Active substanceVaccine for the prevention of viral hepatitis BVaccine for the prevention of viral hepatitis B
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  • COMBIOTECH NPK, ZAO     Russia
  • BINNOFARM, CJSC     Russia
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  • Dosage form: & nbspFROMfor intramuscular administration [without preservative].
    Composition:

    1 adult dose (1 ml) contains:

    With a preservative

    Without preservative

    active substance:

    purified surface antigen of the hepatitis B virus (HBsAg)

    20 μg

    20 μg

    Excipients:

    thiomersal (meriolyate) (preservative)

    50 μg

    -

    aluminum hydroxide (in terms of Al3+) (sorbent)

    0.5 mg

    0.5 mg

    components of the buffer solution:

    sodium chloride

    8.77 mg

    8.77 mg

    sodium hydrogen phosphate

    0.78 mg

    0.78 mg

    sodium dihydrogen phosphate dihydrate

    0.71 mg

    0.71 mg

    sodium hydroxide

    to pH 6.95-7.05

    to pH 6.95-7.05

    water for injections

    up to 1 ml

    up to 1 ml

    A pediatric dose (0.5 ml) contains:

    With a preservative

    Without preservative

    active stuffctin:

    purified surface antigen of hepatitis B virus (HBsAg)

    10 μg

    10 μg

    excipients:

    thiomersal (merthiolate) (preservative)

    25 μg

    -

    aluminum hydroxide (in terms of Al3+) (sorbent)

    0.25 mg

    0.25 mg

    components of the buffer solution:

    sodium chloride

    4.38 mg

    4.38 mg

    sodium hydrogen phosphate

    0.39 mg

    0.39 mg

    sodium dihydrogen phosphate dihydrate

    0.36 mg

    0.36 mg

    sodium hydroxide

    to pH 6.95-7.05

    to pH 6.95-7.05

    water for injections

    up to 0.5 ml

    up to 0.5 ml

    Description:

    A homogeneous suspension of white or white with a grayish hue of color, with no visible foreign particles, separated after settling on a clear supernatant and a white precipitate with a grayish hue, easily resuspended by shaking.

    Pharmacotherapeutic group:MIBP vaccine
    ATX: & nbsp

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

    Pharmacodynamics:

    Regevac® B is a preparation based on the surface antigen of the hepatitis B virus (serotype ayw), obtained by DNA recombination on a yeast culture Hansenula polymorpha, transformed by inserting into their genome a gene that codes for the surface antigen of the hepatitis B virus.

    Immunobiological properties

    Conducting a course of vaccination leads to the formation of specific antibodies to the hepatitis B virus in more than 90% of those vaccinated in a protective titer.

    Indications:

    Prevention of hepatitis B in children in the national calendar of preventive vaccinations and people at high risk of infection with the hepatitis B virus: children and adults with families who have a carrier HBsAg or a patient with chronic hepatitis B; children of children's homes, orphanages and boarding schools, children and adults who regularly receive blood and its preparations, as well as those on hemodialysis, and oncohematological patients; Persons who have been exposed to material infected with the hepatitis B virus; medical workers who have contact with the blood of patients; persons engaged in the production of immunobiological preparations from donor and placental blood; students of medical institutes and students of secondary medical educational institutions (primarily graduates); persons who use drugs by injection.

    In addition to the above categories, vaccinations should be given to all other population groups.

    Contraindications:

    Hypersensitivity to yeast and other components of the vaccine.

    The pronounced reaction (temperature above 40 ° C, edema, hyperemia more than 8 cm in diameter at the site of administration) or complication of the previous administration of hepatitis B vaccine.

    Acute infectious and non-infectious diseases, chronic diseases in the acute stage - immunization is performed no earlier than 1 month after recovery (remission).

    With mild forms of acute respiratory viral infection and acute intestinal infections, grafting can be carried out after normalizing the temperature.

    The use of a vaccine containing a preservative is unacceptable when vaccinating children of the first year of life and pregnant women.

    Pregnancy and lactation:

    The effect of the vaccine on the fetus has not been studied. The possibility of vaccination of a pregnant woman can be considered at an extremely high risk of infection, provided use of an unprepared vaccine.

    Dosing and Administration:

    The vaccine is injected intramuscularly into the deltoid muscle, newborns and young children into the upper-upper surface of the middle part of the thigh: introduction to another place reduces the effectiveness of vaccination. Before the introduction of the ampoule or syringe shake.

    When vaccinating children of the first year of life and pregnant women, vaccines that do not contain preservatives are used.

    A single dose for newborns and persons under 18 years of age is 0.5 ml (10 μg HBsAg). A single dose from 19 years is 1 ml (20 μg HBsAg).

    A single dose for hemodialysis patients was 2 ml (40 μg HBsAg).

    The vaccine in ampoules containing 1 ml of the drug (adult dose) can be used to vaccinate 2 children provided they are simultaneously vaccinated.

    A vaccine in a syringe is designed to vaccinate only one patient.

    Vaccination is performed within the national calendar of preventive vaccinations.

    Vaccination against viral hepatitis B is administered to all newborns in the first 24 hours of the child's life.

    Newborns from the risk group are vaccinated according to the scheme 0-1-2-12 (the first dose in the first 24 hours of life, the second dose at the age of 1 month, the third dose at the age of 2 months, the fourth dose at the age of 12 months. ).

    Simultaneously with the first vaccination, it is recommended to inject an intramuscularly into another thigh the human immunoglobulin against hepatitis B at a dose of 100 ME. The same scheme vaccinates children at risk, not vaccinated in the maternity hospital for medical contraindications after the removal of the latter.

