Clotinab

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Clotinab

  • 1. Description
  • Abciximab, Clotinab®, is the Fab fragment of the chimeric human-murine monoclonal antibody 7E3. Abciximab bind to the glycoprotein (GP)IIb/IIIa receptor of human platelets and inhibits platelet aggregation. Abciximab also binds to the vitronectin receptor found on platelets and vessel wall endothelin and smooth muscle cells.

    The chimeric 7E3 antibody is produced by mammalian cell culture. The 47,615 dalton Fab fragment is pufiried from the cell culture supernatant by a series of steps involving viral inactivation and removal procedures, digestion with papain and column chromatography.

    Clotinab® is a clear, colorless, strile, non-pyrogenic solution for intravenous (IV) use. Each single use vial contains 2 mg/ml of Abciximab in a buffered solution (pH 7.2) of 0.01M sodium phosphate, 0.15M sodium chloride and 0.001% polysorbate 80 in Water for injection. No preservatives are added.
  • 2. Indications and Usage
  • Abciximab is indicated as an adjunct to percutaneous coronary intervention for the prevention of cardiac ischemic complications:
    ㆍIn patients undergoing percutaneous coronary intervention
    ㆍIn patients with unstable angina not responding to conventional medical therapy when percutaneous coronary intervention is planned within 24 hours
    Safety and efficacy of Abciximab use in patients not undergoing percutaneous coronary intervention have not been established. Abciximab is intended for use with aspirin and heparin and has been studies only in that setting.
  • 3. How Supplied
  • Clotinab® (Abciximab) 2 mg/ml is supplied in 5 ml vials containing 10 mg. Vials should be stored at 2 to 8 °C (36 to 46 °F). Do not freeze. Do not use beyond the expiration date. Discard any unused portion left in the vial.
  • 4. Product Description
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