Types of modern hepatitis B vaccines. Hepatitis B vaccine recombinant (rDNA) Instructions for medical use

The main one for the Russian market is the recombinant yeast vaccine against hepatitis B - it is it that is used by all state clinics for scheduled and unscheduled vaccination of hepatitis B. Among many manufacturers, the most common drug is the closed joint-stock company NPK Combiotech. It is this hepatitis B vaccine that will be discussed in detail in our article: composition, characteristics, uses and contraindications.

Characteristic

This drug is used to immunize the population against category B hepatitis, including children under one year old and newborns. The scheme consists of 3 or 4 vaccinations, depending on the period in which it is necessary to form immunity. Fully administered vaccination provides immunity from the hepatitis virus for a 20-year period with a probability of more than 97%. In the Russian Federation, the recombinant yeast hepatitis B vaccine is provided free of charge in any polyclinic for both newborns and adults who wish to undergo routine / unscheduled vaccination. Each batch of the drug is tested on animals before being put into operation.

The main active ingredient in this vaccine is the HBsAg surface antigen, also called the Australian antigen. It is he who destroys the protein of hepadnavirus (the causative agent of hepatitis), which has entered the bloodstream. The antigen is created on the basis of a recombinant strain of a bread yeast species, from which it is subsequently released by a physical or chemical method. This method of antigen production is quite simple and cheap. The main disadvantage of the method is the presence of yeast protein in the finished suspension at a concentration of about 1%, since bread yeast and its derivatives are strong allergens for almost 2% of people.

If you have a strong reaction to the components of the vaccine or an allergy after the first vaccination, you should discuss with your doctor the replacement of the drug.

Compound

The main components of the vaccine:

antigen HBsAg, 20 mcg/ml - the main component of the vaccine;
aluminum hydroxide, 50 mg/ml;
merthiolate, 50 µg/ml - preservative.

The standard dosage for children is 0.5 ml of the drug, for adults - 1 ml. Patients on hemodialysis should be vaccinated with a double dose.

Release form

The drug is produced and sold as a liquid suspension for intramuscular injection. The solution is colorless, with a white precipitate that breaks up easily on shaking. The drug is produced in glass medical ampoules with a volume of 0.5 or 1 ml, which corresponds to one child and one adult dose. The vaccine is packed in plastic blisters or cardboard boxes of 10 pieces. The package always contains instructions and a special ampoule knife.

Storage

The vaccine is stored in an unopened sealed ampoule with strict adherence to the temperature regime of 3-7 °C. The vaccine should not be frozen and placed in direct sunlight. The recombinant yeast hepatitis B liquid vaccine is quite sensitive to storage conditions - if it is kept at room temperature for more than two days, the drug loses half of its effectiveness. The opened drug is used within one hour or disposed of. Frozen ampoules or ampoules with a discolored solution that does not break the sediment should be disposed of without opening.

It is necessary to open the ampoule immediately before vaccination, the open drug is not stored for more than an hour.

Application

This vaccine is used to immunize against the hepatitis B virus in both adults and children. Under the right vaccination conditions and the absence of immunodeficiency, the immune response is about 97%. Strong immunity to the virus lasts for at least 20 years, after which re-vaccination is required.

In total, there are three hepatitis vaccination schemes:

standard 0-1-6 out of three vaccinations;
accelerated 0-1-2-12, serves for faster formation of immunity, however, one additional vaccination is required to consolidate;
emergency vaccination, carried out in 2 weeks according to the scheme 0-7-21-12, where the first three numbers indicate the day of vaccination in order, and the last - a reinforcing vaccination after 12 months.

The drug can be used on the same day with other vaccines, with the exception of BCG. Also, the recombinant vaccine can be easily replaced with another drug if necessary.

Contraindications

The main contraindication to the use of this hepatitis vaccine is an allergic reaction to baker's yeast (which always means a reaction to any baked goods). If the mother of the vaccinated child is allergic to yeast, it is better to refrain from using this vaccine, or to conduct a complete examination. It is also prohibited to vaccinate against hepatitis for people who have recently had acute respiratory diseases or exacerbations of severe chronic diseases. After vaccination, mild general and local reactions are acceptable, such as a short-term fever or a papule at the vaccination site.

