Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2011 Publisher: Medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstraße 3 D-20354 Hamburg, 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 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 to 30 mg 5-aminolevulinic acid hydrochloride (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 II glass vial, with rubber stopper.
Pack sizes: 1, 2 and 10 vials of powder.
Not all pack sizes may be marketed.
Medac
Gesellschaft für klinische
Spezialpräparate mbH
Fehlandtstraße 3
D-20354 Hamburg,
Germany
Tel. + 49 4103 8006 0
Fax: +49 4103 8006 100
EU/1/07/413/001-003
07.09.2007
| 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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