ROTARIX has not been evaluated for carcinogenicity or mutagenicity.
(VAN’s Note: This means that it hasn’t been safety tested to see if it causes cancer or if it mutates into another illness).
Impairment of Fertility
ROTARIX has not been evaluated for its potential to impair fertility.
(VAN’s Note: This means it has not been safety tested to see if it causes infertility).
Genotoxicity
ROTARIX has not been evaluated for genotoxicity.
(VAN’s Note: This means that it hasn’t been safety tested to see if it damages DNA).
Use in Pregnancy (Category B2):
ROTARIX is not intended for use in adolescents or adults. Thus human data on use during pregnancy are not available and animal reproduction studies have not been performed.
Use in Lactation:
ROTARIX is not intended for use in adolescents or adults. Thus human data on use during lactation are not available.
Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against rotavirus gastro-enteritis afforded by ROTARIX. Therefore, breast-feeding may be continued during the vaccination schedule.
Paediatric Use
ROTARIX is intended for use in infants in the first six months of life. ROTARIX should not be administered to children older than 24 weeks of age as safety has not been demonstrated, particularly in relation to risk of intussusception.
Use in the Elderly
ROTARIX is not intended for use in the elderly. Thus human data on use in the elderly are not available.