Features of hepatitis A. Whether or not to vaccinate against it Hepatitis vaccination for adults: contraindications and complications

The vaccine is used exclusively for preventive purposes. The main task of the vaccine (vaccination) is to develop immunity in the body to infection provoked by the hepatitis B virus. The vaccine is intended for all children and adults who have not previously been infected with hepatitis B, newborns whose mothers are carriers of the virus, as well as medical workers. Each of these categories of people has a special approach in terms of vaccination. So doctors, whose specialty is associated with direct contact with a large number of potential carriers of the virus, are vaccinated every five years.

Another role of the vaccine is the prevention of hepatocellular carcinoma. The vaccine stops the development of HBV infection, which usually results in liver cancer. It follows from the above that the hepatitis B vaccine is also the hepatitis D vaccine.

Contraindications

During pregnancy and during breastfeeding, vaccination is delayed for up to two to three years, until breastfeeding of the baby stops.

When determining a person's hypersensitivity to the components of the vaccine (in particular, to thimerosal), special instructions for use should be followed or the vaccination should be completely abandoned. In rare cases, a person may experience intolerance to yeast proteins. It is also a critical contraindication to vaccination.

In case of exacerbation of chronic diseases, as well as in acute infectious and non-infectious diseases, it is necessary to wait for a complete remission. And only after 2-4 weeks from the moment of recovery, vaccination is allowed.

The administration of the drug is also canceled in case of severe and severe immunodeficiency in children with HIV infection. At the same time, HIV infection in itself is not a contraindication.

At elevated temperature (over 40 degrees), hyperemia with a radius of more than 4 cm in the injection zone or other negative reactions to the previous injection of the vaccine, the scheduled vaccination is postponed until the above symptoms are relieved and the temperature normalizes.

Medicinal composition

Genetically modified baker's yeast Saccharomyces cerevisiae

All currently existing vaccines have a similar composition. The reason for this is simple: the vaccine is always based on the genetically modified baker's yeast Saccharomyces cerevisiae. In the process of genetic modification, the baker's yeast genome is supplemented with a segment of the virus genome, which is responsible for the synthesis of HBsAg, the Australian antigen.

As a result, 90-95% of the mass fraction of the vaccine is occupied by the synthesized antigen. The remaining 5-10% is occupied by the adjuvant, the preservative thimerosal, and traces of yeast protein. To enhance the immune response from the body, as a rule, aluminum hydroxide is used as an adjuvant. The role of this component is extremely important, because a vaccine based on a single antigen in itself has a weak immunogenicity. For this reason, the drug is supplemented with an Al(OH)3 adjuvant, due to which an optimal level of viral antibody formation is achieved.

It is also important to supplement the vaccine with thimerosal, better known under the trade name Merthiolate. Thiomersal (–C9H9HgNaO2S–) is a mercury-containing compound that is used as an antiseptic and antifungal agent. Thimerosal is used as an antiseptic and preservative in vaccines.

But there are also certain types of vaccines against hepatitis B, from the composition of which all kinds of preservatives are excluded. There are at least two reasons for this:

Merthiolate intolerance in a small part of the population. In such cases, special instructions for the use of the vaccine are necessary. The relative proportion of such cases is only 1:600,000. But there is still a risk of complications up to anaphylactic shock and even death.
The second reason is insignificant, but still it is the reason for the exclusion of Merthiolate from the composition of some vaccines. The use of thimerosal as a vaccine preservative was once disputed and caused widespread concern. To date, no significant arguments have been presented, evidence of the unsuitability of thimerosal for the above purposes. But still, in response to concerns, in the USA, Europe, and some other countries, merthiolate was excluded from the composition of drugs against hepatitis B.

As a result, the basic composition of the drug is as follows:

antigen Adjuvant (catalyst);
preservative-antiseptic;
traces of yeast proteins in a small proportion.

