PHARMACOR DEFERASIROX deferasirox 500 mg dispersible tablet blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

deferasirox, Quantity: 500 mg

から入手可能:

Pharmacor Pty Ltd

医薬品形態:

Tablet, dispersible

構図:

Excipient Ingredients: microcrystalline cellulose; crospovidone; magnesium stearate; sodium lauryl sulfate; hydrogenated castor oil; hyprolose; dibasic sodium phosphate; colloidal anhydrous silica; hypromellose

投与経路:

Oral

パッケージ内のユニット:

84's, 10's, 14's, 28's

処方タイプ:

(S4) Prescription Only Medicine

適応症:

Deferasirox is indicated in the treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adults and paediatric patients 6 years and older. It is also indicated for the treatment of chronic iron overload in paediatric patients aged 2 to 5 years who are unable to take desferrioxamine therapy or in whom desferrioxamine has proven ineffective. ,Deferasirox is also indicated for the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes aged 10 years and older.

製品概要:

Visual Identification: White to off white, round, flat tablet with beveled edge and debossed with DS on the one side and 500 on other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

認証ステータス:

Registered

承認日:

2020-09-09

情報リーフレット

PHARMACOR DEFERASIROX
_deferasirox _
CONSUMER MEDICINE INFORMATION
PHARMACOR DEFERASIROX
Ver: 01
1
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Pharmacor
Deferasirox.
The information in this leaflet was last
updated on the date listed on the final
page. More recent information on the
medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK TO
YOUR PHARMACIST OR DOCTOR TO OBTAIN
THE MOST UP TO DATE INFORMATION ON
THE
MEDICINE.
YOU
CAN
ALSO
DOWNLOAD THE MOST UP TO DATE LEAFLET
FROM WWW.PHARMACOR.COM.AU
Those updates may contain important
information about the medicine and its
use of which you should be aware.
It does not contain all the available
information. It does not take the place
of talking to your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking this medicine against the
benefits they expect it will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE,
ASK
YOUR
DOCTOR
OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT
PHARMACOR
DEFERASIROX IS USED FOR
Pharmacor Deferasirox is used to treat
a condition called iron overload, which
happens when the body has too much
iron.
This can occur after repeated blood
transfusions.
The
body
has
no
natural
way
to
remove excess iron which comes with
blood transfusions.
Pharmacor Deferasirox is also used to
treat patients who have iron overload
associated
with
their
thalassemia
syndromes,
but
who
are
not
transfusion dependent. 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.
Over time, this excess iron can damage
important organs such as the liver and
heart.
This
medicine
contains
an
active
substance
called
deferasirox.
It
attaches itself to the iron molecules to
remove the excess iron from the body.
This will help
prevent
iron induced
organ damage.
PHARMACOR
DEFERASIROX
IS
TO
BE
TAKEN EVERY DAY.
This type of medic

製品の特徴

PHARMACOR DEFERASIROX
Ver: 01
1
AUSTRALIAN PRODUCT INFORMATION
PHARMACOR DEFERASIROX (DEFERASIROX) DISPERSIBLE TABLETS
1. NAME OF THE MEDICINE
Deferasirox
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Pharmacor Deferasirox Dispersible tablets are available in three
strengths.
Pharmacor Deferasirox Dispersible tablets 125 mg
Each dispersible tablet contains 125 mg deferasirox.
Pharmacor Deferasirox Dispersible tablets 250 mg
Each dispersible tablet contains 250 mg deferasirox.
Pharmacor Deferasirox Dispersible tablets 500 mg
Each dispersible tablet contains 500 mg deferasirox.
For the full list of excipients, see section 6.1 List of Excipients.
3. PHARMACEUTICAL FORM
Dispersible tablet
Pharmacor Deferasirox Dispersible tablets 125 mg
White to off white, round, flat tablet with beveled edge and debossed
with ‘DS’ on the one side
and ‘125’ on other side.
Pharmacor Deferasirox Dispersible tablets 250 mg
White to off white, round, flat tablet with beveled edge and debossed
with ‘DS’ on the one side
and ‘250’ on other side.
Pharmacor Deferasirox Dispersible tablets 500 mg
White to off white, round, flat tablet with beveled edge and debossed
with ‘DS’ on the one side
and ‘500’ on other side.
PHARMACOR DEFERASIROX
Ver: 01
2
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The treatment of chronic iron overload due to blood transfusions
(transfusional haemosiderosis)
in adults and paediatric patients 6 years and older.
Pharmacor Deferasirox
is also indicated for the
treatment of chronic iron overload in paediatric patients aged 2 to 5
years who are unable to take
desferrioxamine therapy or in whom desferrioxamine has proven
ineffective.
Pharmacor Deferasirox
is also indicated for the treatment of chronic iron overload in
patients with
non-transfusion-dependent thalassemia syndromes aged 10 years and
older.
4.2 DOSE AND METHOD OF ADMINISTRATION
TRANSFUSIONAL IRON OVERLOAD
It is recommended that therapy with Pharmacor Deferasirox be started
after the transfusion of
approximately 20 units (about 100