AKM DEFERASIROX deferasirox 500 mg dispersible tablet blister pack
국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
환자 정보 전단 유효 성분:
deferasirox, Quantity: 500 mg
제공처:
Pharmacor Pty Ltd
약제 형태:
Tablet, dispersible
구성:
Excipient Ingredients: microcrystalline cellulose; sodium lauryl sulfate; hydrogenated castor oil; magnesium stearate; hyprolose; crospovidone; dibasic sodium phosphate; colloidal anhydrous silica; hypromellose
관리 경로:
Oral
패키지 단위:
28's, 84's, 14's, 10's
처방전 유형:
(S4) Prescription Only Medicine
치료 징후:
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.
제품 요약:
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
승인 상태:
Registered
승인 날짜:
2020-09-09
환자 정보 전단
AKM DEFERASIROX
_deferasirox _
CONSUMER MEDICINE INFORMATION
AKM DEFERASIROX
Ver: 01
1
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions about AKM 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 AKM DEFERASIROX IS
USED FOR
AKM 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.
AKM 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.
AKM
DEFERASIROX
IS
TO
BE
TAKEN
EVERY DAY.
This type of medicine must be taken
every day to help remove
전체 문서 읽기
제품 특성 요약
AKM DEFERASIROX
Ver: 01
1
AUSTRALIAN PRODUCT INFORMATION
AKM DEFERASIROX (DEFERASIROX) DISPERSIBLE TABLETS
1. NAME OF THE MEDICINE
Deferasirox
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
AKM Deferasirox Dispersible tablets are available in three strengths.
AKM Deferasirox Dispersible tablets 125 mg
Each dispersible tablet contains 125 mg deferasirox.
AKM Deferasirox Dispersible tablets 250 mg
Each dispersible tablet contains 250 mg deferasirox.
AKM 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
AKM 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.
AKM 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.
AKM 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.
AKM 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.
AKM 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.
AKM 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 AKM Deferasirox 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 monit
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