Mode of application

Before filling the injection syringe, the vaccine vial should be shaken. The need for this action is due to the fact that the contents of the ampoule are heterogeneous, since the components settle at the bottom of the ampoule. With good shaking of the capsule, a homogeneous suspension suitable for injection is formed.

Older children, adolescents and adults are injected intramuscularly into the deltoid muscle. In this case, a single dosage is calculated taking into account age.

Patients with acute and chronic renal failure should receive a double dose of the vaccine. Patients diagnosed with thrombocytopenia and hemophilia are injected subcutaneously. For young children, the drug is injected intramuscularly into the anterolateral surface of the thigh.

It is important to know that the vaccine is strictly forbidden to be administered intravenously.

There is a procedure for immunization with a vaccine, because to achieve the required level of antigen formation, a single vaccination is not enough. In most cases, a course consisting of three injections is carried out at regular intervals. In rare cases, 2 injections are enough, or 4 injections may be required.

Consider the most common vaccination procedure. The first injection is administered to newborns within 12 hours of birth, adults - on any chosen date. After 30 days from the date of the primary injection, a second injection should be administered. The third ampoule is prescribed for a period of two to five months from the date of receipt of the second. In total, the vaccination course lasts from 4 to 6 months.

In medicine, there is a definition of a category of people who are at high risk of contracting hepatitis B. This group includes newborns whose mothers are infected or sick with hepatitis B, as well as healthcare workers.

In the first case, a four-time injection regimen is used, carried out as follows: the first injection ampoule is given in the first hours of the baby's life, the next two are administered at intervals of one month, and the final fourth is administered at the age of 12 months. The same vaccination scheme, but with a double dosage, is applied to patients in the hemodialysis department.

In 90% of cases, a one-time course consisting of 2-4 injections is sufficient. Medical studies conducted over the years show that after a course of vaccination, a person develops strong immunity for at least 25 years. People from risk groups, in particular, medical workers, are entitled to regular vaccination with a frequency of 5 years.

Side effects

Redness after injection

Hepatitis B vaccines currently under development are highly purified. The composition of the vaccine includes a single antigen, the mass fraction of which is 90-95%. The above factors suggest that the vaccine itself is almost 100% safe and is also one of the most easily tolerated injections.

After vaccination, 1 out of 10 vaccinated people experience local reactions, such as slight reddening of the injection zone, slight induration of the skin, and a feeling of discomfort during movements. But the aforementioned local reactions cannot be called side effects, because the vaccine is developed taking into account the provocation of a minor inflammatory reaction in the injection zone.

This solution is provided by the fact that the injected antigen requires the maximum degree of contact with the immunocompetent cells of the body. The role of the causative agent of inflammation is played by aluminum hydroxide, which is part of the vaccine. Of course, such a move is provided by the desire to get the maximum return on vaccination.

Temperature may rise slightly after vaccination

In rare cases, vaccinated patients may experience the following symptoms: a slight deterioration in well-being, a slightly elevated body temperature, or slight malaise. The relative proportion of such cases is extremely small - observed in 1-5 people out of a hundred vaccinated. Such a reaction is also considered harmless, does not require medical intervention or additional medication. The above symptoms pass quite quickly - within one to two days.

Another factor to consider is that a small percentage of the population may be allergic to vaccine components. In this case, it is difficult to predict the outcome. Vaccination can be both painless and with serious consequences. Anaphylactic shock, as a result of which death is the most severe type of reaction to the introduction of an allergen into the body. Few such cases were reported, and the percentage of severe allergic reactions was 1 in 600,000.

6 types of vaccines are registered in Russia. In practice, 5 names of drugs from different manufacturers are used. Each of them has a unique composition, designed for different purposes.

Vaccine Euvax

The vaccine, known under the trade name EUVACS, has been withdrawn from use in the Russian Federation. The reason for this was the data that in Vietnam there were cases of death in children due to immunization with the aforementioned drug.

INN: Hepatitis B vaccine

Manufacturer: Merck Sharp and Dome Corp.

