Avaxim (Suspension) Instructions for Use

Instructions
Dosage forms

ATC Code

J07BC02 (Hepatitis A virus inactivated whole)

Active Substance

Hepatitis A vaccine (USP United States Pharmacopeia)

Clinical-Pharmacological Group

Vaccine for the prevention of hepatitis A

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

The vaccine is a mixture of inactivated purified virions adsorbed onto aluminum hydroxide.

It promotes the formation of immunity against the hepatitis A virus by inducing the production of specific antibodies.

The amount of antibodies that appear after the use of the vaccine is practically no different from the amount of antibodies to the hepatitis A virus in individuals who have had this disease.

In most patients, antibodies circulate in the blood for at least 1 year after the primary vaccination course.

Indications

Prevention of viral hepatitis A in adults and children from 12 months of age.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
Z24.6	Need for immunization against viral hepatitis

ICD-11 code	Indication
QC01.6	Need for immunization against viral hepatitis

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer the vaccine by intramuscular injection only into the deltoid muscle.

For adults and children from 12 months of age, the primary vaccination course consists of a single 0.5 ml dose.

Administer a booster dose of 0.5 ml anytime between 6 and 36 months following the primary vaccination to ensure long-term protection.

Do not administer this vaccine intravenously, subcutaneously, or intradermally.

For patients with immunodeficiency or those on hemodialysis, administer an additional dose at the same time as the primary dose; the need for further booster doses should be determined by serological testing.

Shake the vial or pre-filled syringe vigorously before use to obtain a homogeneous, white, cloudy suspension.

Discard the vaccine if it appears discolored or contains particulate matter after shaking.

This vaccine can be administered simultaneously with other inactivated or live vaccines using separate syringes and different injection sites.

Adverse Reactions

Possible headache, malaise, increased fatigue, fever, nausea, loss of appetite; redness, induration, swelling, pain at the injection site.

Extremely rare anaphylactic and anaphylactoid reactions.

Contraindications

Acute infectious and non-infectious diseases, exacerbations of chronic diseases, immunodeficiency conditions, malignant blood diseases and neoplasms, hypersensitivity to vaccine components, pregnancy, lactation period (breastfeeding).

Use in Pregnancy and Lactation

Vaccination during pregnancy is not recommended and is possible only in cases of extreme necessity.

If it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided.

Use in Hepatic Impairment

Immunization is indicated for patients with chronic liver diseases or an increased risk of liver disease.

Use in Renal Impairment

Immunization is indicated for patients on hemodialysis.

Pediatric Use

In children, the vaccine should be used only in the form of dosage forms specifically intended for them.

Geriatric Use

Can be used according to indications.

Special Precautions

Use with caution in patients with thrombocytopenia and a tendency to hemorrhage, due to an increased risk of hematoma at the injection site.

Do not administer intravenously, subcutaneously, or intradermally.

Patients on hemodialysis and patients with immune disorders require the administration of additional doses of the vaccine.

In children, the vaccine should be used only in the form of dosage forms specifically intended for them.

The correspondence of the hepatitis A vaccine used to the recommended indications should be strictly observed.

Drug Interactions

The vaccine can be administered simultaneously with immunoglobulins provided that different parts of the body are used for the injection of the vaccine and immunoglobulins.

Since this vaccine is inactivated, its combination with other inactivated vaccines does not affect the effectiveness of vaccination, provided that the vaccines are administered into different parts of the body (in particular, with the recombinant vaccine for the prevention of hepatitis B, typhoid vaccine, live vaccine for the prevention of yellow fever).

The vaccine can be used for revaccination even in cases where the previous vaccination was carried out with other inactivated vaccines for the prevention of hepatitis A.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer