PHYTOMENADIONE

Posology 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. 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. 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.

1). CAUTION: care is required when calculating and measuring the dose in relation to the baby’s weight (10 times dosing errors are common). 1). Therapy of early and/or late vitamin K deficiency bleeding (VKDB) Initially 1 mg IV and further doses as required, depending on clinical picture and coagulation status.

2 ml 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 this medicine as an antidote to anticoagulant drugs of the coumarin type in infants and children.

Suggested doses are detailed below. 2 ml must be administered by intravenous injection in these patients. 2 ml is being considered. 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. 2 ml 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).

6 kg. 2ml administration may be repeated. Frequent monitoring of vitamin K dependent clotting factors is essential in these patients. Method of administration This medicine can be administered by intramuscular or intravenous injection or by oral administration depending on the indication.

6 Special precautions for disposal and other handling. 2 ml by IV infusion is not recommended because it must not be diluted or mixed with other parenteral medications. 2 Incompatibilities.

Oral use:

For oral administration, oral dispensers are provided in the pack. 2 ml = 2 mg vitamin K). Drop the contents of the dispenser directly into the baby’s mouth by pressing the plunger.

There have been reports of anaphylactoid reactions after intravenous injections of this medicine. Local irritation may occur at the injection site but is unlikely due to the small injection volume. Rarely, injection site reactions may occur which may be severe, including inflammation, atrophy and necrosis.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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. 5 kg may increase the risk for the development of kernicterus (bilirubin encephalopathy).

2 ml by intramuscular or intravenous injection since oral absorption is impaired in these patients. 2 ml must be administered by intravenous injection when used as an antidote to anticoagulant drugs of the coumarin type, as intramuscular injections may result in significant bleeding in these patients.

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