Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..
PHARMACHOLOGIC EFFECT
Hepatitis B vaccine. Promotes the development of immunity against hepatitis B virus. It is a purified basic surface antigen of the hepatitis B virus (HBsAg), obtained by recombinant DNA technology and adsorbed on aluminum hydroxide. The antigen is produced by a yeast cell culture (Saccharomyces cerevisiae) obtained by genetic engineering and having a gene encoding the main surface antigen of the hepatitis B virus. From yeast cells, HBsAg is purified by several sequential physico-chemical methods.
HBsAg is spontaneously transformed 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 that are characteristic of natural HBsAg.
Causes the formation of specific HBs-antibodies, which in the titer of 10 IU / l prevent the disease with hepatitis B.
INDICATIONS
Active immunization of children and adults against hepatitis B, especially those at risk of Hepatitis B virus infection.
The implementation of active immunization against hepatitis B in areas with low incidence is recommended for newborn children and adolescents, as well as those with an increased risk of infection, which include:
- children born by mothers who are carriers of the hepatitis B virus;
- Personnel of medical and dental institutions, including staff of clinical and serological laboratories;
-patients who are undergoing or are planning a transfusion of blood and its components, planned surgical interventions, invasive medical and diagnostic procedures;
- A person who has an increased risk of the disease due to their sexual behavior;
-drug addicts;
-the street, going to regions with a wide spread of hepatitis B;
- children in regions with a wide spread of hepatitis B;
-patients with chronic hepatitis C and carriers of hepatitis C virus;
-bearing sickle-cell anemia;
-patients who plan organ transplantation;
alcohol abusers;
- a person who has close contact with patients or carriers of the virus, and all persons who, due to work or for any other reasons, may be infected with the hepatitis B virus.
Conducting active immunization against hepatitis B in areas with an average or high incidence of hepatitis B, where there is a risk of infection for the whole population, vaccination is necessary (in addition to all the groups listed above) for all children and newborns, as well as adolescents and young people.
DOSING MODE
The vaccine is used in accordance with the country's immunization schedule.
The dose of the vaccine depends on the age of the patient.
SIDE EFFECT
Local reactions: minor soreness, erythema and densification at the site of injection.
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-Barre syndrome, optic neuritis and multiple sclerosis), encephalitis, encephalopathy, meningitis, convulsions, although the cause-and-effect relationship of these complications with grafting is not established.
On the part of the digestive system: rarely - nausea, vomiting, diarrhea, abdominal pain, changes in liver function.
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 side of the cardiovascular system: in some cases - syncopal conditions, arterial hypotension, vasculitis.
Other: in some cases - thrombocytopenia, bronchospasm.
Adverse reactions are mild and transient. In many cases, the causal relationship of adverse events with the introduction of the vaccine has not been established.
CONTRAINDICATIONS
Acute and severe diseases, as well as severe infectious diseases accompanied by fever; hypersensitivity reaction to previous administration of hepatitis B vaccines.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
The drug is used for active immunization of children and adults against hepatitis B. The vaccine does not prevent infection caused by other pathogens, for example hepatitis A, hepatitis C and hepatitis E, as well as pathogens causing other liver diseases.
APPLICATION IN ELDERLY PATIENTS
Usually, in people over 40 years of age, the humoral immune response is less pronounced, so these patients may need to administer additional doses of the vaccine.
SPECIAL INSTRUCTIONS
Due to the long incubation period of hepatitis B, a latent infection of the hepatitis B virus may occur during the course of the vaccination. In such cases, the use of the vaccine can not prevent hepatitis B disease.
The vaccine does not prevent infection caused by other pathogens, such as hepatitis A, hepatitis C and hepatitis E, as well as pathogens that cause other liver diseases.
Immune response to vaccination is associated with various factors, including. age, sex, obesity, smoking and the way the vaccine is administered. Usually, in people over 40 years of age, the humoral immune response is less pronounced, so these patients may need to administer additional doses of the vaccine.
In patients on hemodialysis in HIV-infected patients and in persons with other immunity disorders, an adequate HBs-antibody titer may not be achieved after the main course of immunization, so additional administration of the vaccine may be required.
When a vaccine is administered, it is necessary to have available funds that may be required for the occurrence of anaphylactic reactions. Allergic reactions can develop immediately after the introduction of the vaccine, and therefore vaccinated patients should be kept for 30 minutes under medical supervision.
In the presence of an infectious disease in a mild form, vaccination can be carried out immediately after the temperature normalization.
