Vaccine, hepatitis A


Concise Prescribing Info
Indications/Uses
Active immunisation against hepatitis A.
Dosage/Direction for Use
Adult : IM As inactivated hepatitis A virus vaccine containing 1,440 ELISA units/mL: ≥16 years Primary immunisation: 1 mL as single dose. Booster: 1 mL 6-12 months (up to 36 months) after initial dose. As inactivated hepatitis A virus (CR 326F strain) vaccine containing 50 units/mL: ≥18 years Primary immunisation: 1 mL as single dose. Booster: 1 mL 6-18 months after initial dose; may be given 6-12 months following initial dose of other inactivated hepatitis A vaccine. As inactivated hepatitis A virus (GBM strain) vaccine containing 160 units/0.5 mL: ≥16 years 0.5 mL as single dose. Booster: 0.5 mL 6-12 months (up to 36 months) after initial dose.
Dosage Details
Intramuscular
Active immunisation against hepatitis A
Adult: As inactivated hepatitis A virus vaccine containing 1,440 ELISA units per 1 mL: ≥16 years Primary immunisation: 1 mL as single dose. Booster dose: 1 mL 6-12 months (may be given up to 36 months) after initial dose. As inactivated hepatitis A virus (CR 326F strain) vaccine containing 50 units per 1 mL: ≥18 years Primary immunisation: 1 mL as single dose. Booster dose: 1 mL 6-18 months after initial dose; may be given 6-12 months following initial dose of other inactivated hepatitis A vaccine. As inactivated hepatitis A virus (GBM strain) vaccine containing 160 units per 0.5 mL: ≥16 years 0.5 mL as single dose. Booster dose: 0.5 mL 6-12 months (may be given up to 36 months) after initial dose.
Child: As inactivated hepatitis A virus vaccine containing 720 ELISA units per 0.5 mL: 1-15 years Primary immunisation: 0.5 mL as single dose. Booster dose: 0.5 mL 6-12 months (may be given up to 36 months) after initial dose. As inactivated hepatitis A virus containing 25 units per 0.5 mL: 1-17 years Primary immunisation: 0.5 mL as single dose. Booster dose: 0.5 mL 6-18 months after initial dose; may be given 6-12 months following initial dose of other inactivated hepatitis A vaccine.
Contraindications
Hypersensitivity to hepatitis A-containing vaccine.
Special Precautions
Patient with bleeding disorders (e.g. thrombocytopenia), immunosuppression, personal or family history of febrile convulsions, chronic liver disease. Postpone vaccination in patients with acute severe febrile illness. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Syncope, bleeding disorders (e.g. thrombocytopenia).
Blood and lymphatic system disorders: Lymphadenopathy.
Ear and labyrinth disorders: Otitis media.
Eye disorders: Photophobia, conjunctivitis.
Gastrointestinal disorders: Nausea, abdominal pain, diarrhoea, dysgeusia, vomiting, constipation, gastroenteritis.
General disorders and administration site conditions: Fatigue, fever, malaise, weakness; injection site reactions (e.g. induration, redness, erythema, soreness, swelling).
Investigations: Increased creatine phosphokinase.
Metabolism and nutrition disorders: Anorexia.
Musculoskeletal and connective tissue disorders: Myalgia, arthralgia, hypertonia, back pain, stiffness.
Nervous system disorders: Convulsion, dizziness, headache, drowsiness, paraesthesia, migraine, tremor, vertigo, encephalopathy.
Psychiatric disorders: Insomnia, irritability, somnolence.
Reproductive system and breast disorders: Menstrual disease.
Respiratory, thoracic and mediastinal disorders: Pharyngitis, upper respiratory tract infection, asthma, cough, nasal congestion, nasopharyngitis, rhinorrhea, rhinitis.
Skin and subcutaneous tissue disorders: Pruritus, rash, urticaria.
Vascular disorders: Hot flashes.
Potentially Fatal: Severe hypersensitivity reactions, including anaphylaxis, angioedema, bronchospasm, urticaria).
MonitoringParameters
Monitor LFT, anaphylaxis and syncope for 15 minutes following administration.
Drug Interactions
Decreased efficacy when given with immunosuppressants (e.g. high-dose corticosteroids, cytotoxic drugs). Increased risk of bleeding or haematoma with anticoagulants.
Action
Description: Hepatitis A vaccine stimulates immunity against hepatitis A virus (HAV) infection by inducing production of HAV-specific immunoglobulin G (IgG and M (IgM) antibodies, resulting in humoral immunity.
Storage
Store between 2-8°C. Do not freeze. Protect from light.
Any unused portions should be disposed of in accordance with local requirements.
ATC Classification
J07BC02 - hepatitis A, inactivated, whole virus ; Belongs to the class of hepatitis viral vaccines.
References
Anon. Hepatitis A Vaccine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 09/07/2018.

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 09/07/2018.

Buckingham R (ed). Hepatitis A Vaccines. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/07/2018.

Havrix Injection, Suspension (GlaxoSmithKline Biologicals SA). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 09/07/2018.

Joint Formulary Committee. Hepatitis A Vaccine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/07/2018.

VAQTA Injection, Suspension (Merck Sharp & Dohme Corp.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 09/07/2018.

Disclaimer: This information is independently developed by MIMS based on Vaccine, hepatitis A from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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