Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: STD Pharmaceutical Products Ltd, Plough Lane, Hereford, HR4 0EL, United Kingdom
Fibrovein 3.0%, 1.0%, 0.5%, 0.2% Solution for Injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear, colourless, sterile solution free from visible particles. pH 7.5–7.9. Osmolality 247–273 mOsm/kg. |
Fibrovein 3% Solution for Injection: Each ml solution for injection contains 30mg sodium tetradecyl sulfate. Each 2ml ampoule contains 60mg sodium tetradecyl sulfate. Each 5ml vial contains 150mg sodium tetradecyl sulfate.
Fibrovein 1% Solution for Injection: Each ml solution for injection contains 10mg sodium tetradecyl sulfate. Each 2ml ampoule contains 20mg sodium tetradecyl sulfate.
Fibrovein 0.5% Solution for Injection: Each ml solution for injection contains 5mg sodium tetradecyl sulfate. Each 2ml ampoule contains 10mg sodium tetradecyl sulfate.
Fibrovein 0.2% Solution for Injection: Each ml solution for injection contains 2mg sodium tetradecyl sulfate. Each 5ml vial contains 10mg sodium tetradecyl sulfate.
Excipient(s) with known effect:
Contains benzyl alcohol 20 mg/ml.
Contains sodium up to approximately 1.7 mg/ml.
Contains potassium 0.3 mg/ml.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Sodium tetradecyl sulfate |
Sodium tetradecyl sulfate is a sclerosing agent. Intravenous injection causes intima inflammation and thrombus formation. This usually occludes the injected vein. Subsequent formation of fibrous tissue results in partial or complete vein obliteration that may or may not be permanent. |
| List of Excipients |
|---|
|
Benzyl alcohol |
2ml ampoule (Type I glass).
5ml vial (Type 1 glass) with a stopper (chlorobutyl) and aluminium seal with flip-off cap (polypropylene).
Pack size of 5 ampoules of 2 ml or 2, 5 or 10 vials of 5 ml.
Not all pack sizes may be marketed.
STD Pharmaceutical Products Ltd, Plough Lane, Hereford, HR4 0EL, United Kingdom
Fibrovein 3% PL 00398/0207
Fibrovein 1% PL 00398/0206
Fibrovein 0.5% PL 00398/0205
Fibrovein 0.2% PL 00398/0204
09/10/2012
| Drug | Countries | |
|---|---|---|
| FIBROVEIN | Estonia, France, Hong Kong, Malta, New Zealand, Poland, Romania, United Kingdom |
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