n placed into the cavity after tumour resection. The rate of biodegradation is variable from patient to patient. During the biodegradation process an implant remnant may be observed on brain imaging scans or at re-operation even though extensive degradation of all components has occurred.
5.3 Preclinical safety data
No carcinogenicity, mutagenicity, embryo-foetal toxicity, pre- and post-natal toxicity and impairment of fertili ty studies have been conducted with GLIADEL Implants.
Carmustine, the active component of GLIADEL Implant, when administered systemically, has embryotoxic, genotoxic and carcinogenic effects and can cause testicular degeneration in several animal models.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Polifeprosan 20
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Store in a freezer at or below-20°C.
Unopened outer sachets may be kept at a temperature of not more than 22°C for a maximum of six hours. The product may be refrozen only once if the sachets have been unopened and kept for a maximum of 6 hours at a temperature of not more than 22°C. After refreezing, the product should be used within 30 days.
6.5 Nature and contents of container
GLIADEL Implant is available in a box containing eight implants. Each implant is individually packaged in two aluminium foil laminate sachets.
6.6 Special precautions for disposal and other handling
Implants should be handled by personnel wearing surgical gloves because exposure to carmustine can cause severe burning and hyperpigmentation of the skin. Use of double gloves is recommended and the outer gloves should be discarded into a dedicated biohazard waste container after use. A surgical instrument dedicated to the handling of the implants should be used for implant placement. If repeat neurosurgical intervention is indicated, any implant or implant remnant should be handled as a potentially cytotoxic agent. Any unused product or waste material should be disposed of in accordance with local requirements.
GLIADEL Implants should be handled with care. The sachets containing GLIADEL Implants should be delivered to the operating room and remain unopened until ready to place the implants in the resection cavity. Only the outside surface of the outer sachet is not sterile. In any case, if an implant is dropped, it should be discarded accordingly.
Instructions for opening sachets containing the implant:
• To open the outer sachet, locate the folded corner and slowly pull in an outward motion. Do not pull in a downward motion rolling knuckles over the sachet. This may exert pressure on the implant and cause it to break
• Remove the inner sachet by grabbing with the aid of forceps and pulling upward
• To open the inner sachet, gently hold it and cut in an arc-like fashion around the implant
• To remove the implant, gently grasp the implant with the aid of forceps and place it directly into the resection cavity
In any case, if an implant is dropped, it should be discarded accordingly.
Once the tumour is resected, tumour pathology is confirmed and haemostasis is obtained, up to eight implants may be placed to cover as much of the resection cavity as possible. Slight overlapping of the implants is acceptable. Implants broken in half may be used, but implants broken in more than two pieces should be discarded in the dedicated biohazard waste containers.
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