• The medicine is a vitamin used to prevent bleeding (anti-hemorrhagic).
• The only proven area of ​​application is the treatment of vitamin K deficiency bleeding and the prevention of vitamin K deficiency states that cannot be remedied through nutrition.
• This includes:
  • Prophylaxis of vitamin K deficiency for the newborn by giving vitamin K to the pregnant woman before delivery if she has taken anticonvulsants, tuberculostatics or coumarin derivatives.
  • Prophylaxis of vitamin K deficiency in patients with risk factors for developing vitamin K deficiency as soon as the INR rises above the normal limit.
  • Vitamin K therapy in patients with vitamin K deficiency bleeding, which is usually associated with an INR >/= 5. Vitamin K deficiency bleeding can be caused by a true vitamin K deficiency or by too high a dosage of coumarin derivatives.

• 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 otherwise.
• Prevention of vitamin K deficiency
  • For pregnant women taking anticonvulsants or antituberculostatic drugs:
    • 10 to 20 mg vitamin K ₁ (1 to 2 ml) orally 48 hours to a few hours before delivery.
• Vitamin K treatment
  • In the case of severe or life-threatening vitamin K deficiency bleeding (e.g. during anticoagulant therapy), vitamin K ₁ must be administered slowly (at least 30 seconds) intravenously in a dosage of 5 to 10 mg (1 ampoule contains 10 mg of vitamin K ₁ ) together with fresh frozen plasma or a prothrombin complex preparation (30 U/kg). The vitamin K ₁ dose can be repeated as needed.
• Dosage recommendations for vitamin K ₁ therapy in patients with asymptomatic high INR with or without minor bleeding
  • Anticoagulant: Phenprocoumon
    • INR: 5 - 9
      • Vitamin K1 _, oral: 2.0 to 5.0 mg
      • Vitamin K1 _, intravenously: 2.0 to 5.0 mg
    • INR: >9
      • Vitamin K1 _, oral: 2.0 to 5.0 mg
      • Vitamin K1 _, intravenously: 2.0 to 5.0 mg
      INR: > 10
      • Vitamin K1 _, oral: not recommended
      • Vitamin K ₁ , intravenous: Individual dosage adjustment
  • Anticoagulant: Warfarin
    • INR: 5 - 9
      • Vitamin K ₁ , oral: 1.0 to 2.5 mg for initial reversal; 2.0 to 5.0 mg for rapid reversal; (additional 1.0 to 2.0 mg if INR is still elevated after 24 hours)
      • Vitamin K1 _, intravenously: 0.5 to 1.0 mg
      INR: >9
      • Vitamin K1 _, oral: 2.5 to 5.0 mg (up to 10.0 mg)
      • Vitamin K1 _, intravenously: 1.0 mg
  • Anticoagulant: Acenocoumarol
    • INR: 5 - 8
      • Vitamin K1 _, oral: 1.0 to 2.0 mg
      • Vitamin K1 _, intravenously: 1.0 to 2.0 mg
      INR: > 8
      • Vitamin K1 _, oral: 3.0 to 5.0 mg
      • Vitamin K1 _, intravenously: 1.0 to 2.0 mg
  • For low doses, one or more 2 mg ampoules (2 mg/0.2 ml, same solution) may be used.
• Dosage recommendations for vitamin K ₁ therapy in patients with severe and life-threatening bleeding
  • Anticoagulant: Phenprocoumon
    • Condition: severe bleeding, INR < 5.0
      • Vitamin K1 _, intravenously: 5.0 mg
      • Adjunctive therapy: PCC
    • Condition: severe bleeding, INR > 5.0
      • Vitamin K1 _, intravenously: 10.0 mg
      • Adjunctive therapy: PCC
  • Anticoagulant: Warfarin
    • Condition: severe bleeding
      • Vitamin K1 _, intravenously: 5.0 to 10.0 mg
      • Adjunctive therapy: FFP or PCC
    • Condition: life-threatening bleeding
      • Vitamin K1 _, intravenously: 10.0 mg
      • Concomitant therapy: FFP, PCC or recombinant factor VIIa
  • Anticoagulant: Acenocoumarol
    • Condition: severe bleeding
      • Vitamin K1 _, intravenously: 5.0 mg
      • Concomitant therapy: FFP, PCC or prothrombin concentrates and factor VII
  • FFP: fresh frozen plasma
  • PCC: Prothrombin complex concentrate
• In patients with absorption disorders:
  • Parenteral use is recommended for patients with absorption disorders (e.g. insufficient absorption of food components from the digestive tract [malabsorption], short bowel syndrome, pancreatic disease), with the dosage corresponding to oral use. If the INR value does not drop sufficiently to approx. 2 within 3 to 6 hours or the bleeding does not stop, a second, possibly larger dose of vitamin K ₁ should be given.
• Elderly patients
  • Older patients tend to be more sensitive to anticoagulant reversal with the drug. For these patients, the dosage should be in the lower range of the recommendation.
  • Small doses of 0.5 to 1.0 mg of vitamin K ₁ , administered intravenously or orally, show an effective decrease in INR to < 5.0 within 24 hours.
• Children over 1 year old
  • The optimal dosage should be determined by the attending physician based on the indications and the child's weight. A single dose of 1/10 of the adult intravenous Viramin-K ₁ dose resulted in effective reversal of the asymptomatic high (>8) INR in clinically healthy children.
• Please talk to your doctor or pharmacist if you have the impression that the effect is too strong or too weak.

