Active ingredient
Inactivated split influenza viruses cultured on chicken embryos, represented by strains:
Auxiliary component (solvent)
Does not contain adjuvants or preservatives.
_________________
* - the field contains the names of strains recommended by WHO for the current epidemic influenza season
Industrial impurities (content in one dose):
Dose 0.5 ml
Formaldehyde no more than 30 mcg
Octoxynol-9 no more than 200 mcg
Neomycin no more than 20 picograms
Ovalbumin no more than 0.050 mcg
Description
Slightly opalescent, slightly whitish liquid.
Pharmacotherapeutic group
Inactivated flu vaccine
CodeATXJ 07 BB 02
Immunological properties
The Vaxigrip vaccine is made from three strains of influenza virus, cultured, purified and then inactivated with formaldehyde. Vaxigrip vaccine 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.
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.
Severe allergic reactions after previous administration of a vaccine or a vaccine containing the same components.
For diseases accompanied by increased body temperature, as well as acute or exacerbation chronic disease Vaccination should be postponed until recovery or remission.
Carefully
Vaxigrip vaccine should be used with caution in persons with thrombocytopenia or coagulation disorders due to the possibility of bleeding after intramuscular injection.
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 Vaxigrip 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.
Directions for use and doses
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 under 6 months of age - 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 thigh or area
deltoid muscle;
Children from 36 months and adults - deltoid muscle area.
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 effect"type="checkbox">
Side effect
Information on adverse events was obtained from clinical trials and during post-marketing use of the drug in various countries of 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.
Below are the frequencies (with ranges consistent with individual studies) of adverse events reported at 3 and 7 days of follow-up after immunization.
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
Days after vaccine administration, for adults, seniors 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 system 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
Often: loss of appetite1.
Mental disorder *
Often: irritability1, pathological crying1.
Often: insomnia1.
Violations by nervous system*
Often: headache2,3,4,5, drowsiness1.
Often: diarrhea1.
Often: vomiting1.
Often: increased sweating4,5.
From the musculoskeletal and connective tissue side
Often: myalgia*2,3,4.
Often: arthralgia*4.5, myalgia5.
Often: pain1,2,3,4,5, redness1,2,3,4,5, hardening4,5, swelling2,3,4,5 at the injection site.
________________________
*Not reported in all clinical studies or in all age groups.
1Children (6-35 months).
2Children (3-8 years old).
3Children (9-18 years old).
4Adults (19-56 years old).
5Adults (over 60 years old).
asthenia4, fever >38°C (when measured in the oral cavity)1, chills3, malaise2,3,4.
Often: swelling1, induration2,3, hematoma1,2,3,4,5, itching2,4,5 at the injection site, asthenia5, temperature increase >38°C (when measured in the oral cavity)2,3,4,5, chills2, 4.5, malaise5.
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 pathological 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*
Often: loss of appetite1.
Mental disorder*
Often: irritability, pathological crying1.
Nervous system disorders
Often: headache2,3,4,5, drowsiness*1.
From the gastrointestinal tract*
Often: vomiting1.
From the skin and subcutaneous tissues*
Often: increased sweating4,5.
From the skeletal side muscle and connective tissue
Often: myalgia2,3,4,5.
Often: arthralgia*4.5.
General and administration site disorders
Often: pain1,2,3,4,5, redness1,2,3,4,5, induration1,2,4,5, swelling1,2,3,4,5, itching*4 at the injection site, asthenia*4, increase temperature >38 °C (measured in the oral cavity)1, chills3, malaise2,3,4.
Often: induration3, hematoma2,3,4,5, itching*2,3,5 at the injection site, asthenia*5, fever >38°C (when measured in the oral cavity)2,3,4,5, chills*2, 4.5, malaise5.
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 follow-up 3 or 7 days 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
Infrequently: lymphadenopathy2,4.
Rarely: lymphadenopathy5.
From the immune system*
Infrequently: urticaria2.
Rarely: itching4,5, generalized itching4, erythema4,5, generalized erythema4, rash4,5, urticaria4, swelling of the face4.
From the nervous system*
Often: dizziness3.
Infrequently: drowsiness4, dizziness5.
