- The first injection is given at three months;
- the second injection is given at 4.5 months;
- the third dose is administered at six months;
- revaccination - at 18 months, then every 5 years until the age of 18. Then the vaccine is given every ten years.
If a person was not immunized against polio as a child, then in adulthood the vaccine should be administered according to the following scheme:
- first injection;
- a year later - second injection;
- Revaccinations – every 10 years.
Contraindications for use
Imovax has far fewer contraindications than live vaccines. The manufacturer indicates a list of conditions for which vaccination is not recommended in the instructions for the drug.
The manufacturer indicates in the instructions that the drug can cause adverse reactions. Although negative consequences of vaccination are extremely rare, you still need to be aware of them.
Possible complications after vaccination:
- lymphadenopathy;
- allergies (body rash, angioedema, anaphylaxis);
- fever;
- febrile and afebrile seizures;
- myalgia;
- prolongation of the intervals between respiratory movements (more often observed in premature infants).
To minimize the risk of adverse reactions, it is recommended not to use the drug if there are contraindications.
Price and analogues
You can purchase Imovax Polio in pharmacies across the country or by placing an order in an online store specializing in the sale of medications. The average price of the French vaccine is 300 rubles per single dose.
If the drug is not suitable in terms of tolerability, cost, or it is not available in pharmacies, then it is recommended to purchase an analogue.
Vaccine BiVac Polio
The following vaccinations are substitutes for Imovax Polio::
- BiVac Polio– live attenuated oral polio vaccine against three types of virus;
- MonoVac– a preparation containing a live pathogen of type 2 poliomyelitis;
- – inactivated vaccine to prevent the development of polio;
- Poliorix- a vaccine that contains a killed polio pathogen.
Imovax Polio or Poliorix: which is better?
Sometimes you have to make a choice between Imovax Polio and Poliorix. To make the right decision, you need to know the similar and distinctive features of the two drugs. Poliorix is a Belgian inactivated polio vaccine that protects against infection by three types of viruses.
Poliorix vaccine
The manufacturer is the pharmaceutical organization GlaxoSmithKline Biologicals. These vaccinations have identical composition. Accordingly, their adverse reactions, mechanism of action, period of protection, regimen of use and contraindications are the same.
Poliorix can be called a complete analogue of Imovax Polio. The only difference is the country of manufacture, the manufacturing company and the price. The approximate cost of Poliorix is 450 rubles.
It is impossible to say which of the two vaccines is better. The choice should be made only on the basis of personal preferences and financial status.
BiVac Polio is a vaccine for the prevention of polio; oral, live attenuated types 1, 3, bivalent (contains two types of virus).
Release form and composition
BiVac polio is produced in the form of an oral solution: a pink-raspberry to yellow-red transparent liquid, without visible foreign inclusions or sediment.
Composition of 1 dose (4 drops – 0.2 ml):
- active substance: polio virus, attenuated Sabin strains type 1 - not less than 10 6.0 TCD 50 (tissue cytopathogenic doses) and type 3 - not less than 10 5.5 TCD 50 IE (infectious units) of the virus;
- additional components: magnesium chloride, kanamycin.
Indications for use
BiVac polio solution is intended for the active prevention of poliomyelitis.
Contraindications
- neurological disorders noted during previous vaccination with oral polio vaccine;
- primary (congenital) immunodeficiency conditions;
- severe reaction (including temperature above 40 ° C) or complications to a previous vaccine administration;
- malignant neoplasms;
- acute diseases (infectious or non-infectious nature), exacerbation of chronic diseases (vaccination is allowed only 2-4 weeks after complete recovery or remission);
- immunosuppression (vaccination is allowed no earlier than 12 weeks after completion of treatment);
- pregnancy;
- hypersensitivity to any of the components of the vaccine.
The safety of the drug during breastfeeding has not been established.
Directions for use and dosage
The BiVac polio vaccine is intended for oral administration only!
The drug is prescribed in a vaccination dose of 0.2 ml (4 drops) per dose. The vaccine is instilled into the mouth using a dropper attached to the bottle or a pipette 1 hour before meals. It is prohibited to take the drops with any liquid or drink/eat food for 1 hour after the procedure.
During the first and second vaccination against polio, children are administered inactivated polio vaccine (IPV) to prevent polio according to the instructions for use of IPV.
