Active substanceVaccine for the prevention of viral hepatitis AVaccine for the prevention of viral hepatitis A
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  • Dosage form: & nbsp

    Suspension for intramuscular injection for children - 720 units in 0.5 ml (1 dose). Suspension for intramuscular injection for adults - 1440 units per 1 ml (1 dose).

    Composition:

    The 0.5 ml vaccine contains:

    Name

    ingredient

    Content in a single dose

    Appointment

    Antigen of the hepatitis A virus

    720 ELISA units

    Active

    component

    Aluminum

    hydroxide

    0.25 mg

    Adsorbent

    Polysorbate-20

    0.025 mg

    Buffer

    Sodium

    hydrophosphate

    0.575 mg

    Buffer

    Potassium

    dihydrogen phosphate

    0.100 mg

    Buffer

    Sodium chloride

    4,500 mg

    Buffer

    Potassium chloride

    0.115 mg

    Buffer

    The amino acid component

    1.50 mg

    Stabilizer

    Formaldehyde

    Not more than 0.05 mg

    Residual

    component

    Neomycin sulfate

    Not more than 10 mg

    Residual component

    Water for injections

    up to 0.5 ml

    Solvent

    The 1.0 ml vaccine contains:

    Name

    ingredient

    Content in a single dose

    Appointment

    Antigen of the hepatitis A virus

    1440 ELISA units

    Active

    component

    Aluminum

    hydroxide

    0.5 mg

    Adsorbent

    Polysorbate-20

    0.05 mg

    Buffer

    Sodium

    hydrophosphate

    1.15 mg

    Buffer

    Potassium

    dihydrogen phosphate

    0.20 mg

    Buffer

    Sodium chloride

    9.00 mg

    Buffer

    Potassium chloride

    0.23 mg

    Buffer

    Amino acid

    component

    3.00 mg

    Stabilizer

    Formaldehyde

    Not more than 0.1 mg

    Residual

    component

    Neomycin

    sulfate

    Not more than 20 mg

    Residual

    component

    Water for injections

    up to 1.0 ml

    Solvent

    Description:

    Havrix® is an inactivated vaccine for hepatitis A prophylaxis. It is a sterile suspension of formaldehyde inactivated hepatitis A virions (HM 175 strain) grown in human diploid cells MRC5, concentrated and adsorbed on aluminum hydroxide.

    Homogenous white suspension When standing, a colorless supernatant is formed and a slowly precipitating white precipitate that breaks easily when shaken.

    Pharmacotherapeutic group:Vaccine for the prevention of hepatitis A.
    ATX: & nbsp

    J.07.B.C.02   Hepatitis A virus - purified antigen

    Pharmacodynamics:

    IMMUNOLOGICAL PROPERTIES

    Havrix provides protection against hepatitis A, forming a long-term specific immunity by inducing the production of antibodies against the hepatitis A virus (HAV).

    In clinical trials, it was shown that in 99% of vaccinated patients, seroconversion occurs within 30 days after the administration of the first dose of the vaccine. When studying the kinetics of the immune system, early and rapid seroconversion was demonstrated after the first dose of Havrix vaccine: 79% vaccinated patients on the 13th day, 86.3% on the 15th day, 95.2% on the 17th day, and 100% on the 19th day, that is, for a shorter time compared to the average length of the incubation period of hepatitis A (4 weeks).

    To ensure long-term protection, a second (revaccinating) dose is needed between 6 and 12 months after the first dose of the vaccine is administered. Virtually all vaccinated patients seroconversion occurred within one month after the administration of the revaccinating dose.

    However, if a booster vaccine was not conducted between 6 and 12 months after the administration of the first dose of the Havrix® vaccine, the administration of the revaccination dose may be delayed for up to 60 months. When a booster dose is given within a period of up to 60 months after the administration of the first dose of the vaccine, an induction of antibody production is observed, the extent of which is similar to that of a booster dose in the period of 6 to 12 months after the administration of the first dose.In the course of clinical trials, prolonged retention of the titer level of anti-HAV antibodies after administration of two doses of Havrix® vaccine with a dose interval from 6 to 12 months.

