Posology : מינונים

4.2   Posology and method of administration

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.

Posology
The recommended dose is 20 mg 5-ALA HCl per kilogram body weight.

Patients with renal or hepatic impairment
No trials have been performed in patients with clinically relevant hepatic or renal impairment.
Therefore, this medicinal product should be used with caution in such patients.
Elderly patients
There are no special instructions for use in elderly patients with regular organ function.

Paediatric population
The safety and efficacy of Gliolan in children and adolescents aged 0 to 18 years have not yet been established. No data are available.

Method of administration
The solution should be administered orally three hours (range 2-4 hours) before anaesthesia. Use of 5-ALA under conditions other than the ones used in the clinical trials entail an undetermined risk.

Precautions to be taken before handling or administering the medicinal product For instructions on reconstitution of the medicinal product before administration, see section 6.6.