Gardasil 9

Active immunisation of individuals ≥9 yr against premalignant lesions & cancers affecting the cervix, vulva, vagina & anus caused by vaccine HPV types; genital warts (Condyloma acuminata) caused by specific HPV types. Active immunisation of individuals 9-45 yr against cancers affecting the oropharynx & other head & neck sites caused by HPV types 16, 18, 31, 33, 45, 52, & 58.

IM Primary vaccination Individuals who receive a 1st dose of Gardasil 9 should complete the vaccination course w/ Gardasil 9. Individual 9-14 yr 2-dose schedule (0, 6-12 mth): 1st dose at elected date; 2nd dose at 5-13 mth after 1st dose. If 2nd dose is administered earlier than 5 mth after 1st dose, a 3rd dose should always be administered. 3-dose schedule (0, 2, 6 mth): 1st dose at elected date; 2nd dose at least 1 mth after 1st dose; 3rd dose at least 3 mth after 2nd dose. All 3 doses should be given w/in 1 yr. Individual ≥15 yr 3-dose schedule (0, 2, 6 mth): 1st dose at elected date; 2nd dose at least 1 mth after 1st dose; 3rd dose at least 3 mth after 2nd dose. All 3 doses should be given w/in 1 yr.

Hypersensitivity.

Must not be injected intravascularly, subcutaneously or intradermally. Should not be mixed in the same syringe w/ any other vaccines & soln. The decision to vaccinate an individual should take into account the risk for previous HPV exposure & potential benefit from vaccination. Appropriate medical treatment & supervision should always be readily available in case of rare anaphylactic reactions following vaccination. Observe vaccinees for approx 15 min after vaccination. Postpone vaccination in individuals suffering from acute severe febrile illness. May not result in protection in all vaccine recipients. Will only protect against diseases that are caused by HPV types targeted by the vaccine. Not indicated for treatment of cervical, vulvar, vag, anal, oropharyngeal & other head & neck cancers, high-grade cervical, vulvar, vag & anal dysplastic lesions or genital warts. Not intended to prevent progression of other established HPV-related lesions. Does not prevent lesions due to a vaccine HPV type in individuals infected w/ that HPV type at the time of vaccination. Not a substitute for routine cervical screening. Individuals w/ impaired immune responsiveness (due to use of potent immunosuppressive therapy, genetic defect, HIV infection, or other causes) may not respond to the vaccine. Administer w/ caution to individuals w/ thrombocytopaenia or any coagulation disorder. No safety, immunogenicity or efficacy data to support interchangeability of Gardasil 9 w/ bivalent or quadrivalent HPV vaccines. Postpone vaccination until completion of pregnancy. Safety & efficacy in childn <9 yr have not been established.

Headache; inj site pain, swelling, & erythema. Dizziness; nausea; pyrexia, fatigue, inj site pruritus & bruising.

Safety & immunogenicity have not been studied in individuals who have received Ig or blood-derived products during 3 mth prior to vaccination.

Vaccines, Antisera & Immunologicals

J07BM03 - papillomavirus (human types 6, 11, 16, 18, 31, 33, 45, 52, 58) ; Belongs to the class of papillomavirus vaccines.

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