Vaccine against hepatitis B recombinant

General characteristics. Structure:

Active ingredient: 10 mkg of a surface antigen of a virus of hepatitis B.

Excipients: aluminum hydroxide, mertiolit.

Pharmacological properties:

Pharmacodynamics. Vaccine. Represents drug on the basis of a surface antigen of a virus of the hepatitis B got by DNA recombination method on culture of the yeast transformed by way of inclusion in their genome of the gene coding a surface antigen of a virus of hepatitis B.

Carrying out a course of vaccination leads to formation of specific antibodies to a hepatitis B virus in a protective caption more than at 90% vaccinated.

Indications to use:

Prevention of hepatitis B at children within the National calendar of preventive inoculations and persons from group of the increased risk of infection with a hepatitis B virus:

— children and adults in whose families there are HBsAg carriers or the patient with chronic hepatitis B;

— children of children's homes, orphanages and nursing homes;

— the children and adults who are regularly receiving blood and its drugs, and also being on a hemodialysis and oncohematological patients;

— persons who had a contact with the material infected with a hepatitis B virus;

— the health workers having contact with blood;

— the persons occupied in production of immunobiological drugs from donor and placental blood;

— students of medical institutes and pupils of average medical educational institutions (first of all vypusnik);

— the persons using drugs in the injection way.

All other groups of the population can carry out inoculations.

Route of administration and doses:

The vaccine is entered to adults in oil and children of advanced age into a deltoid muscle, to newborns and children of younger age in hip front lateral face. Introduction to other places is undesirable because of decrease in effect of vaccination.

Single dose for newborn children and patients aged up to 19 years - 0.5 ml (10 mkg of HBsAg).

The single dose for patients is more senior than 19 years - 1 ml (20 mkg of HBsAg).

Single dose for patients of department of a hemodialysis - 2 ml (40 mkg of HBsAg).

A course of vaccination is conducted according to the following schemes.

Standard scheme:

1 dose - in the chosen day (to newborn children it is entered into the first 12 h life).

2 dose - in 1 month.

3 dose - in 6 months after introduction of the first dose.

The revaccination is carried out not earlier than in 5 years by introduction of 1 dose of a vaccine.

Emergency scheme:

1 dose - in the chosen day.

2 dose - in 1 month.

3 dose - in 2 months after introduction of the first dose.

4 dose - in 12 months after introduction of the third dose.

The revaccination is carried out not earlier than in 5 years by introduction of 1 dose of a vaccine.

To the children since 13 years who are not imparted earlier vaccination is carried out according to the standard scheme.

To the children who were born from mothers carriers of a virus of hepatitis B, or patients with a viral hepatitis In in the III trimester of pregnancy, vaccination is carried out according to the emergency scheme.

For patients of department of a hemodialysis the vaccine is entered four-time bucketed 1 month between introductions. Reduction of an interval between the 1 and 2 introduction of a vaccine is not recommended. In need of increase in this interval the next introduction of a vaccine should be carried out to perhaps next time determined by the state of health of vaccinated.

The vaccine against hepatitis B can be applied at the same time in one day with other vaccines of the National calendar of preventive inoculations (except for vaccine BTsZh), and also the inactivated vaccines of a calendar of preventive inoculations according to epidemic indications or at an interval of 1 month.

In case of lengthening of an interval between the first and second inoculations for 5 months and more, the third inoculation will be out not earlier than in 1 month after the second.

Rules of introduction of a vaccine. Before use the vaccine should be stirred up. The drug is not administered in / century.

For an injection it is necessary to use the one-time syringe. An injection site before and after an injection it is necessary to process 70% alcohol solution. It is necessary to carry out opening of ampoules and the procedure of vaccination at observance of rules of an asepsis and antiseptics.

After opening of an ampoule drug is not subject to storage.

Features of use:

Use at pregnancy and feeding by a breast. Influence of a vaccine on a fruit is not studied. A possibility of use of a vaccine for the pregnant woman perhaps only at extremely high risk of infection.

Use at renal failures. For patients of department of a hemodialysis the vaccine is entered four-time bucketed 1 month between introductions. Reduction of an interval between the 1 and 2 introduction of a vaccine is not recommended. In need of increase in this interval the next introduction of a vaccine should be carried out to perhaps next time determined by the state of health of vaccinated.

Use for children. A single dose for newborn children and patients aged up to 19 years - 0.5 ml (10 mkg of HBsAg).

Special instructions. Considering a theoretical possibility of development of allergic reactions of immediate type in especially sensitive persons, it is necessary to provide medical observation for imparted within 30 min. after vaccination. Venues of inoculations have to be provided with means of antishock therapy.

At not severe forms of a SARS and acute intestinal infections vaccination can be carried out after normalization of temperature.

At acute diseases or an exacerbation of chronic diseases vaccination is carried out not earlier than in 1 month after recovery or remission.

The claim for specific and physical properties of drug should be sent to the State scientific research institute of standardization and control of medical biological supplies and to manufacturer.

About the increased reactogenicity of drug and complications after its introduction it is necessary to phone or to telegraph.

Side effects:

Side effects at use of a vaccine are noted seldom.

Local reactions: pain, an erythema, consolidation in the place of an injection (5-10%).

System reactions: seldom - an indisposition, fatigue, an arthralgia, a mialgiya, a headache, dizziness, nausea, vomiting, pains in a stomach.

All reactions usually take place in 2-3 days after an injection.

Interaction with other medicines:

Medicinal interaction of the Vaccine against hepatitis In DNA recombinant is not described.

Contraindications:

— hypersensitivity to drug components (including to yeast);

— acute infectious and noninfectious diseases;

— chronic diseases in an aggravation stage;

— pregnancy.

Overdose:

Data on overdose of the Vaccine against hepatitis In DNA recombinant are absent.

Storage conditions:

Drug should be stored at a temperature from 2 °C to 8 °C. Transportation is allowed short-term (no more than 72 h) at a temperature not above 25 °C. A period of validity - 3 years. The drug which underwent freezing and also expired, is not subject to use.

Issue conditions:

According to the recipe

Packaging:

0.5 ml (1 dose) - ampoules (10) - packs cardboard.