The third vaccination, as well as subsequent revaccinations against polio, is given to children with live oral polio vaccine (LOV).
The vaccination course includes three vaccinations:
- I – IPV at the age of 3 months;
- II – IPV at the age of 4.5 months;
- III – PPV at the age of 6 months.
Revaccination is carried out with PPV in three stages: at 18 months, at 20 months and at 14 years.
Children born to mothers with HIV infection, HIV-infected children or those staying in orphanages are required to receive IPV for the third vaccination and the subsequent 3 stages of revaccination against polio.
If routine immunization begins for a child at an older age, then it is also carried out according to the established scheme (I and II vaccinations - IPV, III vaccination and subsequent revaccinations - PPV).
When carrying out vaccination against polio for epidemic indications, PPV is used.
If there have been cases of the development of poliomyelitis caused by wild poliovirus, isolation of the latter from environmental objects or in human biosamples, the following categories of citizens are subject to mandatory single vaccination (those included in the number of contact persons in the outbreak of poliomyelitis or in cases of suspected damage, including caused by wild poliovirus):
- children aged from 3 months to 18 years;
- children aged 3 months to 15 years who arrived from countries/regions where polio is endemic (in the absence of reliable data on previous vaccinations, three-time vaccination is prescribed);
- medical workers;
- persons from 3 months of age (without age limit) who are in contact with arrivals from polio-endemic countries/regions;
- children aged 3 months to 15 years without a specific place of residence (in the absence of reliable data on previous vaccinations, three-time vaccination is prescribed);
- persons without age restrictions who work with live poliovirus or with materials potentially infected with wild poliovirus when hired.
It is not allowed to shorten the intervals between the first three vaccinations. In exceptional cases, extending the period between vaccinations is possible only if there are strict medical contraindications.
By lengthening the intervals between the first three vaccinations, the interval between the third and fourth can be reduced to 3 months.
Side effects
After vaccination with BiVac polio, immediate allergic reactions may occur during the first few hours.
Side effects that, as a rule, can only develop between the fourth and thirtieth day after taking the drug include the following:
- rarely: nonspecific symptoms - headache, vomiting, fever (may not be associated with vaccination);
- extremely rare: allergic reactions (including urticaria, Quincke's edema);
- isolated cases (registered in vaccinated people, as well as in persons in contact with them): vaccine-associated paralytic poliomyelitis (VAPP); To prevent the development of this complication, the first two vaccinations are carried out with IPV.
special instructions
All persons who are to be vaccinated with BiVac Polio must first undergo an examination by a doctor (paramedic).
It is necessary to plan vaccinations against polio in children's institutions at the same time for all children in the group.
After vaccination, strict personal hygiene rules are required to limit the circulation of the vaccine virus. A vaccinated child must be isolated from patients with immunodeficiency in the family, and he must also be provided with a separate bed, potty, bedding and clothing.
If families still have unvaccinated children (with contraindications to vaccinations or age), children belonging to the target groups should be immunized with IPV.
Vaccinations against polio are required to be registered in established registration forms, which indicate the name of the drug, batch number, dose, date of vaccination and reactions to it.
BiVac polio can be stored in an opened bottle for no more than 48 hours at a temperature of 2–8 °C; the bottle must be tightly closed with a rubber stopper or dropper.
If the integrity and marking of the bottle is damaged or its transparency, color or other physical properties change, the drug cannot be used.
If diarrhea or vomiting occurs during or immediately after taking the vaccine, a second dose should be administered only after these symptoms have resolved.
In the presence of mild forms of acute respiratory viral infections or acute intestinal diseases, vaccination should be carried out after the temperature has normalized.
If the patient is undergoing a planned operation, vaccination must be carried out no later than 30 days before the operation. When prescribing surgical intervention, the vaccine can be administered no earlier than 3–4 weeks after surgery.
There is a potential risk of apnea when using BiVac Polio in children with a history of respiratory distress or in premature infants (less than 28 weeks). As a result, children from this risk group require constant monitoring of respiratory activity for 2–3 days after taking the drug.
Drug interactions
It is allowed to take BiVac polio on the same day as vaccination with adsorbed pertussis-diphtheria-tetanus vaccine (DTP vaccine) or adsorbed diphtheria-tetanus toxoid vaccine (ADS or ADS-M toxoid). The polio vaccine can also be administered simultaneously with other drugs in the National Preventive Vaccination Calendar.
