This vaccine is indicated for active immunisation against infection caused by the hepatitis A virus in adolescents aged 16 years and over and in adults.
This vaccine should be administered in accordance with official recommendations.

Posology
The recommended dose for subjects aged 16 years and over is 0.5 mL.
The initial protection is obtained after one single injection.
In order to obtain a long-term protection against infections caused by the hepatitis A virus, in adolescents aged 16 years and over and in adults, a second dose (booster) should be administered, preferably between 6 and 12 months after the first vaccination and can be administered up to 36 months after the first vaccination (see section 5.1). It is estimated that anti–hepatitis A virus (HAV) antibodies persist several years (beyond 10 years) after the second dose (booster).
This vaccine can also be administered as a booster dose of the hepatitis A vaccination in subjects aged 16 years and over who received a first injection with the combined typhoid fever (Vi purified polysaccharide) and hepatitis A (inactivated) vaccine between 6 and 36 months earlier.
Paediatric population
Not applicable.
Method of administration
 This vaccine must be administered by the intramuscular (IM) route. The recommended injection site is the deltoid region.
 In exceptional cases, the vaccine may be administered by the subcutaneous route in patients with thrombocytopenia or in patients at risk of haemorrhage.
 The vaccine should not be administered into the buttocks because of the varying amount of fat tissue in this region, which may contribute to variability in effectiveness of the vaccine.
 Do not inject by the intravascular route: ensure that the needle does not penetrate a blood vessel.
 Do not inject by the intradermal route.
 See section 6.6 for the instructions on preparation.

As with all injectable vaccines, available appropriate medical treatment and subject monitoring are recommended in case of an anaphylactic reaction after vaccine administration.
Avaxim 160 U has not been studied in patients with impaired immunity.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection, especially in adolescents. This may be accompanied by several neurological signs, such as transient sight disorders, paraesthesia and tonic-clonic limb movements, during the recovery phase. It is important that procedures be in place to avoid any injury from faints.
Immunosuppressive treatment or immunodeficiency may induce a decrease in the immune response to the vaccine.
It is then recommended to wait until the end of treatment before vaccinating or to make sure the subject is well protected. Nevertheless, vaccination of subjects with chronic immunodeficiency, such as HIV infection, is recommended even though the antibody response might be limited.
Because of the incubation period of hepatitis A, infection may already be present, although asymptomatic, at the time of vaccination. The effect of administering Avaxim 160 U during the incubation period of hepatitis A has not been documented. In such a case, vaccination may have no effect on the development of hepatitis A.
The use of this vaccine in subjects with liver disease should be considered with caution, as no studies have been performed in such subjects.
As with all vaccines, a protective immune response may not be obtained in all vaccinees.
The vaccine does not protect against infection caused by hepatitis B, hepatitis C or hepatitis E viruses, or by other known liver pathogens.
Avaxim 160 U contains ethanol, phenylalanine, potassium and sodium
Avaxim 160 U contains 2 mg of alcohol (ethanol) in each 0.5 mL dose. The small amount of alcohol in this medicinal product will not have any noticeable effects.
Avaxim 160 U contains 10 micrograms phenylalanine in each 0.5 mL dose, which is equivalent to 0.17 micrograms/kg for a 60 kg person. Phenylalanine may be harmful to people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Avaxim 160 U contains less than 1 mmol potassium (39 mg) and less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘potassium-free’ and ‘sodium-free’.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of
the administered product should be clearly recorded.

Concomitant administration of immunoglobulins and this vaccine in two separate sites may be
performed. Seroprotection rates are not modified, but antibody titres may be lower than those obtained
when the vaccine is administered alone.
When concomitant administration is deemed necessary, Avaxim 160 U must not be mixed with other
vaccines in a same syringe: the other vaccines must be administered in separate sites using separate
syringes and needles.
As the vaccine is inactivated, association with other inactivated vaccine(s) in a separate injection site
does not generally result in any interaction.
This vaccine can be administered simultaneously, but in two separate sites, with a typhoid
polysaccharide vaccine (Typhim Vi) without modification of the immune response to either antigen.
This vaccine can be administered simultaneously, but in two separate sites, with the live yellow fever
vaccine.
This vaccine can be used as a booster dose in subjects who have received primary vaccination with
another inactivated hepatitis A vaccine.

