Hepatitis B vaccine Engerix. Engeriks B. Eastern Administrative District

Hepatitis B is a viral disease that affects liver cells. As a result of the death of hepatocytes, symptoms of severe intoxication appear: jaundice, increased body temperature. Treatment of such a disease will be long and quite difficult. Often it develops into a chronic form. In order to prevent the onset of the disease, the use of the hepatitis B vaccine "Enjerisx B" is recommended. The main thing is to know the features of this drug and the rules for its use.

Composition and effect of the vaccine

Vaccination against hepatitis using the drug "Engerix B" helps the body develop immunity to the disease. The main component of the vaccine is the HBsAg virus antigen. It is produced using recombinant DNA technology, adsorbed with aluminum hydroxide.

After administration of the drug into the patient’s blood, specific humoral antibodies, as well as memory lymphocytes, are formed. They provide protection against the hepatitis B virus. Effectiveness is achieved after three injections. Experts say that full protection against the disease is achieved in 95% of cases.

If the rules for using the product are violated, the vaccine itself can provoke the development of the disease.

The hepatitis vaccine "Engerix B" is available in two forms: adult and pediatric. The preparation for adults contains 20 mcg of antigen. For children, the dosage is reduced exactly by half.

The vaccine contains as excipients:

• Aluminum hydroxide.
• Sodium hydrogen phosphate dihydrate.
• Sodium chloride.
• 2-Phenoxyethanol.
• Specially prepared water.

The vaccine is produced in the form of a white suspension. After prolonged storage it may delaminate. A white precipitate falls to the bottom. It must be shaken thoroughly before administration. The drug needs to be stored at the correct temperature and cannot be frozen.

The Engerix B vaccine is used in many countries. It is recommended to be used at a very young age.

Experts identify a group of people for whom it is extremely important to receive such a vaccination. These include:

• Children living in boarding schools or orphanages. In large groups of children, the virus can spread very quickly.
• A child born from a mother who is a carrier of hepatitis B.
• Babies born in regions with high rates of hepatitis.
• People who, due to their profession, have to come into contact with infected biological material, for example, employees of blood transfusion stations.
• Those who suffer from blood cancer.
• Adults and children regularly undergoing hemodialysis.
• Medical workers, as well as students of medical colleges and universities.
• Patients undergoing organ transplant surgery.
• Persons who are overly sexually active.
• People suffering from chronic liver diseases.

Manufacturers claim that one course of vaccination is enough to protect a person from the disease for 20 years. But studies show that lasting immunity is developed only for 8 years. Therefore, people at risk need to receive such vaccinations at certain intervals.

The need for a vaccine in each specific case should be discussed with your doctor.

Vaccination rules

The administration of the hepatitis B vaccine "Engerix B" must be carried out in accordance with certain rules. Their violation can provoke the development of a negative reaction of the body. The following recommendations must be followed:

• Children are advised to administer the drug intramuscularly. To do this, select an area on the front of the thigh. For adults, the injection is given in the deltoid muscle of the shoulder. Injecting the product into the gluteal region or subcutaneously does not give the desired effect.
• If the child was born on time, then he must be vaccinated in the first 12 months of life. In this case, the first injection is given at birth, the second at the age of 1 month, and the third at six months.
• For adults, a single dose of the drug is 1 ml. For children, 0.5 ml is enough.
• A child born to a mother infected with hepatitis needs four injections. The first of them is placed immediately after birth, the second - at the age of a month, the third - as soon as 2 months are completed, and the fourth at one year old.
• For people on hemodialysis, vaccinations are given at intervals of 30 days.
• Adults traveling to countries with high rates of hepatitis are given emergency vaccination. The second injection is given on the seventh day after the first, and the third - after another 14 days. After a year, revaccination is carried out.
• Before administering the drug, a healthcare professional should examine her carefully. There should be no foreign particles in it. It is necessary to check the expiration date of the drug.
• If a vial of vaccine is intended for several people, it must be used within one day. The vaccine is drawn into a disposable syringe in compliance with all safety precautions.

Read also on the topic

Ways and methods of infection with hepatitis B

No special preparation is required before vaccination. The drug is approved for use by Russian specialists.

Possible side effects of the vaccine

In some cases, the body may react negatively to the administration of the drug.

Side effects of the vaccine include:

• The appearance of pain in muscles and joints.
• Feeling of weakness, malaise, body temperature may rise.
• The skin puncture site may become red and swollen. Normally, such symptoms should subside after a few hours.
• A person may experience bouts of nausea for several hours after vaccination.
• Manifestation of an allergic reaction. Severe itching begins and a rash resembling hives forms. In severe cases, anaphylactic shock and Quincke's edema may develop.
• A negative reaction to the administration of the drug may also occur from the nervous system. Headaches, dizziness, sleep problems, and numbness of the limbs appear.
• In rare cases, thrombocytopenia or lymphadenopathy may develop.
• Development of symptoms resembling bronchospasms.
• A sharp decrease in blood pressure.

If you notice these symptoms after vaccination, consult your doctor. In some cases, side effects can be dangerous to your health and even life, so you should not ignore them.

Consult your doctor immediately before receiving the vaccine. During the examination, contraindications to the procedure may be identified.

