Flu vaccine Vaxigripp - instructions for use and reviews. What is more effective: Vaxigrip or Influvac? Which flu vaccine is best? Vaxigrip instructions for use

Active ingredient

Inactivated split influenza viruses cultured on chicken embryos, represented by strains:

Auxiliary component (solvent)

Does not contain adjuvants or preservatives.

Industrial impurities (content in one dose):

Slightly opalescent, slightly whitish liquid.

The Vaxigrip vaccine is made from three strains of influenza virus, cultured, purified and then inactivated with formaldehyde.

The Vaxigrip vaccine forms the development of specific immunity to epidemically relevant strains of influenza virus types A and B contained in this vaccine.

Immunity is developed between the 2nd and 3rd weeks after vaccination and lasts from 6 to 12 months.

Prevention of influenza in adults and children from 6 months of age.

Vaccination is especially indicated for individuals at increased risk of developing post-influenza complications.

Hypersensitivity to any of the components of the vaccine, as well as components of chicken meat or chicken eggs, neomycin, formaldehyde and octoxynol-9;

Severe allergic reactions after previous administration of a vaccine or a vaccine containing the same components;

Severe reaction (temperature above 40 °C, swelling and hyperemia at the injection site greater than 8 cm in diameter) or a complication of the previous administration of the drug;

Acute infectious or non-infectious diseases, exacerbation of chronic diseases - vaccinations are carried out 2-4 weeks after recovery or remission. For mild ARVI and acute intestinal diseases, vaccinations are carried out after the temperature has normalized.

The Vaxigrip vaccine should be used carefully in persons with thrombocytopenia or with disorders of the blood coagulation system due to the possibility of bleeding after intramuscular injection.

Available data on the use of the vaccine in pregnant women do not indicate the possibility of negative effects of vaccination on the fetus and the woman’s body.

Vaccination with Vaxigrip can be carried out starting from the second trimester of pregnancy. For medical reasons, if there is an increased risk of developing post-influenza complications, the use of this vaccine is recommended regardless of the stage of pregnancy.

The vaccine can be used during breastfeeding.

The vaccine is administered intramuscularly or deep subcutaneously. Do not administer intravenously! Before use, the vaccine should be kept at room temperature and shaken until a homogeneous solution is formed.

Dosage:

-children from 6 to 35 months- 0.25 ml once;

-children over 36 months and adults- 0.5 ml once;

-children up to 6 months- the safety and effectiveness of the Vaxigrip vaccine in children under 6 months of age has not been studied.

-children from 6 to 11 months - anterolateral surface of the thigh;

-children from 12 months to 35 months- anterolateral surface of the thigh or deltoid muscle area;

-children from 36 months and adults- area of ​​the deltoid muscle.

For children under 9 years of age who are being vaccinated against influenza for the first time, two doses of the Vaxigrip vaccine are recommended with an interval of 4 weeks.

When using a syringe containing 0.5 ml of vaccine to immunize children for whom a 0.25 ml dose is indicated, half the volume of the 0.5 ml syringe must be removed. The syringe should be held in an upright position and the stroke stop should be advanced until it reaches the thin black line printed on the syringe. Inject the remaining volume of 0.25 ml.

Any remaining vaccine in the syringe must be destroyed immediately.

Information on adverse events was obtained from clinical studies and during post-marketing use of the drug in various countries around the world.

Data obtained from clinical studies

Due to the annual change in the composition of influenza vaccine strains and in accordance with European requirements, annual clinical studies of the safety and immunogenicity of the Vaxigrip vaccine are conducted, including at least 50 adults aged 18-60 years and at least 50 elderly persons aged >60 years.

The pooled safety analysis included clinical data from 36 studies. A total of 10,880 people were vaccinated with Vaxigrip intramuscularly (54 children aged 6 to 35 months, 460 children aged 3 to 8 years, 72 children aged 9 to 17 years, 4,775 adults aged 18 to 60 years old and 5,519 adults over 60 years old). Most adverse events were mild to moderate in severity, usually developed on the day of vaccination and resolved within the next 3 days.

