Grippol - instructions for use, reviews, analogs and release forms (suspension or solution in syringes or injection ampoules Plus, Neo) vaccines for vaccination and prevention of influenza in adults, children and pregnancy. Composition and set of strains. Description of lek

Composition of Grippol plus

Hemagglutinin and neuraminidase of the following viral strains:

• A(H3 N2,
• A(H1 N1,
• azoximer bromide (polyoxidonium).

Manufacturers

Petrovax Pharm NPO (Russia), Petrovax FC (Russia)

pharmachologic effect

Vaccine for the prevention of influenza.

The vaccine forms high specific immunity against influenza and is well tolerated by children and adults.

After vaccination, antibodies appear within 8-12 days, immunity lasts up to 12 months, incl. in elderly people.

Protective titers of antibodies to influenza viruses after vaccination of individuals of different ages are determined in 75-92% of vaccinated people.

The inclusion of the immunomodulator polyoxidonium in the drug increases the immunogenicity and stability of antigens, increases immunological memory, significantly reduces the vaccination dose of antigens, and increases the body's resistance to other infections by correcting the immune status.

Side effects of Grippol plus

Local reactions:

• rarely - pain,
• redness of the skin.

Systemic reactions:

• V in some cases- general malaise, headache, increased body temperature, mild rhinitis, sore throat (these reactions usually disappear on their own after 1-3 days); extremely rarely (as with any other vaccination) - allergic reactions, myalgia, neuralgia, paresthesia, neurological disorders.

The vaccine is a highly purified drug and is well tolerated by adults and children.

Indications for use

Preventive immunization against influenza in children from 3 years of age, adolescents and adults without age restrictions:

• - persons over 60 years of age;
• - persons suffering from chronic somatic diseases;
• -frequently suffer from acute respiratory infections; -children preschool age;
• -pupils;
• -medical workers;
• - workers in the service sector, transport, educational institutions, military personnel.

Contraindications Grippol plus

Allergic reactions to chicken protein and vaccine components; - acute and febrile conditions or exacerbation chronic disease(vaccination is carried out after recovery or during remission); - persons who have previously experienced allergic reactions to influenza vaccines; - for non-severe ARVI, acute intestinal diseases Vaccination is carried out after the temperature has normalized.

The inactivated polymer-subunit influenza vaccine does not have embryotoxic or teratogenic effects.

The doctor makes the decision to vaccinate pregnant women individually, taking into account the risk of influenza infection and possible complications influenza infection.

Vaccination is safest in the second and third trimesters of pregnancy.

Directions for use and dosage

Vaccination is carried out annually in the autumn-winter period.

Vaccination is possible at the beginning of an epidemic rise in the incidence of influenza.

Overdose

No data.

Interaction

The vaccine can be used simultaneously with other inactivated vaccines.

In this case, contraindications to each of the vaccines used should be taken into account; drugs should be administered in different areas bodies with different syringes.

The vaccine can be administered against a background basic therapy underlying disease.

Vaccination in patients receiving immunosuppressive therapy may be less effective.

special instructions

On the day of vaccination, a medical examination of the vaccinated person should be carried out with mandatory thermometry.

At temperatures above 37°C, vaccination is not carried out.

Storage conditions

The drug should be stored out of the reach of children, protected from light at a temperature of 2° to 8°C; do not freeze.

Suspension for intramuscular and subcutaneous administration - 1 dose (0.5 ml) hemagglutinin of epidemically relevant influenza virus strains produced by Solvay Biologicals B.V., the Netherlands subtype A (H1N1) - 5 μg subtype A (H3N2) - 5 μg type B - 5 mcg immunoadjuvant Polyoxidonium® - 500 mcg phosphate-buffered saline - up to 0.5 ml does not contain a preservative, 0.5 ml (1 dose) in a disposable syringe; 1 syringe in a blister pack; in a cardboard pack 1 package.

Description dosage form

Colorless or yellowish, slightly opalescent liquid.

