Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: medac, Gesellschaft für klinische, Spezialpräparate mbH, Theaterstr. 6, 22880 Wedel, Germany, Tel. + 49 4103 8006 0, Fax: +49 4103 8006 100
Gliolan 30 mg/ml powder for oral solution.
| Pharmaceutical Form |
|---|
|
Powder for oral solution. The powder is a white to off-white cake. |
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 to 30 mg 5-ALA HCl.
| Active Ingredient | Description | |
|---|---|---|
| Aminolevulinic acid |
5-Aminolevulinic acid (5-ALA) is a natural biochemical precursor of heme that is metabolised in a series of enzymatic reactions to fluorescent porphyrins, particularly PPIX. 5-ALA synthesis is regulated by an intracellular pool of free heme via a negative feedback mechanism. Administration of excess exogenous 5-ALA avoids the negative feedback control, and accumulation of PPIX occurs in target tissue. In the presence of visible light, fluorescence of PPIX (photodynamic effect) in certain target tissues can be used for photodynamic diagnosis. |
| List of Excipients |
|---|
|
None. |
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.
medac, Gesellschaft für klinische, Spezialpräparate mbH, Theaterstr. 6, 22880 Wedel, Germany, Tel. + 49 4103 8006 0, Fax: +49 4103 8006 100
EU/1/07/413/001-003
Date of first authorisation: 07 September 2007
Date of latest renewal: 12 September 2012
| Drug | Countries | |
|---|---|---|
| GLIOLAN | Austria, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom |
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