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GLIOLAN, POWDER FOR ORAL SOLUTION, 30 MG/ML [SIN15244P]
Active ingredients: GLIOLAN, POWDER FOR ORAL SOLUTION, 30 MG/ML
Last updated 26 October 2025
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Product Info
GLIOLAN, POWDER FOR ORAL SOLUTION, 30 MG/ML
[SIN15244P]
Product information
Active Ingredient and Strength | AMINOLEVULINIC ACID 23.4 MG/ML EQUIVALENT AMINOLEVULINIC ACID HYDROCHLORIDE - 30 MG/ML |
Dosage Form | POWDER, FOR SOLUTION |
Manufacturer and Country | LYOCONTRACT GMBH - GERMANY |
Registration Number | SIN15244P |
Licence Holder | LINK HEALTHCARE SINGAPORE PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | L01XD04 |
4.1 Therapeutic indications
Gliolan is indicated in adults for visualisation of malignant tissue during surgery for malignant glioma (WHO grade III and IV).
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.
The total number of bottles needed to achieve the intended dose for the individual patient can be determined according to the equation below (rounded up to the nearest whole bottle):
The administration volume needed to achieve the intended dose for the individual patient can be calculated according to the equation below:
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
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.
If the surgery is postponed by more than 12 hours, surgery should be re-scheduled for the next day or later. Another dose of this medicine can be taken 2 – 4 hours before anaesthesia.
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
4.3 Contraindications
Hypersensitivity to the active substance or porphyrins.
Acute or chronic types of porphyria.
Pregnancy (see sections 4.6 and 5.3 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).