AVAXIM 80 U: PEDIATRIC is indicated for active immunization against infection caused by the hepatitis A virus, in children aged 12 months to 15 years inclusive, which presents a particular risk of contamination or; Transmission of infection or, in the event of infection, a life-threatening disease.

The transmission of hepatitis A virus is usually caused by the ingestion of contaminated water or food.

Contaminated persons are usually infected by oro-fecal.

The possibility of blood-borne or sexual transmission (oro-anal intercourse) has also been demonstrated.

Dosage

Primary vaccination is provided by a single dose of vaccine. The recommended dose is 0.5 ml for each injection. In order to ensure long-term protection, it is recommended to administer a booster dose 6 at 18 months after the first injection.
The persistence of anti-HAV antibodies after vaccination is not currently known. The available data suggest the persistence of anti-HAV antibodies at a protective level up to 10 years after primo-immunization.
Mode of administration

The vaccine should be injected intramuscularly into the deltoid muscle

Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopenia or in patients subjected to haemorrhage.


VACCINE AGAINST, HEPATITIS A, (J: anti-infectives).
This vaccine is prepared from the cultured hepatitis A virus harvested and inactivated by formaldehyde. It confers immunity to hepatitis A virus by inducing more durable and higher antibody titers than those obtained after passive immunization with immunoglobulins. This vaccine provides antibody titers to hepatitis A virus (≥ 20 mIU / ml) within two weeks of injection in more than 95% of subjects and in 100% Of the subjects before administration of the booster dose.
Immunity persists 6 to 18 months and is reinforced by a booster dose.

The long-term persistence of hepatitis A virus antibodies after a booster dose is under study. However, antibody titers obtained after the first booster are compatible, with long-term protection (at least 10 years).
It is unlikely that vaccination will have an effect on the ability to drive or use machines

Contra-indications, usual of all vaccinations: in case of fever, acute disease, chronic evolutive disease, it is preferable to postpone the vaccination.
Hypersensitivity to the active substance, to any of the excipients, to neomycin, to polysorbate 80 or following a previous injection of this vaccine


Do not inject intravascularly: ensure that the needle does not penetrate into a blood vessel

The vaccine will not be administered in the gluteal muscle due to the variability of this anatomic site (presence of more or less tissue, adipose tissue) or intradermally, these modes of administration may induce a more immune response Low.

As for all injectable vaccines, it is recommended to have medical treatment appropriate for the management of a possible anaphylactic reaction following the administration of the vaccine. >

Immunosuppressive therapy or an immunodeficiency state may induce a decrease in the immune response to the vaccine. It is then advisable to wait until the end of the treatment to vaccinate or to ensure the good protection of the subject. Nevertheless, vaccination of subjects with chronic immunosuppression, such as HIV infection, is recommended if the underlying disease allows for even limited antibody response.

Due to the duration of incubation of the disease, it is possibly possible that the unrecognized infection is present at the time of vaccination. In this case, vaccination may have no effect on the development of hepatitis A.

The use of this vaccine in subjects with hepatic impairment should be considered with care, no studies have been carried out in these subjects

No studies concerning the administration of this vaccine in immunocompromised subjects have been carried out.
The vaccine does not protect against infection caused by hepatitis B viruses, hepatitis C, hepatitis E or other known pathogens of the liver
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The simultaneous administration of immunoglobulins with this vaccine at two separate sites can be practiced. The seroprotection rates are not altered but the antibody titres may be less than those obtained when this vaccine is administered in isolation.
In case of simultaneous administration, this vaccine should not be mixed with other vaccines in the same syringe. This vaccine can be administered simultaneously at two sites, separated with the routine vaccine booster in the second year of the vaccine, the different vaccines containing one or more of the valencies, diphtheria, tetanus, pertussis (acellular or Germ, whole), haemophilus influenza type b and poliomyelitis, inactivated or oral poliomyelitis

This vaccine may be used as a recall in subjects who have received a primary vaccination with another inactivated hepatitis vaccine.
In the absence of compatibility studies, this medicinal product should not be mixed with other medicines.
There is no reliable data for teratogenesis in the animal.

There is currently no adequate clinical data to evaluate a possible malformative or fetotoxic effect of the vaccine against hepatitis A when administered during pregnancy.

As a precautionary measure, it is preferable not to use this vaccine during pregnancy unless there is a risk of contamination.

The use of this vaccine is possible during breastfeeding.

During the clinical development more than 3000 children aged 12 months to 15 years were vaccinated with this vaccine (about 5900 doses administered). >
All adverse reactions were moderate and limited to the first days after vaccination with regression, spontaneous. Reactions were more rarely reported after dosing and booster than after the first dose.
However, as with any pharmaceutical specialty, it is possible that more rare adverse events may be reported during widespread use of the vaccine. >
The most frequent reactions with an incidence of 1 to 10% are local reactions at the injection site, such as pain, redness, edema or induration and general reactions such as headache, gastrointestinal disorders (abdominal pain , Diarrhea, nausea, vomiting), myalgia or arthralgia, disorders, transient behavior (decreased appetite, insomnia, irritability), fever, asthenia >
The most frequent reactions with an incidence of less than 1% are skin manifestations (rash, urticaria).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the drug is important. It permits continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and network of Regional Pharmacovigilance Centers -
AVAXIM 80 U: PEDIATRIC is indicated for active immunization against infection caused by the hepatitis A virus, in children aged 12 months to 15 years inclusive, which presents a particular risk of contamination or; Transmission of infection or infection of a life-threatening disease transmission of hepatitis A virus usually occurs through the ingestion of contaminated water or food. Persons in contact with contaminated subjects are usually infected oro-fecally.
The possibility of blood-borne or sexual transmission (oro-anal ratios) has also been demonstrated.