How to behave after vaccination?

In order to reduce the likelihood of developing side effects from the vaccine, precautions must be taken. Follow these guidelines:

• Serious health problems can result from infection entering the body immediately after vaccination. To avoid this, it is necessary to minimize the time spent in crowded places. Try not to come into contact with people who are carriers of the infection.
• It is not recommended to wet the skin puncture site during the first 24 hours.
• After vaccination, it is necessary to support the body's immune system. To do this, try not to eat unhealthy heavy foods. Introduce more foods rich in vitamins and minerals into your diet. Fruits, berries and vegetables are perfect.

In the vast majority of cases, the vaccine is used without negative symptoms. Despite this, you should not neglect the above recommendations.

Vaccine use during pregnancy

The periods of waiting for a child and breastfeeding them become very responsible for a woman. She has to think not only about her health, but also about the well-being of the baby.

Experts were unable to identify a negative effect of Engerix B on the condition of the fetus. Breastfeeding also does not become a direct contraindication to the procedure.

Despite the fact that the drug does not affect the child’s condition, experts recommend using it only in exceptional cases. Administration of the drug to a pregnant woman does not become an indication for termination of pregnancy.

In what cases is vaccination contraindicated?

Not everyone can use the drug "Engerix B". Among the direct contraindications to its use are:

• If you have hypersensitivity to any component of the drug. If after the administration of the first vaccine an allergic reaction occurs, then its further use is impossible.
• Presence of infectious diseases. In this case, the procedure is postponed until complete recovery. If a person is suffering from ARVI or acute intestinal infections, then the vaccine is allowed to be administered after the body temperature has returned to normal.

Cases of overdose with this drug have not yet been identified.

The main advantages and disadvantages of Engerix V

The drug is not the only one of its kind. They have several analogues, for example, Regevak.

However, Engerix B has several advantages:

• Manufacturers claim that the effectiveness of the drug reaches 95%. This result can be achieved only if all vaccination rules are followed.
• It is produced in the form of a ready-made suspension, which makes it convenient to use. During the administration of the drug, the patient does not experience pain. This becomes especially important in pediatrics.
• The vaccine has gone through several stages of purification. Thanks to this, the likelihood of side effects is minimized.
• The drug administration regimen is extremely simple.
• The drug is manufactured by biotechnological synthesis, which eliminates the possibility of using contaminated material.

• Instructions for use Engerix b
• Composition of the drug Engerix b
• Indications for Engerix b
• Storage conditions for the drug Engerix b
• Shelf life of Engerix b

ATX Code: Antimicrobials for systemic use (J) > Vaccines (J07) > Vaccines for the prevention of viral infections (J07B) > Vaccine for the prevention of hepatitis (J07BC) > Hepatitis B, purified antigen (J07BC01)

Release form, composition and packaging

Excipients: aluminum hydroxide, sodium chloride, sodium phosphate dihydrate, monosubstituted sodium phosphate, polysorbate 20, liquid water, 2-phenoxyethanol (as a preservative).

1 ml (1 dose) - bottles (1) - cardboard packs.
10 ml (10 doses) - bottles (1) - cardboard packs.

Excipients: aluminum hydroxide, sodium phosphate dihydrate, sodium phosphate monosubstituted, polysorbate 20, sodium chloride, water, 2-phenoxyethanol (as a preservative).

0.5 ml (1 dose) - bottles (1) - cardboard packs.
5 ml (10 doses) - bottles (1) - cardboard packs.

Description of the drug ENGERIKS B based on officially approved instructions for use of the drug and made in 2007. Update date: 04/18/2006

pharmachologic effect

Hepatitis B vaccine is a purified major surface antigen produced using recombinant aluminum hydroxide-adsorbed DNA technology.

The surface antigen was isolated from a genetically engineered culture of yeast cells (Saccharomyces cerevisiae), which inherit the gene encoding the main surface antigen of the hepatitis B virus (HBV).

The vaccine is highly purified and exceeds WHO requirements for recombinant hepatitis B vaccines. No substances of human origin are used in the production of the vaccine.

Engerix B induces the formation of specific humoral antibodies against HBsAg (anti-HBs antibodies). An anti-HBsAg antibody titer greater than 10 IU/L is considered to provide protection against hepatitis B virus infection.

It has been shown that in newborns, children and adults at risk, the protective effectiveness is 95-100%.

A protective efficacy of 95% was shown among newborns from HBsAg positive mothers who were immunized according to schedules of 0, 1 and 2 months or 0, 1 and 6 months without concomitant administration of immunoglobulin against hepatitis B at birth. However, coadministration of hepatitis B immune globulin and vaccine at birth increases protective efficacy to 98%.

Among healthy individuals in the 0, 1, and 6 month immunization regimens, ≥ 96% of vaccine recipients had protective seropositive antibody levels 7 months after receiving the first dose.

For the 0, 1, and 2 primary immunization schedule plus a booster dose at 12 months, 15% of vaccine recipients had seropositive antibody levels 1 month after the first dose, and 89% of vaccine recipients had seropositive antibody levels one month after completion of the primary course of vaccination.

1 month after receiving a booster dose, 95.8% of vaccine recipients achieved a protective level of antibodies.

