg, 500mg
1
WHAT IS IN THIS LEAFLET
1. What Jedoxred is used for
2. How Jedoxred works
3. Before you use Jedoxred
4. How to use Jedoxred
5. While you are using it
6. Side Effects
7. Storage and Disposal of Jedoxred
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of Revision
WHAT JEDOXRED IS USED FOR
Jedoxred is used to treat chronic iron
overload in:
- adult patients and children aged 2
years and older who receive blood
transfusions for the treatment of
anemias;
- adult patients and children aged 10
years and older with thalassemia
syndromes who do not require regular
blood transfusions for the treatment
of anemia.
HOW JEDOXRED WORKS
Jedoxred is an iron chelating agent
which removes the excess iron from
the body (also called iron overload),
thereby reducing the risk of organ
damage caused by iron overload.
BEFORE YOU USE JEDOXRED
_- When you must not use it _
If you are allergic (hypersensitive)
to deferasirox or any of the other
ingredients (in particular, lactose) of
Jedoxred listed in the section
“Product Description”.
 If you have severe kidney disease.
 If you have an advanced stage of
myelodysplastic syndrome (MDS) or
advanced cancer.
 If you have low platelet count (<50
x 10
9
/L).
_Pregnancy and lactation _
Jedoxred is not recommended during
pregnancy unless clearly necessary. If
you are pregnant or think that you
may be, tell your doctor. Jedoxred
may decrease the effect of hormonal
contraceptives, and you may be at
risk of getting pregnant if you are
taking a hormonal contraceptive.
Breast-feeding is not recommended
during treatment with Jedoxred.
_- Before you start to use it _
Talk to your doctor or pharmacist if
you have:
 severe heart problems (acute
cardiac failure).
 ulcer or bleeding in th

Toote omadused

1
PRESCRIBING INFORMATION
JEDOXRED
DEFERASIROX 125, 250 AND 500 DISPERSIBLE TABLET
COMPOSITION
DEFERASIROX DISPERSIBLE TABLETS 500MG
Each dispersible tablet contains 500mg of Deferasirox
Cellulose Microcrystalline 193.20mg, Crospovidone 40.00mg, Sodium
Lauryl Sulphate 6.20mg,
PoviudoneK30 30.00mg, Microcrystalline Cellulose(pH 200) 28.00mg,
Lactose monohydrate
67.00mg, Crospovidone 90.00mg, Croscarmellose sodium 30.00mg,
Colloidal silicon dioxide
5.20mg ,Magnesium stearate 10.40mg and purified water q.s
DEFERASIROX DISPERSIBLE TABLETS 250MG
Each dispersible tablet contains 250mg of Deferasirox
Cellulose Microcrystalline 48.30mg, Crospovidone 10.00mg, Sodium
Lauryl Sulphate 1.55mg,
PoviudoneK30
7.500mg,
Microcrystalline
Cellulose(pH
200)
7.00mg,
Lactose
monohydrate
16.75mg,
Crospovidone
22.50mg,
Croscarmellose
sodium
7.50mg,
Colloidal
silicon
dioxide
1.30mg ,Magnesium stearate 2.60mg and purified water Q.s
DEFERASIROX DISPERSIBLE TABLETS 125MG
Each dispersible tablet contains 125 mg of Deferasirox
Cellulose Microcrystalline 48.30 mg, Crospovidone 10.00mg, Sodium
Lauryl Sulphate 1.55 mg,
PoviudoneK30 7.50 mg, Microcrystalline Cellulose(pH 200) 7.00mg,
Lactose monohydrate 16.75
mg, Crospovidone 22.50mg, Croscarmellose sodium 7.50 mg, colloidal
silicon dioxide 1.30 mg ,
Magnesium stearate 2.60 mg and purified water Q.s
CLINICAL INFORMATION
THERAPEUTIC INDICATIONS:
Deferasirox 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).
Deferasirox
is
also
indicated
for
the
treatment
of
chronic
iron
overload
in
patients
with
nontransfusion-dependent thalassemia syndromes aged 10 years and over.
POSOLOGY AND METHOD OF ADMINISTRATION
_Transfusional iron overload _
Dosage regimen
It is recommended that therapy with Jedoxred 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