Gliolan 30mg/ml powder for oral solution (2011)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Medac GmbH |
|---|---|
| Διεύθυνση | Fehlandtstrasse 3, 20354 Hamburg, Germany |
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Name of the medicinal product
Gliolan 30 mg/ml powder for oral solution.
Qualitative and quantitative composition
One vial contains 1.17 g of 5-aminolevulinic acid, corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl). One ml of reconstituted solution contains 23.4 mg of 5-aminolevulinic acid, corresponding ...
Pharmaceutical form
Powder for oral solution. The powder is a white to off-white cake.
Therapeutic indications
Gliolan is indicated in adult patients 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 5-aminolevulinic acid hydrochloride 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
One case of an increased phototoxic reaction (severe sunburn lasting for 5 days) has been reported in a patient after co-administration of 5-aminolevulinic acid and a hypericin extract (a known phototoxic ...
Pregnancy and lactation
Use in pregnancy There are no adequate data from the use of this medicinal product in pregnant woman. Some limited animal studies suggest an embryotoxic acitivity of 5-ALA plus light exposure (see section ...
Effects on ability to drive and use machines
Gliolan has no influence on the ability to drive and use machines.
Undesirable effects
Adverse reactions observed after the use of this medicinal product for fluorescence-guided glioma resection are divided into the following two categories: immediate reactions occurring after oral administration ...
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: sensitisers used in photodynamic therapy ATC code: L01XD04 5-aminolevulinic acid (5-ALA), the active substance of Gliolan, is a natural biochemical precursor of heme that is ...
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 HCl administration does not influence the function of the gastro-intestinal 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
3 years The reconstituted solution is physically-chemically stable for 24 hours at 25ºC.
Special precautions for storage
Keep the vial in the outer carton in order to protect from light. For storage conditions of the reconstituted product see section 6.3.
Nature and contents of container
Colourless type II glass vial, with rubber stopper. Pack sizes: 1, 2 and 10 vials of powder. 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 vial in 50 ml of tap water. The reconstituted solution is a clear and colourless to slightly yellowish fluid. Any unused product ...
Marketing authorization holder
Medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstraße 3 D-20354 Hamburg, 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
07.09.2007
Date of revision of the text
07.09.2007