Concise Prescribing Info
Human papillomavirus (HPV) vaccine types 16 & 18 (recombinant, AS04 adjuvanted)
Prevention of incident & persistent infection, premalignant ano-genital lesions (cervical, vulvar, vag & anal) (including ASCUS, CIN, VIN, VaIN, AIS) & cervical, vulvar, vag & anal cancers (squamous-cell carcinoma & adenocarcinoma) caused by oncogenic human papillomavirus (HPV) for individuals ≥9 yr.
Dosage/Direction for Use
IM in the deltoid region ≥15 yr 3-dose (at 0, 1, 6 mth) of 0.5 mL, 9-14 yr 2-doses of 0.5 mL, given between 5 & 13 mth after the 1st dose.
Special Precautions
Do not administer intravascularly or intradermally. Anaphylactic event & syncope may occur. Postpone vaccination in patients w/ acute severe febrile illness. Thrombocytopenia or any coagulation disorder. Not intended for the prevention of progression of HPV-related lesions or protection against all oncogenic HPV types. Not a substitute for regular cervical screening or against exposure to HPV & STD. Immunocompromised patients. Pregnancy & lactation.
Adverse Reactions
Headache; myalgia; inj site reactions including pain, redness, swelling, fatigue. GI disorders including nausea, vomiting, diarrhea & abdominal pain; itching/pruritus, rash, urticaria; arthralgia; fever (≥38°C).
Drug Interactions
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BM02 - papillomavirus (human types 16, 18) ; Belongs to the class of papillomavirus vaccines.
Cervarix vaccine (inj)
(pre-filled syringe + 2 sterile needles) 0.5 mL x 1's (P1,658/pre-filled syringe)
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