Thrombin


Concise Prescribing Info
Indications/Uses
Aid to haemostasis when bleeding from capillaries and small venules.
Dosage/Direction for Use
Adult : Topical As recombinant or human-derived: Apply directly to or flood bleeding site surface or use in conjunction with absorbable gelatin sponge. The amount depends upon the area of tissue to be treated. As bovine-derived: Apply 1,000-2,000 units for profuse bleeding or 100 units for bleeding from skin or mucosal surfaces.
Dosage Details
Topical/Cutaneous
Aid to haemostasis when bleeding from capillaries and small venules
Adult: As recombinant or human-derived: Apply directly to or flood bleeding site surface or use in conjunction with absorbable gelatin sponge. The amount depends upon the area of tissue to be treated. As bovine-derived: Apply 1,000-2,000 units for profuse bleeding or 100 units for bleeding from skin or mucosal surfaces.
Child: Same as adult dose.
Reconstitution
Powder for solution: Reconstitute vial labelled as containing 5,000 or 20,000 units with appropriate volume of NaCl 0.9% solution.
Contraindications
Hypersensitivity to human blood products, snake or hamster protein, material of bovine-origin or known or suspected antibodies to bovine thrombin and/or factor V. Not indicated for treatment of severe or brisk arterial bleeding. Not intended for IV or IA administration.
Special Precautions
Children. Pregnancy and lactation.
Adverse Reactions
Significant: Hypersensitivity reactions (e.g. anaphylaxis), risk of infection transmission.
Blood and lymphatic system disorders: Thromboembolism.
Immune system disorders: Antibody formation.
Potentially Fatal: Severe bleeding or thrombosis (bovine thrombin).
MonitoringParameters
Monitor for signs of hypersensitivity, bleeding, thrombosis, abnormal coagulation laboratory values.
Lab Interference
May alter coagulation test (e.g. prothrombin time, partial thromboplastin time) results.
Action
Description: Thrombin is a protein substance produced from prothrombin. It catalyses the conversion of soluble fibrinogen into insoluble fibrin to producing coagulation and haemostasis.
Synonym: factor IIa, trombin.
Storage
Store between 2-25°C. Frozen solution: Store at -18°C. Unopened thawed vials: Store at 2-8°C for up to 30 days. Protect from light. Do not re-freeze thawed solutions. Do not refrigerate once at room temp. Powder for solution: Do not freeze.
MIMS Class
ATC Classification
B02BC06 - thrombin ; Belongs to the class of local hemostatics. Used in the treatment of hemorrhage.
B02BD30 - thrombin ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
References
Anon. Thrombin (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/05/2018.

Anon. Thrombin. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com/. Accessed 07/05/2018.

Buckingham R (ed). Thrombin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/05/2018.

Evithrom, Topical (Human) (Omrix Biopharmaceuticals Ltd.). U.S. FDA. https://www.fda.gov/. Accessed 08/05/2018.

Recothrom, Topical (Recombinant) (Zymo Genetics, Inc.). U.S. FDA. https://www.fda.gov/. Accessed 08/05/2018.

Thrombin-JMI, Topical (Bovine) (GenTrac, Incorporated). U.S. FDA. https://www.fda.gov/. Accessed 08/05/2018.

Disclaimer: This information is independently developed by MIMS based on Thrombin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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