Rarely: paresthesia4,5, hypoesthesia4, neuralgia5, brachial radiculitis5.
From the gastrointestinal tract*
Infrequently: diarrhea2,4,5, nausea4.
General disorders and administration site disorders*
Often: discomfort3, itching3, increased temperature3 at the injection site.
Infrequently: discomfort4, pain4,5, itching4,5, hardening4, bleeding2, increased temperature2,4 at the injection site, flu-like syndrome4.
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 a 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 disorders and lymphatic systems s
Transient thrombocytopenia, lymphadenopathy
From the immune system
Allergic reactions (itchy skin, 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.
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 with other drugs
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 in incubation period diseases, 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 is characterized by 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. Cases may occur within a few days after vaccination false positive results when determining antibodies to HIV-1, hepatitis C virus and, especially, human T-lymphotropic virus type 1 using the enzyme-linked immunosorbent assay (ELISA) method. 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 must be informed of all cases adverse reactions, not limited to those listed in this manual.
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.
The medical worker must have the medicines and instruments necessary to provide medical care in case of development of rare anaphylactic reactions caused by the administration of the vaccine.
Effect on ability to drive vehicles and potentially engage in others dangerous species activities
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.).
Vaxigrip: instructions for use and reviews
Latin name: Vaxigrip
ATX code: J07BB01
Active substance: inactivated split gravedo virus
Manufacturer: Sanofi Pasteur S.A. (France)
Updating the description and photo: 16.08.2019
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, 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) includes 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 cardio-vascular 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 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 outer surface 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 normalization of body temperature.
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 when enzyme immunoassay False-positive results of serological tests are possible, 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 requirements, with altered conditions is not suitable for use. physical properties(transparency, color) and expired.
Use during pregnancy and lactation
The results of studies of the use of the vaccine in pregnant women confirm the absence of negative impact vaccinations 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 possible occurrence 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.
SPLIT VACCINE FOR FLU PREVENTION
STRAINS 2008/2009
VAXIGRIP
INFLUENZA VACCINE
(SPLIT VIRION,
INACTIVATED)
2009/20010 STRAINS
Registration certificate No. 014493/01-2002
Suspension for intramuscular and subcutaneous administration.
COMPOUND
0.5 ml of suspension contains:
Active ingredient: inactivated, cultured on chicken embryos
split influenza viruses, represented by strains equivalent to
as follows:
A/Brisbane/59/2007 (H1N1)-like strain*. . . . . . . . . . . 15 mcg hemagglutinin;
A/Brisbane/10/2007 (H3N2)-like strain** . . . . . . . . . . 15 mcg hemagglutinin;
B/Brisbane/60/2008-like strain*** . . . . . . . . . . . . . . . . 15 mcg hemagglutinin.
* A/Brisbane/59/2007/H1N1/IVR-148
** A/Uruguay/716/2007/H3N2/NYMC X-175 C
***B/Brisbane/60/2008
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 2009/2010 season.
Vaxigrip may contain no more than 0.05 mcg of ovalbumin per dose.
DESCRIPTION
Slightly opalescent, slightly whitish liquid.
IMMUNOBIOLOGICAL PROPERTIES
Vaxigrip forms the development of specific immunity to epidemic
current strains of influenza virus types A and B contained in this vaccine.
Immunity develops between the 2nd and 3rd weeks after vaccination and
lasts from 6 to 12 months.
PURPOSE
Prevention of influenza in adults and children from 6 months of age. Vaccination
especially indicated for individuals at increased risk of developing
post-flu complications.
CONTRAINDICATIONS
Hypersensitivity to any of the components of the vaccine, as well as components
chicken meat or chicken eggs, neomycin, formaldehyde and octoxynol-9.
For diseases accompanied by increased body temperature, as well as
in case of acute or exacerbation of a chronic disease, vaccination should be
postpone until recovery.
USE DURING 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 body
women. Vaccination with this drug can be carried out starting from
second trimester of pregnancy. For medical reasons, if available
increased risk of developing post-influenza complications, use
The vaccine can be used during breastfeeding.
METHOD OF APPLICATION AND DOSES
The vaccine is administered intramuscularly or deep subcutaneously. Do not enter
intravenously! The vaccine should be kept at room temperature before use.
temperature and shake.
