KONAKION MM PAEDIATRIC Solution (ampoules) Ref.[7154] Active ingredients: Vitamin K1

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Product name and form

Konakion MM Paediatric.

Pharmaceutical Form

The ampoule solution is clear to slightly opalescent, pale yellow in colour and contains the active constituent in a mixed micelles vehicle of glycocholic acid and lecithin.

Qualitative and quantitative composition

Each ampoule contains 2mg phytomenadione in 0.2ml.

Active Ingredient Description
Vitamin K1

The presence of vitamin K (i.e. vitamin K or substances with vitamin K activity) is essential for the formation within the body of prothrombin, factor VII, factor IX and factor X. Lack of vitamin K leads to an increased tendency to haemorrhage. When an antidote to an anticoagulant is necessary it is essential to use vitamin K1 itself, as vitamin K analogues are much less effective.

List of Excipients

Glycocholic acid
Lecithin
Sodium hydroxide
Hydrochloric acid
Water

Pack sizes and marketing

Amber glass ampoules containing 2 mg phytomenadione in 0.2 ml. Plastic oral dispensers. Packs of 5.

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Marketing authorization dates and numbers

PL 27041/0010

20/06/1996 / 11/03/2008

Drugs

Drug Countries
KONAKION Austria, Australia, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Lithuania, Malta, Netherlands, New Zealand, Singapore, Turkey, South Africa

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