Immunosuppressive drugs can reduce the immune response to polio vaccine, multiply vaccine viruses, and increase the time they are excreted in feces.
Analogs
Analogues of BiVac polio are: Imovax Polio, Oral polio vaccine types 1, 2 and 3, Poliorix, Polymilex.
Terms and conditions of storage
Store out of reach of children, at a temperature of −20 °C and below. During transportation, maintain a temperature range of 2 to 8 °C, with possible subsequent re-freezing to −20 °C.
Shelf life: at a temperature of −20 °C and below – 24 months, at a temperature of 2–8 °C – 6 months.
Oral polio vaccine
Instructions for use of oral polio vaccine types 1, 2, 3
Attention: The vaccine is intended for oral use. Under no circumstances should this vaccine be administered parenterally.
The vaccine is a trivalent preparation from attenuated Sabin strains of polio virus types 1,2,3, obtained from a primary culture of African green monkey kidney cells. Stabilizer-magnesium chloride 0.018 g in 1 dose (0.2 ml) and 0.009 g in 1 dose (0.1 ml). Preservative - kanamycin, no more than 30 mcg in 1 dose (0.2 ml) and no more than 15 mcg in 1 dose (0.1 ml). The vaccine is produced in liquid form, 2.0 ml (10 and 20 doses). The drug contains in 1 vaccination dose (0.2 ml or 4 drops and 0.1 ml or 2 drops) infectious units:
- type 1 - not less than 1,000,000
- type 2 - not less than 100,000
- type 3 - not less than 300,000
The vaccine is a transparent liquid of a reddish-orange color, without sediment, without foreign inclusions.
Biological and immunobiological properties
The vaccine creates long-term immunity to polio virus types 1, 2, 3 in the majority of vaccinated people (90-95%).
Purpose
Active prevention of polio. Children aged 3 months to 14 years are subject to routine vaccinations.
Mode of application
Vaccinations with oral polio vaccine are carried out 6 times, at the age established by the calendar of preventive vaccinations (Order of the Ministry of Health of Russia No. 229 of June 27, 2001):
| Vaccinations | ||||||
| Vaccination (IPV) | Revaccination (IPV) | |||||
| 1 | 2 | 3 | 4 | 5 | 6 | |
| Age | 3 months | 4.5 months | 6 months | 18 months | 20 months | 14 years |
Extending the intervals between vaccinations is allowed in exceptional cases; in the presence of medical contraindications, shortening the intervals between the first three vaccinations is not allowed.
It is allowed to reduce the interval between the third and fourth vaccinations to 3 months, if the intervals between the first three vaccinations have been significantly extended. Children arriving in this territory without proof of vaccinations are subject to three-time immunization. Subsequent vaccinations of these children are carried out in accordance with age.
Vaccinations according to epidemiological indications are carried out when polio diseases occur in a children's institution or locality.
The number of persons subject to immunization according to epidemiological indications and the frequency of vaccinations are established in each specific case, taking into account the characteristics of the polio epidemic process. Subsequently, regular scheduled vaccinations against polio are carried out at the scheduled time.
Vaccinations against polio are allowed to be carried out on the same day as vaccination with DTP vaccine (ADS or ADS-M toxoid); simultaneous administration of polio vaccine with other drugs in the vaccination calendar is allowed.
Parents must be notified in advance about the day of upcoming preventive vaccinations for children.
The vaccine is used 4 or 2 drops per dose in accordance with the packaging of the drug. The vaccination dose of the vaccine is instilled into the mouth with a dropper or pipette attached to the bottle 1 hour before meals. It is not allowed to take the vaccine with water or any other liquid, or to eat or drink within an hour after vaccination. Unused vaccine from an opened vial can be stored for no more than 2 days at a temperature of (6 ± 2) ° C in a vial tightly closed with a dropper or rubber stopper. If necessary, it is allowed to draw the vaccine with a sterile syringe through a rubber stopper, subject to aseptic rules. In this case, the vaccine remaining in the vial can be used until the expiration date.
The drug is not suitable for use in a bottle with damaged integrity, labeling, as well as if its physical properties (color, transparency, etc.) have changed, if the expiration date has expired, or if stored improperly.
All vaccinations against polio are registered in established registration forms indicating the date of vaccination, dose, manufacturer, batch number, reaction to vaccination.
Reaction to vaccine administration
There is practically no reaction to the vaccine.