Anatomical-therapeutic-chemical classification: Hepatitis B, antigen depleted

Registration number in the Republic of Kazakhstan: No. RK-BP-5 No. 021575

Registration period: 14.08.2015 - 14.08.2020

Instruction

Tradename

Recombiwax HB, hepatitis B vaccine, recombinant

International non-proprietary name

Dosage form

Suspension for injections, 5 mcg/0.5 ml, 10 mcg/1.0 ml

Compound:

One dose of the vaccine contains

active substance- hepatitis B surface antigen 5.0 mcg in 0.5 ml or 10.0 mcg in 1.0 ml

Excipients - amorphous aluminum hydroxyphosphate, sodium chloride, sodium borate, water for injection

Description

White opaque solution

Pharmacotherapeutic group

Vaccines. Antiviral vaccines. Hepatitis vaccines. Hepatitis B virus - purified antigen

ATX code J07BC01

Pharmacological properties

Pharmacokinetics

Vaccines do not require pharmacokinetic studies.

Pharmacodynamics

Recombivax HB is a non-infectious subunit viral vaccine containing the hepatitis B virus (HBV) surface antigen (HBsAg or Australian antigen) grown in yeast cells. The part of the HBV gene encoding HBsAg is grown in yeast fungi. Hepatitis B vaccine is produced from cultures of a recombinant strain of yeast according to methods developed by the Merck Research Laboratories.

Antigen isolated and purified from cultures of recombinant yeast strain Saccharomyces cerevisiae, containing the gene encoding adw-HBsAg subtype. The HBsAg protein is isolated from yeast cells by destroying and purifying them through a series of physical and chemical methods. Each dose of the vaccine contains less than 1% yeast protein fractions. The purified protein is treated with phosphate buffer with formaldehyde and then precipitated with aluminum (potassium aluminum sulfate) to form the main vaccine formulation with amorphous aluminum hydroxyphosphate sulfate adjuvanted.

The vaccine induces the formation of specific humoral antibodies against HBV surface antigens (anti-HBsAg). An antibody titer against HBV surface antigens (anti-HBsAg) above 10 IU/L, measured 1-2 months after the last injection, provides protection against hepatitis B.

According to studies, after completion of the 3-stage vaccination, in 96% of vaccinated newborns, infants, children, adolescents and adults (n=1497), the effective anti-HBsAg antibody titer was more than 10 IU/l.

Clinical studies in newborns using different dosage regimens or co-administration of vaccines have found that protective levels of antibodies are produced in 97.5% and 97.2%, respectively, and the average level of specific antibodies is 214 IU/l and 297 IU/l, respectively. Other clinical studies conducted among adolescents and adults have shown that the protective level of antibodies after vaccination was achieved in 95.6-97.5% of vaccinated patients and the level of specific antibodies was 535 -793 IU / l.

The protective efficacy in neonates (n=130) born to HBsAg and HBeAg positive mothers with hepatitis B immunoglobulin at birth and subsequent 3-stage vaccination was 95%.

Although the duration of immunological memory in response to vaccination is not known, follow-up of 3000 high-risk patients for 5-9 years after vaccination did not reveal the development of clinical cases of hepatitis B. Production of specific antibodies (HBsAg surface antigen HBsAg) after a booster dose recombinant vaccine confirms the stability of immunological memory. The need for revaccination has not been established.

Reducing the risk of developing hepatocellular carcinoma

Hepatocellular carcinoma is a serious complication of hepatitis B virus infection. Clinical studies have established an association between chronic hepatitis B infection and hepatocellular carcinoma, and in 80% of cases, hepatocellular carcinoma developed due to the presence of HBV. Therefore, HBV vaccination reduces the risk of developing primary liver cancer.

Indications for use

Active immunization against infection with all known hepatitis B virus subtypes in individuals at risk of hepatitis B infection

Immunization with hepatitis B vaccine may provide indirect protection against the development of hepatitis D, since hepatitis D suggests the presence of hepatitis B disease.

Dosage and administration

Dosage. Vaccination is carried out according to a 3-dose scheme.

