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Instructions

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Instruction for use: Vacta

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Dosage form: Suspension for intramuscular injection

Active substance: Vaccinum ad prophylaxim hepatitis epidemicae A

ATX

J07BC02 Hepatitis A virus inactivated whole

Pharmacological group:

Vaccines, serums, phages and toxoids

The nosological classification (ICD-10)

B15 Acute hepatitis A: Botkin's disease; Viral hepatitis A; Hepatitis A; Infectious hepatitis; Acute hepatitis; Acute viral hepatitis A; Subacute hepatitis; Lightning-fast hepatitis

Composition and release form

Suspension for injection for adults 1 dose

Viral hepatitis A antigen 1440 U

(Determination by solid-phase enzyme immunoassay, ELISA)

In vials or syringes of 1 ml; In a pack of cardboard 1 bottle or in a box 1 syringe.

Suspension for injection for children 1 dose

Viral hepatitis A antigen 720 U

(Determination by solid-phase enzyme immunoassay, ELISA)

In vials or syringes of 0.5 ml; In a pack of cardboard 1 bottle or in a box 1 syringe.

Characteristic

Sterile suspension containing the hepatitis A virus (strain HM175 of the hepatitis A virus), inactivated by formaldehyde and adsorbed on aluminum hydroxide. The vaccine contains undetectable traces of the antibiotic neomycin (less than 10 mg). The virus is cultured in human diploid cells MRS5. Before viral isolation, the cells are thoroughly washed to remove the components of the culture medium. Then, a viral suspension is prepared by lysing the cells, followed by purification by ultrafiltration and gel chromatography. The vaccine meets all WHO requirements.

Pharmachologic effect

Mode action - immunostimulating.

Provides active immunity against hepatitis A virus for at least 15-20 years (with a two-dose vaccination scheme).

Clinical Pharmacology

In clinical studies, it was found that antibodies to hepatitis A antigen on day 15 after vaccination in individuals aged 18-50 years are formed in 88% of cases, 1-18 years in 93%; A month after vaccination - in 99% of cases in both age groups. The use of the vaccine is effective in the early incubation period of the disease. The effectiveness of the vaccine is not reduced if there is a vaccine-specific maternal antibody to the hepatitis A virus or antibodies to hepatitis A virus introduced passively into the blood.

Indication of the drug Vacta

Prevention of viral hepatitis A in adults and children older than 2 yeActive immunoprophylaxis of hepatitis A.ars.

Contraindications

Hypersensitivity to any of the components of the vaccine. Acute and chronic inflammatory diseases accompanied by fever (vaccination is postponed until normal body temperature).

Application of pregnancy and breastfeeding

Only in case of emergency.

Side effects

Local: ~ 4% of cases - swelling, redness at the injection site; <0.5% - severe soreness at the injection site.

Systemic: 0,8-12,8% of cases - headache, malaise, nausea, vomiting, loss of appetite (do not require treatment, duration does not exceed 24 h).

Interaction

Do not mix in the same syringe with other vaccines.

It is combined with all vaccinations of the Russian national calendar and all vaccines for travelers.

Dosing and Administration

IM. Adults over 19 years: 1440 units (1 ml) in the deltoid muscle region.

Children from 1 year and adolescents under 18 years of age: 720 ED (0.5 ml) in the anterolateral area of the femoral or deltoid muscle.

After 6-12 months after the first vaccination, it is recommended to repeat it.

Patients with thrombocytopenia or bleeding disorders are injected sc.

Special instructions

When administered simultaneously with other vaccines, injections should be done at different locations.

In patients on programmed hemodialysis and those with severe immunodeficiency, the formation of antibodies to the hepatitis A antigen after the administration of a single dose of the vaccine may not be sufficient, so additional dosages are recommended for such patients.

Storage conditions of the drug Vacta

At a temperature of 2-8 į C (donít freezing).

Keep out of the reach of children.

Shelf life of the drug Vacta

3 years.

Do not use after the expiry date printed on the package.

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