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thrombin human 2000 [iU]/2mL Powder, For Solution, 2 mL — NDC 63713-0461-02 package photo

thrombin human 2000 [iU]/2mL Powder, For Solution, 2 mL

by Ethicon, Inc · 2 mL in 1 VIAL, GLASS (63713-461-02)
NDC 63713-0461-02
🏷️ FDA NDC (as labeled) 63713-461-02 billing pads the product segment with a zero
Brand On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 63713-461-02
Product NDC 63713-461
11-digit billing NDC 63713046102
Application # BLA125247
SPL Set ID 02edcd44-1c26-45f1-a75c-f1f639d1956e
Established class (EPC) Human Blood Coagulation Factor
Physiologic effect Increased Coagulation Factor Activity
Chemical class Blood Coagulation Factors
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-09-19
Route TOPICAL
Dosage form POWDER, FOR SOLUTION
Substance HUMAN THROMBIN
Biologic (Purple Book) 351(a)
Why two NDCs? The FDA registers this code as 63713-461-02 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63713-0461-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerEthicon, Inc
FDA applicationBLA125247 (BLA)
Labeler code63713
First marketedSep 2009
Product typePlasma Derivative
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
thrombin human 2000 [iU]/2mLthis 63713-0461-02 Ethicon, 2 ml — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & biosimilar status

🏛️
2007
First FDA approval
Aug 2007
📍
2026
Currently FDA-listed
19 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Thrombin human — the ingredient across all brands.

Top reported reactions

Cerebrospinal Fluid Leakage15
Intestinal Obstruction11
Post Procedural Haemorrhage11
Product Adhesion Issue11
Pyrexia11
Abdominal Abscess10
Nausea10

Age at onset

Neonate1
Child3
Adult7
Elderly4

Reporter sex

334 reports
Male · 56%
Female · 39%
Unknown · 4%

Serious outcomes

Hospitalization129
Life-threatening31
Death27
Disabling17
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 33 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
63713-0461-02 You're viewing this 2 mL in 1 VIAL, GLASS (63713-461-02) 2009-09-19 Active

🧭 About this NDC listing & data coverage

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 63713-461-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 63713-0461-02, written without dashes as 63713046102. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 63713-0461-02, the first segment (63713) is the labeler code FDA assigned to Ethicon, Inc; the middle segment (0461) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Ethicon, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Ethicon, Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 123 words ▾

1 INDICATIONS AND USAGE 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. EVITHROM is a topical thrombin 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 ( 1 ).

EVITHROM may be used in conjunction with an Absorbable Gelatin Sponge, USP ( 1 ).

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION 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.

Lyophilized powder for reconstitution for topical use only. DO NOT INJECT ( 2.2 ). The amount of EVITHROM required depends upon the area of tissue to be treated and the method of application.

In clinical studies, volumes up to 10ml were used in conjunction with Absorbable Gelatin Sponge, USP ( 2.2 ). Reconstitute in 2ml Water for Injection, USP ( 2.1 ). Reconstituted solution can be stored at room temperature for up to 8 hours and should be used within that time period ( 16 ).

Vials are for single use only. Discard unused contents ( 2.2 ).

2.1Reconstitution Prior to Application Reconstitute 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.

2.2Application Techniques DO 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.

💊 Dosage Forms and Strengths 170 words ▾

3 DOSAGE FORMS AND STRENGTHS EVITHROM is supplied in a vial containing 2000 (1600-2400) units of lyophilized human thrombin powder for reconstitution. When reconstituted with 2ml of Water for Injection, USP, the final solution contains 1000 (800-1200) units/ml of Thrombin, Topical (Human). The potency expressed in units is determined using a clotting assay against an internal reference standard for potency that has been calibrated against the World Health Organisation (WHO) Second International Standard for Thrombin, 01/580.

Therefore, a unit used herein is equivalent to an International Unit. EVITHROM is supplied in vials containing 2000 (1600-2400) units of lyophilized human thrombin powder for reconstitution. When reconstituted with 2 ml of Water for Injection, USP, the final solution contains 1000 (800-1200) units/ml of EVITHROM ( 3 ).

