くすりのしおり

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 24 million [acute phase of ischemic cerebrovascular disorder]
 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 improvement of dysfunction in the acute phase of ischemic cerebrovascular disorder (movement problem such as paralysis or numbness of limb due to reduced blood flow caused by a thrombus in the brain) within the first 4.5 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), suspected of having subarachnoid hemorrhage, at risk of cerebral hemorrhage (high blood pressure, high blood glucose, history of intracranial bleeding, bleeding diathesis [intracranial tumor, arteriovenous malformation, aneurysm], cerebral infarction within 3 months, intracranial or spinal surgery/injury within 3 months) or at risk of bleeding (gastrointestinal bleeding or urinary tract bleeding within 21 days, major surgery within 14 days, reduced blood coagulation).
    If you have liver disorder, acute pancreatitis, low blood glucose level, history of convulsive seizure after ischemic cerebrovascular disorder, chest pain or back pain.
  • 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 will undergo computed tomography (CT) or nuclear magnetic resonance imaging (MRI) of the head before receiving this medicine. You may also undergo chest X-ray.

Precautions while taking 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 discover any bleeding as early as possible.
  • Many individuals who use this medicine have heart disorders. Tests including electrocardiography are thus performed continuously during or after use of this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include hemorrhagic cerebral infarction, subcutaneous bleeding, cerebral hemorrhage, gastrointestinal bleeding, headache, injection site bleeding, oral hemorrhage and hematuria. 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 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 : Day Month Year

For further information, talk to your doctor or pharmacist.

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