Euvax B - Instructions For Use Of The Vaccine, Reviews Of Vaccination, Price

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Euwax B

Latin name: Euvax B

ATX code: J07BC01

Active ingredient: hepatitis B vaccine

Manufacturer: L. G. Life Science, Ltd. (LG Life Sciences, Ltd.) (Republic of Korea)

Description and photo updated: 2020-30-04

Euvax B - recombinant vaccine for the prevention of hepatitis B; medical immunobiological preparation (MIBP).

Release form and composition

The drug is produced in the form of a suspension for intramuscular (i / m) administration: homogeneous, whitish, slightly opalescent, separating into two layers upon settling: the upper is a clear colorless liquid, the lower is a white precipitate that easily breaks down when shaken [0.5 ml (1 dose for children) or 1 ml (1 dose for adults) in a transparent glass bottle, in a cardboard box of 1, 10 or 20 bottles; 5 or 10 ml (10 doses for children or 10 doses for adults, respectively) in a transparent glass bottle, in a cardboard box 10 bottles. Each pack also contains instructions for the use of Euwax B].

1 dose contains:

• active substance: hepatitis B virus surface antigen (HBsAg) purified - 10 μg per 0.5 ml (children's dose) or 20 μg per 1 ml (adult dose);
• additional components: thiomersal, aluminum hydroxide gel, sodium hydrogen phosphate (buffering agent), potassium dihydrogen phosphate (buffering agent), water for injection, sodium chloride.

Pharmacological properties

Euvax B is an MIBP vaccine intended for immunoprophylaxis of hepatitis B, the active ingredient of which is highly purified non-infectious surface protein polypeptides (HBsAg) of the hepatitis B virus adsorbed on aluminum hydroxide. The drug is a genetically engineered vaccine produced using recombinant DNA technology - HBsAg synthesis in Saccharomyces cerevisiae yeast cells.

The introduction of the vaccine, according to the approved scheme, ensures the development of specific immunity against the hepatitis B virus in a protective titer in more than 94.1% of the vaccinated.

Indications for use

The Euvax B vaccine is recommended for use in adults and children from 1 year old to prevent infection caused by all established subtypes of the hepatitis B virus.

Contraindications

Absolute:

• an allergic reaction recorded against the background of previous use of the product;
• hypersensitivity to baker's yeast, or to any component of the Euwax B.

In case of development of post-vaccination complications or a strong reaction (including a temperature above 40 ° C, edema and redness at the injection site more than 8 cm in diameter) to the previous administration of the drug, in the presence of acute infectious or non-infectious lesions, exacerbations of chronic diseases, Euwax B vaccination is required 14-28 days after remission or recovery.

For patients with non-severe acute respiratory viral infections (ARVI), acute intestinal diseases, vaccination is recommended after the temperature has returned to normal.

Euwax B, instructions for use: method and dosage

Suspension Euvax B is administered intramuscularly. For children in the first years of life - in the upper outer surface of the middle part of the thigh, older children and adults - in the deltoid muscle. The gluteal region should not be injected with the vaccine, as this may cause a low immune response.

Before use, the suspension must be shaken vigorously, since during storage a small amount of precipitate, white with a colorless transparent supernatant liquid, may form. When injecting the suspension, it is necessary to make sure that the needle has not penetrated the blood vessel.

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

Children and adolescents from 1 to 18 years old and adults 18–54 years old who are not at risk are recommended the following vaccination schedule, carried out according to the national vaccination schedule:

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

If patients suspect hepatitis B infection or if it is necessary to visit regions with a high incidence rate, there is an alternative immunization scheme:

• I dose - the selected date;
• II dose - after 1 month. after the introduction of the first dose;
• III dose - after 2 months. after the introduction of the first dose;
• maintenance dose - after 12 months. after the 1st dose.