The frequency (with ranges consistent with individual studies) of adverse events reported during 3 and 7 days of follow-up following immunization is provided below.

The most common local reaction observed during the observation period of 7 days after vaccine administration in all populations except children aged 6 to 35 months was pain at the injection site.

For children aged 6 to 35 months, during the observation period of 7 days after the vaccine was administered, mental disorders in the form of irritability were most often noted.

Among general disorders, the most common reaction observed during the observation period of 7 days after vaccine administration in adults, the elderly and children aged 9 to 17 years was headache. For children aged 3 to 8 years, malaise was most often reported.

Adverse events presented below are listed according to systemic organ class and frequency of occurrence. The frequency of occurrence was determined based on the following criteria: very often (≥10%), often (≥1% before<10%), нечасто (≥0,1% до <1%), редко (≥0,01% до <0,1%), очень редко (<0,01%), частота неизвестна (нельзя оценить по имеющимся данным).

Adverse events reported within 3 days after immunization

Metabolic and nutritional disorders *

Very common: loss of appetite 1

Common: insomnia 1.

Very often: headache 2,3,4, 5, drowsiness 1.

From the gastrointestinal tract*

Very common: diarrhea 1.

Common: vomiting 1.

From the skin and subcutaneous tissues*

Often: increased sweating 4.5.

Very often: myalgia *2,3,4.

Often: arthralgia *4, 5, myalgia 5.

General disorders and administration site disorders*

Very often: pain 1.2, 3, 4, 5, redness 1.2,3,4.5, induration 4.5, swelling 2.3,4.5 at the injection site, asthenia 4, fever >

Often: swelling 1, induration 2.3, hematoma 1.2,3,4.5, itching 1.2,4.5 at the injection site, asthenia 5, temperature increase >38 °C (when measured in the oral cavity) 2 , 3, 4, 5, chills 2, 4, 5, malaise 5.

In children aged 9-17 years, pain and redness at the injection site, headache, and myalgia were most often observed within 3 days after the injection.

In children aged 3-8 years, pain and redness at the injection site and malaise were most often observed within 3 days after the injection.

In children aged 6-35 months, pain at the injection site, irritability and abnormal crying were most often observed within 3 days after injection.

Adverse events recorded during the observation period of 7 days after immunization

Metabolic and nutritional disorders*

Very common: loss of appetite 1.

Mental disorder*

Very common: irritability 1, pathological crying 1.

Nervous system disorders

Very often: headache 2, 3, 4, 5, drowsiness* 1.

From the gastrointestinal tract*

Common: vomiting 1.

From the skin and subcutaneous tissues

Common: increased sweating 4.5

From the musculoskeletal and connective tissue side

Very common: myalgia 2, 3, 4, 5

Common: arthralgia * 4.5

Very often: pain 1,2,3,4,5, redness 1,2,3,4,5, hardness 1,2,3,4,5, swelling 1,2,3,4,5, itching* 4 at the injection site, asthenia* 4, fever >38 °C (when measured in the oral cavity) 1, chills 3, malaise 2,3,4.

Often: compaction 3, hematoma 2,3,4,5, itching* 5 at the injection site, asthenia* 5, fever >38 °C (when measured in the oral cavity) 2, 3, 4, 5, chills 2,3 ,4,5, malaise 5.

The above adverse events were more often observed in adults over 60 years of age than in adults aged 18-59 years. Overall, the safety profile of Vaxigrip during 3 or 7 days of observation after injection is identical in both age groups.

In children aged 9-17 years, during the observation period of 7 days after injection, pain and redness at the injection site, headache, and myalgia were most often observed.

In children aged 3-8 years, during the observation period of 7 days after injection, pain and redness at the injection site, malaise, and myalgia were most often observed.

In children aged 6-35 months, during the observation period of 7 days after injection, irritability, fever >38 °C, decreased appetite and pathological crying were most often observed.

