Generic name: Coagulation Factor X Human 100[iU] in 1mL;
Dosage form: kit
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For intravenous use after reconstitution only.
- Dose and duration of the treatment depend on the severity of the Factor X deficiency, location and extent of the bleeding, and on the patient's clinical condition.
- Base the dose and frequency on the individual clinical response. Do not administer more than 60 IU/kg daily.
- Each vial of COAGADEX is labeled with the actual Factor X potency/content in International Units (IU).
- Estimate the expected in vivo peak increase in Factor X level expressed as IU/dL (or % of normal) using the following formula:
Estimated Increment of Factor X (IU/dL or % of normal) = [Total Dose (IU)/Body Weight (kg)] × 2
The dose to achieve a desired in vivo peak increase in Factor X level may be calculated using the following formula:
Dose (IU) = Body Weight (kg) × Desired Factor X Rise (IU/dL) × 0.5
Note: The desired Factor X rise is the difference between the patient's plasma Factor X level and the desired level. The dosing formula is based on the observed recovery of 2 IU/dL per IU/kg.
On-demand Treatment and Control of Bleeding Episodes
Infuse 25 IU/kg of COAGADEX when the first sign of bleeding occurs. Repeat at intervals of 24 hours until the bleed stops.
Perioperative Management of Bleeding
Measure post-infusion plasma Factor X levels for each patient before and after surgery, to ensure that hemostatic levels are obtained and maintained.
Pre-surgery: Calculate the dose of COAGADEX to raise plasma Factor X levels to 70-90 IU/dL using the following formula:
Required dose (IU) = Body Weight (kg) × Desired Factor X Rise (IU/dL) × 0.5
Preparation and Reconstitution
The procedures below are provided as general guidelines for the preparation and reconstitution of COAGADEX.
- Always work on a clean surface and wash your hands before performing the following procedures.
- To reconstitute, use the diluent (Sterile Water for Injection) and transfer device (Mix2Vial) provided in the COAGADEX carton.
- To administer, you will also need a syringe and suitable needle (not provided in the COAGADEX carton).
- Bring the vials of COAGADEX and the Sterile Water for Injection to room temperature before mixing.
- The reconstitution is performed as follows:
For intravenous administration only
- If the dose requires more than one vial of COAGADEX:
- Reconstitute each vial (steps 1 to 5) using a new Mix2Vial for each vial.
- Draw up all the solution into a single syringe (steps 6 to 8).
- Visually inspect the final solution for particulate matter and discoloration prior to administration, and whenever solution and container permit. Do not use if particulate matter or discoloration is observed.
- Attach a suitable needle to the syringe.
- Administer by intravenous infusion at a rate of 10 mL/min, but no more than 20 mL/min.
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