In some vaccinated people who are predisposed to allergic reactions, allergic complications in the form of a rash such as urticaria or Quincke's edema can extremely rarely be observed.
Vaccine-associated diseases, which are observed no more often than 1 case per 3 million vaccinated children, are extremely rare both in vaccinated people and in persons in contact with vaccinated people. They always require a differential diagnosis with polio-like diseases.
To limit the circulation of the vaccine virus among those around the vaccinated child, parents should be explained the need to observe the rules of personal hygiene of the child after vaccination (separate bed, potty, bedding, clothes separate from other children, etc.).
Contraindications
Live polio vaccine is a safe and areactogenic drug. Contraindications are:
1. Neurological disorders that accompanied previous vaccination with polio vaccine;
2. Immunodeficiency state (primary), malignant neoplasms, immunosuppression (vaccinations are carried out no earlier than 6 months after the end of the course of therapy);
3. Routine vaccination is postponed until the end of acute manifestations of the disease and exacerbation of chronic diseases. For mild ARVI, acute intestinal diseases, etc., vaccinations are carried out immediately after the temperature normalizes.
Release form.
2.0 ml (10 and 20 doses) in a bottle.
Storage conditions
In accordance with SP 3.3.2.028-95, frozen at a temperature of minus (20±1)°C in special low-temperature refrigerators or in liquid form at (6±2)°C.
It is permissible to defrost and re-freeze the vaccine, but no more than three times throughout the entire storage period.
Best before date
At a temperature of minus (20±1)°C - two years, at a temperature (6±2)°C - 6 months. A drug that has expired cannot be used.
Similar drugs:
Russia
Russia
Dosage form: suspension for intramuscular and subcutaneous administration Compound:One dose (0.5 ml) contains:
| Active components: | |
| Poliovirus* type 1 inactivated (Mahoney) | 40 units of D antigen |
| Poliomyelitis virus* type 2 inactivated (MEF-1) | 8 units of D antigen |
| Poliomyelitis virus* type 3 inactivated (Socket) | 32 D antigen units |
| Excipients: | |
| 2-phenoxyethanol - preservative | 2 to 3 µl |
| Formaldehyde is a preservative | from 2 to 20 mcg |
| Medium 199 Hanks** - solvent/stabilizer | |
| *cultured on VERO cells |
** Wednesday 199 Hanks(without phenol red) is a mixture of amino acids (D,L-alanine, arginine hydrochloride, D,L-aspartic acid, cysteine hydrochloride monohydrate, cystine dihydrochloride, D,L-glutamic acid monohydrate, glutamine, glycine, histidine hydrochloride monohydrate, D, L-isoleucine, hydroxyproline, D,L-leucine, lysine hydrochloride,
D,L-methionine,D,L-phenylalanine, proline, D,L-cerine, D,L-threonine, D,L-tryptophan, disodium tyrosine, D,L-valine), mineral salts (calcium chloride, iron nitrate nonahydrate, potassium chloride, magnesium sulfate heptahydrate, sodium chloride, potassium dihydrogen phosphate, sodium hydrogen phosphate), vitamins (ascorbic acid, biotin, ergocalciferol, calcium pantothenate, choline chloride, folic acid, inositol, menadione, nicotinic acid, nicotinamide, para-aminobenzoic acid,pyridoxal hydrochloride, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, retinol acetate, disodium alpha-tocopherol phosphate) and other components (adenine sulfate, disodium triphosadenine, adenosine phosphate, cholesterol, deoxyribose, dextrose, glutathione, guanine hydrochloride, disodium hypoxanthine, ribose, sodium acetate, thymine, polysorbate 80, uracil, sodium xanthine) dissolved in water for injection.The pH value is adjusted with hydrochloric acid or sodium hydroxide.
Antibiotics (streptomycin, neomycin and polymyxin B) are used in vaccine production but are not present in detectable quantities in the final product.
The vaccine complies with the requirements of the European Pharmacopoeia and WHO recommendations.
Description:Transparent colorless liquid.
