KONAKION MM Solution (ampoules) Ref.[7155] 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 Ampoules 10 mg/ml solution for injection.

Pharmaceutical Form
Amber glass ampoules containing 10mg phytomenadione in 1ml. 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 Konakion MM Ampoule contains 10.0mg vitamin K1 (phytomenadione) Ph.Eur in 1ml.

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 HSE Sodium hydroxide Ph. Eur Lecithin (phospholipon 100) HSE Hydrochloric acid Ph. Eur. Water for injection Ph. Eur.

Pack sizes and marketing

Konakion MM is supplied in amber glass ampoules containing 10mg phytomenadione in 1ml. 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.

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Marketing authorization dates and numbers

PL 27041/0011

08/04/2008

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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