    Children who were not vaccinated before the age of 1 and who are not at risk, as well as adolescents and adults not vaccinated before, are vaccinated according to the following scheme: 0-1-6 (1 dose - at the time of vaccination, 2 dose - after 1 month after 1 inoculation, 3 dose at 6 months from the start of immunization.)

    Note: in the case of lengthening the interval between the first and second vaccinations to 5 months or more, the third inoculation is carried out 1 month after the second.

    Inoculations in persons who have had contact with material infected with the hepatitis B virus are carried out according to the scheme 0-1-2 months. Simultaneously with the first vaccination, it is recommended to inject the immunoglobulin of a person against hepatitis B intramuscularly (in another place) at a dose of 100 ME (children under 10 years) or 6-8 IU / kg (other ages). Those who received a previous full course of vaccination against hepatitis B before the second vaccination determine the content of antibodies to HBsAg. If the antibody titers are at least 100 IU / L, the second and third vaccinations are not performed.

    Persons at risk, due to professional duties who have constant contact with blood, should annually undergo an examination for the content of antibodies to HBsAg. In the case of a decrease in the antibody titer below 100 IU / l, a one-dose vaccine is recommended for revaccination.

    Vaccinated patients who are planning surgical interventions are recommended an emergency vaccination schedule 0-7-21 days, and subsequent revaccination with a single dose of the vaccine after 12 months.

    Patients of the hemodialysis department receive the vaccine four times according to the scheme 0-1-2-6 months. For injection of the drug in ampoules, only a disposable syringe is used. Place of injection before and after injection is treated with 70% alcohol. Opening of ampoules or syringes and the vaccination procedure are carried out with strict adherence to aseptic and antiseptic rules.

    Do not administer intravenously.

    The drug in an ampoule or syringe should be used immediately after opening the package.

    Instructions for use

    The device and the procedure for working with a syringe with an automatic needle protection device

    A syringe device with an automatic needle protector.

    Description: 1. stock; 2. clamps; 3. protective cover; 4. protective cap; 5. needle.

    a - the type of syringe with the needle protection device before injection, b - the type of the syringe with the needle protection device after the injection

    After completion of the injection, the needle and syringe will move back to the protective device.

    Attention! Avoid contact with the clips during syringe preparation! The device is activated by pressing the rod to the terminals.

    Application Rule:

    1.Carefully inspect the prefilled glass syringe with a protective device.

    2. Remove the protective cap from the needle.

    3. Carry out the injection according to the standard procedure. Press the rod with your thumb and hold until the entire dose of the drug has been injected. The protective device is not activated until the entire dose of the drug has been injected.

    4. Remove the needle, release the stem, allow the protective casing to move forward until the needle is completely protected and locked in place.

    The procedure for working with a syringe with a non-automatic needle protection device

    1. Injection according to standard procedure.

    Attention! When carrying out the injection, it is necessary to keep the fingers on the protective cover to prevent premature activation of the protective device.

    2. After the injection, move the protective device along the needle. An audible click will indicate the correctness of the action. During the entire procedure, the fingers should be behind the needle.

    Side effects:

    Side effects when using the vaccine are rare. In 5-10% of cases, the appearance of pain, erythema and compaction at the injection site. The introduction of the drug occasionally possible: a slight increase in temperature,complaints of malaise, weakness, joint pain, muscle pain, headache, dizziness, nausea, vomiting, abdominal pain.

    All reactions to the administration are weak and usually go through 2-3 days after the injection.

    Given the possibility of developing allergic reactions of immediate type in especially sensitive individuals, vaccinated people should be provided with medical supervision within 30 minutes from the moment of vaccination.

    Vaccination sites should be provided with anti-shock therapy.

    Interaction:

    Routine inoculations against hepatitis B can be carried out simultaneously (on the same day) with vaccines of the national calendar of preventive vaccinations (with the exception of BCG vaccine), as well as inactivated vaccines of the vaccination schedule for epidemiological indications.

    The hepatitis B vaccine can be given with antiallergic drugs.

    Interaction with other drugs has not been established.

    Form release / dosage:Suspension for intramuscular injection [without preservative, preservative], 20 μg / ml.
    Packaging:

    Ampoules: 1.0 ml (adult dose) or 0.5 ml (infant dose) of the drug in glass ampoules.

    5 ampoules are placed in a contour mesh package made of a polyvinyl chloride film.

    For 1 or 2 contour mesh packages together with a knife ampoule or scarifier and instructions for use are placed in a cardboard box. When using ampoules with incisions, rings or fracture points, a scarifier or ampoule knife is not inserted.

    Syringes

    For 1.0 ml (adult dose) or 0.5 ml (infantile dose) of the drug in a sterile disposable syringe of neutral glass (with or without automatic or non-automatic needle protection device).

    By 1 or 3 syringes in a contour mesh package made of a film of PVC with or without coating.

    1 or 2 (for 3 syringes), contour mesh packages are put in a cardboard box together with instructions for use.

    Storage conditions:

    Transport and store in accordance with SP 3.3.2.1248-03.

    Transport at a temperature of 2 to 8 ° C.

    Short-term (not more than 72 hours) transportation at a temperature of 9 to 30 ° C is allowed. Freezing is not allowed.

    Store at a temperature of 2 to 8 ° C. Freezing is not allowed.

    Shelf life:

    3 years.

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

    Terms of leave from pharmacies:For hospitals
    Registration number:P N003741 / 01
    Date of registration:01.10.2009 / 01.09.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:BINNOFARM, CJSC BINNOFARM, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspBINNOFARM CJSC BINNOFARM CJSC Russia
    Information update date: & nbsp17.12.2016
    Illustrated instructions
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