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Gardasil 9

Gardasil 9 Dosage/Direction for Use

human papillomavirus 9-valent recombinant vaccine

Manufacturer:

MSD

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
General: Dosage: GARDASIL 9 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 14 years of age, GARDASIL 9 can be administered according to a 2-dose schedule; the second dose should be administered between 5 and 13 months after the first dose. If the second vaccine dose is administered earlier than 5 months after the first dose, a third dose should always be administered.
The use of GARDASIL 9 should be in accordance with official recommendations.
It is recommended that individuals who receive a first dose of GARDASIL 9 complete the vaccination course with GARDASIL 9.
The need for a booster dose has not been established. The duration of protection is currently unknown.
Method of Administration: GARDASIL 9 should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.
GARDASIL 9 must not be injected intravascularly. Neither subcutaneous nor intradermal administration has been studied. These methods of administration are not recommended.
Administration of GARDASIL 9 in Individuals Who Have Been Previously Vaccinated with GARDASIL: Studies using a mixed regimen (interchangeability) of HPV vaccines were not performed for GARDASIL 9.
Safety and immunogenicity of GARDASIL 9 were assessed in individuals who previously completed a three-dose vaccination series with GARDASIL [see Adverse Reactions and Pharmacology: Clinical Studies under Actions].
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