Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2011 Publisher: Medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstraße 3 D-20354 Hamburg, Germany Tel. + 49 4103 8006 0 Fax: +49 4103 8006 100
Gliolan is indicated in adult patients for visualisation of malignant tissue during surgery for malignant glioma (WHO grade III and IV).
This medicinal product should only be used by experienced neurosurgeons conversant with surgery of malignant gliomas and in-depth knowledge of functional brain anatomy who have completed a training course in fluorescence-guided surgery.
The recommended dosage is 20 mg 5-aminolevulinic acid hydrochloride per kilogram body weight. The solution should be administered orally three hours (range 2-4 hours) before induction of anaesthesia. Use of 5-ALA under conditions other than the ones used in the clinical trials entail an undetermined risk.
No studies have been performed in patients with clinically relevant hepatic or renal impairment. Therefore, this medicinal product should be used with caution in such patients.
There is no experience in children
There are no special instructions for use in elderly patients with regular organ function.
Within a clinical trial, a 63 year old patient with known cardiovascular disease was accidentally given an overdose of 5-ALA HCl (3000 mg instead of 1580 mg). During surgery he developed respiratory insufficiency, which was managed by adaptation of ventilation. After surgery the patient also displayed facial erythema. It was stated that the patient had been exposed to more light than permitted for the trial. Respiratory insufficiency and erythema completely resolved.
In the event of overdose, supportive measures should be provided as necessary, including sufficient protection from strong light sources (e.g. direct sunlight).
3 years
The reconstituted solution is physically-chemically stable for 24 hours at 25ºC.
Keep the vial in the outer carton in order to protect from light.
For storage conditions of the reconstituted product see section 6.3.
Colourless type II glass vial, with rubber stopper.
Pack sizes: 1, 2 and 10 vials of powder.
Not all pack sizes may be marketed.
The oral solution is prepared by dissolving the amount of powder of one vial in 50 ml of tap water. The reconstituted solution is a clear and colourless to slightly yellowish fluid.
Any unused product or waste material should be disposed of in accordance with local requirements.
Single use vial – discard any content remaining after first use.
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