Pregnancy
No reliable data are available on teratogenesis in animals.
To date, there are no sufficiently relevant clinical data available to assess a potential vaccine-related
malformation or fetotoxic effect of the hepatitis A vaccine when it is administered during pregnancy.
As a precautionary measure, it is preferable not to use this vaccine during pregnancy except in case of
a major contamination risk.
Breast-feeding
The use of this vaccine is possible during breast-feeding.

The effects on the ability to drive and use machines have not been studied.

Summary of tolerance profile
During clinical studies, adverse reactions were generally moderate and limited to the first days following
vaccination with spontaneous regression.
The reactions were less frequently reported after administration of the booster dose than after the first
dose.
In subjects seropositive against hepatitis A virus, Avaxim was as well tolerated as in seronegative
subjects.
Tabulated list of adverse reactions
The adverse reactions are derived from clinical studies and worldwide post-marketing experience.
The adverse reactions are ranked under headings of frequency using the following convention:
Very common (≥ 1/10)
Common (≥ 1/100 to < 1/10)
Uncommon (≥ 1/1 000 to < 1/100)
Rare (≥ 1/10 000 to < 1/1 000)
Very rare (< 1/10 000)
Not known (cannot be estimated from available data): adverse reactions were spontaneously reported
after the marketing of Avaxim 160 U. Given that these reactions were reported voluntarily by a
population of unknown size, it is not possible to accurately estimate their frequency.
To report any side effect(s):
• Saudi Arabia:
- The National Pharmacovigilance and Drug Safety Centre (NPC)
• SFDA call center : 19999
• E-mail: npc.drug@sfda.gov.sa
• Website: https://ade.sfda.gov.sa/
• Sanofi- Pharmacovigilance: KSA_Pharmacovigilance@sanofi.com

A few cases of overdose have been reported with Avaxim 160 U, with no specific adverse reactions.

Pharmacotherapeutic group: Vaccine against hepatitis A, ATC code: J07BC02.
This vaccine is prepared from hepatitis A virus cultured, purified and then inactivated by formaldehyde.
It confers immunity against hepatitis A virus by inducing a higher antibody response than that obtained
after passive immunisation with immunoglobulins. The antibodies appear soon after the first injection,
and 14 days after vaccination, more than 90% of immunocompetent subjects are seroprotected (titres
above 20 mIU/mL).
One month after the first injection, almost 100% of subjects have titres higher than 20 mIU/mL. Immunity may persist up to the 36th month. In a study with 103 healthy subjects whose serology levels were monitored for 3 years after the first injection of Avaxim 160 U, 99% still had, by the 36th month, antibody titres of at least 20 mIU/mL against the hepatitis A virus.
Long-term persistence of a protective antibody level against the hepatitis A virus after a second dose (booster) of Avaxim 160 U is not currently established. However, the available data suggest that the antibodies against the hepatitis A virus persist beyond 10 years after the second dose in healthy people.

Not applicable.

Non-clinical data reveal no special hazard for humans based on conventional studies of acute toxicity, repeated dose toxicity, local tolerance and hypersensitivity.

2-Phenoxyethanol, ethanol, formaldehyde, and Hanks 199 medium*, water for injections, polysorbate 80, hydrochloric acid and sodium hydroxide for pH adjustment.
* Hanks 199 medium (without phenol red) is a complex mixture of amino acids (including phenylalanine), mineral salts, vitamins and other components, including potassium.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Store in a refrigerator (2 °C–8 °C).
Do not freeze.
If frozen, the vaccine must be discarded.
Keep in the original packaging, protected from light.

0.5 mL of suspension in prefilled syringe (type I glass) with a plunger stopper (chlorobutyl or bromobutyl), and an attached needle. Box of 1, 5, 10 or 20.
0.5 mL of suspension in prefilled syringe (type I glass) with a plunger stopper (chlorobutyl or bromobutyl), without needle. Box of 1 or 10.
0.5 mL of suspension in prefilled syringe (type I glass) with a plunger stopper (chlorobutyl or bromobutyl), with 1 or 2 separate needles. Box of 1 or 10.
All pack sizes may not be marketed.

Shake before injection, until a homogenous suspension is obtained.
For the syringes without attached needles, the separate needle must be fitted firmly to the syringe, rotating it by one quarter turn.
The vaccine must be visually inspected before administration to verify the absence of foreign particles.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.