AVAXIM Suspension for injection in a prefilled syringe Ref.[28228] Active ingredients: Hepatitis A, inactivated vaccine

• 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.
• Immunosupressive 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 small amounts of ethanol (alcohol), less than 100 mg per dose.
  • AVAXIM 160 U contains 10 micrograms of phenylalanine in each 0.5 ml dose, which is equivalent to 0.17 micrograms/kg for a 60 kg person. Phenylalanine may be harmful for 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 of potassium (39 mg) and 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 foetotoxic 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.

The undesirable effects are derived from clinical studies and worldwide post-marketing experience.

The undesirable effects are ranked under headings of frequency using the following convention: Very common (≥1/10), Common (≥1/100 and <1/10), Uncommon (≥1/1,000 and <1/100), Rare (≥1/10,000 and <1/1,000), Very rare (<1/10,000), Not known: cannot be estimated from available data.

Nervous system disorders

Common: cephalalgia.

Not known: vasovagal syncope in response to injection.

Gastrointestinal disorders

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

Skin and subcutaneous tissue disorders

Not known: urticaria, rash associated or not with pruritus.

Musculoskeletal and connective tissue disorders

Common: myalgia, arthralgia.

General disorders and administration site conditions

Very common: asthenia, mild injection site pain.

Common: mild fever.

Uncommon: injection site erythema.

Rare: injection site nodule.

Investigations

Rare: increase in serum transaminases (mild and transient).

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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22 608649.

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