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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.
OncoSil™ has not been studied in study participants 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.
Pain relief may be required to treat abdominal pain experienced immediately following implantation of OncoSil™.
A prophylactic treatment with a proton-pump inhibitor prior to implantation, and to continue to receive this treatment for at least 6 months post implantation.
Adequate shielding must be effected during storage, handling and use of OncoSil™.
Personnel radiation exposure limiting procedures and practices must be effected during storage, handling and use of OncoSil™.
Unshielded vials and syringes must be handled with forceps that set the fingers away from the unshielded radioactive source by a minimum of 20 cm.
Care must be taken to ensure minimum radiation exposure to the study participants extraneous to the therapeutic objective.
Care must be taken to ensure minimum radiation exposure to all staff and other personnel who come in to contact with the study participant.
Radiation safety practices must be implemented in accordance with Federal, State and local regulatory requirements. All spills and/or leakages of OncoSil™ must be cleaned up immediately and contamination monitoring radiation safety practices followed to ensure effective cleaning.
Usual good clinical practice should be implemented with respect to the implantation deliverymethod used for OncoSil™.
OncoSil™ must be prepared behind a screen suitable for shielding from beta particles e.g. Perspex or Lucite.
OncoSil™ must be stored inside adequate shielding at all times pre-and post-implantation.
All contaminated waste must be placed in a designated radioactive waste container and disposed of in accordance with institutions policy.
The safety of OncoSil™ has not been established in study participants who are pregnant or who, within twelve months of implantation, become pregnant.
The safety of OncoSil™ has not been established for future children of study participants 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 study participants at the time of implantation or subsequent to implantation.
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.