Havrix vaccine against hepatitis A for children syringes 0.5 ml


general description

HAVRIX is a vaccine designed to provide active immunization against disease caused by hepatitis A virus (HAV). It is approved for use by people aged 12 months and older. Primary immunization should be carried out at least 2 weeks before expected exposure to HAV.

The hepatitis A virus belongs to the picornavirus family. It is one of several hepatitis viruses that cause systemic liver disease.

The incubation period for hepatitis A averages 28 days (range 15 to 50 days). The course of treatment depends on the severity of the disease. Hepatitis A infection is extremely varied, ranging from asymptomatic infection to icteric hepatitis, which is fatal.

The presence of antibodies to HAV provides protection against hepatitis A infection. However, the minimum titer required to provide protection has not been determined.

"HAVRIX" - vaccination against hepatitis A

Viral inactivated hepatitis A antigen
Manufacturer: GlaxoSmithKline Biologicals, Belgium.

Protects against viral diseases: hepatitis A.

Trying on:

  • Vaccine "Havrix 720 units" - for vaccination of children under 16 years of age.
  • Vaccine "Havrix 1440 units" - for vaccination of children over 16 years of age and adults.

Not included in the national calendar of preventive vaccinations in Russia.

Compound

Each 1 ml dose of the vaccine for adults contains 1440 EL.U. viral antigen adsorbed onto 0.5 mg of aluminum in the form of aluminum hydroxide. Each 0.5 ml dose of vaccine for children contains 720 EL.U. viral antigen adsorbed onto 0.25 mg of aluminum in the form of aluminum hydroxide.

The virus (strain HM175) replicates in human diploid MRC-5 cells. After removal of the culture medium, the cells are lysed to form a suspension. This purification is carried out using ultrafiltration and gel permeation chromatography procedures. Treatment of this lysate with formaldehyde inactivates the viruses. Viral antigen activity follows the standard established using an enzyme-linked immunosorbent assay (ELISA) and is therefore expressed in ELISA Units (EL.U.).

Compatibility with other vaccines

The Havrix vaccine can be administered simultaneously with such vaccines of the National Preventive Vaccination Calendar and the Preventive Vaccination Calendar for epidemic indications, such as: a vaccine for the prevention of typhoid fever, a vaccine for the prevention of yellow fever, a vaccine for the prevention of tetanus, monovalent and combined vaccines for the prevention of measles, mumps , rubella, chickenpox.

When administered simultaneously with human immunoglobulins, the protective effect of the vaccine is not reduced.

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

Description

HAVRIX (hepatitis A vaccine) is a sterile suspension of inactivated virus for intramuscular injection.

HAVRIX is administered intramuscularly.

Children and teenagers:

  • single dose 0.5 ml and revaccination 0.5 ml;
  • the dose is administered 6 to 12 months later.
  • Adults:

  • administer a single dose of 1 ml and a booster dose of 1 ml;
  • 6 to 12 months later.

Shake the suspension well before use. When thoroughly mixed, HAVRIX is a homogeneous, cloudy, white solution. Do not enter unless otherwise indicated. Parenteral drugs should be inspected visually for particulate matter and discoloration before administration. If there is any deviation from these conditions, the vaccine should not be administered. For prefilled syringes, attach a sterile needle and inject intramuscularly.

Indications for vaccination with Havrix

Children and adults who are or will be at risk of contracting viral hepatitis A should be vaccinated:

people living in areas with high incidence of hepatitis A;

  • children and adults traveling on vacation or for work to regions with a high incidence of hepatitis A (military personnel, travelers, etc.);
  • children and adults visiting swimming pools;
  • children and adults visiting public catering places (restaurants, cafes);
  • people who are contacts of hepatitis A outbreaks;
  • people at occupational risk of infection: medical personnel and patient care personnel (especially in infectious diseases, gastroenterological and pediatric departments); staff of preschool institutions; sewer and water supply workers; food industry and catering personnel;
  • persons from special risk groups (patients with chronic liver disease or an increased risk of liver disease; patients with hemophilia; patients with multiple blood transfusions; drug addicts; homosexuals; persons who are promiscuous).
  • Special conditions

    Warnings and precautions include:

    • Prefilled syringe caps contain natural rubber latex, which may cause allergic reactions.
    • Fainting (loss of consciousness) may occur due to injectable vaccines, including HAVRIX. Procedures must be on-site, with a physician present, to avoid injury from falls and restore cerebral perfusion after syncope.

    The safety and effectiveness of HAVRIX in pregnant women and nursing mothers have not been established.

    Possible side effects

    Pain and redness at the injection site, fatigue, malaise, fever (≥ 37.5°C), injection site reactions (such as swelling or induration), diarrhea, nausea, vomiting, headache, drowsiness, loss of appetite.

    Anaphylaxis, allergic reactions, including anaphylactoid reactions and symptoms of an allergic condition resembling those of serum sickness. Cramps. Vasculitis. Angioedema, urticaria, erythema multiforme. Arthralgia.

