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THROMBIN-JMI® (thrombin, topical, bovine origin) Use in Specific Populations

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

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 or can affect reproduction capacity. THROMBIN-JMI should be given to a pregnant woman only if clearly needed.

8.2 Labor and Delivery

Information is unknown.

8.3 Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when THROMBIN-JMI is administered to a nursing woman.

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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