Konakion Mm 10 mg/1 mℓ Ampoule

Haemorrhage or threatened haemorrhage associated with Vitamin K deficiency of coagulation factors II, VII, IX and X due, for instance, to overdosage of anticoagulants of the coumarin-type, or their combination with phenylbutazone, or to other forms of hypovitaminoses K (e.g. obstructive jaundice, liver and intestinal disorders, or prolonged administration of antibiotics, sulfonamides or salicylates). For prophylaxis and treatment of haemorrhagic disease in the newborn, KONAKION MM paediatric ampoules (2 mg/0,2 mu2113) should be used.

KONAKION MM ampoules are for intravenous injection or oral use. KONAKION MM ampoule solution should not be diluted or mixed with other injectables, but may be injected, where appropriate into the lower part of an infusion set, during continuous infusion of sodium chloride 0,9 % or dextrose 5 %.

Standard dosage

Severe or life-threatening haemorrhage e.g. during anticoagulant therapy: The coumarin anticoagulant should be withdrawn and an intravenous (i.v.) injection of KONAKION MM given slowly (in at least 30 seconds) in a dose of 5 u2013 10 mg together with fresh frozen plasma (FFP) or prothrombin complex concentrate (PCC). The dose of Vitamin K 1 can be repeated as needed.

Dose recommendations for vitamin K 1 therapy in patients with asymptomatic high International Normalised Ratio (INR) with or without mild haemorrhage

• Warfarin
• 5 u2013 9: 1,0 to 2,5 mg for initial reversal; 2,0 to 5,0 mg for rapid reversal (add 1,0 to 2,0 mg if INR remains high after 24 hours); 0,5 to 1,0 mg
• > 9: 2,5 to 5,0 mg (up to 10,0 mg); 1,0 mg
• Acenocoumarol
• 5 u2013 8: 1,0 to 2,0 mg; 1,0 to 2,0 mg
• > 8: 3,0 to 5,0 mg; 1,0 to 2,0 mg
• Phenprocoumon
• 5 u2013 9: 2,0 to 5,0 mg; 2,0 to 5,0 mg
• > 9: 2,0 to 5,0 mg; 2,0 to 5,0 mg
• > 10: Not recommended

Individually adapted doses

For small doses one or more ampoules of KONAKION MM Paediatric (2 mg/0,2 mu2113; same solution) can be used.

Special dosage instructions

Use in the elderly: Elderly patients tend to be more sensitive to reversal of anticoagulation with KONAKION; dosage in this group should be at the lower end of the ranges recommended. Small doses of 0,5 to 1,0 mg i.v. or oral Vitamin K 1 have shown to effectively reduce the INR to < 5,0 within 24 hours. See PHARMACOKINETICS.

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 K 1 has been reported to be effective in reversing asymptomatic high (> 8) INR in clinically well children.

Haemorrhage or threatened haemorrhage in the newborn and infants under one year of age: Refer to the KONAKION MM Paediatric package insert for details.

Use in patients with a known hypersensitivity to any of the constituents.

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. Careful monitoring of the INR is necessary after administration of KONAKION MM in patients with severely impaired liver function. In potentially fatal and severe haemorrhage due to overdosage of coumarin anticoagulants, intravenous injections of KONAKION MM (maximum of 40 mg in 24 hours) should be accompanied by a more immediately 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. Large doses of KONAKION should be avoided if it is intended to continue with anticoagulant therapy. Vitamin K 1 is not an antidote to heparin.

Vitamin K 1 antagonises the effects of coumarin-type anticoagulants. Co-administration of anticonvulsants can impair the action of Vitamin K 1.

Safety in pregnancy and lactation has not been established.

Not specified in the document.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: Very common u2265 1/10; Common u2265 1/100, < 1/10; Uncommon u2265 1/1 000, < 1/100; Rare u2265 1/10 000, < 1/1 000; Very rare < 1/10 000, including isolated reports.

• 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.

If surgical intervention should be necessary in a patient receiving anticoagulants of the coumarin or indandione series, their anticoagulant action, if not required for the purpose of the operation, may be counteracted by means of KONAKION. If there is a recurrence of thrombosis while KONAKION is being used, i.v. administration of heparin is recommended as a first measure. Note: When a patient on KONAKION is referred to another doctor, it is particularly important to notify the latter that KONAKION has been prescribed.

See u201cWARNINGS AND SPECIAL PRECAUTIONSu201d. Treatment is symptomatic and supportive. Re-introduction of anti-coagulation may be affected.