ROTARIX (Rotavirus Vaccine, Live, Oral), for oral administration, is a live, attenuated rotavirus vaccine derived from the human 89-12 strain which belongs to G1P[8] type. The rotavirus strain is propagated on Vero cells. After reconstitution, the final formulation (1 mL) contains at least 10^6.0 median Cell Culture Infective Dose (CCID₅₀) of live, attenuated rotavirus.

The lyophilized vaccine contains amino acids, dextran, Dulbecco's Modified Eagle Medium (DMEM), sorbitol, and sucrose. DMEM contains the following ingredients: sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, sodium hydrogenocarbonate, and phenol red. The liquid diluent contains calcium carbonate, sterile water, and xanthan. The diluent includes an antacid component (calcium carbonate) to protect the vaccine during passage through the stomach and prevent its inactivation due to the acidic environment of the stomach.

ROTARIX (rotavirus vaccine, live, oral suspension) contains no preservatives.

The tip cap and the rubber plunger of the oral applicator contain dry natural latex rubber. The vial stopper and transfer adapter are latex-free.

Last reviewed on RxList: 10/30/2009
This monograph has been modified to include the generic and brand name in many instances.