Universal reference book for medicines
Product name: REGEVAK ® B (REGEVAC B)

Active substance: hepatitis B vaccine (rDNA)

Type: Vaccine for the prevention of hepatitis B

Manufacturer: BINNOFARM (Russia) produced the MEDICAL TECHNOLOGICAL HOLDING "MTX" (Russia)
Composition, form of production and packaging
Suspension for intravenous administration of
white with a grayish shade of color, without visible foreign particles;
Separated after settling on a clear supernatant and a white precipitate with a grayish tint, easily resuspendable with shaking.
0.5 ml (1 dose of children)

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

[PRING] aluminum hydroxide (sorbent), thiomersal (preservative) 25 μg (or does not contain), buffer components.

0.5 ml - ampoules (5) - packings contour mesh (1) - packs cardboard.

0.5 ml - ampoules (5) - packings contour mesh (2) - packs cardboard.

Suspension for intravenous administration of white with a grayish shade of color, without visible foreign particles;
Separated after settling on a clear supernatant and a white precipitate with a grayish tint, easily resuspendable with shaking.
1 ml (1 dose of adult)

recombinant purified surface antigen of hepatitis B virus (serotype ayw) 20 μg

[PRING] aluminum hydroxide (sorbent), thiomersal (preservative) 50 μg (or not containing), water d / and (up to 1 ml), components of the buffer.

1 ml - ampoules (5) - packings contour mesh (1) - packs cardboard.

1 ml - ampoules (5) - packings contour mesh (2) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

Vaccine for the prevention of hepatitis B. It contains the surface antigen of the hepatitis B virus (serotype ayw), obtained by DNA recombination on a yeast culture, transformed by incorporating into their genome a gene that codes for the surface antigen of the hepatitis B virus.

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

INDICATIONS

Prevention of hepatitis B:

- in children in
the national calendar of preventive vaccinations;
- people from the group have an increased risk of infection with the hepatitis B virus (children and adults with HBsAg or chronic hepatitis B carriers in their families, children of children's homes, orphanages and boarding schools, children and adults who regularly receive blood and its drugs, and who are on hemodialysis and oncohematological patients);

- in persons who have had contact with material infected with the hepatitis B virus;

- for medical workers who have contact with the blood of patients;

- for persons engaged in the production of immunobiological preparations from donor and placental blood;

- Students of medical institutes and students of secondary medical schools (first of all graduates);

- in persons who inject drugs.

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

DOSING MODE

The vaccine is given in / m in the deltoid muscle;
Newborn and young children - in the antero-lateral surface of the thigh. Introduction to another place reduces the effectiveness of vaccination. Before the injection, the vial is shaken.
A single dose for newborns and children and adolescents under the age of 19 is 0.5 ml (10 μg HBsAg).

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

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

The vaccination course consists of three I / m injections of the vaccine according to the scheme: 0 - 1 - 6 months.
In the case of lengthening the interval between vaccine administrations, the next administration 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 were not vaccinated before , are vaccinated according to the standard scheme.
Children born to mothers who are carriers of hepatitis B virus or sick with hepatitis B virus in the III trimester of pregnancy , vaccination against hepatitis B is carried out according to scheme 0 (on the day of birth) - 1 - 2 - 12 months.

Vaccination of previously uninitiated persons who had contact with the material with an infected hepatitis B virus was carried out according to the scheme 0 - 1 - 2 months.

Patients of hemodialysis departments receive the vaccine four times with a monthly interval between administrations.

Vaccination against hepatitis B can be carried out simultaneously (one day) with the introduction of vaccines of the national calendar of preventive vaccinations and inactivated vaccines of the calendar of preventive vaccinations for epidemic indications.
Introduction is carried out by different syringes in different parts of the body.
For injection, only a disposable syringe is used.
Place of injection before and after injection is treated with 70% alcohol. Opening of ampoules and the vaccination procedure are carried out with strict adherence to aseptic and antiseptic rules.
Do not use ampoules that are physically deformed, leading to a breach of their tightness.

Do not administer IV vaccine.

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

SIDE EFFECT

Side effects when using 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 administration are weak and usually go through 2-3 days after the injection.

CONTRAINDICATIONS

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

- acute infectious and non-infectious diseases, chronic diseases in the acute stage - immunization is performed no earlier than 1 month after recovery (remission);

- Hypersensitivity to yeast and other components of the vaccine.

PREGNANCY AND LACTATION

The effect of the vaccine on the fetus has not been studied.
The possibility of vaccination of a pregnant woman can be considered at an extremely high risk of infection.
APPLICATION FOR CHILDREN

Applied in children according to indications.

SPECIAL INSTRUCTIONS

Considering the possibility of developing allergic reactions of immediate type in especially sensitive individuals, it is necessary to provide medical supervision for vaccinated persons within 30 minutes after vaccination.
Vaccination sites should be provided with anti-shock therapy.
Complaints on the specific and physical properties of the drug should be sent to the State Research Institute for Standardization and Control of Medical Biological Preparations.
LA Tarasevich (119002, Moscow, Sivtsev Vrazhek, 41, phone: (499) 241-39-22, fax (499) 241-92-38) and to the address of CJSC Binnopharm (124460, Moscow, Zelenograd, 4th Western Passage, 3, building 1. Tel / Fax: (495) 510- 32-88).
The increased reactogenicity of the drug and complications after its introduction should be reported by telephone or telegraph to the Federal Service for Supervision of Consumer Rights Protection and Human Welfare and to the State Scientific Research Institute for Standardization and Control of Medical Biological Preparations.L.A. Tarasevich.

OVERDOSE

Data on the overdose of the vaccine Regevac B are not available.

DRUG INTERACTION

Patient interaction of the vaccine Regevac B is not described.

TERMS OF RELEASE FROM PHARMACY

The drug is dispensed on prescription (packing of 5 ampoules).

The drug is released into medical and prophylactic institutions (packaging of 10 ampoules).

TERMS AND CONDITIONS OF STORAGE

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 in a place inaccessible to children.
Short-term (not more than 72 hours) transportation is allowed at temperatures from 9 ° C to 30 ° C. Shelf life - 3 years.
The drug, which has been frozen, as well as expired, is not subject to application.

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