Components ofRotavirus Vaccines |
Components Page Excipients Table Allergens Table |
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Name | RotaTeq | Rotarix | |
Manufacturer | Merck Sharp & Dohme Corp | GlaxoSmithKline Biologicals | |
Viability | Live | Live | |
Indicated Ages | 6-32 weeks | 6-24 weeks | |
Dose | 2 mL | 1 mL | |
Schedule | 3 doses: 6-12 weeks, then at 4-10 week intervals (before 32 weeks of age) | 2 doses: 6 weeks of age, then after at least 4 weeks (before 24 weeks of age) | |
Route | Oral | Oral | |
Appearance | Pale yellow clear liquid that may have a pink tint | White, turbid suspension | |
Concentration | Rotavirus Reassortants: • G1, ≥2.2 x 106 infectious units • G2, ≥2.8 x 106 infectious units • G3, ≥2.2 x 106 infectious units • G4, ≥2.0 x 106 infectious units • P1A, ≥2.3 x 106 infectious units |
• Rotavirus type G1P, 106.0 median Cell Culture Infective Dose | |
Preservative | None | None | |
Adjuvant | None | None | |
Excipients | Unspecified amounts: • Sucrose • Sodium citrate • Sodium phosphate monobasic monohydrate • Sodium hydroxide, • Polysorbate 80 • Cell culture media • Fetal bovine serum, trace amounts • PCV 1&2 |
Unspecified amounts: • 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 |
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Allergens | None | • Albumin, Fetal Bovine Serum, trace amounts | |
Media | Buffered stabilizer solution | Dulbecco’s Modified Eagle Medium (DMEM) | |
Packaging | • 10-pack of single-dose tubes • 25-pack of single dose tubes |
10-packs of single-dose vials with oral applicator diluents | |
Storage | 2-8°C (36-46°F) Do not freeze |
2-8°C (35-46°F) Do not freeze |
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PI date | February 2017 | April 2016 | |
table last updated 10/24/17 |