Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
deferasirox, Quantity: 90 mg
Arrotex Pharmaceuticals Pty Ltd
Tablet, film coated
Excipient Ingredients: povidone; crospovidone; magnesium stearate; microcrystalline cellulose; sodium starch glycollate type A; colloidal anhydrous silica; poloxamer; titanium dioxide; indigo carmine aluminium lake; hypromellose; macrogol 4000; purified talc
Oral
30
(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 AGH 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 AGH 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: Light blue, oval, biconvex, film-coated tablet with beveled edges, debossed with "L" on one side and "663" on the other side Approximately 10 mm in length and approximately 4 mm in width; 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
Registered
2020-11-16
DEFERASIROX ARX 1 DEFERASIROX ARX 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 DEFERASIROX ARX? Deferasirox ARX contains the active ingredient Deferasirox. Deferasirox ARX 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. For more information, see Section 1. Why am I using Deferasirox ARX? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE DEFERASIROX ARX? Do not use if you have ever had an allergic reaction to Deferasirox ARXor 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 Deferasirox ARX? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Deferasirox ARX 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 DEFERASIROX ARX? The dose of DEFERASIROX ARX is related to body weight for all patients. Your doctor will calculate the dose you need and tell you how many tablets to take each day. The usual starting dose is 14 mg per kilogram body weight each day for patients receiving regular blood transfusions. More instructions can be found in Section 4. How do I use Deferasirox ARX? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING DEFERASIROX ARX? THINGS YOU SHOULD DO If you notice substantially reduced urine output, tell your doctor straight away. If you become pregnant while taking this medicine, tell your doctor immediately. THINGS YOU SHOULD NOT DO Do not give this medicine to anyone else, even if their condition seems similar to yours. Do not use it to treat any other complaints unless your doctor tells you to. DRIVING OR US Pročitajte cijeli dokument
1 AUSTRALIAN PRODUCT INFORMATION – DEFERASIROX ARX (DEFERASIROX) FILM-COATED TABLETS 1 NAME OF THE MEDICINE Deferasirox 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DEFERASIROX ARX 90 mg film-coated tablets Each film-coated tablet contains 90 mg deferasirox. DEFERASIROX ARX 180 mg film-coated tablets Each film-coated tablet contains 180 mg deferasirox. DEFERASIROX ARX 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. The API is practically insoluble in water and across the pH range 1.2 – 6.00, and soluble at pH 8.00. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Film-coated tablet. 90 MG: Light blue, oval, biconvex, film-coated tablet with beveled edges, debossed with “L” on one side and “663” on the other side. Approximately 10 mm in length and approximately 4 mm in width. 180 MG: Medium blue, oval, biconvex, film-coated tablet with beveled edges, debossed with “L” on one side and “664” on the other side. Approximately 13 mm in length and approximately 5 mm in width. 360 MG: Dark blue, oval, biconvex, film-coated tablet with beveled edges, debossed with “L” on one side and “665” on the other side. Approximately 17 mm in length and approximately 7 mm in width. 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 ARX 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 ARX 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 D OSE AND METHOD OF ADMI Pročitajte cijeli dokument