Warnings and Precautions:

Traceability

• In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
• The decision to vaccinate an individual should take into account the risk of previous HPV exposure and the potential benefit from vaccination.
• As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
• Syncope (Fainting), sometimes associated with falling; 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, Therefore, vaccines should be observed for approximately 15 minutes after vaccine administration, it is important that procedures are in place to avoid injury from faints.
• As with any vaccine, vaccination with GARDASIL may not result in protection in all vaccine recipients.
• GARDASIL will only protect against diseases that are caused by HPV types 6, 11, 16, and 18 and to a limited extent against diseases caused by certain related HPV types, therefore, appropriate precautions against sexually transmitted diseases should continue to be used.
• GARDASIL is for prophylactic use only and has no effect on active HPY infections or established clinical disease. Gardasil has not been shown to have a therapeutic effect. The vaccine is, therefore, not indicated for treatment of cervical cancer, high-grade cervical, vulvar, and vaginal dysplastic lesions, or genital warts. It is also not intended to prevent the progression of other established HPV-related lesions.
• GARDASIL does not prevent lesions due to a vaccine HPV type in individuals infected with that HPV type at the time of vaccination.
• The use of GARDASIL in adult women should take into consideration the variability of HPV-type prevalence in different geographical areas.
• Vaccination is not a substitute for routine cervical screening. Since no vaccine is 100% effective and GARDASIL will not provide protection against every HPV type, or against existing HPV infections, routine cervical screening remains critically important and should follow local recommendations.
• Safety and immunogenicity of the vaccine have been assessed in individuals aged from 7 to 12 years who are known to be infected with human immunodeficiency virus (HIV).
• Individuals with impaired immune responsiveness, due to either the use of potent immunosuppressive therapy, a genetic defect, or other causes, may not respond to the vaccine.
• This vaccine should be given with caution to individuals with thrombocytopenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals.
• Long-term follow-up studies were conducted to determine the duration of the protection.
• There are no safety, immunogenicity, or efficacy data to support change during vaccination with GARDASIL to other HPV vaccines which do not cover the same HPV types. Therefore, it is important that the same vaccine should be prescribed for the whole dose regimen.

Sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.