Vaccine against viral hepatitis in instructions. Hepatitis B vaccine: instructions

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

Characteristic

This drug is used to immunize the population against hepatitis B category, including children under one year of age and newborns. The regimen consists of 3 or 4 vaccinations, depending on the period in which immunity must be formed. Fully completed 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 clinic to both newborns and adults wishing to undergo scheduled/unscheduled vaccination. Each batch of the drug is tested on animals before being put into use.

The main active component in this vaccine is the surface antigen HBsAg, also called the Australian antigen. It is this that destroys the protein of the hepadnavirus (the virus that causes hepatitis) that has entered the blood. The antigen is created on the basis of a recombinant strain of a species of bread yeast, from which it is subsequently released by physical or chemical methods. This method of producing antigen 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 vaccine components or an allergy after the first vaccination, you should discuss changing the drug with your doctor.

Compound

The main components of the vaccine:

HBsAg antigen, 20 μg/ml - the main component of the vaccine;
aluminum hydroxide, 50 mg/ml;
merthiolate, 50 mcg/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 in the form of a liquid suspension for intramuscular injection. The solution is colorless, with a white precipitate that breaks easily when shaken. The drug is produced in glass medical ampoules with a volume of 0.5 or 1 ml, which corresponds to one pediatric and one adult dose. The vaccine is packaged 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 or placed in direct sunlight. The recombinant yeast liquid vaccine against hepatitis B is quite sensitive to storage conditions - if left at room temperature for more than two days, the drug loses half of its effectiveness. The opened drug is used within one hour or discarded. Frozen ampoules or ampoules with a discolored solution that does not break into sediment should be disposed of without opening.

The ampoule must be opened immediately before vaccination; the opened drug should not be 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%. Lasting immunity to the virus lasts for at least 20 years, after which repeated vaccination is required.

There are three hepatitis vaccination schemes:

standard 0-1-6 of three vaccinations;
accelerated 0-1-2-12, serves for faster formation of immunity, however, one additional vaccination is required for consolidation;
emergency vaccination is carried out 2 weeks in advance according to the scheme 0-7-21-12, where the first three numbers indicate the day of vaccination in order, and the last - the final 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 has an allergy to yeast, it is better to refrain from using this vaccine, or conduct a full examination. Vaccination against hepatitis is also prohibited for people who have recently suffered acute respiratory diseases or exacerbations of severe chronic diseases. After vaccination, mild general and local reactions are acceptable, for example, a short-term increase in temperature or a papule at the vaccination site.

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

Hepatitis B is a disease that has a detrimental effect on the liver, so the hepatitis B vaccine, instructions for administration of which are known to every medical worker, is becoming increasingly popular.

Today, there are 6 main drugs for administering the hepatitis B vaccine, all of these drugs are interchangeable because they contain the same components.

Vaccination against viral hepatitis has been carried out for more than 30 years. Moreover, the effect of the main part of vaccines is based on the introduction of a surface-type antigen - HBsAg - into the body.

The first vaccine to combat the virus was obtained from the plasma of infected people in 1982 in China. The drug for administering the vaccine gained particular popularity and began to be used all over the world, but in the late 80s the product was withdrawn from production due to the increased risk of developing neuralgic diseases.

The next type of drugs was developed in 1987 and is still used today - these are recombinant drugs.

The use of genetic engineering technologies in the process of creating the drug made it possible to reduce the risk of viruses entering the body.

Today, there are the following 6 types of hepatitis B vaccines, the recommendations for their use are identical:

Regevak B - produced by Binnopharm in Russia;
vaccine to combat HBV (viral hepatitis B) - the manufacturing country is Russia, the company is Microgen;
H-B-VAX ll is a product produced in the USA;
recombinant type of drugs to combat HBV - the product is produced in Russia by the Combiotech company;
Engerix B is a drug being developed in the UK;
Eberbiovak NV is a vaccine created within Cuba.

In our country, vaccines made by foreign scientists are more popular.

