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GARDASIL(R) is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.
Prescribing information and patient product information for GARDASIL(R) is attached and is also available at www.gardasil.com. -0-
MERCK & CO., INC.
Whitehouse Station, NJ 08889, USA 9682301
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GARDASIL(R)
(Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant
Vaccine)
DESCRIPTION
GARDASIL* is a non-infectious recombinant, quadrivalent vaccine
prepared from the highly purified virus-like particles (VLPs) of the
major capsid (L1) protein of HPV Types 6, 11, 16, and 18. The L1
proteins are produced by separate fermentations in recombinant
Saccharomyces cerevisiae and self-assembled into VLPs. The
fermentation process involves growth of S. cerevisiae on
chemically-defined fermentation media which include vitamins, amino
acids, mineral salts, and carbohydrates. The VLPs are released from
the yeast cells by cell disruption and purified by a series of
chemical and physical methods. The purified VLPs are adsorbed on
preformed aluminum-containing adjuvant (amorphous aluminum
hydroxyphosphate sulfate). The quadrivalent HPV VLP vaccine is a
sterile liquid suspension that is prepared
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