Concise Prescribing Info
Contents
Per mL Inactivated HAV 720 ELISA U, recombinant HBsAg 20 mcg
Indications/Uses
Non-immune adults, adolescents & childn 2-15 yr who are at risk of both hepatitis A & B infection & never or incompletely vaccinated w/ hepatitis B vaccine.
Dosage/Direction for Use
IM in deltoid region in adult, adolescents & childn; anterolateral thigh in infants Primary dose Adult & adolescent ≥16 yr 3 doses given at 0, 1, 6 mth or 4 doses given at 0, 7, 21 days & 12 mth after 1st dose. Childn 2-15 yr 2 doses w/ 2nd dose given 6-12 mth after 1st dose. Booster dose General guideline can be drawn from experience w/ the monovalent vaccines.
Contraindications
Hypersensitivity to any constituent of Twinrix or after previous administration of Twinrix or the monovalent hepatitis A or hepatitis B vaccines.
Special Precautions
Do not administer intravascularly. Postpone vaccination in subjects w/ acute severe febrile illness. Syncope (fainting) can occur. Not recommended for post-exposure prophylaxis (needle stick injury). Patients w/ impaired immune system & undergoing haemodialysis may require additional doses. Does not prevent infection caused by other agents eg, hepatitis C & E & other pathogens known to infect the liver. Pregnancy & lactation.
Adverse Reactions
Headache; fatigue, pain & redness at the inj site. GI symptoms eg, diarrhoea, nausea, vomiting; swelling at the inj site. Adult & adolescent ≥16 yr: Inj site reaction, malaise. Childn 1-15 yr: Loss of appetite; irritability, fussiness. Drowsiness; fever.
Drug Interactions
Adequate response may not be achieved in patients receiving immunosuppressants or w/ immunodeficiency.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BC20 - combinations ; Belongs to the class of hepatitis viral vaccines.
Presentation/Packing
Form
Twinrix vaccine (inj)
Packing/Price
(pre-filled syringe) 1 mL x 1's
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