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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

GLIOLAN Powder for oral solution (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Gliolan 30 mg/ml powder for oral solution.

Qualitative and quantitative composition

One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA), corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl). One ml of reconstituted solution contains 23.4 mg of 5-ALA, corresponding ...

Pharmaceutical form

Powder for oral solution. The powder is a white to off-white cake.

Therapeutic indications

Gliolan is indicated in adults for visualisation of malignant tissue during surgery for malignant glioma (WHO grade III and IV).

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 ...

Contraindications

Hypersensitivity to the active substance or porphyrins. Acute or chronic types of porphyria. Pregnancy (see sections 4.6 and 5.3).

Special warnings and precautions for use

5-ALA-induced fluorescence of brain tissue does not provide information about the tissues underlying neurological function. Therefore, resection of fluorescing tissue should be weighed up carefully against ...

Interaction with other medicinal products and other forms of interaction

Patients should not be exposed to any photosensitizing agent up to 2 weeks after administration of Gliolan.

Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of 5-ALA in pregnant women. Some limited animal studies suggest an embryotoxic activity of 5-ALA plus light exposure (see section 5.3). Therefore, ...

Effects on ability to drive and use machines

Not relevant, the treatment itself will have an influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile Adverse reactions observed after the use of this medicinal product for fluorescence-guided glioma resection are divided into the following two categories: immediate reactions ...

Overdose

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, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, sensitisers used in photodynamic therapy ATC code: L01XD04 Mechanism of action 5-ALA is a natural biochemical precursor of heme that is metabolised in ...

Pharmacokinetic properties

General characteristics This medicinal product shows good solubility in aqueous solutions. After ingestion, 5-ALA itself is not fluorescent but is taken up by tumour tissue (see section 5.1) and is intracellularily ...

Preclinical safety data

Standard safety pharmacology experiments were performed under light protection in the mouse, rat and dog. 5-ALA administration does not influence the function of the gastrointestinal and central nervous ...

List of excipients

None.

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Unopened bottle: 3 years. Reconstituted solution: The reconstituted solution is physically-chemically stable for 24 hours at 25°C.

Special precautions for storage

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.

Nature and contents of container

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.

Special precautions for disposal and other handling

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 ...

Marketing authorization holder

medac, Gesellschaft für klinische, Spezialpräparate mbH, Theaterstr. 6, 22880 Wedel, Germany, Tel. + 49 4103 8006 0, Fax: +49 4103 8006 100

Marketing authorization number(s)

EU/1/07/413/001-003

Date of first authorization / renewal of the authorization

Date of first authorisation: 07 September 2007 Date of latest renewal: 12 September 2012

Πηγαίο έγγραφο

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