Active ingredient: phytomenadione ( synthetic vitamin K1 ). One amber glass ampoule contains 0.2 ml of a clear mixed-micelle solution of 2 mg vitamin K1 ( filling volume 0.3 ml ) for oral or parenteral administration.
Excipients: glycocholic acid, sodium hydroxide, lecithin, hydrochloric acid, water for injection.
Properties and effects
The presence of vitamin K1, the active ingredient of Konakion MM paediatric, is essential for the formation of prothrombin, factors VII, IX and X, and the coagulation inhibitors protein C and protein S in the body. Vitamin K1 does not readily cross the placental barrier from mother to child and is poorly excreted in breast milk.
Lack of vitamin K1 leads to an increased tendency to hemorrhagic disease in the newborn. Vitamin K1 administration, which promotes synthesis of the abovementioned coagulation factors by the liver, can reverse an abnormal coagulation status and bleeding due to vitamin K1 deficiency.
In the mixed-micelle solution, vitamin K1 is solubilized by means of a physiological colloidal system consisting of lecithin and bile acid.
Vitamin K1 is absorbed from the small intestine. Absorption is limited in the absence of bile.
Vitamin K1 accumulates predominantly in the liver. It is up to 90% bound to lipoproteins in the plasma and is stored in the body only for short periods of time.
Vitamin K1 is converted to more polar metabolites, such as phytomenadione-2, 3-epoxide.
The half-life of vitamin K1 in plasma is about 1.5 to 3 hours. Vitamin K1 is excreted in the bile and urine as glucuronide and sulphate conjugates.
Indications and usage
Prophylaxis and treatment of hemorrhagic disease of the newborn.
Dosage and administration
For all healthy neonates:
2 mg orally at birth or shortly after birth, followed by a further 2 mg dose 4-7 days later.
A single 1 mg (0.1 ml) dose i.m. is recommended in children who are not assured of receiving a second oral dose
or, in the case of breast-fed children, who are not assured of receiving a third oral dose.
Exclusively breast-fed babies:
In addition to the recommendations for all neonates, 2 mg orally should be given after 4-6 weeks.
Neonates with special risk factors ( e.g. prematurity, birth asphyxia, obstructive jaundice, inability to swallow, maternal use of anticoagulants or antiepileptics ):
• 1 mg i.m. or i.v. at birth or shortly after birth if the
oral route is unsuitable.
• I.m. and i.v doses should not exceed 0.4 mg/kg ( equivalent to 0.04 ml/kg ) in premature infants weighing
less than 2.5 kg (see Precautions).
• The size and frequency of further doses should be
based on coagulation status.
Initially, 1 mg by i.v. injection with further doses as required, based on the clinical picture and coagulation status. In certain circumstances, treatment with Konakion MM paediatric may need to be accompanied by more direct forms of effective hemorrhage control, such as transfusion of whole blood or coagulation factors, to compensate for severe blood loss and the delayed response to vitamin K1.
• With the dispenser included in the package:
- after breaking the ampoule, place the dispenser vertically into the ampoule;
- withdraw the solution from the ampoule into the
dispenser until the solution reaches the marking of
the dispenser ( =2 mg vitamin K1 );
- administer the contents of the dispenser directly
into the newborn's mouth.
• If no dispenser is available an alternative method of oral administration is the use of a syringe as follows:
- the required volume should be withdrawn from the
ampoule with a syringe and needle;
- after removal of the needle the content of the syringe
should be administered directly from the syringe
into the newborn's mouth.
Konakion MM paediatric should not be diluted or mixed
with other parenteral medications. It may however be
injected into the lower part of an infusion set.
The use of Konakion MM paediatric is contraindicated in cases of known hypersensitivity to any of the ingredients.
Parenteral administration may be associated with an increased risk of kernicterus in premature infants weighing less than 2.5 kg.
In rare cases, anaphylactoid reactions have been reported after parenteral use of Konakion MM paediactric. Local irritation may occur at the injection site, but is unlikely in view of the small injection volume.
Vitamin K1 antagonizes the effect of coumarin-type anticoagulants.
No overdose effects are known.
This medicine should not be used after the expiry date (EXP) shown on the pack.
See also outer pack for storage remark.
The ampoule solution must be clear when used. Improper storage can cause turbidity or phase separation. In such cases, ampoules must not be used.
Ampoules, 2 mg in 0.2 ml 5
Dispenser for oral administration 1