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Clotinab®

Abciximab for Injection

Classification
Rx/ Orphan Drug
Therapeutic Area
Antiplatelet Agent
Active Substance
Abciximab
Download Product Information
Product Appearance
Colorless and transparent liquid in colorless and transparent vial
Quantitative Composition
(per 1 vial)
Active ingredient: Abciximab (in-house) 10 mg
Stabilizer: Sodium Chloride 43.83 mg, Polysorbate 80 0.05 mg
Inactive ingredients: Sodium Phosphate Dibasic Heptahydrate, Sodium Phosphate Monobasic, Water for injection
Indications and Usage

Clotinab (abxicimab) is indicated as an adjunct to percutaneous coronary intervention for the prevention of cardiac ischemic complications:
• in patients undergoing percutaneous coronary intervention
• in patients with unstable angina not responding to conventional medical therapy when percutaneous coronary intervention is planned within 24 hours
Safety and efficacy of Clotinab use in patients not undergoing percutaneous coronary intervention have not been established. Clotinab is intended for use with aspirin and heparin and has been studied only in that setting.

Dosage and Administration

The safety and efficacy of Clotinab (abciximab) have only been investigated with concomitant administration of heparin and aspirin. In patients with failed percutaneous coronary interventions, the continuous infusion of Clotinab should be stopped because there is no evidence for Clotinab efficacy in that setting. In the event of serious bleeding that cannot be controlled by compression, Clotinab and heparin should be discontinued immediately.
The recommended dosage of Clotinab in adults is a 0.25 mg/kg intravenous bolus administered 10-60 minutes before the start of percutaneous coronary intervention, followed by a continuous intravenous infusion of 0.125 μg/kg/min (to a maximum of 10 μg/min) for 12 hours.
Patients with unstable angina not responding to conventional medical therapy and who are planned to undergo percutaneous coronary intervention within 24 hours may be treated with an Clotinab 0.25 mg/kg intravenous bolus followed by an 18 to 24-hour intravenous infusion of 10 μg/min, concluding one hour after the percutaneous coronary intervention.

Storage Condition
Hermetic container, under refrigeration (2~8°C)
포장단위
1 vial (10mg)/box
Reporting Adverse Events
If you have experienced an adverse event or adverse drug reaction from Clotinab, please report to ISU ABXIS by phone +82-31-696-4631 (limited to South Korea) or email to safety.isuabxis@isu.co.kr

*The information provided in this product page of ISU ABXIS’s corporate website is for general information purposes only and does not constitute product advertising or medical advice. The material contained herein is not intended to be a source of prevention, diagnosis, and treatment without consulting healthcare professionals. Please discuss it with your doctor for any medical advice and medication guide for the product.