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Haemophilus b conjugate (prp-t) vaccine Pregnancy and Breastfeeding Warnings

Brand names: ActHIB, Hiberix

Medically reviewed by Drugs.com. Last updated on Dec 4, 2023.

Haemophilus b conjugate (prp-t) vaccine Pregnancy Warnings

Use is not recommended.

AU TGA pregnancy category: B2
US FDA pregnancy category: C

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

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.

See references

Haemophilus b conjugate (prp-t) vaccine Breastfeeding Warnings

Use is not recommended.

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

Comments:
-This vaccine is not intended for adult use.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2022) "Product Information. ActHIB (Hib) (haemophilus b conjugate (PRP-T) vaccine)." sanofi pasteur
  4. (2022) "Product Information. Hiberix (Hib) (haemophilus b conjugate (PRP-T) vaccine)." GlaxoSmithKline

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2022) "Product Information. ActHIB (Hib) (haemophilus b conjugate (PRP-T) vaccine)." sanofi pasteur
  4. (2022) "Product Information. Hiberix (Hib) (haemophilus b conjugate (PRP-T) vaccine)." GlaxoSmithKline

Further information

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