Pharmacotherapeutic group: MIBP - ATX vaccine:J.07.B.F Vaccines to prevent polio
J.07.B.F.03 Poliovirus - trivalent inactivated
Pharmacodynamics:The drug Imovax Polio is a suspension of polio viruses types 1, 2 and 3, cultured on a cell line
VERO, purified and then inactivated with formaldehyde.1 month after three-time vaccination with Imovax Polio, the frequency of detection of antibodies to polio viruses types 1 and 3 is 100%, and to polio virus type
2 - 99-100%.In children aged 1 to 3 years, revaccination leads to a significant increase in the geometric mean titer (GMT) of antibodies, and the frequency of detection of antibodies in the blood serum approaches 100%. Protective SHT of antibodies to polio viruses of all three types persists 4-5 years after revaccination. After the 1st revaccination, immunity persists for at least 5 years.
U
panIn its immunized adolescents and adults, revaccination leads to a pronounced immune response with a high level of seroprotection, approaching 100%, and a significant increase in GMT antibodies. Indications: Specific prevention of polio for both primary immunization and revaccination of children, adolescents and adults. Contraindications:Allergy to the active component, to one of the excipients included in the vaccine, neomycin, streptomycin or polymyxin B; allergic reaction to previous administration of the Imovax Polio vaccine;
Diseases accompanied by fever, acute infectious or chronic disease in the acute stage. Vaccination is carried out 2-4 weeks after recovery or during the period of convalescence or remission. For mild ARVI, acute intestinal diseases, etc., vaccinations are carried out immediately after the temperature has normalized.
Carefully:In case of thrombocytopenia or blood coagulation disorders, the vaccine should be administered subcutaneously.
If there is a need to take medications that suppress the immune system, as the immune response to the vaccine may be reduced. In such cases, it is recommended to postpone vaccination until the end of treatment. If vaccination cannot be delayed, the patient's antibody levels should be checked after vaccination to ensure they are sufficient to provide protection against polio.
In very premature babies (born at 28 weeks or earlier). The potential risk of apnea and the need to monitor breathing for 48-72 hours should be considered when administering the primary course of immunization to children born at or before 28 weeks, especially those with a history of signs of respiratory immaturity. Because the benefits of immunization for this group of children are high, vaccination should not be delayed or considered contraindicated.
Pregnancy and lactation:There are no sufficient data on the use of the vaccine during pregnancy. Animal studies have not provided sufficient data on the effect of the drug Imovax Polio on pregnancy, embryonic and fetal development, and childbirth.
Andpostnatal development. Potential risk unknown.If necessary, the Imovax Polio vaccine can be used during pregnancy.
Breastfeeding is not a contraindication to vaccination.
Directions for use and dosage:The vaccine is administered intramuscularly or subcutaneously in a single dose of 0.5 ml. The intramuscular route of administration is preferred.
In children under 2 years of age The vaccine is administered into the upper outer surface of the middle part of the thigh.
In children over 2 years of age, adolescents and adults The vaccine is administered to the deltoid muscle area.
Before administering the drug, you must make sure that the needle does not enter a blood vessel.
The vaccine should not be used if its appearance changes.
Routine vaccination against polio is carried out for all children by administering one dose of vaccine at 3 and 4.5 months according to the National Preventive Vaccination Calendar.
The third vaccination and subsequent revaccinations are carried out with live polio vaccine within the time limits specified in the National Preventive Vaccination Calendar. The Imovax Polio vaccine is used for the third vaccination and subsequent revaccinations of children born to mothers with HIV infection, children with HIV infection, as well as children in orphanages, in accordance with the age and intervals between vaccinations and revaccinations specified in the National Calendar preventive vaccinations - at 6, 18, 20 months and 14 years.
If an oral live vaccine is used for vaccination and revaccination, the instructions for its use should be followed.
Side effects:Adverse events are listed according to systemic organ class and frequency of occurrence. The frequency was determined based on the following criteria: very often (≥ 1/10), often (≥ 1/100 to< 1/10), нечасто (≥ 1/1000 до < 1/100), редко (≥ 1/10000 до < 1/1(00), очень редко < 1/10000), частота неизвестна (нельзя оценить по имеющимся данным).
Clinical trial data
Local and general reactions
Often:
pain at the injection site, fever after vaccination with the 1st and 2nd dose;Often:
erythema at the injection site, fever after revaccination with the 3rd dose;Infrequently:
swelling at the injection site.From very often to often:
an increase in body temperature to 38.5-39.5 °C, transient within 24-48 hours after vaccination/re-vaccination with the drug Imovax Polio.Post-marketing surveillance data
Since 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.”
