Description
Manufacturer
Alexion Pharma International Operations Limited(IRELAND)
Registraction Number
MAL24116035ACRZ
Here’s a summary of Andexxa 200mg Powder for Solution for Infusion:
Contents
Active Ingredient: Coagulation Factor Xa (recombinant), inactivated-zhzo (200 mg per vial).
Inactive Ingredients: May include stabilizers and excipients like sucrose, polysorbate, and others (specifics depend on the manufacturer).
Indications
Used for the reversal of anticoagulation in patients treated with rivaroxaban or apixaban during life-threatening or uncontrolled bleeding.
Instructions
Dosage:
Administered intravenously as prescribed by a healthcare professional
Dosage depends on the specific Factor Xa inhibitor, its dose, and the time since the last dose.
Two regimens:
Low Dose: 400 mg IV bolus followed by 4 mg/min infusion for 120 minutes.
High Dose: 800 mg IV bolus followed by 8 mg/min infusion for 120 minutes.
Preparation:
Reconstitute each 200 mg vial with 20 mL of sterile water for injection.
Gently swirl to dissolve; avoid shaking to prevent foaming.
Inspect the solution for clarity and absence of particulates before use.
Administration:
Infuse using an IV bolus followed by a continuous infusion.
Use a low protein-binding filter during infusion.
Precautions:
Monitor for thromboembolic events, ischemic risks, and cardiac complications.
Resume anticoagulation therapy as soon as medically appropriate.
Storage: Keep refrigerated at 2°C to 8°C. Do not freeze. Protect from light.
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