ROTARIX offers early protection to help prevent RGE and its consequences [1]
Only ROTARIX provides completion of the rotavirus immunization series by 4 months of age in just 2 oral doses. [1,2]
ROTARIX provides significant reduction in serious consequences of RGE [1,3]
The following graph shows the significant and sustained protection of ROTARIX against hospitalizations through 2 rotavirus seasons. [1,3]
Study design: A randomized, double-blind, placebo-controlled study was conducted in 6 European countries comparing ROTARIX (n=2,572) vs placebo (n=1,302). The first dose was given at 6 to 14 weeks of age, and the second dose was given at least 4 weeks after the first dose. The 2-dose series was completed by 24 weeks of age. Analysis includes all infants who received 2 doses of vaccine. [1]
- 92% reduction in medically attended visits through the first rotavirus season [3]
NEXT: G1 and Non-G1 Protection >>
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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Download Complete Prescribing Information for ROTARIX |