Characteristic

The vaccine consists of protective antigens (hemagglutinin and neuraminidase), isolated from purified influenza viruses of types A and B grown on chicken embryos, associated with a water-soluble high-molecular immunoadjuvant N-oxidized derivative of poly-1,4-ethylenepiperazine (Polyoxidonium®, INN - Azoximer bromide ). The antigenic composition of the vaccine changes every year in accordance with the epidemic situation and WHO recommendations.

Pharmacodynamics

The vaccine causes the formation high level specific immunity against the flu. The protective effect after vaccination, as a rule, occurs after 8-12 days and lasts up to 12 months, incl. and in elderly people. Protective titers of antibodies to influenza viruses after vaccination of people of different ages are determined in 75-95% of vaccinated people. Inclusion in the vaccine preparation of the immunomodulator Polyoxidonium®, which has wide range immunopharmacological action, provides an increase in the immunogenicity and stability of antigens, increases immunological memory, significantly reduces the vaccination dose of antigens, and increases the body's resistance to other infections by correcting the immune status.

Indications for use Grippol plus

Specific prevention of influenza in children from the age of three, adolescents and adults without age restrictions. The vaccine is especially indicated for: 1. Persons at high risk of complications in case of influenza: over 60 years of age; preschool children, schoolchildren; adults and children who often suffer from acute respiratory infections, suffering from chronic somatic diseases, including: diseases and malformations of the central nervous system, cardiovascular and bronchopulmonary systems, bronchial asthma, chronic kidney disease; diabetes mellitus, metabolic diseases, autoimmune diseases, allergic diseases(except for allergies to chicken proteins); chronic anemia, congenital or acquired immunodeficiency; HIV-infected. 2. Persons who, by profession, have high risk getting sick with the flu or infecting others with it: healthcare workers, workers educational institutions, spheres social services, transport, trade, police, military personnel, etc.

Contraindications to the use of Grippol plus

allergic reactions to chicken protein and vaccine components; acute febrile conditions or exacerbation of a chronic disease (vaccination is carried out after recovery or during remission); previously existing allergic reactions to the administration of influenza vaccines. For mild ARVI and acute intestinal diseases, vaccination is carried out after the temperature has normalized.

Grippol plus Use during pregnancy and children

Preclinical studies have shown that the inactivated polymer-subunit influenza vaccine does not have embryotoxic or teratogenic effects. The decision to vaccinate pregnant women should be made by a doctor individually, taking into account the risk of contracting influenza and possible complications of influenza infection. Vaccination is safest in the second and third trimesters. Breastfeeding is not a contraindication for vaccination.

Grippol plus Side effects

The vaccine is a highly purified drug and is well tolerated by children and adults. Local and general reactions for the introduction of vaccines, as a rule, are absent. Rarely, reactions such as pain, swelling and redness of the skin may develop at the injection site. Very rarely, individuals may experience general reactions in the form of malaise, headache, fever, slight runny nose, sore throat. These reactions usually disappear on their own after 1-3 days. Extremely rarely, as with any other vaccination, allergic reactions, myalgia, neuralgia, paresthesia, and neurological disorders can be observed.

Drug interactions

The Grippol® plus vaccine can be used simultaneously with other inactivated vaccines. In this case, contraindications to each of the vaccines used must be taken into account; the drugs must be injected into different parts of the body with different syringes. The vaccine can be administered against the background of basic therapy for the underlying disease. Vaccination in patients receiving immunosuppressive therapy may be less effective.

Dosage of Grippol plus

IM or s/c (deep) in the upper third outer surface shoulder (deltoid muscle), children younger age- in the anterior outer surface of the thigh. Vaccination is carried out annually in the autumn-winter period. Vaccination is possible at the beginning of an epidemic rise in the incidence of influenza. Before use, the vaccine should be kept at room temperature and shaken well. Children over 3 years of age and adults without age restrictions - 0.5 ml once. For patients with immunodeficiency and receiving immunosuppressive therapy, the vaccine can be administered twice 0.5 ml with an interval of 4 weeks.

