AVAXIM 80 U PEDIATRIC

Abbreviated Prescribing Information

See local prescribing information for full details prior to prescribing

TRADE NAME OF THE MEDICINAL PRODUCT AND PRESENTATION

AVAXIM 80 U PEDIATRIC suspension for injection of hepatitis A vaccine (inactivated, adsorbed) is available in 0.5 mL pre-filled syringe. The active ingredient is inactivated hepatitis A virus GBM strain and other excipients are 2-phenoxyethanol, ethanol, formaldehyde, Hanks medium 199 *, 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

THERAPEUTIC INDICATION

AVAXIM 80U Pediatric comes in the form of a suspension for injection in a prefilled syringe (0.5 ml) This vaccine is recommended in the prevention of infection induced by hepatitis A virus in children 12 months to 15 years inclusive. This vaccine should be administered in accordance with official recommendations.

POSOLOGY AND METHOD OF ADMINISTRATION

Primary vaccination : Primary vaccination is achieved with one vaccine dose of 0.5 mL. Booster : One booster dose of 0.5 mL is in order to provide long-term protection. This booster will preferably be administered 6 to 36 months following primary vaccination dose, but administration will be possible until 7 years after this primary vaccination. Available data on vaccination with AVAXIM 80 U PEDIATRIC show that after the two doses of the initial vaccination schedule, no other booster vaccination is necessary in immunocompetent individuals, which is in agreement with the official recommendations.

The recommended injection site is the deltoid region. The vaccine should not be administered into the buttocks because of the varying amount of fat tissue in this region, that may contribute to variability in effectiveness of the vaccine.

Shake before use until you obtain a homogeneous suspension.

Do not inject by the intravascular route: ensure that the needle does not penetrate a blood vessel. Do not inject by the intradermal route

CONTRA-INDICATIONS

Hypersensitivity to the active substance, to one of the excipients, to neomycin (that may be present as traces in each dose due to its use during the manufacturing process).
Hypersensitivity following a previous injection of this vaccine.
Vaccination should be postponed in case of febrile disease, acute disease, progressive chronic disease.

SPECIAL WARNING AND SPECIAL PRECAUTIONS FOR USE:

In case of an anaphylactic reaction after vaccine administration, medical treatment and subject monitoring are recommend.
As a psychogenic response to needle injection like syncope (fainting) especially in adolescent, it is important that procedures be in place to avoid any injury from faints. This may be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during the recovery phase.
AVAXIM 80 U Pediatric has not been studied in patients with impaired immunity.
The immune response to the vaccine may be impaired by immunosuppressive treatment or immunodeficiency states. In such cases it is recommended to wait for the end of treatment before vaccination 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.
As with all vaccines, vaccination may not induce a protective response in all susceptible vaccines. Avaxim 80 U Pediatric does not protect against infection caused by hepatitis B virus, hepatitis C virus, hepatitis E virus or by other known liver pathogens.
AVAXIM 80 U PEDIATRIC contains 10 micrograms of phenylalanine in each 0.5 mL dose. 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 80 U PEDIATRIC contains 2 mg of alcohol (ethanol) per dose of 0.5 mL. The small quantity of alcohol contained in this medicinal product is not likely to cause any notable effects. AVAXIM 80 U PEDIATRIC contains less than 1 mmol (39 mg) of potassium and less than 1 mmol (23 mg) of sodium per dose, that is to say essentially “potassium-free” and “sodium-free”.

INTERACTIONS

The response may be diminished in person who have immunosuppressive treatment.
The simultaneous administration of immunoglobulins with this vaccine in two different injection sites may be performed. The seroprotection rates are not modified, but the antibody titers may be lower than those obtained when the vaccine is administered alone.
In case of simultaneous administration, this vaccine must not be mixed with other vaccines in the same syringe. The vaccine may be administered simultaneously, in two different injection sites, with the routine booster vaccine of the child during the second year of life
This vaccine can be administered simultaneously, but at two different injection sites, with a vaccine against measles, mumps and rubella.
This vaccine can be used as a booster in subjects previously vaccinated with another inactivated Hepatitis A vaccine.

PREGNANCY AND LACTATION

Pregnancy

No suficcient teratogenic data on animal are available.

In humans, up to now, the data is inadequate to assess teratogenic or foetotoxic risk of the vaccine against hepatitis A when 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.

Breastfeeding

It is not known whether this vaccine is excreted in human milk. Caution must be exercised when Avaxim 80 U Pediatric is administered to a nursing mother.

UNDESIRABLE EFFECTS

Most undesirable effects were moderate and limited to the first few days following vaccination with spontaneous recovery.

Reactions were more rarely reported after the booster dose than after the first dose. However, as with all pharmaceuticals, expanded commercial use of the vaccine might reveal rarer undesirable effects. The undesirable effects are derived from clinical studies and worldwide post- marketing experience.

Very common: headache, local injection site reaction such as pain

Metabolism and nutrition disorders

Common: appetite decrease

Psychiatric disorders

Very common : abnormal crying after primary dose and after any dose

Common: irritability, insomnia

Nervous system disorders

Very common : cephalgia after any dose

Common: cephalgia after primary and booster dose

Gastrointestinal disorders

Common: abdominal pain, diarrhoea, nausea, vomiting

Musculoskeletal and connective tissue disorders

Common: arthralgia (after primary dose), myalgia

General disorders and administration site conditions

Very common : Local Reactions : Paint at injection site (after primary and any dose)

Common: local reactions such as redness at injection site, induration or oedema at injection site, haematoma at injection site (after primary and any dose); Systemic reaction such as malaise (after any dose), fever, asthenia or somnolence

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

Post-marketing experience

Based on spontaneous reporting, the following adverse events have also been reported during the commercial use of AVAXIM 80 U PEDIATRIC. These events were very rarely reported. However, the exact incidence is not known (cannot be estimated based on the available data).

Nervous system disorders.

Vasovagal syncope (fainting) in response to injection.

OVERDOSE

An overdose is unlikely to provoke any harmful effects

10. PHARMACODYNAMIC PROPERTIES

ATC code: J07BC02.

Presentation: Box, 1 prefilled syringe @ 0.5 mL (DKI0459702343B1)

Manufactured by: Sanofi Pasteur, Val de Reuil, France

Released by : Sanofi Pasteur, Lyon, France

Date of revision: 04 February 2023 (based on BPOM approval 30 January 2023

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