Konakion Mm Paediatric 2 mg Ampoule

Prophylaxis and treatment of haemorrhagic disease of the newborn.

Known hypersensitivity to any of the constituents.

Parenteral administration may be associated with an increased risk of kernicterus in premature infants weighing less than 2,5 kg. At the time of use, the ampoule solution should be clear. Following incorrect storage, the solution may become turbid or present a phase-separation. In this case the ampoule must not be used.

Vitamin K 1 antagonises the effect of warfarin.

Safety and efficacy in pregnancy and lactation have not been demonstrated.

Prophylaxis
For all healthy neonates: 2 mg orally at birth, or soon after birth, followed by 2 mg between 4 - 7 days later. Exclusively breast-fed babies: In addition to the recommendations for all neonates, 2 mg orally should be given after four to six weeks. A single 1 mg (0,1 mu2113) dose IM is recommended in babies who are not assured of receiving a second oral dose or, in the case of breast-fed babies, who are not assured of receiving a third oral dose.
Neonates at special risk (e.g. premature, hepatobilliary disease, inability to swallow, birth asphyxia, maternal use of anticoagulants or antiepileptics): 1 mg IM or IV at birth or soon after birth if the oral route is not suitable. Intramuscular and intravenous doses should not exceed 0,4 mg/kg (equivalent to 0,04 mu2113/kg) in premature infants weighing less than 2,5 kg, see WARNINGS. Size and frequency of further doses depend on coagulation status. Therapy: Initially, 1 mg IV and further doses as required, depending on clinical picture and coagulation status. KONAKION MM PAEDIATRIC therapy may need to be accompanied by a more immediately effective treatment such as transfusion of whole blood or blood clotting factors to compensate for severe blood loss and the delayed response to vitamin K 1.

Skin disorders: Tissue necrosis and acute ischaemia at the injection site. General disorders: Anaphylactoid reactions. Local irritation at the injection site.

The following adverse events have been reported concerning overdose with use of KONAKION in neonates and infants: jaundice, hyperbilirubinaemia, increased Aspartate transaminase (AST) and Gamma-glutamyltransferase (GGT), abdominal pain, constipation, soft stools, malaise, agitation and cutaneous eruption. The causality of those events cannot be established. Treatment of suspected overdose is palliative and supportive.