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Brilliant blue g ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: TissueBlue

Brilliant blue g ophthalmic Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not Assigned.

Risk summary:
-No data available on use of this stain in pregnant women to inform a stain-related risk.

Comments:
-Fetal exposure to the stain is unlikely, due to the negligible systemic exposure following intravitreal injection and subsequent removal of the stain at the completion of surgical procedures.

Animal studies have not been reported. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Brilliant blue g ophthalmic Breastfeeding Warnings

Safety has not been established.

Excreted into human milk: Data not available
Excreted into animal milk: Data not available

Comments:
-The effects on the nursing infant or on milk production are unknown.
-Exposure of this stain to a nursing infant is unlikely due to the negligible systemic exposure following intravitreal injection and subsequent removal of the stain at the completion of surgical procedures.

See references

References for pregnancy information

  1. (2022) "Product Information. TissueBlue (brilliant blue G ophthalmic)." Dutch Ophthalmic USA

References for breastfeeding information

  1. (2022) "Product Information. TissueBlue (brilliant blue G ophthalmic)." Dutch Ophthalmic USA

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.