It is noted that the vaccine against hepatitis B contains a number of the following elements (more details about them can be found in the instructions for use of the drug):

20-25 milligrams of surface type antigen;
0.5 milligrams of adjuvant, presented in the form of aluminum hydroxide;
50 mcg merthiolate (basic type of preservative).

There are a number of drugs that do not contain merthiolate; these are the vaccines that are recommended for use when vaccinating infants.

It was noted that during storage of the vaccine, it separates into a loose white precipitate and a colorless solvent. If the preparation is shaken, it will return to a homogeneous state.

The release of drugs for vaccination is carried out in glass ampoules with one or half doses. A full dose of the drug (1 milligram) is used to vaccinate adults, half a dose (0.5 milligrams) is used to vaccinate infants or small children.

One pack of the drug contains 10 ampoules of hepatitis B vaccine and an insert with instructions for use.

The ampoules should be stored in a room with a temperature range from +2 to +8 degrees. Short-term storage of the drug is allowed at temperatures up to +29 degrees (the period of such storage should not exceed 3 days).

Storing such drugs in the refrigerator, and even more so in the freezer, is strictly prohibited.

If the vaccine is stored in accordance with all rules and regulations, then it is suitable for use for 3 years.

vaccination is carried out to all healthy newborns when they reach the age of one month to six months;
people who are in constant contact with an infected person;
children living in an orphanage or boarding school;
patients who need to regularly undergo blood transfusions associated with blood pathologies;
people with chronic renal failure (CKD);
persons suffering from cancer;
medical workers;
people directly involved in the production of blood products or immunobiological drugs;
students of higher medical educational institutions;
addicted to drugs.

In addition, according to a number of guidelines, the vaccine can be used by other members of the population who express a desire to prevent the virus from entering their body.

As for contraindications to hepatitis B vaccination, according to information received from doctors, it is strictly prohibited for use in the following cases:

If you have an allergic reaction to any of the components of the vaccine;
In the case of the presence of an acute form of various diseases, in such a situation vaccination should be postponed until complete recovery or the disease goes into remission.
Exacerbation of existing chronic diseases. In this case, vaccination is allowed no earlier than a month after the disease enters the remission stage.

As for vaccinating pregnant women, in this case the vaccine can be used only when there is a very high probability of infection with hepatitis B.

The vaccine to combat hepatitis B, according to the instructions, is injected into the muscle. The injection site for adults and adolescents is the deltoid muscle of the shoulder; for the prevention of childhood hepatitis B, the drug is administered to the outer thigh.

Injecting the vaccine into a vein or into the buttocks is strictly prohibited.

As a rule, vaccination is carried out according to the following scheme:

first dose - an adult independently selects a convenient vaccination date; as for newborns, they are vaccinated in the first 12 hours after birth;
second dose - injected one month after the first vaccination;
the third dose is administered six months after the initial vaccination.

In addition, after every five years, a person needs to undergo revaccination - a one-time administration of the vaccine, which helps to increase all the protective functions of the body.

If for some reason the period between the first and second vaccination is more than a month, then the time of administration of the third vaccination must be adjusted.

When hepatitis B vaccine is administered, instructions for emergency vaccination are as follows:

first vaccination – date selected by the patient;
second vaccination - performed 30 days after the first;
third vaccination - carried out two months after the initial administration of the drug;
fourth vaccination - 14 months after the first dose of the vaccine.

As for revaccination, it is allowed to be carried out no earlier than 5 years after the last dose of the drug was administered.

There is also a special vaccination regimen intended only for patients with chronic renal failure:

the initial administration of the vaccine is carried out at any time convenient for the patient;
the second dose of the vaccine is administered a month after the first;
the third dose of the drug is used 2 months after the initial administration of the vaccine;
The fourth vaccination is performed 3 months after the first.