The following is the frequency (with a range corresponding to the rates obtained in 7 clinical studies) of adverse events reported voluntarily within 21 days after immunization. A total of 7,680 people took part in these studies, including 20 children aged 6-35 months, 384 children aged 3-8 years, 72 children aged 9-17 years, 2,607 adults aged 18-59 years and 4,597 adults over 60 years of age.

Adverse events recorded during the observation period 21 days after immunization

Blood and lymphatic system disorders*

Uncommon: lymphadenopathy 2.4.

Rarely: lymphadenopathy 5.

From the immune system*

Uncommon: urticaria 2.

Rarely: itching 4, 5, generalized itching 4, erythema 4, 5, generalized erythema 4, rash 4, 5, urticaria 4, swelling of the face 4.

From the nervous system*

Common: dizziness 3.

Uncommon: drowsiness 4, dizziness 5.

Rarely: paresthesia 4 '5, hypoesthesia 4, neuralgia 5, brachial radiculitis 5.

From the gastrointestinal tract*

Uncommon: diarrhea 2,4,5, nausea 4.

General and administration site disorders*

Often: discomfort 3, itching 3, increased temperature 3 at the injection site.

Uncommon: discomfort 4, pain 4, 5, itching 4, 5, induration 4, bleeding 2, fever 2, 4 at the injection site, flu-like syndrome 4.

The limited data base for children 6–35 months, as well as age-specific safety criteria, preclude direct comparison of the safety profile in this age group with the safety profile in adults.

Data obtained during post-marketing surveillance

Since spontaneous reports of adverse events during commercial use of the drug were received very rarely and from a population with an unknown number of patients, their frequency was classified as “frequency unknown.”

Blood and lymphatic system disorders

Transient thrombocytopenia, lymphadenopathy

From the immune system

Allergic reactions (itching, erythematous skin rash, urticaria, dyspnea, angioedema or shock)

From the nervous system

Paresthesia, Guillain-Barré syndrome, neuritis, neuralgia, seizures, encephalomyelitis

From the side of blood vessels

Vasculitis, in particular Henoch-Schönlein purpura, in some cases with transient kidney damage

Special patient groups

Although only a limited number of individuals with underlying medical conditions were included, studies conducted in renal transplant patients, patients with asthma, or children aged 6 months to 3 years with medical conditions at particularly high risk of developing serious complications associated with influenza did not show significant differences in the safety profile of the Vaxigrip vaccine in these groups of patients.

*Not reported in all clinical studies or in all age groups.

1 Children (6-35 months).

2 Children (3-8 years old).

3 Children (9-17 years old).

4 Adults (18-59 years old).

5 Adults (over 60 years old).

Registered adverse events in case of overdose of the Vaxigrip vaccine correspond to the safety profile of the drug described in the “Side Effects” section.

The Vaxigrip vaccine can be used simultaneously (on the same day) with other vaccines. In this case, the drugs must be injected into different parts of the body using different syringes.

Although inhibition of the hepatic clearance of phenytoin, theophylline and warfarin has been observed following influenza vaccination, subsequent studies have shown no adverse effects associated with this phenomenon.

When the Vaxigrip vaccine is administered to persons undergoing immunosuppressive therapy (corticosteroids, cytotoxic or radioactive drugs), the immune response after vaccination may be reduced.

Due to the fact that the incidence of influenza is seasonal, it is recommended to vaccinate annually in the autumn-winter period, when the risk of influenza is greatest.

The vaccine leads to the development of immunity only against 3 strains of the influenza virus contained in the drug, or against strains similar to those indicated. The Vaxigrip vaccine does not provide immunity against influenza when vaccinated during the incubation period of the disease, as well as against influenza caused by other strains of the virus.

The Vaxigrip vaccine does not form the development of immunity against diseases similar in symptoms to influenza, but caused by other pathogens.

Vaccination against influenza carried out during the previous epidemic season cannot provide reliable protection for the next season, since each epidemic season has its own most common strains of the influenza virus.

