Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
arsenic trioxide, Quantity: 1 mg/mL
Phebra Pty Ltd
arsenic trioxide
Injection, concentrated
Excipient Ingredients: water for injections; hydrochloric acid; sodium hydroxide
Intravenous
10 x 10 mL 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 and colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2009-05-13
Phenasen ® 1 of 3 _Version 11_ _ _ PHENASEN ® CONTAINS 10 MG IN 10 ML ARSENIC TRIOXIDE CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Phenasen. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits . Your doctor has weighed the risks of you being given Phenasen against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET IN A SAFE PLACE. You may need to read it again. WHAT PHENASEN IS USED FOR Phenasen is used to treat acute promyelocytic leukaemia also known as APL. This medicine works by interfering with the growth of cancer cells and slowing their growth and spread in the body. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor’s prescription. There is not enough information to recommend the use of this medicine for children under the age of 5 years. BEFORE YOU ARE GIVEN PHENASEN _WHEN YOU MUST NOT BE GIVEN _ _IT_ _ _ YOU SHOULD NOT BE GIVEN PHENASEN IF YOU HAVE AN ALLERGY TO: • any medicine containing arsenic or arsenic trioxide • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. _ _ YOU SHOULD NOT BE GIVEN THIS MEDICINE IF YOU ARE PREGNANT. It may affect your developing baby if you are given it during pregnancy. Men and women of childbearing age must use effective birth control while they are being treated with Phenasen. Your doctor will discuss this with you. DO NOT BREAST-FEED IF YOU ARE BEING GIVEN THIS MEDICINE. The active ingredient in Phenasen passes into breast milk and there is a Les hele dokumentet
PRODUCT INFORMATION Australian Product Information – Phenasen Injection Version 18 Page 1 of 14 PHENASEN ® CONCENTRATED SOLUTION FOR INFUSION (ARSENIC TRIOXIDE) 1 NAME OF THE MEDICINE Arsenic trioxide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of Phenasen contains 10 mg arsenic trioxide as the active ingredient in a 10 mL glass vial. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Phenasen is a clear, colourless, concentrated solution for infusion. It is a sterile solution for single use. The pH of Phenasen is between 5.0 - 8.5. Phenasen must be diluted before use. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC 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 D OSE 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. Phenasen may be given in combination with all-_trans _retinoic acid (ATRA) and/or chemotherapy. IN PATIENTS WITH NEWLY DIAGNOSED/_DE NOVO _APL COMBINATION TREATMENT Phenasen may be given in combination with all-_trans_-retino Les hele dokumentet