However, selecting a suitable drug administration regimen is not everything; in order to prevent the virus from entering the body to be successful, a number of requirements must be met:

Each administration of the drug should be carried out with a new syringe.
Before and after inserting the syringe, the vaccination site should be treated with 70% alcohol.
Before introducing the vaccine into the human body, it is imperative to check the condition of the ampoule with the drug. In this case, more attention should be paid to checking the expiration date of the medicine, as well as its labeling.
During the procedure, all rules of asepsis and antisepsis must be observed.
After opening the ampoule, it must be used immediately; further storage of the drug in this form is prohibited.

Compliance with these simple requirements guarantees successful vaccination.

Even if the hepatitis B vaccine was administered according to the instructions, a number of side effects cannot be ruled out.

Among the most common side effects after vaccination are the following:

painful sensation and development of inflammation in the area where the vaccine was administered;
deterioration of general condition, constant feeling of weakness;
the occurrence of severe pain in the joints;
pain in the skeletal muscles;
severe headaches;
feeling of nausea, vomiting;
aching painful sensations in the abdominal area.

As a rule, all the symptoms presented are not very pronounced and disappear after 2-3 days.

There are situations when a person becomes ill immediately after receiving the vaccine, which is why it is recommended that the person stay within the hospital setting for half an hour after administering the drug.

In the rooms where the drug is administered, anti-submarine equipment must be present in the event of anaphylactic shock.

It is noted that the risk of side effects increases in the following cases:

over the age of 40;
if you are overweight;
in case of alcohol and cigarette abuse;
with parallel immunosuppressive therapy;
in case of diagnosis of chronic renal failure.

There are always risks of side effects, but this is not a reason to refuse a vaccination, which, if all instructions for administration and dosage are followed, can save your life.

There are a huge number of ways to become infected with hepatitis B, so it is better to protect yourself in advance rather than spend money and effort on treatment later. Taking care of your health should be above all else.

INN: Hepatitis B vaccine

Manufacturer: Merc Sharp and Dome Corp.

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

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

Registration period: 14.08.2015 - 14.08.2020

Instructions

Tradename

Recombivax HB, hepatitis B vaccine, recombinant

International nonproprietary name

Dosage form

Suspension for injection, 5 µg/0.5ml, 10 µg/1.0ml

Compound:

One dose of the vaccine contains

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

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

Description

White opaque solution

Pharmacotherapeutic group

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

ATX code J07BC01

Pharmacological properties

Pharmacokinetics

Pharmacokinetic studies are not required for vaccines.

Pharmacodynamics

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

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

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

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

Clinical studies in neonates using different dosing regimens or co-administration of vaccines found protective antibody levels to be produced in 97.5% and 97.2%, respectively, and mean specific antibody levels of 214 IU/L and 297 IU/L, respectively. Other clinical studies conducted among adolescents and adults showed that protective antibody levels after vaccination were achieved in 95.6-97.5% of vaccinated patients and the level of specific antibodies was 535-793 IU/L.

The protective efficacy in newborns (n=130) born from HBsAg and HBeAg positive mothers when administered immunoglobulin against hepatitis B at birth and subsequent vaccination in 3 stages was 95%.

Although the duration of immunological memory in response to vaccination is unknown, observation of 3,000 high-risk patients for 5-9 years after vaccination did not reveal the development of clinical cases of hepatitis B. Development of specific antibodies (HBV surface antigen HBsAg) after administration of 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 caused by all known subtypes of hepatitis B virus in persons at risk of acquiring hepatitis B

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

Directions for use and doses

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

Children and adolescents from the neonatal period to 15 years

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

For newborn children, vaccination is carried out according to the schedule 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 old who are not vaccinated at birth, vaccination is carried out according to the schedule 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 over one year old who were not vaccinated at birth, vaccination is carried out according to the schedule of 0, 1, 6 months with intervals between the first and second vaccinations of 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 preliminary marker diagnosis for the presence of HBV. Persons with a positive test result for HBV are not allowed to receive 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 a schedule 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 the Recombivax HB vaccine is administered intramuscularly using a sterile syringe and needle.

Do not administer intravenously or intradermally!

