NOVARTIS PRODUCT
8.3 Nursing Mothers
It is not known whether FLUVIRIN or Influenza A (H1N1) 2009 Monovalent Vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Influenza A (H1N1) 2009 Monovalent Vaccine is administered to a nursing woman.
8.4
Pediatric Use
Safety and effectiveness in pediatric subjects below the age of 4 years have not been established. [see ADVERSE REACTIONS (6) and CLINICAL STUDIES (14)]
SEE ENTIRE FDA REPORT HERE:
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182242.pdf
