Vaccine Euvax B

"EUVAX" - a vaccine for the prevention of viral hepatitis B

Recombinant vaccine

, South Korea.

Protects against diseases: viral hepatitis B.

Applicable: for newborns, children, teenagers and adults.

Not included in the national vaccination calendar.

IMPORTANT: vaccinations with the Euvax vaccine are not performed in clinics

Advantages of the Euvax vaccine:

• With immunization, specific immunity against the hepatitis B virus is created in 98%.
• Revaccination: WHO does not recommend revaccination because vaccination with three doses of hepatitis B vaccine provides protection for 15 years.

Side effects

Vaccination with the MIBP vaccine Euvax B can contribute to the development of the following adverse reactions from systems and organs:

• gastrointestinal tract: often – vomiting, diarrhea, abdominal pain; rarely – nausea;
• metabolism and nutrition: often – anorexia;
• infectious and parasitic diseases: infrequently – rhinitis, candidiasis;
• cardiovascular system: often – hematoma;
• circulatory and lymphatic systems: extremely rarely – neutropenia;
• nervous system: often – drowsiness, unusual crying; rarely – dizziness, headache; extremely rarely - facial paralysis, optic neuritis, exacerbation of multiple sclerosis, Guillain-Baré syndrome;
• skin and subcutaneous tissues: often – redness, erythematous rash; uncommon – rash, including maculopapular; pityriasis rosea;
• mental disorders: often – increased excitability, insomnia;
• pregnancy, postpartum and perinatal conditions: uncommon – jaundice;
• musculoskeletal and connective tissue: rarely – myalgia, arthritis;
• general disorders and reactions at the injection site: very often - pain at the injection site; often - increased body temperature, swelling, induration, pain at the injection site; rarely – fatigue, malaise;
• instrumental and laboratory data: rarely - transient increase in transaminase activity.

According to the results of clinical studies of HBsAg, the development of allergic reactions was not recorded during vaccination. During post-marketing surveillance after the administration of Euvax B, 3 cases of hypersensitivity reactions were observed - swelling and redness of the eyelids, itching, urticaria, scleral hyperemia, and erythematous-papular rash.

Indications for vaccination with Euvax

Prevention of hepatitis B in children within the framework of the national schedule of preventive vaccinations and persons from groups at increased risk of infection with the hepatitis B virus:

Children and adults in whose families there is a carrier of the HBs antigen or a patient with chronic hepatitis B;

Indications for use

• Healthy children and adults - for the prevention of infection and development of viral hepatitis B within the framework of the National Calendar of Preventive Vaccinations of the Russian Federation
• Children and adults at risk of contracting the hepatitis B virus (family contact with a carrier of the virus; those born from a mother who is a carrier of the virus; patients who have received a transfusion of blood or its components; patients with malignant blood diseases; workers of medical institutions, laboratories, students of medical universities and etc.)

We recommend that people who are concerned about their health take the Euvax B hepatitis vaccine because viral hepatitis B may not cause any symptoms for a long time after infection.

Scheme and method of administration of the Euvax vaccine

The vaccine is administered to adolescents and adults intramuscularly into the deltoid muscle, and to newborns and young children intramuscularly into the upper outer surface of the mid-thigh. Children's dose (for newborns and children up to 15 years inclusive) - 0.5 ml. The adult dose for persons over 16 years of age is 1.0 ml.

The vaccination course consists of three doses of vaccines according to the scheme:

1st dose: selected date,
• 2nd dose: 30 days after the 1st dose,
• 3rd dose 180 days after 1st dose.

For newborns whose mothers are infected with the hepatitis B virus, and according to epidemic indications, vaccination is carried out according to an alternative scheme:

• 1st dose – selected date,
• 2nd dose – 1 month after the 1st dose,
• 3rd dose – 2 months after the 1st dose,
• revaccination – 12 months after the first dose.

Euvax B, instructions for use: method and dosage

Euvax B suspension is administered intramuscularly. For children of the first years of life - into the upper outer surface of the middle part of the thigh, for older children and adults - into the deltoid muscle. The vaccine should not be administered into the buttock area as this may cause a low immune response.

Before use, the suspension must be shaken vigorously, since during storage a small amount of precipitate may form - white with a colorless transparent supernatant liquid. When administering the suspension, it is necessary to ensure that the needle does not penetrate into the bed of the blood vessel.

For patients from 1 to 16 years of age, Euvax B is administered in a dose of 10 μg of HBsAg (0.5 ml), from 16 years of age and older - 20 μg of HBsAg (1 ml).

For children and adolescents from 1 to 18 years of age and adults 18 to 54 years of age who are not at risk, the following vaccination schedule is recommended, carried out in accordance with the national preventive vaccination schedule:

• I dose – selected date;
• II dose – after 1 month. after administration of the first dose;
• III dose – after 6 months. after administration of the first dose.

