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Cervarix

Human Papillomavirus vaccine (Types 16, 18) (Recombinant, adjuvanted, adsorbed)

Product Overview

Cervarix - What is it?

Cervarix is a vaccine for use from the age of 9 years for the prevention of premalignant cervical lesions and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types. See sections 4.4 and 5.1 of the SPC for important information on the data that support this indication.

Presentation of Cervarix:

Human Papillomavirus vaccine (Types 16, 18) (Recombinant, adjuvanted, adsorbed) is supplied in a pre-filled syringe for intramuscular injection in the deltoid at 0, 1, 6 months.

If flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose and the third dose between 5 and 12 months after the first dose.

The need for a booster dose has not been established.

 

How Cervarix works:

Cervarix induces an immune response providing protection for at least 6.4 years in 15 to 25-year-olds. [1]

 

Side Effects of Cervarix:

Cervarix is generally well tolerated with the commonest adverse events being injection site reactions including pain, redness and swelling, fatigue, headache and myalgia.

 

Contraindications of Cervarix:

Cervarix is contraindicated in any subjects who are hypersensitive to the active substances or excipients or in anyone suffering from an acute, severe febrile illness. The presence of a minor infection, such as a cold, is not a contraindication for immunisation.

The use of Cervarix should be in accordance with official recommendations.

 

For further information on Human Papillomavirus vaccine (Types 16, 18) (Recombinant, adjuvanted, adsorbed), please see the Cervarix Summary of Product Characteristics (SPC). [2]

 

 

 

References:

  1. Romanowski B, Colares de Borba P, Naud PS, et al. Sustained efficacy and immunogenicity of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine: analysis of a randomised placebo-controlled trial up to 6-4 years. Lancet 2009; 374: 1975–85
  2. Cervarix Summary of Product Characteristics.
Cervarix is a trade mark of the GlaxoSmithKline group of companies.

Y.V.: Last updated 21 December 2011: UK/CER/0087/11

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UK/MARK/0222/10     DECEMBER 2010

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