Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Amsacrine
Eurocept International BV
L01XX; L01XX01
Amsacrine
75 mg/1.5 millilitre(s)
Concentrate and solvent for concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Other antineoplastic agents; amsacrine
Marketed
2012-08-17
AMSA IE PIL 1 PATIENT INFORMATION LEAFLET AMSIDINE 75 MG/1.5 ML CONCENTRATE AND SOLVENT FOR CONCENTRATE FOR SOLUTION FOR INFUSION Amsacrine Concentrate and Solvent for Concentrate for Solution 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 is and what it is used for 2. Before you are given Amsidine 3. How Amsidine is given 4. Possible side effects 5. How to store Amsidine 6. Further information 1. WHAT AMSIDINE IS AND WHAT IT IS USED FOR Amsidine 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 YOU SHOULD NOT BE GIVEN AMSIDINE 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 infusion if any of these apply to you. BEFORE YOU ARE GIVEN AMSIDINE, 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 have ever had a kidney or liver disease • You have any problem with your heart • You have a problem with your nervous system or brain • You have been told that the potassium level in your blood is too low • You have pre-existing bone marrow depression • You have a raised uric acid level. Speak to your doctor before you are given this infusion if any of these apply Lue koko asiakirja
Health Products Regulatory Authority 16 February 2023 CRN00DFHP Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amsidine 75 mg/1.5 ml Concentrate and Solvent for Concentrate 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 concentrate for solution for infusion. Concentrate is a clear, bright orange/red coloured solution and solvent 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 Lue koko asiakirja