Maa: Ruotsi
Kieli: ruotsi
Lähde: Läkemedelsverket (Medical Products Agency)
amsakrin
Eurocept International B.V.
L01XX01
amsacrine
75 mg
Pulver till koncentrat till infusionsvätska, lösning
amsakrin 75 mg Aktiv substans
Receptbelagt
Förpacknings: Injektionsflaska, 5 st
Godkänd
2018-06-14
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AMSALYO 75 MG POWDER 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 or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Amsalyo is and what it is used for 2. What you need to know before you use Amsalyo 3. How to use Amsalyo 4. Possible side effects 5. How to store Amsalyo 6. Contents of the pack and other information 1. WHAT AMSALYO IS AND WHAT IT IS USED FOR This medicine is an anticancer (cytostatic) agent. It is used in combination with other chemotherapeutic (anticancer) agents to treat a form of cancer of the white cells in your blood, acute myeloid leukaemia. It prevents the growth of certain cells. Amsalyo is mainly indicated in case of recurrence or failure of conventional treatments. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AMSALYO DO NOT USE AMSALYO - if you are allergic (hypersensitive) to amsacrine or any of the other ingredients of this medicine listed in section 6. - if your bone marrow does not produce enough blood cells following the administration of other chemotherapy products and/or radiation therapy. - during breast-feeding. WARNINGS AND PRECAUTIONS Talk to your doctor before taking Amsalyo: Your doctor will take special care if any of the following conditions apply to you. - this medicine can cause a decrease in the production of white blood cells and platelets where severe infections and haemorrhages may occur. Your doctor will check this by blood samples and reduce the dose and interrupt treatment if necessary. - there is a risk Lue koko asiakirja
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Amsalyo 75 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 75 mg amsacrine. After reconstitution, each ml of solution contains 1.5 mg amsacrine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. Red-orange lyophilized powder. 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 should be supervised by a physician experienced in the management of patients with AML. Before treatment is started the potassium level in serum must be controlled and corrected. A serum potassium level >4 mEq/L prior to administration is recommended. Amsacrine is given in combination with other cytostatic drugs. Numerous dose levels and dosing schedules exist and depend on concomitant therapy, patient and disease characteristics, bone marrow reserve and hematoxicity, and response to therapy. Refer to the protocol by which the patient is being treated and to applicable guidelines. Dosing schedules reported for induction treatment with combination chemotherapy typically include doses of 90 to 150 mg/m2 per day, for three to five consecutive days. For consolidation treatment, lower doses may be considered. Renal impairment Caution is advised when administering amsacrine to patients with renal impairment, see section 5.2. _ _ In patients with mild-renal dysfunction (GFR 60–89 ml/min/1.73 m 2 ), no starting dose _ _ adjustment is recommended. _ _ In patients with moderate or severe renal impairment (GFR <59 ml/min/1.73 m 2 ), a starting dose reduction by approximately 20-30% should be considered. Subsequent dose adjustments may be needed based on clinical toxicity. _ _ Hepatic impairment: Caution is advised when administering amsacrine to patients Lue koko asiakirja