AVAXIM ADULT

Abbreviated Prescribing Information

See local prescribing information for full details prior to prescribing

TRADE NAME OF THE MEDICINAL PRODUCT AND PRESENTATION

AVAXIM ADULT suspension for injection is available as a prefilled syringe (0.5 ml) containing inactivated adsorbed hepatitis A virus 160 ELISA units. The other ingredients are alumunium hydroxide, 2-phenoxyethanol, ethanol, formaldehyde, Hanks medium 199 *, water for injections, polysorbate 80, hydrochloric acid and sodium hydroxide for pH adjustment.

Hanks medium 199 (without phenol red) is a complex mixture of amino acids (including phenylalanine) , mineral salts, vitamins and other components, including potassium), water for injection, polysorbate 80, hydrochloric acid and sodium hydroxide

THERAPEUTIC INDICATION

This medicinal product is a VACCINE.

This medicinal product is recommended in the prevention of infection caused by hepatitis A virus in adults over the age of 16 years.
Vaccination against hepatitis A is recommended for subjects exposed to hepatitis A virus risks such as:
Non-immunized adults traveling in an endemic area (region where the hepatitis A virus is commonly found).
Adults professionally exposed to a risk of contamination: nursery personnel, boarders and staff of establishments and services for handicapped infants and children, swage and water treatment personnel, food industry and catering personnel).
Adults in particular risk categories (haemophilia, multiple transfusion, IV drug dependency, homosexual practices).
It does not protect against infection due to other types of hepatitis virus or to other known pathogens of the liver.

POSOLOGY AND METHOD OF ADMINISTRATION

DOSAGE

The recommended dose is 0.5 mL for each injection.

The primary vaccination is performed with one single dose of vaccine followed by a booster injection: 6 to 12 months later for adults over 16 years of age and can be administered up to 36 months after the first vaccination. This vaccine can also be administered as a booster dose of the hepatitis A vaccination in subjects from 16 years of age who received a first injection with the combined typhoid fever (Vi purified polysaccharide) and hepatitis A (inactivated) vaccine between 6 and 36 months earlier.

METHOD AND ROUTE OF ADMINISTRATION

It is recommended that this vaccine be administered by the intramuscular route (IM) in order to minimize local reactions.

The recommended injection site is: the deltoid (upper arm muscle) in adults.

Do not inject via the intravascular route: insure that the needle does not penetrate a blood vessel. The vaccine should not be administered into the gluteal muscle of the buttocks (due to the presence of varying amounts of adipose tissue) nor intradermally, since these modes of administration may induce a lesser degree of immune response.

In exceptional cases, the vaccine may be administered subcutaneously in patients with thrombocytopenia (inadequate amount of platelets, a specific blood component with an important role in blood clotting) or in patients subject to haemorrhages.

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

Do not inject by the intradermal route

CONTRA-INDICATIONS

This medicinal product MUST NOT BE USED in the following cases:

In the event of fever, acute illness, chronic progressive disease (it is preferable to postpone vaccination).
Hypersensitivity to one of its component , to neomycin (that may be present as traces in each dose due to its use during manufacturing process), or following a previous injection.

SPECIAL WARNING AND SPECIAL PRECAUTIONS FOR USE

SPECIAL WARNINGS

Do not inject by the intravascular route: ensure that the needle does not penetrate a blood vessel.
This vaccine is not to be injected into buttocks (due to the presence of varying amounts of adipose tissue) nor administered intradermally, since these routes of administration may induce a reduced degree of immune response.
Immunosuppressant treatment or a state of immune deficiency may lead to a diminished 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.
Vaccination may have no effect on the development of hepatitis A if administered during the incubation period of the disease.
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. It is important that procedures be in place to avoid any injury from faints.
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 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. 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’.

INTERACTIONS

The vaccine may be administered simultaneously with immunoglobulins provided two different injection sites are used.

Since this vaccine is inactivated, it can be given at the same time as other inactivated vaccines using a different injections site, without in general causing interference.

This vaccine can be administered at the same time as a recombinant hepatitis B vaccine, a typhoid polysaccharide vaccine typhim Vi or yellow fever vaccine, but two separates site injection should be used.

This vaccine can be used as a booster dose in subjects who have received primary vaccination with another inactivated hepatitis A vaccine.

PREGNANCY AND LACTATION

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 foetoxic 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 effect of administering this vaccine during breast feeding has not been studied and its use during feeding is therefore not recommended

UNDESIRABLE EFFECTS

Nervous system disorders

Common: cephalalgia.

Gastrointestinal disorders

Common: nausea, vomiting, appetite decrease, diarrhoea, abdominal pain.

Musculoskeletal and connective tissue disorders

Common: myalgia, arthralgia.

General disorders and administration site conditions

Very common: asthenia, mild injection site pain.

Common: mild fever.

The reactions were less frequently reported after the booster injection than after the first dose. In subjects seropositive against hepatitis A virus, this vaccine was as well tolerated as in seronegative subjects

For uncommon, rare, and very rare side effects see full prescribing information.

OVERDOSE

A few cases of overdose have been reported with AVAXIM 160 U, with no specific undesirable effects.

PHARMACODYNAMIC PROPERTIES

ATC code: J07BC02.

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.

Presentation: Box of 1 pre-filled syringe 0.5 mL (DKI0159702343A1)

Date of revision: 04 February 2023 (Based on BPOM approval date 02 February 2023)

This information is intended for Health Care Professional only. See local product information for full details information

AVAXIM 160U