SELESYN Oral solution Ref.[49863] Active ingredients: Sodium selenite

Source: Health Products Regulatory Authority (IE)  Revision Year: 2016  Publisher: biosyn Arzneimittel GmbH, Schorndorfer Str. 32, Dโ€“70734 Fellbach, Germany

Product name and form

Selesyn 500 micrograms/10 ml, oral solution (50 micrograms/ml).

Pharmaceutical Form

Oral solution.

Clear and colourless solution.

Qualitative and quantitative composition

Each drinking bottle of 10 ml oral solution contains 500 micrograms selenium in the form of 1.665 mg sodium selenite pentahydrate (Na2SeO3 โˆ™ 5 H2O), corresponding to 50 ยตg/ml.

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
Hydrochloric acid
Water for injections

Pack sizes and marketing

Drinking bottles of plastic (LDPE) each containing 10 ml of oral solution with a PP screw cap, a measuring cup and a dosing pipette.

Pack sizes: 10, 20, 50.

Not all pack sizes may be marketed.

Marketing authorization holder

biosyn Arzneimittel GmbH, Schorndorfer Str. 32, D–70734 Fellbach, Germany

Marketing authorization dates and numbers

PA 1131/1/2

Date of first authorisation: 26 May 2006
Date of last renewal: 01 November 2008

Drugs

Drug Countries
SELESYN Hong Kong, Ireland, South Africa

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