human thrombin [Topical]

Adult Dosing

Hemostasis aid

Apply topically to surfaces of bleeding tissue with a sterile syringe and small gauge needle
If drawn into a syringe, apply an auxiliary label indicating that the product is for topical use only; never leave it in a syringe as an intermediate step

Transfer human thrombin solution into a sterile container using aseptic techniques
Immerse sponge strips of desired size in the thrombin solution
Vigorously knead the sponge with gloved fingers to remove trapped air and facilitate saturation of the sponge. Apply the saturated sponge to the bleeding area using moderate pressure and hold it in place with gauze or cotton pledget until hemostasis is achieved

Notes:

Recipient surface should be sponged (not wiped) before thrombin is applied; do not sponge after treatment to ensure that the clot remains securely in place
Amount of thrombin required depends upon the size of the bleeding area and method of application
Use vials for single use only and discard unused contents
Volumes up to 10 mL may be use in conjunction with absorbable gelatin sponge
The frozen solution must be thawed prior to use

Pediatric Dosing

Hemostasis aid

Apply topically to surfaces of bleeding tissue with a sterile syringe and small gauge needle
If drawn into a syringe, apply an auxiliary label indicating that the product is for topical use only; never leave it in a syringe as an intermediate step

Transfer human thrombin solution into a sterile container using aseptic techniques
Immerse sponge strips of desired size in the thrombin solution
Vigorously knead the sponge with gloved fingers to remove trapped air and facilitate saturation of the sponge. Apply the saturated sponge to the bleeding area using moderate pressure and hold it in place with gauze or cotton pledget until hemostasis is achieved

Notes

Recipient surface should be sponged (not wiped) before thrombin is applied; do not sponge after treatment to ensure that the clot remains securely in place
Amount of thrombin required depends upon the size of the bleeding area and method of application
Use vials for single use only and discard unused contents
Volumes up to 10 mL may be use in conjunction with absorbable gelatin sponge
The frozen solution must be thawed prior to use

[Outline]

Indications ⬆ ⬇

As an aid to hemostasis at accessible sites of oozing blood and minor bleeding from capillaries and small venules when control of bleeding by standard surgical techniques is ineffective or impractical
In various types of surgery, topical thrombin may be used in conjunction with an absorbable gelatin sponge to establish hemostasis

Contraindications ⬆ ⬇

Black Box Warnings ⬆ ⬇

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Hepatic Dose Adjustment

Warnings/Precautions ⬆ ⬇

Indicated for topical use only; do not inject
This product is prepared from human plasma; products made from human plasma may contain infectious agents, such as viruses, that can cause disease. Also, it may carry a risk of transmitting infectious agents such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk of transmission may be reduced by screening plasma donors for prior exposure to certain viruses and by inactivating and/or removing certain viruses during manufacture. Despite these measures, these products may still contain human pathogenic agents, including those not yet known or identified. Discuss the risks and benefits of this product with the patient
Potential risk of thrombosis exists if absorbed systemically
Product should not be injected or otherwise allowed directly into the circulatory system, as extensive intravascular clotting and even death may occur. Exercise caution to avoid inadvertent injection
Therapy may be associated with allergic-type hypersensitivity reactions, including anaphylaxis. Antihistamines may be used to manage mild reactions; immediate intervention including standard treatment for shock should be instituted if severe hypotension occurs
Antibody formation has been reported in patients receiving human thrombin

Caution: Use cautiously in

Supplemental Patient Information

Advise patients to consult their physician on development of symptoms including poor appetite, fatigue and low-grade fever followed by nausea, vomiting and abdominal pain; dark urine and a yellowed complexion
Instruct patients to consult their physician if they experience any new or unusual symptoms

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:C

Breastfeeding: Safety unknown.

Adverse Reactions ⬆ ⬇

Clinical Pharmacology ⬆ ⬇

Hematologic agent; activates platelets and catalyzes the conversion of fibrinogen to fibrin, which are the essential steps for blood clot formation
Metabolism: Unknown
Excretion: Unknown
Half-life: Unknown

Brands and Availability ⬆ ⬇