Regevac B suspension 20 µg/ml 1ml/1 dose ampoules, 10pcs

Composition

Active ingredient:

purified hepatitis B virus surface antigen (HBsAg) – 20 mcg,

Auxiliary substances:

thiomersal (preservative) – 50 mcg(or does not contain),

aluminum hydroxide (sorbent) – 0.5 mg;

buffer components;

water for injection up to 1 ml

Pharmacological action

Regevac B-a vaccine for the prevention of hepatitis B.

Contains the surface antigen of the hepatitis B virus (ayw serotype) obtained by recombination of DNA on yeast culture transformed by including in their genome the gene encoding the surface antigen of the hepatitis B virus.

The course of vaccination leads to the formation of specific antibodies to the hepatitis B virus in more than 90% of those vaccinated in the protective titer.

Indications

• Prevention of hepatitis b In children in the national calendar of preventive vaccinations and individuals at high risk of infection with hepatitis b virus: children and adults who are HBsAg carrier or a patient with hepatitis b Ironic;
• the children of orphanages, children’s homes and boarding schools, children and adults who receive regular blood and blood products, as well as in hemodialysis, and oncohematological patients;
• persons who have had contact with the material infected with the hepatitis b virus;
• health care workers having contact with the blood of the sick;
• persons involved in the production of immunobiological Preparations from donor blood and placenta;
• students of medical institutes and medical students of secondary educational institutions (especially graduates);
• persons who inject drugs.

In addition to the above categories, vaccinations should be given to all other population groups.

Use during pregnancy and lactation

The effect of the vaccine on the fetus has not been studied.

The possibility of vaccinating a pregnant woman may be considered if the risk of infection is extremely high.

Contraindications

Hypersensitivity to yeast and other components of the vaccine.

Severe reaction (temperature above 40°C, edema, hyperemia more than 8 cm in diameter at the injection site) or complication to the previous use of the hepatitis B vaccine.

Acute infectious and non-infectious diseases, chronic diseases in the acute stage-immunization is carried out no earlier than 1 month after recovery (remission).

In non-severe forms of acute respiratory viral infections and acute intestinal infections, vaccinations can be carried out after the temperature normalizes.

Pregnancy. The effect of the vaccine on the fetus has not been studied. The possibility of vaccinating a pregnant woman may be considered if the risk of infection is extremely high.

Side effects

Side effects of the vaccine are rare. In 5-10% of cases, pain, erythema and compaction at the injection site may occur. On the introduction of the drug occasionally possible: a slight increase in temperature, complaints of malaise, weakness, joint pain, muscle pain, headache, dizziness, nausea, vomiting, abdominal pain.

All reactions to the injection are mild and usually resolve 2-3 days after the injection.

Taking into account the possibility of developing immediate allergic reactions in particularly sensitive individuals, those vaccinated should be provided with medical supervision within 30 minutes from the moment of vaccination.

Vaccination sites should be provided with anti-shock therapy.

Interaction

Routine hepatitis B vaccinations can be carried out simultaneously (on the same day) with the vaccines of the national preventive vaccination calendar (with the exception of BCG vaccine), as well as inactivated vaccines of the preventive vaccination calendar for epidemic indications.

The hepatitis B vaccine can be administered with anti-allergic drugs.

Interaction with other drugs has not been established.

How to take, course of use and dosage

The vaccine is administered intramuscularly in the deltoid muscle, in newborns and young children in the anterolateral surface of the thigh: introduction to another place reduces the effectiveness of vaccination. Before use, the ampoule is shaken.

Children of the first year of life, as well as those with a history of somatic diseases, are recommended to be vaccinated using a vaccine that does not contain : preservative thiomersal (merthiolate).

A single dose for newborns and persons under 18 years of age is 0.5 ml (10 micrograms of HBsAg). A single dose from 19 years of age is 1 ml (20 micrograms of HBsAg).

