IntramuscularActive immunisation against hepatitis AAdult: As inactivated hepatitis A virus (GBM strain) vaccine containing 160 ELISA units per 0.5 mL: Primary immunisation: 0.5 mL as a single dose. Booster dose: 0.5 mL 6-12 months (may be given up to 36 months) after the initial dose. As inactivated hepatitis A virus (HM 175 strain) vaccine containing 1,440 ELISA units per 1 mL: Primary immunisation: 1 mL as a single dose. Booster dose: 1 mL 6-12 months (may be given up to 36 months) after the initial dose. As inactivated hepatitis A virus (CR 326F strain) vaccine containing 25 international units per 0.5 mL: Primary immunisation: 1 mL as a single dose. Booster dose: 1 mL 6-18 months after the initial dose. Recommendations may vary between individual products or local immunisation guidelines (refer to latest local guidelines).
Child: As inactivated hepatitis A virus (GBM strain) vaccine containing 80 ELISA units per 0.5 mL: 1-15 years Primary immunisation: 0.5 mL as a single dose. Booster dose: 0.5 mL 6-36 months (may be given up to 84 months) after the initial dose. As inactivated hepatitis A virus (GBM strain) vaccine containing 160 ELISA units per 0.5 mL: ≥16 years Same as adult dose. As inactivated hepatitis A virus (HM 175 strain) vaccine containing 720 ELISA units per 0.5 mL: 1-15 years Primary immunisation: 0.5 mL as a single dose. Booster dose: 0.5 mL 6-12 months (may be given up to 36 months) after the initial dose. As inactivated hepatitis A virus (HM 175 strain) vaccine containing 1,440 ELISA units per 1 mL: ≥16 years Same as adult dose. As inactivated hepatitis (CR 326F strain) vaccine containing 25 units per 0.5 mL: 1-17 years Primary immunisation: 0.5 mL as a single dose. Booster dose: 0.5 mL 6-18 months after the initial dose. Recommendations may vary between individual products or local immunisation guidelines (refer to specific local guidelines).
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Avaxim 160U
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Avaxim 80U Pediatric
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Epaxal
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Havrix 1440
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Hypersensitivity to hepatitis A containing vaccines.
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Patient with thrombocytopenia or bleeding disorder; history of febrile convulsions or neurological disorders. Patient receiving anticoagulant therapy. Delay vaccination in patients with acute severe febrile illness or during periods of severe immunosuppression (e.g. patients receiving chemotherapy or radiation therapy or other immunosuppressive treatment including high-dose corticosteroids), if appropriate. Carefully review product labelling prior to administration, available products may differ by concentration and appropriate ages. Current international guidelines recommend that doses should be given from the same brand or manufacturer; however, administration of whichever hepatitis A vaccine available may be given if this is not possible or the previous vaccine is unknown. Children. Pregnancy and lactation.
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Significant: Syncope, anaphylactoid or hypersensitivity reactions, shoulder injury related to vaccine administration (e.g. bursitis, tendinopathy), bleeding or haematoma (particularly in patients with bleeding disorder).
Gastrointestinal disorders: Nausea, diarrhoea, vomiting, abdominal pain.
General disorders and administration site conditions: Fatigue, lethargy, malaise, fever (≥38.5°C), inj site reactions (e.g. pain, erythema, swelling, induration).
Metabolism and nutrition disorders: Decreased appetite, anorexia.
Musculoskeletal and connective tissue disorders: Myalgia, arthralgia, stiffness.
Nervous system disorders: Headache, dizziness, drowsiness.
Psychiatric disorders: Insomnia; irritability, crying (particularly in children).
Respiratory, thoracic and mediastinal disorders: URTI, rhinitis, pharyngitis.
Skin and subcutaneous tissue disorders: Urticaria, rash.
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Monitor for anaphylactic reactions and syncope for 15 minutes after administration.
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Therapeutic effect may be decreased with immunosuppressants (e.g. alkylating agents, antimetabolites, cytotoxic drugs, high dose corticosteroids).
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Description:
Mechanism of Action: Hepatitis A vaccine is an inactivated virus vaccine. It induces active immunity to hepatitis A virus (HAV) by stimulating immune responses as presented by the production of antibodies against HAV.
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Store between 2-8°C. Do not freeze. Protect from light. Storage recommendations may vary among countries and individual products (refer to specific product guidelines).
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J07BC02 - hepatitis A, inactivated, whole virus ; Belongs to the class of hepatitis viral vaccines.
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Anon. Hepatitis A Virus Vaccine Inactivated. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 19/04/2024. Avaxim 160 Units, Suspension for Injection in Pre-filled Syringe (Sanofi-Aventis [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 19/04/2024. Avaxim 80 Units, Suspension for Injection in Pre-filled Syringe (Sanofi-Aventis [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 19/04/2024. Avaxim Junior, Suspension for Injection in Pre-filled Syringe (Sanofi Pasteur). MHRA. https://products.mhra.gov.uk. Accessed 19/04/2024. Avaxim, Suspension for Injection in Pre-filled Syringe (Sanofi Pasteur Europe). MHRA. https://products.mhra.gov.uk. Accessed 19/04/2024. Buckingham R (ed). Hepatitis A Vaccines. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 19/04/2024. GlaxoSmithKline NZ Ltd. Havrix 1,440 EU/mL, Havrix Junior 720 EU/0.5 mL Suspension for Injection data sheet 01 March 2023. Medsafe. http://www.medsafe.govt.nz. Accessed 19/04/2024. Havrix 1,440 Adult/720 Junior Suspension for Injection (GlaxoSmithKline Pharmaceutical Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 19/04/2024. Havrix Injection, Suspension (GlaxoSmithKline Biologicals SA). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 19/04/2024. Havrix Junior Monodose Vaccine Suspension for Injection in a Pre-filled Syringe (SmithKline Beecham Ltd). MHRA. https://products.mhra.gov.uk. Accessed 19/04/2024. Havrix Monodose Vaccine Suspension for Injection in a Pre-filled Syringe (SmithKline Beecham Ltd). MHRA. https://products.mhra.gov.uk. Accessed 19/04/2024. Hepatitis A Vaccine. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 19/04/2024. Joint Formulary Committee. Hepatitis A Vaccine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 19/04/2024. Vaqta Adult, Suspension for Injection (Merck Sharp & Dohme [UK] Limited). MHRA. https://products.mhra.gov.uk. Accessed 19/04/2024. Vaqta Paediatric, Suspension for Injection (Merck Sharp & Dohme [UK] Limited). MHRA. https://products.mhra.gov.uk. Accessed 19/04/2024.
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