Adult Dosing

Hemostasis aid

• Human thrombin alone
• 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

• Human thrombin in conjunction with an absorbable gelatin sponge
• 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

• 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

• Human thrombin alone
• 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

• Human thrombin in conjunction with an absorbable gelatin sponge
• 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

• 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

• 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

• Hypersensitivity to any of the ingredients of the product
• Anaphylactic/severe systemic reaction to human blood products
• Treatment of massive or brisk arterial bleeding
• Injection directly into the circulatory system

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• 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

• Contaminated areas of the body

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 Category:C

Breastfeeding: Safety unknown.

• HYPERSENSITIVITY: Anaphylactic reactions

• 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

US Trade Name(s)

• Evithrom

US Availability

Evithrom

• SOLN: 800-1200 IU/mL

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

Hematology/Oncology

Clotting Factors