Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: photonamic GmbH & Co. KG, Eggerstedter Weg 12, 25421 Pinneberg, Germany
Alacare 8 mg medicated plaster.
| Pharmaceutical Form |
|---|
|
Medicated plaster. Each plaster has a size of 4 cm², is square with rounded corners and consists of a skin tone backing foil and a self-adhesive matrix, covered by a release liner which is removed prior to use. |
Each medicated plaster of 4 cm² contains 8 mg 5-aminolevulinic acid, 2 mg per cm².
For the full list of excipients, see section 6.1.
| 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 |
|---|
|
Plasters: Acrylic pressure sensitive adhesive (Poly[(2-ethylhexyl)acrylate-co-methylacrylate-co-acrylic acid-co-glycidylmethacrylate]) Backing film: Pigmented polyethylene Aluminium vapor coated polyester Release liner (polyethylene terephthalate film) which is removed prior to application. |
4 medicated plasters sealed in protective sachets consisting of 4 layers: paper (outer layer), polyethylene LDPE, aluminium, ethylene copolymer (inner layer).
Pack sizes of 4 or 8 medicated plasters (1 or 2 protective sachet(s)).
Not all pack sizes may be marketed.
photonamic GmbH & Co. KG, Eggerstedter Weg 12, 25421 Pinneberg, Germany
PL 45451/0001
23/07/2009
| Drug | Countries | |
|---|---|---|
| ALACARE | Austria, Finland, Ireland, Netherlands, Poland, United Kingdom |
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