    Havrix should be administered with caution to patients with thrombocytopenia or bleeding disorders as bleeding may occur in these patients following intramuscular injection. After the injection, such patients should apply a pressure bandage (but do not rub) for at least 2 minutes. The vaccinated person must be under medical supervision for 30 minutes after immunization.

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    Contraindications

    Only a doctor can decide whether Havrix is ​​suitable for a child to be vaccinated

    Vaccination with Havrix is ​​contraindicated if there is a history of an allergic reaction to any component of the vaccine and in the following cases:

      Acute infectious and non-infectious diseases, exacerbations of chronic diseases. It is a temporary contraindication for vaccination. The vaccination is carried out no earlier than 1 month after recovery (remission). For mild ARVI and acute intestinal diseases, vaccination can be carried out immediately after the temperature has returned to normal.
    • Severe reaction (temperature above 40°C; hyperemia, swelling at the injection site with a diameter of more than 8 cm) with the previous administration of the drug.
    • Immunodeficiency conditions, malignant blood diseases and neoplasms.
    • Pregnancy.
    • Hypersensitivity to any component of the vaccine.
    • Hepatitis A seropositivity

    Vaccine Havrix 1440

    Havrix is ​​a vaccine for the prevention of hepatitis A. Promotes the formation of immunity against the hepatitis A virus. Indicated for active immunization of individuals with an increased risk of developing hepatitis A. Two doses of the vaccine, administered with an interval of 6-12 months, provide protection against clinically manifest forms of hepatitis A at a period of no less than 20 years.

    Properties and action

    Havrix is ​​a vaccine for the prevention of hepatitis A. Havrix promotes the formation of immunity against the hepatitis A virus (HAV) by inducing the production of specific anti-HAV antibodies and the formation of memory lymphocytes. The number of antibodies that appear after using the Havrix vaccine is practically no different from the number of antibodies to the hepatitis A virus in people who have had this disease. In most patients, antibodies circulate in the blood for at least 1 year after the initial course of Havrix vaccination. To provide longer-term protection against infection, a second dose of Havrix is ​​recommended. Two doses of the Havrix vaccine, administered at intervals of 6-12 months, provide protection against clinically manifest forms of hepatitis A for a period of at least 20 years. In clinical studies of Havrix, which included individuals aged 18 to 50 years, the formation of antibodies to the hepatitis A virus antigen was detected in more than 88% of those vaccinated on day 15 and in 99% 1 month after administration of one dose of the vaccine Havrix (containing 1440 ELISA units). In clinical studies of Havrix, which included individuals aged 1 to 18 years, the formation of antibodies to the hepatitis A virus antigen was detected in more than 93% of those vaccinated on day 15 and in 99% 1 month after administration of one dose Havrix (containing 720 ELISA units). Clinical studies have shown that the use of the Havrix vaccine is effective in the early incubation period of the disease, incl. during outbreaks and foci of infection in the family. The Havrix vaccine does not reduce its effectiveness if there are maternal antibodies to the hepatitis A virus or passively administered antibodies to the hepatitis A virus in the blood of the vaccinated person. Simultaneous administration of normal human immunoglobulin or specific immunoglobulin to the hepatitis A virus with the Havrix vaccine is allowed in both children and adults.

    Pharmacokinetics

    The Havrix vaccine is an immunobiological drug.

    Indications

    The Havrix vaccine is indicated for active immunization of individuals at increased risk of developing hepatitis A:

    • persons who are in close contact with patients with hepatitis A (the virus can be shed for quite a long time, therefore vaccination is recommended for all persons who are in contact with an infected person);
    • persons planning to travel to areas where hepatitis A is endemic;
    • population groups in which the incidence of hepatitis A is increased due to low sanitary and hygienic conditions (employees of military units stationed in areas with unsatisfactory sanitary conditions or unguaranteed water supply);
    • specific population groups with an increased incidence of hepatitis A (employees of schools and preschool institutions, nursing and junior medical personnel, workers of sewerage systems and water treatment facilities, workers of public catering and food industry enterprises, staff of closed institutions of the GUIN system, social security and medical institutions) ;
    • persons with a behavioral risk of contracting the hepatitis A virus (homosexuals; persons with multiple sexual partners; drug addicts);
    • populations experiencing an epidemic;
    • patients suffering from chronic diffuse liver diseases (chronic carriers of hepatitis B, C, delta viruses; persons with chronic hepatitis of alcoholic, autoimmune, toxic, drug and other origins, persons with Konovalov-Wilson disease, hepatoses and hepatopathies).

    In regions of moderate or high endemicity, vaccination with Havrix is ​​recommended for the entire susceptible population. In areas with low or moderate endemicity of hepatitis A, immunization with Havrix is ​​particularly recommended for persons at increased risk of infection, persons in whom hepatitis A may be severe, or persons whose occupational status of hepatitis A may lead to outbreaks. .