If patients are suspected of being infected with hepatitis B or if they need to visit regions with a high incidence rate, there is an alternative immunization regimen:

• I dose – selected date;
• II dose – after 1 month. after administration of the first dose;
• III dose – after 2 months. after administration of the first dose;
• maintenance dose – after 12 months. after the first dose.

The World Health Organization (WHO) does not recommend revaccination because immunization with 3 doses of Euvax B to prevent hepatitis B has been found to provide protection for up to 15 years. In addition, after this period of time, if the protective level of antibodies in the blood decreases, the vaccinated patient's body is able to provide a protective level of antibodies in response to contact with the hepatitis B virus. Revaccination, however, may be recommended at the regional level.

Patients with immunodeficiencies and those receiving hemodialysis treatment may require additional doses of the vaccine, taking into account the age-related dosage. Because in this group of patients, protective antibody titers after primary immunization [more than 10 international units (IU)/L] may not be induced.

Contraindications

Only a doctor can decide whether Euvax is suitable for vaccination

The drug "Euvax" is contraindicated if there is a history of an allergic reaction to any component of the vaccine and in the following cases:

Hypersensitivity and hypersensitivity to baker's yeast and other components of the vaccine.
• Severe reaction (temperature above 40C, edema, hyperemia more than 8 cm in diameter at the injection site) or complication to previous administration of the hepatitis B vaccine.

Acute infectious and non-infectious diseases, chronic diseases in the acute stage - immunization is carried out no earlier than 1 month after recovery (remission). For mild forms of ARVI and acute intestinal infections, vaccinations can be carried out after the temperature has normalized

Possible side effects

Side effects with the vaccine are rare. An increase in body temperature above 38.8°C, headache, dizziness, weakness, malaise, myalgia, arthritis, nausea, vomiting, a transient increase in the activity of liver transaminases, and skin rash may be observed. Local reactions include pain, redness, swelling and induration at the site where the vaccine was administered. In patients with multiple sclerosis, vaccination may worsen symptoms.

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How to help your young child feel comfortable during vaccinations

Vaccination works better when the baby is calm and not afraid. To avoid scaring your child, try the following:

Distract and calm your baby, hug him, talk softly to him
• Be calm, confident, smile.
• Maintain eye contact with your child
• Communicate with your child, show that you are nearby and everything is fine.
• Let your child hold a favorite toy or blanket.
• Ask your doctor if you can hold your baby on your lap and gently rub his back during vaccination.
• Be sure to praise your child after vaccination, tell him how great he is and how proud you are of him.
• Support your baby, even if he couldn't help but cry.

Euvax B

Euvax B is a vaccine whose purpose is to prevent hepatitis B. It is a recombinant DNA vaccine that contains purified HBs antigen (95% of its volume). The result of this is the ability to use such a vaccine in children from the first hours of their life and a minimal number of adverse reactions. The Euvax B vaccine was first registered in 1992; today it is used in 37 countries around the world. In European countries, this vaccine is registered in Bulgaria, Romania, Lithuania, Estonia, Latvia and almost all republics of the former USSR. It was certified for vaccine quality by a special WHO commission in 1996 and 2001. (this is evidenced by an official WHO document), in our time it is used within the framework of WHO and UNICEF programs. Euvax B is produced in South Korea at the factories of LG Chemical Ltd in accordance with European quality standards and international Good Manufacturing Practice standards.

Advantages

• Vast experience of use (both in Russia and in other countries of the world)
• To make the Euvax B vaccine, a live virus is not used, so the possibility of causing illness is excluded.
• No substances of human origin are used in the production of the vaccine.
• Regarding recombinant vaccines used to prevent hepatitis B, it meets all WHO requirements
• Can be used from the first hours of baby's life
• Effective for specific immunoprophylaxis of infection caused by known subtypes of viral hepatitis B
• A higher dosage can be used to vaccinate adolescents who are at high risk of contracting hepatitis B
• Provides long-lasting protection – existing research has shown that immunity can last at least 15 years
• Vaccination is not contraindicated during lactation

Cautions

General precautions include:

• If the patient has a progressive disease that is accompanied by a high body temperature, vaccination should be postponed
• In patients who suffer from multiple sclerosis, there are unconfirmed cases where the disease worsened after vaccination. Therefore, when planning to vaccinate such patients, be sure to carefully weigh the possible risk of exacerbation of the disease
• Immunization may not have the expected effect in people who have advanced or latent hepatitis B

The following warnings for use can be identified:

• Euvax B is not injected into the gluteal region
• The vaccine cannot be administered intravenously

You can make an appointment for vaccination at the Children's Clinic or make an appointment with an immunologist-vaccinologist (pediatrician) by calling in St. Petersburg, 301-62-47