Condition on Arrival

Should not have been frozen; refrigerate on arrival.
Storage

Store refrigerated at 2°C to 8°C (36°F to 46°F); DO NOT FREEZE.
Protect from light.
Handling

• Using the UltraSafe Passive^® Delivery System prefilled safety syringe

• Vial use: Shake well before withdrawal and use. Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine.
• The vaccine should be used as supplied; no dilution or reconstitution is necessary.
• Parental drug products should be inspected visually for particulate matter and discoloration prior to administration. After thorough agitation GARDASIL is a white, cloudy liquid. Do not use the product if particulates are present or if it appears discolored.

General Tips

If you have questions about the condition of the vaccine at the time of delivery, you should:

1. Immediately place vaccine in recommended storage; and
2. Notify the Merck Vaccine Customer Center at 1-877-VAX-MERCK
   (1-877-829-6372) or
3. Notify the National Immunization Program, CDC, Atlanta,
   Georgia at 1-800-CDC-INFO (1-800-232-4636).

Rotate stock so that the shortest-dated vaccine is used first.²

Ensure that the refrigerator is plugged into an outlet in a protected area where it cannot be disconnected accidentally.²

Record refrigerator and freezer temperatures twice a day in a
temperature log.²

It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of hepatitis and other infectious agents from one person to another.

Needles should be disposed of properly and should not be recapped.³

All vaccines must be discarded after the expiration date; expired or damaged Vaccines for Children (VFC) vaccines must be returned to your State Immunization Program.

For vaccines that are used as supplied, no reconstitution is necessary.
Click here for a demonstration of proper handling when reconstitution is
not required.

For general questions concerning the proper storage and handling of
Merck vaccines, please contact the Merck Vaccine Customer Center at
1-800-MERCK-90 (1-800-637-2590), Monday through Friday, 8:00 am to 7:00 pm ET.

GARDASIL is a vaccine indicated in girls and women 9 to 26 years of age for the prevention of cervical cancer, precancerous or dysplastic lesions, and genital warts caused by human papillomavirus (HPV) Types 6, 11, 16, and 18.

Select Safety Information

GARDASIL is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine.

GARDASIL does not substitute for routine cervical cancer screening, and women who receive GARDASIL should continue to undergo screening per standard of care.

GARDASIL is not recommended for use in pregnant women.

Vaccination with GARDASIL may not result in protection in all vaccine recipients.

GARDASIL is not intended to be used for treatment of active genital warts, cervical cancer, cervical intraepithelial neoplasia, vulvar intraepithelial neoplasia, or vaginal intraepithelial neoplasia.

GARDASIL has not been shown to protect against diseases due to non-vaccine HPV types.

The vaccine-related adverse experiences that were observed among recipients of GARDASIL at a frequency of at least 1.0% and greater than placebo were pain, swelling, erythema, fever, nausea, pruritus, and dizziness. In addition, common postmarketing reports include vomiting and syncope.

GARDASIL should be administered in 3 separate intramuscular injections in the deltoid region of the upper arm or in the higher anterolateral area of the thigh over a 6-month period with the first dose at an elected date, the second dose 2 months after the first dose, and the third dose 6 months after the first dose.

Before administering GARDASIL, please read the Prescribing Information and Patient Product Information.

^aUltraSafe Passive^® Delivery System is a registered trademark of Safety Syringes, Inc.

GARDASIL is a registered trademark of Merck & Co., Inc.