KONAKION MM Solution (ampoules) Ref.[7155] Active ingredients: Vitamin K1

When treating patients with severely impaired liver function, it should be borne in mind that one Konakion MM Ampoule 10 mg/1ml contains 54.6mg glycocholic acid and this may have a bilirubin displacing effect. Careful monitoring of the INR is necessary after administration of Konakion MM in patients with severely impaired liver function.

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.

In potentially fatal and severe haemorrhage due to overdosage of coumarin anticoagulants, intravenous injections of Konakion MM must be administered slowly and not more than 40 mg should be given during a period of 24 hours. Konakion MM therapy should be accompanied by a more immediate effective treatment such as transfusion of whole blood or blood clotting factors. When patients with prosthetic heart valves are given transfusions for the treatment of severe or potentially fatal haemorrhage, fresh frozen plasma should be used. The use of vitamin K₁ in patients with mechanical heart valves is generally to be avoided, unless there is major bleeding.

Large doses of Konakion MM (not more than 40 mg per day) should be avoided if it is intended to continue with anticoagulant therapy because there is no experience with doses above this maximum of 40 mg per day and higher doses may give rise to unexpected adverse events. Clinical studies have shown a sufficient decrease in the INR with the recommended dosage. If haemorrhage is severe, a transfusion of fresh whole blood may be necessary whilst awaiting the effect of the vitamin K₁.

Vitamin K₁ is not an antidote to heparin.

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

There is no specific evidence regarding the safety of Konakion MM in pregnancy but, as with most drugs, the administration during pregnancy should only occur if the benefits outweigh the risks.

Konakion is not recommended for pregnant women as prophylaxis of vitamin K deficiency bleeding in the newborn.

None.

There have been reports of anaphylactoid reactions after intravenous injections of Konakion MM. Very rarely, venous irritation or phlebitis has been reported in association with intravenous administration of Konakion mixed micelle solution.

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.

None.