Gardasil 9

Gardasil 9

vaccine, human papillomavirus 9-valent

Manufacturer:

MSD

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Recombinant 9-valent HPV vaccine
Indications/Uses
Prevention of cervical, vulvar, vag & anal cancer; premalignant genital (cervical, vulvar & vag) & anal lesions; HPV infections; cervical adenocarcinoma in situ; & external genital warts causally related to HPV types 6, 11, 16, 18, 31, 33, 45, 52 & 58 in girls & women from 9-45 yr. Prevention of premalignant lesions & HPV infections caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 & 58; anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 & 58 & genital warts caused by HPV types 6 & 11 in boys & men 9-45 yr.
Dosage/Direction for Use
IM Administer as 3 separate 0.5 mL doses in the deltoid region of the upper arm or in the higher anterolateral area of the thigh, according to the following schedule: 1st dose: at elected date; 2nd dose: 2 mth after 1st dose; 3rd dose: 6 mth after 1st dose. Completion of the vaccination course w/ Gardasil 9 is recommended for individuals who received Gardasil 9 as 1st dose. Individual 9-14 yr Alternatively, a 2-dose schedule may be administered. Administer 2nd dose between 5-13 mth after 1st dose. Administer 3rd dose if 2nd dose is administered earlier than 5 mth after 1st dose.
Contraindications
Special Precautions
Appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following vaccination. Not for intravascular use. Not recommended for SC or intradermal administration. May not result in protection in all vaccine recipients. Not intended for active external genital lesions; cervical, vulvar, vag or anal cancer or intraepithelial neoplasia. No protection against diseases that are not caused by HPV. Does not substitute for routine cervical cancer screening. Syncope, sometimes associated w/ tonic-clonic movements & other seizure-like activity, following HPV vaccination. Current or recent febrile illness. Individuals w/ impaired immune responsiveness may have reduced Ab response to active immunization. Individuals w/ thrombocytopenia or any coagulation disorder. Immunologic response to Gardasil 9 may be diminished in immunocompromised individuals. Women who receive Gardasil 9 should continue to undergo cervical cancer screening per standard of care. Pregnancy & lactation. Childn <9 yr. Elderly ≥65 yr.
Adverse Reactions
Inj site pain, swelling, erythema, pruritus & bruising; headache, pyrexia, nausea, dizziness, fatigue.
Drug Interactions
Immunosuppressive therapies including irradiation, antimetabolites, alkylating agents, cytotoxic drugs & corticosteroids (used in greater than physiologic doses) may reduce the immune responses to vaccines.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BM03 - papillomavirus (human types 6, 11, 16, 18, 31, 33, 45, 52, 58) ; Belongs to the class of papillomavirus vaccines.
Presentation/Packing
Form
Gardasil 9 susp for inj
Packing/Price
((single dose)) 1's
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