SELENIUM Concentrate for solution for infusion Ref.[8601] Active ingredients: Sodium selenite

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Laboratoire Aguettant, 1, rue Alexander Fleming, 69007, Lyon, France

Product name and form

SELENIUM 10 micrograms/ml concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion.

Clear colourless solution.

pH 8.0–9.5

Osmolality = 20 mOsm/kg

Qualitative and quantitative composition

Each vial of 10 ml contains 100 micrograms of selenium as sodium selenite (219 micrograms).

Each ml of solution contains 10 micrograms of selenium as sodium selenite (21.9 micrograms).

Each vial of 10 ml contains 58 micrograms equivalent to 2.5 ยตmol of sodium.

Each ml of solution contains 5.8 micrograms equivalent to 0.25 ยตmol of sodium.

For the 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

Water for injection

Pack sizes and marketing

10 ml solution in a type I glass vial with a type I elastomer (bromobutyl) stopper fitted with an aluminium cover and crimped.

Pack of 10 vials.

Marketing authorization holder

Laboratoire Aguettant, 1, rue Alexander Fleming, 69007, Lyon, France

Marketing authorization dates and numbers

PL 14434/0030

25/06/2018

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