Cervarix (prefilled syringe)

3.1 Therapeutic indications

Cervarix is a vaccine indicated in females from 9 to 25 years of age for the prevention of persistent infection, premalignant cervical lesions and cervical cancer caused by Human Papillomavirus (HPV) Types 16 & 18. See sections 3.4 and 4.1 for important information on the data regarding HPV-16 and/or HPV-18, and other oncogenic HPV types that support this indication – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

The indication is based on the demonstration of efficacy in women aged 15 to 25 years following vaccination with Cervarix and on the immunogenicity of the vaccine in girls and women aged 9 to 25 years.

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

3.3 Contraindications

Cervarix should not be administered to subjects with known hypersensitivity to any component of the vaccine (see sections 2 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information ).

Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of Cervarix should not receive further doses of Cervarix.

3.2 Posology and method of administration

The vaccination schedule depends on the age of the subject.

The necessity for a booster dose has not been established (see section 4.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information ).

Cervarix is for intramuscular injection in the deltoid region. Cervarix should under no circumstances be administered intravascularly or intradermally. No data are available on subcutaneous administration of Cervarix.

Paediatric population: Cervarix is not recommended for use in children below 9 years of age.