Farmacia

9883616
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use GARDASIL safely and effectively. See full prescribing information for GARDASIL. GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] Suspension for intramuscular injection Initial U.S. Approval: 2006 --------------------------- RECENT MAJORCHANGES --------------------------Indications and Usage (1) Girls and Women (1.1) 12/2010 Boys and Men (1.2) 12/2010 Limitations of GARDASIL Use and Effectiveness (1.3) XX/XXXX ----------------------------INDICATIONS AND USAGE ---------------------------GARDASIL is a vaccine 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 And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:  Cervical intraepithelial neoplasia (CIN) grade 2/3 and Cervical adenocarcinoma in situ (AIS)  Cervical intraepithelialneoplasia (CIN) grade 1  Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3  Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3  Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 GARDASIL 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 And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:  Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3. (1) Limitations of GARDASIL Use and Effectiveness:  GARDASIL does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening. (1.3) (17) Recipients of GARDASIL should not discontinue anal cancer screening if it has been recommended by a health care provider. (1.3) (17)  GARDASIL has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity. (1.3) (14.4) (14.5)  GARDASIL is not intended to be used for treatment of activeexternal genital lesions; cervical, vulvar, vaginal, and anal cancers; CIN; VIN; VaIN, or AIN. (1.3)  GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine. (1.3) (14.4) (14.5)     Not all vulvar, vaginal, and anal cancers are caused by HPV, and GARDASIL protects only against those vulvar, vaginal, and anal cancers caused by HPV 16 and 18.(1.3) GARDASIL does not protect against genital diseases not caused by HPV. (1.3) Vaccination with GARDASIL may not result in protection in all vaccine recipients. (1.3) GARDASIL has not been demonstrated to prevent HPV-related CIN 2/3 or worse in women older than 26 years of age. (14.7)

----------------------- DOSAGE AND ADMINISTRATION ----------------------0.5-mL suspension for intramuscularinjection at the following schedule: 0, 2 months, 6 months. (2.1) --------------------- DOSAGE FORMS AND STRENGTHS -------------------- 0.5-mL suspension for injection as a single-dose vial and prefilled syringe. (3) (11) -------------------------------CONTRAINDICATIONS ------------------------------ Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after aprevious dose of GARDASIL. (4) (11) ------------------------WARNINGS AND PRECAUTIONS----------------------- Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with...