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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

Download Complete Prescribing Information for ROTARIX

ROTARIX is a registered trademark of GlaxoSmithKline.
Manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium
Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709