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  • Cervarix
    / GSK

    Active Ingredient *
    HPV-16 L1 20 mcg / 0.5 ml
    HPV-18 L1 20 mcg / 0.5 ml

    Status in Israel

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Syringe

    1 X 0.5 ml

    partial basket chart 86349 3917

    Related information


    The vaccination schedule depends on the age of the subject. If at any age the second vaccine dose is administered before the 5th month after the first dose, the third dose should always be administered. The need for a booster dose has not been established. It is recommended that subjects who receive a first dose of Cervarix complete the vaccination course with Cervarix.
    Paediatric population: Cervarix is not recommended for use in girls below 9 years of age due to lack of data on safety and immunogenicity in this age-group.
    For full details see prescribiung information.


    For females from 10 to 45 years of age for the prevention of cervical cancer by protecting against incident and persistent infections, cytological abnormalities including atypical squamous cells of undetermined significance (ASC-US) and cervical intraepithelial neoplasia (CIN), CIN 1 and pre-cancerous lesions (CIN 2 and CIN 3) caused by human papillomavirus types 16 and 18. Immunogenicity studies have been conducted in females aged 10 to 14 years and 26 to 45 years to link efficacy in females aged 15 to 25 years to other populations.


    Known hypersensitivity to any component of the vaccine.

    Special Precautions

    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 otheroncogenic related HPV types. 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.
    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, 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.
    For full details see prescribiung information.

    Side Effects

    Injection site pain, Fatigue, headache, myalgia.

    Drug interactions

    In all clinical trials individuals who had received immunoglobulin or blood-derived products within 3 months prior to the first vaccine dose were excluded.
    Use with other vaccines: Cervarix may be administered concomitantly with a combined booster vaccine containing diphtheria (d), tetanus (T) and pertussis [acellular] (pa) with or without inactivated poliomyelitis (IPV), (dTpa, dTpa-IPV vaccines), with no clinically relevant interference with antibody response to any of the components of either vaccine. The sequential administration of combined dTpa-IPV followed by Cervarix one month later tended to elicit lower anti-HPV-16 and anti-HPV-18 GMTs as compared to Cervarix alone. The clinical relevance of this observation is not known. Cervarix may be administered concomitantly with a combined hepatitis A (inactivated) and hepatitis B (rDNA) vaccine (Twinrix) or with hepatitis B (rDNA) vaccine (Engerix B). Administration of Cervarix at the same time as Twinrix has shown no clinically relevant interference in the antibody response to the HPV and hepatitis A antigens. Anti-HBs geometric mean antibody concentrations were significantly lower on co-administration, but the clinical relevance of this observation is not known since the seroprotection rates remain unaffected. The proportion of subjects reaching anti-HBs ≥ 10mIU/ml was 98.3% for concomitant vaccination and 100% for Twinrix given alone. Similar results were observed when Cervarix was given concomitantly with Engerix B with 97.9% of subjects reaching anti-HBs ≥ 10mIU/ml compared to 100% for Engerix B given alone. If Cervarix is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.
    For full details see prescribiung information.

    Pregnancy and Lactation

    Pregnancy: Specific studies of the vaccine in pregnant women were not conducted. However, during the clinical development program, a total of 10,476 pregnancies were reported including 5,387 in women who had received Cervarix. Overall, the proportions of pregnant subjects who experienced specific outcomes (e.g., normal infant, abnormal infants including congenital anomalies, premature birth, and spontaneous abortion) were similar between treatment groups. Animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/foetal development, parturition or post-natal development. These data are insufficient to recommend use of Cervarix during pregnancy. Vaccination should, therefore, be postponed until after completion of pregnancy.
    Breast-feeding: The effect on breast-fed infants of the administration of Cervarix to their mothers has not been evaluated in clinical studies. Cervarix should only be used during breast-feeding when the possible advantages outweigh the possible risks.
    Fertility: No fertility data are available.


    No case of overdose has been reported.

    GlaxoSmithKline Biologicals S.A., Rixensart, Belgium