Dosage: 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 of age receiving the first influenza vaccine should
two-time administration of Vaxigrip with an interval of 4 weeks.
When using a syringe containing 0.5 ml of vaccine for immunization
children for whom administration of a dose of 0.25 ml is indicated, half should be removed
contents by pressing the piston to the special mark. Enter the patient
remaining amount of vaccine.
When using an ampoule containing 0.5 ml of vaccine for immunization of children,
for whom the administration of a dose of 0.25 ml is indicated, it is necessary to take it from
using a syringe that has appropriate graduations. Remainder
The vaccine in the ampoule must be destroyed immediately.
SIDE EFFECT
During clinical trials, it was usually observed (with a frequency ranging from
1/100 to 1/10):
General reactions: increased body temperature, malaise, chills, sensation
fatigue, headache, sweating, muscle pain (myalgia), pain in
joints (arthralgia).
Local reactions: redness, swelling, pain, bruising
(ecchymosis), compaction at the injection site.
These reactions usually resolve within 1-2 days and do not require special treatment.
With the mass use of Vaxigrip, in very rare cases there were
the following adverse reactions:
From the circulatory and lymphatic systems: transient thrombocytopenia,
lymphadenopathy, vasculitis with possible short-term involvement of the kidneys (in
isolated cases)
From the nervous system: paresthesia, Guillain-Barre syndrome, neuritis, neuralgia,
convulsions, encephalomyelitis;
Allergic reactions: urticaria, itching, skin rashes; dyspnea,
angioedema, shock.
SPECIAL INSTRUCTIONS
Due to the fact that the incidence of influenza is seasonal,
the risk of influenza is greatest.
The vaccine leads to the development of immunity against only 3 strains of the virus
influenza contained in the drug or against strains similar to those indicated.
Vaxigrip does not provide immunity against influenza when
vaccinations during the incubation period of the disease, as well as against influenza,
caused by other strains of the virus . Vaxigrip does not shape development
immunity against diseases similar in symptoms to influenza, but
caused by other pathogens. Influenza vaccination given in
time of the previous epidemic season, cannot provide reliable
protection for the next season, because each epidemic season is characterized by
their most common strains of influenza virus.
The doctor must be informed about the patient's immunodeficiency,
allergies or unusual reactions to a previous vaccination, or any
treatment that coincided with vaccination or preceded
vaccinations.
The vaccine should not be used if the color of the suspension is uncharacteristic or
presence of foreign particles in it.
The use of this vaccine does not affect the ability to drive a car.
or other equipment.
The doctor should be informed about all cases of adverse reactions, not
limited to those listed in these instructions.
Cases may occur within a few days after vaccination
false positive results when determining antibodies to HIV-1, virus
hepatitis C and especially human T-lymphotropic virus type 1
enzyme immunoassay (ELISA) method. In these cases, the assessment of the result,
obtained by ELISA is performed using Western blotting.
When carrying out vaccination, it is necessary to have available medications,
necessary to provide emergency assistance in case of anaphylactic
reactions.
INTERACTION WITH OTHER MEDICINES
Vaxigrip can be used simultaneously (on the same day) with other vaccines.
In this case, drugs must be administered to different parts of the body using
different syringes. The vaccine cannot be mixed with any other
medicine in one syringe.
In patients undergoing immunosuppressive therapy (corticosteroids,
cytotoxic or radioactive drugs), immune response after vaccination
may not be sufficient.
RELEASE FORM
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.
0.5 ml of vaccine per ampoule, 10 ampoules per blister pack, per
2 blister packs (20 ampoules) with instructions for use in
cardboard pack.
BEST BEFORE DATE
12 months. The expiration date is considered last number months,
indicated on the packaging.
Do not use after the expiration date stated on the packaging.
STORAGE CONDITIONS
Store in the refrigerator (2 to 8°C), away from light. Not
freeze.
Keep out of the reach of children.
VACATION CONDITIONS
Syringes: According to a doctor's prescription.
Ampoules: For medical institutions.
