Concise Prescribing Info
Contents
Per 0.5 mL Human papillomavirus type 16 L1 protein 20 mcg, human papillomavirus type 18 L1 protein 20 mcg (recombinant, AS04 adjuvanted)
Indications/Uses
Female & male ≥9 yr: Prevention of persistent infection, premalignant ano-genital (cervical, vulvar, vag & anal) lesions & cervical, vulvar, vag & anal cancers (squamous-cell carcinoma & adenocarcinoma) caused by oncogenic human papillomaviruses (HPV).
Dosage/Direction for Use
IM in the deltoid region Subjects ≥15 yr 3 dose each of 0.5 mL at 0, 1, 6 mth, 9-14 yr 2 doses each of 0.5 mL. 2nd dose given between 5 & 13 mth after 1st dose or 3 doses each of 0.5 mL at 0, 1, 6 mth.
Contraindications
Special Precautions
Do not administer intravascularly or intradermally. Postpone vaccination in case of acute severe febrile illness. Thrombocytopenia or any coagulation disorder. Not intended for the prevention of progression of HPV-related lesions present, 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, diarrhoea & abdominal pain; itching/pruritus, rash, urticaria; arthralgia; fever (≥38°C).
Drug Interactions
Adequate response may not be elicited w/ immunosuppressants.
ATC Classification
J07BM02 - papillomavirus (human types 16, 18) ; Belongs to the class of papillomavirus vaccines.
Presentation/Packing
Form
Cervarix vaccine (inj)
Packing/Price
1's
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