Influenza virus vaccine, h5n1 Pregnancy and Breastfeeding Warnings
Brand names: Audenz
Influenza virus vaccine, h5n1 Pregnancy Warnings
The manufacturer makes no recommendation regarding use during pregnancy.
US FDA pregnancy category: Not assigned
Comments:
-Pregnant women infected with influenza are at increased risk of severe illness compared to non-pregnant women.
-Pregnant women with influenza may have increased risk of adverse pregnancy outcomes, including preterm labor and delivery.
Animal studies did not show evidence of harm to the fetus or offspring. 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.
Influenza virus vaccine, h5n1 Breastfeeding Warnings
Benefit should outweigh risk.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
See also
References for pregnancy information
- Product Information. Influenza Virus Vaccine, H5N1, Inactivated (influenza virus vaccine, H5N1, inactivated). GlaxoSmithKline. 2022.
References for breastfeeding information
- Product Information. Influenza Virus Vaccine, H5N1, Inactivated (influenza virus vaccine, H5N1, inactivated). GlaxoSmithKline. 2022.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
