Vaccine, hepatitis A + hepatitis B


Concise Prescribing Info
Indications/Uses
Active immunisation against hepatitis A and B.
Dosage/Direction for Use
Adult : IM Each 1 mL inj contains hepatitis A virus (inactivated) 720 ELISA U and recombinant hepatitis B surface antigen 20 mcg: Primary immunisation: 3 doses, given at 0, 1, and 6 months. Alternatively, in exceptional circumstances, accelerated dose of 3 doses may be given on day 0, 7, and 21 followed by a booster at 12 months. May be given via SC administration in patients with bleeding disorders.
Dosage Details
Intramuscular
Active immunisation against hepatitis A, Active immunisation against hepatitis B
Adult: Available preparation:
Each 1 mL inj contains hepatitis A virus (inactivated) 720 ELISA U and recombinant hepatitis B surface antigen 20 mcg. Primary immunisation: 1 mL for 3 doses given at 0-, 1-, and 6-months. Alternatively, in exceptional circumstances, an accelerated dose of 1 mL for 3 doses, may be given on days 0, 7, and 21 followed by a booster at 12 months. May be given via SC administration in patients with bleeding disorders.
Child: Available preparations:
Each 0.5 mL inj contains hepatitis A virus (inactivated) 360 ELISA U and recombinant hepatitis B surface antigen 10 mcg
1-15 years Primary immunisation: 0.5 mL for 3 doses, given at 0, 1, and 6 months; ≥16 years Same as adult dose. May be given via SC administration in patients with bleeding disorders.

Each 1 mL inj contains hepatitis A virus (inactivated) 720 ELISA U and recombinant hepatitis B surface antigen 20 mcg.
1-15 years Primary immunisation: 1 mL for 2 doses given at 0 and between 6-12 months; ≥16 years Same as adult dose. May be given via SC administration in patients with bleeding disorders.
Contraindications
Hypersensitivity. Acute severe febrile illness.
Special Precautions
Patient with immunodeficiency or receiving immunosuppressive therapy or on haemodialysis, thrombocytopenia, bleeding disorder. Obese patients (BMI ≥130%). Not intended for postexposure prophylaxis. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Syncope, bleeding/haematoma.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain.
General disorders and administration site conditions: Fatigue, malaise, fever, irritability, inj site reaction (e.g. pain, swelling, redness, bruising, pruritus).
Metabolism and nutrition disorders: Appetite loss.
Musculoskeletal and connective tissue disorders: Myalgia.
Nervous system disorders: Headache, drowsiness.
Respiratory, thoracic and mediastinal disorder: Upper respiratory tract infection.
Potentially Fatal: Rarely, anaphylactic reactions.
MonitoringParameters
Monitor for syncope for 15 minutes following administration. Maintain supine or Trendelenburg position to establish adequate cerebral perfusion for seizure-like activity associated with syncope.
Drug Interactions
Reduced immune response to vaccination with immunosuppressants. Risk of bleeding with anticoagulants.
Action
Description: Vaccine, hepatitis A + hepatitis B is a combined vaccine from purified, inactivated hepatitis A virus (HAV) and recombinant hepatitis B surface antigen (HBsAg). It stimulates the production of HAV immunoglobulin and antibodies and anti-HBs antibodies that neutralizes the pathogenic properties of HAV and hepatitis B virus (HBV).
Onset: Within 2-4 weeks.
Duration: 15 years.
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
J07BC - Hepatitis vaccines ; Used for active immunizations.
References
Anon. Hepatitis A and Hepatitis B Recombinant Vaccine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/08/2017.

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 08/08/2017.

Anon. Hepatitis B Vaccine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 22/08/2018.

Buckingham R (ed). Hepatitis A and B Vaccines. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/08/2017.

Twinrix Vaccine Injection, Suspension (GlaxoSmithKline Biologicals SA). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 22/08/2018.

Disclaimer: This information is independently developed by MIMS based on Vaccine, hepatitis A + hepatitis B 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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