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Drug Details

Havrix Monodose Vaccine

• Drug Class Description
  Inactivated viruses (vaccines).
• Generic Name
  Hepatitis A vaccine
• Presentation
  Vaccine suspension for injection.
• Description
  Each vial or syringe contains 1440 ELISA units/1 ml dose of hepatitis A virus antigen.
• Indications
  

  Active immunisation against infections caused by hepatitis A virus. The vaccine is particularly indicated for those at increased risk of infection or transmission. For example immunisation should be considered for the following risk groups:

  travellers visiting areas of medium or high endemicity, i.e. anywhere outside northern or western Europe, Australia, North America and New Zealand.

  military and diplomatic personnel, haemophiliacs and patients, intravenous drug abusers, homosexual men, laboratory workers working directly with the hepatitis A virus, sanitation workers in contact with untreated sewage.

  patients with chronic liver disease (including alcoholic cirrhosis, chronic hepatitis B, chronic hepatitis C, autoimmune hepatitis, primary biliary cirrhosis).

  close contacts of hepatitis A cases.

  Since virus shedding from infected persons may occur for a prolonged period, active immunisation of close contacts may be considered.

  Under certain circumstances additional groups could be at increased risk of infection or transmission. Immunisation of such groups should be considered in the light of local circumstances. Such groups might include:

  staff and inmates of residential institutions for the mentally handicapped and other institutions where standards of personal hygiene are poor.

  staff working in day care centres and other settings with children who are not yet toilet trained.

  food packagers or handlers.

  In addition there may be other groups at risk or specific circumstances such as an outbreak of hepatitis A infection when immunisation should be given.

• Adult Dosage
  

  Adults (16 years and over)

  Primary immunisation consists of a single dose of Havrix Monodose vaccine (1440 ELISA units/ml) given intramuscularly. This provides anti-HAV antibodies for at least one year.

  Havrix Monodose confers protection against hepatitis A within 2-4 weeks.

  In order to obtain more persistent immunity, a booster dose is recommended between 6 and 12 months after primary immunisation.

  Although a booster should be given within 6 – 12 months of the initial vaccination with Havrix Monodose, it has been shown that immunocompetent subjects given a booster up to 3 years after the initial vaccination can develop similar antibody levels to subjects given a booster within the recommended time period. Subjects given a booster up to 5 years after initial vaccination can also show a satisfactory antibody response but approximately 30% of individuals receiving a delayed booster have no detectable anti-HAV antibodies prior to booster dosing.

  It is unnecessary to restart the primary vaccination schedule of Havrix Monodose if the booster is administered within 5 years of the primary vaccination.

  Current recommendations do not support the need for further booster vaccination among immunocompetent subjects after a 2 dose vaccination course.

  The results described above should be considered to apply only to immunocompetent adults.

  Havrix Monodose can be used as a booster in subjects previously immunised with any inactivated hepatitis A vaccine.

  In the event of a subject being exposed to a high risk of contracting hepatitis A within 2 weeks of the primary immunisation dose human normal immunoglobulin may be given simultaneously with Havrix Monodose at different injection sites.

  Method of administration

  Havrix Monodose vaccine should be injected intramuscularly in the deltoid region.

  The vaccine should never be administered intravenously.

• Child Dosage
  

  Havrix Monodose is not recommended (Havrix Junior Monodose should be used).

• Contra Indications
  

  Hypersensitivity to any component of the vaccine. Severe febrile illness.

• Special Precautions
  

  As for all vaccinations, appropriate medication e.g. epinephrine (adrenaline) should be readily available for immediate use in case of anaphylaxis. Havrix Monodose may contain traces of the antibiotic neomycin B sulphate.

  It is possible that subjects may be in the incubation period of a hepatitis A infection at the time of immunisation. It is not known whether Havrix Monodose will prevent hepatitis A in such cases.