About all unusual cases vaccination reactions inform the National
medical control body immuno biological drugs- FGUN
“State Research Institute of Standardization and Control
medical biological preparations named after. L.A. Tarasevich" Rospotrebnadzor
(119002, Moscow, Sivtsev-Vrazhek lane, 41, tel. 241-39-22) and Representative Office
Sanofi Pasteur in the CIS countries (115035, Moscow, Sadovnicheskaya st., 82, bldg.
2, tel. 935-86-90).
MANUFACTURER
Sanofi Pasteur S.A., 2, Avenue Pont Pasteur 69007, Lyon, France__
VACCINATION SCHEME
|
It should be especially noted that, unlike some other registered in Russia imported vaccines(for example, Influvac), this dosage regimen fully coincides with international recommendations. In particular, a completely identical vaccination regimen is recommended in the USA. Half dose of Vaxigrip vaccine(0.25 ml, half adult dose, special release form) is used in children under 36 months of age. Full dose(0.5 ml) is used in children over 36 months and adults. Why do children under 8 years of age who have not previously been vaccinated need two doses of the vaccine 1 month apart? Like any other vaccine inactivated vaccine in children, the Vaxigrip vaccination requires repeated administrations, since the strength of the immune response to one vaccination is not enough. This is explained by the so-called booster phenomenon boost- strengthening), which lies in the fact that repeated administration of antigens causes a faster and stronger immune response than their initial administration. In turn, the booster phenomenon is based on the appearance after the first vaccination of special immune cells memories that remember the structure of the antigen and, if it reappears in the body, help the immune system produce antibodies faster and in greater quantities. Thus, the flu vaccine consists of a primary vaccination and revaccination, like DPT vaccinations and ADS. In the case where the child was vaccinated in previous years, the previous vaccination serves as the primary vaccination, and the current vaccination is the revaccination. In Russia, special studies were conducted on this issue - what is the benefit of repeated vaccination in children under 8 years of age who have not been vaccinated and who have not been ill? The results of this study showed that in these children, a single vaccination is not sufficient to protect against influenza. The morbidity rate practically does not decrease compared to unvaccinated people. At the same time, it was demonstrated that in this group of children, double vaccination can reduce the incidence by 4 times. Why is the dose of 0.5 ml used in children over 3 years of age and not 0.25 ml? As shown by comparative studies of two various dosages, a half dose causes the development of immunity in 70-80% of vaccinated children, while a full dose (0.5 ml) forms immunity in 90-99% of children. Why do adults only need one Vaxigrip vaccination? There is no need for re-vaccination due to the guaranteed presence of adult memory cells in the body as a result of previous influenza illnesses (it is believed that by the age of 9 a person has had the flu at least once). The immune response after a single vaccination is completely sufficient for effective prevention flu At the same time, studies conducted abroad have shown that repeated vaccination in adults does not provide any benefit compared to a single vaccination. CONTRAINDICATIONS Like any other vaccination, Vaxigrip has a number of contraindications. Among them are nonspecific, that is, applicable to all vaccines, and one specific contraindication. Among the contraindications there are relative ones, that is, those that can be temporary or in which vaccination is possible, and one absolute one. Contraindications
1. Vaxigrip vaccination is not carried out ifacute illness and exacerbation of chronic illness I. This contraindication is common to all vaccines and is relative. The general meaning of this contraindication is that the vaccine cannot aggravate (even theoretically) the course of an acute disease. For example, vaccination during an acute respiratory infection accompanied by an increase in temperature can lead to a further increase in temperature. Any deterioration in well-being, even if not related to the vaccination, in this case will be attributed by the patient and the attending physician specifically to the vaccination. It is also believed that vaccination during illness can “overload the immune system.” And although this is not true, because the immune system a person is multitasking and cannot be overloaded during acute illness V general case Vaccinations are not recommended. An exception may be cases when the patient is at increased risk of illness and mortality due to influenza, but at the time when it is necessary to get vaccinated, he was sick and there is no time left for vaccination. In this case, the doctor (and only the doctor) must decide whether to vaccinate if there is a relative contraindication or not. 2. Allergy to chicken egg whites is absolute contraindication. In practice, such an allergy includes immediate swelling of the lower lip and throat when trying to eat a chicken egg in any form (boiled egg, scrambled egg, salad). If there are no such reactions and a person eats chicken eggs calmly and without consequences, then there is no allergy to chicken egg whites. 