Allgemeines Anwendungsbeispiel.


Bivalirudin for Injection

Vials:xxxmg/vial

Indications and Usage:

Use as an anticoagulant in adult patients in undergoing percutaneous coronary intervention (PCI)


Therapeutic indications:


A. Bivalirudin is for injection for intravenous administration

PCI/intravenous injection: 0.xx mg/kg intravenous (IV) bolus dose followed immediately by a 1.xx mg/kg/h IV infusion for the duration of the procedure. Five min after the bolus dose has been administered, an activated clotting time (ACT) should be performed and an additional bolus of 0.x mg/kg should be given if needed. After four hours, an additional IV infusion may be initiated at a rate of 0.x mg/kg/h (low-rate infusion), for up to 20 hours, if needed. Use with use with glycoprotein Ⅱb/Ⅲa inhibitors(GPI) in situations as list in Replace-2 clinical test.The recommended dose in patients with HIT/HITTS undergoing PCI is an IV bolus of 0.xx mg/kg. This should be followed by a continuous infusion at a rate of x.xx mg/kg/h for the duration of the procedure. Recommend to use with aspirin (xxx-xxx mg daily).


B. Patients with renal impairment

The infusion dose may need to be reduced, and anticoagulant status monitored in patients with renal impairment. Patients with moderate renal impairment (xx-xx mL/min) should receive an infusion of x.xx mg/kg/h. If the creatinine clearance is less than xx mL/min, reduction of the infusion rate to x mg/kg/h should be considered. If a patient is on hemodialysis, the infusion rate should be reduced to 0.xx mg/kg/h, dose of intravenous injection remains the same. Drug half-life as regard to patients with renal impairment (pharmacokinetics).


Glycoprotein inhibitors(GPI):

Can use with glycoprotein Ⅱb/Ⅲa inhibitors(GPI)

Instructions for Administration:

Add x mL x% of glucose injection or 0.9% sodium chloride for injection, gently swirl until all material is dissolved. Then dilute a final concentration of x mg/mL with x% glucose injection or 0.9% Sodium Chloride for Injection. The dose to be administered is adjusted according to the patient's weight. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Preparations of bivalirudin containing particulate matter should not be (re)used. Reconstituted material will be a clear to slightly opalescent, colorless to slightly yellow solution.

If the low-rate infusion is used after the initial infusion, a lower concentration bag should be prepared. Each vial add 5 mL x% of glucose injection or 0.9% sodium chloride for injection, gently swirl until all material is dissolved. Then dilute a final concentration of x mg/mL with 5% glucose injection or 0.9% Sodium Chloride for Injection.




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