Rotavirus vaccine Pregnancy and Breastfeeding Warnings
Rotavirus vaccine Pregnancy Warnings
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.
This product is not indicated for women of childbearing age and should not be administered to pregnant females. AU TGA pregnancy category: B2 US FDA pregnancy category: C
Rotavirus vaccine Breastfeeding Warnings
Safety has not been established. This medication is not indicated for adolescents or adults. Excreted into human milk: Data not available Excreted into animal milk: Data not available Comments: -Breast-feeding does not reduce the protection against rotavirus gastroenteritis. -The child being vaccinated may continue to be breastfed during vaccination.
References for pregnancy information
- "Product Information. Rotarix (rotavirus vaccine)." GlaxoSmithKline, Research Triangle Park, NC.
References for breastfeeding information
- "Product Information. RotaTeq (rotavirus vaccine)." Merck & Company Inc, West Point, PA.
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