The Recombivax HB vaccine is administered by intramuscular injection into the deltoid muscle of the shoulder in adults, adolescents and children over 1 year of age and into the anterolateral thigh in children under 1 year of age. In children over 1 year of age, the vaccine should be administered to the deltoid muscle area only if anatomical development is sufficient for intramuscular injection. When the vaccine is administered in the gluteal region, a low rate of seroconversion is observed, therefore the Recombivax HB vaccine is not recommended for administration in the gluteal region.

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

The vaccine is used as provided. The vial of vaccine must be carefully mixed to obtain a white, opaque solution. Before administration, parenteral drugs must be visually inspected for the presence of mechanical particles and discoloration. The drug is unsuitable for use if particles or color changes are present.

Groups at increased risk of hepatitis B infection

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

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

persons studying in secondary and higher medical education organizations, regardless of their form of ownership

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

newly diagnosed HIV-infected people

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 additional revaccination is carried out six months after completed vaccination

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

It is necessary to follow official recommendations for vaccination for HBV and carefully read the instructions for medical use of hepatitis B immunoglobulin before vaccination for patients at risk of HBV infection, including newborns born to infected mothers, or persons exposed to the risk of infection through damaged mucous membranes or skin. . If necessary, the Recombivax NV vaccine and immunoglobulins are administered intramuscularly into different parts of the body in the near future after contact; in newborns, injections can be given into the anterolateral thigh of different lower extremities. Additional doses of Recombivax NV to complete the vaccination regimen should be administered in accordance with official recommendations.

Booster dose

The duration of the protective effect of the Recombivax NV 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 primary vaccination in healthy patients is made based on local recommendations.

Side effects

Side effects that occurred with a frequency of ˃1%

irritation, fever, diarrhea, fatigue/weakness, decreased appetite, rhinitis

Side effects that occurred with a frequency of ≥1%

soreness, pain, induration, itching, erythema, ecchymosis, swelling, warmth, nodule formation

headache, fever (˃37.7 °C), malaise

pharyngitis, upper respiratory tract infections

Side effects that occurred with frequency< 1%

sweating, malaise, feeling of fever, dizziness, chills, hot flashes

vomiting, abdominal pain and cramps, dyspepsia

flu, cough

vertigo/dizziness, paresthesia

itching, rash (non-specific), angioedema, urticaria

arthralgia, including single injuries, 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 hypersensitivity, including manifestations of serum sickness; delayed 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 enzyme levels, constipation

Guillain-Barré syndrome, multiple sclerosis, exacerbation of multiple sclerosis, myelitis, including transverse myelitis, seizures, febrile seizures, 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

Recombivax HB can be administered:

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

to complete the course of primary vaccination if other vaccines against hepatitis B have previously been 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, and may cause hypersensitivity reactions.

The needle cap and plunger of the syringe are made of dry natural rubber (a latex by-product), which may cause allergic reactions in latex-sensitive individuals.

Vaccination of newborns born at less than 28 weeks' gestation, especially those with a history of respiratory failure, is associated with an increased risk of apnea and requires monitoring of pulmonary function for 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 include: older age, male gender, obesity, smoking, incorrect 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. In patients who are immunocompromised or receiving immunosuppressive therapy, the immune response to vaccines is less pronounced than in healthy people, so higher doses of the vaccine should be considered in these patients. It is also necessary to consider the possibility of administering additional doses to such patients.

If HBV infection has already occurred before vaccination and latent infection is not diagnosed due to the length of the 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 hepatitis B virus, therefore vaccination with Recombivax HB also prevents the development of 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 effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

No studies have been conducted on the effect of the drug on the ability to drive vehicles or operate other machinery. . However, the vaccine is not expected to have any effect on the ability to drive vehicles or operate complex machinery.

Overdose

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

Release form and packaging

JSC "Combiotech", Russia

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

Instructions for use

Registration Certificate Holder:

COMBIOTECH NPK, JSC (Russia)

Active substance: recombinant 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 preservative - ampoules (10) - contour plastic packaging (1) - cardboard packs.
Clinical and pharmacological group: Vaccine for the prevention of hepatitis B
Pharmacotherapeutic group: MIBP vaccine
The scientific information provided is general and cannot be used to make a decision about the possibility of using a particular drug.

pharmachologic effect

Hepatitis B vaccine. Promotes the development of immunity against the hepatitis B virus. It is a purified main 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 is purified from yeast cells using several sequentially applied physicochemical methods.

