Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
aflibercept
Sanofi Winthrop Industrie
L01XX44
aflibercept
Antineoplastic agents
Colorectal Neoplasms
Treatment of metastatic colorectal cancer (MCRC).
Revision: 13
Authorised
2013-02-01
34 B. PACKAGE LEAFLET 35 PACKAGE LEAFLET: INFORMATION FOR THE USER ZALTRAP 25 MG / ML CONCENTRATE FOR SOLUTION FOR INFUSION aflibercept READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again, or provide it to future healthcare providers. • 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 ZALTRAP is and what it is used for 2. What you need to know before you are given ZALTRAP 3. How ZALTRAP is given 4. Possible side effects 5. How to store ZALTRAP 6. Contents of the pack and other information 1. WHAT ZALTRAP IS AND WHAT IT IS USED FOR WHAT ZALTRAP IS AND HOW IT WORKS ZALTRAP contains the active substance aflibercept, a protein that works by blocking the growth of new blood vessels within the tumour. The tumour needs nutrients and oxygen from blood in order to grow. By blocking the growth of blood vessels, ZALTRAP helps to stop or slow down the growth of the tumour. WHAT ZALTRAP IS USED FOR ZALTRAP is a medicine used to treat advanced cancers of the colon or rectum (parts of the large intestine) in adults. It will be given with other medicines called ‘chemotherapy’, including ‘5-fluorouracil’, ‘folinic acid’, and ‘irinotecan’. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZALTRAP DO NOT USE ZALTRAP • if you are allergic to aflibercept or any of the other ingredients of this medicine (listed in section 6). • in your eye, since it may severely damage it. Please also read the package leaflets for the other medicines (‘chemotherapy’) that are part of your treatment, to see if they are suitable for you. If you are unsure, ask your doctor, pharmacist or nurse if there are any reasons why you cannot use these medicines. WARNINGS AND PRECAUTIONS Talk to your doctor, phar Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT ZALTRAP 25 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of concentrate for solution for infusion contains 25 mg aflibercept*. One vial of 4 ml of concentrate contains 100 mg of aflibercept. One vial of 8 ml of concentrate contains 200 mg of aflibercept. * Aflibercept is produced in a Chinese hamster ovary (CHO) K-1 mammalian expression system by recombinant DNA technology. Excipient(s) with known effect: Each 4 ml vial contains 0.484 mmol of sodium, which is 11.118 mg of sodium, and 8 ml vial contains 0.967 mmol of sodium, which is 22.236 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM _ _ Concentrate for solution for infusion (sterile concentrate). The concentrate is a clear colourless to pale yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ZALTRAP in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy is indicated in adults with metastatic colorectal cancer (MCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ZALTRAP should be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products. Posology The recommended dose of ZALTRAP, administered as an intravenous infusion over 1 hour, is 4 mg / kg of body weight, followed by the FOLFIRI regimen. This is considered as one treatment cycle. The FOLFIRI regimen to be _ _ used is irinotecan 180 mg/m 2 intravenous infusion over 90 minutes and folinic acid (dl racemic) 400 mg/m² intravenous infusion over 2 hours at the same time on day 1 using 3 a Y-line, followed by 5-fluorouracil (5-FU) 400 mg / m² intravenous bolus, followed by 5-FU 2400 mg / m² continuous intravenous infusion over 46 hours. The treatment cycle is repeated every 2 weeks. ZALTRAP treatment should be continued until disease progression or unacceptable toxicity occur Lesen Sie das vollständige Dokument