Full Prescribing Info
Special Precautions
It is good clinical practice to precede vaccination by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints.
As with other vaccines, the administration of Cervarix should be postponed in subjects suffering from acute severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Cervarix should under no circumstances be administered intravascularly or intradermally. No data are available on subcutaneous administration of Cervarix.
As for other vaccines administered intramuscularly, Cervarix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Cervarix is a prophylactic vaccine. It is not intended to prevent progression of HPV-related lesions present at the time of vaccination. Cervarix does not provide protection against all oncogenic HPV types (see Pharmacology: Pharmacodynamics under Actions). Vaccination is primary prevention and is not a substitute for regular cervical screening (secondary prevention) or for precautions against exposure to HPV and sexually transmitted diseases.
Vaccination alongside cervical screening will reduce the risk of cervical cancer further than screening alone. It is important to continue cervical screening (i.e. pap smear, VIA) after vaccination and follow recommended local screening guidelines.
There are no data on the use of Cervarix in subjects with impaired immune responsiveness such as patients receiving immunosuppressive treatment. For these individuals, an adequate immune response may not be elicited.
Duration of protection has not fully been established. Sustained protective efficacy has been observed for up to 9.4 years after the first dose. Long-term studies are ongoing to establish the duration of protection (see Pharmacology: Pharmacodynamics under Actions).
Effects on Ability to Drive and Use Machines: No studies on the effects on the ability to drive or use machines have been performed.
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