Active Ingredients: ProQuad, when reconstituted as directed, is a sterile preparation for intramuscular or subcutaneous administration. Each approximately 0.5-mL dose contains not less than 3.00 log10 TCID50 (50% tissue culture infectious dose) of measles virus; 4.30 log10 TCID50 of mumps virus; 3.00 log10 TCID50 of rubella virus; and a minimum of 3.99 log10 PFU (plaque-forming units) of Oka/Merck varicella virus.
Chemistry: ProQuad is a combined attenuated live virus vaccine containing measles, mumps, rubella, and varicella viruses. ProQuad is a sterile lyophilized preparation of (1) the components of M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live): a more attenuated line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo cell culture; the Jeryl Lynn (B level) strain of mumps virus propagated in chick embryo cell culture; the Wistar RA 27/3 strain of live attenuated rubella virus propagated in WI-38 human diploid lung fibroblasts; and (2) the Oka/Merck strain of varicella-zoster virus propagated in MRC-5 cells (same varicella strain as in VARIVAX).
Excipients/Inactive Ingredients: Each approximately 0.5-mL dose of the vaccine contains no more than 20 mg of sucrose, 11 mg of hydrolyzed gelatin, 2.5 mg of urea, 2.3 mg of sodium chloride, 16 mg of sorbitol, 0.38 mg of monosodium L-glutamate, 1.4 mg of sodium phosphate, 0.25 mg of recombinant human albumin, 0.13 mg of sodium bicarbonate, 94 μg of potassium phosphate, 58 mcg of potassium chloride; residual components of MRC-5 cells including DNA and protein; 5 μg of neomycin, bovine serum albumin (0.5 μg), and other buffer and media ingredients. The product contains no preservative.
The cells, virus pools, bovine serum, and recombinant human albumin used in manufacturing are all screened to ensure the absence of adventitious agents.
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