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Mixed grass pollens allergen extract Pregnancy and Breastfeeding Warnings

Mixed grass pollens allergen extract is also known as: Oralair

Medically reviewed by Drugs.com. Last updated on Dec 10, 2018.

Mixed grass pollens allergen extract Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

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

Animal studies at doses up to 76 times the maximum clinical exposure have failed to reveal evidence of fetotoxicity. 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 B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Mixed grass pollens allergen extract Breastfeeding Warnings

Caution is recommended.

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

See references

References for pregnancy information

  1. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. Available from: URL: http://www.tga.gov.au/docs/html/medpreg.htm." ([1999]):
  2. "Product Information. Oralair (mixed grass pollens allergen extract)." Greer Laboratories Inc, Lenoir, NC.

References for breastfeeding information

  1. "Product Information. Oralair (mixed grass pollens allergen extract)." Greer Laboratories Inc, Lenoir, NC.

Further information

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

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