Children and adolescents from the neonatal period to 15 years of age

The vaccine Recombivax HB 5 mcg (1 dose 0.5 ml) is intended for use in children and adolescents from the neonatal period up to 15 years. The vaccination schedule includes three injections of the vaccine Recombivax HB 5 mcg (1 dose of 0.5 ml) according to the scheme 0, 2, 4 months up to 1 year and according to the scheme 0, 1, 6 months - over 1 year.

For newborns, vaccination is carried out according to the scheme of 0, 2, 4 months (in the first twelve hours after birth, at 2 months of life, and at 4 months of life)

For children under one year of age, unvaccinated at birth, vaccination is carried out according to the scheme of 0, 2, 6 months with intervals between the first and second vaccinations of 2 months, between the second and third at 4 months

For children older than one year, unvaccinated at birth, vaccination is carried out according to the scheme of 0, 1, 6 months with intervals between the first and second vaccinations at 1 month, between the second and third at 5 months.

Adults over 15 years old

Vaccination of persons over 15 years of age is carried out after a preliminary marker diagnosis for the presence of HBV. Individuals who test positive for HBV are not eligible for vaccination. Recombivax HB 10 mcg (1 dose 1.0 ml) is intended for use in patients over 15 years of age. The vaccination schedule includes three injections (1 dose of 1.0 ml) according to the scheme of 0, 1, 6 months with an interval of 1 month after the first vaccination and 5 months after the second vaccination.

Mode of application. The entire dose of Recombivax HB is administered intramuscularly using a sterile syringe and needle.

Do not administer intravenously or intradermally!

Recombivax HB is given by intramuscular injection into the deltoid region of the upper arm in adults, adolescents and children over 1 year of age and into the anterolateral thigh in children under 1 year of age. Children over the age of 1 year should only be given the vaccine in the deltoid region of the shoulder if they are of sufficient anatomical development to allow intramuscular injection. With the introduction of the vaccine into the gluteal region, a low level of seroconversion is noted, therefore the Recombivax HB vaccine is not recommended to be administered into the gluteal region.

In exceptional cases, the vaccine may be given subcutaneously in patients with thrombocytopenia or a tendency to bleed, such as patients with hemophilia. It is known that with subcutaneous administration of vaccines against hepatitis B, there is a lower level of antibody production. There is also anecdotal evidence that with the introduction of aluminum-adsorbed vaccines, local reactions at the injection site, including the development of subcutaneous nodular seals, were more often noted. Therefore, Recombivax HB should only be administered subcutaneously to patients with a bleeding tendency.

The vaccine is used as supplied. The vaccine vial must be gently mixed to obtain a white, opaque solution. Parenteral preparations should be visually inspected for particulate matter and discoloration prior to administration. The drug is not suitable for use in the presence of particles or discoloration.

Groups at increased risk of hepatitis B infection

contact persons in HBV foci for the prevention of sexual and domestic transmission

medical workers (doctors, paramedical and junior medical personnel) of medical organizations, regardless of ownership

persons studying in organizations of secondary and higher education of a medical profile, regardless of ownership

recipients of blood, its components and preparations, regardless of the frequency of transfusion

newly diagnosed HIV-infected

newly identified persons subject to hemodialysis and transplantation of tissues and (or) organs (parts of organs), regardless of the multiplicity

oncohematological patients, as well as patients receiving immunosuppressive drugs, who, due to a weak immune response, are given a double dose of the vaccine and an additional revaccination is carried out six months after the vaccination is completed

police officers, firefighters, military personnel who, due to work or lifestyle, may be exposed to HBV

Official recommendations for HBV vaccination should be followed and the prescribing information for hepatitis B immunoglobulin should be carefully read before vaccination for patients at risk of HBV infection, including newborns born to infected mothers or those exposed to the risk of infection through broken mucous membranes or skin. . If necessary, the Recombivax HB vaccine and immunoglobulins are administered intramuscularly in different parts of the body in the near future after contact; in newborns, injections can be given in the anterolateral thigh of the various lower extremities. The appointment of additional doses of Recombivax HB to complete the vaccination schedule should be carried out according to official recommendations.

