Rotarix components

Rotarix components are:

  • Human rotavirus RIX4414 strain (live, attenuated)*
    *Produced on Vero cells

Powder:

  • Sucrose
  • Dextran
  • Sorbitol
  • Amino acids
  • Dulbecco’s Modified Eagle Medium (DMEM)**

**Dulbecco’s Modified Eagle Medium (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.

Solvent:

  • Calcium carbonate
  • Xanthan gum
  • Sterile water

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.

In the manufacturing process, porcine-derived materials are used. Porcine circovirus type 1 (PCV-1) is present in ROTARIX. PCV-1 is not known to cause disease in humans.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 is available in single-dose vials of lyophilized vaccine, accompanied by a prefilled oral applicator of liquid diluent.

ROTARIX contains no preservatives.

The exact immunologic mechanism by which ROTARIX protects against rotavirus gastroenteritis is unknown. ROTARIX contains a live, attenuated human rotavirus that replicates in the small intestine and induces immunity.

Source:
https://www.fda.gov/media/75726/download
https://www.ema.europa.eu/en/documents/product-information/rotarix-epar-product-information_en.pdf

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