Engerix-B - Injection Hepatitis B Vaccine (rDNA) BP - 20mcg 1 1.0 ml vial(s) / 1.0 ml vial Glaxo SmithKline Pharmaceuticals Ltd Indication: To prevent Hepatiis B virus For active immunization against the, Hepatitis B infection Administration: Administer in deltoid muscle for older children and adolescents; anterolateral thigh preferred for neonates/infants/small children Do not give IV/intradermal Adult Dose: Intramuscular Active immunisation against hepatitis B Neonates and children up to 19 years of age: The recommended dose of Hepatitis B vaccine (rDNA) is 10 mcg of antigen protein in 0.5 ml. Adults 19 years of age and older: The recommended dose of Hepatitis B vaccine (rDNA) is 20 mcg of antigen in 1 ml. The usual immunization regimen consists of 3 doses of vaccine for adult and children. 0,1 and 6 months First dose: at selected date, Second dose: 1 month later after first dose, Third dose: 6 months after first dose. Or Accelerated schedule for all ages- 0,1,2... Child Dose: Intramuscular Active immunisation against hepatitis B Neonates and children up to 19 years of age: The recommended dose of Hepatitis B vaccine (rDNA) is 10 mcg of antigen protein in 0.5 ml. Adults 19 years of age and older: The recommended dose of Hepatitis B vaccine (rDNA) is 20 mcg of antigen in 1 ml. The usual immunization regimen consists of 3 doses of vaccine for adult and children. 0,1 and 6 months First dose: at selected date, Second dose: 1 month later after first dose, Third dose: 6 months after first dose. Or Accelerated schedule for all ages- 0,1,2... Contraindication: Previous confirmed anaphylactic reaction to a previous dose of a vaccine containing the same antigens. Hypersensitivity. Vaccines prepared in egg cultures are contraindicated in patients with hypersensitivity reactions to egg. Severe immunodeficiency. Malignant disease being treated with chemotherapy or radiotherapy and for at least 6 mth after stopping treatment. Patients with compromised immune system such as those on high-dose systemic corticosteroids, immunosuppressants or HIV positive. Mode of Action: Hepatitis B vaccines are used for active immunisation against hepatitis B infection. Two types of vaccine have been available each containing hepatitis B surface antigen (HBsAg) adsorbed onto aluminium hydroxide or a similar adsorbent. Precaution: If any alcohol or disinfectant is used for cleansing the skin it should be allowed to evaporate before vaccination otherwise inactivation of live vaccines may occur. Lactation: not known if excreted in breast milk Side Effect: >10% Pain (10-29%),Pruritus (10-29%),Erythema (10-29%),Burning (10-29%),Nodules (10-29%),Fatigue (15%),Headache (15%),Fever (15%),Vertigo (15%) 1-10% Lightheadedness,Flushinig,Insomnia,Irritability,Arthralgia,Constipation,Pruritus,Lupus-like syndrome,Lymphadenopathy,Tachycardia Pregnancy Category Note: Pregnancy: Adequate human data on use during pregnancy and adequate animal reproduction studies are not available. This vaccine should be used during pregnancy only when clearly needed and when the possible advantages outweigh the possible risks for the fetus. Lactation: Adequate data on the administration of this vaccine to women who are breast-feeding are not available. This vaccine should be administered to women who are breast-feeding when needed and the possible advantages outweigh the possible risks. Interaction: Reduced response to vaccination when used concurrently with immunosuppressants such as corticosteroids or antineoplastics.