Components of Rotavirus Vaccine	Excipients Table Allergens Table Components Table
Indication Prevention of Rotavirus Gastroenteritis Proprietary Name Rotarix RotaTeq Manufacturer GlaxoSmith Kline Merck Viability Live Live Microorganism 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated human G1P rotavirus Reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 – 2.8 x 106 IU, depending on the serotype, and not greater than 116 x 106 IU Dose 1 mL 2 mL Recommended Ages 6-24 weeks 6-32 weeks Route Oral Oral Dose form Liquid Liquid Appearance White and turbid Pale yellow clear liquid that may have a pink tint Concentration (per dose) ≥ 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated human G1P rotavirus 2.0 - 2.8 x 106 infectious units of each reassortant Excipients Amino Acids Calcium carbonate Calcium chloride Concentrated Vitamin solution Dextran D-glucose Dulbecco's Modified Eagle Medium (DMEM) Ferric nitrate L-cystine L-glutamine L-tyrosine Magnesium Sulfate Phenol red Porcine circovirus type 1, trace amounts Sodium chloride Sodium phosphate Sodium pyruvate Solidum hydrogenocarbonate Sorbitol Sucrose Xanthan Fetal bovine serum, trace amounts Polysorbate 80 Sodium citrate Sodium phosphate monobasic monohydrate Sodium hydroxide Sucrose Adjuvant None None Allergens Latex, contained in the oral applicator PCV-1, trace amounts Fetal bovine serum (trace) Preservatives None None Media Vero cells Vero cells Packaging Vial, a prefilled oral applicator of liquid diluent (1 mL) with a plunger stopper, and a transfer adapter for reconstitution. 10-pack of individually pouched single-dose tubes Routine Storage 2° to 8°C (36° to 46°F) or at room temperature up to 25°C (77°F), after reconstitution. Do not freeze. S2-8°C (36-46°F) Protect from light Package Insert date February 2011 September 2011 updated January 2012
This page was last updated on January 24, 2012 © 2012 Institute for Vaccine Safety