Important Safety Information

• In clinical studies, common adverse events were fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting.
• History of uncorrected congenital malformation of the gastrointestinal tract is a contraindication.
• Previous hypersensitivity to any component of ROTARIX, including latex rubber, should be reviewed prior to administration.
• Administration in infants suffering from acute diarrhea or vomiting should be delayed.
• Safety and effectiveness in infants with chronic gastrointestinal disorders, or with known primary or secondary immunodeficiencies, have not been evaluated.