Special Warning : אזהרת שימוש

4.4     Special warnings and precautions for use

The decision to vaccinate an individual woman should take into account her risk for previous HPV exposure and her potential benefit from vaccination.

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.

Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints.

Cervarix should under no circumstances be administered intravascularly or intradermally.
No data are available on subcutaneous administration of Cervarix.

As with 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 will only protect against diseases that are caused by HPV types 16 and 18 and to some extent against diseases caused by certain other oncogenic related HPV types (see section 5.1). Therefore, appropriate precautions against sexually transmitted diseases should continue to be used.

Cervarix is for prophylactic use only and has no effect on active HPV infections or established clinical disease. Cervarix has not been shown to have a therapeutic effect. The vaccine is therefore not indicated for treatment of cervical cancer or cervical intraepithelial neoplasia (CIN). It is also not intended to prevent progression of other established HPV-related lesions or existing HPV infections with vaccine or non-vaccine types (see section 5.1 “Efficacy in women with evidence of HPV-16 or HPV-18 infection at study entry.”).

Vaccination is not a substitute for routine cervical screening. Since no vaccine is 100% effective and Cervarix will not provide protection against every HPV type, or against existing HPV infections, routine cervical screening remains critically important and should follow local recommendations.

Duration of protection has not fully been established. Timing and need of booster dose(s) has not been established.

Except for asymptomatic human immunodeficiency virus (HIV) infected subjects for whom limited immunogenicity data are available (see section 5.1), there are no data on the use of Cervarix in subjects with impaired immune responsiveness such as patients receiving immunosuppressive treatment. As with other vaccines, an adequate immune response may not be elicited in these individuals.

There are no safety, immunogenicity or efficacy data to support interchangeability of Cervarix with other HPV vaccines.

Effects on Driving

4.7         Effects on ability to drive and use machines

No studies on the effects on the ability to drive or use machines have been performed.