2010/06/16

Havrix

Composition, structure and packing

Suspension for V / m introducing children homogenous, white; on standing formed a colorless supernatant and slowly precipitate of white color, breaks very easily with shaking. 0.5 ml of inactivated hepatitis A virus (strain HM 175) 720 ed.IFA. Excipients: aluminum hydroxide, 0.5 mg (sorbent), 2-Phenoxyethanol 5 mg (preservative), neomycin sulfate (traces), amino acids (mixture), formaldehyde, sodium hydrophosphate, potassium dihydrogen, polysorbate 20, potassium chloride, sodium chloride, neomycin sulfate (traces), water d / and.

The product contains formaldehyde inactivated hepatitis A virus (strain HM 175 hepatitis A virus) grown in human diploid cell MRC5, concentrated, and adsorbed on aluminum hydroxide. Suspension for i / m administration for adults homogenous, white; on standing formed a colorless supernatant and slowly precipitate of white color, breaks very easily when shaken. 1 ml of inactivated hepatitis A virus (strain HM 175) 1440 ed.IFA. Excipients: aluminum hydroxide, 0.5 mg (sorbent), 2-Phenoxyethanol 5 mg (preservative), amino acids (mixture), formaldehyde, sodium hydrophosphate, potassium dihydrogen, polysorbate 20, potassium chloride, sodium chloride, neomycin sulfate (traces), water q / and.

The product contains formaldehyde inactivated hepatitis A virus (strain HM 175 hepatitis A virus) grown in human diploid cell MRC5, concentrated and adsorbed on aluminum hydroxide.

Pharmacological action

A vaccine to prevent hepatitis A. It provides protection against hepatitis A, forming a specific immunity by inducing production of antibodies against hepatitis A virus (HAV), as well as activation of cellular mechanisms of immunity. Clinical studies have shown that 99% of vaccinated 30 days after the first dose is achieved seroprotektsiya (> 20 mIU / ml). The data obtained from two injections of vaccine with an interval of 6-12 months, allow us to conclude that 97% of vaccinated within 25 years after the course will have a protective antibody titer (> 20 mIU / ml). In studying the kinetics of the immune response it was found that after a single dose of vaccine Havriks in 79% of vaccinated seroprotektsiya attained on the 13th day, at 86.3% - to 15-day, at 95.2% - to 17-day, and in 99 % - to 19-day, ie these intervals are shorter than the average incubation period for hepatitis A (4 weeks). The effectiveness of the vaccine Havriks was estimated during outbreaks of diseases affecting large populations (Alaska, Slovakia, United States, Britain, Israel, Italy), as well as in the home, organized groups of children. These studies have shown that vaccination Havriks led to the cessation of outbreaks.

If coverage is not less than 80% susceptible contingent cropping outbreak reached within 4-8 weeks. In order to ensure long-term protection should be introduced a second (booster) dose between 6 and 12 months after the first dose.

It was found that revaccination, conducted in the period up to 12-60 months after vaccination, which induce the same level of antibodies, as well as revaccination, conducted in 6-12 months after vaccination. Based on the available data we can conclude that individuals with intact immune status after the course of vaccination, consisting of two doses, there is no need to conduct additional booster.

Pharmacokinetics

Data on the pharmacokinetics Havriks not available.

Statement
prevention of hepatitis A with 12 months of age.

Dosage regimen

Havriks not be entered into / in! The vaccine is designed to Havriks i / m injection.

Adults and children older vaccine should be injected into the deltoid region, and children 12-24 months - in the anterolateral thigh region. The vaccine should not be injected in the buttock, as well as s / c, since for such routes of administration of antibodies to hepatitis A virus may not reach the optimum level. Before the introduction of the vaccine should be explored visually to identify foreign particles and changes in appearance.

Immediately prior to the introduction of the vaccine vial or syringe should be shaken vigorously to obtain a slightly turbid white suspension. If the vaccine there is any deviation from the norm, then this package with the vaccine should be destroyed.

Vaccination schedules

A single dose primary vaccination for adults and adolescents over the age of 16 years is 1.0 ml for children and adolescents under the age of 16 years - 0.5 ml. Re-vaccination is carried out 6-12 months after vaccination, using a dosage appropriate to age. The optimal interval between vaccination is 6-12 months. Booster (booster), the effect achieved by the introduction of booster doses and in the period 12-60 months after the introduction of vaccinating dose.

Side effect

The vaccine is usually well tolerated. Local reactions: short-term pain at the injection site (assessed as severe in less than 0.5% of cases), redness and swelling (frequency - about 4% of the total number of vaccinations). General reactions: headache, malaise, vomiting, fever, nausea and loss of appetite (frequency - from 0.8% to 12.8% of total vaccinations). All of these adverse events were no effects were predominantly mild, with the duration of most of them did not exceed 24 hours

The nature of adverse reactions and symptoms in children was the same as in adults, but they have adverse reactions were observed less frequently. During the post-approval observations in rare cases, there were fatigue, diarrhea, myalgia, arthralgia, allergic reactions (including anaphylactoid reactions), as well as seizures.

