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)

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Complete the Rotavirus Vaccination Series in Just 2 Oral Doses "toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"[1,3]

Important Dosing Information

ROTARIX is administered orally with the ease of an oral applicator, offering precise delivery "toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"[1]

 

Do not use a needle with ROTARIX.  Not for injection.

Storage and Handling "toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"[1]

Each package of ROTARIX contains "toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"[1]

  • 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 reconstitution "toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"[1]

  • 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 reconstitution "toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"[1]

  • 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

622801R0 July 2016