21 DOSAGE Patti Labelle 2

(2.1) DOSAGE expresses Patti LaBelle FORMS AND patti labelle's lite cuisine indicates 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 vaccinecomponent), or after a previous dose of GARDASIL. (11).WARNINGS AND PRECAUTIONS* Women who receive GARDASIL should continue to undergo cervical cancerscreening. (17.1) * 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. (14.2)* GARDASIL is not intended to be used for treatment of active genital warts;cervical, vulvar, and vaginal cancers; CIN; VIN; or VaIN. (5.1) * GARDASIL has not been demonstrated to protect against diseases due to HPVtypes not contained in the vaccine. (14.3) * Not all vulvar and vaginal cancers are caused by HPV and GARDASIL protectsonly against those vulvar and vaginal cancers caused by HPV 16 and 18.ADVERSE REACTIONSThe most common adverse reaction was headache.

Common adverse reactions(frequency of at least 1.0% and greater than AAHS control or saline placebo) arefever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus,and bruising patty labelle . (6.1) Syncope has been reported following vaccination with GARDASIL, sometimesresulting in falling with injury; observation for 15 minutes afteradministration is recommended patti labella . (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Merck & Co., Inc patti lebelle . at1-877-888-4231 or VAERS at 1-800-822-7967 or INTERACTIONSGARDASIL may be administered concomitantly with RECOMBIVAX HB patti labele . (7.1) USE IN SPECIFIC POPULATIONSSafety and effectiveness of GARDASIL have not been established in the followingpopulations:* Pregnant women.

Physicians are encouraged to register pregnant women exposedto GARDASIL by calling 1-800-986-8999 so that Merck can monitor maternal andfetal outcomes (8.1).* Children below the age of 9 years and pediatric males of any age (8.4)* Women 27 years of age and older patti labelle songs . (14.4).See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 12/2008FULL PRESCRIBING INFORMATION: CONTENTS*1INDICATIONS AND USAGE2DOSAGE AND ADMINISTRATION2.1Dosage 2.2Method of Administration 3DOSAGE FORMS AND STRENGTHS4CONTRAINDICATIONS5WARNINGS AND PRECAUTIONS5.1 Limitations of GARDASIL Use and Effectiveness 5.2 Immunocompromised Individuals 5.3 Managing Allergic Reactions 6ADVERSE REACTIONS6.1 Clinical Trials Experience 6.2 Post-Marketing Experience 7DRUG INTERACTIONS7.1 Use with RECOMBIVAX HB 7.2 Use with Hormonal Contraceptives 7.3 Use with Systemic Immunosuppressive Medications 8USE IN SPECIFIC POPULATIONS8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 10OVERDOSAGE11DESCRIPTION12CLINICAL PHARMACOLOGY12.1 Mechanism of Action 13NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14CLINICAL STUDIES14.1 Prophylactic Efficacy - HPV Types 6, 11, 16, and 18 in Women 16 Through 26Years of Age 14.2 Effectiveness of GARDASIL in Prevention of HPV Types 6-, 11-, 16-, or18-Related Disease in Women 16 Through 26 Years of Age, Regardless of Current orPrior Exposure to Vaccine HPV Types 14.3 Effectiveness of GARDASIL in Prevention of Any HPV Type Related GenitalDisease in Women 16 Through 26 Years of Age, Regardless of Current or PriorInfection with Vaccine or Non-Vaccine HPV Types 14.4 Other Studies 14.5 Immunogenicity 14.6 Studies with RECOMBIVAX HB 16HOW SUPPLIED/STORAGE AND HANDLING17PATIENT COUNSELING INFORMATION17.1 Information for the Patient, Parent, or Guardian 17.2 FDA-Approved Patient Labeling *Sections or subsections omitted from the full prescribing information are notlisted patti . FULL PRESCRIBING INFORMATION1INDICATIONS AND USAGEGARDASIL1 is a vaccine indicated in girls and women 9 through 26 years of agefor the prevention of the following diseases caused by Human Papillomavirus(HPV) types included in the vaccine:* Cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18 * Genital warts (condyloma acuminata) caused by HPV types 6 and 11And the following precancerous or dysplastic lesions caused by HPV types 6, 11,16, and 18:* Cervical intraepithelial neoplasia (CIN) grade 2/3 and Cervical adenocarcinomain situ (AIS) * Cervical intraepithelial neoplasia (CIN) grade 1 * Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3 * Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 32DOSAGE AND ADMINISTRATION2.1DosageGARDASIL should be administered intramuscularly as a 0.5-mL dose at thefollowing schedule: 0, 2 months, 6 months patte labelle . [See Clinical Studies (14.5).]2.2Method of AdministrationShake well before use pati labelle . Thorough agitation immediately before administration isnecessary to maintain suspension of the vaccine GARDASIL should not be dilutedor mixed with other vaccines After thorough agitation, GARDASIL is a white,cloudy liquid. Parenteral drug products should be inspected visually forparticulate matter and discoloration prior to administration. Do not use theproduct if particulates are present or if it appears discolored.

GARDASIL should be administered intramuscularly in the deltoid region of theupper arm or in the higher anterolateral area of the thigh patti labelle albums . Do not administer GARDASIL intravenously, intradermally, or subcutaneously patti labelle's . Syncope has been reported following vaccination with GARDASIL and may result infalling with injury; observation for 15 minutes after administration isrecommended patti webster . Single-Dose Vial UseWithdraw the 0.5-mL dose of vaccine from the single-dose vial using a sterileneedle and syringe and use promptly labelle . Prefilled Syringe Use With and Without Needle Guard (Safety) DevicePrefilled Syringe With Needle Guard (Safety) DeviceInstructions for using the prefilled single-dose syringes preassembled withneedle guard (safety) device[OBJECT OMITTED] NOTE: Please use the enclosed needle for administration. If a different needleis chosen, it should fit securely on the syringe and be no longer than 1 inch toensure proper functioning of the needle guard device.

Two detachable labels areprovided which can be removed after the needle is guarded.At any of the following steps, avoid contact with the Trigger Fingers to keepfrom activating the safety device prematurely.Remove Syringe Tip Cap and Needle Cap . Attach Luer Needle by pressing bothAnti-Rotation Tabs to secure syringe and by twisting the Luer Needle in aclockwise direction until secured to the syringe on my own labelle . Remove Needle Sheath.Administer injection per standard protocol as stated above under DOSAGE ANDADMINISTRATION patti if only you knew . Depress the Plunger while grasping the Finger Flange until theentire dose has been given .