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Gardasil

Gardasil Dosage/Direction for Use

Manufacturer:

Merck Sharp & Dohme

Distributor:

Zuellig
Full Prescribing Info
Dosage/Direction for Use
QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (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, QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) can be administered according to a 2-dose (0, 6 months or 0, 12 months) schedule.
The use of QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) should be in accordance with official recommendations.
It is recommended that individuals who receive a first dose of QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) complete the vaccination course with QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL).
The need for a booster dose has not been established.
Administration: QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.
QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) must not be injected intravascularly. Neither subcutaneous norintradermal 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, QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (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.
Prefilled Syringe Use: Inject the entire contents of the syringe.
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