Product Information
Registration Status: ActiveSIN13921P
EVICEL FIBRIN SEALANT (HUMAN) SOLUTION, 50-90mg/ML, 800-1200 IU/ML is approved to be sold in Singapore with effective from 2011-02-23. It is marketed by JOHNSON & JOHNSON PTE LTD, with the registration number of SIN13921P.
This product contains Clottable Protein (Human Fibrinogen) 50-90mg/ml, and Human Thrombin 800-1200 IU/ml in the form of SOLUTION. It is approved for OTHERS use.
This product is manufactured by OMRIX biopharmaceuticals Ltd in ISRAEL.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.
Description
Human Thrombin is a sterile solution, pH 6.8-7.2, containing highly purified human thrombin for the activation of clotting. Thrombin is a highly specific serine protease encoded by the F2 gene that transforms soluble fibrinogen into insoluble fibrin. This transformation mimics the final coagulation cascade step which involves the clotting mass that adheres to the wound surface and achieves hemostasis and sealing of open tissues. In particular, while human thrombin products are made from pooled human source plasma, recombinant thrombin is a human coagulation protein produced via recombinant DNA technology from a genetically modified Chinese hamster ovary cell line [FDA Label]. Furthermore, human thrombin is manufactured by chromatographic purification of prothrombin from cryo-poor plasma followed by activation with calcium chloride [FDA Label].
Indication
Human thrombin is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules are accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical [FDA Label].
Mechanism of Action
Human thrombin (coagulation factor IIa) is a highly specific protease that transforms plasma fibrinogen into fibrin which, in the presence of clotting factor XIII in the patient's plasma, is cross-linked to form a stable clot [FDA Label]. When applied to a surgical wound where bleeding is present, thrombin activates fibrinogen in the patient's plasma to form fibrin, which results in clot formation and hemostasis [FDA Label]. The fibrin clot is stabilized by cross-linking occurring as a result of activation of the patient's endogenous factor XIII, which requires the presence of calcium [FDA Label]. Human thrombin does not require any intermediate physiological agent because it naturally clots the fibrinogen of the blood directly [FDA Label]. Any failure to clot blood occurs in the rare case where the primary clotting defect is the absence of fibrinogen itself [FDA Label]. The speed with which human thrombin clots blood is dependent upon the concentration of both the human thrombin used and fibrinogen present [FDA Label].
Pharmacokinetics
- Absorption
- Due to the nature of the product, which is intended for topical application to the surface of the tissue at the surgical site, pharmacokinetic studies were not conducted [FDA Label]. Particularly because the agent is topical, systemic absorption is expected to be small [A32427].
- Distribution
- Due to the nature of the product, which is intended for topical application to the surface of the tissue at the surgical site, pharmacokinetic studies were not conducted [FDA Label]. Precisely because human thrombin is applied only topically, systemic exposure or distribution to other organs and tissues is not expected [A32427].
- Metabolism
- Due to the nature of the product, which is intended for topical application to the surface of the tissue at the surgical site, pharmacokinetic studies were not conducted [FDA Label]. Nevertheless, commercial human thrombin products are expected to be metabolized in the same way as endogenous thrombin is. Endogenous thrombin does not circulate in the blood as a free, active molecule for very long [L2079]. After performing its function it is rapidly inactivated after formation of complexes with various circulating endogenous plasma inhibitors (like antithrombin III) [L2079]. This rapid inactivation prevents the active agent from diffusing into the general circulation. The complexes formed are then generally cleared and eliminated by the liver [L2079].
- Elimination
Clearance
Due to the nature of the product, which is intended for topical application to the surface of the tissue at the surgical site, pharmacokinetic studies were not conducted [FDA Label]. Regardless, commercial human thrombin, like endogenous thrombin, is generally rapidly neutralized by naturally circulating plasma inhibitors limiting its duration of action and preventing the active form from diffusing into the general circulation [L2079].
Toxicity
No cases of overdose have been reported at this time [FDA Label]. The LD50 value for the mouse model is calculated to be approximately 3 gm/kg [MSDS].
Active Ingredient/Synonyms
Thrombin (human) | Thrombin human | Thrombin Human Plasma-derived | Human Thrombin |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.