Human papilloma virus vaccine

Indications & Dose:

Prevention of cervical cancer and other precancerous lesions caused by human papilloma virus types 16 and 18 . Prevention of genital warts and precancerous lesions caused by human papilloma virus types 6, 11, 16, and 18. Human papilloma virus vaccine will be most effective if given before sexual activity starts. The duration of protection has not been established but sustained immunity has been observed in women who have been followed up for 4.5 years after completion of the primary course,

As the vaccines do not protect against all strains of human papilloma virus, routine cervical screening should continue.

DOSE: by intramuscular injection preferable into deltoid region or higher anterolateral thigh, 

Adult and Child 9-26 years, 3 doses of 0.5mL, the second 2 months and the third 6 months after the first dose Alternative schedule for 

Adult and Child 9-26 years, 3 doses of 0.5 mL, the second at least 1 month, and the third at least 4 months after the first dose; schedule shoul be completed within 12 months

The primary vaccination course consists of three doses.: The recommended vaccination schedule is 0, 1, 6 months. If flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose and the third dose between 5 and 12 months after the first dose. Although the necessity for a booster dose has not been established, an anamnestic response has been observed after the administration of a challenge dose. Cervarix is for intramuscular injection in the deltoid region

Contraindications:

CONTRA-INDICATIONS AND SIDE-EFFECTS. 

Injection-site reactions are very common with human papilloma virus vaccine. Other side-effects include gastrointestinal disturbances and dizziness. Headache, myalgia, and arthralgia have been reported frequently with Cervarix From autumn 2008, human papilloma virus vaccine will be offered to girls aged 12-13 years as part of the immunization schedule.

Side Effects:

Cautions:

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

As for other vaccines administered intramuscularly, Cervarix TM 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 TM is a prophylactic vaccine. It is not intended to prevent progression of HP V-related lesions present at the time of vaccination. CervarixTM does not provide protection against all oncogenic HPV types (see Pharmacodynamics). 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.

There are no data on the use of Cervarix TM in subjects with impaired immune responsiveness such as HIV infected patients or 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 6.4 years after the first dose. Long-term studies are ongoing to establish the duration of protection (see Pharmacodynamics).

Interaction:

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Very common: headache, myalgia,injection site reactions including pain, redness, swelling, fatigue . Common: gastrointestinal including nausea, vomiting, diarrhoea and abdominal pain,f ever (>380C) Skin and subcutaneous tissue disorders:, itching/pruritus, rash, urticaria, arthralgia 

Patient And Carer Advice: