Vaxigrip- inactivated split vaccine for the prevention of influenza. STRAINS 2019/2020.
Registration certificate: P NO1449З/01
Tradename: Vaxigrip
Group name: flu vaccine
Dosage form: suspension for intramuscular and subcutaneous administration
Manufacturer country: Sanofi Pasteur, France
Exploratory survey: not required
Vaccine cost: 2400 rub.
Applicable: For adults and children from 6 months.
Conditions for dispensing from pharmacies: Syringes - according to prescription, Ampoules - For medical institutions
Availability of vaccine: in stock
Analogues of this vaccine:
Vaccine "Influvac" (for adults and children from 6 months.)
Vaccine "Ultrix quadri" (Ultrix) (for adults 18+)
DESCRIPTION OF THE MEDICINE
Appearance: Slightly opalescent, slightly whitish liquid.
Immunobiological properties
Vaxigrip shapes development 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.
COMPOUND
0.5 ml of suspension contains:
Active components:
Inactivated split influenza viruses cultured on chicken embryos, represented by strains equivalent to the following:
- A/Brisbane/02/2018, IVR-190 similar to A/Brisbane/02/2018(H1N1) pdm09- 15 μg GA;
- A/Kansas/14/2017 NYMC X-327, similar to A/Kansas/14/2017(H3N2) - 15 μg of GA;
- B/Maryland/15/2016 NYMC BX-69A, similar to B/Colorado/06/2017 - 15 mcg GA.
Auxiliary components:
- buffer solution (sodium chloride, potassium chloride, sodium hydrogen phosphate dihydrate, potassium dihydrogen phosphate, water for injection) - up to 0.5 ml;
- The strain composition of the vaccine complies with WHO recommendations for the Northern Hemisphere and the EU decision on the composition of influenza vaccines for the 2019/2020 season. Vaxigrip may contain no more than 0.05 mcg of ovalbumin per dose.
INDICATIONS FOR USE
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.
CONTRAINDICATIONS
- Hypersensitivity to any of the components of the vaccine, as well as components chicken meat or chicken egg, neomycin, formaldehyde and octoxynol-9;
- In case of diseases accompanied by an increase in body temperature, as well as in acute or exacerbation of a chronic disease, vaccination should be postponed until recovery;
USE DURING PREGNANCY AND LACTATION
The 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 can be carried out starting from the second trimester of pregnancy. For medical reasons, if available increased risk development of post-influenza complications, the use of this vaccine is recommended regardless of the stage of pregnancy.
The vaccine can be used during breastfeeding.
METHOD OF APPLICATION AND DOSAGE
The vaccine is administered intramuscularly or deep subcutaneously. Do not administer intravenously! The vaccine should be kept at room temperature and shaken before use.
- For children over 36 months and adults - 0.5 ml once;
- For children aged 6 months to 35 months inclusive - 0.25 ml once;
- For children under 9 years of age who are being vaccinated against influenza for the first time, two doses of Vaxigrip are indicated with an interval of 4 weeks.
When using a syringe containing 0.5 ml of vaccine to immunize children for whom a dose of 0.25 ml is indicated, it is necessary to remove half of the contents by pressing the plunger to the special mark. Inject the remaining amount of vaccine into the patient.
When using an ampoule containing 0.5 ml of vaccine to immunize children for whom a dose of 0.25 ml is indicated, it must be withdrawn using an appropriately graduated syringe. The remainder of the vaccine in the ampoule must be destroyed immediately.
SIDE EFFECTS
General reactions
- Increased body temperature;
- Malaise;
- Chills;
- Feeling tired;
- Headache;
- Sweating;
- Muscle pain (myalgia);
- Joint pain (arthralgia).
Local reactions
- Redness;
- Swelling;
- Soreness;
- Bruising (ecchymosis);
- Lump at the injection site.
These reactions usually resolve within 1-2 days and do not require special treatment.
