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CDC Advisory Committee Recommends Cervarix To Prevent Cervical Cancer in Girls and Young Women
Date:10/21/2009

available in the U.S. in late 2009.

About CERVARIX®( )

CERVARIX is administered to girls and young women between the ages of 10-25 in a three dose schedule with the second and third doses administered one and six months after the first dose. To date, CERVARIX has been approved in 100 countries around the world, including the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico and Taiwan. GSK also received World Health Organization (WHO) prequalification in July 2009.

CERVARIX®( ) (Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant) is a registered trademark of the GlaxoSmithKline group of companies.

Important Safety Information

  • CERVARIX is contraindicated in patients with severe allergic reactions to any component of the vaccine.
  • CERVARIX is not recommended for use in pregnant women.
  • Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with CERVARIX. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position.
  • The most common local adverse reactions and general adverse events in greater than or equal to 20% of subjects were pain, redness, and swelling at the injection site, fatigue, headache, myalgia, gastrointestinal symptoms, and arthralgia.
  • Vaccination with CERVARIX may not result in protection in all vaccine recipients.

About Cervical Cancer

Women are at risk of HPV infection and cervical cancer throughout their lives. Approximately 100 types of HPV have been identified to date and, of these, appro
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SOURCE GlaxoSmithKline
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