Gardasil

Gardasil

Manufacturer:

Merck Sharp & Dohme

Distributor:

Zuellig
Concise Prescribing Info
Contents
HPV vaccines (types 6, 11, 16, 18) (recombinant, adsorbed)
Indications/Uses
Indicated in girls & women 9-45 yr for the prevention of cervical, vulvar, vag & anal cancer; precancerous or dysplastic lesions; genital warts & infections caused by HPV. Indicated to prevent the following diseases: Cervical, vulvar, vag & anal cancer caused by HPV types 16 & 18. Genital warts (condyloma acuminata) caused by HPV types 6 & 11. Infections & the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18: Cervical intraepithelial neoplasia (CIN) grade 2/3 & cervical adenocarcinoma in situ (AIS). Cervical intraepithelial neoplasia (CIN) grade 1. Vulvar intraepithelial neoplasia (VIN) grade 2 & 3. Vag intraepithelial neoplasia (VaIN) grade 2 & 3. VIN grade 1 & VaIN grade 1. Anal intraepithelial neoplasia (AIN) grade 1, 2 & 3. Indicated in boys & men 9-26 yr for the prevention of anal cancer caused by HPV types 16 & 18, & external genital lesions & infection caused by HPV types 6, 11, 16 & 18.
Dosage/Direction for Use
0.5 mL. 1st dose: At elected date. 2nd dose: 2 mth after the 1st dose. 3rd dose: 6 mth after the 1st dose. If an alternate vaccination is necessary: 2nd dose: At least 1 mth after the 1st dose. 3rd dose: At least 3 mth after the 2nd dose. To be given IM in the deltoid region of the upper arm or in the higher anterolateral area of the thigh. Childn 9-13 yr 2 doses (1st dose: At elected date; 2nd dose: 6 mth or 12 mth) or 3 doses (1st dose: At elected date; 2nd dose: 2 mth after the 1st dose; 3rd dose: 6 mth after the 1st dose).
Contraindications
Hypersensitivity. Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of Gardasil should not receive further doses. Pregnancy.
Special Precautions
Do not use for the treatment of active external genital lesions, cervical, vulvar, vag or anal cancers; CIN, VIN, VaIN or AIN. Individuals w/ impaired immune responsiveness due to immunosuppressive therapy, a genetic defect or HIV infection w/ thrombocytopenia or any coagulation disorder. Syncope may follow any vaccination, especially in adolescents. Appropriate medical treatment should be readily available in case anaphylactic reactions occur following administration of vaccine. Increase in headache & inj site swelling have been observed w/ concomitant administration w/ other vaccines. Inj at a separate inj site when administered concomitantly w/ other vaccines. Pregnancy.
Adverse Reactions
Pyrexia, erythema, pain, pruritus, nausea, bruising, swelling at inj site, headache. Pain in extremity, dizziness, arthralgia, myalgia, asthenia, chills, fatigue, malaise, anaphylactic/anaphylactoid reactions, bronchospasm, urticaria.
Drug Interactions
Systemic immunosuppressive medications.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BM01 - papillomavirus (human types 6, 11, 16, 18) ; Belongs to the class of papillomavirus vaccines.
Presentation/Packing
Form
Gardasil vaccine (inj)
Packing/Price
(pre-filled syringe) 0.5 mL x 1's (P4,546/pre-filled syringe)
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