When the Vaxigrip vaccine is administered to persons with a reduced ability to produce antibodies due to a genetic defect, immunodeficiency, as well as persons undergoing immunosuppressive therapy, the immune response after vaccination may be reduced. Within a few days after vaccination, cases of false-positive results may occur when determining antibodies to HIV-1, hepatitis C virus and, especially, human T-lymphotropic virus type 1 by enzyme-linked immunosorbent assay (ELISA). A false positive result may be due to the formation of IgM in response to the vaccine. In these cases, the result obtained by ELISA is assessed using Western blotting.

The physician should be informed if the patient has an immunodeficiency, allergy, or unusual reaction to a previous vaccination, as well as any treatment that coincides with or precedes the vaccination. The doctor should be informed of all cases of adverse reactions, not limited to those listed in this instruction.

The vaccine should not be used if the suspension is uncharacteristically colored or if there are foreign particles in it.

The vaccine cannot be mixed with any other medicine in the same syringe.

The health care professional should have the medications and equipment necessary to provide medical care in the event of rare anaphylactic reactions caused by the administration of the vaccine.

Studies have not been conducted to study the effect of the Vaxigrip vaccine on the ability to drive cars and engage in other potentially hazardous activities (working with moving mechanisms, working as a dispatcher and operator, etc.).

0.25 ml or 0.5 ml of vaccine in a syringe, 1 syringe in a closed cell package.

1 closed cell packaging with instructions for use in a cardboard box.

Store at a temperature of 2 to 8 °C, protected from light.

Do not freeze.

Keep out of the reach of children.

Transportation conditions

At temperatures from 2 to 8 °C. Do not freeze.

12 months.

The expiration date is considered to be the last day of the month indicated on the packaging. Do not use after the expiration date stated on the packaging.

Vaxigrip is a vaccine for the prevention of influenza, which forms the development of specific immunity (lasting from 6 to 12 months) to epidemically relevant strains of influenza A and B viruses.

Release form and composition

The dosage form of Vaxigrip is a suspension for intramuscular and subcutaneous administration, a slightly whitish, slightly opalescent liquid. Available according to:

• 0.5 ml of vaccine in a syringe, 1 syringe in a closed cell package, 1 package in a cardboard box;
• 0.5 ml of vaccine in an ampoule, 10 ampoules in a blister pack, 2 packs in a cardboard box (20 ampoules);
• 1 dose of vaccine (0.25 ml) in a syringe, 1 syringe in a closed cell package, 1 package in a cardboard box;
• 5 ml bottle (bottle), 1 pc. in a cardboard pack.

1 dose (0.5/0.25 ml) contains active substances - hemagglutinin and neuraminidase of the following viral strains:

• A (H1 N1) – 15/7.5 µg GA;
• A (H3 N2) – 15/7.5 µg GA;
• B – 15/7.5 µg GA.

Excipients: buffer solution (sodium chloride, sodium hydrogen phosphate dihydrate, potassium chloride, potassium dihydrogen phosphate, water for injection) – up to 0.5 ml.

Pharmacological properties

Vaxigrip promotes the formation of high specific tissue and humoral immunity against influenza (strengthening the body's defenses when faced with epidemically relevant strains of influenza virus types A and B included in this vaccine) in 80–95% of patients.

Antiviral antibodies, as a rule, are produced 10–15 days after vaccination, and immunity lasts for 6–12 months.

Pharmacodynamics

The pharmacodynamics of the drug have not been sufficiently studied.

Pharmacokinetics

Detailed studies of the pharmacokinetic characteristics of Vaxigrip have not been conducted.

Indications for use

According to the instructions, Vaxigrip is used to prevent influenza in adults and children over 6 months of age. Vaccination is allowed for the following diseases/conditions:

• Diabetes;
• Chronic renal failure;
• Diseases of the cardiovascular system and respiratory organs;
• Immunodeficiency (including HIV infection);
• Malignant blood diseases;
• Concomitant therapy with cytostatics, immunosuppressants, high doses of glucocorticosteroids;
• Radiation therapy.

Vaxigrip can be used by older people (over 65 years of age) and pregnant women if they are at high risk of influenza infection.

