Concise Prescribing Info
Contents
Per 0.5 mL HPV type 16 L1 protein 20 mcg, HPV type 18 L1 protein 20 mcg (recombinant, AS04 adjuvanted)
Indications/Uses
Prevention of persistent infection, premalignant ano-genital lesions (cervical, vulvar, vag & anal) & cervical, vulvar, vag & anal cancers (squamous-cell carcinoma & adenocarcinoma) caused by oncogenic HPV in patients ≥9 yr.
Dosage/Direction for Use
IM Inj in deltoid region. Subjects ≥15 yr Three 0.5 mL doses at 0, 1, 6 mth (2nd dose can be administered between 1 & 2.5 mth after 1st dose & 3rd dose between 5 & 12 mth after 1st dose), 9-14 yr Two 0.5 mL doses w/ 2nd dose given between 5 & 13 mth after 1st dose (if 2nd dose is administered before the 5th mth after 1st dose, a 3rd dose should always be administered) or three 0.5 mL doses at 0, 1, 6 mth (2nd dose can be administered between 1 & 2.5 mth after 1st dose & 3rd dose between 5 & 12 mth after 1st dose).
Contraindications
Special Precautions
Postpone vaccination in case of acute severe febrile illness. Not intended to prevent progression of HPV-related lesions present at the time of vaccination or provide protection against all oncogenic HPV types. Not a substitute for regular cervical screening or against exposure to HPV & STD. Not to be administered intravascularly or intradermally. Syncope. Thrombocytopenia or any coagulation disorder. Immunocompromised patients. Perform review of medical history & clinical exam before vaccination. Postpone vaccination until completion of pregnancy. Lactation.
Adverse Reactions
Headache; myalgia; inj site reactions eg, pain, redness, swelling & fatigue. GI disorders eg, nausea, vomiting, diarrhoea & abdominal pain; itching/pruritus, rash, urticaria; arthralgia; fever (≥38°C).
Drug Interactions
Concomitant use w/ immunosuppressants.
MIMS Class
Vaccines, Antisera & Immunologicals
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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