CIPLA DEFERASIROX deferasirox 360 mg tablet blister pack

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

deferasirox, Quantity: 360 mg

Prieinama:

Cipla Australia Pty Ltd

Vaisto forma:

Tablet, film coated

Sudėtis:

Excipient Ingredients: microcrystalline cellulose; crospovidone; povidone; poloxamer; magnesium stearate; lactose monohydrate; titanium dioxide; hypromellose; macrogol 8000; purified talc; iron oxide red

Vartojimo būdas:

Oral

Vienetai pakuotėje:

30 tablets

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

The treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adults and paediatric patients 6 years and older. [Invented name] 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. [Invented name] is also indicated for the treatment of chronic iron overload in patients with non-transfusiondependent thalassemia syndromes aged 10 years and older.

Produkto santrauka:

Visual Identification: Light pink oval biconvex film-coated tablet, debossed with C393 on one side and plain on the other; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorizacija statusas:

Registered

Leidimo data:

2021-04-21

Pakuotės lapelis

CIPLA DEFERASIROX
1
Cipla Deferasirox
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 CIPLA DEFERASIROX?
Cipla Deferasirox contains the active ingredient deferasirox. Cipla
Deferasirox is used to treat a condition called iron overload
and also used to treat patients who have iron overload associated with
their thalassemia syndromes.
For more information, see Section 1. Why am I using Cipla Deferasirox?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CIPLA DEFERASIROX?
Do not use if you have ever had an allergic reaction to deferasirox 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
Cipla Deferasirox? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Cipla Deferasirox 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 CIPLA DEFERASIROX?
•
The dose depends on your body weight. Your doctor will calculate the
dose you need and tell you how many tablets you
need to take each day. Take the tablets once a day with either empty
stomach or with a light meal.
•
Follow all directions given to you by your doctor or pharmacist
carefully.
More instructions can be found in Section 4. How do I use Cipla
Deferasirox? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CIPLA DEFERASIROX?
THINGS YOU SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Cipla Deferasirox.
•
If you notice substantially reduced urine out, tell your doctor
straight away,
•
Tell your doctor if you become pregnant or are trying to become
pregnant.
•
Tell your doctor if for any reason you have not taken your medicine
exa

Prekės savybės

AUSTRALIAN PRODUCT INFORMATION
CIPLA DEFERASIROX (DEFERASIROX) FILM-COATED TABLETS
1.
NAME OF THE MEDICINE
Deferasirox.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cipla Deferasirox
90 mg film-coated tablets
Each film-coated tablet contains 90 mg deferasirox.
Cipla Deferasirox
180 mg film-coated tablets
Each film-coated tablet contains 180 mg deferasirox.
Cipla Deferasirox
360 mg film-coated tablets
Each film-coated tablet contains 360 mg deferasirox.
Excipients with known effect
Cipla Deferasirox 90 mg film-coated tablets
Each 90 mg film-coated tablet contains 5 mg of lactose monohydrate.
Cipla Deferasirox
180 mg film-coated tablets
Each 180 mg film-coated tablet contains 10 mg of lactose monohydrate.
Cipla Deferasirox 360 mg film-coated tablets
Each 360 mg film-coated tablet contains 20 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
90 mg: Light pink oval biconvex film-coated tablet, debossed with
‘C391’ on one side and plain on the
other.
180 mg: Light pink oval biconvex film-coated tablet, debossed with
‘C392’ on one side and plain on
the other.
360 mg: Light pink oval biconvex film-coated tablet, debossed with
‘C393’ on one side and plain on
the other.
Dimensions
90 mg: Length: 10.94 – 10.97 mm; Breadth: 4.41 – 4.44 mm;
Thickness: 3.79 – 3.84 mm
180 mg: Length: 14.14 – 14.20 mm; Breadth: 5.49 – 5.53 mm;
Thickness: 4.59 – 4.63 mm
360 mg: Length: 16.97 – 17.08 mm; Breadth: 6.83 – 6.87 mm;
Thickness: 6.09 – 6.12 mm
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. Cipla 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.
Cipla Deferasirox is also indicated for the treatment of chronic iron
overload in pat