Euwax® B (Euvax® B)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceVaccine for the prevention of viral hepatitis BVaccine for the prevention of viral hepatitis B
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    Al Gee Life Senses Ltd     The Republic of Korea
    • Dosage form: & nbsp

    Suspension for intramuscular injection.

    Composition:composition for 1 dose:

    Active ingredient:

    Dose for children (0.5 ml)

    Adult Dose (1.0 mL)

    The surface antigen of the hepatitis B virus (HBsAg) purified

    10 μg

    20 μg

    Excipients:



    Aluminum Hydroxide Gel

    (for aluminum)

    0.25 mg

    0, 50 mg

    Thiomersal

    0.004 m / o%

    0.004 m / o%

    Potassium dihydrogen phosphate

    (buffering agent)

    q.s.

    q.s.

    Sodium hydrogen phosphate

    (buffering agent)

    q.s.

    q.s.

    Sodium chloride

    4.25 mg

    8.50 mg

    Water for injections

    up to 0.5 ml

    up to 1.0 ml
    Description:

    Euwax B is a highly purified, non-infectious polypeptide of the surface protein (HBsAg) of the hepatitis B virus adsorbed on aluminum hydroxide. The drug is a genetically engineered vaccine produced by recombinant DNA technology - production HBsAg in yeast cells Saccharomyces cerevisiae.

    The whitish, homogeneous slightly opalescent suspension, when settled, is divided into 2 layers: the upper one is a colorless transparent liquid, the lower one is a white precipitate that breaks easily when shaken.

    Pharmacotherapeutic group:MIBP vaccine
    ATX: & nbsp

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

    Pharmacodynamics:

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

    Indications:Specific prevention of infection caused by all known subtypes of the hepatitis B virus in children aged 1 year and adults.
    Contraindications:

    Hypersensitivity to baking yeast, as well as to any component of the vaccine; the allergic reaction observed with the previous administration of the drug.

    Strong reaction (temperature above 40 ° C, swelling and hyperemia at the injection site exceeding 8 cm in diameter) or post-vaccination complications for previous administration of the drug, acute infectious or non-infectious diseases, exacerbation of chronic diseases - vaccinations are carried out 2-4 weeks after recovery or remission . With non-severe acute respiratory infections, acute intestinal diseases, etc.Inoculations are carried out after the temperature is normalized.

    Pregnancy and lactation:

    Impact HBsAg on fetal development has not been studied. However, as with any inactivated vaccine, it is unlikely that the drug will affect the embryo or fetus. However, the Euvax B vaccine can be used in pregnant women only if the high risk of infection with the hepatitis B virus exceeds the possible adverse effect.

    The effect of the Euvax B vaccine on infants after vaccination of their mothers has not been studied in special studies. However, there are no contraindications for using this vaccine in nursing mothers.

    Dosing and Administration:

    Before administration, the preparation should be shaken well, since a small amount of precipitate may be formed during storage (white with a clear, colorless supernatant).

    Euvax vaccine is given intramuscularly, children of the first years of life - in the upper-outer surface of the middle part of the thigh, patients of other ages - in the deltoid muscle. Do not inject Euvax B into the gluteal region.

    When administering the vaccine, make sure that the needle does not enter the vascular bed.

    - Pediatric dose (from 1 year to 15 years (inclusive)): 0.5 ml (10 μg HBsAg).

    - Adult dose (for persons from 16 years of age): 1.0 ml (20 μg HBsAg).

    Vaccination of children from 1 year to 18 years and adults from 18 to 55 years, not belonging to risk groups, is carried out in accordance with the National Calendar of preventive vaccinations in Russia according to the scheme 0-1-6 months. (The first dose is the selected date, the second dose is given 1 month after the administration of the first dose, the third dose after 6 months after the administration of the first dose).

    For patients with suspected infection with hepatitis B virus and people going to regions with a high incidence, there is an alternative vaccination scheme: 1st dose - selected date, 2nd dose - after 1 month. after the introduction of the first dose, the third dose - after 2 months. after the introduction of the first dose, revaccination - after 12 months. after the first dose of primary immunization.

    Revaccination: WHO does not recommend revaccination because it was shown that vaccination with three doses of the vaccine for the prevention of hepatitis B provides protection for up to 15 years, in addition, if the protective level of antibodies in the blood decreases after this time, the organism of the vaccinated person remains able to provide a protective level of antibodies in response to contact with the virus hepatitis B.At the same time, revaccination can be recommended by the vaccination program at the regional level.

    The introduction of additional doses of the vaccine (according to the age-related dosage) can be shown to patients on hemodialysis and immunodeficiencies, since protective titers of antibodies (> 10 IU / L) in this category of patients after primary immunization may not be induced.