When using a rapid immunization regimen on days 0, 7 and 21 plus a booster dose after 12 months in exceptional cases, seropositive antibody levels were achieved in 65.2% and 76% of vaccine recipients after completion of the primary vaccination course after 1 and 5 weeks, respectively. 1 month after receiving the booster dose, 98.6% of vaccine recipients achieved protective antibody levels.

A significant reduction in the incidence of hepatocellular carcinoma was observed among children aged 6–14 years as a result of the national hepatitis B vaccination program in Taiwan, due to a significant reduction in the prevalence of hepatitis B antigen, the presence of which is a major factor in the development of hepatocellular carcinoma.

The long-term effect of immunization against hepatitis B reduces not only the incidence of this infection, but also its chronic complications, such as chronic active hepatitis B or hepatitis B-related cirrhosis.

Indications for use

• for active immunization against hepatitis B, caused by all known subtypes of the virus, in persons of all ages at risk of contracting hepatitis B; immunization with Engerix B vaccine can also be expected to prevent viral hepatitis D (as hepatitis D caused by delta agent does not exist in the absence of hepatitis B);
• in regions with a low prevalence of hepatitis B, immunization of persons at high risk; believe that immunization of all children and adolescents without exception will contribute to the control of hepatitis B at the population level;
• in regions with intermediate and high prevalence of hepatitis B, where the majority of the population is at risk of exposure to hepatitis B virus, to immunize all newborns, infants, children and adolescents, as well as adults at increased risk of infection.

Dosage regimen

The vaccine at a dose of 20 mcg (in 1 ml of suspension) is intended for adults and adolescents aged 16 years and older.

The vaccine at a dose of 10 mcg (in 0.5 ml suspension) is intended for use in newborns, infants and children up to and including 15 years of age.

Children aged 11 to 15 years, if a weak immune response is expected, a dose of 20 mcg can be prescribed, because A higher percentage of vaccine recipients achieve protective levels of antibodies after just two injections of this dose.

Primary immunization

A series of three IM injections is required to achieve optimal protection.

1.Immunization schedules that have a longer period of time between the second and third dose, such as 0, 1 and 6 months, may require more time to develop protection, but provide a higher antibody titer after the third dose.

2. The 0, 1 and 2 month immunization schedule provides faster protection and is more preferable for the patient.

A booster dose should be given after 12 months.

In infants, this regimen allows Engerix B to be given concomitantly with other childhood vaccines.

These schedules can be tailored to existing local vaccination schedules, taking into account the recommended timing of other childhood vaccines.

Rapid immunization

In exceptional circumstances in adults, when a more rapid development of protection is required, for example, for persons traveling to regions with high endemicity and who begin a course of vaccination against hepatitis B 1 month before departure, a course of three intramuscular injections according to the 0.7 schedule can be used th and 21st days. When using this vaccination schedule, a booster dose is recommended 12 months after the first dose.

Revaccination

The need for a booster dose in healthy people who have received the full course of primary vaccination has not been confirmed. Therefore, a booster dose is not recommended under these conditions. U patients on hemodialysis, as well as for disorders in the immune system, booster doses are recommended to maintain an antibody level of 10 IU/l. The booster dose is as well tolerated as the primary vaccination course.

U newborns from mothers who are carriers of the hepatitis B virus immunization with Engerix B vaccine (10 mcg) should begin immediately after birth, using either the 0, 1 and 2, or 0, 1 and 6 month schedules; however, the first regimen provides a faster immune response.

At recent known or suspected exposure to hepatitis B virus(eg, a contaminated needle stick), the first dose of Engerix B vaccine can be given at the same time as hepatitis B immune globulin, and the injections must be given in different parts of the body. It is recommended to use a rapid immunization schedule.

The primary immunization schedule for patients on chronic hemodialysis consists of four doses of 40 mcg - on the selected day, 1 month, 2 months and 6 months after the first dose. This vaccination regimen was adopted in order to ensure that the antibody titer remains above the accepted protective level of 10 IU/l.

Rules for administering the vaccine

For adults and children Engerix B should be injected intramuscularly into the deltoid region, newborns, infants and young children- into the anterolateral surface of the thigh. In exceptional cases, the vaccine can be administered subcutaneously patients with thrombocytopenia or blood coagulation disorders.

Engerix B should not be administered intramuscularly or intramuscularly into the gluteal region, because this may cause an insufficient immune response.
Under no circumstances should Engerix B vaccine be administered intravenously.

Before administration, the vaccine should be visually inspected for the presence of any foreign particles and/or discoloration. Before use, the vaccine vial must be shaken well to obtain a slightly opalescent white suspension. If the contents look different, the vaccine should not be used.

Each dose should be administered with a sterile needle and syringe, strictly observing the rules of asepsis and antisepsis to avoid contamination of the contents of the vial.

Different needles should be used to draw the vaccine through the rubber stopper and to inject it.

Side effects

Local reactions: rarely - redness, pain, swelling at the injection site.

From the central nervous system and peripheral nervous system: rarely - dizziness, headache, paresthesia;

From the digestive system: rarely - nausea, vomiting, diarrhea, abdominal pain, changes in liver function tests.

From the musculoskeletal system: rarely - arthralgia, myalgia;

Allergic reactions: rarely - rash, itching, urticaria;

From the cardiovascular system: in some cases - fainting, arterial hypotension.

