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
  • Shanwak-B
    suspension for injections 
  • Angeryx® B
    suspension w / m 
  • Euwax® B
    suspension w / m 
    Al Gee Life Senses Ltd     The Republic of Korea
  • Dosage form: & nbspSuspension for injection.
    Composition:

    1 ml of the preparation without preservative contains 20 μg HBsAg, 0.5 mg of aluminum hydroxide. 1 ml of the drug with a preservative contains 20 μg HBsAg, 0.5 mg of aluminum hydroxide and 0.05 thiomersal (preservative). The vaccine does not contain substances of human and animal origin.

    Description:

    Shanwak-B - Hepatitis B vaccine A recombinant yeast, "infla" suspension, is a surface antigen of the hepatitis B virus (HBsAg), subtype adw, obtained by recombinant technology of methylotropic yeast Pichia pastoris. The drug contains an adjuvant - aluminum hydroxide gel. The vaccine meets WHO requirements for a recombinant vaccine for the prevention of hepatitis B. No substance of human origin is used in the manufacture of the drug.

    The whitish, slightly opalescent liquid, when settled, is divided into 2 layers: the top layer is a colorless transparent liquid; lower - a gel-like white precipitate that breaks easily when shaken.

    Pharmacotherapeutic group:MIBP vaccine
    ATX: & nbsp

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

    Pharmacodynamics:

    Immunobiological properties

    Conducting a course of vaccination leads to the formation of specific antibodies to the hepatitis B virus in a protective titer in more than 90% of the vaccinated. Vaccination also reduces the incidence of complications associated with hepatitis B - chronic hepatitis B, liver cirrhosis, hepatocellular carcinoma and others.

    Indications:

    Prevention of hepatitis B in children as part of the national calendar of preventive vaccinations and people at high risk of infection with the hepatitis B virus (children and adults in families who have carriers 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 drugs, as well as those on hemodialysis and oncohematological patients; Persons who have experienced contact with the material,infected hepatitis B virus; medical workers who have contact with blood; 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 inject drugs).

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

    Contraindications:

    Hypersensitivity to yeast and other components of the vaccine.

    Strong reaction (temperature above 40 ° C, edema, hyperemia> 8 cm in diameter at the injection site) or complication preceding administering Shanvak or other recombinant hepatitis B vaccine Routine vaccination is postponed until after the acute manifestations of the disease (exacerbation of chronic diseases). When not heavy SARS, acute intestinal diseases and others. Grafting may be carried out after normalization temperature.

    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 provided at an extremely high risk of infection, if the potential benefits outweigh the potential risk to the fetus.

    Dosing and Administration:

    The vaccine is administered intramuscularly: adults, adolescents and older children in the deltoid muscle, newborns and young children - in the antero-lateral region of the thigh. Introduction to another place is undesirable due to a decrease in the effectiveness of vaccination. Persons with diseases of the blood coagulation system may be administered a subcutaneous injection of the vaccine. DO NOT INSERT.

    Before vaccination, the shampoo with Shanwak-B should be shaken well until a whitish uniform suspension is obtained without foreign inclusions. A drug with altered physical properties is not subject to application.

    Single dose is:

    - for children and persons up to 19 years of age - 0.5 ml (10 μg HBsAg )

    - for persons older than 19 years - 1 ml (20 mcg HBsAg )

    - for hemodialysis patients - 2 ml (40 μg HBsAg )

    For injection use a disposable syringe.


    Selection of the drug in a syringe and the vaccination procedure are carried out with strict adherence to the rules of aseptic and antiseptic.

    Place of injection before and after injection is treated with 70% alcohol.

    The drug in the opened multi-dose vial should be used during the working day.

    Vaccination of children in the national calendar of preventive vaccinations.

    Vaccinations are performed three times according to the scheme: 0 (on the day of birth of the child) - 1-6 months.

    Children who are not vaccinated when they reach the age of 13 are vaccinated at this age according to the following scheme: 0-1-6 months.

