Components of Rotavirus Vaccine	Excipients Table Allergens Table Components Table
Indication Prevention of Rotavirus Gastroenteritis Proprietary Name RotaTeq Rotarix Manufacturer Merck GlaxoSmith Kline Viability Live Live Microorganism Four reassortant rotaviruses express one of the outer capsid proteins (G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein (P7) from the bovine rotavirus parent strain The fifth reassortant virus expresses the attachment protein, P1A (genotype P[8]), from the human rotavirus parent strain and the outer capsid protein G6 from the bovine rotavirus parent strain 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 106 median Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus. Dose 2 mL 1 mL Recommended Age 6-32 weeks 6-24 weeks Route Oral Oral Dose form Liquid Liquid Appearance Pale yellow clear liquid that may have a pink tint White and turbid Concentration 2.0 - 2.8 x 106 infectious units of each reassortant ≥ 106 median Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus Preservatives None None Adjuvant None None Excipients Fetal bovine serum (trace) Polysorbate 80 Sodium citrate Sodium phosphate monobasic monohydrate Sodium hydroxide Sucrose 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 Sodium chloride Sodium phosphate Sodium pyruvate Solidum hydrogenocarbonate Sorbitol Sucrose Xanthan Allergens Fetal bovine serum (trace) Latex, contained in the oral applicator Media Cell culture Dulbecco’s Modified Eagle Medium (DMEM) Packaging 1 individually pouched single-dose tube 10-pack of individually pouched single-dose tubes ROTARIX is available as a vial of lyophilized vaccine, a prefilled oral applicator of liquid diluent (1 mL) with a plunger stopper, and a transfer adapter for reconstitution. Routine Storage Store and transport refrigerated at 2-8°C (36-46°F). RotaTeq should be administered as soon as possible after being removed from refrigeration. For information regarding stability under conditions other than those recommended, call 1-800-MERCK-90. Protect from light May be stored refrigerated at 2° to 8°C (36° to 46°F) or at room temperature up to 25°C (77°F), after reconstitution. Discard the reconstituted vaccine if not used within 24 hours in biological waste container. Do not freeze. Discard if the vaccine has been frozen. Package Insert last updated June 2013 September 2012 updated June 2013
This page was last updated on February 12, 2014 © 2014 Institute for Vaccine Safety