Recothrom Dosage

Reconstitution of RECOTHROM Thrombin

The volume of reconstituted RECOTHROM Thrombin topical (Recombinant) 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.

5,000-unit RECOTHROM Thrombin topical (Recombinant) 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.

1.

Remove flip-off cap from the top of the RECOTHROM vial.

2.

Attach the needle-free vial access device (VAD) and snap it into place on the vial by placing the vial on a flat surface and pushing the VAD straight down into the center of the vial stopper.

3.

Attach the prefilled diluent syringe to the VAD.

4.

Transfer the 5 mL of diluent from the syringe into the RECOTHROM vial.

5.

DO NOT reuse the diluent syringe for transfer of the reconstituted product. Remove and discard the diluent syringe.

6.

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. RECOTHROM solution should remain in the vial until ready for transfer to a labeled sterile bowl or basin.

7.

Withdraw reconstituted RECOTHROM solution into transfer syringe labeled For topical use only, DO NOT INJECT. Transfer RECOTHROM solution into a labeled sterile bowl or basin.

8.

RECOTHROM is ready for application. RECOTHROM is for topical use only – DO NOT INJECT. See Application techniques below (2.2). RECOTHROM is for single use only. Discard unused contents.

20,000-unit RECOTHROM Thrombin topical (Recombinant) Reconstitution

1.

Remove the flip-off cap from the top of the RECOTHROM vial and the diluent vial.

2.

There are two needle-free vial access devices (VADs) provided. Attach one VAD to the RECOTHROM vial and one VAD to the diluent vial. To attach a VAD to a vial, place the vial on a flat surface and push straight down on the VAD into the center of the vial stopper.

3.

​Attach the empty 20-mL transfer syringe to the VAD on the diluent vial (injection of air into the diluent vial may facilitate withdrawal of the diluent). This syringe will be used twice: 1. To draw up the diluent from the diluent vial to be transferred into the RECOTHROM vial for reconstitution and 2. To draw up the reconstituted RECOTHROM solution.

4.

Draw up 20 mL of diluent from the vial into the syringe.

5.

Remove the diluent-filled syringe from the diluent vial and attach the syringe to the VAD on the RECOTHROM vial.

6.

Transfer the 20 mL of diluent from the syringe into the RECOTHROM vial.

7.

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. RECOTHROM solution should remain in the vial until ready for transfer to a labeled sterile bowl or basin.

8.

​Withdraw reconstituted RECOTHROM solution into the attached transfer syringe labeled For topical use only, DO NOT INJECT. Use the transfer syringe for immediate transfer of RECOTHROM solution into a labeled sterile bowl or basin.

9.

RECOTHROM is ready for application. RECOTHROM is for topical use only—DO NOT INJECT. See Application Techniques below (2.2). RECOTHROM vial is for single use only. Discard unused contents.

Application Techniques

For topical use only. DO NOT INJECT.

RECOTHROM solution should remain in the vial until ready for transfer to a labeled sterile bowl or basin.

RECOTHROM Thrombin topical (Recombinant) solution is now ready to use, either with an absorbable gelatin sponge, FLOSEAL NT or used with the RECOTHROM Spray Applicator Kit for surface application. 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.

1.

Transfer RECOTHROM solution from transfer syringe labeled For topical use only, DO NOT INJECT to a labeled sterile bowl or basin.

2.

Place the desired size pieces of the absorbable gelatin sponge into the bowl containing reconstituted RECOTHROM to completely saturate the sponge(s).

3.

Remove the saturated sponge(s) and squeeze gently to remove excess RECOTHROM.

4.

Apply the sponge to the bleeding site in a single layer.

Use with RECOTHROM Spray Applicator Kit

The RECOTHROM Spray Applicator Kit is double-packaged to allow for the aseptic transfer of the inner sterile package into a sterile field. Refer to Spray Applicator Kit instructions for use.

​Use in conjunction with FLOSEAL NT Hemostatic Matrix, 5mL

1.

​5,000-unit RECOTHROM may be used with FLOSEAL NT Hemostatic Matrix, 5mL according to the FLOSEAL NT Hemostatic Matrix, 5mL instructions for use (IFU).