The potency expressed in units is determined using a clotting assay against an internal reference standard for potency that has been calibrated against the World Health Organisation (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit used herein is equivalent to an International Unit.

⛔ Contraindications 65 words ▾

4 CONTRAINDICATIONS Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products. Do not use for the treatment of severe or brisk arterial bleeding. Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products ( 4 ). Do not use for treatment of severe or brisk arterial bleeding ( 4 ).

⚠️ Warnings and Cautions 163 words ▾

5 WARNINGS AND PRECAUTIONS Potential risk of thrombosis if absorbed systemically ( 5.1 ). May carry a risk of transmitting infectious agents such as viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite manufacturing steps designed to reduce the risk of viral transmission ( 5.2 ).

5.1 Thrombosis Potential risk of thrombosis if absorbed systemically

5.2Transmission of Infectious Agents Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk of transmitting an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections and by inactivating and removing certain viruses. Despite these measures, such products can still potentially transmit disease.

There is also the possibility that unknown infectious agents may be present in such products. The physician should discuss the risks and benefits of this product with the patient.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions during clinical trial (reported in at least 2% of subjects treated with EVITHROM) were prolonged activated partial thromboplastin time, increased INR, decreased lymphocyte count, prolonged prothrombin time and increased neutrophil count. The most common adverse reactions during clinical trial (reported in at least 2% of subjects treated with EVITHROM) were prolonged activated partial thromboplastin time, increased INR, decreased lymphocyte count, prolonged prothrombin time and increased neutrophil count.

Adverse events were reported in the clinical trial with similar frequency in the two study groups (EVITHROM or bovine thrombin group) ( 6 ) . Anaphylactic reactions may occur ( 6 ). Immunogenicity was evaluated by testing for the development of antibodies to highly purified antigens: human thrombin, human Factor V/Va, bovine thrombin and bovine Factor V/Va.

None of the patients treated with EVITHROM developed antibodies to human thrombin or to human Factor V/Va. To report SUSPECTED ADVERSE REACTIONS, contact ETHICON Customer Support Center at (877) 384-4266 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug product cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Anaphylactic reactions may occur in rare cases. No adverse events of this type were reported during the conduct of the clinical trials.

Mild reactions can be managed with anti-histamines. Severe hypotensive reactions require immediate intervention using current principles of shock therapy. In a phase III multicenter, prospective, controlled, randomized, double-blinded study of 305 subjects where EVITHROM (n=153) was compared with bovine thrombin (n=152), occurrence of adverse events was not statistically different between the two groups.

Overall, adverse events occurred in similar proportions of subjects in the two study groups (see Table 1 ). No clinically significant differences were seen in age (<65 years, >65 years) or gender subgroup analyses of adverse events. At least one serious adverse event (SAE) was reported for 26/153 (17%) subjects treated with human thrombin and 17/152 (11%) subjects treated with bovine thrombin.

The SAEs reported were associated with post-surgical complications (e.g. wound infection 3/153 for EVITHROM and 2/152 for bovine thrombin) and the medical condition of the subject and were not considered related to study drug. Two subjects (1.3%) in EVITHROM group experienced a treatment emergent severe adverse event: respiratory arrest and post-procedural hematoma (in one subject) and extradural hematoma. Three subjects in the bovine thrombin group experienced a treatment emergent severe adverse event: hyperhidrosis, pyrexia and post-procedural hematoma.

No deaths were reported during the study period. Viral serology was not monitored during the study with EVITHROM. However, no adverse events indicative of infection with transfusion-transmissible agents were reported.