Others: rarely - malaise, fever, fatigue, flu-like symptoms;

Engerix B is generally well tolerated. Side effects are usually mild and transient. In most cases, a cause-and-effect relationship between the development of these adverse reactions and vaccination was not established.

Use during pregnancy and breastfeeding

There is insufficient data on the safety of the Engerix B vaccine during pregnancy and lactation in humans and on the effect on reproduction in animals.

However, as with other inactivated viral vaccines, it is believed that no risk to the fetus should be expected.

During pregnancy, Engerix B should be used only when there is an established risk of contracting hepatitis B, and the expected benefit of vaccination should outweigh the possible risk to the fetus.

There are no contraindications for use during lactation.

special instructions

HIV infection is not considered a contraindication to the use of the Engerix B vaccine.

As with other vaccines, administration of Engerix B should be delayed in persons with acute febrile fever. However, minor infections are not a contraindication to immunization.

Because of the long incubation period for hepatitis B, there is a possibility that there is an unrecognized infection at the time the vaccine is administered. In such cases, the vaccine may not prevent the disease from developing.

This vaccine does not protect against infection caused by other hepatitis viruses, such as hepatitis A, hepatitis C, and hepatitis E, and other pathogens that infect the liver.

The immune response to hepatitis B vaccine depends on a number of factors, including older age, male gender, smoking, excess weight, and route of administration. For those patients who may have a less adequate response to hepatitis B vaccine (eg, those over 40 years of age), additional doses should be considered.

Hemodialysis patients, HIV-infected patients, and those with weakened immune systems may not achieve adequate antibody levels after receiving primary immunization and may therefore require additional doses of the vaccine.

As with other injectable vaccines, appropriate treatment and monitoring is required for rare anaphylactic reactions to vaccine administration.

Engerix B can be used to complete a primary course of immunization initiated with a plasma or other genetically engineered hepatitis B vaccine, or as a booster dose in individuals who have previously received a primary course of immunization with a plasma or other genetically engineered hepatitis B vaccine.

Impact on the ability to drive vehicles and operate machinery

It is unlikely that Engerix B vaccine will affect the ability to drive or use machines.

Groups at increased risk of hepatitis B infection

• healthcare workers;
• patients frequently receiving blood products;
• persons with frequent casual sexual contacts;
• persons who illegally use injecting drugs;
• persons visiting regions with high endemicity of the hepatitis B virus;
• infants born to mothers who are carriers of the hepatitis B virus;
• persons with origin from regions with high endemicity of the hepatitis B virus;
• patients with sickle cell anemia;
• patients preparing for organ transplantation;
• persons who are in constant contact with any of the above groups and with patients with acute or chronic hepatitis B infection;
• patients with chronic liver diseases with an increased risk of their development (for example, carriage of the hepatitis C virus, chronic alcoholism);
• law enforcement personnel, firefighters, military personnel and anyone who may be exposed to the hepatitis B virus due to their work or lifestyle.

WHO, the American Committee on Immunization Practices, and the American Academy of Pediatrics state that neonatal and/or adolescent vaccination is the optimal strategy for hepatitis B control in all countries.

Drug interactions

Co-administration of Engerix B and a standard dose of hepatitis B immune globulin does not reduce the titre of anti-HBs antibodies, provided that these drugs are administered to different sites of the body.

Engerix B can be co-administered with DTP, DPT and/or OPV if this coincides with the vaccination schedule established by the local Ministry of Health.

Engerix B can be co-administered with measles-mumps-rubella vaccine, Haemoplilus influenzae b vaccine, hepatitis A vaccine and BCG. Different injectable vaccines should always be given at different sites.

Pharmaceutical incompatibility

Engerix B should not be mixed with other vaccines.

Storage conditions of the drug

New and partially used vials of Engerix B vaccine should be stored at 2° to 8°C; do not freeze; if the vaccine has been frozen, the vial should be thrown away.

Shelf life of the drug

The expiration date of the vaccine is indicated on the label and packaging.

The contents of the vials after storage may be a clear white suspension with a clear, colorless supernatant. After shaking, the vaccine becomes slightly opalescent.

Treatment of viral hepatitis is one of the important tasks of infectious disease specialists and general practitioners. The disease is dangerous not only due to its severe clinical manifestations. Scientists believe that more than ⅔ of infected people are unaware that the virus has begun to multiply in their bodies. A mild course of the disease is a predisposing factor to the active spread of hepatitis. In rare cases, the process can be completely cured, but there are not many of these people. One of the most dangerous types of this viral disease is hepatitis B. More than 350 million people around the world suffer from this disease and are trying in vain to cope with the complications.

To prevent the disease, the hepatitis B vaccine Engerix B was created. Does this vaccine protect against the virus and who is it indicated for? How is it tolerated?

Description of "Engerix B" and instructions for use

The manufacturer of Engerix B is SmithKline Beecham - Biomed, Belgium.

This vaccination protects and promotes the development of immunity not only from hepatitis B, but also D. The bottle contains 0.5 ml of suspension or one dose, which corresponds to 10 mcg of antigen. There are 1 ml bottles with a dose of 20 mcg.