  In haemodialysis patients and in subjects with an impaired immune system, adequate anti-HAV antibody titres may not be obtained after the primary immunisation and such patients may therefore require administration of additional doses of vaccine.

• Interactions
  

  Simultaneous administration of Havrix at a dose of 720 ELISA units/ml with ISG does not influence the seroconversion rate to Havrix, however, it may result in a lower antibody titre. A similar effect could be observed with Havrix Monodose.

  Preliminary data on the concomitant administration of Havrix at a dose of 720 ELISA units/ml, with recombinant hepatitis B virus vaccine suggest that there is no interference in the immune response to either antigen. On this basis and since it is an inactivated vaccine interference with immune response is unlikely to occur when Havrix Monodose is administered with other inactivated or live vaccines. When concomitant administration is considered necessary the vaccines must be given at different injection sites.

  Havrix Monodose must not be mixed with other vaccines in the same syringe.

• Adverse Drug Reactions
  

  The safety profile presented below is based on data from more than 5300 subjects that participated in clinical trials, plus reactions observed through post-marketing surveillance. It should be noted that it was not possible to calculate the frequency of reactions from the post-marketing data, therefore the frequency is noted as “Not known”.

  The most frequently reported reactions are pain and redness at site of injection (Havrix Monodose reports in over 50% of doses, Havrix Junior Monodose reports in 18.2% of doses overall). Swelling at the site of injection was the next most frequently reported reactions.

  Frequencies per dose are defined as follows:

  Very common:	10%
  Common:	1% and < 10%
  Uncommon:	0.1% and < 1%
  Rare:	0.01% and < 0.1%
  Very rare:	< 0.01%
  Not Known:	Cannot be estimated from the data available

  Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness

  * refers to adverse reaction reported only for Havrix Monodose (1ml adult dose)

  ** refers to adverse reactions reported only for Havrix Junior Monodose (0.5ml children's dose)

  # this adverse reaction was identified through post-marketing surveillance but was not observed in randomised controlled clinical trials. The frequency category of rare was estimated from a statistical calculation based on the total number of paediatric patients exposed to Havrix in randomised controlled clinical trials (n=4574).

  System Organ Classes	Frequency	Adverse reaction
  Infections and infestations	Uncommon	Upper respiratory tract infection* Rhinitis*
  Immune system disorders	Not known	Anaphylaxis Allergic reactions including anaphylactoid reactions and mimicking serum sickness
  Metabolism and nutrition disorders	Common	Appetite lost
  Psychiatric disorders	Very common	Irritability**
  Nervous system disorders	Very common	Headache (common with Havrix Junior Monodose formulation)
  	Common	Drowsiness**
  	Uncommon	Dizziness*
  	Rare	Hypoaesthesia Paraesthesia
  	Not known	Convulsions Guillain Barre Syndrome Transverse myelitis Neuralgic amyotrophy
  Vascular disorders	Not known	Vasculitis
  Gastrointestinal disorders	Common	Gastrointestinal symptoms* (rare with Havrix Junior Monodose formulation#) Nausea Diarrhoea (uncommon with Havrix Junior Monodose formulation)
  	Uncommon	Vomiting
  Hepatobiliary disorders	Not known	Transient increase in Liver Function Tests
  Skin and subcutaneous tissue disorders	Uncommon	Rash**
  	Rare	Pruritus
  	Not known	Angioneurotic oedema Erythema multiforme Urticaria
  Musculoskeletal and connective tissue disorders	Uncommon	Myalgia* Musculoskeletal stiffness* General disorders and administration site conditions
  	Not known	Arthralgia
  General disorders and administration site conditions	Very common	Pain and redness at the injection site Fatigue* (rare with Havrix Junior Monodose formulation#)
  	Common	Fever (37.5°C) Swelling Injection site reaction, such as induration (uncommon with Havrix Junior Monodose formulation) Malaise
  	Uncommon	Influenza like illness*
  	Rare	Chills