Booster dose

The duration of the protective effect of the Recombivax HB vaccine in healthy patients and the need for a booster dose have not been established, therefore, the decision to administer a booster dose or revaccination after completion of the primary vaccination in healthy patients is made on the basis of local recommendations.

Side effects

Side effects that occurred with a frequency of ˃1%

irritation, fever, diarrhoea, fatigue/weakness, loss of appetite, rhinitis

Side effects that occurred with a frequency of ≥1%

soreness, pain, induration, pruritus, erythema, ecchymosis, swelling, sensation of warmth, nodules

headache, fever (˃37.7 °C), malaise

pharyngitis, upper respiratory infections

Side effects that occurred with frequency< 1%

sweating, malaise, fever sensation, dizziness, chills, hot flashes

vomiting, abdominal pain and cramps, dyspepsia

flu, cough

vertigo/dizziness, paresthesia

itching, rash (not specific), angioedema, urticaria

arthralgia, including single lesions, myalgia, pain in the back, neck, shoulders, occipital region

lymphadenopathy

insomnia / sleep disorders

ear pain

arterial hypotension

Post marketing data

hypersensitivity reactions, including anaphylactic and anaphylactoid reactions, bronchospasm, urticaria; immediate-type hypersensitivity, including manifestations of serum sickness; delayed-type reactions, including arthralgia/arthritis (transient), fever; skin manifestations including urticaria, erythema multiforme, ecchymosis, erythema nodosum; autoimmune diseases, including systemic lupus erythematosus (SLE), lupus-like syndrome, vasculitis, polyarteritis nodosa

increased liver enzymes, constipation

Guillain-Barré syndrome, multiple sclerosis, exacerbation of multiple sclerosis, myelitis, including transverse myelitis, convulsions, febrile convulsions, peripheral neuropathy, including Bell's palsy, radiculopathy, herpes zoster, migraine; muscle weakness, hypoesthesia; encephalitis

Stevens-Johnson syndrome, alopecia, petechiae, eczema

arthritis, pain in limbs

increased erythrocyte sedimentation rate; thrombocytopenia

irritability, agitation, drowsiness

neuritis; noise in ears; conjunctivitis; impaired visual acuity; uveitis

fainting, tachycardia

Contraindications

Drug Interactions

Recombiwax HB can be administered:

together with immunoglobulin against hepatitis B, in different parts of the body;

to complete the primary vaccination course if other hepatitis B vaccines have been previously used;

together with other vaccines, in different parts of the body and with separate syringes.

special instructions

As with any injectable vaccine, an emergency shock kit should be available in the event of an anaphylactic reaction to the vaccine.

This vaccine contains trace levels of formaldehyde and potassium thiocyanate, which are used in the manufacturing process, so hypersensitivity reactions may develop.

The needle cap and syringe plunger are made from dry natural rubber (a by-product of latex), which can cause allergic reactions in people who are sensitive to latex.

Vaccination of newborns born at a gestational age of less than 28 weeks, especially newborns with a history of respiratory failure, is associated with an increased risk of developing sleep apnea and requires monitoring of pulmonary function within 48 to 72 hours. However, the benefits of vaccination for this group of patients are quite high, so vaccination should not be canceled or postponed.

Factors that reduce the immune response to the vaccine are: older age, male gender, obesity, smoking, improper method of vaccine administration and the presence of underlying chronic diseases. It is necessary to monitor the level of specific antibodies in patients at risk of lack of an immunological response after primary vaccination. Immunocompromised patients or those receiving immunosuppressive therapy have a less pronounced immune response to vaccines than healthy individuals, so higher doses of the vaccine should be considered in such patients. It is also necessary to consider the possibility of introducing additional doses in such patients.

If HBV infection has already occurred before vaccination and latent infection is not diagnosed due to the long incubation period, the vaccine may not prevent hepatitis B. The vaccine does not protect against hepatitis A, C, E and other infections that affect the liver.

