Konakion MM 10 mg/ml

/ Tzamal

Konakion MM ampoules are for i.v. injection or oral use. The ampoule solution should not be diluted or mixed with other injectables, but may be injected, where appropriate, into the lower part of the infusion set, during continuous infusion of sodium chloride 0.9% or dextrose 5%.
Because of the lower doses required, Konakion MM paediatric should be used in neonates and infants under one year of age.
Standard dosage
Severe or life-threatening haemorrhage, e.g. during anticoagulant therapy: The coumarin anticoagulant should be withdrawn and an i.v. injection of Konakion MM given slowly (in at least 30 seconds) in a dose of 5-10 mg together with fresh frozen plasma (FFP) or prothrombin complex concentrate (PCC). The dose of Vitamin K1 can be repeated as needed.
Dose recommendations for vitamin K1 therapy in patients with asymptomatic high International Normalized Ratio (INR) with or without mild haemorrhage: Please refer to Table 1 at the attached doctor’s leaflet.
Dose recommendations for vitamin K1 therapy in patients with major and life-threatening bleeding: Please refer to Table 2 at the attached doctor’s leaflet.
Special dosage instructions
Use in the elderly: Elderly patients tend to be more sensitive to reversal of anticoagulation with Konakion. The dosage for this patient group should therefore be at the lower end of the ranges recommended. Small doses of 0.5 to 1.0 mg i.v. or oral Vitamin K1 have shown to effectively reduce the INR to <5.0 within 24 hours.
Children over one year of age: The optimal dose should be decided by the treating physician according to the indication and weight of the patient. A single dose of one tenth of the full i.v. adult dose of vitamin K1 has been reported to be effective in reversing asymptomatic high (> 8) INR in clinically well children.
Infants under one year of age: For this patient group, Konakion MM paediatric should be used.
Oral use: Either with a Konakion MM dispenser or a syringe.
Syringe: Konakion MM solution can be given orally with a syringe as follows: withdraw required amount from ampoule using a syringe with attached needle. Remove needle from syringe and administer contents of syringe directly into patient’s mouth. Wash down with fluid.

Hemorrhage or risk of hemorrhage as a result of severe ‘hypoprothrombinemia’ (i.e. deficiency of clotting factors II, VII, IX and X) of various etiologies, including overdosage of coumarin-type anticoagulants, their combination with phenylbutazone and other forms of hypovitaminosis K (e.g. in obstructive jaundice as well as liver and intestinal disorders, and after prolonged treatment with antibiotics, sulfonamides or salicylates).
For prophylaxis and treatment of hemorrhagic disease in the newborn, Konakion MM paediatric ampoules (2 mg/ 0.2 ml) should be used.

Hypersensitivity to phytomenadione or any of the excipients.
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 re-institution of anticoagulation therapy. Furthermore, i.m. injections given to anticoagulated subjects cause a risk of haematoma formation.

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.
Careful monitoring of the INR is necessary after administration of Konakion MM in patients with severely impaired liver function.

Immune system disorders: Very rare: Anaphylactoid reactions after intravenous administration of Konakion MM.
General disorders and administration site conditions: Very rare: Venous irritation or phlebitis in association with intravenous administration of Konakion MM.
See prescribing information for full details.

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

Pregnancy: 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.
Lactation: 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.

There is no known clinical syndrome attributable to hypervitaminosis of vitamin K1. Reintroduction of anticoagulation may be affected.