Instruction for use: Vacta

Dosage form: Suspension for 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

Z29.1 Prophylactic immunotherapy: Vaccination against viral infections; donor Vaccination; Vaccination and revaccination; Vaccination of newborns; Vaccination against hepatitis B; Immunization; Correction of the immune status; Therapeutic and prophylactic immunization; Preventive immunization; Specific immunoprophylaxis; Stimulation of the processes of nonspecific immunit

Composition and release form

Suspension for injection for children and adolescents 0.5 ml

Inactivated hepatitis A virus 25 U

Auxiliary substances: aluminum hydroxide; Sodium tetraborate; Traces of formaldehyde

In vials of 0.5 ml (1 dose); In a pack of cardboard 10 bottles or in disposable syringes of 0.5 ml (1 dose), in a contiguous cell pack 1 syringe; In a pack of cardboard 1 package.

Suspension for injection for adults 1 ml

Inactivated hepatitis A virus 50 U

Auxiliary substances: aluminum hydroxide; Sodium tetraborate; Traces of formaldehyde

In vials of 1 ml (1 dose); In a pack of cardboard 10 bottles or in disposable syringes 1 ml (1 dose), in a contiguous cell pack 1 syringe; In a pack of cardboard 1 package.

Pharmachologic effect

Mode action - immunostimulating.

Pharmacodynamics

The whole-viral vaccine against viral hepatitis A, obtained by culturing the virus in diploid cells of human fibroblasts MRS-5 (followed by its purification, inactivation with formalin and adsorption on aluminum hydroxide).

The course of immunization consists of 2 vaccinations - vaccination and revaccination.

After vaccination, immunity develops after 14 days in 95-97% of vaccinated persons. Revaccination ensures the preservation of immunity for 6 years (for the entire observation period).

Indication of the drug Vacta

Prevention of viral hepatitis A in adults and children older than 2 years.

Contraindications

Hypersensitivity to the components of the drug;

A pronounced reaction to the previous administration of the drug (a rise in body temperature above 40 ° C, edema, hyperemia at the injection site of more than 8 cm);

An allergic reaction of immediate type to the first administration of the drug;

Acute or exacerbation of a chronic disease (with routine vaccination).

Application of pregnancy and breastfeeding

Clinical and experimental studies to study the effect of the drug Vacta on reproductive function or on the development of the fetus were not carried out.

It is not known whether active substances of the drug are excreted in breast milk. During the lactation period (breastfeeding), the vaccine should be administered with caution.

Side effects

Children and adolescents aged 2 to 17 years

On the part of the body as a whole: 3.1% - an increase in body temperature of more than 38.8 ° C.

On the part of the digestive system: 1% - diarrhea, vomiting; 1.6% - abdominal pain.

From the side of the central nervous system: 2,3% - headache.

On the part of the respiratory system: 1.5% - pharyngitis; 1,1% - respiratory tract infection; 1% - cough.

Local reactions: 18.7% - pain; 16.8% - soreness when touched; 8,6% - feeling of heat; 7.5% hyperemia; 7.3% - edema; 1,3% - hemorrhage.

Other: in some cases - increased activity of hepatic transaminases, eosinophilia, an increase in protein in the urine.

Data were obtained in combined clinical trials (2,595 healthy children and adolescents, including 1,037 participants in the placebo-controlled study). During the first 5 days after vaccination, temperature reactions, complaints of unpleasant sensations at the injection site were actively detected, and for 14 days - systemic complaints.

Information on the frequency of complaints registered in ≥1% of vaccinated is given regardless of the cause of the occurrence.

Adults (persons aged 18 years and over)

On the part of the body as a whole: 3.1% - increase in body temperature above 38.8 ° C; 3.9% - weakness, fatigue.

From the digestive system: 2.4% - diarrhea; 2,3% - nausea; 1,3% - pain in the abdomen.

From the musculoskeletal system: 2% - myalgia; 1,3% - pain in the hands; 1,1% - back pain; 1% - stiffness of muscles.

From the side of the central nervous system: 16.1% - headache.

On the part of the respiratory system: 2.7% - pharyngitis; 2.8% infection of the upper respiratory tract; 1.1% - congestion of the nose.

On the part of the reproductive system: 1.1% - a violation of menstruation.

Allergic reactions: less than 1% - skin itching, urticaria, skin rash.

Local reactions: 52.6% - soreness when touched; 51,1% - pain; 17,3% - feeling of heat; 13,6% - edema; 12,9% - hyperemia; 1,5% - hemorrhage; 1,2% - pain or burning sensation.

Local reactions, as a rule, are weakly expressed and are of short duration.

Data were obtained in combined clinical trials (1,529 healthy subjects). During the first 5 days after vaccination, temperature reactions, complaints of unpleasant sensations at the injection site were actively detected, and for 14 days - systemic complaints.

Information on the frequency of complaints recorded in ≥1% of vaccinated is given regardless of the cause of the occurrence.

Interaction

With simultaneous application, no drug interaction was established between the Vaccines with the yellow fever vaccine and the inactivated typhoid vaccine. Interaction studies There are no vaccines with other vaccines (such combinations are not recommended).

Dosing and Administration

IM. The vaccine is only for IM administration. Preferred injection site - deltoid muscle. It is forbidden to administer the vaccine IV, SC or ID.

The course of immunization consists of 2 vaccinations - vaccination and revaccination.

Children and adolescents aged 2 to 17 years - 25 units (0.5 ml) once. Revaccination is carried out at 6-18 months in the same dose (25 units).

Persons aged 18 years and over - 50 units (1 ml) once. Revaccination is carried out at 6 months in the same dose (50 units).

Vacta is produced in ready-to-use form and does not need additional dilution.

Prior to the dose in the syringe, the vial should be shaken to form a translucent suspension of white color without foreign suspended particles.

Special instructions

When using Vacta in patients with malignant neoplasms or receiving immunosuppressants, as well as in persons with immune system disorders, the expected immune response may not develop.

The vaccine does not prevent the onset of hepatitis caused by other pathogens.

In persons vaccinated in the incubation period of hepatitis A (duration - 20-50 days), the use of the drug may not prevent hepatitis A.

The vaccine can be used concomitantly with the yellow fever vaccine and inactivated typhoid vaccine, use with other vaccines is not recommended.

For the prevention of hepatitis A after contact with the causative agent of the disease or, if necessary, rapid and long-term prevention of the disease (for example, in persons urgently leaving for endemic areas), a vaccine can be administered simultaneously with an immunoglobulin by individual syringes in different parts of the body.

When the vaccine is introduced, it is necessary to have all the necessary medicines ready to stop the anaphylactic or anaphylactoid reaction.

Use in Pediatrics

The vaccine is well tolerated and highly immunogenic for children over the age of 2 years.

Safety and efficacy Vaccines in children under 2 years of age have not been established.

The vaccine should not be frozen. This leads to a loss of its effectiveness.

Storage conditions of the drug Vacta

At a temperature of 2-8 ° C.

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.