    Children born to mothers carriers of hepatitis B virus or patients with viral hepatitis B in the third trimester of pregnancy, vaccination is carried out under the scheme: 0 (the day of birth) - 12 - 12 months. Simultaneously with the first vaccination, the child should be injected intramuscularly into another thigh with the human immunoglobulin against hepatitis B at a dose of 100 ME.

    Scheduled vaccinations at other ages.

    Children, adolescents and adults who were not previously vaccinated against hepatitis B are vaccinated according to the scheme 0-1-6 months.

    Inoculations of previously vaccinated individuals who had contact with the material with an infected hepatitis B virus are carried out according to the scheme 0-1-2-12 months. Simultaneously with the first inoculation, one should inject intramuscularly (elsewhere) a human immunoglobulin against hepatitis B at a dose of 100 ME (children under 10 years) or 6-8 IU / kg (other age).

    Patients of the hemodialysis department the vaccine is administered four times at intervals of 1 month.

    Scheduled vaccinations against hepatitis B can be carried out simultaneously (on the same day) with other vaccines of the national immunization schedule (forexclusion of BCG vaccine), as well as inactivated vaccines of the vaccination calendar for epidemiological indications, with the drugs being injected with different syringes into different parts of the body. In the case of an increase in the interval between the first and W with a second vaccination up to 5 months and more than one third of the vaccination is carried out 1 month after the second.

    Shanwak-B can be used to complete the immunization course initiated by other recombinant hepatitis B vaccines.

    Edit Warnings

    Shanwak-B does not prevent diseases caused by hepatitis A, hepatitis C, hepatitis E viruses, as well as pathogens causing other liver diseases. Due to the long incubation period of hepatitis B, there may be a latent infection before or during immunization. In such cases, the use of the vaccine can not prevent hepatitis B.

    The immune response to vaccination is related to the age of the vaccinated. The weaker immune response is for people over the age of 40, as well as those with impaired immunity or previous immunosuppressive therapy. These persons may need additional vaccination, the conclusion about the expediency of which can be made in the case,if the content of specific antibodies is less than 10 IU / l.

    Side effects:Adverse reactions are mild and rapid in nature and occur in individual vaccinated during the first days after vaccination (pain in the vaccination site, fever, malaise, weakness, myalgia, headache, dizziness, nausea, vomiting, diarrhea, abdominal pain, rash) . As with parenteral administration of any other vaccine, it is necessary to have anti-shock therapy at hand, which should be used in case of anaphylactic reaction.
    Special instructions:


    Form release / dosage:

    Suspension for injection.

    Packaging:Firms of the manufacturer SHANTA BIOTEKNIKS LTD:

    1 bottle 0.5 ml - 10 mcg 1 infant dose;

    1 bottle 1.0 ml - 20 mcg 1 adult dose;

    1 vial 5.0 ml - 100 mcg 5 adult doses (10 children's doses);

    1 bottle 10.0 - 200 μg 10 adult doses (20 children's doses).

    The enterprise, carrying out packing and packing in the territory of the Russian Federation W Federation, FGUP "NPO" Microgen "M3 RF:

    1 ampoule 0.5 ml - 10 mcg (no preservative) 1 infant dose;

    1 ampoule 1.0 ml - 20 mcg (no preservative) 1 adult dose;

    For 10 ampoules of vaccine with the Instruction for use, with a knife ampoule or scarifier ampoule in the pack.

    Storage conditions:

    The preparation is stored and transported in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C in a place inaccessible to children. Freezing is not allowed.

    Do not heat above 30 ° C.

    Shelf life:3 years. The drug with expired shelf life is not subject to application.
    Terms of leave from pharmacies:For hospitals
    Registration number:П N013018 / 01
    Date of registration:17.07.2008
    The owner of the registration certificate:Shanta Biotecniks LimitedShanta Biotecniks Limited India
    Manufacturer: & nbsp
    Representation: & nbspShanta Biotecniks LimitedShanta Biotecniks LimitedIndia
    Information update date: & nbsp17.07.2008
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