Precautionary measures

Do not administer i.v. In the rooms where vaccination is carried out, it is necessary to have anti-shock therapy. The vaccinated person should be under the supervision of a health care worker for 30 minutes after immunization.

pharmachologic effect

Vaccine for the prevention of influenza. The vaccine forms high specific immunity against influenza and is well tolerated by children and adults. After vaccination, antibodies appear within 8-12 days, immunity lasts up to 12 months, incl. in elderly people. Protective titers of antibodies to influenza viruses after vaccination of people of different ages are determined in 75-92% of vaccinated people.

The inclusion of the immunomodulator polyoxidonium in the drug increases the immunogenicity and stability of antigens, increases immunological memory, significantly reduces the vaccination dose of antigens, and increases the body's resistance to other infections by correcting the immune status.

Indications

Active preventive immunization against influenza in children from 6 years of age one month old, teenagers and adults without age limit:

— persons over 60 years of age;

— persons suffering from chronic somatic diseases;

-frequently suffer from acute respiratory infections;

— children of preschool age;

-pupils;

-medical workers;

—workers in the service sector, transport, educational institutions, military personnel.

Dosage regimen

Vaccination is carried out annually in the autumn-winter period. Vaccination is possible at the beginning of an epidemic rise in the incidence of influenza.

0.5 ml once.

For patients with immunodeficiency it is possible to administer the vaccine twice, 0.5 ml each, with an interval of 4 weeks between injections.

The vaccine is administered intramuscularly or deeply subcutaneously into the upper third of the outer surface of the shoulder (into the deltoid muscle), and into the anterior outer surface of the thigh for young children.

The opening of ampoules and the vaccination procedure are carried out in strict compliance with the rules of asepsis and antiseptics. The drug cannot be stored in an opened ampoule.

Side effect

Local reactions: very rarely - pain, swelling and redness of the skin.

Systemic reactions: extremely rarely - malaise, headache, weakness, low-grade fever(passing on their own in 1-2 days); exclusively in rare cases- allergic reactions (with high individual sensitivity).

Contraindications for use

- allergic reactions to previous vaccinations, chicken protein and vaccine components;

- acute febrile conditions or exacerbation of a chronic disease.

For mild ARVI and acute intestinal diseases, vaccination is carried out after the temperature has normalized.

Use during pregnancy and breastfeeding

The decision to vaccinate pregnant women should be made by a doctor individually, taking into account the risk of contracting influenza and possible complications of influenza infection. Vaccination is safest in the second and third trimesters.

IN experimental studies It has been established that the Grippol vaccine does not have embryotoxic or teratogenic effects.

Breastfeeding is not a contraindication for vaccination.

Use in children

Children aged 6 months to 3 years vaccination is carried out in a dose of 0.25 ml twice with an interval between injections of 4 weeks; or in a dose of 0.5 ml once, if the child was vaccinated against influenza in the previous season.

Children over 3 years old and adults without age limit 0.5 ml once.

Overdose

There is no data on an overdose of the Grippol vaccine.

Drug interactions

The vaccine can be administered against the background of basic therapy for the underlying disease.

Vaccination in patients receiving immunosuppressive therapy may be less effective.

The Grippol vaccine can be used simultaneously with other inactivated vaccines. In this case, contraindications to each of the vaccines used must be taken into account; the drugs must be injected into different parts of the body with different syringes.

Storage conditions and periods

The drug should be stored and transported at a temperature of 2° to 8°C.

Transportation is possible at temperatures up to 25°C for 6 hours.

The drug that has been frozen cannot be used.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

special instructions

The drug cannot be administered intravenously.

In the rooms where vaccination is carried out, it is necessary to have medicines for anti-shock measures and relief of anaphylactic reactions. The vaccinated person must be under medical supervision within 30 minutes after vaccine administration.

On the day of drug administration, vaccine recipients must be examined by a doctor with mandatory thermometry. At temperatures above 37.0°C, vaccination is not carried out.

It should be borne in mind that the drug is not suitable for use in ampoules with damaged integrity or labeling, if the physical properties (color, transparency) have changed, if the expiration date has expired, or if the requirements for storage conditions are violated.