Table 1: Incidence of subjects with related adverse events reported in at least 2% of subjects treated with either human or bovine thrombin Thrombin Type System Organ Class/Adverse Event EVITHROM (n=153) Bovine (n=152) Total (n=305) Investigations 11 (7.2%) 14 (9.2%) 25 (8.2%) Activated partial thromboplastin time increased 4 (2.6%) 8 (5.3%) 12 (3.9%) International normalized ratio increased 4 (2.6%) 5 (3.3%) 9 (3.0%) Lymphocyte count decreased 4 (2.6%) 2 (1.3%) 6 (2.0%) Prothrombin time prolonged 4 (2.6%) 8 (5.3%) 12 (3.9%) Neutrophil count increased 3 (2.0%) 2 (1.3%) 5 (1.6%) Skin and Subcutaneous Tissue Disorders 1 (0.7%) 3 (2.0%) 4 (1.3%) Pruritis 1 (0.7%) 3 (2.0%) 4 (1.3%) General Disorders and Administration Site Conditions 0 3 (2.0%) 3 (1.0%) Immunogenicity In the clinica…

🔄 Drug Interactions 8 words ▾

7 DRUG INTERACTIONS No drug interactions are known.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Animal data are summarized in the Non Clinical Toxicology section ( 13 ). No data in pregnant women. EVITHROM should only be used in pregnancy if clearly indicated ( 8.1 ).

8.1Pregnancy Teratogenic effects: Pregnancy category C Adequate and well-controlled studies in pregnant women have not been performed. EVITHROM should be used in pregnancy only if the potential benefit to the pregnant woman justifies the potential risk to the fetus. Studies to evaluate the potential reproductive/developmental toxicity of EVITHROM have not been performed due to the human origin of thrombin.

However, studies to evaluate the potential reproductive/developmental toxicity of residual levels of Triton X-100 and tri-n-butyl phosphate (solvent/detergent reagents) were conducted in animals and are summarized in the Non Clinical Toxicology section ( 13 ).

8.2Labor and Delivery The safety of EVITHROM for use during labor and delivery has not been established.

8.3Nursing Mothers The safety of EVITHROM for use during breast-feeding has not been established. Use only if clearly needed.

8.4Pediatric Use Of the 155 patients undergoing liver surgery who were treated in adequate and well-controlled studies of EVICEL Fibrin Sealant (Human), in which EVITHROM is a component, eight were pediatric patients. Of these, five were less than 2 years old and three were between 2 and 12 years old. Use of EVITHROM in pediatric patients is supported by these data and by extrapolation of findings for safety and efficacy in adults.

8.5Geriatric Use Sixty three (63) subjects over 65 years of age received EVITHROM in the phase III clinical trial. No differences in safety or effectiveness were observed between the elderly and younger patients. Greater susceptibility of older patients to adverse reactions cannot be ruled out.

🤰 Pregnancy 95 words ▾

8.1Pregnancy Teratogenic effects: Pregnancy category C Adequate and well-controlled studies in pregnant women have not been performed. EVITHROM should be used in pregnancy only if the potential benefit to the pregnant woman justifies the potential risk to the fetus. Studies to evaluate the potential reproductive/developmental toxicity of EVITHROM have not been performed due to the human origin of thrombin.

However, studies to evaluate the potential reproductive/developmental toxicity of residual levels of Triton X-100 and tri-n-butyl phosphate (solvent/detergent reagents) were conducted in animals and are summarized in the Non Clinical Toxicology section ( 13 ).

🧒 Pediatric Use 73 words ▾

8.4Pediatric Use Of the 155 patients undergoing liver surgery who were treated in adequate and well-controlled studies of EVICEL Fibrin Sealant (Human), in which EVITHROM is a component, eight were pediatric patients. Of these, five were less than 2 years old and three were between 2 and 12 years old. Use of EVITHROM in pediatric patients is supported by these data and by extrapolation of findings for safety and efficacy in adults.

🧓 Geriatric Use 46 words ▾

8.5Geriatric Use Sixty three (63) subjects over 65 years of age received EVITHROM in the phase III clinical trial. No differences in safety or effectiveness were observed between the elderly and younger patients. Greater susceptibility of older patients to adverse reactions cannot be ruled out.

🆘 Overdosage 9 words ▾

10 OVERDOSAGE No case of overdose has been reported.

🧬 Clinical Pharmacology 194 words ▾

12 CLINICAL PHARMACOLOGY EVITHROM requires no intermediate physiological agent because it clots the fibrinogen of the blood directly. Failure to clot blood occurs in the rare case where the primary clotting defect is the absence of fibrinogen itself. The speed with which thrombin clots blood is dependent upon the concentration of both thrombin and fibrinogen.

