XAVRIKS

Active material: hepatitis A antigen
When ATH: J07BC02
CCF: Vaccine for hepatitis A prevention a
ICD-10 codes (testimony): Z24.6
When CSF: 14.03.01.01
Manufacturer: Glaxosmitklyain Trading CJSC (Russia)

Pharmaceutical form, composition and packaging

SUSSENSION FOR IN/M Introduction for Children Homogeneous, white; When standing, a colorless superfluous fluid and a slowly dropping white precipitate are formed, easily broken when shaking.

Excipients: aluminum hydroxide 0.5 mg (sorbent), 2-phenoxyethanol 5 mg (preservative), amino acids (mixture), sodium hydrogen phosphate, Potassium dihydrogen phosphate, polysorbate 20, potassium chloride, sodium chloride, neomycin sulfate (Traces), water d / and.

The drug contains inactivated by formaldehyde virions of hepatitis A (HM strain 175), Grown in the culture of diploid cells of human MRC5, Hydroxide concentrated and adsorbed aluminum.

1 dose (0.5 ml) – disposable syringes (1) – packs cardboard.
1 dose (0.5 ml) – colorless glass vials (1) – packs cardboard.
1 dose (0.5 ml) – colorless glass vials (10) – cardboard boxes.
1 dose (0.5 ml) – colorless glass vials (25) – cardboard boxes.
1 dose (0.5 ml) – colorless glass vials (100) – cardboard boxes.

SUSSENSION FOR IN/M In Introduction for Adults Homogeneous, white; When standing, a colorless superfluous fluid and a slowly dropping white precipitate are formed, easily broken when shaking.

Excipients: aluminum hydroxide 0.5 mg (sorbent), 2-phenoxyethanol 5 mg (preservative), amino acids (mixture), sodium hydrogen phosphate, Potassium dihydrogen phosphate, polysorbate 20, potassium chloride, sodium chloride, neomycin sulfate (Traces), water d / and.

The drug contains inactivated by formaldehyde virions of hepatitis A (HM strain 175), Grown in the culture of diploid cells of human MRC5, Hydroxide concentrated and adsorbed aluminum.

1 dose (1 ml) – disposable syringes (1) – packs cardboard.
1 dose (1 ml) – colorless glass vials (1) – packs cardboard.
1 dose (1 ml) – colorless glass vials (10) – cardboard boxes.
1 dose (1 ml) – colorless glass vials (25) – cardboard boxes.
1 dose (1 ml) – colorless glass vials (100) – cardboard boxes.

Pharmacological action

Vaccine for hepatitis A prevention a. Provides protection against hepatitis A, Forming specific immunity by inducing antibodies against hepatitis A virus (VGA), as well as by activating cellular immunity mechanisms.

Clinical studies have shown, that 99% vaccinated through 30 days after the introduction of the first dose, seroprotection is achieved (> 20 mIU / ml). Data, obtained with a double introduction of the vaccine with the interval 6-12 Months, allow you to make a conclusion, what 97% vaccinated through 25 years after the course will have a protective titer of antibodies (>20 mIU / ml). When studying the kinetics of the immune response, it was established, that after the introduction of one dose of the Havrix vaccine^® in 79% vaccinated seroprotection is achieved on the 13th day, in 86.3 % – 15 day, in 95.2 % – On the 17th day, and 99% – On the 19th day, ie. These temporary intervals are shorter, than the average incubation period of hepatitis A (4 of the week).

The effectiveness of the Havrix vaccine^® was evaluated during the outbursts of the disease, amazing large groups of the population (Alaska, Slovakia, United States, Great Britain, Israel, Italy), as well as in family foci and organized children's groups. These studies have shown, that the vaccination is Havricks^® led to the cessation of outbreaks.

With vaccinations of at least 80% susceptible contingent, stopping the outbreak of the disease is achieved during 4-8 weeks.

To ensure long -term protection, the second (revaccinating) dose between 6 and 12 months after the first dose.

It was found, that revaccination, spent in the period before 12-60 month after vaccination, inducing the production of the same level of antibodies, How and Revakitation, spent through 6-12 month after vaccination.

Based on the available data, you can conclude, that persons with unchanged immune status after a vaccination course, consisting of two doses, there is no need to carry out additional revaccination.

Pharmacokinetics

Data on pharmacokinetics of the drug Havricks^® not provided.

Testimony

-prevention of hepatitis A C 12-month-old age.

Dosage regimen

Havriks^® you can not enter in /! Havrix vaccine^® Designed for V/M Introduction.

Older adults and children the vaccine should be entered into the area of the deltoid muscle, and children 12-24 Months – to the forefool area of the thigh. The vaccine should not be entered into the gluteal muscle, as well as p/c, Since with such routes of introduction the formation of antibodies to the hepatitis A virus may not reach the optimal level.

Before introducing, the vaccine should be examined visually for the identification of foreign particles and changes in the appearance. Immediately before the introduction of the vaccine, the bottle or syringe must be shaken vigorously until a slightly muddy suspension of white color is obtained. If the vaccine discovered any abnormalities, then such packaging with the vaccine must be destroyed.

Vaccination schemes

A single dose for primary vaccination for adults and adolescents older 16 years is 1 ml, to children and adolescents under the age of 16 years – 0.5 ml.

Revaccination is carried out through 6-12 month after vaccination, Using the dose of the drug, corresponding to age.

The optimal interval between vaccinations is 6-12 Months. Revaccinating (booster-) The effect is achieved with the introduction of booster doses and during the period 12-60 months after the introduction of a vaccinating dose.

Side effect

The vaccine is usually well tolerated.

Local reactions: short -term pain in the place of introduction (was evaluated as strong less than 0.5% cases); Redness and swelling (frequency – about 4% from the total number of vaccination).