Any unusual reactions following vaccination should be reported to your local health department. State Institute standardization and control of medical immunobiological preparations named after. L.A. Tarasevich Ministry of Health of Russia (GISC) (121002, Moscow, Sivtsev Vrazhek, 41) with subsequent presentation medical documentation at GISC named after. L.A. Tarasevich. To GISK named after. L.A. Tarasevich is also sent complaints about the non-compliance of the drug with the specified requirements for physical properties, packing, packaging.

Influenza and its complications are serious illnesses Therefore, doctors are actively promoting preventive vaccinations. This topic is especially relevant for young children and the elderly, patients with chronic diseases of the respiratory tract and of cardio-vascular system.

According to WHO recommendations, immunization against influenza should cover up to 90% of the population by 2016. This will prevent acute seasonal outbreaks of the disease, reduce the rate of complications and prevent the circulation of the virus among the population. In most regions, vaccination is carried out with domestic drugs “Grippol” and “Grippol Plus”. Let's take a closer look at what the Grippol flu shot is, what the features of this drug are and what side effects it has.

Influenza immunization is included in National Calendar vaccinations since 2006 and are provided free of charge to the following categories of citizens (with their consent or their parents):

• elderly people over 60 years of age;
• persons suffering from chronic diseases, including bronchopulmonary and cardiovascular diseases;
• people exposed respiratory infections;
• children over six months;
• schoolchildren and students;
• medical workers;
• other categories of persons permanently located in in public places- employees of educational institutions, services, trade, transport, military personnel.

There is a recommendation to vaccinate “Grippol” during pregnancy in the second and third trimester, but most doctors treat it with caution, carefully weighing it possible risks. Although it has been experimentally established that the vaccine does not have embryotoxic or teratogenic effects, possible adverse reactions vaccination will not benefit the mother and child.

Flu shot - pros and cons

In addition to the official position of health workers, there is another opinion about flu vaccinations. There are strong arguments for and against vaccination.

Proponents of vaccination talk about the positive effects of vaccination.

1. Vaccinated people have a reduced incidence of influenza.
2. If a person does get sick with the flu, the disease progresses in mild form and does not cause complications.

Opponents of vaccination explain their position with the following facts.

1. The influenza virus is constantly changing its structure, so it is almost impossible to guess which flu will appear next year. Thus, they vaccinate us against one disease, but another threatens us.
2. After vaccination, influenza-like conditions often occur, which is comparable to the “field” virus. If you then get sick in the midst of an epidemic, you will get two diseases instead of one.

Composition and effect of the Grippol vaccine

The drug belongs to the so-called split vaccines. This means that the Grippol vaccine contains split components of the shell and intracellular structures of the influenza virus. The virus is grown in chicken embryos and then processed and purified.

The vaccine was developed at the State scientific center- Institute of Immunology of the Ministry of Health of the Russian Federation. Its peculiarity is that the virus antigens are linked to a special carrier that has an immunostimulating effect. It's called polyoxidonium. It is associated with three variants of the viral antigen, belonging to groups A/H1N1, A/H3N2 and B. Like all influenza vaccines, the manufacturer Grippol periodically changes the antigenic structure of the vaccine in accordance with the epidemiological situation. That is, virologists annually monitor which strains of the influenza virus are most common this year and update the vaccine next year if necessary.

"Grippol" has been approved for use since 1996. It is produced by the largest Russian association for the production of immunological drugs, NPO Microgen. This class of vaccines has optimal ratio reactogenicity and immunogenicity. This means that immunity is developed quite quickly - within 10–14 days and with a minimum of side effects. Protective titers after vaccination are determined in 80–90% of vaccinated people, and immunity lasts for one year.

Application of "Grippol"

Instructions for using the Grippol vaccine are as follows.

The vaccine is stored in accordance with temperature regime, the injection is carried out according to the rules of asepsis and antiseptics. Opened ampoules cannot be stored - they must be disposed of in the same way as syringes and used ampoules.

