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

Prophylaxis of vitamin K deficiency bleeding (VKDB)

Healthy neonates of 36 weeks gestation and older:

Either:

• 1 mg administered by intramuscular injection at birth or soon after birth

or

• 2 mg orally at birth or soon after birth. The oral dose should be followed by a further dose of 2 mg at 4-7 days of age. A further 2 mg oral dose should be given at 1 month after birth. In exclusively formula fed infants the third oral dose can be omitted

Preterm neonates of less than 36 weeks gestation weighing 2.5 kg or greater, and term neonates at special risk (e.g. prematurity, birth asphyxia, obstructive jaundice, inability to swallow, maternal use of anticoagulants or antiepileptics): 1 mg IM or IV at birth or soon after birth. The amount and frequency of further doses should be based on coagulation status.

Preterm neonates of less than 36 weeks gestation weighing less than 2.5 kg: 0.4 mg/kg (equivalent to 0.04 ml/kg) IM or IV at birth or soon after birth. This parenteral dose should not be exceeded. The amount and frequency of further doses should be based on coagulation status.

There is evidence that oral prophylaxis is insufficient in patients with underlying cholestatic liver disease and malabsorption (see section 5.1).

Caution: care is required when calculating and measuring the dose in relation to the baby’s weight (10 times dosing errors are common).

Dosing information for preterm babies at birth for the prophylaxis of Vitamin K deficiency bleeding:

Further oral doses in breast-fed infants have been advised, but safety or efficacy data for these additional doses is limited (see section 5.1).

Therapy of early and/or late vitamin K deficiency bleeding (VKDB)

Initially 1mg IV and further doses as required, depending on clinical picture and coagulation status. Konakion therapy may need to be accompanied by a more immediate effective treatment, such as transfusion of blood or blood clotting factors to compensate for severe blood loss and delayed response to vitamin K1.

Antidote therapy to anticoagulant drugs of the coumarin type

There have been no dose ranging studies performed to recommend a specific dose of Konakion MM Paediatric used as an antidote to anticoagulant drugs of the coumarin type in infants and children. Suggested doses are detailed below. Konakion MM Paediatric must be administered by intravenous injection in these patients. It is advisable that a haematologist is consulted about appropriate investigation and treatment in any infant or child in whom Konakion MM Paediatric is being considered.

For patients on warfarin therapy, therapeutic intervention must consider the reason for the patient being on warfarin and whether or not anticoagulant therapy has to be continued (e.g. in a patient with mechanical heart valve or repeated thrombo-embolic complications) as vitamin K administration is likely to interfere with anticoagulation with warfarin for 2-3 weeks. For patients continuing to receive warfarin, the suggested dose for the partial reversal of anticoagulation is 30 micrograms/kg administered by IV injection. Konakion MM Paediatric is only suitable for the administration of doses of 30 micrograms/kg in children weighing over 13 kg.

The suggested dose of vitamin K for patients requiring a complete reversal of a warfarin overdose is 250-300 micrograms/kg administered by IV injection. It should be noted that the earliest effect seen with vitamin K treatment is at 4 to 6 hours and therefore, in patients with severe haemorrhage, replacement with coagulation factor concentrates may be indicated (discuss with haematologist). Konakion MM Paediatric is only suitable for the administration of doses of 250-300 micrograms/kg in children weighing over 1.6 kg. Prothrombin time should be measured 2 to 6 hours later and if the response has not been adequate, Konakion MM Paediatric administration may be repeated. Frequent monitoring of vitamin K dependent clotting factors is essential in these patients.

Method of administration

Konakion MM Paediatric can be administered by intramuscular or intravenous injection or by oral administration depending on the indication.

Parenteral use

For the administration of injection volumes of 0.04 ml (0.4 mg) to 0.1 ml (1 mg), 0.5 ml syringes with 0.01 ml graduations are recommended, see section 6.6 Instructions for use/handling.

Administration of Konakion MM Paediatric by i.v. infusion is not recommended because Konakion MM Paediatric must not be diluted or mixed with other parenteral medications. However, Konakion MM Paediatric may be administered by injecting the dose into the lower part of an infusion set containing 5% dextrose or 0.9% sodium chloride running at ≥0.7 ml/minute, see section 6.2 Incompatibilities.

Oral use

For oral administration, oral dispensers are provided in the pack. After breaking the ampoule open, 0.2 ml of solution should be withdrawn into the oral dispenser until it reaches the mark on the dispenser (0.2 ml = 2 mg vitamin K). Drop the contents of the dispenser directly into the baby’s mouth by pressing the plunger.

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

The following adverse events have been reported concerning overdose with use of Konakion in neonates and infants: jaundice, hyperbilirubinaemia, increase GOT and GGT, abdominal pain, constipation, soft stools, malaise, agitation and cutaneous eruption. The causality of those cannot be established. The majority of these adverse events were considered non-serious and resolved without any treatment.

Treatment of suspected overdose should be aimed at alleviating symptoms.

Shelf life: 3 years.

Konakion MM Paediatric Ampoule solution should be stored below 25°C and be protected from light. The solution should not be frozen. Do not use if the solution is turbid.

Amber glass ampoules containing 2 mg phytomenadione in 0.2 ml. Plastic oral dispensers. Packs of 5.

See section 4.2 Posology and method of administration, section 4.4 Special warnings and precautions for use and section 6.2 Incompatibilities for advice regarding the administration of Konakion MM Paediatric.

Undiluted Konakion MM Paediatric is compatible with 0.5ml Omnican 50 syringes supplied by B.Braun.