Common reactions: headache, malaise, vomiting, fever, nausea and loss of appetite (frequency – from 0.8% to 12.8% from the total number of vaccination). All these unwanted phenomena took place without consequences, were predominantly weakly expressed, Moreover, the duration of most of them did not exceed 24 no.

The nature of unwanted reactions and symptoms in children was the same, as in adults, however, they had undesirable reactions with a lower frequency.

During post -passage observations in rare cases, fatigue was noted, diarrhea, myalgia, arthralgia, allergic reactions (including anaphylactoid reactions), as well as convulsions.

Contraindications

-hypersensitivity to any component of the vaccine;

- the presence of reactions of increased sensitivity to the previous introduction of the Havrix vaccine^®.

Acute infectious and non -infectious diseases, exacerbation of chronic diseases are temporary contraindications for conducting vaccination; in netagelah VIRAL RESPIRATORY INFECTIONS, acute intestinal diseases vaccinations are immediately after the normalization of the temperature.

Pregnancy and lactation

IN Relations with the lack of adequate data, the use of a vaccine during pregnancy and during lactation is not recommended, Despite the minimum risk of inactivated vaccines on the fetus and child.

Havriks^® During pregnancy and lactation should be used only in the presence of absolute indications.

Cautions

Havriks^® does not provide protection against hepatitis, caused by other pathogens, such as hepatitis B virus, hepatitis C virus, hepatitis E virus, as well as other known pathogens, affecting the liver.

Havriks^® should be administered with caution to patients with thrombocytopenia or with disorders from the coagulation system, since after/m injection in such patients, bleeding may occur. After the injection, such patients should apply a pressure dressing (But do not rub) at least 2 m. Patients with thrombocytopenia or with impaired blood coagulating systems allowed the administration of the Havrix vaccine^®.

Patients, hemodialysis, as well as in patients with disorders from the immune system after a single administration of the dose of the Havrix vaccine^® you can not achieve the development of an adequate titer of antibodies against the hepatitis virus A. Таким пациентам может потребоваться введение дополнительных доз вакцины.

As with the parenteral administration of any other vaccines, In the vaccination room there should be everything you need to stop a possible anaphylactic reaction to the Havrix vaccine^®. Vaccinated should be under medical supervision during 30 min after immunization.

In regions with low or moderate endemic hepatitis A immunization of the Havrix vaccine^® It is especially recommended for people with an increased risk of infection, as well as persons, whose hepatitis or can have a severe current or persons, the disease of which hepatitis A due to their professional affiliation can lead to outbreaks. These include: person, leaving for hyperendemic regions or to regions, Where is hepatitis A outbreak reported?; Employees of military units, deployed in areas with unsatisfactory sanitary conditions or ungranted water supply; person, The disease of which by hepatitis A, due to their professional affiliation, can lead to outbreaks and for which there is a professional risk of hepatitis A infection with a virus (school workers and children's preschool institutions, Middle and junior medical staff, Especially in infectious ones, gastroenterological and pediatric medical institutions, employees of sewage systems and water -cleaning structures, public catering enterprises, food industry, grocery warehouses, Personnel of closed institutions of the Guin system, social security and medical institutions); person, living or in the foci of hepatitis A (incl. family, или проживающие на территориях, where the outbreak incidence is recorded); Persons with a behavioral risk of infection of hepatitis a (homosexuals, person, leading random sex life, drug addicts, Using injection drugs); Patients with hemophilia; person, having household contacts with infected (The release of the virus can occur for a rather long time, In this regard, vaccination is recommended for all persons, in contact with the infected), groups of the population with a high incidence of hepatitis A or those population groups, in which the incidence of hepatitis A is increased due to low sanitary and hygienic conditions; faces with chronic liver diseases or an increased risk of liver diseases (chronic carriers of hepatitis in, FROM, delta, person, suffering from chronic alcohol hepatitis, Autoimmune, toxic, medicinal and other genesis, faces with Wilson-Konovalov's disease, Hepatosis and hepatopathies).

In the regions of moderate or high endemic, vaccination against hepatitis A is recommended to the entire susceptible population.

The introduction of the Havrix vaccine^® Against the background of the disease with hepatitis A in the incubation period, does not worsen the course of the disease.

Havriks^® can be introduced by HIV-infected patients.

The presence of antibodies to the hepatitis A virus after the first vaccination is not a contraindication for revaccination.

Effects on ability to drive vehicles and management mechanisms

The impact on the ability to concentrate attention is unlikely.

Overdose

To date, cases of overdose of the Havrix vaccine^® not reported.

Drug Interactions

Havrix vaccine^® It can be introduced simultaneously with inactivated vaccines of the National Calendar of the preventive vaccinations of the Russian Federation and the vaccination calendar for the epidemic testimony of the Russian Federation.

Since the Havrix vaccine^® It is inactivated, unlikely, that its simultaneous administration with other inactivated vaccines will lead to a violation of the formation of an immune response. With the simultaneous introduction with inactivated vaccines against the typhoid fever, cholera, stolbnyaka, as well as yellow fever, reducing the immune response to the Havrix vaccine^® Not marked. With the simultaneous introduction with human immunoglobulins, the protective effect of the vaccine does not decrease.

If there is a need to introduce Havricks^® with other vaccines or with immunoglobulins, then the drugs are administered using different syringes and needles into various parts of the body.

Conditions of supply of pharmacies

Vaccine in the package, contains 1 bottle or syringe, Vocated the recipe.

Vaccine in the package, contains 10, 25 and 100 bottles, Designed for medical institutions.

Conditions and terms

The vaccine should be stored and transported at a temperature of 2 ° to 8 ° C; Do not freeze. Shelf life – 3 year. Do not use beyond the expiration date, on the package.