GLIADEL Implant Ref.[2621] Active ingredients: Carmustine

For intralesional use in adults only.

Each GLIADEL Implant contains 7.7 mg of carmustine, resulting in a dose of 61.6 mg when eight implants are placed in the tumour resection cavity.

It is recommended that a maximum of eight implants be placed if the size and shape of the resection cavity allows it. Implants broken in half may be used, but implants broken in more than two pieces should be discarded in the dedicated biohazard waste containers (see section 6.6).

It is recommended that the placement of the implants should be directly from the product’s inner sterile packaging into the resection cavity. Oxidised regenerated cellulose may be placed over the implants to secure them to the cavity surface (see section 6.6).

Not applicable.

4 years.

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.

GLIADEL Implant is available in a box containing eight implants. Each implant is individually packaged in two aluminium foil laminate sachets.

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.