Ebv

Ebv Manufacturers

• Deseret Biologicals, Inc.
  

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  Ebv | Bio Products Laboratory Limited

  

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  For intravenous use after reconstitution only.

  2.1 Dose 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

  Post-surgery: Repeat dose as necessary to maintain plasma Factor X levels at a minimum of 50 IU/dL until the patient is no longer at risk of bleeding due to surgery.

  2.2 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: Table 1 COAGADEX Reconstitution Instructions Step 1 Remove the cap from the vial of COAGADEX and clean the top of the rubber stopper with an alcohol swab (not supplied) and allow to dry prior to opening the Mix2Vial package. Repeat this step with the vial of sterile water. Step 2 Peel back the top of the Mix2Vial package. Do not remove the device from the package.  
  Step 3 Place the blue end of the Mix2Vial over the water vial and push straight down until the spike penetrates the rubber stopper and snaps into place. Remove the plastic outer packaging from the Mix2Vial and discard it. Do not touch the exposed end of the device.  
  Step 4 With the COAGADEX vial placed on a flat surface, invert the water vial with the Mix2Vial device still attached. Place the clear end of the Mix2Vial on the product vial and push straight down until the spike penetrates the rubber stopper and snaps into place. The water will automatically transfer into the COAGADEX vial by the vacuum contained within it. Do not use if the water is not pulled into the vial of COAGADEX.  
  Step 5 Gently swirl the COAGADEX vial to make sure that the powder is fully dissolved. Do not shake the vial. The reconstituted solution should be clear or a slightly pearl-like solution. Do not use if particulate matter or discoloration is observed and contact BPL. Step 6 Separate the empty water vial and blue part of the Mix2Vial from the clear part that is attached to the COAGADEX vial by unscrewing counter-clockwise. Step 7 Draw air into an empty, sterile syringe (not supplied) by pulling the plunger to the volume of water added. Connect the syringe to the clear part of the Mix2Vial and push the air in the syringe into the vial.  
  Step 8 Immediately invert the COAGADEX vial. The solution will automatically be drawn into the syringe. Draw the remaining solution into the syringe by pulling the plunger back slowly. Disconnect the filled syringe from the device. Use the product immediately after reconstitution. Do not store the reconstituted product. 2.3 Administration

  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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