Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
trabectedin
Pharma Mar S.A.
L01CX01
trabectedin
Antineoplastic agents
Ovarian Neoplasms; Sarcoma
Yondelis is indicated for the treatment of patients with advanced soft-tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.Yondelis in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.
Revision: 27
Authorised
2007-09-17
34 B. PACKAGE LEAFLET 35 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT YONDELIS 0.25 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION YONDELIS 1 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION trabectedin 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. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Yondelis is and what it is used for 2. What you need to know before you are given Yondelis 3. How to use Yondelis 4. Possible side effects 5. How to store Yondelis 6. Contents of the pack and other information 1. WHAT YONDELIS IS AND WHAT IT IS USED FOR Yondelis contains the active substance trabectedin. Yondelis is an anti-cancer medicine that works by preventing the tumour cells from multiplying. Yondelis is used for the treatment of patients with advanced soft tissue sarcoma, when previous medicines have been unsuccessful or the patients are unsuited to receive them. Soft tissue sarcoma is a malignant disease that starts somewhere in the soft tissues, such as the muscles, fat or other tissues (for example cartilages or vessels). Yondelis in combination with pegylated liposomal doxorubicin (PLD: another anti-cancer medicine) is used for the treatment of patients with ovarian cancer that has come back after at least 1 previous therapy and are not resistant to anti-cancer medicines containing platinum compounds. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN YONDELIS DO NOT USE YONDELIS - if you are allergic to trabectedin or any of the other ingredients of this medicine (listed in section 6). - if you have any serious infections. - if you are breast-feeding. - if you will receive yellow fever vaccine. 36 WARNINGS AND PRECAUTIONS Talk to your doctor before using Yondelis Yondelis or its combination with PLD must not be Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Yondelis 0.25 mg powder for concentrate for solution for infusion. Yondelis 1 mg powder for concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION YONDELIS 0.25 MG Each vial of powder contains 0.25 mg of trabectedin. One ml of reconstituted solution contains 0.05 mg of trabectedin. Excipients with known effect: Each vial of powder contains 2 mg of potassium and 0.1 g of sucrose. For the full list of excipients, see section 6.1. YONDELIS 1 MG Each vial of powder contains 1 mg of trabectedin. One ml of reconstituted solution contains 0.05 mg of trabectedin. Excipients with known effect: Each vial of powder contains 8 mg of potassium and 0.4 g of sucrose. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White to off-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Yondelis is indicated for the treatment of adult patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients. Yondelis in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Yondelis must be administered under the supervision of a physician experienced in the use of chemotherapy. Its use should be confined to qualified oncologists or other health professionals specialised in the administration of cytotoxic agents. Posology For the treatment of soft tissue sarcoma, the recommended dose is 1.5 mg/m 2 body surface area, administered as an intravenous infusion over 24 hours with a three-week interval between cycles. For the treatment of ovarian cancer Yondelis is administered every three weeks as a 3-hour infusion at a dose of 1.1 mg/m 2 , immediately after PLD 30 mg/m 2 . To minim Lestu allt skjalið