For topical use only. DO NOT INJECT.
2.1 Reconstitution of RECOTHROM
The volume of reconstituted RECOTHROM required will vary depending on the size and number of bleeding sites to be treated and the method of application.
Inspect the integrity of the RECOTHROM package and contents. Do not use if the packaging or contents have been damaged or opened.
Reconstitute the lyophilized powder using the supplied diluent.
Use aseptic technique when handling vials and syringes.
5000-unit RECOTHROM Reconstitution
Units used herein represent international units of potency determined using a reference standard that has been calibrated against the World Health Organization Second International Standard for Thrombin.
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Remove flip-off cap from the top of the RECOTHROM vial.
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Attach the needle-free transfer device and snap it into place on the vial by placing the vial on a flat surface and attaching the transfer device straight into the center of the vial stopper.
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Attach the prefilled diluent syringe to the needle-free transfer device.
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Inject the 5 mL of diluent from the syringe into the product vial. Keep the syringe plunger depressed.
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DO NOT reuse the diluent syringe for transfer of the reconstituted product. Remove and discard the diluent syringe.
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Gently swirl and invert the product vial until the powder is completely dissolved. Avoid excessive agitation. The powder should dissolve in less than one minute at room temperature.
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Apply the pre-printed "DO NOT INJECT" label to the sterile, empty transfer syringe provided, then draw up the RECOTHROM solution.
20,000-unit RECOTHROM Reconstitution
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Remove the flip-off cap from the top of the RECOTHROM vial and the diluent vial.
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Attach a needle-free transfer device (one each) to the RECOTHROM and diluent vials and snap them into place by placing the vial on a flat surface and attaching the transfer device straight into the center of the vial stopper.
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Open the sterile, empty 20-mL syringe package and apply the pre-printed "DO NOT INJECT" label to the syringe.
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Attach the labeled 20-mL syringe to the needle-free transfer device on the diluent vial (injection of air into the diluent vial may facilitate withdrawal of the diluent).
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Draw up 20 mL of diluent from the vial into the syringe.
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Remove the diluent-filled syringe from the diluent vial and attach it to the transfer device on the RECOTHROM vial.
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Transfer the 20 mL of diluent from the syringe into the RECOTHROM vial; the vacuum in the vial facilitates transfer.
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Leave the syringe attached and gently swirl and invert the RECOTHROM vial until the powder is completely dissolved. Avoid excessive agitation. The powder should dissolve in less than one minute at room temperature.
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With the same syringe, draw up the RECOTHROM solution.
2.2 Application Techniques
Topically apply RECOTHROM solution directly or in conjunction with absorbable gelatin sponge onto the bleeding site. DO NOT INJECT.
The amount required depends upon the area of tissue to be treated and the method of application.
Vials are for single use only. Discard unused contents.
Use with Absorbable Gelatin Sponge
Refer to the absorbable gelatin sponge labeling for safety information and instructions on appropriate use.
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Transfer solution from syringe to a sterile bowl or basin.
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Place the desired size pieces of the absorbable gelatin sponge i
