Thrombin Human
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
EVITHROM®, Thrombin, Topical (Human), is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
EVITHROM, Thrombin, Topical (Human), may be used in conjunction with an Absorbable Gelatin Sponge, USP.
History
There is currently no drug history available for this drug.
Other Information
EVITHROM is provided as a sterile powder of purified human thrombin.The lyophilized powder is white to slightly yellowish in color. When reconstituted, EVITHROM solution, pH 6.8-7.2, is clear to slightly opalescent and colorless to slightly yellowish in color.
The composition of the lyophilized powder of EVITHROM is as follows:
Active Ingredients:
Human thrombin (1600-2400 units)
Other Ingredients:
Calcium chloride, Human albumin, Mannitol, Sodium acetate
EVITHROM is made from pooled Human Source and Recovered Plasma obtained from US licensed plasma collection centers. Individual plasma units obtained for production of EVITHROM are tested by licensed serological tests for HBsAg, HIV 1 & 2 Ab and HCV Ab and recovered plasma units are also tested for HTLV I/II. Additionally, the plasma units are tested by licensed Nucleic Acid Testing (NAT) for HIV-1, HCV, HBV, HAV and parvovirus 19. All tests for HIV, HCV, HBV and HAV must be negative (non-reactive). However, since the effectiveness of the HBV and HAV NAT methods in detecting low levels of viral material is still under investigation, the significance of a negative result for these viruses is unknown. The level of parvovirus B19 contamination is not permitted to exceed 10,000 copies/ml. This limit is applied to restrict the viral load of parvovirus B19 in the starting plasma pool. In addition to the screening of plasma units, each manufacturing pool is tested for HBsAg, HIV-1 & 2 Ab, and for HCV NAT. Manufacturing pool testing, however, is of lower sensitivity than individual unit testing.
EVITHROM is manufactured by chromatographic purification of prothrombin from cryo-poor plasma followed by activation with calcium chloride. The manufacturing process includes two targeted steps for inactivation or removal of viruses. The first of these is treatment with a solvent/detergent (S/D) mixture (1% tri-n-butyl phosphate, 1% Triton X-100) for 6 hours at 26°C to inactivate lipid enveloped viruses. The S/D reagents are removed by cation exchange chromatography. Mannitol and human albumin are used to stabilize the solution, which undergoes nanofiltration for removal of both enveloped and non-enveloped viruses. After nanofiltration, the solution is formulated with calcium chloride, sterile filtered and aseptically filled and frozen.
The effectiveness of the S/D treatment and nanofiltration procedures for reducing virus content has been assessed using a series of viruses with a range of physico-chemical characteristics. The results of the validation studies are summarized in Table 2.
| Virus | HIV-1 | SBV | BVDV | PRV | EMCV | HAV | CPV |
|---|---|---|---|---|---|---|---|
| Reduction factor (log10) | |||||||
| HIV-1: Human Immunodeficiency Virus Type 1 |
|||||||
| SBV: Sindbis Virus |
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| BVDV: Bovine Viral Diarrhea Virus |
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| PRV: Pseudorabies Virus |
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| EMCV: Encephalomyocarditis virus |
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| HAV: Hepatitis A Virus |
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| CPV: Canine Parvovirus |
|||||||
| SD Treatment | >5.82 | >5.31 | >4.74 | >4.25 | Not Done | Not Done | 0.0 |
| Nanofiltration | >4.36 | >5.32 | Not Done | >5.47 | 6.37 | 6.95 | 5.85 |
| Global Reduction Factor | >10.18 | >10.63 | >4.74 | >9.72 |
6.37 |
6.95 | 5.85 |
Sources
Thrombin Human Manufacturers
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Ethicon, Inc
![Thrombin Human Powder, For Solution [Ethicon, Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Thrombin Human | Ethicon, Inc
FOR TOPICAL USE ONLY. DO NOT INJECT.
The amount of EVITHROM required depends upon the area of tissue to be treated and the method of application.
2.1 Reconstitution Prior to ApplicationReconstitute the lyophilized human thrombin powder.
Use aseptic technique when handling vials and syringes.
Remove the flip-off plastic cap from the vial to expose the rubber stopper. Using a sterile needle and syringe, add 2 ml of Water for Injection, USP to the glass vial. Shake gently until the solution is clear.Reconstituted solution is stable for up to 8 hours at room temperature and should be used within this time period.
2.2 Application TechniquesDO NOT INJECT. Use EVITHROM topically.
Apply only on the surface of bleeding tissue.
EVITHROM alone
Sponge target surface (do not wipe) or suction free of blood before application. The surface may be flooded with EVITHROM using a sterile syringe and small gauge needle. After treatment, avoid sponging the clot to assure that it remains securely in place.EVITHROM in conjunction with Absorbable Gelatin Sponge, USP
Transfer EVITHROM into a sterile container using aseptic techniques. Immerse gelatin sponge of desired shape in the EVITHROM solution. Vigorously knead the sponge with moistened gloved fingers until all air is expelled and it can return to its original size and shape. Hold the saturated sponge in place with gauze or cotton pledget using moderate pressure until hemostasis is achieved.The amount of EVITHROM required depends upon the area of tissue to be treated and the method of application. As an approximate guide, volumes up to 10 ml were used in clinical studies where EVITHROM was used in conjunction with Absorbable Gelatin Sponge, USP.
Vials are for single use only. Discard unused contents.
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