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 at a titer of 10 IU/l prevent hepatitis B disease.

Indications

Conducting active immunization of children and adults against hepatitis B, primarily those at risk of infection with the hepatitis B virus.
Active immunization against hepatitis B in areas with low incidence is recommended for newborns and adolescents, as well as people at increased risk of infection, which include:

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 a transfusion of blood and its components, planned surgical interventions, invasive therapeutic and diagnostic procedures;
persons whose increased risk of disease is associated with their sexual behavior;
drug addicts;
persons traveling to regions with widespread hepatitis B;
children in regions with widespread hepatitis B;
patients with chronic hepatitis C and carriers of the hepatitis C virus;
patients with sickle cell anemia;
patients planning organ transplantation;
persons 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 reasons, may be infected with the hepatitis B virus.

Conducting active immunization against hepatitis B in areas with a medium 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 groups listed above) for all children and newborns, as well as adolescents and young adults.
ICD-10 codes

Dosage 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 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 the cause-and-effect relationship of these complications with the vaccine has not been established.
From the digestive system: rarely - nausea, vomiting, diarrhea, abdominal pain, changes in liver function tests.
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.
Others: in some cases - thrombocytopenia, bronchospasm.
Adverse reactions are mild and transient. In many cases, the cause-and-effect relationship of adverse events with the administration 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 previous administration of hepatitis B vaccines.

Use for liver dysfunction

The drug is used to actively immunize 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, or pathogens that cause other liver diseases.

Use in elderly patients

Typically, people over 40 years of age have a less robust humoral immune response, so these patients may require additional doses of the vaccine.

special instructions

Due to the long incubation period of hepatitis B, it is possible to have a latent infection with the hepatitis B virus during the course of vaccination. In such cases, the vaccine may not prevent hepatitis B disease.

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

The immune response to vaccination is associated with various factors, incl. age, gender, obesity, smoking and method of vaccine administration. Typically, people over 40 years of age have a less robust humoral immune response, so these patients may require additional doses of the vaccine.

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

When administering a vaccine, it is necessary to have on hand supplies that may be needed if anaphylactic reactions occur. Allergic reactions can develop immediately after administration of the vaccine, and therefore vaccinated patients should be under medical supervision for 30 minutes.

Poliomyelitis - symptoms, consequences, how not to get infected

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Many parents panic, confusing rotavirus, dysentery and poisoning. Doctors warn that one of the main differences is stool 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 research to structure it into a coherent whole if it could help others process all the information available about the coronavirus.

Dosage form:

suspension for intramuscular administration

Compound:

Components	1 dose for children (0.5 ml) contains	1 dose for adults (1 ml) contains
Active substance:
Hepatitis B surface antigen (HBsAg) purified
Excipients:
Aluminum (Al+3) hydroxide	0.25 mg in terms of aluminum	0.5 mg in terms of aluminum
Thiomersal

The vaccine does not contain any substrates of human or animal origin.

The vaccine meets WHO requirements for recombinant hepatitis B vaccines.

Description:

A homogeneous suspension of white color with a gray tint, without visible foreign inclusions, when settling, it separates into 2 layers: the upper one is a colorless, transparent liquid, the lower one is a white sediment, easily broken when shaken.

Pharmacotherapeutic group: MIBP - ATX vaccine:

J.07.B.C.01 Hepatitis B virus - purified antigen

Pharmacodynamics:

The vaccine is a purified surface antigen of the hepatitis B virus (HBsAg) adsorbed on an aluminum hydroxide gel.

The surface antigen is obtained by cultivating genetically modified yeast cells Hansenula polymorpha K 3/8-1 ADW 001/4/7/96, into which the surface antigen gene is integrated.

