Drug Information Sheet("Kusuri-no-Shiori") Injection Revised: 02

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Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 02/2013
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:Novastan HI Inj. 10mg/2mL [prophylaxis or treatment of
thrombosis in patients with heparin-induced
thrombocytopenia type II]
Active ingredient:Argatroban hydrate
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine makes one's blood hard to clot and prevents blood clots in the vessels by inhibiting the action of
thrombin (an enzyme involved in blood clotting).
Usually, it is used for prophylaxis in patients with heparin-induced thrombocytopenia (HIT) type II (disease that
causes thronmocytopenia after the administration of heparin, then blood clotting in the vessels).
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.
Patients with haemorrhage (thrombocytopenic purpura, bleeding tendency due to angiopathy, haemophilia or other
coagulopathy, women during menstruation, gastrointestinal haemorrhage, haemorrhage of urinary tract,
haemoptysis, pregnant or parturient women with genital haemorrhage due to recent abortion, premature labour or
delivery).
Patients at risk of haemorrhage (patients with gastric/duodenal ulcer, colitis, bacterial endocarditis, a history of
cerebral haemorrhage, hypertension, diabetes).
Patients with liver disease.
・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>>
・In general, for adults, this medicine is given by intravenous infusion.
・Your doctor decides the duration of treatment according to your symptoms.
Precautions while taking this medicine
・When this medicine is used, blood tests should be conducted.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include prolonged coagulation time, haemorrhage, haematuria,
anaemia, liver disease, skin eruption, itch, urticaria, vomiting, diarrhoea and headache. 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.
・headache, paralysis of the limbs on either or both sides, abdominal pain, blood vomiting, blood in stool (black stools)
[cerebral haemorrhage, gastrointestinal haemorrhage]
・urticaria, pale face, respiratory distress [shock, anaphylactic shock]
・general fatigue, loss of appetite, yellowing of the skin or the whites of the eyes [fulminant hepatitis, hepatic function
disorder, jaundice]
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
For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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