• The preparation is a vitamin to prevent bleeding (anti-hemorrhagic).
• The medicine is used to prevent and treat vitamin K deficiency bleeding in newborns.

• Always use this medicine exactly as described or exactly as discussed with your doctor, pharmacist or nurse. If you are unsure, ask your doctor, pharmacist or nurse.
• The following information applies unless your doctor has prescribed the product differently.
• Prevention of vitamin K deficiency bleeding
  • Healthy newborns born on or near their due date
  • These newborns will receive either:
    • a single injection of 1 mg at birth or shortly after birth, or
    • a first dose of 2 mg by drip into the mouth (orally) at birth or shortly after birth. This dose is followed by a second dose of 2 mg after 4 - 7 days and a third dose of 2 mg after 1 month. The third dose may be omitted for infants who are exclusively formula-fed.
  • Newborns at particular risk of bleeding who were born prematurely or at the expected due date (e.g. newborns with respiratory distress syndrome at birth; newborns with inflammatory and/or cholestatic liver dysfunction caused by disruption of bile formation and flow; newborns who cannot swallow; newborns of mothers who are being treated with anticoagulants or anti-seizure medications (antiepileptics)
    • These newborns will receive Konakion MM 2 mg as an injection at or shortly after birth.
    • Additional injections may be given later if your child is still at risk of bleeding.
  • Further dosages:
    • Newborns who are receiving vitamin K by instillation in the mouth (orally) and who are breastfed (ie not receiving formula) may require more than three oral doses of vitamin K.
    • Formula-fed newborns who have received the scheduled two doses of vitamin K are unlikely to need additional doses of vitamin K because vitamin K is already contained in formula.
• Treatment of vitamin K deficiency bleeding
  • Initial dose: 1 mg phytomenadione (corresponding to 0.1 ml solution) for term babies or 0.4 mg/kg body weight (corresponding to 0.04 ml/kg body weight) intravenously for premature babies; If necessary, further doses depending on the clinical picture and the coagulation status. Treatment with the drug may need to be accompanied by additional measures, such as transfusion of whole blood or coagulation factors, in order to compensate for severe blood loss and the delayed response to vitamin _{K1 .}
• Please talk to your doctor or pharmacist if you have the impression that the effect of the medicine is too strong or too weak.

• If you have used more than you should
  • There are currently no known effects of an overdose.

• If you have any further questions about the use of this medicine, talk to your doctor, pharmacist or nurse.

• The medicine is either instilled into the mouth or administered intramuscularly or intravenously (that is, by injection into the muscle or vein).
• How you use it depends on what the medicine is being used for and whether your child was born prematurely.
• Oral administration
  • The clear solution is placed directly into the infant's mouth.
• Parenteral administration
  • The preparation must not be diluted or mixed with other drugs to be administered parenterally.
  • The intravenous administration of the drug must be carried out particularly slowly in order to ensure that the injection solution is diluted as much as possible with the bloodstream.

• Like all medicines, this medicine can cause side effects, although not everyone gets them.
• In extremely rare cases, hypersensitivity (anaphylactoid reaction) to vitamin K ₁ has been observed.
• In general, parenteral administration can cause reactions at the injection site, such as: B, pain, inflammation or hematomas.
• If you notice any side effects, contact your doctor, pharmacist or nurse. This also applies to side effects that are not specified.

• Using the preparation together with other medicines
  • Tell your doctor or pharmacist if you are taking/using any other medicines, have recently taken/used any other medicines or might take/use any other medicines.
  • Coumarin derivatives, like cephalosporins with an N-methyl-thiotetrazole group, inhibit the epoxide reductase in the vitamin K cycle and thus the cofactor function of vitamin K ₁ in the carboxylation reaction.
  • Acetylsalicylic acid and other salicylates also reduce the effect of vitamin K by inhibiting the carboxylase-reductase system.
  • Antispasmodics (anticonvulsants) such as phenobarbital and diphenylhydantoin, as well as certain anti-tuberculosis drugs (tuberculostatics) such as INH and rifampicin, may cause vitamin K deficiency bleeding on the first day of life in newborns whose mothers took these drugs during pregnancy. The exact mechanism is still unclear.
  • When anticoagulants are treated with coumarin derivatives, vitamin K ₁ prevents their therapeutic effect and therefore poses a risk of thrombosis.

• The medicine must not be used
  • if your child is allergic to phytomenadione (vitamin K1) or any of the other ingredients of this medicine.

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• Warnings and Precautions
  • Please talk to your doctor, pharmacist or nurse before using the medicine.
  • If possible, the solution should be administered intramuscularly for prevention in newborns at particular risk, as intravenous administration is associated with a temporary reduction in the level of protein binding of bilirubin in the blood. This bilirubin, which is no longer bound to protein, is fat-soluble and can damage nerve cells in the brain (kernicterus). In general, if intravenous administration is necessary due to the potential risk of developing kernicterus (a special disease of the brain), the dose of 0.4 mg phytomenadione per kg body weight (corresponding to 0.04 ml solution per kg body weight) should not be exceeded and monitoring should be carried out the plasma level of indirectly reacting bilirubin in icteric newborns.