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III. INDICATIONS
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
IV. 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. If an alternate vaccination schedule
is necessary, 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.
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.
Syncope (fainting) may follow any vaccination,
especially in adolescents and young adults. Syncope, sometimes associated with falling,
has occurred after vaccination with GARDASIL. Therefore, vaccinees should be carefully observed
for approximately 15 min after administration of GARDASIL (See SIDE EFFECTS, Post-Marketing Reports).
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 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.
Prefilled Syringe Use: Inject the entire contents of the syringe.
V 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.
VI. PRECAUTIONS
General: As for any vaccine, vaccination with
GARDASIL may not result in protection in all vaccine recipients.
This vaccine is not intended to be used for treatment of active genital warts; cervical, vulvar,
or vaginal cancers; CIN, VIN, or VAIN.
This vaccine will not protect against diseases that are not caused by HPV.
As with all injectable vaccines, appropriate medical treatment should always be readily
available in case of rare anaphylactic reactions following the administration of the vaccine.
The decision to administer or delay vaccination because of a current or recent febrile
illness depends largely on the severity of the symptoms and their etiology. Low-grade fever
itself and mild upper respiratory infection are not generally contraindications to vaccination.
Individuals with impaired immune responsiveness, whether due to the use of immunosuppressive therapy,
a genetic defect, Human Immunodeficiency Virus (HIV) infection, or other causes, may have
reduced antibody response to active immunization (see DRUG INTERACTIONS).
This vaccine should be given with caution to individuals with thrombocytopenia or any
coagulation disorder because bleeding may occur following an intramuscular administration in these individuals.
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