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

At the time of use, the ampoule contents should be clear. Following incorrect storage, the contents may become turbid or present a phase-separation. In this case the ampoule must no longer be used.

Parenteral administration to premature babies weighing less than 2.5kg may increase the risk for the development of kernicterus (bilirubin encephalopathy).

Infants with cholestatic disease must receive Konakion MM Paediatric by intramuscular or intravenous injection since oral absorption is impaired in these patients.

Konakion MM Paediatric must be administered by intravenous injection when used as an antidote to anticoagulant drugs of the coumarin type, as intramuscular injections may result in significant bleeding in these patients.

No significant interactions are known other than antagonism of coumarin anticoagulants.

Not applicable.

Not applicable.

There have been reports of anaphylactoid reactions after intravenous injections of Konakion MM. Local irritation may occur at the injection site but is unlikely due to the small injection volume. Rarely, injection site reactions may occur which may be severe, including inflammation, atrophy and necrosis.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Incompatibilities have been observed with diluted Konakion MM solution and certain siliconised syringes, therefore, Konakion MM Paediatric must not be diluted before injection.

Do not dilute with sodium chloride containing solutions as precipitation may occur, see section 4.2 Posology and Method of Administration.