3. The Vaxigrip vaccine is a highly purified drug . However, in extremely rare cases there may be allergic reactions to any components of the vaccine. If a person had a severe allergy after a previous Vaxigrip vaccination, this is also an absolute contraindication to the vaccine. Vaccination and pregnancy Pregnancy and lactation are not a contraindication to vaccination. However, vaccinations during the first trimester of pregnancy are generally not recommended. This is due to the fact that during the first three months the risk of miscarriage is already quite high and therefore a situation may arise when the vaccination coincides with the miscarriage, and the woman and the doctor may get the impression that it was the vaccination that caused the termination of pregnancy. In fact, no vaccine contains substances that can cause miscarriage. Moreover, flu vaccinations in pregnant women are a fairly common practice in developed countries of the world and are even recommended for use in those women whose pregnancy will be in the 2-3 trimester during a flu epidemic. |
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, exacerbation of chronic diseases, increased sensitivity to 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 - skin itching, 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 concomitant 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 and acute intestinal diseases, vaccination is carried out immediately after the temperature has normalized.
When using a vaccine, it is necessary to always have on hand supplies that may be needed in the event of rare anaphylactic reactions occurring after administration. For this reason, the vaccinee must be under medical supervision for 30 minutes after immunization.
Following influenza vaccination, false-positive results from serological ELISA tests 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.
Inactivated split vaccine for the prevention of influenzaSTRAINS 2014/2015
Registration certificate № 014493/01
Dosage form
Suspension for intramuscular and subcutaneous administration.
Compound
0.5 ml of suspension contains:
Active ingredient: inactivated split influenza viruses cultured on chicken embryos, represented by strains:
A/California/7/2009/NUMS X-179A, derived from
A/California/7/2009/H1N1/pdm09 15 mcg hemagglutinin;
A/Texas/50/2012 NYMC X-223A, derived from A/Texas/50/2012 (НЗN2) 15 μg of hemagglutinin;
B/Massachusetts/2/2012 15 mcg hemagglutinin.
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 2014/2015 season. Vaxigrip may contain no more than 0.05 mcg of ovalbumin per dose.
Description
Slightly opalescent, slightly whitish liquid.
Immunobiological properties
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.
Purpose
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.
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 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 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.
Directions for use and doses
The vaccine is administered intramuscularly or deep subcutaneously. Do not administer intravenously! The vaccine should be kept at room temperature and shaken before use.Dosage: 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 effect
During clinical studies, the following were usually noted (with a frequency of 1/100 to 1/10):
General reactions: increased body temperature, malaise, chills, feeling tired, headache, sweating, muscle pain (myalgia), joint pain (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 the mass use of Vaxigrip, in very rare cases the following adverse reactions occurred:
From the circulatory and lymphatic systems: transient thrombocytopenia, lymphadenopathy, vasculitis with possible short-term involvement of the kidneys (in isolated cases)
From the nervous system: paresthesia, Guillain-Barré syndrome, neuritis, neuralgia, convulsions, encephalomyelitis;
Allergic reactions: urticaria, itching, skin rashes; shortness of breath, angioedema, shock.
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 preparation 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 form the development of immunity against diseases similar in symptoms to the flu, but 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 influenza virus.
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 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 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 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 medications necessary to provide emergency assistance in case of an anaphylactic reaction.
Interaction with other drugs
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
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.
Storage conditions
Store in the refrigerator (2 to 8°C), protected from light. Do not freeze.
Keep out of the reach of children.
Vacation conditions
Syringes: According to a doctor's prescription.
Ampoules: For medical institutions.
Please report any unusual vaccine reactions to:
FSBI " Science Center examination of funds medical use"(119002, Moscow, Sivtsev Vrazhek lane, 41) and the Representative office of the manufacturing company Sanofi-aventis Group JSC (115035, Moscow, Tverskaya St., 22).
Manufacturer
Sanofi Pasteur S.A., 2, Avenue Pont Pasteur 69007, Lyon, France
