Description
Release form
Suspension for intramuscular administration.
Packing
In a package of 10 ampoules.
Pharmacological action
Hepatitis B vaccine. Helps build up immunity against hepatitis B virus. It is a purified main surface antigen of hepatitis B virus (HBsAg) , obtained using 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 the hepatitis B virus. HBsAg was purified from yeast cells using several physicochemical methods used in series.
HBsAg spontaneously transforms into spherical particles with a diameter of 20 nm 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.
Indications
Active immunization of children and adults against hepatitis B, especially those at risk of hepatitis B.
Active immunization against hepatitis B in areas with low morbidity is recommended for newborns and adolescents, as well as people with increased infection risk, which include:
—children, born by mothers of hepatitis B virus
— personnel of medical and dental institutions, including employees of clinical and serological laboratories
— patients who undergo or plan a transfusion of blood and its components, planned surgical interventions, invasive medical and diagnostic procedures
— a person who an increased risk of the disease is associated with their sexual behavior
—
addicts — people traveling to regions with a high prevalence of hepatitis B
— children in the regions with a wide spread of hepatitis B
— patients with chronic hepatitis C and carriers of the hepatitis C virus
— sick with sickle cell anemia
— patients whose organ transplantation is planned
— a person who abuse alcohol
— a person having close contact with patients or carriers of the virus, and all persons who, due to work or for any other reason, may be infected with hepatitis B.
Active immunization against hepatitis B in areas with medium or high incidence of hepatitis B, where there is a risk of infection for the entire population, vaccination is necessary (in addition to all the groups listed above) for all children and newborns, as well as adolescents and young adults.
Contraindications
Acute and severe illnesses, as well as severe infectious diseases accompanied by fever, hypersensitivity reaction to the previous administration of hepatitis B vaccines.
Special instructions
Due to the long incubation period of hepatitis B, there may be a latent infection of the hepatitis B virus during the course of vaccination. In such cases, the use of the vaccine cannot prevent hepatitis B.
The vaccine does not prevent infection caused by other pathogens, such as hepatitis A, hepatitis C and hepatitis E, as well as pathogens, causing other liver diseases.
The immune response to vaccination is associated with various factors, including age, gender, obesity, smoking and method of administration of the vaccine. Typically, people over 40 years of age have a less pronounced humoral immune response, so these patients may need additional doses of the vaccine.
In patients undergoing hemodialysis, in HIV-infected patients and in people with other disorders of the immune system, an adequate titer of HBs antibodies may not be achieved after the main course of immunization, therefore, additional vaccine may be required.
When administering the vaccine, funds must be available that may be required if anaphylactic reactions occur. Allergic reactions may develop immediately after the vaccine is administered. therefore, vaccinated patients should be under medical supervision for 30 minutes.
If there is a mild infectious disease, vaccination can be done immediately after normalizing the temperature.
Composition of
1 ml of the vaccine contains 20 mcg hepatitis B surface antigen.
Dosage and administration
The vaccine is administered in accordance with the country’s immunization schedule.
The dose of vaccine depends on the age of the patient.
Side effects
Local reactions: slight soreness, erythema and tightening at the injection site.
On the part of the body as a whole: rarely – weakness, fever, malaise, flu-like symptoms in some cases – lymphadenopathy.
From the side of the central nervous system and peripheral nervous system: rarely – headache, dizziness, paresthesia in some cases – neuropathy, paralysis, neuritis (including Guillain-Barré syndrome, optic neuritis and multiple sclerosis), encephalitis, encephalopathy, meningitis, convulsions, although a causal relationship between these complications and vaccination has not been established.
From the digestive system: rarely – nausea, vomiting, diarrhea, abdominal pain, changes in liver function indices.
From the musculoskeletal system: rarely – arthralgia, myalgia in some cases – arthritis.
Allergic reactions: rarely – rash, itching, urticaria in some cases – anaphylaxis, serum sickness, angioedema, erythema multiforme.
From the cardiovascular system: in some cases – syncope, arterial hypotension, vasculitis.
Other: in some cases – thrombocytopenia, bronchospasm.
Adverse reactions are mild and transient. In many cases, a causal relationship between side effects and vaccine administration has not been established.
Active ingredient
Vaccine for the prevention of viral hepatitis B
lekarstvennaja form
Solution for
Combiotech NPK, Russia