12.1Mechanism of Action Thrombin (coagulation factor IIa) is a highly specific protease that transforms plasma fibrinogen into fibrin which, in the presence of Factor XIII in the patient's plasma, is cross-linked to form a stable clot. 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. 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.

12.2Pharmacodynamics Clinical pharmacodynamic studies with human thrombin have not been performed as this would be ethically unacceptable with this type of product.

12.3Pharmacokinetics Due to the nature of the product, intended for topical application to the surface of tissue at the surgical site, pharmacokinetic studies were not conducted.

🧬 Mechanism of Action 89 words ▾

12.1Mechanism of Action Thrombin (coagulation factor IIa) is a highly specific protease that transforms plasma fibrinogen into fibrin which, in the presence of Factor XIII in the patient's plasma, is cross-linked to form a stable clot. 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. 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.

📦 How Supplied / Storage and Handling 104 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING EVITHROM is supplied in a 2 ml vial containing 2000 (1600-2400) units of lyophilized human thrombin powder for reconstitution in 2 ml Water for Injection, USP. Storage and handling Store EVITHROM powder vials at 2- 25°C (36-77°F) for up to 2 years. Store reconstituted EVITHROM solution at room temperature for up to 8 hours.

Do not use after the expiration date stated on the vial. Do not freeze or refrigerate EVITHROM once it has been reconstituted. Vials are for single use only.

Discard unused contents. Discard if the packaging of EVITHROM is damaged. Keep the vials protected from light.

📦 Storage and Handling 73 words ▾

Storage and handling Store EVITHROM powder vials at 2- 25°C (36-77°F) for up to 2 years. Store reconstituted EVITHROM solution at room temperature for up to 8 hours. Do not use after the expiration date stated on the vial. Do not freeze or refrigerate EVITHROM once it has been reconstituted. Vials are for single use only. Discard unused contents. Discard if the packaging of EVITHROM is damaged. Keep the vials protected from light.

📋 Description ~2 min read ▾

11 DESCRIPTION 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 . Table 2: Reducing factors of S/D treatment and nanofiltration for a series of viruses Virus HIV-1 SBV BVDV PRV EMCV HAV CPV Reduction factor (log 10 ) HIV-1: Human Immunodeficiency Virus Type 1 SBV: Sindbis Virus BVDV: Bovine Viral Diarrhea Virus PRV: Pseudorabies Virus EMCV: Encephalomyocarditis virus HAV: Hepatitis A Virus CPV: Canine Parvovirus SD Treatment >5.82 >5.31 >4.74 >4.25 Not Done Not Done

0.0Nanofiltration >4.36 >5.32 Not Done >5.47 6.37 6.95

5.85Global Reduction Factor >10.18 >10.63 >4.74 >9.72 6.37 6.95 5.85

💬 Information for Patients 159 words ▾

17 PATIENT COUNSELING INFORMATION Some viruses such as hepatitis A virus and parvovirus B19 are particularly difficult to remove or inactivate. Parvovirus B19 most seriously affects pregnant women or immune-compromised individuals. Symptoms of parvovirus B19 infection include: fever, drowsiness, chills and runny nose followed about two weeks later by a rash and joint pain.

Evidence of hepatitis A may include several days to weeks of poor appetite, fatigue and low-grade fever followed by nausea, vomiting and abdominal pain. Dark urine and a yellowed complexion are also common symptoms. Consult your physician if such symptoms appear.

If absorbed systemically EVITHROM could potentially cause blood clotting disorders. Consult your physician for any new or unusual symptoms. Distributed by: ETHICON, INC.

(logo) P.O. Box 151, Somerville, NJ 08876-0151 USA Manufactured by: Omrix Biopharmaceuticals Ltd. [logo] MDA blood bank, Sheba Hospital, Ramat-Gan POB 888, Kiryat Ono 55000 ISRAEL U.S. License No.

1603 Art. No. 80YZ00Z3D0 ETHICON, Inc.

2009 © Omrix Biopharmaceuticals Ltd., 2009

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 63713-0050-24 · Ethicon, 63730-0001-01 · NATURA →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.