A single dose for hemodialysis patients is 2 ml (40 mcg HBsAg).

The vaccine in ampoules containing 1 ml of the drug (adult dose) can be used for vaccination of 2 children, provided that they are simultaneously vaccinated.

Vaccination within the national calendar of preventive vaccinations.

Vaccination against viral hepatitis B is carried out in all newborns in the first 24 hours of the child’s life.

Newborns from mothers at risk are vaccinated according to the 0-1-2-12 scheme (the first dose – in the first 24 hours of life, the second dose-at the age of 1 month, the third dose-at the age of 2 months, the fourth dose-at the age of 12 months). Simultaneously with the first vaccination [it is recommended to inject human hepatitis B immunoglobulin intramuscularly into the other thigh at a dose of 100 IU. According to the same scheme, children belonging to the risk group who were not vaccinated in the maternity hospital for medical contraindications after the latter were removed are vaccinated. Newborns and all children of the first year of life who do not belong to the risk group are vaccinated according to the 0-3-6 scheme (1 dose – at the time of the start of vaccination,2 dose – 3 months after the first vaccination,3 dose – 6 months after the start of immunization. )

Children who have not received vaccinations under the age of 1 year and are not at risk, as well as adolescents and adults who have not been vaccinated before, are vaccinated according to the scheme: 0-1-6 (jl dose – at the time of the start of vaccination,2 dose – 1 month after 1 vaccination,3 dose – 6 months after the start of immunization. )

Note: if the interval between the first and second vaccinations is prolonged to 5 months or more, the third vaccination is carried out 1 month after the second.

Vaccinations in individuals who have had contact with material infected with the hepatitis B virus are carried out according to the 0-1-2 month scheme. Simultaneously with the first vaccination, it is recommended to inject intramuscularly (in another place) human immunoglobulin against hepatitis B at a dose of 100 IU (children under 10 years of age) or 6-8 IU / kg (other ages). In these individuals who have previously received a full course of hepatitis B vaccination, the content of antibodies to HBsAg is determined before the second vaccination. If the antibody titers are not less than 100 IU / L, the second and third vaccinations are not performed.

People at risk who have constant blood contact due to their professional duties should be tested annually for HBsAg antibodies. If the antibody titer decreases below 100 IU/L, revaccination with a single dose of the vaccine is recommended. An emergency vaccination schedule of 0-7-21 days is recommended for unvaccinated patients who are planning surgical interventions.

Patients of the hemodialysis department are given the vaccine four times according to the scheme of 0-1-2-6 months.

Only a single-use syringe is used for injection.

The injection site is treated with 70% alcohol before and after the injection. The opening of ampoules and the vaccination procedure are carried out in strict compliance with the rules of asepsis and antiseptics. Do not administer intravenously.

Special instructions

Taking into account the possibility of developing immediate allergic reactions in particularly sensitive individuals, those vaccinated should be provided with medical supervision within 30 minutes after vaccination. Vaccination sites should be provided with anti-shock therapy.

Complaints about specific and physical properties of the drug should be sent to the State Research Institute for Standardization and Control of Medical Biological Preparations named after L. A. Tarasevich (119002, Moscow, per. 41 Sivtsev Vrazhek Street, tel. (499) 241-39-22, fax (499) 241-92-38) and to the address of Binnopharm CJSC (3 4th Western Proezd, building 1, Zelenograd, Moscow,124460. Tel/Fax: (495) 510-32-88).

The increased reactogenicity of the drug and complications after its use should be reported by phone or telegraph to the Federal Service for Supervision of Consumer Rights Protection and Human Welfare and to the L. A. Tarasevich State Research Institute for Standardization and Control of Medical Biological Preparations.

Product form

suspension for intramuscular use

Storage conditions

Store at a temperature of 2 to 8°C. Freezing is not allowed.

Shelf life

3 years

Active ingredient

Vaccine for the prevention of viral hepatitis B

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection