in several animal models.
6. Pharmaceutical particulars
6.1 List of excipients
Polifeprosan 20
6.2 Incompatibilities
Not applicable..
6.3 Shelf life
4 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.
Oxidised regenerated cellulose may be placed over the implants to secure them to the cavity surface. After placement of the implants, the resection cavity should be irrigated and the dura closed in a water, tight fashion.
Any unused product or waste material should be disposed of in accordance with local requirements for biohazardous waste.
7. Marketing authorisation holder
MGI PHARMA LIMITED
European Knowledge Centre
Mosquito Way
Hatfield
Hertfordshire
AL10 9SN
United Kingdom
8. Marketing authorisation number(s)
PL 18753/0001
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 28/05/1999 |
