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Influenza virus vaccine, inactivated Pregnancy and Breastfeeding Warnings

Influenza virus vaccine, inactivated is also known as: Afluria, Agriflu, FluLaval, FluLaval Quadrivalent, Fluarix, Fluarix Quadrivalent, Fluarix Quadrivalent 2015-2016, Flublok, Flublok 2015-2016, Flucelvax, Flucelvax 2015-2016, Fluogen, Flushield, Fluvirin, Fluvirin Preservative-Free, Fluzone, Fluzone High-Dose, Fluzone Intradermal, Fluzone Intradermal Quadrivalent, Fluzone Preservative-Free, Fluzone Preservative-Free Pediatric, Fluzone Preservative-Free Pediatric Quadrivalent, Fluzone Preservative-Free Quadrivalent, Fluzone Quadrivalent

Influenza virus vaccine, inactivated Pregnancy Warnings

Animal studies did not show effects on pregnancy, embryo-fetal development, postnatal development, or fertility. There are no controlled data in human pregnancy. Limited post-marketing data do not indicate adverse fetal or maternal outcomes. A pregnancy registry has been established in the US for women receiving FLULAVAL(R), FLUARIX(R), or FLUARIX QUADRIVALENT(R) flu vaccine at 1-888-452-9633, for Flublock(R) at 1-888-855-7871, or for Fluzone(R) (all formulations) at 1-800-822-2463 AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is not recommended unless clearly needed. AU TGA pregnancy category: B2 US FDA pregnancy category: C Comments: -Pregnant women, particularly during the second and third trimester, are at increased risk of influenza related complications. -Vaccination before pregnancy and/or flu season is recommended.

Influenza virus vaccine, inactivated Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Data not available

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