AKM DEFERASIROX FC deferasirox 360 mg film-coated tablet bottle

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

deferasirox, Quantity: 360 mg

可用日期:

Pharmacor Pty Ltd

药物剂型:

Tablet, film coated

组成:

Excipient Ingredients: povidone; sodium stearylfumarate; hydrogenated castor oil; poloxamer; sodium hydroxide; crospovidone; colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; hypromellose; purified talc; macrogol 4000; indigo carmine aluminium lake

给药途径:

Oral

每包单位数:

30's, 90's

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

The treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adults and paediatric patients 6 years and older. 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.,Deferasirox is also indicated for the treatment of chronic iron overload in patients with nontransfusion-dependent thalassemia syndromes aged 10 years and older.

產品總結:

Visual Identification: Dark blue colour, film coated, oval shaped, biconvex tablets, debossed with 'DFX' on the one side and '360' on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure and restricted flow insert

授权状态:

Registered

授权日期:

2021-03-22

资料单张

AKM DEFERASIROX FC
1
AKM DEFERASIROX FC
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING AKM DEFERASIROX FC?
AKM DEFERASIROX film-coated tablets contains the active ingredient
Deferasirox. AKM DEFERASIROX FC is used to treat a
condition called iron overload, which happens when the body has too
much iron.
For more information, see Section 1. Why am I using AKM DEFERASIROX
FC? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE AKM DEFERASIROX FC?
Do not use if you have ever had an allergic reaction to AKM
DEFERASIROX FC or any of the ingredients listed at the end of the
CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
AKM DEFERASIROX FC? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with AKM DEFERASIROX FC and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE AKM DEFERASIROX FC?
•
The dose of AKM DEFERASIROX FC is related to body weight for all
patients. Your doctor will calculate the dose you need
and tell you how many tablets to take each day.
•
Take AKM DEFERASIROX FC once a day, every day, at about the same time
each day with some water.
More instructions can be found in Section 4. How do I use AKM
DEFERASIROX FC? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING AKM DEFERASIROX FC?
THINGS YOU SHOULD
DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
AKM DEFERASIROX FC.
•
Keep all of your doctor's appointments so that your progress can be
checked. Your doctor will do
regular tests (blood, urine or Magnetic Resonance Imaging (MRI)) to
make sure the medicine is
working and to prevent unwanted side effects. Your doctor will also
use these tests

产品特点

AKM DEFERASIROX FC
1
AUSTRALIAN PRODUCT INFORMATION
AKM DEFERASIROX FC (DEFERASIROX) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Deferasirox
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Deferasirox is a white to slightly yellow powder and is a non-chiral
compound. At the
physiological pH of the intestine, the solubility is about 40 mg/L. It
is practically insoluble in
water and across the pH range 1.2 – 6.00, and soluble at pH 8.00.
AKM DEFERASIROX FC
90 MG
: Each film-coated tablet contains 90 mg deferasirox.
AKM DEFERASIROX FC
180 MG
: Each film-coated tablet contains 180 mg deferasirox.
AKM DEFERASIROX FC
360 MG
: Each film-coated tablet contains 360 mg deferasirox.
Excipient with known effect: Not Applicable
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Film-coated tablet.
AKM DEFERASIROX FC
90 MG:
Light blue color, film coated oval shaped biconvex
tablets, debossed with ‘DFX’ on the one side and ‘90’ on other
side.
AKM DEFERASIROX FC
180 MG:
Blue color, film coated oval shaped biconvex tablets,
debossed with ‘DFX’ on the one side and ‘180’ on other side.
AKM DEFERASIROX FC
360 MG:
Dark blue color, film coated, oval shaped, biconvex
tablets, debossed with ‘DFX’ on the one side and ‘360’ on
other side.
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
FC 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 FC
is also indicated for the treatment of chronic iron overload in
patients with non-transfusion-dependent thalassemia syndromes aged 10
years and older.
AKM DEFERASIROX FC
2
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
TRANSFUSIONAL IRON OVERLOAD (AKM DEFERASIROX FC FILM-COATED TABLETS)
It is recommended that therapy