    Data obtained over 17 years of observations indicate
    preservation of a seropositive response in
    vaccinated 17 years after the initial vaccination with Havriks in 100% of cases (vaccination schedule 0-6 months). Based on these data, the predicted duration of immune protection was also calculated, which was 30 years in more than 95% vaccinated and 40 years old 90% of the vaccinated.

    Based on the available data, it can be concluded that persons with
    Immunized immune status after the course of vaccination,
    consisting of the introduction of vaccine and revaccination doses, no
    the need for repeated revaccination.


    Indications:

    Prevention of hepatitis A from 12 months of age.

    Contraindications:

    Hypersensitivity to any component of the vaccine; symptoms of hypersensitivity to previous administration of Havrix®.

    Acute infectious and non-infectious diseases, exacerbation of chronic diseases are temporary contraindications for vaccination; at non-severe acute respiratory viral infections, acute intestinal diseases, vaccinations are carried out immediately after the temperature normalization.

    PRECAUTIONARY MEASURES

    Havrix® does not provide protection against hepatitis caused by other pathogens, such as hepatitis B virus, hepatitis C virus, hepatitis E virus, and other known pathogens that damage the liver.

    Havrix® should be administered with caution to patients with thrombocytopenia or. with violations of the blood coagulation system, since after intramuscular injection, such patients may experience bleeding. After the injection patients should apply a pressure bandage (but not rub off) for at least 2 minutes.

    In patients on hemodialysis, as well as in patients with impairments from the immune system after a single dose of Havrix®, the immune response may be reduced. Such patients may require additional doses of the vaccine.

    As with parenteral administration of any other vaccine, all must be ready necessary for the relief of possible anaphylactic reaction to Havrix®. Vaccinated should be administered medical supervision during 30 minutes after immunization.

    After vaccination, or sometimes in front of it, fainting or severe weakness is possible as a psychological reaction to injection. Before vaccination it is important to make sure that the patient does not receive damage in the event of a syncope. Havrix® under no circumstances should not be administered intravenously.

    Carefully:


    Pregnancy and lactation:Due to the lack of adequate data on the use of the vaccine during pregnancy and lactation, it is not recommended to administer Havrix® to pregnant and lactating women, despite the minimal risk of exposure to inactivated vaccines for the fetus and the baby.
    Dosing and Administration:

    Method of administration

    Havrix® is administered intramuscularly.

    Before administration, the vaccine should be visually inspected for foreign matter and changes in appearance. Immediately before the administration of Havriks®, the vial or syringe should be vigorously shaken until a slightly cloudy white suspension is obtained. If any deviations from the norm are found in the vaccine, then such a package with the vaccine must be destroyed.

    For adults and older children, the vaccine should be introduced into the deltoid muscle region, and children 12-24 months old should be injected into the anterolateral region of the thigh.

    The vaccine should not be injected into the gluteus muscle, but also subcutaneously / intradermally, because with such routes of administration, the formation of antibodies to the hepatitis A virus may not reach the optimal level.

    Vaccination schedule

    Single dose for vaccinesFor adults and adolescents 16 years and older is 1.0 ml, for children and adolescents under 16 years - 0.5 ml. The optimal time for the introduction of the revaccinating dose is 6-12 months after the administration of the vaccination dose, which ensures a long-term protection of the vaccinated.

    If the booster vaccination is not carried out within 6 to 12 months, if necessary, protection against infection with hepatitis A, the booster is given within 60 months after the first dose.

