Medicinal Products

AVAXIM 160 U

Generic drug of the therapeutic class: Infectiology - Parasitology
Active Ingredients: Hepatitis A Vaccine
laboratory: Sanofi Pasteur Europe

Injectable suspension
in pre-filled syringe. Hepatitis A vaccine (inactivated adsorbed) 1-needle prefilled syringe without ½ mL needle
All forms

Indication

This vaccine is indicated for active immunization against infection with hepatitis A virus in adolescents from 16 years of age and adults.

This vaccine should be administered according to official recommendations.

Posology AVAXIM 160 U suspension for injection in pre-filled syringe. Hepatitis A vaccine (inactivated adsorbed) 1-needle prefilled syringe without ½ mL needle

This vaccine is indicated for active immunization against infection with hepatitis A virus in adolescents from 16 years of age and adults.

This vaccine should be administered according to official recommendations.

Against indications

· Hypersensitivity to the active substance or to any of the excipients or to neomycin (which may be present in each trace dose due to its use during manufacture).

· Hypersensitivity following an earlier injection of this vaccine.

· Vaccination should be postponed in case of acute severe febrile illness.

Avaxim side effects

The adverse effects are from clinical studies and postmarketing experience around the world.

Adverse effects are classified in terms of frequency according to the following convention:

Very common (≥ 1/10)

Frequent (≥ 1/100 and <1/10)

Uncommon (≥ 1/1000 and <1/100)

Rare (≥ 1/10 000 and <1/1000)

Very rare (<1 / 10, 000), including isolated cases

Not known: can not be estimated from the available data.

Nervous system disorders

Frequent: headache.

Not known: vasovagal syncope in response to injection.

Gastrointestinal disorders

Frequent: nausea, vomiting, decreased appetite, diarrhea, abdominal pain.

Skin and subcutaneous tissue disorders

Not known: urticaria, rash with or without associated pruritus

Musculoskeletal and systemic disorders

Frequent: myalgia, arthralgia.

General disorders and administration site conditions

Very common: asthenia, slight pain at the injection site.

Common: mild fever

Uncommon: erythema at the injection site.

Rare: nodule at the injection site.

investigations

Rare: elevation of serum transaminases (mild and transient).

Reactions were reported less frequently after the booster injection than after the first dose.

This vaccine has been as well tolerated in seropositive subjects, with respect to the hepatitis A virus, as in seronegative subjects.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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