Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
deferasirox, Quantity: 125 mg
Juno Pharmaceuticals Pty Ltd
Tablet, dispersible
Excipient Ingredients: microcrystalline cellulose; sodium lauryl sulfate; povidone; magnesium stearate; colloidal anhydrous silica; lactose monohydrate; crospovidone; croscarmellose sodium
Oral
84 Tablets, 28 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 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 non-transfusion-dependent thalassemia syndromes aged 10 years and older.
Visual Identification: White to off white, round, flat, uncoated tablets, with debossing D on one side and 125 on other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2019-11-07
Deferasirox Juno Consumer Medicine Information Deferasirox Juno CMI 1 DEFERASIROX JUNO _Deferasirox _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Deferasirox Juno. 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 receiving Deferasirox Juno against the benefits this medicine is expected to have for you. If you have any concerns about being given Deferasirox Juno, ask your doctor. KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN. WHAT DEFERASIROX JUNO IS USED FOR Deferasirox Juno 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 Juno 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. Deferasirox Juno attaches itself to the iron molecules to remove the excess iron from the body. This will help prevent iron-induced organ damage. Deferasirox Juno is to be taken every day. This type of medicine must be taken every day to help remove the excess iron from your body. Your doctor may have prescribed Deferasirox Juno for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. THIS MEDICINE IS AVAILABLE ONLY WITH A DOCTOR'S PRESCRIPTION. BEFORE YOU TAKE DEFERASIROX JUNO _WHEN YOU MUST NOT TAKE IT: _ _ _ Do not take Deferasirox Juno tablets if you have an allergy to deferasirox, the active ingredient, or to any of the ot Leggi il documento completo
DEFERASIROX JUNO PI Ver 3.0 1 AUSTRALIAN PRODUCT INFORMATION DEFERASIROX JUNO (DEFERASIROX) DISPERSIBLE TABLETS 1. NAME OF THE MEDICINE The active ingredient is Deferasirox. 2. QUALITIATIVE AND QUANTITATIVE COMPOSITION Deferasirox is an orally active iron chelating agent. Deferasirox Juno dispersible tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Excipient with known effect: Tablets contain lactose monohydrate (16.75 mg per 125 mg tablet, 33.50 mg per 250 mg tablet, and 67.00 mg per 500 mg tablet). For the full list of excipients, see SECTION 6.1 LIST OF EXIPIENTS. 3. PHARMACEUTICAL FORM Deferasirox Juno tablets are white to off-white, round, flat, uncoated tablets, with debossing “D” on one side and the dosage (“125”, “250” or “500”) 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. Deferasirox Juno 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 Juno 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 TRANSFUSIONAL IRON OVERLOAD _DEFERASIROX JUNO DISPERSIBLE TABLETS _ It is recommended that therapy with Deferasirox Juno 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 mg/kg) must be calculated and rounded to the nearest whole tablet size. Deferasirox Juno is available in three tablet strengths (125 mg, 250 mg and 500 mg). Dosing recommendations are the same for adult, paediatric and elderly patients. The goals of i Leggi il documento completo