    Side effects:
    The security profile presented below is based on data collected in
    The result is the observation of more than 5300 patients.
    Frequency of occurrence of undesirable phenomena is determined as follows:
    very often:> 10%
    often:> 1% and <10%
    sometimes:> 0.1% and <1%
    rarely:> 0.01% and <0.1%
    very rarely: <0.01%,
    Clinical Trials Data:
    Infections and infestations: sometimes - infections of the upper respiratory tract, rhinitis.
    From the side of metabolism and nutrition: often - loss of appetite.
    Neurological and psychiatric disorders: very often - irritability, headache; often drowsiness; sometimes - dizziness; rarely - reduced sensitivity, parasthesia.
    From the gastrointestinal tract: often - gastrointestinal symptoms (such as diarrhea, nausea, vomiting).
    From the skin and subcutaneous fat: sometimes - a rash; rarely - itching.
    From the osteomuscular system and connective tissue: sometimes - myalgia, musculoskeletal tension.
    General and local reactions: very often - pain and redness at the injection site, fatigue; often - malaise, fever (> 37.5 ° C), swelling and tightness in. place of administration; sometimes - influenza-like symptoms; rarely - chills.
    Post-production data:
    From the immune system: anaphylaxis, allergic reactions, including anaphylactoid reactions and allergic symptoms reminiscent of those with serum sickness.
    From the nervous system: convulsions.
    From the cardiovascular system: vasculitis.
    From the skin and subcutaneous fat: angioedema, urticaria, erythema multiforme.
    From the osteomuscular system and connective tissue: arthralgia.


    Overdose:

    As a result of post-registration surveillance, cases of overdose have been reported. The adverse events that occurred as a result of an overdose were similar to those observed when the recommended dose of the vaccine was administered.

    Interaction:

    Havrix® can be administered concomitantly with inactivated vaccines of the National calendar of preventive vaccinations and a calendar of preventive vaccinations for epidemic indications.

    With simultaneous administration with inactivated vaccines against typhoid fever, cholera, tetanus, and yellow fever, a decrease in the immune response to Havrix® was not observed. Since Havrix® is an inactivated vaccine, it is unlikely that its simultaneous administration with other inactivated vaccines will lead to a disruption in the formation of an immune response. With the simultaneous administration of immunoglobulins, the protective effect of the vaccine does not decrease.

    If it becomes necessary to administer Havrix® with other vaccines or immunoglobulins, the drugs are administered using different syringes and needles in different parts of the body.

    Special instructions:

    Immunization with Havrix® is especially recommended for people at increased risk of infection, as well as for people who have hepatitis A or who have severe hepatitis A, or who, because of their professional status, can cause outbreaks. These include:

    -Persons living in areas with a high incidence of hepatitis A;

    - persons traveling to regions with a high incidence of hepatitis A (military personnel, travelers, etc.);

    - face, contact in the hearths. Postexposure prophylaxis of Havrix® does not guarantee 100% effectiveness and depends on the time, the moment of contact with the hepatitis A virus, the infectious dose and the predicted state of health of the vaccinated;

    - persons at occupational risk of infection: medical staff and nursing staff (especially in infectious, gastroenterological and pediatric departments); personnel of preschool institutions; employees of sewerage and water supply services; personnel of the food industry and public catering establishments;

    -persons from special groupsrisk (patients with chronic liver disease or an increased risk of liver disease, patients with hemophilia, patients with multiple blood transfusions, drug addicts, homosexuals, people with promiscuity).

    Vaccination of Havrix® is also indicated to all other population groups.

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

    It is unlikely.

    Form release / dosage:

    Suspension for intramuscular injection for children - 720 units in 0.5 ml, 1440 units in 1 ml.

    Packaging:For 0.5 ml in a disposable syringe with a capacity of 1.5 ml of borosilicate glass type I USP with a needle 23G5/8 stainless steel type 304 and polypropylene piston, equipped with a protective cap made of rubber, covering the needle.
    Storage conditions:

    CONDITIONS OF TRANSPORTATION

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

    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 expiry date printed on the package. Expiration date is the last day of the month indicated on the package.

    Terms of leave from pharmacies:For hospitals
    Registration number:П N013236 / 01
    Date of registration:09.08.2007
    The owner of the registration certificate:GlaxoSmithKline Trading, ZAO GlaxoSmithKline Trading, ZAO Russia
    Manufacturer: & nbsp
    Representation: & nbspZAO "GlaxoSmithKline Trading"ZAO "GlaxoSmithKline Trading"
    Information update date: & nbsp05.11.2014
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