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GARDASIL (CERVICAL CANCER) VACC PFS EA

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GARDASIL (CERVICAL CANCER) VACC PFS EA

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GARDASIL (CERVICAL CANCER) VACC PFS EA

GardasilL is a recombinant, quadrivalent vaccine.

The quadrivalent Human Papillomavirus Virus-Like Particle vaccine (HPV VLP vaccine) is a sterile liquid suspension prepared from the highly purified virus-like particles (VLPs) of the recombinant major capsid (L1) protein of HPV Types 6, 11, 16, and 18. The L1 proteins are produced by separate fermentations in recombinant yeast Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895) and self-assembled into VLPs. The VLPs for each type are purified and adsorbed on aluminium-containing adjuvant (amorphous aluminium hydroxyphosphate sulfate, or AAHS). The quadrivalent HPV VLP vaccine is prepared by combining the adsorbed VLPs of each HPV type, the aluminium-containing adjuvant formulation, and a buffer.

Gardasil is a sterile preparation for intramuscular administration. Each 0.5-mL dose contains approximately 20 mcg of HPV 6 L1 protein, 40 mcg of HPV 11 L1 protein, 40 mcg of HPV 16 L1 protein, and 20 mcg of HPV 18 L1 protein.

Each 0.5-mL dose of the vaccine contains approximately 225 mcg of aluminium (as amorphous aluminium hydroxyphosphate sulfate adjuvant), 9.56 mg of sodium chloride,
0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of borax, residual traces (<7mcg/dose) of yeast protein and water for injection. The product does not contain a
preservative or antibiotics.

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SKU CSL80860101