くすりのしおり

Self-injection
Published: 8/2020

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
VONVENDI Intravenous 1300
 Active ingredient:
Vonicog alfa(genetical recombination)
 Dosage form:
white mass or powder injectable preparation
 Print on wrapping:

Effects of this medicine

This medicine improves bleeding tendency by supplementing blood-clotting protein (von Willebrand factor).
It is usually used to suppress bleeding tendency in patients with von Willebrand's disease.

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
    If you have previously been told that thromboembolism is prone to occur.
  • If you are pregnant or breastfeeding.
  • If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Dosing schedule (How to take this medicine)

  • Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
  • Dissolve this medicine with the full amount of the supplied solvent, and inject intravenously slowly at a rate of not exceeding 4 mL/minute. In general, for patients aged 18 or over, administer 40 to 80 IU per kilogram of the body weight. The dosage may be decreased according to the condition.
    For bleeding
    Mild bleeding (nasal bleeding, oral cavity bleeding, hypermenorrhea, etc.): In general, administer 40 to 50 IU per kilogram of the body weight for the first time, and administer 40 to 50 IU per kilogram of the body weight in 8 to 24 hours intervals for the second time and thereafter.
    Massive bleeding (severe or refractory nasal bleeding, hypermenorrhea, gastrointestinal bleeding, trauma in the central nervous system, joint bleeding, traumatic bleeding, etc.): In general, administer 50 to 80 IU per kilogram of the body weight for the first time, and administer 40 to 60 IU per kilogram of the body weight in 8 to 24 hours intervals for about 2 or 3 days.
    During surgery (including pre- or post-operative period)
    Administer as directed by your doctor.
    This preparation contains 1,300 IU of the active ingredient in a vial. Strictly follow the instructions.
  • Do not use except the supplied solvent.
  • Do not mix with any other medicines.
  • If this medicine is stored in the refrigerator, warm it and the solvent to room temperature before dissolution.
  • When you draw the dissolved medicine into syringe, be sure to use the supplied dissolver (VONVENDI dissolver).
  • It may contain particles after dissolved and before filtrated by VONVENDI dissolver, but they are removed by passing through the filter inserted in VONVENDI dissolver.
  • When you need more than one vials per injection of this medicine, dissolve each vial separately, discard the VONVENDI dissolver previously used and use new one.
  • Once this medicine has been dissolved, use it within 3 hours. Discard this medicine if it has not been used within 3 hours after dissolved.
  • Do not use this medicine if turbidity or precipitation occurs in it before use.
  • You may self-inject this medicine if you or your family receive appropriate instructions at a medical facility for self-injection at home.
  • If you miss a dose, consult with your doctor, pharmacist or nurse. You should never inject two doses at one time.
  • If you accidentally inject more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop injecting this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • Use of this medicine may induce production of antibody (inhibitor) to von Willebrand factor or blood coagulation factor VIII. The inhibitor weakens the effect of this medicine. If you feel the effect of this medicine is not sufficient, consult with your doctor immediately.
  • If expected hemostatic effect cannot be obtained with this medicine, blood tests may be required.
  • If you notice any abnormality or feel the effect of this medicine is not sufficient after self-injection, contact your doctor immediately.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include dizziness, vertigo, vomiting and nausea. If any of these symptoms occur, consult with your doctor or pharmacist. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
  • hives, chest discomfort, respiratory distress, nausea [shock, anaphylaxis]
  • nausea, weakness, paralysis, shortness of breath, abdominal bloating, local pain [thromboembolism]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storage conditions and other information

  • Keep out of reach of children. Store it in the original box away from direct sunlight at room temperature.
    If this medicine is stored in the refrigerator, avoid freezing.
  • Discard the remainder. Do not store them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.