GARDASIL™ VACCINE VIAL [SIN13227P]

Product Info

GARDASIL™ VACCINE VIAL

[SIN13227P]

II. INDICATIONS

GARDASIL is a vaccine indicated in girls and women aged 9 through 26 years for the prevention of cervical, vulvar and vaginal cancer, premalignant genital lesions (cervical, vulvar and vaginal), HPV infection, cervical adenocarcinoma in situ (AIS) and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18. For efficacy data, see section XIV CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

GARDASIL is indicated in boys and men 9 through 26 years of age for the prevention of HPV infection caused by HPV types 6, 11, 16 and 18 and genital warts (condyloma acuminata) caused by HPV types 6 and 11. For efficacy data, see section XIV CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

GARDASIL is also indicated in individuals 9 through 26 years of age for the prevention of anal cancer and premalignant lesions due to HPV types 6, 11, 16 and 18. For efficacy data, see section XIV CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

III. DOSAGE AND ADMINISTRATION

Dosage
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

Individuals are encouraged to adhere to the 0, 2, and 6 months vaccination schedule. However, in clinical studies, efficacy has been demonstrated in individuals who have received all 3 doses within a 1-year period. The second dose should be administered at least 1 month after the first dose, and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period.

Alternatively, in individuals 9 through 13 years of age, GARDASIL can be administered according to a 2-dose (0, 6 months) schedule.

The use of GARDASIL should be in accordance with official recommendations.

It is recommended that individuals who receive a first dose of GARDASIL complete the vaccination course with GARDASIL.

The need for a booster dose has not been established. The duration of protection is currently unknown.

Method of Administration

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. Neither subcutaneous nor intradermal administration has been studied. These methods of administration are not recommended.

The prefilled syringe is for single use only and should not be used for more than one 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. Discard the product if particulates are present or if it appears discolored.

Single-dose Vial Use
Withdraw 0.5-mL 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.

Prefilled Syringe Use
Inject the entire contents of the syringe.

IV. CONTRAINDICATIONS

Hypersensitivity to the active substances or to any of the excipients of the vaccine.

Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of GARDASIL should not receive further doses of GARDASIL.