The active ingredient "Engerix B" is HBsAg (antigen). This is part of the protein shell of the virus, which promotes the production of specific proteins - antibodies. The drug itself cannot cause disease, and if prophylaxis is carried out according to the calendar, stable long-term immunity is created.

Composition of the Engerix B vaccine:

• HBsAg - protein antigen of the hepatitis virus;
• aluminum hydroxide;
• sodium chloride and hydrogen phosphate dihydrate;
• water for injections;
• 2-Phenoxyethanol.

In appearance, the Engerix B vaccine is a white homogeneous suspension, which during long-term storage can become two-layer (transparent supernatant and white sediment). After shaking, the precipitate should dissolve. To preserve its properties, certain storage conditions for Engerix B must be observed. The optimal temperature is 2–8 °C. Even for transportation, the vaccine cannot be frozen.

Who is recommended for the Engerix B vaccine?

Engerix B vaccination is carried out in almost all countries of the world. It was included in the compulsory vaccination calendar and is used from birth. In addition, there are several other categories of people who are indicated for this drug.

1. Children born to mothers who are carriers of hepatitis B or have had such a disease.
2. Vaccination is mandatory for all newborns in cities or areas with a high incidence of hepatitis B.
3. Children in boarding schools and orphanages.
4. Engerix B is a type of hepatitis vaccine that is given even to children and adults on hemodialysis or those receiving blood and its products.
5. Patients with blood cancer.
6. People who have come into contact with biological material (blood and other biological fluids) of an infected person.
7. Medical workers, medical students.
8. Persons involved in the production of immunobiological agents from donor and placental blood.
9. Vaccination is indicated if a previously unvaccinated person is scheduled for surgery.

For how many years does Engerix B protect against hepatitis? It is believed that if the vaccination was given from birth on time, it protects for at least 20 years. But that's the best case scenario. Lasting immunity is developed for 5–8 years.

Contraindications

The Engerix B vaccine is not indicated for everyone.

1. The vaccine is not prescribed for pregnant and breastfeeding women. There are no studies on such women, so they are not vaccinated.
2. If allergic reactions occur to the first vaccine or to one of the components of the drug.
3. For acute infectious diseases, vaccination is carried out a month later.

Timing of vaccination and route of administration

The instructions for use of Engerix B recommend administering the drug to children intramuscularly (this is the anterior outer area of ​​the thigh). Teens and adults receive an injection into the deltoid muscle of the shoulder.

If the baby was born full-term, the first administration of the drug should be within 12 hours. The vaccination schedule is as follows: 0-1-6 months. Children under 16 years of age are administered 0.5 ml of the drug. Adolescents and adults are prescribed 1 ml.

If a child was born from a mother who is a carrier of hepatitis B, the Engerix B vaccination schedule looks different: 0–1–2–12 months.

If a person travels abroad, where there is a high risk of contracting hepatitis or was not vaccinated in childhood, then emergency vaccination can be carried out at 0, 7, 21 days with revaccination after 12 months.

There are no special conditions for administering the Engerix B vaccine; no preparation is required.

Possible body reactions

Children and adults are vaccinated with Engerix B without prior preparation. But, as before any vaccination, you need to consult a doctor with a general examination. In some cases, reactions to the Engerix B vaccine are possible.

How is the Engerix B vaccine tolerated?

All these reactions can develop when a vaccine is administered and simultaneously infected with another acute infectious disease. To prevent this from happening, after applying the vaccine, it is not recommended to walk or be in places with a lot of people. Any vaccination is a burden on the immune system. Therefore, after administering Engerix B, you should not stay in crowded places for two to three days.

How is Engerix B tolerated? The vaccine leaves no traces and in rare cases causes complications.

Analogues of "Engerix B"

Currently, more than 10 vaccines that protect against viral hepatitis B are registered and used in Russia. Several options for preventing the disease are used in medicine. Here are some analogues of Engerix B:

• "Biovac-B";
• vaccine "HB-Vax II" made in the USA;
• "Shanvac-B";
• "Euvax B";
• recombinant hepatitis B vaccine.

"Engerix B" is a vaccine that protects a person from viral hepatitis B. Its safety is evidenced by the fact that it is prescribed to children in the first day after birth. The duration of prophylaxis is short, and revaccination with Engerix B is carried out depending on the indications. Should you vaccinate your children with this vaccine? Yes, but you need to prepare for each scheduled vaccination. After all, half of the complications are the result of the wrong behavior of the person himself.

One of the vaccines to prevent hepatitis is Engerix. Hepatitis is characterized by an inflammatory process in the liver and is difficult to treat. Doctors confirm the difficulty of identifying and treating them. In addition to vivid manifestations, an asymptomatic course of the disease is also possible. This sign does not indicate a slow spread, but, on the contrary, its rapidity.

It is impossible to cure hepatitis completely. According to doctors, the most severe form of the disease is hepatitis B. According to infectious disease specialists, more than 300 million of the population suffer from hepatitis of various forms or are still being treated for the consequences of a viral disease.

More information about the drug Engerix

The Engerix vaccine is a product of a Belgian pharmaceutical company. Thanks to it, the patient’s body begins to develop its own immune defense against group B and D viruses.

