Concise Prescribing Info
Contents
Human papillomavirus vaccine types 16 & 18 (recombinant, AS04 adjuvanted)
Indications/Uses
Prevention of persistent infection, premalignant cervical lesions & cervical cancer (squamous cell carcinoma & adenocarcinoma) caused by oncogenic human papillomavirus (HPV) types 16 & 18 in females 9-25 yr.
Dosage/Direction for Use
IM in the deltoid region Female 15-25 yr Three 0.5-mL doses at 0, 1, 6 mth. 2nd dose can be administered between 1 & 2.5 mth after the 1st dose. 3rd dose between 5 & 12 mth after the 1st dose; 9-14 yr Two doses each of 0.5 mL. 2nd dose given between 5 & 13 mth after the 1st dose (if the 2nd dose is administered before the 5th mth after the 1st dose, a 3rd dose should always be administered).
Contraindications
Hypersensitivity to any component of Cervarix.
Special Precautions
Do not administer intravascularly or intradermally. Syncope (fainting) may occur. Postpone vaccination in patients w/ acute severe febrile illness. Patients w/ thrombocytopenia or any coagulation disorder; impaired immune responsiveness or receiving immunosuppressive treatment. A protective immune response may not be elicited in all vaccinees. Do not use for the prevention of HPV-related lesion progression at the time of vaccination. Postpone vaccination until completion of pregnancy in women who are pregnant or trying to become pregnant. Lactation.
Adverse Reactions
Headache; myalgia; inj site reactions eg, pain, redness, swelling, fatigue. 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
(pre-filled syringe) 0.5 mL x 1's
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