    Side effects:

    Disturbances from the circulatory and lymphatic systems:

    Rarely - 1/10000 prescriptions (<0.01%): neutropenia.

    Disorders from the gastrointestinal tract:

    Often - 1/100 appointments (1-10%): abdominal pain, diarrhea, vomiting.

    Rarely - 1/10000 prescriptions (0.01-0.1%): nausea.

    General disorders and reactions at the site of administration:

    Often - 1/10 appointments (> 10%): pain in the injection site.

    Often - 1/100 appointments (1-10%): fever, tightness, swelling, tenderness at the injection site.

    Rarely - 1/10000 prescriptions (0.01-0.1%): malaise, fatigue.

    Infectious and parasitic diseases:

    Infrequently - 1/1000 appointments (0.1-1%): candidiasis, rhinitis.

    Laboratory and instrumental data:

    Rarely - 1/10000 prescriptions (0.01-0.1%): transient increase in activity transaminase.

    Disorders from the metabolism and nutrition:

    Often - 1/100 appointments (1-10%): anorexia.

    Disturbances from the musculoskeletal and connective tissue:

    Rarely - 1/10000 prescriptions (0.01-0.1%): myalgia, arthritis.

    Onof the nervous system:

    Rarely - 1/10000 prescriptions (<0.01%): optic neuritis, paralysis facial nerve, Guillain-Barre syndrome, exacerbation of multiple sclerosis.

    Often - 1/100 appointments (1-10%): unusual crying, drowsiness.

    Rarely - 1/10000 prescriptions (0.01-0.1%): headache, dizziness.

    Pregnancy, postpartum and perinatal conditions:

    Infrequently - 1/1000 appointments (0.1-1%): jaundice.

    Disorders of the psyche:

    Often - 1/100 appointments (1-10%): insomnia, increased excitability.

    Disturbances from the skin and subcutaneous tissues:

    Often - 1/100 appointments (1-10%): erythematous rash, redness.

    Infrequently - 1/1000 appointments (0.1-1%): pink lichen, rash, maculopapular rash.

    Disorders from the cardiovascular system:

    Often - 1/100 appointments (1-10%): hematoma.

    In the course of clinical studies, the vaccine Euvaks B has not been reported in allergic reactions. In the course of post-marketing surveillance, three cases of hypersensitivity reaction were recorded (erythematous-papular rash, hives, reddening and edema of the eyelids, scleral hyperemia,skin itching) after the introduction of the vaccine.

    Overdose:

    Cases of overdose are unknown.

    Interaction:

    Euwax B can be used simultaneously (in one day) with vaccines for the prevention of diphtheria, tetanus, whooping cough, rubella, measles, mumps or polio. In this case, the drugs are injected into different parts of the body using different syringes.

    Special instructions:

    Vaccination should be postponed in the presence of an acute, accompanied by a fever, a disease.

    In patients with multiple sclerosis, vaccination, like any other stimulation of the immune system, can cause an exacerbation of symptoms. Therefore, when vaccinating these patients, the benefits of using the vaccine should be carefully weighed against the possible risk of exacerbation of the disease (see Adverse Reactions). Given the theoretical possibility of developing allergic reactions of immediate type, during vaccination it is necessary to have available drugs necessary to provide emergency assistance in case of an anaphylactic reaction, and vaccinated should be under medical supervision for at least 30 minutes after vaccination.

    Immunization may be ineffective in persons vaccinated in the latent or progressing stage of hepatitis B.

    Effect on the ability to drive transp. cf. and fur:

    Studies to study the effect of the vaccine on the ability to drive cars and other mechanisms were not conducted.

    Form release / dosage:

    Suspension for intramuscular injection of 20 μg / ml.

    Packaging:

    0.5 ml (1 dose for children), 1.0 ml (1 dose for adults), 5.0 ml (10 doses for children), 10.0 ml (10 doses for adults) in a vial of clear glass.

    For 1, 10 or 20 bottles of 0.5 ml or 1.0 ml with instructions for use in a cardboard pack.

    For 10 vials of 5.0 ml or 10.0 ml with instructions for use in a cardboard pack.

    Storage conditions:

    At a temperature of 2 to 8 ° C. Do not freeze.

    Keep out of the reach of children.
    Shelf life:

    3 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N011073
    Date of registration:27.10.2006
    The owner of the registration certificate:Al Gee Life Senses LtdAl Gee Life Senses Ltd The Republic of Korea
    Manufacturer: & nbsp
    LG LIFE SCIENCES, Ltd. The Republic of Korea
    Representation: & nbspSanofi Aventis GroupSanofi Aventis Group
    Information update date: & nbsp21.07.2014
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