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Dosing and Administration
ROTARIX is administered orally with the ease of an oral applicator, offering precise delivery1
Ready for oral administration.
Do not use a needle with ROTARIX. Not for injection.
Storage and Handling1
Each package of ROTARIX contains1
- 10 vials of lyophilized vaccine
- 10 oral applicators prefilled with diluent
- 10 transfer adapters
The tip caps of the prefilled oral applicators of diluent contain natural rubber latex, which may cause allergic reactions.
Storage before reconstitution1
- Lyophilized vaccine in vials: Store refrigerated at 2° to 8°C (36° to 46°F). Protect vials from light
- Diluent in oral applicators: Store refrigerated at 2° to 8°C (36° to 46°F) or at a controlled room temperature up to 25°C (77°F). Do not freeze. Discard if the diluent has been frozen
Storage after reconstitution1
- ROTARIX should be administered within 24 hours of reconstitution
- After reconstitution, store refrigerated at 2° to 8°C (36° to 46°F) or at a controlled room temperature up to 25°C (77°F). Discard the reconstituted vaccine in biological waste container if not used within 24 hours
- Do not freeze. Discard if the reconstituted vaccine has been frozen
REFERENCES
- Prescribing Information for ROTARIX.
- Vesikari T, Karvonen A, Prymula R, et al. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet. 2007;370:1757-1763.
- Centers for Disease Control and Prevention. Recommended Immunization Schedules for Persons Aged 0 Through 18 Years—United States, 2016. http://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf. Accessed November 26, 2019.
Indication
ROTARIX is a vaccine 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. ROTARIX is approved for use in infants 6 weeks to 24 weeks of age.
Important Safety Information
- Contraindications for ROTARIX include a history of any of the following: hypersensitivity to the vaccine or any component of the vaccine, intussusception, uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception, or Severe Combined Immunodeficiency Disease (SCID)
- The tip caps of the prefilled oral applicators of diluent contain natural rubber latex, which may cause allergic reactions
- Administration in infants suffering from acute diarrhea or vomiting should be delayed. Safety and effectiveness in infants with chronic gastrointestinal disorders have not been evaluated
- Safety and effectiveness in infants with known primary or secondary immunodeficiencies have not been established
- A study conducted after approval of ROTARIX showed an increased risk of intussusception in the 31 days after the first dose of ROTARIX, especially in the first 7 days. In other reports, an increased risk of intussusception has been observed within 7 days after dose 2
- In clinical studies, common adverse reactions in infants receiving ROTARIX included fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting
- Vaccination with ROTARIX may not result in protection in all vaccine recipients
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