The safety profile of the Imovax Polio vaccine does not vary significantly among patients of different ages, given the relative frequency of adverse events and the fact that some events are age-specific (for example, seizures in infants and children 2 to 11 years of age, myalgia/arthralgia in adolescents and grown up
lх). In addition, due to the simultaneous administration of other vaccines with the vaccineImovaxPolio, it is impossible to establish an exact cause-and-effect relationship between the occurrence of adverse events and the use of the vaccine.The most common adverse events: local reactions and increased body temperature (approximately 20% and 10% of all registered adverse events, respectively).
Local and general reactions
Swelling, pain, redness at the injection site, appearing in the first 48 hours after injection and lasting 1-2 days; fever in the first 24-48 hours after vaccination.
From the central nervous system
Excitement, drowsiness, irritability in the first hours or days after vaccination (short-term).
From the nervous system
Brief convulsions, febrile convulsions in the first few days after vaccination; headache; transient mild paresthesia (mainly in the extremities) in the first 2 weeks after vaccination.
In very rare cases, seizures may occur later than the specified time. However, after 7 days there is no evidence linking seizures to vaccination.
From the skin and subcutaneous tissues
Rash, hives.
From the immune system
Allergic reaction, anaphylactic reaction, anaphylactic shock.
From the musculoskeletal system
Mild and transient arthralgia and myalgia in the first few days after vaccination.
From the hematopoietic organs
Lymphadenopathy.
In very premature infants (born at or before 28 weeks of gestation), there may be cases of prolonged breathing intervals within 2-3 days after vaccination (see section "Precautions").
The patient should be warned that if he experiences any adverse events not listed in these instructions, he should consult a doctor.
Overdose:No data available.
Interaction:The drug Imovax Polio can be administered simultaneously with different syringes into different parts of the body with other vaccines of the National Preventive Vaccination Calendar (except for BCG and BCG-M vaccines).
The vaccine must not be mixed in the same syringe with other vaccines or medications. Special instructions:Vaccination of persons with chronic immunodeficiencies, such as HIV infection, is recommended even if the immune response to vaccine administration may be reduced due to the underlying disease.
Vaccination is also indicated for persons who are contraindicated for the administration of an oral live vaccine and for revaccination of persons whose primary vaccination was carried out with an oral vaccine.
Impact on the ability to drive vehicles. Wed and fur.:The effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities has not been studied.
Release form/dosage:Suspension for intramuscular and subcutaneous administration, 0.5 ml/dose.
Package:One dose (0.5 ml) in a 1 ml syringe made of type 1 glass with an elastomer piston, with a fixed needle and a protective cap for the needle or without a needle with a protective cap for the cannula of the syringe complete with two separate needles.
1 or 5 syringes with a fixed needle or without a needle, complete with two separate needles and in a closed blister pack (PET/PVC).
When packaged at Sanofi Pasteur S.A., France
1 closed cell package (blister) (PET/PVC), containing 1 syringe with a fixed needle or without a needle, complete with two separate needles in a cardboard pack with instructions for use.
When packaging at the Federal State Unitary Enterprise "Enterprise for the production of bacterial and viral preparations of the Institute of Poliomyelitis and Viral Encephalitis named after MP. Chumakov RAMP"
1 closed cell package (blister) (PET/PVC) containing 1 syringe with a fixed needle in a cardboard pack with instructions for use.
4 closed cell packages (blisters) (PET/PVC), containing 5 syringes each with a fixed needle or without a needle, complete with two separate needles, in a cardboard pack with instructions for use. Storage conditions:Store at temperature from 2 to 8
°С, in a place protected from light. Do not freeze.Keep out of the reach of children.
Best before date:3 years.
A drug that has expired cannot be used.
Conditions for dispensing from pharmacies: On prescription Registration number: P N015627/01 Registration date: 27.01.2009 / 16.07.2010 Expiration date: Indefinite Owner of the Registration Certificate:Imovax Polio: instructions for use and reviews
Latin name:
Imovax PolioATX code: J07BF03
Active substance: Vaccine for the prevention of polio (Vaccinum ad prophylaxim poliomyelitidis)
Manufacturer: Sanofi Pasteur, France
Updating the description and photo: 18.10.2018
Imovax Polio is a MIBP vaccine.
