Download Drug Information Sheet("Kusuri-no-Shiori") Injection Revised: 11

Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 11/2014
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:ACTIVACIN for Injection 12 million [acute myocardial
infarction]
Active ingredient:Alteplase (genetical recombination)
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine dissolves thrombus (blood clots) through specific adsorption to thrombus formed in blood vessels.
It is usually used for dissolution of coronary thrombosis (thrombus in surrounding vessel of the heart) in acute
myocardial infarction within the first 6 hours of onset.
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 are bleeding (intracranial bleeding, gastrointestinal bleeding, urinary tract bleeding, retroperitoneal bleeding,
hemoptysis), at risk of bleeding (history of intracranial bleeding, bleeding diathesis [intracranial tumor,
arteriovenous malformation, aneurysm], cerebral infarction within 3 months, intracranial or spinal surgery/injury
within 3 months, gastrointestinal bleeding or urinary tract bleeding within 21 days, major surgery within 14 days).
If you have hypertension, liver disorder, acute pancreatitis.
・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, this medicine is administered intravenously by rapid injection for 1 to 2 minutes, then the remainder is
administered over 1 hour.
・You may undergo coronary angiography to identify the thrombus before receiving this medicine.
Precautions while taking this medicine
・Electrocardiography is performed on a continuous basis during treatment with this medicine.
・Use of this medicine may lead to serious bleeding such as cerebral hemorrhage. Blood pressure measurements and
blood tests are thus performed on a frequent basis during and after use of this medicine to detect bleeding as early
as possible.
・Use of this medicine dissolves thrombus in blood vessels surrounding the heart, restores blood flow and may thereby
result in arrhythmia. If symptoms such as vision darkening or chest pain occur, consult with your doctor
immediately.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include hematuria, injection site bleeding, gingival bleeding,
gastrointestinal bleeding, hematoma, cerabral hemorrhage, bleeding tendency, subcutaneous bleeding, and
arrhythmia associated with restoration of blood flow following dissolution of thrombus. 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.
・paralysis of unilateral limb, black stool, bloody phlegm [serious bleeding (cerebral hemorrhage, gastrointestinal
bleeding, pulmonary hemorrhage, retroperitoneal bleeding)]
・headache, paralysis of unilateral limb, impaired consciousness [hemorrhagic cerebral infarction, cerebral infarction]
・cold sweats, difficult to breathe, hives [shock, anaphylaxis]
・general malaise, difficult to breathe, shortness of breath [heart rupture, cardiac tamponade]
・dizziness, palpitation, chest pain [serious arrhythmia (ventricular fibrillation, ventricular tachycardia)]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your
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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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