Source: Health Products Regulatory Authority (IE) Revision Year: 2016 Publisher: biosyn Arzneimittel GmbH, Schorndorfer Str. 32, 70734 Fellbach, Germany
Selesyn 100 micrograms/2 ml, solution for injection (50 micrograms/ml).
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear and colourless solution. |
Each 2 ml injection ampoule contains 100 micrograms selenium in the form of 333 micrograms sodium selenite pentahydrate (Na2SeO3 ∙ 5 H2O), corresponding to 50 µg/ml.
Excipients: sodium compounds corresponding to 0.16 mmol (3.57 mg) sodium.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Sodium selenite |
Selenium is an essential trace element. In human, selenium compounds are glutathione peroxidase and a selenium protein P found in the plasma. Deficiency of selenium has been associated with an endemic form of cardiomyopathy, Keshan disease and with Kaschin-Beck disease, an endemic osteoarthropathy which causes a severe deformity of the joints. |
| List of Excipients |
|---|
|
Sodium chloride |
Injection ampoules each containing 2 ml of solution for injection are made of glass (Ph. Eur. Type I).
Pack sizes: 5, 10, 50.
Not all pack sizes may be marketed.
biosyn Arzneimittel GmbH, Schorndorfer Str. 32, 70734 Fellbach, Germany
PA 1131/1/3
Date of first authorisation: 26 May 2006
Date of last renewal: 01 November 2008
| Drug | Countries | |
|---|---|---|
| SELESYN | Hong Kong, Ireland, South Africa |
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