Regevac B for children, 20 µg/ml 0.5 ml 10 pcs

Hepatitis B prevention:

– in children as part of the national calendar of preventive vaccinations;

– in persons from groups at high risk of infection with hepatitis B virus (children and adults whose families have a carrier of HBsAg or a patient with chronic hepatitis B; Children in orphanages, children’s homes and boarding schools, children and adults who regularly receive blood and blood products, as well as those who are on hemodialysis and oncohematological patients). – In persons who have had contact with material infected with hepatitis B virus;

– In medical workers who have had contact with the blood of patients;

– In persons engaged in the production of immunobiological products from donor and placental blood;

– in students of medical institutions and students of secondary medical schools (primarily graduates);

– in persons who inject drugs.

In addition to the above categories, all other populations should be vaccinated.

Active ingredient

Composition

recombinant surface purified hepatitis B virus antigen (serotype ayw)10 µg

Excipients:

Aluminum hydroxide (sorbent),

Thiomersal (preservative) 25 µg (or none),

Buffer components.

How to take, the dosage

Inject the vaccine into the deltoid muscle; in newborns and young children, into the anterolateral surface of the thigh. Injection in another place reduces the effectiveness of vaccination. The ampoule is shaken before injection.

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

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

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

The course of vaccination consists of three injections/injections of the vaccine according to a schedule: 0 – 1 – 6 months. If the interval between the shots is too long, the next shot should be given as soon as the health condition of the person concerned permits. Children over 13 years of age who have not been previously vaccinated shall be vaccinated according to the standard schedule.

In children born by mothers carrying the hepatitis B virus or sick with viral hepatitis B in the 3rd trimester of pregnancy vaccination against viral hepatitis B should be done in accordance with the schedule 0 (at the day of birth) – 1 – 2 – 12 months.

Previously unvaccinated people who have had contact with the material infected with hepatitis B virus shall be vaccinated according to the scheme 0 – 1 – 2 months.

Patients in hemodialysis units get the vaccine four times with one month intervals between injections.

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

Injection uses only disposable syringes. The injection site is treated with 70% alcohol before and after the injection. Opening of ampoules and the vaccination procedure is carried out in strict compliance with the rules of asepsis and antiseptics.

Ampoules with physical defects leading to failure of their tightness must not be used.

The vaccine should not be administered intravenously.

The vaccine should not be stored in an open ampoule.

The vaccine should be injected into the deltoid muscle; in newborns and young children, into the anterolateral surface of the thigh. Injection in another place reduces the effectiveness of vaccination. The ampoule is shaken before injection.

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

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

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

The course of vaccination consists of three injections/injections of the vaccine according to a schedule: 0 – 1 – 6 months. If the interval between injections is lengthened, the next injection should be given as soon as the health condition of the person concerned determines. Children over 13 years of age who have not been previously vaccinated shall be vaccinated according to the standard schedule.

In children born by mothers carrying the hepatitis B virus or sick with viral hepatitis B in the 3rd trimester of pregnancy vaccination against viral hepatitis B should be done in accordance with the schedule 0 (at the day of birth) – 1 – 2 – 12 months.

Previously unvaccinated people who have had contact with the material infected with hepatitis B virus shall be vaccinated according to the scheme 0 – 1 – 2 months.

Patients in hemodialysis units get the vaccine four times with one month intervals between injections.

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

Injection uses only disposable syringes. The injection site is treated with 70% alcohol before and after the injection. Opening of ampoules and the vaccination procedure is carried out in strict compliance with the rules of asepsis and antiseptics.

Ampoules with physical defects leading to failure of their tightness must not be used.

The vaccine must not be administered intravenously.

The product cannot be stored in an open ampoule.

Special Instructions

In view of the possibility of immediate allergic reactions in particularly sensitive individuals, vaccinated persons should be medically monitored for 30 minutes after vaccination. Vaccination sites must be provided with anti-shock therapy.

Contraindications

– expressed reaction (temperature above 40 ° C, edema, hyperemia more than 8 mm in diameter at the injection site) or a complication of the previous administration of hepatitis B vaccine;

– Acute infectious and non-infectious diseases, chronic diseases in the acute stage – immunization 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: 5-10% of cases – pain, erythema and thickening 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 go away 2-3 days after injection.