Concise Prescribing Info
Contents
Human papillomavirus (HPV) vaccine types 16 & 18 (recombinant, AS04 adjuvanted)
Indications/Uses
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 HPV in individuals from 9 yr.
Dosage/Direction for Use
IM in the deltoid region ≥15 yr 3 doses each of 0.5 mL 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 if flexibility in vaccination schedule is necessary, 9-14 yr 2 doses each of 0.5 mL. 2nd dose given between 5 & 13 mth after 1st dose. If 2nd vaccine dose is administered before the 5th mth after 1st dose, a 3rd dose should always be administered.
Contraindications
Special Precautions
Do not administer intravascularly or intradermally. SC administration. Not intended to prevent progression of HPV-related lesions present at the time of vaccination. Does not provide protection against all oncogenic HPV types. Not a substitute for regular cervical screening (secondary prevention) or for precautions against exposure to HPV & STDs. Anaphylactic event (rare) & syncope may occur. Postpone vaccination in patients suffering from acute severe febrile illness. Individuals w/ thrombocytopenia or any coagulation disorder. Subjects w/ impaired immune responsiveness eg, those receiving immunosuppressive treatment. Postpone vaccination in women who are pregnant or trying to become pregnant until completion of 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
May not elicit an adequate response in patients receiving immunosuppressive treatment.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BM02 - papillomavirus (human types 16, 18) ; Belongs to the class of papillomavirus vaccines.
Presentation/Packing
Form
Cervarix susp for inj
Packing/Price
0.5 mL x 1's
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