Gardasil
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Same generic (Human Papillomavirus Quadrivalent), same form (IM Injection)No other brands currently registered with this exact active generic and dosage form.
Clinical Prescribing Information
Medical monograph and safety information for healthcare professionals & patients.Indications & Clinical Uses
Gardasil is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Gardasil Papillomavirus (HPV) types included in the vaccine:
Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16 and 18.
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Gardasil is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Gardasil Papillomavirus (HPV) types included in the vaccine:
Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16 and 18.
Genital warts (condyloma acuminata) caused by HPV types 6 and 11.
And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:
Cervical intraepithelial neoplasia (CIN) grade 2/3 and Cervical adenocarcinoma in situ (AIS).
Cervical intraepithelial neoplasia (CIN) grade 1.
Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3.
Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3.
Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.
Gardasil is indicated in boys and men 9 through 45 years of age for the prevention of the following diseases:
Anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18 , 31, 33, 45, 52, and 58.
Genital warts (condyloma acuminata) caused by HPV types 6 and 11.
And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.
Contraindications
Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of Human Papillomavirus Quadrivalent.
Side Effects & Adverse Reactions
The most common (≥10%) local and systemic adverse reactions reported:
In girls and women 16 through 26 years of age: injection-site pain (89.9%), injection-site swelling (40.0%), injection-site erythema (34.0 %) and headache ( 14.6%).
In girls 9 through 15 years of age: injection-site pain (89.3%), injection-site swelling (47.8%), injection-site erythema (34.1%) and headache ( 11.4%).
In women 27 through 45 years of age: injection-site pain (82.8%), injection-site swelling (23.3%), injection-site erythema (16.9%), and headache (13.6%)
In boys and men 16 through 26 years of age: injection-site pain (63.4%), injection-site swelling (20.2%) and injection-site erythema (20.7%).
In boys 9 through 15 years of age: injection-site pain (71.5%), injection-site swelling (26.9%), and injection-site erythema (24.9%).
Warnings & Precautions
Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with Gardasil. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position.
Pharmacology & Mechanism of Action
HPV only infects human beings. Animal studies with analogous animal papillomaviruses suggest that the efficacy of L1 VLP vaccines may involve the development of humoral immune responses. Efficacy of Human Papillomavirus Quadrivalent against anogenital diseases related to the vaccine HPV types in h uman beings is thought to be mediated by humoral immune responses induced by the vaccine, although the exact mechanism of protection is unknown.