This vaccine is indicated for the active immunization against infection caused by the hepatitis A virus in the adolescent from the age of 16 and in the adult
< Br>

The vaccine does not protect against infection caused by hepatitis B viruses, hepatitis C, hepatitis E or other known pathogens of the liver
< Br>

The transmission of hepatitis A virus usually occurs through ingestion of contaminated water or food. Persons in contact with contaminated subjects usually become infected oro-fecally.

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

This vaccine should be administered in accordance with official recommendations.
Dosage

The recommended dose for subjects from 16 years is 0.5 ml.
The initial protection is obtained after a single injection.

In order to obtain long-term protection against infections caused by the hepatitis A virus in adolescents from the age of 16 years and in the adult, a booster dose should preferably be administered 6 to 12 months after the first vaccination and may be vaccinated up to 36 months after the first vaccination (see section 5.1 Pharmacodynamic properties). It is estimated that anti-HAV antibodies persist for several years (at least 10 years) after the second dose (recall).


Mode of administration

Given the adsorbed nature of the vaccine, it is recommended to administer it intramuscularly (IM) in order to minimize local reactions.

The recommended injection site is the deltoid muscle.


· Do not inject intravascularly: ensure that the needle does not enter a blood vessel

· This vaccine should not be mixed with other vaccines in the same syringe

VACCINE AGAINST HEPATITIS A, ATC Code: J07BC02.

This vaccine is prepared from the cultured hepatitis A virus, purified and then inactivated by formaldehyde. It confers immunity to the hepatitis A virus by inducing an antibody response greater than that obtained after passive immunization with immunoglobulins. Immunity appears rapidly after the first injection and 14 days after vaccination, more than 90% of immunocompetent subjects are seroconverted with protective titers (titre greater than 20, mUI / ml). >

One month after the first injection, nearly 100% of the subjects are protected. Immunity may persist until the 36th month. It is reinforced after a reminder.

Without object.

· Usual contra-indications of all vaccinations: in case of fever, acute disease, chronic disease, evolutionary, it is preferable to defer vaccination. >
· Hypersensitivity to any of the components of the vaccine or, following a previous injection of this vaccine

· Do not inject intravascularly: ensure that the needle does not enter a blood vessel

· As with any vaccination, it is recommended to have an injectable solution of adrenaline in case of a possible anaphylactic reaction

The vaccine will not be administered to the buttock muscle because of the variability of this anatomic site (presence of varying size of adipose tissue) or intradermally, as these modes of administration may induce a response Immune system
· Immunosuppressive therapy or immunodeficiency may induce a decrease in immune response to the vaccine

It is then recommended 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 an even limited antibody response.

Due to the incubation period 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 patients with hepatic disease should be considered with caution, as no studies have been carried out in these subjects.
· Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopenia or in patients prone to haemorrhages.

< Br>
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.
This vaccine is inactivated and the combination with other inactivated vaccine (s) using a different injection site generally does not cause interference. >

This vaccine may be administered simultaneously but in two separate sites with a polyosidic typhoid vaccine (Typhim Vi) or a recombinant hepatitis B vaccine obtained by cloning and expression of the viral gene in yeasts Saccharomyces cerevisiae, Without the immune response to any of the antigens being altered.

This vaccine can be administered simultaneously but in two separate sites with a live Amaril vaccine, stabilized.

Pregnancy

There is no reliable evidence of teratogenesis in animals.

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,

Breastfeeding

The use of this vaccine is possible during breastfeeding.

The undesirable effects reported in clinical trials were mostly moderate, short-lived and favorable without treatment.


It was most commonly local pain, sometimes associated with erythema The appearance of a nodule at the injection site was very rarely observed

· General reactions

A fever, moderate, asthenia, headache, myalgia or arthralgia and gastrointestinal disorders were most frequently reported.


Reactions were less frequently reported after the booster injection than after the first dose.
This vaccine was both well tolerated in seropositive subjects with respect to hepatitis A virus and in seronegative subjects.



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 -
This vaccine is indicated for the active immunization against infection caused by the hepatitis A virus in the adolescent from the age of 16 years and in the adult The vaccine does not protect against, Infection caused by hepatitis B viruses, hepatitis C, hepatitis E or other known pathogens of the liver The transmission of hepatitis A virus usually occurs through ingestion Water or contaminated food. Contaminants are usually infected by oro-fecal route The possibility of blood or sexual transmission (oro-anal ratios) has also been demonstrated. Administered in accordance with official recommendations.