Actions after vaccination "Grippol"

There are no special restrictions after vaccination. People often ask, is it possible to swim after the Grippol vaccine? Yes, there are no contraindications to water procedures No. The only exception is if the temperature rises on the day of vaccination, especially in children. Then it is better to postpone swimming until tomorrow, so as not to accidentally become hypothermic after the bath.

Another question that plagues most men is the compatibility of “Grippol” and alcohol. No interaction was noted between them, but this does not mean that after vaccination you need to go and wash the event. All alcoholic drinks have a bad effect on health in general and on the formation of immunity in particular, so try to limit your alcohol intake over the next 1–2 weeks.

Side effects from the Grippol vaccine

"Grippol" is an inactivated vaccine. It does not contain live or whole cell virus. Therefore, complications after it occur very rarely.

1. Local reactions may manifest themselves in the form of redness and hardening of the injection site.
2. The temperature after the Grippol vaccination can rise to around 37–38 °C for 1–2 days.
3. Headache, runny nose, general malaise, and weakness may also occur.

Side effects after the Grippol vaccination disappear within 24–48 hours and do not require medical intervention.

In very rare cases, an allergic reaction may develop to the administration of the vaccine, up to anaphylactic shock. Therefore, do not go far from the vaccination room immediately after the injection, but wait about half an hour.

The reaction to the Grippol vaccine in children is generally no different from that in adults. As a rule, children, even under three years of age, tolerate the vaccine very well. In some cases it is possible side effects- slight increase in temperature, runny nose, general weakness, which disappear after 2–4 days. Approximately 10% of children experience swelling and pain at the injection site, which disappears after 2-3 days. In this case, it is advisable not to wet the injection site when swimming.

Contraindications "Grippol"

Contraindications to the use of the Grippol vaccine are as follows:

• elevated temperature bodies;
• any acute diseases infectious and non-infectious;
• chronic diseases in the acute stage;
• allergic reactions to previous vaccinations with Grippol and its analogues;
• allergy to chicken egg white.

Analogues of "Grippol"

In addition to Grippol, there are other vaccines to prevent influenza. They can be alive or inactivated (killed). Inactivated vaccines may contain whole cells of the virus, its internal and external fragments, or only part of its shell. As already mentioned, “Grippol” refers to split vaccines, that is, it contains only fragments of the virus. The following vaccines are analogues of Grippol:

All of these drugs are third-generation trivalent inactivated vaccines. They consist of surface antigens influenza viruses type A and B. Cultivation of the virus is carried out on chicken embryos. Strains are periodically updated by manufacturers according to WHO recommendations.

So, is it still worth getting the Grippol flu vaccine or not? In general, “Grippol” is a good domestic vaccine, in no way inferior imported analogues. The issue of vaccination must be considered individually. If you have previously had a negative experience with the vaccine, and you do not have the flu, then it is better to refrain from going to vaccination room. But if an acute respiratory infection attacks you every year, and even gives various complications, then it is better to get vaccinated. The same applies to people who are forced to come into contact with a large number of visitors - it is better to play it safe by taking measures to prevent influenza and get vaccinated, especially since the Grippol vaccine is known to be well tolerated.

Suspension for intramuscular and subcutaneous administration - 1 dose (0.5 ml) hemagglutinin of epidemically relevant influenza virus strains produced by Solvay Biologicals B.V., the Netherlands subtype A (H1N1) - 5 μg subtype A (H3N2) - 5 μg type B - 5 mcg immunoadjuvant Polyoxidonium® - 500 mcg phosphate-buffered saline - up to 0.5 ml does not contain a preservative, 0.5 ml (1 dose) in a disposable syringe; 1 syringe in a blister pack; in a cardboard pack 1 package.

Description of the dosage form

Colorless or yellowish, slightly opalescent liquid.

