Recothrom Dosage

Generic name: thrombin, topical (recombinant)
Dosage form: topical kit

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

For topical use only. DO NOT INJECT.

Apply on the surface of bleeding tissue only.

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. The healthcare professional should determine the number of vials required to produce a sufficient volume of reconstituted product.

Inspect the integrity of the RECOTHROM package and contents.  Do not use if the packaging or contents have been damaged or opened.

Reconstitution of RECOTHROM

The lyophilized powder is reconstituted, using the supplied diluent, in less than 1 minute at room temperature.

NOTE: Use aseptic technique when handling vials and syringes.

5,000-unit1 RECOTHROM Reconstitution

1 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 transfer device and snap it into place on the vial by placing the vial flat on a surface and attaching the transfer device straight into the center of the vial stopper.
  3. Attach the prefilled diluent syringe to the needle-free transfer device.
  4. Inject the 5 mL of diluent from the syringe into the product vial. Keep the syringe plunger depressed.
  5. DO NOT re-use the diluent syringe for transfer of the reconstituted product. Remove and discard the diluent syringe.
  6. Gently swirl and invert the product vial until the powder is completely dissolved (avoid excessive agitation).
  7. 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

  1. Remove the flip-off cap from the top of the RECOTHROM vial and the diluent vial.
  2. Attach a needle-free transfer device (one each) to the RECOTHROM and diluent vials and snap them into place by placing the vial flat on a surface and attaching the transfer device straight into the center of the vial stopper.
  3. Open the sterile, empty 20-mL syringe package and apply the pre-printed “DO NOT INJECT” label to the syringe.
  4. 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).
  5. Draw up 20 mL of diluent from the vial into the syringe.
  6. Remove the diluent-filled syringe from the diluent vial and attach it to the transfer device on the RECOTHROM vial.
  7. Transfer the 20 mL of diluent from the syringe into the RECOTHROM vial; the vacuum in the vial facilitates transfer.
  8. Leave the syringe attached and gently swirl and invert the RECOTHROM vial until the powder is completely dissolved (avoid excessive agitation).
  9. With the same syringe, draw up the RECOTHROM solution.

Application Techniques

DO NOT INJECT

Topically apply RECOTHROM solution directly to bleeding site or in conjunction with absorbable gelatin sponge.

Use with Absorbable Gelatin Sponge

  1. Refer to the absorbable gelatin sponge labeling for instructions on appropriate use.
  2. Transfer solution from syringe to a sterile bowl or basin.
  3. Place the desired size pieces of the absorbable gelatin sponge into the bowl containing reconstituted RECOTHROM to completely saturate the sponge(s).
  4. Remove the saturated sponge(s) and squeeze gently to remove excess RECOTHROM.
  5. Apply the sponge to the bleeding site in a single layer.

Use with ZymoGenetics Spray Applicator Kit

  1. Hold the outer sealed tray, peel back the lid, and aseptically transfer the inner sealed sterile tray to the sterile field.
  2. Open the inner tray seal and use the sterile bowl as the receptacle for reconstituted RECOTHROM solution.
  3. Refer to Spray Applicator Kit instructions for spray pump and syringe spray assembly and use.

The amount of RECOTHROM required depends upon the area of tissue to be treated and the method of application.

Vials are for single use only. Discard unused contents.

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