With mass use of Vaxigrip, in very rare cases the following adverse reactions occurred:
- Transient thrombocytopenia;
- Lymphadenopathy;
- Vasculitis with possible short-term involvement of the kidneys (in isolated cases);
- Paresthesia;
- Guillain-Barre syndrome;
- Neuritis;
- Neuralgia;
- Convulsions;
- Encephalomyelitis;
- Hives;
- Skin rashes;
- Dyspnea;
- Angioedema;
SPECIAL INSTRUCTIONS
- 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. Vaxigrip does not provide immunity against influenza when vaccinated in incubation period diseases, as well as against influenza caused by other strains of the virus. Vaxigrip does not develop the development of immunity against diseases that are similar in symptoms to the flu, but are caused by other pathogens. Influenza vaccination administered during the previous epidemic season cannot provide reliable protection
- for next season, because Each epidemic season has its own most common strains of the influenza virus;
- The physician should be informed about the patient's immunodeficiency, allergy, or unusual reaction to a previous vaccination, as well as about any treatment that coincided with or preceded the vaccination.
- The vaccine should not be used if the suspension is uncharacteristically colored or if there are foreign particles in it; The use of this vaccine does not affect the ability to drive a car or use other equipment; The doctor must be informed of all cases
- adverse reactions
- , not limited to those listed in these instructions; 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). In these cases, the result obtained by ELISA is assessed using Western blotting; When carrying out vaccination, it is necessary to have available the medications necessary to provide
emergency assistance
Vaxigrip 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. The vaccine cannot be mixed with any other medicine in the same syringe.
In patients undergoing immunosuppressive therapy (corticosteroids, cytotoxic or radioactive drugs), the immune response after vaccination may be insufficient.
RELEASE FORM
- 0.5 ml of vaccine in a syringe, 1 syringe in a closed cell package, 1 closed cell package with instructions for use in a cardboard box;
- 0.5 ml of vaccine per ampoule, 10 ampoules in a blister pack, 2 blister packs (20 ampoules) with instructions for use in a cardboard box.
BEST BEFORE DATE
susp. intramuscular and subcutaneous administration 0.5 ml/1 dose: syringes 1 pc., amp. 20 pcs.Reg. No.: 4150/99/04/08/13 dated 07/25/2013 - Valid
Suspension for intramuscular and subcutaneous administration slightly whitish, slightly opalescent.
Excipients: buffer solution - sodium chloride, potassium chloride, sodium hydrogen phosphate dihydrate, potassium dihydrogen phosphate, water (up to 0.5 ml).
0.5 ml - syringes (1) - contour cell packaging (1) - cardboard packs.
0.5 ml - ampoules (10) - contour cell packaging (2) - cardboard packs.
* - cultured on chicken embryos.
** - the strain composition complies with WHO recommendations for the Northern Hemisphere and the EU decision on the composition of influenza vaccines for the current epidemic season.
*** - hemagglutinin.
The vaccine may contain no more than 0.05 mcg of ovalbumin per dose.
Description of the drug VAXIGRIP based on officially approved instructions for use of the drug and made in 2009. Update date: 08/23/2010
Vaccine for the prevention of influenza. Vaxigrip 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.
The vaccine is administered intramuscularly or deeply subcutaneously. Do not administer IV! The vaccine should be kept at room temperature and shaken before use.
For children over 36 months and adults - 0.5 ml once, for children aged 6 months to 35 months inclusive - 0.25 ml once.
Children under 9 years old, who are being vaccinated against influenza for the first time, a double dose of Vaxigrip with an interval of 4 weeks is indicated.
When using a syringe containing 0.5 ml of vaccine to immunize children for whom a dose of 0.25 ml is indicated, it is necessary to remove half of the contents by pressing the plunger to a special mark. Inject the remaining amount of vaccine into the patient.
When using an ampoule containing 0.5 ml of vaccine to immunize children for whom a dose of 0.25 ml is indicated, it must be withdrawn using a syringe that has the appropriate graduation. The remainder of the vaccine in the ampoule must be destroyed immediately.
During clinical studies, they were usually observed (with a frequency of 1/100 to 1/10).
General reactions: increased body temperature, malaise, chills, feeling tired, headache, sweating, myalgia, arthralgia.
Local reactions: redness, swelling, pain, bruising (ecchymosis), hardening at the injection site.
These reactions usually resolve within 1-2 days and do not require special treatment.
With mass use of Vaxigrip, the following adverse reactions occurred in very rare cases.
From the hematopoietic system: transient thrombocytopenia, lymphadenopathy, vasculitis with possible short-term involvement of the kidneys (in isolated cases)
From the outside nervous system: paresthesia, Guillain-Barré syndrome, neuritis, neuralgia, convulsions, encephalomyelitis.
