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Active immunisation against hepatitis A in children from 1 year of age, and adults.


Hypersensitivity to any of the vaccine’s components. Hypersensitivity to eggs and chicken protein or formaldehyde. In cases of acute infectious disease with fever, vaccination with Epaxal should be postponed.

Adverse reactions:

The possible undesirable effects are mild and of short duration. The frequencies of adverse events provided were base on clinical studies. The most common adverse reactions fatigue, local pain and headache, were registered at frequencies of 6 to 32%, 5 to 25% and 6 to 25% respectively. Very common (=1/10) Nervous system disorders: Headache General disorders and administration site conditions: Local pain, fatigue Common (=1/100 and <1/10) Metabolism and nutrition disorders: Anorexia Gastrointestinal disorders: Mild and transient diarrhoea, nausea General disorders and administration site conditions: Injection site reactions (induration, redness, swelling), malaise, fever Uncommon (=1/1000 and <1/100): Nervous system disorders: Dizziness Skin and subcutaneous tissue disorders: Skin rash/pruritus Gastrointestinal disorders: Vomiting Musculoskeletal, connective tissue and bone disorders: Arthralgia The degree of dizziness is not more pronounced as compared to other vaccines in comparative trials. A transient and mild rise in levels of liver enzymes was observed on single occasions at the time of vaccination. As observed with other vaccines, occasional inflammatory diseases of the central and peripheral nervous system may occur, including ascending paralysis up to respiratory paralysis, e.g. Guillain-Barré Syndrome.


A prospectively planned interaction study was performed with yellow fever vaccine in 55 subjects. In addition, concomitant vaccination against yellow fever, typhoid fever, poliomyelitis, diphtheria, tetanus, meningococci A + C, as well as concomitant malaria prophylaxis was studied as part of a travel prophylaxis program in 38 subjects. A prospectively planned interaction study was performed with concomitant whole influenza virus vaccine in 163 subjects. The concomitant administration does neither impair immunogenicity against hepatitis A nor influenza. In addition, immunogenicity against hepatitis A is independent of the level of influenza pre-immunisation titres. These results indicate that Epaxal can be administered simultaneously with the above vaccines but in separate syringes, as well as with malaria prophylaxis.


Influenza hemagglutinin contained in Epaxal does not provide an alternative for influenza vaccination. Immunodeficiency disorders may impair immune response. In splenectomised patients, the booster vaccination should be administered 1 to 6 months after primary immunisation, owing to the lower titres achieved in these subjects. This also applies to other categories of immunocompromised patients. Experience of the vaccination of children under 1 year of age and adults over 60 years of age is limited. There is no adequate data on the use of Epaxal in pregnant women. The effect of Epaxal on the development of the foetus has not been determined. Like with other inactivated vaccines, lesions in the foetus are not expected. The vaccine should not be given to pregnant women, unless the risk of infection by hepatitis A is increased. Whether the vaccine passes into the milk of a lactating mother is unknown. Breast-feeding women should use Epaxal with caution. As it was previously referred, in patients with coagulation disorders the vaccine may be administered by subcutaneous route in the arm. It was also referred that experience of the vaccination of children under 1 year of age and adults over 60 years of age is limited.



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