Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
deferasirox, Quantity: 180 mg
Cipla Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; crospovidone; povidone; poloxamer; magnesium stearate; lactose monohydrate; titanium dioxide; hypromellose; macrogol 8000; purified talc; iron oxide red
Oral
30 tablets
(S4) Prescription Only Medicine
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.
Visual Identification: Light pink oval biconvex film-coated tablet, debossed with C392 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
Registered
2021-04-21
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 Perskaitykite visą dokumentą
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 Perskaitykite visą dokumentą