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Konakion MM

paediatric

Phytomenadione

 

Composition

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.

 

Pharmacokinetics

In the mixed-micelle solution, vitamin K1 is solubilized by means of a physiological colloidal system consisting of lecithin and bile acid.

 

Absorption

Vitamin K1 is absorbed from the small intestine. Absorption is limited in the absence of bile.

 

Distribution

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.

 

Metabolism

Vitamin K1 is converted to more polar metabolites, such as phytomenadione-2, 3-epoxide.

 

Elimination

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

Documented indications Prophylaxis and treatment of hemorrhagic disease of the newborn.

 

Dosage and administration

Prophylaxis

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.

 

Therapy

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.

 

Administration

Oral use:

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.

 

Parenteral use:

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.

 

Contraindications

The use of Konakion MM paediatric is contraindicated in cases of known hypersensitivity to any of the ingredients.

 

Precautions

Parenteral administration may be associated with an increased risk of kernicterus in premature infants weighing less than 2.5 kg.

 

Undesirable effects

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.

 

Interactions

Vitamin K1 antagonizes the effect of coumarin-type anticoagulants.

 

Overdosage

No overdose effects are known.

 

Stability

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.

 

Packs

Ampoules, 2 mg in 0.2 ml              5

Dispenser for oral administration    1

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