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The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
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Brand name :
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BeneFIX Intravenous 1000
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Active ingredient:
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Nonacog Alfa (Genetical Recombination)
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Dosage form:
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white freeze-dry powder injectable preparation
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Effects of this medicine
This medicine suppresses bleeding tendency by supplying blood coagulation factor IX.
Usually, used for suppression of bleeding tendency due to hemophilia B (congenital factor IX deficiency).
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Before using this medicine, be sure to tell your doctor and pharmacist
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If you have previously experienced any allergic reactions (itch, rash etc.) to any medicines.
If you have: hepatic disorders, risk for thromboembolic events, signs of fibrinolysis or disseminated intravascular coagulation (DIC) syndrome.
If you are in postoperative period or a newborn.
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If you are pregnant or breastfeeding.
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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.)
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Dosing schedule (How to take this medicine)
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Your dosing schedule prescribed by your doctor is << to be written by a healthcare professional>>
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In general, inject slowly intravenously 50 IU/kg as a first dose over several minutes. The dosage should be adjusted according to your condition. Strictly follow the instructions.
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Use this medicine within 3 hours after dissolution.
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A user (patient) can self-inject this medicine (self injection), only if he/she wants to and the doctor has confirmed that he/she meets certain criteria for the self-injection.
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If you miss a dose, consult with your doctor, pharmacist or nurse.
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If you accidentally inject more than your prescribed dose, consult with your doctor or pharmacist.
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Do not stop injecting this medicine unless your doctor instructs you to do so.
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Precautions while taking this medicine
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Possible adverse effects of this medicine
The most commonly reported adverse reactions include headache, injection site reactions (redness, etc.), dizziness, rash, hives, injection site pain and nausea. 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 effects indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
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hives, chill, angioedema [shock, anaphylactic symptoms]
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pain/swelling of feet, breathing difficulty, sever headache [thrombosis]
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.
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Storage conditions and other information
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Keep out of the reach of children. This medicine should be stored at room temperature (1-30℃) and avoid freezing.
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Discard the remainder. Do not store them. If you dispose of unused medicines, seek advice of your pharmacist or healthcare provider about proper disposal of drugs.
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