The delta virus that causes hepatitis D is pathogenic only in the presence of the hepatitis B virus, so vaccination with Recombivax HB also prevents the development of the hepatitis D virus.

Pregnancy and lactation

There are no clinical data on the use of Recombivax HB in pregnant and lactating women, and the effect on fertility has not been studied.

The vaccine is used only when the potential benefit to the pregnant woman justifies the potential risk to the fetus. At this time, there are no clinical data on the use of Recombivax HB in nursing mothers.

Features of the influence of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

Studies of the effect of the drug on the ability to drive vehicles or work with other mechanisms have not been conducted. . However, the development of any effect of the vaccine on the ability to drive vehicles or work with complex mechanisms is not expected.

Overdose

According to reports of accidental overdose, the profile of adverse reactions is comparable to that of the vaccine at recommended doses.

Release form and packaging

Composition and form of release of the drug

1 ml (1 dose) - ampoules (10) - blisters (5) - cardboard packs.
1 ml (1 dose) - bottles (50) - packs of cardboard.
10 ml (10 doses) - bottles (50) - packs of cardboard.

pharmachologic effect

Against hepatitis B. Promotes the development of immunity against the hepatitis B virus. It is a purified basic surface antigen of the 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 virus B. HBsAg was purified from yeast cells using several sequentially applied physicochemical methods.

HBsAg spontaneously transforms into 20 nm diameter spherical particles containing non-glycosylated HBsAg polypeptides and a lipid matrix composed primarily 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

Conducting active immunization of children and adults against hepatitis B, especially those at risk of infection with the hepatitis B virus.

Hepatitis B active immunization in low-incidence areas is recommended for newborns and adolescents, as well as those at increased risk of infection, such as:

children born to mothers who are carriers of the hepatitis B virus;
personnel of medical and dental institutions, including employees of clinical and serological laboratories;
patients undergoing or planning to transfuse blood and its components, elective surgical interventions, invasive medical and diagnostic procedures;
persons who have an increased risk of disease associated with their sexual behavior;
drug addicts;
persons traveling to regions with a high prevalence of hepatitis B;
children in regions with high prevalence of hepatitis B;
patients with chronic and carriers of the hepatitis C virus;
patients with sickle cell anemia;
patients undergoing organ transplantation;
people who abuse alcohol;
persons who have 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 the hepatitis B virus.

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

Contraindications

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

Dosage

The vaccine is used in accordance with the immunization scheme adopted in the country.

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

Side effects

Local reactions: slight soreness, erythema and induration at the injection site.

From 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 - 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 of these complications with vaccination has not been established.

From the digestive system: rarely - nausea, vomiting, diarrhea, 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 - syncope, arterial hypotension, vasculitis.

Others: in some cases - thrombocytopenia, bronchospasm.

Adverse reactions are mild and transient. In many cases, the causal relationship of side effects with the introduction of the vaccine has not been established.

special instructions

Due to the long incubation period of hepatitis B, latent hepatitis B virus infection may occur during the course of vaccination. In such cases, the vaccine cannot prevent hepatitis B.

The vaccine does not prevent infections caused by other pathogens, such as hepatitis C and hepatitis E, and pathogens that cause other liver diseases.

The immune response to vaccination is associated with various factors, incl. age, sex, obesity, smoking and route of administration of the vaccine. Usually, in people over 40 years of age, the humoral immune response is less pronounced, so additional doses of the vaccine may be required in such patients.

In patients on hemodialysis, in HIV-infected patients and in individuals 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.

When administering the vaccine, it is necessary to have funds available that may be required in the event of anaphylactic reactions. Allergic reactions can develop immediately after the introduction of the vaccine, and therefore vaccinated patients should be under medical supervision for 30 minutes.

In the presence of an infectious disease in a mild form, vaccination can be carried out immediately after the temperature returns to normal.

For impaired liver function

The drug is used for active immunization of children and adults against hepatitis B. The vaccine does not prevent infections caused by other pathogens, such as hepatitis A, hepatitis C and hepatitis E, as well as pathogens that cause other liver diseases.