The drug against hepatitis is available for children under 18 years of age and for adult patients. Release form: white suspension. The “children’s” form of the medicine contains a vaccine dosage of 0.5 ml, which is bottled in glass bottles. The container can contain up to 10 doses of medication, with a total volume of up to 5 ml. The medicine is also packaged in disposable syringes designed for one dose of the medicine.

In the “adult” form of the medicine, the dosage is 1 ml per injection. The drug can be packaged in glass containers with a volume of 10 ml. or a disposable syringe for injections.

Engerix contains the protein shells of the virus; when they enter the body, they stimulate the immune defense, promoting the production of antibodies. At the same time, the ingredients included in the medicine do not provoke the development of the virus in the body. If the medicine is introduced into the patient’s body according to the established scheme, then the person’s immune defense against the disease is activated. In addition to protein compounds, the medicine contains aluminum hydroxide, chloride, water for injection and other components.

If you look at the bottle, you can see the separation of the medicine into 2 phases: a white sediment and a clear liquid. When shaking the container, the medicine becomes homogeneous.

Indications of the drug

Doctors recommend vaccinating patients who have an increased risk of contracting the virus, such as infants after birth, adolescents, and children born to mothers who carry the virus. Doctors recommend vaccinating medical personnel who work in dental hospitals and offices, laboratories, clinics and other medical institutions.

The risk group also includes people who have recently undergone or are planning to undergo a transfusion of blood or its components, abdominal surgery, internal organ transplantation, invasive procedures or diagnosis of diseases. Vaccinations are given to people with an increased risk of infection due to a chaotic intimate life, and to people who use drugs.

Vaccination against hepatitis is necessary for adults and children who travel to regions with a high degree of spread of the virus or live in this region. People who suffer from hepatitis C or are carriers of the virus or are anemic must be vaccinated.

It is recommended to vaccinate against hepatitis with Engerix for people who suffer from alcohol addiction or who have close contact with people infected with the virus. In areas where the spread of the virus has been recorded and the risk of infection remains, vaccination is recommended for the entire population, including infants and adolescents.

Vaccine contraindications

The instructions for use of Engerix state that temporary contraindications include infectious diseases accompanied by high temperature and fever, severe and acute forms of chronic pathologies. The vaccine can be given after the temperature has dropped and the patient’s condition has returned to normal.

Subtleties of use during pregnancy

In the instructions for use, the manufacturer did not consider it necessary to indicate data on use among this group of patients. According to doctors, the vaccine has no effects on the mother and fetus. But since additional studies have not been conducted, the doctor, before giving the injection, additionally evaluates the potential risks and benefits to the body.

Side effects

After using the vaccine, pain, swelling, and hardness may occur at the injection site. Such symptoms disappear after a couple of days. You may feel a slight fever and malaise. There are mild cold symptoms.

When using Engerix, the patient may experience migraines, dizziness, and, less commonly, paralysis or neuritis, including optic neuritis. Less commonly, side effects include meningitis or seizures. Negative effects after use may manifest themselves in attacks of nausea or vomiting, abdominal pain, and impaired liver function.

After vaccination, the patient may complain of the development of myalgia or arthritis. Less commonly, allergic reactions to the drug occur, for example, urticaria, rash, anaphylactic reactions. Negative manifestations from the cardiovascular system or bronchospasms are possible. Most often, such side effects are mild and go away without additional treatment.

Vaccination scheme

In childhood, patients receive the Engerix vaccine in the hip area, while patients in other age groups receive the vaccine in the shoulder. For bleeding disorders, it is possible to administer the medication subcutaneously to prevent bleeding.

The Engerix hepatitis vaccine is recommended for infants within 12 hours of birth. Upon reaching one month of age, vaccination is repeated, and then the injection is given another six months later. During the procedure, the patient develops a strong immunity to the disease. It does not form immediately, but the degree of protection is higher. This vaccination is used for all full-term infants.

For children whose mothers are carriers of the virus, injections are given according to the following schedule: 12 hours after birth, after a month, after 2 months, after 12 months.

When planning an operation, when moving to a place with a high probability of getting sick, or if a person was not given an injection in infancy, vaccination is carried out according to an accelerated option. The injection is given on the first day, after a week, after 21 days. The effectiveness of such vaccination against hepatitis is up to 86%, the next revaccination is carried out after 12 months.

There is another option for an accelerated version of inoculating immunity, when vaccinations are given at intervals of 30 days. In this case, antigens are formed faster, but their effectiveness in protecting against the disease is weaker. Repeated vaccination is done after a year. It is used for children whose mothers have hepatitis, for pregnant women with a viral disease.

If a person has completed all vaccinations against the virus in a timely manner, then additional medication is not required. Booster vaccinations should be given to people who work in health care facilities every seven years. In immunodeficiency conditions, additional administration of the drug is possible. It is carried out according to doctors' indications.

How to use the vaccine

Doctors use this medicine to develop immune protection in all age groups of patients against the hepatitis B virus. The drug is not able to cope with pathogens of other organ pathologies and hepatitis A, E.

If the Engerix vaccine is given to a patient over forty years of age, then the patient’s immunity is weaker, so an additional injection may be required for greater effectiveness.

