5mL singledose vial NDC 0006404500 Carton of ten 0

Anti-GMTs for HPV types 6, 11, 16, and 18 weresimilar between measurements at month 24 and month 60 in Study 2. 14.6Studies with RECOMBIVAX HBThe safety and immunogenicity of co-administration of GARDASIL with RECOMBIVAXHB hepatitis B vaccine (recombinant) (same visit, injections at separate sites)were evaluated in a randomized study of 1871 women aged 16 through 24 years atenrollment. Immune response to both hepatitis B vaccine (recombinant) andGARDASIL was non-inferior whether they were administered at the same visit or ata different visit. 16HOW SUPPLIED/STORAGE AND HANDLINGAll presentations for GARDASIL contain a suspension of 120 mcg L1 protein fromHPV types 6, 11, 16, and 18 in a 0.5 mL dose GARDASIL is supplied in vials andsyringes Carton of one 0.5-mL single-dose vial, NDC 0006-4045-00 Carton of ten 0.5-mL single-dose vials, NDC 0006-4045-41.

One-inch, 25-gauge needles are providedseparately in the package NDC 0006-4109-06. Carton of six 0.5-mL single-dose prefilled Luer Lock syringes with tip caps NDC0006-4109-09 Store refrigerated at 2 to 8C (36 to 46F) Do not freeze Protect from light. GARDASIL should be administered as soon as possible after being removed fromrefrigeration. GARDASIL can be out of refrigeration (at temperatures at or below 25C/77F),for a total time of not more than 72 hours.

17PATIENT COUNSELING INFORMATIONSee FDA-Approved Patient Labeling (17.2).17.1Information for the Patient, Parent, or GuardianInform the patient, parent, or guardian: Vaccination does not substitute for routine cervical cancer screening. Womenwho receive GARDASIL should continue to undergo cervical cancer screening perstandard of care. GARDASIL has not been demonstrated to provide protection against disease fromvaccine and non-vaccine HPV types to which a woman has previously been exposedthrough sexual activity. Syncope has been reported following vaccination sometimes resulting in fallingwith injury; observation for 15 minutes after administration is recommended. Vaccine information is required to be given with each vaccination to thepatient, parent, or guardian. Information regarding benefits and risks associated with vaccination GARDASIL is not recommended for use in pregnant women. Importance of completing the immunization series unless contraindicated.