Use in the elderly

Usually, in people over 40 years of age, the humoral immune response is less pronounced, so additional doses of the vaccine may be required in such patients.

CJSC Combiotech, Russia

Release form:
1 ampoule / 1 dose / 1 ml No. 10 for adults over 19;
1 ampoule / 1 dose / 0.5 ml No. 10 for children and adolescents up to 19 years of age inclusive.
Vaccination schedule:
0 day - 1 month - 6 months.

Instructions for use

Registration certificate holder:

KOMBIOTECH NPK, CJSC (Russia)

Active ingredient: recombinant hepatitis B vaccine (hepatitis B vaccine (rDNA))
Ph.Eur. European Pharmacopoeia

Dosage form

reg. No.: Р N000738/01 dated 11/19/07 - Indefinitely

Release form, composition and packaging

0.5 ml (1 dose) without preservative - ampoules (10) - contour plastic packaging (1) - cardboard packs.
0.5 ml (1 dose) with a preservative - ampoules (10) - contour plastic packaging (1) - cardboard packs.
Clinico-pharmacological group: Hepatitis B vaccine
Pharmacotherapeutic group: MIBP vaccine
The provided scientific information is general and cannot be used to make a decision on the possibility of using a particular medicinal product.

pharmachologic effect

Hepatitis B vaccine. Promotes immunity against the hepatitis B virus. It is a purified basic surface antigen of the 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 sequentially applied physicochemical methods.

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

Indications

Conducting active immunization of children and adults against hepatitis B, especially those at risk of infection with the hepatitis B virus.
Hepatitis B active immunization in low-incidence areas is recommended for newborns and adolescents, as well as those at increased risk of infection, such as:

children born to mothers who are carriers of the hepatitis B virus;
personnel of medical and dental institutions, including employees of clinical and serological laboratories;
patients undergoing or planning to transfuse blood and its components, elective surgical interventions, invasive medical and diagnostic procedures;
persons who have an increased risk of disease associated with their sexual behavior;
drug addicts;
persons traveling to regions with a high prevalence of hepatitis B;
children in regions with high prevalence of hepatitis B;
patients with chronic hepatitis C and hepatitis C virus carriers;
patients with sickle cell anemia;
patients undergoing organ transplantation;
people who abuse alcohol;
persons who have 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 the hepatitis B virus.

Dosing regimen

The vaccine is used in accordance with the immunization scheme adopted in the country.
The dose of the vaccine depends on the age of the patient.

Side effect

Local reactions: slight soreness, erythema and induration at the injection site.
From 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 of these complications with vaccination has not been established.
From 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 - syncope, arterial hypotension, vasculitis.
Others: in some cases - thrombocytopenia, bronchospasm.
Adverse reactions are mild and transient. In many cases, the causal relationship of side effects with the introduction of the vaccine has not been established.

Contraindications for use

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

Application for violations of liver function

Use in elderly patients

Usually, in people over 40 years of age, the humoral immune response is less pronounced, so additional doses of the vaccine may be required in such patients.

special instructions

Due to the long incubation period of hepatitis B, latent hepatitis B virus infection may occur during the course of vaccination. In such cases, the vaccine cannot prevent hepatitis B.

The vaccine does not prevent infections caused by other pathogens, such as hepatitis A, hepatitis C, and hepatitis E, as well as pathogens that cause other liver diseases.

Polio - symptoms, consequences, how not to get infected

Poliomyelitis is an acute infectious human disease, which is accompanied by damage to the nervous system, the development of paresis and paralysis. Poliomyelitis mainly affects children under 5 years of age. 1 in 200 infections results in permanent paralysis. Among those paralyzed, 5% to 10% die when their breathing muscles become immobile.

Many parents panic, confusing rotavirus, dysentery and poisoning. Doctors warn that one of the main differences is chair character.

This article was the result of an incredible effort by a group of ordinary people working around the clock to find all the relevant studies to structure them into a coherent whole if it can help others process all the information available about the coronavirus.