THROMBIN-JMI® Use in Specific Populations

(thrombin, topical, bovine origin)

8 USE IN SPECIFIC POPULATIONS

     

8.1 Pregnancy

Risk Summary

Animal reproduction studies have not been conducted with THROMBIN-JMI. It is also not known whether THROMBIN-JMI can cause fetal harm when administered to a pregnant woman. THROMBIN-JMI should be given to a pregnant woman only if clearly needed.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

8.2 Lactation

It is not known whether this drug is excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for THROMBIN-JMI and any potential adverse effects on the breastfed infant from THROMBIN-JMI or from the underlying maternal condition.

8.4 Pediatric Use

Safety and effectiveness in children have not been established.

8.5 Geriatric Use

Clinical studies of THROMBIN-JMI did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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Use in Specific Populations

8 USE IN SPECIFIC POPULATIONS

     

8.1 Pregnancy

Risk Summary

Animal reproduction studies have not been conducted with THROMBIN-JMI. It is also not known whether THROMBIN-JMI can cause fetal harm when administered to a pregnant woman. THROMBIN-JMI should be given to a pregnant woman only if clearly needed.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

8.2 Lactation

It is not known whether this drug is excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for THROMBIN-JMI and any potential adverse effects on the breastfed infant from THROMBIN-JMI or from the underlying maternal condition.

8.4 Pediatric Use

Safety and effectiveness in children have not been established.

8.5 Geriatric Use

Clinical studies of THROMBIN-JMI did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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