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

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

Side effects

Vaccination with MIBP vaccine Euvax B can contribute to the development of such 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 rare - neutropenia;
• nervous system: often - drowsiness, unusual crying; rarely - dizziness, headache; extremely rare - paralysis of the facial nerve, optic neuritis, exacerbation of multiple sclerosis, Guillain-Baré syndrome;
• skin and subcutaneous tissue: often - redness, erythematous rash; infrequently - rash, including maculopapular; pink lichen;
• mental disorders: often - increased excitability, insomnia;
• pregnancy, postpartum and perinatal conditions: infrequently - jaundice;
• musculoskeletal and connective tissue: rarely - myalgia, arthritis;
• general disorders and reactions at the injection site: very often - pain at the injection site; often - an increase in body temperature, edema, induration, soreness at the injection site; rarely - fatigue, malaise;
• instrumental and laboratory data: rarely - a transient increase in transaminase activity.

According to the results of clinical studies of HBsAg, the development of allergic reactions was not recorded during vaccination. In the process of post-marketing observation after the introduction of Euwax B, 3 cases of hypersensitivity reactions were noted - edema and redness of the eyelids, pruritus, urticaria, scleral hyperemia, erythematous-papular rash.

Overdose

Cases of overdose of Euwax B have not been established.

special instructions

Suspension Euvax B is prohibited to be administered intravenously.

In the presence of a progressive disease, proceeding with an increase in temperature, it is necessary to delay vaccination.

Taking into account the theoretical possibility of an immediate type of allergic reaction during vaccination, it is necessary to have the medicines necessary to provide emergency assistance with the development of this side effect. The patient who has received the vaccine needs medical supervision for at least 30 minutes after the administration of the Euwax B vaccine.

If people with multiple sclerosis are vaccinated, consideration should be given to the increased risk of exacerbation of symptoms due to stimulation of the immune system. In this category of patients, with the introduction of Euwax B, it is necessary to carefully weigh the expected benefit from its use and the potential threat of exacerbation of the disease.

In patients vaccinated in latent / advanced hepatitis B, the vaccine may not be effective.

Influence on the ability to drive vehicles and complex mechanisms

There are no data from studies examining the possible effect of Euwax B on the ability to drive vehicles and control other complex moving mechanisms.

Application during pregnancy and lactation

The effects of HBsAg on fetal development have not been studied. At the same time, as with the administration of any inactivated vaccine, the ability of this agent to affect the embryo / fetus is unlikely. However, the use of Euwax B in pregnant women is only allowed if the real threat of infection with the hepatitis B virus significantly outweighs the potential adverse effect of the MIBP vaccine.

In special studies, the effect of the drug on infants after vaccination of their mothers has not been studied, however, there are no contraindications for the administration of Euwax B to lactating women.

Pediatric use

Euwaxa B is indicated for use in children from 1 year of age and older in accordance with the recommended vaccination regimens.

Drug interactions

Suspension Euvax B is incompatible in the same solution with any drugs.

The drug can be used simultaneously (on the same day) with vaccines intended for the prevention of the following diseases: whooping cough, tetanus, diphtheria, measles, rubella, mumps or poliomyelitis. In this case, these MIBP vaccines must be injected into different parts of the body and not mixed in one syringe.

Analogs

The analogs of Euwax B are Regevak B, Hepatitis B recombinant yeast vaccine, Engerix B, Shanvak-B.

Terms and conditions of storage

Store out of the reach of children at 2–8 ° C, without freezing.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Euwax B

Rare reviews about Euwax B, mainly left by the parents of young patients, are ambiguous. Everyone notes the importance of immunization against such a serious infectious disease as hepatitis B, but many are worried about the risk of developing severe side effects of the vaccine, including at the neurological level. Among the disadvantages, it is also noted the need for sequential administration of 3 doses of the drug and the painfulness of the Euwax B.

Price for Euwax B in pharmacies

There is no reliable data on the price of Euwax B, since the vaccine is currently not available in the pharmacy network.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!