• If you have used more than you should
  • Even after massive overdose, no toxic symptoms have been reported so far. Resumption of anticoagulation may be impaired.

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

• The medicine can be administered orally or intravenously.
• For oral administration, the required amount (1 mg vitamin K ₁ corresponds to 0.1 ml solution) must be taken from the ampoule using a syringe with an attached cannula, remove the cannula from the syringe and pour the contents of the syringe directly into the patient's mouth apply. You should then drink more liquid.
• Because of the glycocholic acid content, the drug must not be used parenterally in cases of jaundice with bile stasis (cholestatic jaundice). To treat the risk of bleeding due to vitamin K deficiency in severe liver dysfunction, the preparation should be administered orally.
• The medicine must not be injected intramuscularly in patients with an increased tendency to bleeding.

• Like all medicines, this medicine can cause side effects, although not everyone gets them.
• The frequency information on side effects is based on the following categories:
  • Very common: more than 1 patient in 10
  • Common: 1 to 10 treated in 100
  • Uncommon: 1 to 10 people treated in 1,000
  • Rare: 1 to 10 people treated in 10,000
  • Very rare: less than 1 person treated in 10,000 people treated
  • Not known: Frequency cannot be estimated from the available data
• Diseases of the immune system
  • Very rare: Anaphylactic reactions after intravenous administration.
• General disorders and administration site conditions
  • Very rare: Venous irritation or inflammation of the veins (phlebitis) associated with intravenous administration of the drug.
• If you notice any side effects, contact your doctor, pharmacist or nurse. This also applies to side effects that are not specified.

• Use 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.
  • Cephalosporins with the N-methyl-thiotetrazole group inhibit vitamin K epoxide reductase and thus the vitamin K effect.
  • Anticonvulsants such as phenobarbital and diphenylhydantoin, as well as the tuberculostatic drugs INH and rifampicin, can 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 (coumarin-type anticoagulants) are used, vitamin K prevents their therapeutic effect and thus creates a risk of thrombosis.

• The medicine must not be used
  • if you are allergic to phytomenadione (vitamin K1) or any of the other ingredients of this medicine
  • in newborns; A different potency is available to prevent neonator haemorrhagic disease.

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

• Warnings and Precautions
  • Please talk to your doctor, pharmacist or nurse before using the medicine. Because of the glycocholic acid content, the preparation must not be used parenterally in cases of jaundice with bile stasis (cholestatic jaundice). To treat the risk of bleeding due to vitamin K deficiency in severe liver dysfunction, the drug should be administered orally. Careful monitoring of the INR value is necessary in these patients.
  • The drug must not be injected intramuscularly in patients with an elevated INR value due to the risk of extensive hematomas.
  • If you are undergoing anticoagulant treatment with coumarin derivatives and the aim is to reverse this effect, it must be borne in mind that the renewed ability of the blood to clot can cause the risk of thrombosis, i.e. the risk of vascular occlusion, to arise again and possibly even to increase. Therefore, self-treatment is very dangerous and should be avoided. If you monitor your coagulation through self-management, you should always consult your doctor if you have an elevated INR value of >/= 5.
  • Newborns and children under 1 year old
    • The medicine must not be given to newborns and children under 1 year of age. The preparation should be used for these patient groups.

• Ability to drive and use machines
  • There are no known effects on the ability to drive or use machines.

Phytomenadione, KONAKION MM 10 mg solution