Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Ferndale Pharmaceuticals Ltd, Unit 740, Thorp Arch Estate, Wetherby, West Yorkshire, LS23 7FX
Aethoxysklerol 2.5 mg/ml solution for injection.
Aethoxysklerol 5 mg/ml solution for injection.
Aethoxysklerol 10 mg/ml solution for injection.
Aethoxysklerol 20 mg/ml solution for injection.
Aethoxysklerol 30 mg/ml solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear, colourless to very faintly greenish yellow sterile solution. pH 7.0–8.0 Osmolality 920–975 mOsmol/kg |
The active substance in Aethoxysklerol is lauromacrogol 400 also known as polidocanol.
| Each ml solution for injection contains: | Each 2ml ampoule of solution contains: | |
| Aethoxysklerol 2.5 mg/ml | 2.5 mg lauromacrogol 400 | 5 mg lauromacrogol 400 |
| Aethoxysklerol 5 mg/ml | 5 mg lauromacrogol 400 | 10 mg lauromacrogol 400 |
| Aethoxysklerol 10 mg/ml | 10 mg lauromacrogol 400 | 20 mg lauromacrogol 400 |
| Aethoxysklerol 20 mg/ml | 20 mg lauromacrogol 400 | 40 mg lauromacrogol 400 |
| Aethoxysklerol 30 mg/ml | 30 mg lauromacrogol 400 | 60 mg lauromacrogol 400 |
Excipients with known effect:
All strengths contain 42 mg ethanol per ml.
All strengths contain 0.310 mg sodium per ml.
All strengths contain 0.124 mg potassium per ml.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Polidocanol |
Polidocanol has a concentration-dependent and volume-dependent damaging effect on the endothelium of blood vessels. |
| List of Excipients |
|---|
|
Ethanol 96% |
2ml ampoule (Type I glass):
| Ampoule identification Stripe colours & format | |
| Aethoxysklerol 2.5 mg/ml | Two red |
| Aethoxysklerol 5 mg/ml | Two white and one red |
| Aethoxysklerol 10 mg/ml | One yellow and one red |
| Aethoxysklerol 20 mg/ml | One green and one red |
| Aethoxysklerol 30 mg/ml | One blue and one red and one white |
Ferndale Pharmaceuticals Ltd, Unit 740, Thorp Arch Estate, Wetherby, West Yorkshire, LS23 7FX
| Aethoxysklerol | 2.5 mg/ml | 5 mg/ml | 10 mg/ml | 20 mg/ml | 30 mg/ml |
| Authorisation number | PL20685/0042 | PL20685/0039 | PL20685/0040 | PL20685/0043 | PL20685/0041 |
24/12/2018
| Drug | Countries | |
|---|---|---|
| AETHOXYSKLEROL | Austria, Finland, Japan, Lithuania, Malta, Netherlands, Poland, Turkey, United Kingdom |
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