GLIOLAN Powder for oral solution Ref.[6162] Active ingredients: Aminolevulinic acid

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):

Number of bottles = Patient body weight (kg) / 75 kg/bottle

The administration volume needed to achieve the intended dose for the individual patient can be calculated according to the equation below:

Administration volume (ml) = Patient body weight (kg) x 20 mg/kg / 30 mg/ml

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.

Within a clinical trial, a 63-year old patient with known cardiovascular disease was accidentally given an overdose of 5-ALA HCl (3,000 mg instead of 1,580 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).

Unopened bottle: 3 years.

Reconstituted solution: The reconstituted solution is physically-chemically stable for 24 hours at 25°C.

Keep the bottle in the outer carton in order to protect from light.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

Colourless type I glass bottle with butyl rubber stopper containing 1.5 g powder for reconstitution in 50 ml of drinking water.

Pack sizes: 1, 2 and 10 bottles.

Not all pack sizes may be marketed.

The oral solution is prepared by dissolving the amount of powder of one bottle in 50 ml of drinking water. One bottle of Gliolan 30 mg/ml powder for oral solution reconstituted in 50 ml of drinking water corresponds to a total dose of 1,500 mg 5-aminolevulinic acid hydrochloride (5-ALA HCl). The reconstituted solution is a clear and colourless to slightly yellowish fluid.

Gliolan is for single use only and any content remaining after first use must be discarded.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.