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Influenza virus vaccine, inactivated Pregnancy and Breastfeeding Warnings

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

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.

See references

Influenza virus vaccine, inactivated Breastfeeding Warnings

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

See references

References for pregnancy information

  1. "Product Information. Afluria 2015-2016 (influenza virus vaccine, inactivated)." bioCSL Inc, King of Prussia, PA.
  2. "Product Information. Fluzone Influenza Vaccine (influenza virus vaccine)." Connaught, Swiftwater, PA.
  3. "Product Information. Fluarix Quadrivalent 2015-2016 (influenza virus vaccine, inactivated)." GlaxoSmithKline, Research Triangle Park, NC.
  4. "Product Information. Fluvirin 2015-2016 (influenza virus vaccine, inactivated)." Novartis Vaccines & Diagnostics Inc, Cambridge, MA.
  5. "Product Information. Fluzone High-Dose 2015-2016 (influenza virus vaccine, inactivated)." sanofi pasteur, Swiftwater, PA.
  6. "Product Information. Flublok 2015-2016 (influenza virus vaccine, inactivated)." Protein Sciences Corporation, Meriden, CT.
  7. Cerner Multum, Inc. "Australian Product Information." O 0
  8. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  9. "Product Information. Fluzone Quadrivalent (influenza virus vaccine, inactivated)." Sanofi Pasteur, Toronto, IA.
  10. "Product Information. FluLaval 2014-2015 (influenza virus vaccine, inactivated)." GlaxoSmithKline, Research Triangle Park, NC.
  11. "Product Information. FluMist Quadrivalent (influenza virus vaccine, live)." AstraZeneca Pharma Inc, Mississauga, IA.
  12. "Product Information. FluLaval Quadrivalent 2015-2016 (influenza virus vaccine, inactivated)." GlaxoSmithKline, Research Triangle Park, NC.
  13. "Product Information. Fluzone Intradermal 2014-2015 (influenza virus vaccine, inactivated)." sanofi pasteur, Swiftwater, PA.
  14. "Product Information. Fluarix 2014-2015 (influenza virus vaccine, inactivated)." GlaxoSmithKline, Research Triangle Park, NC.
  15. "Product Information. Agriflu (influenza virus vaccine, inactivated)." Novartis Pharmaceuticals, East Hanover, NJ.
  16. "Product Information. Flucelvax 2015-2016 (influenza virus vaccine, inactivated)." Novartis Vaccines & Diagnostics Inc, Cambridge, MA.

References for breastfeeding information

  1. "Product Information. Fluzone High-Dose 2015-2016 (influenza virus vaccine, inactivated)." sanofi pasteur, Swiftwater, PA.
  2. "Product Information. Fluzone Quadrivalent (influenza virus vaccine, inactivated)." Sanofi Pasteur, Toronto, IA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Flublok 2015-2016 (influenza virus vaccine, inactivated)." Protein Sciences Corporation, Meriden, CT.
  5. Cerner Multum, Inc. "Australian Product Information." O 0
  6. "Product Information. FluLaval 2014-2015 (influenza virus vaccine, inactivated)." GlaxoSmithKline, Research Triangle Park, NC.
  7. "Product Information. FluMist (influenza virus vaccine, live, trivalent)." Medimmune Inc, Gaithersburg, MD.
  8. "Product Information. FluLaval Quadrivalent 2015-2016 (influenza virus vaccine, inactivated)." GlaxoSmithKline, Research Triangle Park, NC.
  9. "Product Information. Fluzone Intradermal 2014-2015 (influenza virus vaccine, inactivated)." sanofi pasteur, Swiftwater, PA.
  10. "Product Information. FluMist Quadrivalent (influenza virus vaccine, live)." AstraZeneca Pharma Inc, Mississauga, IA.
  11. "Product Information. Fluarix 2014-2015 (influenza virus vaccine, inactivated)." GlaxoSmithKline, Research Triangle Park, NC.
  12. "Product Information. Flucelvax 2015-2016 (influenza virus vaccine, inactivated)." Novartis Vaccines & Diagnostics Inc, Cambridge, MA.
  13. "Product Information. Agriflu (influenza virus vaccine, inactivated)." Novartis Pharmaceuticals, East Hanover, NJ.
  14. "Product Information. Fluarix Quadrivalent 2015-2016 (influenza virus vaccine, inactivated)." GlaxoSmithKline, Research Triangle Park, NC.
  15. "Product Information. Afluria 2015-2016 (influenza virus vaccine, inactivated)." bioCSL Inc, King of Prussia, PA.
  16. "Product Information. Fluvirin 2015-2016 (influenza virus vaccine, inactivated)." Novartis Vaccines & Diagnostics Inc, Cambridge, MA.

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