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Contraindications

Konakion is contraindicated in patients with known hypersensitivity to any of its constituents. Konakion MM ampoules should not be administered intramuscularly because the i.m. route exhibits depot characteristics and continued release of vitamin K₁ would lead to difficulties with the reinstitution of anticoagulation therapy. Furthermore, i.m. injections given to anticoagulated subjects cause a risk of hematoma formation.

Precautions

At the time of use, the mixed-micelle ampoule solution must be clear Following incorrect storage, the solution may become turbid or a phase separation may occur. In such cases, the ampoule must not be used.

When patients with severely impaired liver function are treated, the formation of prothrombin may be impaired. Therefore, careful monitoring of the coagulation parameters is necessary after administration of Konakion.

In potentially fatal and severe hemorrhage due to overdosage of coumarin anticoagulants, i.v. injections of Konakion MM should be accompanied by a more immediately effective treatment, such as transfusions of whole blood or blood-clotting factors. When patients with prosthetic heart valves are given transfusions for the treatment of severe or potentially fatal hemorrhages, fresh frozen plasma should be used.

Large doses of Konakion should be avoided if it is intended to continue with anticoagulant therapy.

Pregnancy, nursing mothers

No controlled studies of Konakion have been performed in animals or pregnant women. On the basis of many years' clinical experience, however, it is safe to assume that neither vitamin K₁ nor the excipients contained in the Konakion formulations have any reproductive toxicological effects when the drug is given at the recommended dosages. As with all medications, however, Konakion should be given to pregnant women only if the benefit to the mother outweighs the risk to the fetus.

As vitamin K₁ does not readily cross the placental barrier, it is not recommended that Konakion be given to expectant mothers as prophylaxis of hemorrhagic disease in the newborn.

Only a small fraction of administered vitamin K₁ enters the breast milk. At therapeutic doses, administration of Konakion to nursing mothers accordingly does not pose a risk to their infants.

However, Konakion is not recommended for nursing mothers as prophylaxis of hemorrhagic disease in the newborn.

Undesirable effects

There are isolated unconfirmed reports on the possible occurrence of anaphylactoid reactions after i.v. injection of Konakion MM.

Very rarely, venous irritation or phlebitis has been reported in association with intravenous administration of Konakion mixed-micelle solution.

Interactions

Vitamin K₁ antagonizes the effect of coumarin-type anticoagulants. Coadministration of anticonvulsants can impair the action of vitamin K₁.

Overdosage

There is no known clinical syndrome attributable to hypervitaminosis of vitamin K₁.

Special remarks

Stability

This medicine should not be used after the expiry date (EXP) shown on the pack.

Konakion MM ampoule solution should be protected from light and should not be frozen. See also outer carton for storage remark.

Packs

Chewable dragees 10 mg      10

Ampoules MM 10 mg/ml        5

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