Maa: Malta
Kieli: englanti
Lähde: Medicines Authority
AMSACRINE
NordMedica A/S
L01XX01
AMSACRINE
CONCENTRATE FOR SOLUTION FOR INFUSION
AMSACRINE 50 mg/ml
POM
ANTINEOPLASTIC AGENTS
Authorised
2006-01-16
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AMSACRINE NORDMEDICA 75 MG/1.5 ML CONCENTRATE AND SOLVENT FOR CONCENTRATE FOR SOLUTION FOR INFUSION amsacrine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Amsacrine NordMedica is and what it is used for 2. What you need to know before you use Amsacrine NordMedica 3. How to use Amsacrine NordMedica 4. Possible side effects 5. How to store Amsacrine NordMedica 6. Contents of the pack and other information 1. WHAT AMSACRINE NORDMEDICA IS AND WHAT IT IS USED FOR Amsacrine NordMedica belongs to a group of medicines called cytostatics (medicine for the treatment of cancer). It is used to treat acute myeloid leukaemia also known as AML. AML is a form of cancer of the blood and bone marrow. Amsacrine NordMedica is used in adults, whose disease has not responded to other therapies or in case of relapse. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AMSACRINE NORDMEDICA DO NOT USE AMSACRINE NORDMEDICA: - if you are allergic to amsacrine or acridine derivates or any of the other ingredients of this medicine (listed in section 6) - if you are already receiving (or have recently received) other treatments for cancer - if you are breast-feeding. Talk to your doctor before you use this medicine if any of these conditions apply to you. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before you are given Amsacrine NordMedica. Your doctor will take special care if any of the following conditions apply to you. - You have ever had kidney or liver disease - You have any problem with your heart - You have been told that the potassium level in your blood is too low - You suffer from Lue koko asiakirja
Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Amsacrine NordMedica 75 mg/1,5 ml concentrate and solvent for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate for solution for infusion contains 50 mg amsacrine. Each vial of 1.5 ml of concentrate for solution for infusion contains 75 mg amsacrine. Each ml concentrate after the first dilution with the solvent contains 5 mg amsacrine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate and solvent for concentrate for solution for infusion. The concentrate is a clear bright orange/red liquid, the pH of the concentrate is between 3.50 – 4.50. The solvent is a clear solution, the pH of the solvent is between 2.50 – 3.50. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Salvage therapy of refractory/relapsed acute myeloid leukaemia (AML) in adults, in combination with other chemotherapeutic agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Treatment with Amsacrine NordMedica should be introduced by or in cooperation with a doctor experienced in treatment with cytostatics. Before treatment is started the potassium level in serum must be controlled and corrected. Amsacrine NordMedica is given in combination with other cytostatics.Serum potassium level >4 mEq/L prior to administration is recommended. Induction phase: Optimal dose is individual and dependent on the combination. Usual dose per treatment period is 300-650 mg/m 2 and is divided over 3-7 days. The total dose during a treatment period should not exceed 750 mg/m 2 . In order to achieve remission more than one treatment period may be necessary. Consolidation /Maintenance phase: Comparable or somewhat lower doses compared with the induction phase are given. Page 2 of 10 Renal impairment Caution is advised when administering amsacrine to patients with renal impairment._ _ In patients with mild-renal dysfunction, no starting dose_ _adjustment is recommended._ _In patients with mode Lue koko asiakirja