The disease has a long incubation period, which does not manifest the presence of the virus in the body with additional symptoms. In such cases, injection with a suspension will not protect against the virus. The same thing happens in cases of infection of a patient with hepatitis types A, C, E. The developed immunity does not extend to other liver pathologies.

The development of immunity in the patient’s body depends on the medication used and other reasons, for example, excess weight, gender, age group, bad habits. If there is an immunodeficiency state, HIV has been diagnosed, or hemodialysis has developed, then they may need additional booster vaccination or a vaccine injection during the main course.

Anti-anaphylactic shock medications should be available in the doctor's office to prevent an allergic reaction in the patient. Such consequences may develop after the injection. After the injection, the patient needs to remain under the supervision of medical personnel for about 30 minutes to minimize the risk of developing anaphylactic shock.

If the patient has a mild infection, it is temporarily necessary to postpone vaccination until the temperature returns to normal.

Interaction with other drugs

The medicine can be used with hepatitis B immunoglobulin, provided that the injections are given in different parts of the body. Engerix can be used with other vaccinations that are intended to prevent infectious diseases, but it is important that the injections with these medications are given in different areas of the body.

Engerix is ​​easily combined with other medications that are included in the international vaccination schedule for vaccination. It can be given simultaneously with injections for other types of hepatitis or for tick-borne encephalitis and influenza virus. Pentaxim and Engerix can also be used at the same time.

Doctors use this drug as a substitute for other drugs for vaccination against the hepatitis B virus, even if the first injection was given with a different vaccine.

Preparing the medicine for use

Before administering Engerix intramuscularly, the doctor must properly prepare it. To do this, the container with the drug is first shaken until the suspension becomes homogeneous, without suspension and sediment. If the medicine has sediment after shaking, was stored incorrectly, the packaging is damaged or has changed color, then it is discarded.

If the container contains several doses of medication, then each dose of the drug is removed from the bottle and injected with a sterile instrument (syringe with needle). If the container is opened, the product is used immediately within 24 hours. The remaining medicine is destroyed. The injection site must be treated with an antiseptic solution. In the doctor's office during vaccination, all antiseptic and hygiene measures must be observed during the procedure.

Special instructions for use

The manufacturer has not conducted additional research to obtain information about the dangers of the drug during lactation and pregnancy. There have been no experiments on the use of the drug on animals. But drugs of this class are not highly toxic and carry minimal risk of harm to the health of the mother and child.

For patients with kidney pathologies over the age of 16 years, primary vaccination can be carried out with 4 injections with a double dosage of the suspension. The medicine is given on the selected date, then after 30, 60 days and after six months.

Patients under 16 years of age who suffer from kidney disease can be vaccinated according to the accelerated and standard options. For accelerated vaccination, doctors recommend using a dosage of 10 mcg/0.5 ml. The use of this dosage improves immunity against hepatitis.

Pros and cons of the drug

Engerix cannot be called the only cure for hepatitis B. It has a number of effective analogues.

Advantages of the medicine

According to medical research, doctors say that the effectiveness of this drug reaches 95%, but if you follow the timing of vaccination, its schedule and dosage.

The Engerix vaccine is available in ready-made form; it does not need to be diluted or undergo additional preparation procedures. The injection is not painful, which is convenient when vaccinating children and people with a low pain threshold.

The vaccine is considered a highly purified medicine, so there are practically no side effects. Such reactions rarely occur. The scheme for using the medicine is simple and does not require special calculations. Engerix is ​​manufactured using technologies that ensure that the material cannot be contaminated.

Disadvantages of the drug

The suspension also has a number of disadvantages, for example, storage and transportation conditions. The drug cannot be stored at temperatures above 34 degrees and cannot be frozen. The storage temperature of the medicine is from 2 to 8 degrees. The drug can be stored for up to 36 months. After this, the medicine must be disposed of, because the use of an expired suspension may have health consequences.

The medicine is administered only intramuscularly, in some cases subcutaneously. The drug must not be used intravenously. If the patient already has the virus or has a latent form of it, then the use of the medicine is ineffective.

In rare cases, the drug provokes anaphylactic reactions, so the patient must be observed in the doctor’s office for half an hour, and the room itself is equipped with medications to eliminate the shock reaction.

Drug analogues

About 10 medications are used to prevent hepatitis B, which also help build immunity, protecting against the virus.

1. Biovac. The medicine is effective in 95–98% of cases. This is a suspension for intramuscular administration. Method of administration: subcutaneous or intramuscular. The patient is given 3 injections. The medicine rarely causes side effects. It cannot be used for infectious diseases and multiple sclerosis. It is not used simultaneously with BCG.
2. Regevak V. This is a budget medicine intended for the prevention of hepatitis B virus. Release form: suspension. The drug is effective in 90% of cases. Adverse reactions of the body may occur, which are expressed in dizziness, pain in muscles and joints.
3. Euvax. It does not contain particles of a live virus, but nevertheless its effectiveness reaches 98% of cases. Protection of the drug against the virus for up to 10 years. At the same time, the medicine does not cause severe negative effects.
4. HB-Vax II. The drug is available in the form of a suspension. Country of origin: USA. To vaccinate against the hepatitis B virus, three injections are sufficient. But the medicine has many side effects. It is not used if you are prone to allergies to the ingredients of the medicine.
5. Shanvak V. This is an Indian vaccine that helps the body develop stable immunity to the virus. It is not used for infections accompanied by fevers or allergies to the components of the drug. Vaccination is contraindicated for people over 60 years of age.

