|ABBREVIATED PRESCRIBING INFORMATION: (Please refer to Summary of Product Characteristics for full product information)|
CERVARIX®▼ Human Papillomavirus Vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed). Suspension for injection. Uses: Prevention of high-grade cervical intraepithelial neoplasia (CIN 2/3) and cervical cancer causally related to Human Papillomavirus (HPV) types 16 and 18. Indication is based on clinical efficacy in women aged 15-25 years, and inferred efficacy in adolescent girls aged 10 -14 years on the basis of non-inferior immunogenicity. Data in women aged 26-55 years: Cervarix® is immunogenic in women aged 26-55 years, but antibody levels were lower than those in women aged 15-25 years. Dosage and administration: It is recommended that a 3-dose vaccination course with Cervarix® is completed. The recommended vaccination schedule is one 0.5ml dose at 0, 1 and 6 months. Cervarix® should be administered by intramuscular injection (IM) in the deltoid region. Need for booster dose has not been established. Girls under 10 years: not recommended. Active ingredients: Each 0.5 ml dose contains: HPV 16 L1 protein (20 micrograms), HPV 18 L1 protein (20 micrograms), adjuvanted by AS04 containing monophosphoryl lipid A (50 micrograms), adsorbed on aluminium hydroxide (0.5 milligrams Al3+ in total). Contraindications: Hypersensitivity to any component of the vaccine. Acute severe febrile illness. Precautions and warnings: Appropriate treatment should be available in case of rare anaphylactic reactions. Cervarix® must not be administered intravascularly or intradermally. Caution in thrombocytopenia or any coagulation disorder, as bleeding may occur following an IM injection. As with any vaccine, a protective immune response may not be elicited in all vaccinees. Cervarix® protects against disease caused by HPV 16 and 18. Other oncogenic HPV types can also cause cervical cancer. Vaccination is not therefore a substitute for regular cervical screening, or for precautions against exposure to HPV and sexually transmitted diseases. Cervarix® does not prevent HPV-related lesions in women infected with HPV-16 or HPV-18 at the time of vaccination and has not been shown to have a therapeutic effect. There are no data on the use of Cervarix® in subjects with impaired immune responsiveness. Duration of protection has not been fully established. Timing and need of booster has not been investigated. Interactions: Data not generated on the concomitant administration of Cervarix® and other vaccines. As with other vaccines it may be expected that, in patients receiving immunosuppressive treatment, an adequate response may not be elicited. Pregnancy/lactation: Vaccination should be postponed until after pregnancy. Cervarix® should only be used during breast-feeding if possible advantages outweigh possible risks. Undesirable effects: See SPC for full details. Very common: headache, myalgia and injection site reactions (including pain, redness, swelling), and fatigue. Common: gastrointestinal symptoms (including nausea, vomiting, diarrhoea and abdominal pain), itching/pruritus, rash, urticaria, arthralgia and fever (≥38°C). Uncommon: dizziness, upper respiratory tract infection and other injection site reactions such as induration and local paraesthesia. Overdose: No case of overdose has been reported. Legal category: POM. Presentation and basic NHS cost: Pre-filled 0.5 ml syringe (pack of 1) NHS cost £80.50. MA number EU/1/07/419/004. MA holder: GlaxoSmithKline Biologicals s.a. Rue de l'Institut 89, B-1330 Rixensart, Belgium. Further information is available from Customer Contact Centre, GlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex UB11 1BT; firstname.lastname@example.org; Freephone 0808 100 9997. Date of preparation: June 2008
Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to GlaxoSmithKline on 0808 100 9997.