Immunobiological properties

The vaccine causes the formation of specific antibodies to the hepatitis B virus and thereby stimulates the development of immunity to hepatitis B.

Indications:

Specific prevention of infection caused by the hepatitis B virus in children aged 1 year and older and adults.

Contraindications:

Pregnancy and breastfeeding period;

Hypersensitivity to the hepatitis B vaccine and its components - yeast or thiomersal;

Symptoms of hypersensitivity to previous administration of hepatitis B vaccine;

Severe reaction (temperature above 40 °C, swelling at the injection site, hyperemia over 8 cm in diameter) or a post-vaccination complication to a previous administration of the drug;

Acute infectious and non-infectious diseases, exacerbation of chronic diseases. Vaccination is carried out 2-4 weeks after recovery (remission). For mild ARVI and acute intestinal diseases, vaccinations are carried out immediately after the temperature has normalized;

Severe and severe immunodeficiency in children with HIV infection. HIV infection is not a contraindication to hepatitis B vaccination.

Children of the first year of life :

When vaccinating against hepatitis B in children of the first year of life, vaccines that do not contain preservatives are used.

Persons temporarily exempt from vaccinations should be monitored and vaccinated after the contraindications are lifted.

Pregnancy and lactation:Contraindicated. Directions for use and dosage:

Before use, the vial (ampoule) with the vaccine must be shaken well several times until a homogeneous suspension is obtained.

The vaccine is administered intramuscularly:

For young children (1-2 years) - in the upper outer surface of the middle part of the thigh;

Adults, teenagers and older children (over 2 years old) - into the deltoid muscle.

For patients with bleeding disorders, the vaccine should be administered subcutaneously.

It is prohibited to administer the vaccine intravenously!

When administering the vaccine, you should make sure that the needle does not enter the vascular bed. The drug from an opened bottle with 10 doses of the vaccine must be stored at a temperature of 2-8 0 C and used within one day.

A single dose of the vaccine is:

-for children from 1 year old, teenagers and persons under 19 years old- 0.5 ml (10 µg HBsAg);

-for persons over 19 years old- 1 ml (20 µg HBsAg).

Vaccination against viral hepatitis B for persons not previously vaccinated and not at risk, is carried out in accordance with the National calendar of preventive vaccinations of the Russian Federation and the calendar of preventive vaccinations for epidemic indications (Order of the Ministry of Health of Russia dated March 21, 2014 No. 125n) according to the 0-1-6 scheme (1st dose at the start of vaccination, 2nd dose - 1 month after the 1st dose, 3rd dose - 6 months after the 1st dose).

Children at risk(born from mothers who are carriers of HBsAg, patients with viral hepatitis B or who have had viral hepatitis B in the third semester of pregnancy, who do not have test results for markers of hepatitis B, who consume narcotic drugs or psychotropic substances, from families in which there is a carrier of HBsAg or a patient with acute viral hepatitis B and chronic viral hepatitis) vaccination is carried out according to the 0-1-2-12 scheme (1st dose at the start of vaccination, 2nd dose 1 month after the 1st dose, 3rd dose after 2 months after the 1st dose, the 4th dose - 12 months after the 1st dose).

Contact persons from the outbreaks of the disease who have not been sick, have not been vaccinated and do not have information about preventive vaccinations against viral hepatitis B are subject to vaccination according to the 0-1-6 scheme.

Vaccinations against hepatitis B according to the 0-1-6 scheme are also subject to:

Children and adults who regularly receive blood and its preparations;

Oncohematological patients;

Medical workers who have contact with the blood of patients;

Persons involved in the production of immunological preparations from donor and placental blood;

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

Persons who inject drugs.

Patients receiving hemodialysis treatment, the vaccine is administered four times according to the scheme: 0-1-2-6 or 0-1-2-3 at a double age dose

Unvaccinated persons who have been exposed to hepatitis B virus-infected material should vaccination is carried out according to the 0-1-2 scheme. Simultaneously with the first vaccination, it is recommended to administer intramuscularly (to another place) human immunoglobulin against hepatitis B at a dose of 100 IU (children under 10 years old) or 6-8 IU/kg (other ages).

