EFERAS deferasirox 360 mg film coated tablet blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

deferasirox, Quantity: 360 mg

Διαθέσιμο από:

Alphapharm Pty Ltd

Φαρμακοτεχνική μορφή:

Tablet, film coated

Σύνθεση:

Excipient Ingredients: crospovidone; poloxamer; magnesium stearate; povidone; colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; hypromellose; purified talc; macrogol 6000; indigo carmine aluminium lake

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

30

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Visual Identification: A Blue, film coated, modified capsule shaped, biconvex tablet debossed with M on one side of the tablet and DF2 on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2021-03-12

Φύλλο οδηγιών χρήσης

EFERAS
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ACTIVE INGREDIENT: _deferasirox_
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
EFERAS. YOU SHOULD ALSO SPEAK TO YOUR DOCTOR OR
PHARMACIST IF YOU WOULD LIKE FURTHER INFORMATION OR IF YOU
HAVE ANY CONCERNS OR QUESTIONS ABOUT USING EFERAS.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1. Why am I using EFERAS?
2. What should I know before I use EFERAS?
3. What if I am taking other medicines?
4. How do I use EFERAS?
5. What should I know while using EFERAS?
6. Are there any side effects?
7. Product details
1.
WHY AM I USING EFERAS?
EFERAS CONTAINS THE ACTIVE INGREDIENT DEFERASIROX.
EFERAS 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.
EFERAS 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 cell counts.
Over time, this excess iron can damage important organs
such as the liver and heart.
2.
WHAT SHOULD I KNOW BEFORE I USE EFERAS?
WARNINGS
DO NOT USE EFERAS IF:
•
you are allergic to deferasirox, or any of the ingredients
listed at the end of this leaflet.
•
Always check the ingredients to make sure you can use
this medicine.
CHECK WITH YOUR DOCTOR IF YOU:
•
have any other medical conditions such as kidney or liver
problems
•
have low platelet or white blood cell counts
•
have an advanced stage of myelodysplastic syndrome
(MDS) or advanced cancer
•
take any medicines for any other condition
During treatment, you may be at risk of developing certain
side effects. It is important you understand these risks and
how to monitor for them. See additional information under
Section 6. Are there any side effects?
PREGNANCY

Αρχείο Π.Χ.Π.

AUSTRALIAN PRODUCT INFORMATION
EFERAS
_deferasirox _
1
NAME OF THE MEDICINE
Deferasirox
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains either 90 mg, 180 mg or 360 mg of
deferasirox as the active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
EFERAS 90 mg tablet: A Blue, film coated, modified capsule shaped,
biconvex tablet debossed with “
” on
one side of the tablet and ‘DF’ on the other side.
EFERAS 180 mg tablet: A Blue, film coated, modified capsule shaped,
biconvex tablet debossed with “
” on
one side of the tablet and ‘DF1’ on the other side.
EFERAS 360 mg tablet: A Blue, film coated, modified capsule shaped,
biconvex tablet debossed with “
” on
one side of the tablet and ‘DF2’ on the 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. EFERAS 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.
EFERAS 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
DEFERASIROX DISPERSIBLE TABLET IS UNAVAILABLE IN THIS BRAND, HOWEVER
THIS DOSAGE FORM IS AVAILABLE IN OTHER
BRANDS. WHERE CORRECT DOSING REQUIRES DEFERASIROX DISPERSIBLE TABLET
FORMULATION REFER TO THE SPECIFIC
PRODUCT INFORMATION FOR THIS FORMULATION FOR ITS COMPLETE DOSAGE AND
ADMINISTRATION INSTRUCTIONS.
TRANSFUSIONAL IRON OVERLOAD
It is recommended that therapy with EFERAS 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 > 1000 microgram/L). Doses
(in