Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
deferasirox, Quantity: 360 mg
Sandoz Pty Ltd
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; crospovidone; povidone; magnesium stearate; colloidal anhydrous silica; poloxamer; hypromellose; titanium dioxide; macrogol 4000; purified talc; indigo carmine aluminium lake
Oral
30 film-coated 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. Deferasirox Sandoz 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 Sandoz is also indicated for the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes aged 10 years and older.
Visual Identification: Dark blue unscored ovaloid biconvex film-coated tablet with bevelled edges, debossed with NVR on one side and 360 on a slight upward slope in between two debossed curved lines on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2021-05-28
DEFERASIROX SANDOZ ® 1 DEFERASIROX SANDOZ ® _deferasirox _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DEFERASIROX SANDOZ. 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.NOVARTIS.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 DEFERASIROX SANDOZ IS USED FOR DEFERASIROX SANDOZ 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. DEFERASIROX SANDOZ 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. DEFERASIROX SANDOZ IS TO BE TAKEN EVERY DAY. This type of medicine must be taken every Leggi il documento completo
1 AUSTRALIAN PI – DEFERASIROX SANDOZ ® FILM-COATED TABLETS 1 NAME OF THE MEDICINE Deferasirox. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DEFERASIROX SANDOZ 90 mg film-coated tablets Each film-coated tablet contains 90 mg deferasirox. DEFERASIROX SANDOZ 180 mg film-coated tablets Each film-coated tablet contains 180 mg deferasirox. DEFERASIROX SANDOZ 360 mg film-coated tablets Each film-coated tablet contains 360 mg deferasirox. 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. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. 90 mg: Light blue unscored ovaloid biconvex film-coated tablet with bevelled edges, debossed with ‘NVR’ on one side and ‘90’ on a slight upward slope in between two debossed curved lines on the other side. 180 mg: Medium blue unscored ovaloid biconvex film-coated tablet with bevelled edges, debossed with ‘NVR’ on one side and ‘180’ on a slight upward slope in between two debossed curved lines on the other side. 360 mg: Dark blue unscored ovaloid biconvex film-coated tablet with bevelled edges, debossed with ‘NVR’ on one side and ‘360’ on a slight upward slope in between two debossed curved lines on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS The treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adults and paediatric patients 6 years and older. DEFERASIROX SANDOZ 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 SANDOZ is also indicated for the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes aged 10 years and older. 2 4.2 D OSE AND METHOD OF ADMINISTRATION DOSE TRANSFUSIONAL IRON OVERLOAD (DEFERASIROX SANDOZ) FILM-COATED TABLETS)_ _ It is recom Leggi il documento completo