Concise Prescribing Info
Contents
9-valent HPV (types 6, 11, 16, 18, 31, 33, 45, 52, 58) recombinant vaccine
Indications/Uses
Prevention of cervical, vulvar, vag & anal cancer, genital warts (condyloma acuminata) & precancerous or dysplastic lesions (eg, cervical intraepithelial neoplasia grades 1 & 2/3, cervical adenocarcinoma in situ, vulvar intraepithelial neoplasia grades 2 & 3, vag intraepithelial neoplasia grades 2 & 3 & anal intraepithelial neoplasia grades 1, 2 & 3) caused by HPV in girls & women 9-45 yr. Prevention of anal cancer, genital warts & precancerous or dysplastic lesions (eg, anal intraepithelial neoplasia grades 1, 2 & 3) caused by HPV in boys & men 9-26 yr.
Dosage/Direction for Use
3 separate 0.5-mL IM doses administered at 0, 2 & 6 mth. Individual 9-14 yr Alternatively, can be administered according to a 2-dose schedule. 2nd dose: Administer between 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.
Contraindications
Special Precautions
Anaphylactic reactions. Not to be inj intravascularly, SC or intradermally. Not for treatment of cervical, vulvar, vag & anal cancer, high-grade cervical, vulvar, vag & anal dysplastic lesions or genital warts. Not for prevention of progression of other established HPV-related lesions. Not for prevention of lesions due to HPV type vaccine in individuals infected w/ that HPV at the time of vaccination. Syncope. Individuals suffering from acute severe febrile illness; impaired immune responsiveness; thrombocytopenia or any coagulation disorder. May temporarily affect ability to drive & use machines. Vaccination should be postponed during pregnancy.
Adverse Reactions
Headache; inj site pain, swelling & erythema. Dizziness; nausea; pyrexia, fatigue, inj site pruritus & bruising.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BM03 - papillomavirus (human types 6, 11, 16, 18, 31, 33, 45, 52, 58) ; Belongs to the class of papillomavirus vaccines.
Presentation/Packing
Form
Gardasil 9 susp for inj
Packing/Price
0.5 mL x 1's
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