Avaxim 80 U Pediatric

/ Medici

Primary vaccination is achieved with one single dose of vaccine. The recommended dosage is 0.5 ml for each injection. In order to provide long-term protection, a booster dose is recommended within the 6 to 18 month period following the initial dose.
HAV antibody persistence following vaccination is not currently available. Available data suggest that HAV antibodies persist at protective levels up to ten years after primary vaccination.
Method of administration: The vaccine must be injected by the intramuscular route in the deltoid region.
In exceptional cases, the vaccine may be administered by the subcutaneous route in patients suffering from thrombocytopaenia or in patients at risk of haemorrhage.

AVAXIM 80 U pediatric is indicated for active immunisation against infection caused by hepatits A virus in children aged from 12 months to 15 years inclusive, who are at risk either of contaminating or spreading infection or of a lifethreatening diseases if infected.
Transmission of the Hepatits A virus usually occurs through the consumption of contaminated water or food. Person in contact with contaminated subjects are usually infected through orofecal routes.
The possibility of transmission through the blood or by sexual contacts (oral-anal relations) has also been proved.

Usual contra-indications to any immunization: vaccination should be delayed In the case of fever, acute or chronic evolving disease.
Hypersensitivity to the active substance, to one of the excipients, to neomycin, to polysorbate or following a previous injection of this vaccine.

Do not inject by intravascular route: make sure that the needle does not enter a blood vessel.
The vaccine should never be administered into the buttocks due to the variability of this anatomical site (varying amount of fatty tissue), nor by intradermal route as these methods of administration may induce a weaker immune response.
As with all vaccines for injection, it is recommended to have appropriate medication available in the event of an anaphylactic reaction following injection.
Immunogenicity of the vaccine could be impaired by immunosuppressive treatment or by an immunodeficiency state. In such cases, it is recommended to wait for the end of any suppressive treatment before vaccination or to measure the antibody response to be sure of protection. Nevertheless, vaccination of subjects with chronic immunodeficiency such as HIV infection is recommended if the underlying pathology allows the induction of antibody response, even if limited.
Because of the incubation period of the disease, infection may be present but not clinically apparent at the time of vaccination. In this case, the vaccination may have no effect on the development of Hepatitis A.
As no studies have been performed with this vaccine in subjects suffering from liver disease, the use of this vaccine in such subjects should be considered with care. No study relative to the administration of this vaccine in patients with impaired immunity has been performed.
This Vaccine does not provide protection against infection caused by hepatitis B virus, hepatitis C virus, hepatitis E virus or by other known liver pathogens.

The most common reactions with an incidence of 1% to 10% are local reactions at the injection site such as pain, redness, oedema or induration and systematic reactions such as headache gastrointestinal tract disorders (abdominal pain, diarrhea, nausea, vomiting), myalgia or arthralgia, transitory behavior changes (appetite decrease, insomnia, irritability), fever, asthenia.
The less common reactions with an incidence of less than 1% are cutaneous manifestations (rash, urticaria).

The simultaneous administration of immunoglobulins with this vaccine is possible using 2 different injection sites. The seroprotection rates are not modified, however the antibody titres may be lower than those obtained when the vaccine is administrated alone.
In case of simultaneous administration, this vaccine must not be mixed with other vaccines in the same syringe. The vaccine may be administered simultaneously, in two different injection sites, with the routine booster vaccine of the child during the second year of life, i.e. various vaccines containing one or more of following valences: diphtheria, tetanus, pertussis (acellular or whole cell), haemophilus influenza of type b and inactivated or oral poliomyelitis.
This vaccine can be used as a booster in subjects previously vaccinated with another inactivated Hepatitis A vaccine.

No relevant teratogenic data on animal are available.
In humans, up to now, the data is inadequate to assess teratogenic or foetotoxic risk of the vaccine against Hepatits A when administered during pregnancy.
As a precaution, this vaccine should not be used during pregnancy except in case of high contamination risk.
This vaccine may be used during lactation.

Overdose is unlikely to have untoward effect.