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All persons handling, dispensing and implanting OncoSil™ must be familiar with and abide by all Federal, State and local regulatory requirements governing therapeutic radioactive materials. Standard approved radiation protection techniques should be used to protect staff when handling both OncoSil™ and the study participant.
If any signs of damage or ineffective sterile barrier integrity are observed for the OncoSil™ System, DO NOT USE the system and contact OncoSil Medical. Signs of damage and/or ineffective sterile barrier integrity may include, for example, broken vial, cracked vial, broken ring pull, non-intact tamper evident seals, missing vial caps etc.
OncoSil™ System is supplied sterile. There is no data to support the sterility or functionality of OncoSil™ past its expiration date.
Implantation of OncoSil™ should not occur in the following special situations:
Presence of multiple collateral vessels surrounding or adjacent to the target tumour
Presence (or significant risk) of varices near the target tumour
Caution is advised where previous EUS (e.g. diagnostic EUS-FNA) was considered technically too difficult
Caution is strongly advised in the setting of recent, clinically significant pancreatitis. Implantation is not recommended
Chemotherapy should not be administered within 48 hours either side of the OncoSil™ implantation
OncoSil™ has not been studied in patients who have previously received radiotherapy to the target organ
Since the combination of standard radiotherapy and OncoSil™ has not been investigated, additional radiotherapy is not recommended following OncoSil™ treatment
Antibiotic prophylaxis to cover the OncoSil™ implantation procedure is advised. The selection and duration of antimicrobial regimen is based on local guidelines and practice
Pain relief may be required to treat abdominal pain experienced immediately following implantation of OncoSil™
Gastro-protection e.g. with a proton-pump inhibitor or similar therapy, starting just prior to or at the time of implantation, and continued for up to 6 months post-implantation is considered reasonable
The safety of OncoSil™ has not been established in patients who are pregnant or who, within twelve months of implantation, become pregnant
The safety of OncoSil™ has not been established for future children of patients who are pregnant at the time of implantation, or who, within twelve months of implantation, become pregnant
The safety of OncoSil™ has not been established for children being breastfed by patients at the time of implantation or subsequent to implantation
The safety of OncoSil™ has not been established in patients who are < 18 years of age and is therefore not indicated for use in this population group
Due to limited clinical experience, caution is advised when treating tumours with volumes in excess of 50cc with OncoSil™. A risk-benefit assessment by the implanting physician is strongly advised
Individual monitoring of staff is generally a requirement in accredited facilities and is recommended for staff handling OncoSil™. All staff generally wear film badges or some form of personal dosimeters.
Nursing care and ward cleaning requirements will be at the discretion of the institutions radiation safety procedures.