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Storage
Beriplast® P Combi-Set should be stored in the refrigerator at 2-8C. Beriplast® P Combi-Set must always be used before the expiry date.Presentation
Beriplast® P Combi-Set is available in packages of 0.5, 1, and 3 mL. In addition, a 5 mL presentation is available in Japan. Each fibrin sealant set package contains two parts: one containing the fibrinogen component and the other containing the thrombin component. The packages are sealed in a sterile foil pouch, and consist of two vials (one containing solution and the other lyophilizate), joined by a transfer device. The package also contains a cardboard stand (1), applicator syringes (2), an application device (1; PantajectR) and two application cannules (2). The 1 mL and 3 mL packs contain 2 and 3 spray tips, respectively.Preparation
1, Remove the Beriplast® P Combi-Set from the refrigerator. Place the two sterile foil pouches in the cardboard stand and leave them to reach room temperature (RT). This takes approximately 4 minutes for the 1 mL size and 30 minutes for the 3 mL pack. Do not shake or invert the vials.
2, Press down on the top of each to transfer the aqueous solution from the top vial into the lower vial containing the lyophilizate. Leaving it in the sterile package, let the lyophilizate dissolve for a few minutes. Air bubbles may make the solution appear cloudy, but this does not affect the performance of the product. Do not shake or invert the vial. Write the date and time of reconstitution on the side of the cardboard rack.
3, The solutions are stable at +15C to +25C for 24 hours in the unopened sterile package or for up to 8 hours outside the sterile package.
4, Open the sterile package by pulling the pack open and remove the vials; transfer the vials to the sterile field using aseptic technique.
5, Remove the green plastic transfer piece from the vials and discard both the transfer pieces and the empty vials. The lower vials contain the fibrinogen (blue vial) and thrombin solutions (red vial). When the fibrinogen and thrombin have dissolved, the solutions are ready for use.
6, Using the sharp needles provided, release the vacuum from each vial. Insert the needle so that it is pointing towards the outer edge of the vial. Attach the appropriate applicator syringe (blue scale for fibrinogen solution) to the needle and draw up the solution using a slow, even pulling action. Repeat the above procedure for the thrombin solution using the syringe with the red scale. The fibrinogen and thrombin syringes are now ready for use with a number of possible Delivery Devices.