Allergic reactions: hives, itching, skin rash, shortness of breath, angioedema, shock.
- increased sensitivity to any of the components of the vaccine, as well as components of chicken meat or chicken eggs, neomycin, formaldehyde and octoxynol-9;
In diseases accompanied by an increase in body temperature, as well as in acute or exacerbation of a chronic disease, vaccination should be postponed until recovery.
Use during pregnancy and breastfeeding
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 this drug 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.
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.
Vaxigrip 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. Vaxigrip does not develop the development of immunity against diseases that are similar in symptoms to the flu, but are caused by other pathogens.
Vaccination against influenza, carried out during the previous epidemic season, cannot provide reliable protection for the next season, because Each epidemic season has its own most common strains of the influenza virus.
The physician should be informed if the patient has an immunodeficiency, allergy, or unusual reaction to a previous vaccination, as well as of any treatment that coincided with or preceded the vaccination.
The vaccine should not be used if the suspension is uncharacteristically colored or if there are foreign particles in it.
The doctor should be informed of all cases of adverse reactions, not limited to those listed in this instruction.
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
enzyme immunoassay (ELISA) method. In these cases, the result obtained by ELISA is assessed using Western blotting.
When carrying out vaccination, it is necessary to have available medications necessary to provide emergency assistance in case of an anaphylactic reaction.
Impact on the ability to drive vehicles and operate machinery
The use of this vaccine does not affect the ability to drive a car or use other equipment.
Vaxigrip 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.
The vaccine cannot be mixed with any other medicine in the same syringe.
In patients undergoing immunosuppressive therapy (corticosteroids, cytotoxic or radioactive drugs), the immune response after vaccination may be insufficient.
Shelf life - 12 months. The expiration date is considered last number month indicated on the package.
Do not use after the expiration date stated on the package.
SANOFI PASTER S.A., representative office, (France)
Officially authorized distributor
on the territory of the Republic of Belarus SJSC "Medvax"
For the prevention of influenza, inactivated (split) (influenza vaccine (split virion), inactivated)
Composition and release form of the drug
Suspension for intramuscular and subcutaneous administration slightly whitish, slightly opalescent.
Excipients: buffer solution (potassium chloride, sodium hydrogen phosphate dihydrate, potassium dihydrophosphate, water for injection) - up to 0.25 ml.
Does not contain adjuvants or preservatives.
Industrial impurities (content in 1 dose): formaldehyde - no more than 15 mcg, octoxynol-9 - no more than 100 mcg, - no more than 10 pkg, ovalbumin - no more than 0.025 mcg.
0.25 ml - syringes (1) - closed cell packaging (1) - cardboard packs.
The strain composition of the vaccine complies with WHO recommendations for the Northern Hemisphere and the EU decision on the composition of vaccines for the current epidemic influenza season.
pharmachologic effect
Inactivated purified split influenza vaccine. Prevents diseases caused by influenza virus types A and B.
Induces the formation of humoral antibodies to hemagglutinins, neutralizing influenza viruses. Seroprotective antibody levels are usually achieved within 7-10 days after vaccine administration. The duration of post-vaccination immunity to homologous or related strains varies from 6 to 12 months.
Indications
Flu prevention.
Contraindications
Acute infectious diseases, exacerbations chronic diseases, hypersensitivity to the active or auxiliary components of the vaccine; hypersensitivity to sulfate, formaldehyde, merthiolate, sodium deoxycholate, egg and chicken whites used in the technological process.
Dosage
For different age categories, appropriate vaccine preparations should be used, taking into account contraindications.
Vaccination should be carried out before the start of the epidemic influenza season or taking into account the epidemic situation.
The vaccine is administered intramuscularly or deeply subcutaneously. In patients with thrombocytopenia and other diseases of the coagulation system, the vaccine should be administered subcutaneously. Under no circumstances should the vaccine be administered intravenously.
Side effects
Systemic reactions: possibly - a slight short-term increase in body temperature, fever, general malaise (these phenomena resolve on their own within 1-2 days); extremely rarely - neuralgia, paresthesia, convulsions, transient thrombocytopenia, neurological disorders, vasculitis.
Allergic reactions: in patients with known sensitivity to individual components of the vaccine - itchy skin, urticaria, rash; extremely rare - severe allergic reactions, such as.
Local reactions: soreness, redness and swelling at the injection site.
