Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
AMSACRINE
NordMedica A/S
L01XX01
AMSACRINE
50 Mg/Ml
Concentrate and solvent for solution for infusion
Product subject to prescription which may not be renewed (A)
Other antineoplastic agents
Authorised
2012-08-17
AMSA IE PIL Feb2016 1 PATIENT INFORMATION LEAFLET AMSIDINE 50 MG/ML INJECTION Amsacrine Concentrate for Infusion READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Amsidine Injection is and what it is used for 2. Before you are given Amsidine Injection 3. How Amsidine Injection is given 4. Possible side effects 5. How to store Amsidine Injection 6. Further information 1. WHAT AMSIDINE INJECTION IS AND WHAT IT IS USED FOR Amsidine Injection is one of a group of medicines called antineoplastic (anticancer) agents. It is used to treat acute leukaemia, a form of cancer of the white cells in your blood. 2. BEFORE YOU RECEIVE AMSIDINE INJECTION YOU SHOULD NOT BE GIVEN AMSIDINE INJECTION IF: • You know that you are allergic to amsacrine or to any of the other ingredients (see section 6 of this leaflet) • You are already receiving other treatments for cancer, including radiation, which have affected your bone marrow or you have received treatments in the past (your doctor will advise you) • You are under 12 years old. • You are breast feeding Speak to your doctor _before _you are given this injection if any of these apply to you. BEFORE YOU ARE GIVEN AMSIDINE INJECTION, YOUR DOCTOR WILL TAKE SPECIAL CARE IF ANY OF THE FOLLOWING SITUATIONS APPLY TO YOU. MAKE SURE YOUR DOCTOR IS AWARE OF THESE SITUATIONS IF IT IS NOT ALREADY OBVIOUS: • You hav Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amsidine 50mg/ml Concentrate and Solvent for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 75mg amsacrine in 1.5ml (50mg per ml). Each solvent vial contains 13.5ml of Lactic Acid and water for injection to give a concentration of 0.0353M L-Lactic acid. Each ml of the combined solution of the concentrate when diluted with the solvent contains 5mg amsacrine per ml For a full list of exipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate and solvent for solution for Infusion. Concentrate is a clear, bright orange/red coloured solution and solvent for infusion is clear colourless solution. The pH of the combined solution is 3.5 - 4.5. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amsidine is indicated for the induction and maintenance of remission in acute leukaemia of adults. It is effective in patients refractory to the anthracycline antibiotics used singly or in combination with other chemotherapeutic agents, and in patients who were formerly treated with maximum cumulative doses of these antibiotics. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Intravenous infusion Amsidine must be diluted in 500ml 5% Dextrose Injection BP and infused over 60 to 90 minutes. Phlebitis or pain at the injection site may occur at doses greater than 70 mg/m 2 . (NOTE: DO NOT USE OTHER DILUENTS. AMSIDINE IS INCOMPATIBLE WITH SALINE). Care must be taken that no extravasation occurs which might produce severe irritation or necrosis. Caution in the handling and preparation of the solution should be exercised, and the use of polyethylene gloves is recommended. If the solution of Amsidine contacts the skin or mucosae, immediately wash thoroughly with soap and water. Adults Induction of remission phase The usual dosage of Amsidine in the induction phase is 90mg/m 2 every day for five consecutive days (total dose 450 mg/m 2 per course of treatment). If bone marrow biopsy performed on day six displays over 50% cellularity and the b Прочитайте повний документ