Universal reference book for medicines
Name of drug: VACCINE AGAINST HEPATITIS B RECOMBINANT (VACCINE AGAINST HEPATITIS B RECOMBINANT)

Active substance: hepatitis B vaccine (rDNA)

Type: Vaccine for the prevention of hepatitis B

Producer: NGO MICROGEN (Russia) branch VIRION NGO (Russia) produced by NGO MICROGEN (Russia) manufactured by SHANTHA BIOTECHNICS (India)
Composition, form of production and packaging
Suspension for the / m introduction
for children: homogeneous, when standing, it is divided into a colorless transparent liquid and a loose white precipitate that breaks easily when shaken.

0.5 ml (1 dose)

surface antigen of hepatitis B virus 10 μg

Excipients: aluminum hydroxide, merthiolate.

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

Suspension for the / m introduction for adults: homogeneous, when standing, it is divided into a colorless transparent liquid and a loose white precipitate that breaks easily when shaken.

1 ml (1 dose)

surface antigen of the hepatitis B virus 20 μg

Excipients: aluminum hydroxide, merthiolate.

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

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2005.

PHARMACHOLOGIC EFFECT

Vaccine.
It is a preparation based on the surface antigen of hepatitis B virus, obtained by DNA recombination on a yeast culture, transformed by inserting into their genome a gene encoding 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 a protective titer in more than 90% of the vaccinated.

INDICATIONS

Prevention of hepatitis B in children as part of the National calendar of preventive vaccinations and those at high risk of infection with the hepatitis B virus:

- children and adults in families who have carriers of HBsAg or a patient with chronic hepatitis B;

- children of children's homes, orphanages and boarding schools;

- Children and adults who regularly receive blood and its products, as well as those on hemodialysis and oncohematological patients;

-the person who has been exposed to material infected with the hepatitis B virus;

-medical workers who have contact with blood;

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

- students of medical institutes and students of secondary medical educational institutions (primarily graduates);

-The drug injecting drug users.

Vaccinations can be administered to all other groups of the population.

DOSING MODE

The vaccine is given in / m to adults and older children in the deltoid muscle, newborns and young children in the antero-lateral side of the thigh.
Introduction to other places is undesirable because of the reduced effect of vaccination.
A single dose for newborns and patients under the age of 19 years is 0.5 ml (10 μg HBsAg).

A single dose for patients older than 19 years is 1 ml (20 μg HBsAg).

A single dose for hemodialysis patients was 2 ml (40 μg HBsAg).

The course of vaccination is carried out according to the following schemes.

Standard scheme

1 dose - on the selected day (newborn children are injected in the first 12 hours of life).

2 dose - after 1 month.

3 dose - 6 months after the first dose.

Revaccination is carried out no earlier than 5 years by administering 1 dose of vaccine.

Emergency scheme

1 dose on the selected day.

2 dose - after 1 month.

3 dose - 2 months after the first dose.

4 dose - 12 months after the third dose.

Revaccination is carried out no earlier than 5 years by administering 1 dose of vaccine.

Children from the age of 13 who were not vaccinated before are vaccinated according to the standard scheme.

Children born to mothers who are carriers of the hepatitis B virus, or those infected with hepatitis B virus in the third trimester of pregnancy, are vaccinated according to an emergency schedule.

For hemodialysis patients, the vaccine is administered four times at intervals of 1 month between administrations.
Reduction of the interval between 1 and 2 administration of the vaccine is not recommended. If it is necessary to increase this interval, the next administration of the vaccine should be carried out as soon as possible, determined by the state of health of the vaccinated person.
The hepatitis B vaccine can be used simultaneously on the same day as the other vaccines of the National Schedule of Prophylactic Inoculations (with the exception of BCG vaccine), as well as inactivated vaccines of the preventive vaccination calendar for epidemic indications or with an interval of 1 month.

In case of prolongation of the interval between the first and second vaccinations for 5 months or more, the third vaccination is carried out no earlier than 1 month after the second.

Regulations for the introduction of the vaccine

Before use, the vaccine should be shaken.

The drug is not administered iv.

For injection, use a disposable syringe.
Place the injection before and after the injection should be treated with a 70% solution of ethyl alcohol. Opening of ampoules and vaccination procedure should be carried out in compliance with the rules of aseptic and antiseptic.
The drug is not subject to storage after opening the ampoule.

SIDE EFFECT

Side effects when using the vaccine are rare.

Local reactions: pain, erythema, compaction at the injection site (5-10%).

Systemic reactions: rarely - malaise, fatigue, arthralgia, myalgia, headache, dizziness, nausea, vomiting, abdominal pain.

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

CONTRAINDICATIONS

-increased sensitivity to the components of the drug (including yeast);

- Acute infectious and non-infectious diseases;

-cronic diseases in the acute stage;

-pregnancy.

PREGNANCY AND LACTATION

The effect of the vaccine on the fetus has not been studied.
The possibility of using a vaccine in a pregnant woman is possible only at an extremely high risk of infection.
APPLICATION FOR FUNCTIONS OF THE LIVER

For hemodialysis patients, the vaccine is administered four times at intervals of 1 month between administrations.
Reduction of the interval between 1 and 2 administration of the vaccine is not recommended. If it is necessary to increase this interval, the next administration of the vaccine should be carried out as soon as possible, determined by the state of health of the vaccinated person.
APPLICATION FOR CHILDREN

A single dose for newborns and patients under the age of 19 years is 0.5 ml (10 μg HBsAg).

SPECIAL INSTRUCTIONS

Given the theoretical possibility of developing allergic reactions of immediate type in especially sensitive individuals, it is necessary to provide medical supervision of vaccinated people within 30 minutes after vaccination.
Vaccination sites should be provided with anti-shock therapy.
With mild forms of acute respiratory viral infection and acute intestinal infections, vaccination can be carried out after normalizing the temperature.

In acute illnesses or exacerbation of chronic diseases, vaccination is given no earlier than 1 month after recovery or remission.

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 and to the manufacturer's address.

Increased reactogenicity of the drug and complications after its administration should be reported by telephone or telegraph.

OVERDOSE

Data on overdose Hepatitis B vaccines are not recombinant.

DRUG INTERACTION

Drug Interactions Hepatitis B vaccine DNA recombinant is not described.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored at a temperature of 2 ° to 8 ° C.
Short-term (not more than 72 hours) transportation is allowed at a temperature not exceeding 25 ° C. Shelf life - 3 years.
The drug, which has been frozen, as well as expired, is not subject to application.

Conditions of leave from pharmacies

The drug is released by prescription.

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