Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
arsenic trioxide, Quantity: 12 mg
AFT Pharmaceuticals Pty Ltd
Injection, solution
Excipient Ingredients: sodium hydroxide; hydrochloric acid; water for injections
Intravenous
10 vials
(S4) Prescription Only Medicine
For the induction of remission and consolidation in patients with acute promyelocytic leukaemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterised by the presence of the t(15:17) translocation or PML/RAR-alpha gene expression.,For the induction of remission and consolidation in patients with previously untreated acute promyelocytic leukaemia (APL) in combination with all-trans retinoic acid (ATRA) and/or chemotherapy and whose APL is characterised by the presence of the t(15:17) translocation or PML/RAR-alpha gene expression.
Visual Identification: Clear, colourless solution; Container Type: Vial; Container Material: Glass; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Registered
2023-02-27
Arsenic trioxide - AFT 1 ARSENIC TRIOXIDE - AFT 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 ARSENIC TRIOXIDE - AFT? Arsenic trioxide - AFT contains the active ingredient arsenic trioxide. Arsenic trioxide - AFT is used to treat acute promyelocytic leukaemia also known as APL. For more information, see Section 1. Why am I using Arsenic trioxide - AFT? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ARSENIC TRIOXIDE - AFT? Do not use if you have ever had an allergic reaction to arsenic trioxide 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 Arsenic trioxide - AFT? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Arsenic trioxide - AFT 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 ARSENIC TRIOXIDE - AFT? Arsenic trioxide – AFT injections are administered to you by doctors or nurses in hospital. More instructions can be found in Section 4. How do I use Arsenic trioxide - AFT? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING ARSENIC TRIOXIDE - AFT? THINGS YOU SHOULD DO • Remind any doctor, surgeon, dentist or pharmacist you visit that you are using Arsenic trioxide - AFT. • If you become pregnant or are about to have any blood tests, tell your doctor that you are being given this medicine. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly. DRIVING OR USING MACHINES • Be careful before you drive or use any machines or tools until you know how Arsenic trioxide - AFT affects you. Refer to full CMI for details. LOOKING AFTER YOUR MEDICINE • Arsenic trioxide – AFT will be stored in Preberite celoten dokument
1 AUSTRALIAN PRODUCT INFORMATION ARSENIC TRIOXIDE - AFT (ARSENIC TRIOXIDE) CONCENTRATED SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Arsenic trioxide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Arsenic trioxide – AFT: Each 10 mL glass ampoule contains 10 mg arsenic trioxide as the active ingredient. Each 12 mL glass vial contains 12 mg arsenic trioxide as the active ingredient For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMCEUTICAL FORM ARSENIC TRIOXIDE – AFT is clear, colourless, concentrated solution for injection. It is a sterile solution for single use. The pH of ARSENIC TRIOXIDE – AFT is between 7.0-8.5. It must be diluted before use for Intravenous Infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the induction of remission and consolidation in patients with acute promyelocytic leukaemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterised by the presence of the t(15:17) translocation or PML/RAR-alpha gene expression. For the induction of remission and consolidation in patients with previously untreated acute promyelocytic leukaemia (APL) in combination with all-trans retinoic acid (ATRA) and/or chemotherapy and whose APL is characterised by the presence of the t(15:17) translocation or PML/RAR-alpha gene expression. 4.2 DOSE AND METHOD OF ADMINISTRATION METHOD OF ADMINISTRATION 0.15 mg/kg/day diluted with 100 - 250 mL of 5% glucose injection or 0.9% sodium chloride injection and administered intravenously (iv) over two hours. Cycles of treatment are given to achieve complete remission, defined as the complete disappearance of all leukaemic myeloblasts and promyelocytes and < 5% overall myeloblasts by morphological examination of the marrow. After induction of remission, consolidation cycles may be given, and maintenance therapy considered. Arsenic trioxide – AFT may be given in combination with all-trans retinoic acid (ATRA) and/or chemotherapy. 2 _IN PATIENTS WITH NEWLY DIAGNOSED/DE N Preberite celoten dokument