Contraindications

• Acute febrile condition or exacerbation of chronic diseases (vaccination can be carried out after remission or recovery);
• Allergic reactions to previous use of the drug;
• Non-severe ARVI (vaccination can be carried out after normalization of body temperature);
• Hypersensitivity to the components of the drug, incl. to aminoglycosides and chicken protein.

The decision to vaccinate pregnant women should be made by a doctor individually, taking into account the risk of the disease and possible complications of influenza infection. It is safest to vaccinate in the II-III trimesters of pregnancy.

The use of Vaxigrip during breastfeeding is possible, since the drug does not have a toxic or teratogenic effect on the fetus.

Instructions for use of Vaxigrip: method and dosage

Vaxigrip vaccine can be administered:

• Subcutaneously deep into the upper third of the outer surface of the shoulder;
• Intramuscularly into the deltoid muscle;
• In the anterolateral surface of the thigh - in young children.

Children from 6 months to 3 years are administered a single dose of 0.25 ml of the drug; those who have not been vaccinated and have not previously had the flu, the vaccine is administered twice with an interval of 4 weeks.

For adults and children over 3 years of age, Vaxigrip is administered once, 0.5 ml.

For patients with immunodeficiency, the drug can be administered twice, 0.25 ml with an interval of 4 weeks.

Side effects

• Often - sweating, fatigue, headache, malaise, hyperthermia, trembling, pain in joints and muscles, neuralgia (transient, disappear after 1-2 days);
• Rarely - paresthesia, thrombocytopenia, neuritis, encephalomyelitis, convulsions, Guillain-Barre syndrome (a clear connection with vaccination has not been established);
• Very rarely - allergic reactions up to shock, vasculitis with transient renal dysfunction.

The most likely local reactions are: hyperemia, induration, pain and swelling at the injection site, ecchymosis.

Overdose

Information about overdose of Vaxigrip is not provided by the manufacturer.

special instructions

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

Intravenous administration of Vaxigrip is not allowed.

For mild ARVI and acute intestinal diseases, vaccination can be carried out after body temperature has normalized.

On the day of vaccination, patients must be examined by a doctor (paramedic). Vaccination is not carried out at body temperatures above 37 °C.

After using Vaxigrip, enzyme-linked immunosorbent assays may result in false-positive results of serological tests, which is due to the production of IgM.

Vaccination rooms should contain anti-shock medications (epinephrine, glucocorticosteroids, etc.).

Vaxigrip vaccine may contain trace amounts of gentamicin.

Vaccination does not affect the speed of psychomotor reaction and the ability to concentrate.

After immunization, the patient should be under the supervision of a healthcare professional for half an hour.

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

A drug with damaged labeling or integrity of ampoules, stored in violation of the requirements, with altered physical properties (transparency, color) and with an expired expiration date is not suitable for use.

Use during pregnancy and lactation

The results of studies of the use of the vaccine in pregnant women confirm the absence of negative effects of vaccination on the fetus and the body of the expectant mother. The presence of embryotoxic and teratogenic effects has not been proven. The decision to vaccinate a pregnant woman is made on an individual basis exclusively by a specialist who takes into account the risk of contracting influenza and the possible complications of this infectious disease. It is preferable to administer Vaxigrip in the second to third trimesters of pregnancy. If a pregnant woman is at increased risk of developing serious post-influenza complications, use of the vaccine is recommended at any stage of pregnancy.

Vaccination during lactation is allowed.

Drug interactions

Vaxigrip can be used simultaneously with other inactivated vaccines, but contraindications for each of them must be taken into account (the drugs should be administered with different syringes to different parts of the body).

Immunosuppressants and glucocorticosteroids reduce the immune response to the drug.

Analogs

Analogs of Vaxigrip are: Agrippal S1, Begrivak, Inactivated influenza vaccine, eluate-centrifuge, Pandeflu.

Terms and conditions of storage

Store in a place protected from light, out of reach of children, at a temperature of 2-8 °C. Do not freeze.

Shelf life – 12 months.

Conditions for dispensing from pharmacies

It is used only in medical institutions.