Unvaccinated patients scheduled for surgery, it is recommended to vaccinate according to the 0-7-21 day schedule one month before surgery.

Side effects:

World Health Organization (WHO) classification of the incidence of side effects:

Very common: ≥1/10

Common: ≥ 1/100 to<1/10

Uncommon: ≥ 1/1000 to<1/100

Rare: ≥ 1/10,000 to<1/1000

Very rare: from< 1/10 000

During clinical and post-marketing studies of the recombinant hepatitis B vaccine (rDNA), the following adverse reactions were identified:

From the nervous system:

Often: headache.

Rarely: dizziness.

From the respiratory, pulmonary and mediastinal systems:

Common: pneumonia, cough, chills.

From the skin and subcutaneous tissue:

Rarely: rash.

From the musculoskeletal system, connective and bone tissue:

Rarely: pain throughout the whole body.

Adverse reactions, general and at the injection site

Very common: fever, pain at the injection site.

Common: prolonged crying, local induration, local swelling, redness.

Rarely: nodular thickening at the injection site, local pain.

All these symptoms are transient and do not require drug treatment.

Interaction:

The vaccine can be prescribed simultaneously (on the same day) with vaccines of the National Preventive Vaccination Calendar, with the exception of vaccines for the prevention of tuberculosis, and with the vaccine against yellow fever. In this case, vaccines must be administered with different syringes to different parts of the body. The interval between vaccinations against different infections when administered separately (not on the same day) should be at least 1 month.

Special instructions:

The vaccination procedure must be carried out in strict compliance with the rules of asepsis and antiseptics. In very rare cases, immediate allergic reactions may develop; therefore, those vaccinated with the vaccine should be under medical supervision for 30 minutes after vaccination.

As with the administration of other parenteral vaccines, vaccination sites should be provided with anti-shock therapy, primarily adrenaline. Impact on the ability to drive vehicles. Wed and fur.:

The vaccine does not affect the ability to drive.

Release form/dosage:

Suspension for intramuscular administration, 20 mcg/ml.

Package: Serum Institute of India Ltd.

0.5 ml or 1 ml in ampoules and vials.

10 ampoules of 0.5 ml or 1 ml in a PVC blister, 5 blisters each along with 5 copies of the Instructions for Medical Use in a cardboard box.

50 bottles of 0.5; 1; 5 ml or 25 bottles of 10 ml along with 5 copies of Instructions for Medical Use in a cardboard box.

Horizontal blue stripes are applied to the ampoule or vial of the vaccine for children. An ampoule or vial containing 10 doses of vaccine for children is marked with horizontal red stripes.

Horizontal green stripes are applied to the ampoule or vial of the vaccine for adults. An ampoule or vial containing 10 doses of vaccine for adults is marked with horizontal purple stripes.

LLC "Nanolek"

10 ampoules of 1 ml in a PVC blister along with instructions for medical use in a cardboard box.

10 bottles of 1 ml along with Instructions for medical use in a cardboard box.

10 bottles of 10 ml each along with 10 copies of Instructions for Medical Use in a cardboard box.

Horizontal green stripes are applied on the label of a cardboard pack of ampoules or vials with 1 dose of vaccine for adults.

The label of a carton of vials containing 10 doses of vaccine for adults has horizontal purple stripes on the label.

Storage conditions:

In a place protected from light, at a temperature of 2 to 8 ° C. Keep out of the reach of children. Do not freeze.

Transportation conditions

In containers protected from light, at a temperature of 2 to 8 ° C. Do not freeze.

Best before date:

Do not use after the expiration date stated on the label.

Conditions for dispensing from pharmacies: For hospitals Registration number: LS-001140 Registration date: 15.08.2011 / 20.11.2015 Expiration date: Indefinite Owner of the Registration Certificate: India Manufacturer: Representative office: Serum Institute of India, Ltd. India Information update date: 06.02.2017 Illustrated instructions