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Gliolan 30mg/ml powder for oral solution (2011)

Active ingredients: Aminolevulinic acid

Product Name and Form

Gliolan 30 mg/ml powder for oral solution.

Pharmaceutical form

Powder for oral solution.

The powder is a white to off-white cake.

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 to 30 mg 5-aminolevulinic acid hydrochloride (5-ALA HCl).

Chemical substance
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.

Pack sizes and Marketing

Colourless type II glass vial, with rubber stopper.

Pack sizes: 1, 2 and 10 vials of powder.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Medac
Gesellschaft für klinische
Spezialpräparate mbH
Fehlandtstraße 3
D-20354 Hamburg,
Germany

Tel. + 49 4103 8006 0
Fax: +49 4103 8006 100

07.09.2007

Marketing authorization number:

EU/1/07/413/001-003