External Websites
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Indications and Usage
ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series in infants and children.
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.
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