Injection suspension for children 0.5 ml (1 dose)

hepatitis B virus surface antigens at least 95% per 10 μg of protein

0.5 ml (1 dose) - bottles (1) - cardboard packs.

0.5 ml (1 dose) - disposable syringes.

5 ml (10 doses) - bottles (1) - cardboard packs.

Injection suspension for adults 1 ml (1 dose)

hepatitis B virus surface antigens at least 95% per 20 μg of protein

Other ingredients: thiomersal (50 mcg/ml).

1 ml (1 dose) - bottles (1) - cardboard packs.

1 ml (1 dose) - disposable syringes.

10 ml (10 doses) - bottles (1) - cardboard packs.

pharmachologic effect

Hepatitis B Vaccine promotes immunity against the hepatitis B virus. Contains purified hepatitis B virus core surface antigen (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. Long-term studies have shown that these particles have properties characteristic of natural HBsAg.

The administration of Engerix B induces the appearance of specific humoral antibodies and memory lymphocytes (T- and B-), which provide protection against hepatitis B in at least 98% of individuals who received 3 injections of the drug.

The level of protection in newborns from mothers carrying the hepatitis B virus after the administration of Engerix B, administered simultaneously with or without hepatitis B immunoglobulin, was more than 95%.

In homosexual men and psychiatric patients after completing a course of immunization with the Engerix B vaccine, the level of protection against hepatitis B was 100%.

Engerix B provides prevention of hepatitis B and its complications (liver cirrhosis, hepatocellular carcinoma).

Standard fermentation and purification procedures ensure the required consistency of the composition of Engerix B. The vaccine is highly purified and meets WHO requirements for recombinant hepatitis B vaccines.

Pharmacokinetics

The HBsAg antigen expressed in yeast cells is spontaneously transformed (in the absence of chemical exposure) into spherical particles with a diameter of 20 nm containing non-glycosylated HBsAg polypeptides and a lipid matrix consisting mainly of phospholipids. Long-term studies have shown that these particles have immunological properties characteristic of the natural antigen HBsAg.

Indications

– carrying out active immunization against hepatitis B of persons exposed to materials contaminated with the hepatitis B virus;

– conducting active immunization against hepatitis B in areas with a low incidence of hepatitis B (recommended for newborns and adolescents, as well as for persons 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 clinical and serological laboratory staff; patients who have undergone or are scheduled to receive blood transfusions; elective surgical procedures; invasive medical and diagnostic procedures; those at increased risk of illness associated with sexual behavior; drug addicts; persons traveling to areas with high prevalence of hepatitis B ; children born in areas with widespread hepatitis B; chronic patients and carriers of viral hepatitis C; police officers, firefighters, military personnel, persons who have physical contact with patients or carriers of the virus, and all persons who, in connection with work or for any reason, - may be infected with the hepatitis B virus for other reasons);

– carrying out 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.

Dosage regimen

Adults: 20 mcg (1 ml)

Children: 10 mcg (0.5 ml)

Immunization schedules

To obtain optimal immune protection, 3 IM injections of the vaccine are required. 3 possible immunization schedules are recommended:

1. Standard immunization is carried out according to the schedule of 0, 1, 6 months. Immune protection is formed at a slightly later date, however, a higher antibody titer is achieved.

2. Accelerated immunization is carried out according to the scheme 0, 1, 2 months, i.e. at monthly intervals. In this case, immune protection is formed faster, but the antibody titer of some vaccinated people may be at a lower level. In this regard, revaccination is necessary 12 months after the first dose.

A booster dose is not required unless specifically indicated for all vaccine groups other than healthcare workers. Revaccination of medical workers is carried out once every 7 years.

3. When a more rapid formation of immune protection is necessary, for example, in the case of a planned elective surgical intervention or travel to an area with widespread hepatitis B, immunization of adults can be carried out according to the schedule of 0, 7, 21 days, i.e. 3 injections with an interval between the first and second injection - 7 days, between the second and third - 14 days. Revaccination should be carried out 12 months after the first dose.

4. Procedure for immunization of newborns from mothers who are carriers of hepatitis B

The first dose is recommended at birth and then 1 and 2 months after the first dose. Concomitant administration of hepatitis B immune globulin is not necessary, but if it is given at the same time as the first administration of Engerix B, then these drugs should be administered at different sites. Revaccination is carried out at 1 year.

5. Procedures for immunization of persons who may have been exposed to hepatitis B infection (for example, through the use of a contaminated injection needle).

The first dose of Engerix B can be given at the same time as hepatitis B immune globulin, but the injections are given in different areas of the body. An accelerated immunization schedule of 0-1-2 months or 0-7-21 days is recommended. A booster dose is administered 12 months after the first immunization.

6. The procedure for immunization of persons with severe immunodeficiency who are on program hemodialysis

The usual procedure for adults on hemodialysis and immunocompromised patients is to administer 4 doses of 40 mcg (2 ml) on a chosen day, 1, 2 and 6 months after the first dose.