Characteristic

The vaccine consists of protective antigens (hemagglutinin and neuraminidase), isolated from purified influenza viruses of types A and B grown on chicken embryos, associated with a water-soluble high-molecular immunoadjuvant N-oxidized derivative of poly-1,4-ethylenepiperazine (Polyoxidonium®, INN - Azoximer bromide ). The antigenic composition of the vaccine changes every year in accordance with the epidemic situation and WHO recommendations.

Pharmacodynamics

The vaccine causes the formation of a high level of specific immunity against influenza. The protective effect after vaccination, as a rule, occurs after 8-12 days and lasts up to 12 months, incl. and in elderly people. Protective titers of antibodies to influenza viruses after vaccination of people of different ages are determined in 75-95% of vaccinated people. The inclusion of the immunomodulator Polyoxidonium®, which has a wide range of immunopharmacological effects, in the vaccine preparation ensures an increase in the immunogenicity and stability of antigens, increases immunological memory, significantly reduces the vaccination dose of antigens, and increases the body's resistance to other infections by correcting the immune status.

Indications for use Grippol plus

Specific prevention of influenza in children from the age of three, adolescents and adults without age restrictions. The vaccine is especially indicated for: 1. Persons at high risk of complications in case of influenza: over 60 years of age; preschool children, schoolchildren; adults and children who often suffer from acute respiratory infections, suffering from chronic somatic diseases, including: diseases and malformations of the central nervous system, cardiovascular and bronchopulmonary systems, bronchial asthma, chronic kidney diseases; diabetes mellitus, metabolic diseases, autoimmune diseases, allergic diseases (except allergies to chicken proteins); chronic anemia, congenital or acquired immunodeficiency; HIV-infected. 2. Persons who, by profession, have a high risk of contracting the flu or infecting others with it: healthcare workers, employees of educational institutions, social services, transport, trade, police, military personnel, etc.

Grippol plus contraindications

allergic reactions to chicken protein and vaccine components; acute febrile conditions or exacerbation of a chronic disease (vaccination is carried out after recovery or during remission); previously existing allergic reactions to the administration of influenza vaccines. For mild ARVI and acute intestinal diseases, vaccination is carried out after the temperature has normalized.

Use of Grippol plus during pregnancy and lactation

Preclinical studies have shown that the inactivated polymer-subunit influenza vaccine does not have embryotoxic or teratogenic effects. The decision to vaccinate pregnant women should be made by a doctor individually, taking into account the risk of contracting influenza and possible complications of influenza infection. Vaccination is safest in the second and third trimesters. Breastfeeding is not a contraindication for vaccination.

Side effects of Grippol plus

The vaccine is a highly purified drug and is well tolerated by children and adults. Local and general reactions to the vaccine are usually absent. Rarely, reactions such as pain, swelling and redness of the skin may develop at the injection site. Very rarely, individuals may experience general reactions in the form of malaise, headache, fever, slight runny nose, sore throat. These reactions usually disappear on their own after 1-3 days. Extremely rarely, as with any other vaccination, allergic reactions, myalgia, neuralgia, paresthesia, and neurological disorders can be observed.

Drug interactions

The Grippol® plus vaccine can be used simultaneously with other inactivated vaccines. In this case, contraindications to each of the vaccines used must be taken into account; the drugs must be injected into different parts of the body with different syringes. The vaccine can be administered against the background of basic therapy for the underlying disease. Vaccination in patients receiving immunosuppressive therapy may be less effective.

Dosage

IM or s/c (deep) into the upper third of the outer surface of the shoulder (into the deltoid muscle), for young children - into the anterior outer surface of the thigh. Vaccination is carried out annually in the autumn-winter period. Vaccination is possible at the beginning of an epidemic rise in the incidence of influenza. Before use, the vaccine should be kept at room temperature and shaken well. Children over 3 years of age and adults without age restrictions - 0.5 ml once. For patients with immunodeficiency and receiving immunosuppressive therapy, the vaccine can be administered twice 0.5 ml with an interval of 4 weeks.

Precautionary measures

Do not administer i.v. In the rooms where vaccination is carried out, it is necessary to have anti-shock therapy. The vaccinated person should be under the supervision of a health care worker for 30 minutes after immunization.