    Directions for use and doses

    Havrix is ​​prescribed intramuscularly. The injection is made into the deltoid muscle area. For children over 12 months of age and during the first years of life, the vaccine is administered into the anterolateral region of the femoral muscle. Havrix cannot be used intravenously. The Havrix vaccine is not recommended for administration intramuscularly into the gluteal muscle and subcutaneously or intravenously, as this may reduce the intensity of the humoral immune response. Adults aged 19 years and older are given one dose (1 ml) of Havrix vaccine, which contains 1440 units, for primary immunization. ELISA. For primary immunization, children and adolescents (from 12 months to 18 years of age) are given 1 dose (0.5 ml) of the Havrix vaccine, which contains 720 units. ELISA. A booster dose of Havrix may be administered 6 to 12 months after the first dose (to provide long-term protection against infection). In some cases (for persons traveling to regions with an increased incidence of hepatitis A for a short period of time, for military personnel performing temporary operations in these areas), a single vaccination with Havrix is ​​allowed. When storing Havrix, a thin white precipitate with a clear, colorless supernatant may form. Before use, it is necessary to visually examine the vaccine for the presence of foreign mechanical particles. Before administering Havrix, the vial must be shaken well until a homogeneous cloudy white suspension is formed and make sure that the vaccine has reached room temperature. After immunization with Havrix, the patient should be under medical supervision for 30 minutes.

    Overdose

    Currently, no cases of overdose with Havrix have been reported.

    Contraindications
    • feverish conditions, incl. for infectious diseases (for mild ARVI, acute intestinal infections, vaccination with Havrix can be carried out immediately after recovery);
    • hypersensitivity to the components of Havrix.
    Use during pregnancy and lactation

    Havrix is ​​prescribed with caution during pregnancy and lactation. Havrix is ​​prescribed during pregnancy only if absolutely necessary. There have been no studies of the effect of the use of the Havrix vaccine on fetal development, however, as with the use of other inactivated vaccines, the danger to the fetus when vaccinating the mother can be considered absolutely insignificant. You should carefully consider the need for vaccination with Havrix during lactation (breastfeeding), despite the fact that the danger to the child in this case is extremely low. Clinical studies of the effect of the Havrix vaccine on infants when administered to nursing mothers have not been conducted.

    Side effect

    The administration of the Havrix vaccine is easily tolerated by the body. Systemic adverse reactions were predominantly mild, the duration of most of them did not exceed 24 hours. The frequency of these reactions varied from 0.8% to 12.8%. All reactions did not require treatment. The nature of adverse reactions and symptoms in children were the same as in adults, but in children adverse reactions occurred with less frequency. The incidence of reported adverse reactions in subjects surveyed after the second vaccination with Havrix vaccine was significantly lower. The majority of the observed adverse events were assessed by the subjects as mild, their duration did not exceed 24 hours. The frequency of adverse reactions to the administration of the Havrix vaccine did not exceed that to the administration of other vaccines containing purified viral antigen adsorbed on aluminum hydroxide. From the central nervous system: headache, malaise, increased fatigue. Allergic reactions: extremely rarely - anaphylactic and anaphylactoid reactions. Local reactions: hyperemia, induration, swelling, pain at the injection site. Other: fever, nausea, loss of appetite.

    Special instructions and precautions

    Caution should be exercised when administering Havrix to persons with thrombocytopenia and a tendency to hemorrhage, which is associated with an increased risk of developing hematoma after intramuscular administration of the vaccine. Due to the long incubation period of viral hepatitis A (up to 21 days), the disease may develop over a certain period after vaccination with Havrix. It is unknown whether vaccination with Havrix during the incubation period prevents the development of the disease. Hemodialysis patients and patients with compromised immune systems require additional doses of the Havrix vaccine. In cases where the patient is at high risk of infection with the hepatitis A virus, it is possible to prescribe Havrix and immunoglobulin against the hepatitis A virus together. There is experience in the mass use of the Havrix vaccine in children under 12 months of age.

    Impact on the ability to drive vehicles and operate machinery

    It is unlikely that administration of the Havrix vaccine will have an impact on the ability to engage in potentially hazardous activities that require increased alertness.

    Drug interactions

    The Havrix vaccine can be administered simultaneously with other inactivated vaccines and is compatible with all vaccinations of the National Vaccination Calendar of the Russian Federation and all vaccines for travelers. Using Havrix with other inactivated vaccines may result in an altered immune response. When necessary, vaccines are administered in different syringes and at different locations. Simultaneous administration of the Havrix vaccine with vaccines against typhoid fever, yellow fever, cholera (injectable), tetanus does not lead to a decrease in the immune response to the Havrix vaccine, does not affect the immunogenicity of simultaneously administered vaccines and does not lead to a change in the frequency, type and duration of reactions to vaccine administration . Preliminary clinical studies have shown satisfactory results with the combined use of Havrix-A and hepatitis B vaccine (Engerix-B). However, no changes in the immune response to both antigens were detected. Havrix vaccine should not be mixed with other vaccines in the same syringe.

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