Drug interactions
The effectiveness of immunization may be reduced due to concurrent immunosuppressive therapy, as well as in the presence of immunodeficiency.
special instructions
This vaccine prevents illness caused by the influenza virus and does not prevent upper respiratory tract infections. respiratory tract caused by other pathogens.
For mild ARVI, acute intestinal diseases Vaccination is carried out immediately after the temperature normalizes.
When using a vaccine, it is necessary to always have on hand supplies that may be needed in the event of rare anaphylactic reactions after introduction. For this reason, the vaccinee must be under medical supervision for 30 minutes after immunization.
Following influenza vaccination, false-positive results from serological tests using ELISA to detect antibodies against HIV 1, and particularly human T-lymphotropic virus 1 (HTLV 1), have been reported, which may be due to an immune response (IgM production) to vaccination.
Pregnancy and lactation
Currently, there is insufficient data on the embryotoxicity and teratogenicity of this vaccine.
The doctor decides on an individual basis whether to use the vaccine during lactation.
Dosage form: suspension for intramuscular and subcutaneous administration Compound:Active ingredient
Inactivated split influenza viruses cultured on chicken embryos, represented by strains:
| Dose 0.2 5 ml | Dose 0.5 ml |
|
| A/ (H3N2) * | 7.5 mcg hemagglutinin | 15 mcg hemagglutinin |
| A/ (H1N1)* | 7.5 mcg hemagglutinin | 15 mcg hemagglutinin |
| 7.5 mcg hemagglutinin | 15 mcg hemagglutinin |
Auxiliary component (solvent)
Does not contain adjuvants or preservatives.
Industrial impurities (content in one dose):
| Dose 0.25 ml | Dose 0.5 ml |
|
| Formaldehyde | no more than 15 mcg | no more than 30 mcg |
| Octoxynol-9 | no more than 100 mcg | no more than 200 mcg |
| Neomycin | no more than 10 picograms | no more than 20 picograms |
| Ovalbumin | no more than 0.025 mcg | no more than 0.050 mcg |
Slightly opalescent, slightly whitish liquid.
Pharmacotherapeutic group: MIBP - ATX vaccine:J.07.B.B.01 Influenza virus - inactivated whole virus
J.07.B.B Vaccine to prevent influenza
Pharmacodynamics: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.
Indications: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.
Contraindications: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-communicable 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.
Carefully: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.
Pregnancy and lactation: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.
Directions for use and dosage: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. In this case, the syringe should be kept in vertical 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.
Side effects: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 study rates) 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 administration of the vaccine, 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 following criteria: very often (≥10%), often (≥1% to<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 outside 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 disorders at the injection site*
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 disorders and lymphatic system*
Uncommon: lymphadenopathy 2.4.
Rarely: lymphadenopathy 5.
From the outside 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 (skin itching, erythematous skin rashes, 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 concomitant diseases, studies conducted in patients after kidney transplantation, patients with bronchial asthma or in children aged 6 months to 3 years with diseases in which there is a special high risk development of serious complications associated with influenza did not show significant differences in the safety profile of the Vaxigrip vaccine in these groups of patients.
*Not registered in all clinical studies and not 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).
Overdose: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.
Interaction: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 hepatic clearance of phenytoin, theophylline, and warfarin has been reported following influenza vaccination, subsequent studies of the occurrence of unwanted effects no connection was found in connection 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.
Special instructions: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). False positive result may be associated with 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 one syringe.
Medical worker must have medicines and the tools necessary to provide medical care in case of rare anaphylactic reactions caused by the administration of the vaccine.
Impact on the ability to drive vehicles. Wed and fur.:Studies examining the effects of the Vaxigrip vaccine on the ability to drive and engage in other potentially dangerous species activities (work with moving mechanisms, work of the dispatcher and operator, etc.) were not carried out.
Release form/dosage:Suspension for intramuscular and subcutaneous administration, 0.25 ml/dose or 0.5 ml/dose. Package: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.
Storage conditions: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.
Best before date: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 package.
Conditions for dispensing from pharmacies: On prescription Registration number: P N014493/01 Registration date: 26.05.2008 / 03.04.2018 Expiration date: Indefinite Owner of the Registration Certificate:Sanofi Pasteur S.A. France Manufacturer: Representative office: Sanofi Pasteur S.A. Information update date: 08.12.2018 Illustrated instructions
