Avaxim 160 U suspension for injection – hepatitis A vaccine for adolescents from 16 years and adults

Avaxim 160 U is an inactivated, adsorbed vaccine against hepatitis A. Hepatitis A is a viral liver infection transmitted through food and drink containing the virus; symptoms include yellowing of the skin (jaundice) and feeling generally unwell.

The vaccine stimulates the body’s natural defences to build protection against the hepatitis A virus. It is intended for adolescents from 16 years and adults and is used in line with national immunisation recommendations. The vaccine contains no live virus and cannot cause the infection it protects against.

Who is the Avaxim 160 U vaccine for and how is it given?

Key facts about the medicine

What is Avaxim 160 U used for?

The vaccine is intended for active immunisation – prevention of infection caused by the hepatitis A virus – in adolescents from 16 years of age and in adults. It is used in line with national immunisation recommendations.

Protection develops about 14 days after the first dose. If a person is already infected with hepatitis A at the time of vaccination, the vaccine may not work properly.

How is it given and dosed?

• Dose for people over 16 years: 0.5 mL.
• For long-term protection a second (booster) dose of inactivated hepatitis A vaccine is needed, usually 6 to 12 months after the first dose; it can also be given up to 36 months after the first vaccination. After the booster, protection lasts more than 10 years.
• Avaxim 160 U can be used as a booster in people who received an inactivated hepatitis A vaccine combined with a typhoid vaccine 6 to 36 months earlier.
• The vaccine is injected into the muscle on the outer side of the upper arm (deltoid region); in people with bleeding disorders or who bruise easily it may be given under the skin. It must not be given into the buttock, into the skin or into a blood vessel.
• Before use, the healthcare professional shakes the syringe to obtain a uniform suspension.

Your vaccination schedule is decided by your doctor in line with national recommendations.

Special patient groups

• Children and adolescents under 16 years: this vaccine is not intended for this age group.
• Weakened immune system (corticosteroids, cytotoxic medicines, radiotherapy, HIV infection): the vaccine can be given, but protection may be weaker; the doctor may wait until treatment ends.
• Liver disease: tell your doctor before vaccination.
• Phenylketonuria: the vaccine contains 10 micrograms of phenylalanine per dose.

Contraindications – when the medicine must not be used

• allergy to the active substance, any excipient or to neomycin (an antibiotic that may be present in traces)
• allergic reaction to a previous dose of Avaxim 160 U
• illness with fever – vaccination is postponed until recovery

Warnings and precautions

• Tell your doctor if you have fainted with a previous injection.
• The vaccine does not protect against hepatitis B, C and E.
• The vaccine contains small amounts of ethanol (less than 100 mg per dose) and is essentially potassium- and sodium-free (less than 1 mmol per dose).

Interactions with other medicines, food and drink

• Other inactivated vaccines given at different sites generally do not interact.
• Avaxim 160 U may be given at the same time as the typhoid polysaccharide vaccine and the yellow fever vaccine – at different sites (other arm or leg), never mixed in the same syringe.
• It may be given at the same time as immunoglobulins at different sites; protection may then be incomplete, but you are most likely protected.
• Tell your doctor about all medicines you take.

Pregnancy and breast-feeding

Pregnancy: as a precaution, use during pregnancy is not recommended unless there is a significant risk of infection. Breast-feeding: the vaccine can be given during breast-feeding. Ask your doctor for advice before vaccination.

Driving and using machines

The vaccine is unlikely to affect your ability to drive or use machines, although no studies have been performed.

Possible side effects

• Very common: mild pain at the injection site, general weakness.
• Common: headache, nausea, vomiting, reduced appetite, diarrhoea, abdominal pain, muscle and joint pain, mild fever.
• Uncommon: redness at the injection site.
• Rare: a lump at the injection site, mild and transient changes in liver tests.
• Frequency not known: fainting in response to the injection, hives, itchy rash.
• Very rarely, as with all vaccines: serious allergic reactions.

Report suspected side effects to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose: a few cases of overdose have been reported without specific adverse events (SmPC).
• Missed dose: tell your doctor about a missed (booster) dose – the second dose can be given up to 36 months after the first.
• Stopping: receiving the booster dose is important for long-term protection.

Related information

For more information about hepatitis A vaccination, ask your doctor or the competent healthcare institution; there is no substitute for the vaccine among products available without prescription.

Composition, pack and manufacturer

• Active substance: hepatitis A virus, inactivated, GBM strain – 160 antigen units in 0.5 mL; adsorbed on hydrated aluminium hydroxide (0.3 mg Al).
• Excipients: phenoxyethanol-ethanol (50% v/v solution), formaldehyde, medium 199 Hanks (without phenol red; contains amino acids including phenylalanine, mineral salts and vitamins), water for injections.
• Pack: carton with one pre-filled syringe (0.5 mL, type I glass) with needle.
• Marketing authorisation holder: Amicus SRB d.o.o. (authorisation transferred on 16 Dec 2021). Manufacturers: Sanofi Pasteur – Val de Reuil and Marcy l’Etoile, France; Sanofi-Aventis Zrt., Budapest, Hungary.

Storage

• Store in a refrigerator (2–8 °C).
• Do not freeze – a frozen vaccine must be discarded.
• Keep out of the sight and reach of children; shelf life: 3 years.

Frequently asked questions

How many doses of Avaxim 160 U are needed?

One dose gives initial protection after about 14 days. For long-term protection (more than 10 years) a second, booster dose is needed, usually 6–12 months after the first and at the latest within 36 months.

Can the vaccine cause hepatitis A?

No. The vaccine contains inactivated virus and cannot cause the infection it protects against.

Can it be given together with other travel vaccines?

According to the leaflet, it can be given at the same time as the typhoid vaccine and the yellow fever vaccine, but at different sites and never mixed in the same syringe.

Does Avaxim protect against hepatitis B?

No. The vaccine protects only against hepatitis A, not against hepatitis B, C or E.

Sources

• ALIMS – Patient leaflet Avaxim® 160 U, suspension for injection in a pre-filled syringe (May 2020, Serbian)
• ALIMS – Summary of Product Characteristics Avaxim® 160 U (Serbian)

Sources checked on: 25 October 2026.