Concise Prescribing Info
Contents
Quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine
Indications/Uses
Prevention of cervical cancer; low-grade & high-grade cervical, vulvar & vag dysplasia; external genital warts (condyloma acuminata) caused by HPV types 6, 11, 16 & 18 in 9-45 yr female. Prevention of external genital lesions including genital warts (condyloma acuminata), anal intraepithelial neoplasia (AIN 1/2/3) & infection caused by HPV types 6, 11, 16 & 18 in 9-26 yr male.
Dosage/Direction for Use
3 separate 0.5-mL IM doses administered at 0, 2 & 6 mth. Childn & adolescent 9-13 yr May follow a 2-dose schedule administered at 0 & 6 mth.
Contraindications
Hypersensitivity. Acute severe febrile illness.
Special Precautions
Not for the prevention of lesions due to HPV type vaccine in women infected at the time of vaccination. Not for the treatment of cervical cancer, high-grade cervical, vulvar & vag dysplastic lesions, anal intraepithelial neoplasia or genital warts, & for prevention of progression of other established HPV-related lesions. Thrombocytopenia or any coagulation disorders. Individuals w/ impaired immune responsiveness. Vaccination should be postponed during pregnancy.
Adverse Reactions
Headache, nausea, dizziness; pain in extremity, pyrexia; local inj site reactions.
Drug Interactions
Concomitant administration w/ vaccines other than hepatitis B (recombinant) vaccine, a combined booster vaccine containing diphtheria & tetanus w/ either pertussis &/or poliomyelitis, has not been studied.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BM01 - papillomavirus (human types 6, 11, 16, 18) ; Belongs to the class of papillomavirus vaccines.
Presentation/Packing
Form
Gardasil vaccine (inj)
Packing/Price
(pre-filled syringe) 0.5 mL x 1's
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