Contraindications
Hypersensitivity to any vaccine component;
the presence of hypersensitivity reactions to previous vaccine Havriks.

Acute infectious and noninfectious diseases, exacerbation of chronic diseases are temporary contraindications for vaccination, with mild viral respiratory infections, intestinal disease vaccinations carried out immediately after the normalization of temperature.

Pregnancy and lactation

In the absence of adequate data in the application of the vaccine during pregnancy and during lactation are not recommended, despite the minimal risk of exposure to inactivated vaccine on the fetus and child. Havriks during pregnancy and lactation should be used only if there is absolute evidence.

Cautions

Havriks not provide protection against hepatitis caused by other pathogens such as hepatitis B virus, hepatitis C virus, hepatitis E, as well as other known pathogens affecting the liver. Havriks should be administered with caution to patients with thrombocytopenia or with disorders of the blood coagulation system, because after i / m injections in such patients can cause bleeding. After the injection of such patients should apply a pressure bandage (not rubbing) not less than 2 minutes.

Patients with thrombocytopenia or disorders of blood coagulation system allowed n / a vaccine Havriks. Patients who are on hemodialysis, and patients with disorders of the immune system after a single dose of vaccine Havriks can not achieve an adequate development of antibody titer against hepatitis A. Such patients may require the introduction of additional doses of vaccine. As with the parenteral administration of any vaccine in the vaccination room should be all that is necessary for coping with a possible anaphylactic reaction to the vaccine Havriks. Vaccinated should be under medical observation for 30 minutes after immunization.

In regions with low or moderate endemichnostyu hepatitis A vaccination Havriks particularly recommended for those at risk of infection, as well as persons who have hepatitis A may have a severe course, or those whose disease is hepatitis A because of their professional affiliation can lead to outbreaks.

These include: persons traveling to hyperendemic regions or in regions where the flare recorded incidence of hepatitis A, members of military units deployed in areas with poor sanitary conditions or insecure water supply, persons with hepatitis A disease which, because of their professional affiliation can lead to outbreaks and for which there is a professional risk of acquiring hepatitis A virus (employees of schools and kindergartens, middle and junior medical staff, particularly in infectious, gastroenterological and pediatric hospitals, employees of sewerage and water treatment plants, the workers of public catering, food industry, grocery stores, the staff closed institutions of MDPA, social welfare and health facilities), persons residing or located in areas of hepatitis A (including family or living in areas where the recorded incidence of flare), persons with behavioral risk of acquiring hepatitis A virus (homosexuals, persons conducting sexually promiscuous, drug addicts who inject drugs), patients suffering from hemophilia, persons with household contact with infected (virus excretion may occur over a relatively long time in connection with the conduct of Vaccination is recommended for all persons in contact with an infected person), populations with known high incidence of hepatitis A, or those groups in which the incidence of hepatitis A increased due to low hygienic conditions), those with chronic liver disease or increased risk liver disease (chronic carriers of hepatitis viruses B, C, delta, persons with chronic hepatitis of alcoholic, autoimmune, toxic, pharmaceutical and other origin, persons with Wilson's disease, hepatosis and hepatopathy). In regions of moderate or high endemicity for hepatitis A vaccination is recommended for all susceptible populations.

Introduction Havriks vaccine against the passing of hepatitis A in the incubation period does not worsen the disease. Havriks can enter HIV-infected patients. The presence of antibodies to hepatitis A virus after the first vaccination is not a contraindication to revaccination.

Effects on ability to drive vehicles and management mechanisms

Likely.

Overdose

So far, cases of overdose vaccine Havriks not reported.

Drug Interactions

Havriks vaccine may be introduced simultaneously with inactivated vaccines, the National calendar of vaccination RF and immunization schedule an epidemic of Russia. Because the vaccine is an inactivated Havriks, it is unlikely that its simultaneous introduction with other inactivated vaccines will lead to a breach of the immune response.

With simultaneous injection of inactivated vaccines against typhoid, cholera, tetanus and yellow fever, reduce the immune response to the vaccine Havriks was not found. With simultaneous injection with immunoglobulins rights protective effect of vaccine is not reduced. If there is a need to introduce Havriks with other vaccines or immunoglobulins, the drugs are introduced with different syringes and needles in different parts of the body.

Terms and Conditions of storage

The vaccine should be stored and transported at a temperature of 2 ° to 8 ° C; not freeze. Shelf life - 3 years. Do not use after the expiry date stated on the package.