Regevac B for children, suspension 20 µg/ml 0.5ml/1 dose ampoules

Composition

Recombinant surface purified hepatitis B virus antigen (ayw serotype) 10 mcg

Auxiliary substances:

aluminum hydroxide (sorbent),

thiomersal (preservative) 25 mcg (or does not contain),

buffer components.

Pharmacological action

Vaccine for the prevention of hepatitis B.

Indications

Prevention of hepatitis b:

— in children under the national calendar of preventive vaccinations;

— persons-risk of infection with hepatitis b virus (children and adults who are HBsAg carrier or a patient with chronic hepatitis b; 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 patients and hematopoietic);

— persons who have had contact with the material infected with the hepatitis b virus;

— health workers having contact with the blood of patients;

— persons involved in the production of immunobiological preparations from donor and placental blood;

— from medical students and students of nursing schools (especially graduates);

— persons who inject drugs.

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

Contraindications

— severe reaction (temperature above 40°C, swelling, redness of more than 8 mm in diameter at the injection site) or a complication of the previous use of the vaccine against hepatitis b;

acute infectious and non-communicable diseases, chronic diseases in the acute stage – immunization is carried out not earlier than 1 month after recovery (remission);

— hypersensitivity to yeast and other components of the vaccine.

Side effects

Side effects of the vaccine are rare.

Local reactions:  in 5-10% of cases – pain, erythema and compaction at the injection site.

Systemic reactions:  slight fever, 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.

How to take, course of use and dosage

The vaccine is administered intravenously in the deltoid muscle; in newborns and young children – in the anterolateral surface of the thigh. Introduction to another location reduces the effectiveness of vaccination. Before use, the ampoule is shaken.

A single dose for newborns and children and adolescents under 19 years of age is 0.5 ml (10 micrograms of HBsAg).

A single dose for patients over 19 years of age is 1 ml (20 micrograms of HBsAg).

Patients in hemodialysis units receive the vaccine in a double dose of 2 ml (40 mcg HBsAg).

The vaccination course consists of three intravenous injections of the vaccine according to the scheme: 0 – 1 – 6 month. If the interval between injections of the vaccine is prolonged, the next use should be carried out as soon as possible, determined by the state of health of the vaccinated person. Children over 13 years of age who have not been vaccinated before are vaccinated according to the standard scheme.

Children born to mothers who are carriers of the hepatitis B virus or patients with viral hepatitis B in the third trimester of pregnancy are vaccinated against viral hepatitis B according to scheme 0 (on the day of birth) – 1 – 2 – 12 month.

Vaccination of previously unvaccinated persons who have had contact with material infected with the hepatitis B virus is carried out according to the scheme 0 – 1 – 2 month.

Patients of hemodialysis departments are given the vaccine four times with a monthly interval between injections.

Hepatitis B vaccination can be carried out simultaneously (on the same day) with the introduction of vaccines of the national preventive vaccination calendar and inactivated vaccines of the preventive vaccination calendar for epidemic indications. Introduction is carried out with different syringes in different parts of the body.

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 use ampoules that have a physical defect that leads to a violation of their tightness.

The vaccine should not be administered intravenously.

The drug in the opened ampoule is not subject to storage. The vaccine is administered intravenously in the deltoid muscle; in newborns and young children – in the anterolateral surface of the thigh. Introduction to another location reduces the effectiveness of vaccination. Before use, the ampoule is shaken.

A single dose for newborns and children and adolescents under 19 years of age is 0.5 ml (10 micrograms of HBsAg).

A single dose for patients over 19 years of age is 1 ml (20 micrograms of HBsAg).

Patients in hemodialysis units receive the vaccine in a double dose of 2 ml (40 mcg HBsAg).

The vaccination course consists of three intravenous injections of the vaccine according to the scheme: 0 – 1 – 6 month. If the interval between injections of the vaccine is prolonged, the next use should be carried out as soon as possible, determined by the state of health of the vaccinated person. Children over 13 years of age who have not been vaccinated before are vaccinated according to the standard scheme.

Children born to mothers who are carriers of the hepatitis B virus or patients with viral hepatitis B in the third trimester of pregnancy are vaccinated against viral hepatitis B according to scheme 0 (on the day of birth) – 1 – 2 – 12 month.

Vaccination of previously unvaccinated persons who have had contact with material infected with the hepatitis B virus is carried out according to the scheme 0 – 1 – 2 month.

Patients of hemodialysis departments are given the vaccine four times with a monthly interval between injections.

Hepatitis B vaccination can be carried out simultaneously (on the same day) with the introduction of vaccines of the national preventive vaccination calendar and inactivated vaccines of the preventive vaccination calendar for epidemic indications. Introduction is carried out with different syringes in different parts of the body.

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 use ampoules that have a physical defect that leads to a violation of their tightness.

The vaccine should not be administered intravenously.

The drug in the opened ampoule is not subject to storage.

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.

Form of production

Suspension for intravenous use of white with a grayish tinge, without visible foreign particles; separating after settling into a transparent supernatant and a white precipitate with a grayish tinge, easily resuspended when shaken.

Storage conditions

The vaccine should be stored and transported in accordance with SP 3.3.2.1248-03 at a temperature of 2°C to 8°C out of the reach of children. Short-term (no more than 72 hours) transportation is allowed at temperatures from 9°C to 30°C.

Shelf

life is 3 years.

Active ingredient

Vaccine for the prevention of viral hepatitis B

Conditions of release from pharmacies

By prescription

Dosage form

suspension for injection