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Important Safety Information:
INDICATION:
DC Bead LUMI™ can be used as an embolic agent with or without delivery of doxorubicin or irinotecan. Unloaded DC Bead LUMI™ are intended to be used for the embolisation of non-malignant hypervascular tumours and arteriovenous malformations (AVMs).
For the use in malignant indications:
- DC Bead LUMI™ are primarily intended as an embolic agent for the local treatment of malignant hypervascularised tumour(s) in the liver.
- DC Bead LUMI™ are compatible with doxorubicin for the local treatment of tumours in patients with hepatocellular carcinoma (HCC). Doxorubicin can be loaded prior to embolisation and then as a secondary action, the beads will elute a local, controlled and sustained dose to the tumour after embolisation.
- DC Bead LUMI™ are also intended to embolise the vessels supplying malignant colorectal cancer metastasised to the liver (mCRC).
- DC Bead LUMI™ are compatible with irinotecan which can be loaded prior to embolisation and then as a secondary action, the beads will elute a local, controlled and sustained dose to the liver metastases from colorectal cancer after embolisation.
WARNING:
It is the doctor’s responsibility to give due consideration to the details in the drug product marketing authorisation in deciding which drug (either doxorubicin or irinotecan) to load DC Bead LUMI™ with and whether loading with that drug is appropriate for the patient under his/her care .The relevant Summary of Product Characteristics (SmPC) must be consulted. The type and dose of drug should also be assessed according to the individual patient’s clinical circumstances.
DC Bead and DC Bead LUMI are trademarks and/or registered trademarks of Biocompatibles UK Limited, a BTG International group company. Imagine where we can go, BTG and the BTG roundel logo are trademarks of BTG International Ltd. BTG and the BTG roundel logo are registered trademarks in the USA, the European Union and certain other territories. © 2017 Biocompatibles UK Ltd. EM-LUM-2017-0025. EMEA. Date of preparation January 2017.