Hepatitis B recombinant yeast vaccine, 1 ml 10 pcs.

Hepatitis B vaccine. Promotes development of immunity against hepatitis B virus. It is purified basic surface antigen of hepatitis B virus (HBsAg) obtained by recombinant DNA technology and adsorbed on aluminum hydroxide.

The antigen is produced by a culture of yeast cells (Saccharomyces cerevisiae) obtained by genetic engineering and having a gene encoding the main surface antigen of hepatitis B virus. From the yeast cells, HBsAg was purified using several successive physicochemical methods.

HBsAg spontaneously transforms into spherical particles 20 nm in diameter containing non-glycosylated HBsAg polypeptides and a lipid matrix consisting mainly of phospholipids. Studies have shown that these particles have properties characteristic of natural HBsAg.

Causes the formation of specific HBs antibodies, which in a titer of 10 IU/L prevent hepatitis B disease.

Indications

Vigorous immunization of children and adults against hepatitis B, especially those at risk of hepatitis B virus infection.

Hepatitis B active immunization in areas of low incidence is recommended for newborn children and adolescents, as well as those at high risk for infection, which include:

Children born to mothers who are carriers of hepatitis B virus;

Personnel in medical and dental facilities, including clinical and serological laboratory staff;

-Patients receiving or planning transfusions of blood and blood components, elective surgical interventions, invasive medical and diagnostic procedures;

Persons with an increased risk of disease due to their sexual behavior;

Drug abusers;

-People traveling to regions with a high prevalence of hepatitis B;

Children in regions with a high prevalence of hepatitis B;

Patients with chronic hepatitis C and carriers of hepatitis C virus;

Patients with sickle cell anemia;

-Patients with planned organ transplants;

Persons who abuse alcohol;

Persons who have close contact with people with the virus or carriers of the virus, and anyone else who may be infected with hepatitis B virus because of their work or for any other reason.

Vigorous immunization against hepatitis B in areas with moderate or high hepatitis B incidence, where there is a risk of infection for the entire population, vaccination is required (in addition to all groups listed above) for all children and newborns, as well as adolescents and young adults.

Active ingredient

Composition

1 ml of the vaccine contains 20 µg of hepatitis B virus surface antigen.

How to take, the dosage

The vaccine is administered according to the national immunization schedule.

The dose of the vaccine depends on the age of the patient.

Special Instructions

With regard to the long incubation period of hepatitis B, there may be a latent infection of the hepatitis B virus during the vaccination course. In these cases, the vaccine may not prevent hepatitis B infection.

The vaccine does not prevent infection with other pathogens, such as hepatitis A, hepatitis C and hepatitis E, or pathogens that cause other liver diseases.

The immune response to vaccination is related to a variety of factors, including age, sex, obesity, smoking, and the way the vaccine is given. Humoral immune response is usually less strong in people over 40 years of age, so these patients may need additional doses of vaccine.

In patients on hemodialysis, in HIV-infected patients, and in those with other immune disorders, an adequate titer of HBs antibodies may not be achieved after the main course of immunization, so additional vaccine administration may be required.

Anaphylactic reactions should be available when administering the vaccine. Allergic reactions can develop immediately after the vaccine is given, so vaccinated patients should be under medical supervision for 30 minutes.

In case of mild infectious disease, the vaccination can be given as soon as the temperature returns to normal.

Contraindications

Acute and severe illnesses, as well as severe infectious diseases with fever; manifestation of a hypersensitivity reaction to a previous administration of hepatitis B vaccines.

Side effects

Local reactions: slight soreness, erythema and thickening at the site of drug administration.

The body in general: rarely – weakness, fever, malaise, flu-like symptoms; in some cases – lymphadenopathy.

CNS and peripheral nervous system disorders: rarely Рheadache, dizziness, paresthesias; in some cases Рneuropathy, paralysis, neuritis (including Guillain-Barr̩ syndrome, optic neuritis and multiple sclerosis), encephalitis, encephalopathy, meningitis, seizures, although the causal relationship of these complications with vaccination is not established.

Digestive system disorders: rarely – nausea, vomiting, diarrhea, abdominal pain, changes in liver function parameters.

Muscular system disorders: rare – arthralgia, myalgia; in some cases – arthritis.

Allergic reactions: rash, itching, urticaria, in rare cases – anaphylaxis, serum sickness, angioedema, erythema multiforme.

Cardiovascular system: in single cases – syncope, arterial hypotension, vasculitis.

Others: in some cases – thrombocytopenia, bronchospasm.

The adverse reactions are mild and transient. In many cases, a causal relationship of adverse events to the vaccine administration has not been established.