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Gardasil 9

Gardasil 9

vaccine, human papillomavirus 9-valent

Manufacturer:

Merck Sharp & Dohme

Distributor:

Zuellig
Concise Prescribing Info
Contents
Human papillomavirus 9-valent (type 6, 11, 16, 18, 31, 33, 45, 52, 58)
Indications/Uses
Prevention of cervical, vulvar, vag, anal, oropharyngeal & other head & neck cancers; precancerous or dysplastic lesions; genital warts & persistent infections caused by HPV in girls & women from ≥9 yr. Prevention of cervical, vulvar, vag, anal, oropharyngeal & other head & neck cancers caused by HPV types 16, 18, 31, 33, 45, 52 & 58; genital warts (condyloma acuminata) caused by HPV types 6 & 11; precancerous or dysplastic lesions (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) grades 1, 2, & 3). Prevention of anal, oropharyngeal & other head & neck cancers, anal precancerous or dysplastic lesions; external genital lesions (including genital warts); & persistent infections caused by HPV in boys & men from ≥9 yr. Prevent anal, oropharyngeal & other head & neck cancers caused by HPV types 16, 18, 31, 33, 45, 52 & 58; genital warts (condyloma acuminata) caused by HPV types 6 & 11. Persistent infections & the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, & 58; anal intraepithelial neoplasia (AIN) grades 1, 2, & 3.
Dosage/Direction for Use
IM Administered as 3 separate 0.5 mL doses. 1st dose: At elected date. 2nd dose: 2 mth after 1st dose. 3rd dose: 6 mth after 1st dose. Adhere to the 0, 2 & 6 mth vaccination schedule w/in a 1-yr period. Childn 9-14 yr 2-dose schedule: Administer between 5th & 13th mth after 1st dose. If the 2nd dose is administered earlier than 5 mth after the 1st dose, a 3rd dose should always be administered.
Contraindications
Special Precautions
Not for treatment of active external genital lesions; cervical, vulvar, vag, anal, oropharyngeal & other head & neck cancers; CIN, VIN, VaIN, or AIN. Not for use against diseases that are not caused by HPV. Appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine. Syncope may follow any vaccination, especially in adolescents & young adults. Delay vaccination if current or recent febrile illness. Patients w/ impaired immune response due to immunosuppressive therapy, genetic effect or HIV infection. Patients w/ thrombocytopenia or any coagulation disorder. Childn <9 yr. Elderly ≥65 yr.
Adverse Reactions
Pain, swelling, erythema, pruritus, bruising, mass, hemorrhage, hematoma, warmth, induration, reaction. Headache, pyrexia, nausea, dizziness, fatigue, diarrhea, myalgia, oropharyngeal pain, upper abdominal pain, upper resp tract infection, syncope sometimes accompanied by tonic-clonic movement, vomiting.
Drug Interactions
Reduced immune responses w/ immunosuppressive therapies including irradiation, antimetabolites, alkylating agents, cytotoxic drugs & corticosteroids.
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 vaccine (inj)
Packing/Price
1's (P7,500/box)
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