くすりのしおり

Injection
Revised: 6/2012

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 :
Cleactor for Intravenous Injection 400,000
 Active ingredient:
Monteplase (genetical recombination)
 Dosage form:
Injection
 Print on wrapping:

Effects of this medicine

This medicine has an affinity for fibrin. It decomposes fibrin by activating plasminogen to plasmin at the thrombus (blood clots) site, and therefore dissolves thrombus.
It is usually used to dissolve coronary artery thrombus in acute myocardial infraction (within 6 hours after the onset) and pulmonary artery thrombus in acute pulmonary embolism with unstable hemodynamics.

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 or have gastrointestinal bleeding, urinary tract bleeding, retroperitoneal bleeding, intracranial bleeding, hemoptysis, bleeding diathesis, intracranial or spinal cord surgery/injury within 2 months, intracranial tumor, arteriovenous malformation, aneurysm or hypertension.
  • 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, administer by intravenous injection.
  • The treatment span depends on your symptoms.

Precautions while taking this medicine

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include arrhythmia, bleeding at injection site, gum bleeding, bloody urine, bleeding in mouth, wound bleeding, subcutaneous bleeding, nausea, vomiting and rash. 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, nausea, semi-consciousness, limb incoordination, inarticulateness [cerebral bleeding]
  • chest pain, black stool, blood vomiting [gastrointestinal bleeding]
  • breathing difficulty, blood vomiting [pulmonary bleeding]
  • pallor of face/body, cold sweat, palpitation, decreased urine output, nausea, breathing difficulty [hemorrhagic shock]
  • palpitation, breathing difficulty, bluish purple discoloration of lips/mouth/ears/nails/fingertips, syncope [heart rupture, ventricular septal perforation, cardiac tamponade]
  • palpitation, dizziness, syncope, breathing difficulty [ventricular fibrillation, ventricular tachycardia]
  • palpitation, hives, pallor of face/body, cold sweat, dizziness, breathing difficulty [shock]
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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