Description
CERVAVAC® is indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types, included in the vaccine:
Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16 and 18.
Genital warts (condyloma acuminata) caused by HPV types 6 and 11.
CERVAVAC® is indicated in boys and men 9 through 26 years of age for the prevention of the following diseases caused by HPV types included in the vaccine:
Anal cancer caused by HPV types 16 and 18.
Genital warts (condyloma acuminata) caused by HPV types 6 and 11.
ROUTE OF ADMINISTRATION
CERVAVAC® should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.
CERVAVAC® must not be injected intravascularly, subcutaneous or intradermally. These methods of administration are not recommended.
The vaccine should be used as supplied; no dilution or reconstitution is necessary. The full recommended dose of the vaccine should be used.
Shake well before use. Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine. After thorough agitation, CERVAVAC® is a whitish turbid suspension.
Parenteral drug products should be inspected usually for particulate matter and discoloration prior to administration. Discard the product if particulates are present or if it appears discoloured.
DOSAGE
Individuals 9 to 14 years of age –
CERVAVAC® should be administered according to a 2-dose schedule (0.5 ml at 0, 6 months).
Individuals 15 to 26 years of age CERVAVAC® should be administered according to a 3-dose (0.5 ml at 0, 2, 6 months) schedule.
The second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period.
The use of CERVAVAC® should be in accordance with official recommendations.
Paediatric population –
The safety and efficacy of CERVAVAC® in children below 9 years of age have not been established. No data are available.
It is recommended that individuals who receive a first dose of CERVAVAC® complete the vaccination course with CERVAVAC®.
The need for a booster dose has not been established.
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