(thrombin, topical, bovine origin)

Prescribing Information
Download Prescribing Information

Health Professional Information

Nonclinical Toxicology

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been undertaken examining carcinogenicity, genetic toxicity or fertility.

13.2 Animal Toxicology and/or Pharmacology

Thrombin Concentration Study

In a blinded pre-clinical study conducted on a liver lesion model in swine, an inverse dose related response was observed between the visual bleeding scores and the thrombin1 concentration within the absorbable gelatin powder delivery system (GEL-FLOW™ NT) syringe, a device containing 550 mg of absorbable gelatin powder (GELFOAM® Powder).1 Bleeding was assigned scores according to a visual scale, with scores of 0 (no bleeding), 0.5 (ooze), 1 (very slight), 2 (slight), 3 (moderate), and 4 (severe). Scores of 1 and less were considered clinically acceptable. The 770 IU/mL thrombin concentration provided statistically significant lower bleeding scores than either 375 IU/mL or 250 IU/mL thrombin concentrations2 (Table 1). The results of this study showed that higher concentrations of thrombin within the GEL-FLOW™ NT syringe resulted in improved hemostasis as measured by lower bleeding scores.

Table 1: Comparison of Effect on Hemostasis of Varying Thrombin Concentrations in GEL-FLOW™ NT as Measured by Bleeding Scores in Swine Liver Lesion Model using Repeated Measures Logistic Regression
Parameter250 IU/mL
Mean (Standard Error)		375 IU/mL
Mean (Standard Error)		770 IU/mL
Mean (Standard Error)
*
Significantly different from both 250 and 375 IU/mL at <0.001 significance level. Tukey adjusted p-values for multiple comparisons.
†
Significantly different from 250 IU/mL at the 0.05 significance level. Tukey adjusted p-value for multiple comparisons.

3 Minute Bleeding Score

1.8 (0.2)

1.6 (0.2)

0.7 (0.2)*

6 Minute Bleeding Score

1.7 (0.2)

1.5 (0.2)

0.6 (0.2)*

9 Minute Bleeding Score

1.5 (0.2)

1.2 (0.2)

0.5 (0.2)*

12 Minute Bleeding Score

1.4 (0.2)

1.0 (0.2)†

0.4 (0.2)*

1
THROMBIN-JMI (Thrombin, Topical (Bovine) U.S.P.) was used for all thrombin concentrations tested in this study.
2
Per the THROMBIN-JMI prescribing information, for routine use THROMBIN-JMI is reconstituted with sterile isotonic saline at a recommended concentration of 1,000 to 2,000 IU per mL.
Medication Guide
Download Consumer Medicine Information

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Additional Resources

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine or vaccine.

Speak with a Pfizer Medical Information Professional regarding your Pfizer medicine or vaccine inquiry.

Available 9AM-5PM ET Monday to Friday; excluding holidays.

 

Submit a medical question for a Pfizer medicine or a vaccine. 

The submission will be reviewed during our standard business hours.

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this medication, click the link below to submit your information: 
Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer medication, please call (800) 438-1985.

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.