GARDASIL is a vaccine indicated in girls and women 9-26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types 6, 11, 16, and 18:

· Cervical cancer

· Genital warts (condyloma acuminata) and the following precancerous or dysplastic lesions:

· Cervical adenocarcinoma in situ (AIS)

· Cervical intraepithelial neoplasia (CIN) grade 2 and grade 3

· Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3

· Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3

· Cervical intraepithelial neoplasia (CIN) grade 1

GARDASIL should be administered intramuscularly as 3 separate 0.5-mL doses according to the following schedule:

First dose: at elected date
Second dose: 2 months after the first dose
Third dose: 6 months after the first dose

GARDASIL should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.

GARDASIL must not be injected intravascularly. Subcutaneous and intradermal administration have not been studied, and therefore are not recommended.

The prefilled syringe is for single use only and should not be used for more than 1 individual. For single-use vials a separate sterile syringe and needle must be used for each individual.

The vaccine should be used as supplied; no dilution or reconstitution is necessary. The full recommended dose of the vaccine should be used.

Shake well before use. Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine.

After thorough agitation, GARDASIL is a white, cloudy liquid. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use the product if particulates are present or if it appears discolored.

Withdraw the 0.5-mL dose of vaccine from the single-dose vial using a sterile needle and syringe free of preservatives, antiseptics, and detergents. Once the single-dose vial has been penetrated, the withdrawn vaccine should be used promptly, and the vial must be discarded.

Inject the entire contents of the syringe.

NOTE: Please use the enclosed needle for administration. If a different needle is chosen, it should fit securely on the syringe and be no longer than 1 inch to ensure proper functioning of the needle guard device. Two detachable labels are provided which can be removed after the needle is guarded.

Remove Syringe Tip Cap. Attach Luer Needle. Depress both Anti-Rotation Tabs to secure syringe and attach Luer Needle by twisting in clockwise direction. Remove Needle Sheath. Administer injection per standard protocol as stated above under DOSAGE AND ADMINISTRATION. Depress the Plunger while grasping the Finger Flange until the entire dose has been given. The Needle Guard Device will NOT activate to cover and protect the needle unless the ENTIRE dose has been given. Remove needle from the vaccine recipient. Release the Plunger and allow syringe to move up until the entire needle is guarded. For documentation of vaccination, remove detachable labels by pulling slowly on them. Dispose in approved sharps container.

No. 4045 GARDASIL is supplied as a carton of one 0.5-mL single-dose vial, NDC 0006-4045-00.
No. 4045 GARDASIL is supplied as a carton of ten 0.5-mL single-dose vials, NDC 0006-4045-41.

No. 4109 GARDASIL is supplied as a carton of one 0.5-mL single-dose prefilled Luer Lock syringe, preassembled with UltraSafe Passive^Ã?†delivery system. A one-inch, 25-gauge needle is provided separately in the package. NDC 0006-4109-31.

No. 4109 GARDASIL is supplied as a carton of six 0.5-mL single-dose prefilled Luer Lock syringes, preassembled with UltraSafe Passive^Ã? delivery system. One-inch, 25-gauge needles are provided separately in the package. NDC 0006-4109-06.

Store refrigerated at 2 to 8°C (36 to 46°F). Do not freeze. Protect from light.

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