Release form and composition
Imovax Polio is available in the form of a suspension for subcutaneous and intramuscular administration (0.5 ml/1 dose): colorless transparent liquid (1 dose in a 1 ml syringe made of type I glass with a piston made of elastomer, with a fixed needle and a protective cap for it, or without a needle, with a protective cap for the syringe cannula in a set with two separate needles, 1 or 5 syringes in a closed package).
The composition of 1 dose (0.5 ml) includes:
- active components: inactivated polio virus type 1 (Mahoney) – 40 D antigen units, inactivated polio virus type 2 (MEF-1) – 8 D antigen units, inactivated polio virus type 3 (Socket) – 32 D antigen units;
- auxiliary components: preservatives – 2-phenoxyethanol, formaldehyde; stabilizer/solvent – up to 0.5 ml.
Pharmacological properties
Pharmacodynamics
The Imovax Polio vaccine is a suspension of polio viruses types 1, 2 and 3, cultured on the VERO cell line, purified and inactivated with formaldehyde.
At the end of 1 month after three-time vaccination with Imovax Polio, the detection rate of antibodies to polio viruses types 1 and 3 is 100%, and to type 2 virus – 99–100%.
In children aged 1 to 3 years, revaccination leads to a significant increase in the geometric mean titer (GMT) of antibodies, and the frequency of detection of antibodies in the blood serum approaches 100%. Protective SHT of antibodies to polio viruses persists 4–5 years after revaccination of all three types. After the first revaccination, immunity lasts for 5 years.
In previously immunized adults and adolescents, revaccination leads to a pronounced immune response with a high level of seroprotection, approaching 100%, and a significant increase in antibody GCT.
Indications for use
Imovax Polio is prescribed for the prevention of polio.
Contraindications
- allergic reactions to the components of the drug;
- diseases accompanied by fever, chronic or acute infectious disease in the acute stage. Vaccination is carried out 2–4 weeks after recovery or during convalescence or remission. For mild ARVI, acute intestinal diseases, etc., vaccinations are carried out immediately after the temperature returns to normal.
Conditions in which Imovax Polio should be used with caution:
- in case of thrombocytopenia or blood coagulation disorders, the vaccine must be administered subcutaneously;
- in children born at 28 weeks or earlier (extremely premature). In these children, during the initial course of immunization, it is necessary to take into account the potential risk of developing apnea and monitor breathing for 48–72 hours, especially in those with a history of signs of immaturity of the respiratory system. Because the benefits of immunization are high in this group of children, vaccination should not be delayed or considered contraindicated;
- if necessary, take medications that suppress the immune system, since the immune response to the vaccine may be reduced. In these cases, vaccination should be postponed until the end of therapy. In situations where vaccination cannot be rescheduled, the patient's antibody levels should be checked after vaccination to ensure they are sufficient to provide protection against polio.
Instructions for use Imovax Polio: method and dosage
The Imovax Polio vaccine is used subcutaneously or intramuscularly in a single dose of 0.5 ml, preference is given to the intramuscular route of administration.
Children under 2 years of age should be injected into the upper outer surface of the middle part of the thigh.
For children over 2 years old, adolescents and adults, the drug must be injected into the deltoid muscle area.
Before administering the medicine, make sure that the needle does not enter a blood vessel.
The vaccine cannot be used if there are external changes.
Routine vaccination against polio is carried out for all children by administering one dose of vaccine at 3 and 4.5 months in accordance with the National Preventive Vaccination Calendar.
The third vaccination and subsequent revaccinations are done with live polio vaccine within the time limits indicated in the National Preventive Vaccination Calendar. Imovax Polio is used for the third vaccination and subsequent revaccinations of children suffering from HIV infection, born from mothers with HIV infection, as well as children who are in orphanages, in accordance with the number of years and intervals between revaccinations and vaccinations prescribed in the National Preventive Calendar vaccinations - at 6, 18, 20 months and at 14 years.
If an oral live vaccine is used for revaccination and vaccination, the instructions for its use must be taken into account.
Side effects
- hematopoietic organs: lymphadenopathy;
- skin and subcutaneous tissues: urticaria, rash;
- immune system: allergic and anaphylactic reactions, anaphylactic shock;
- musculoskeletal system: transient and mild myalgia and arthralgia in the first days after vaccination;
- local and general reactions: pain, swelling, redness at the injection site, appearing in the first two days after injection and lasting 1–2 days; fever in the first 24–48 hours after using the drug;
- central nervous system: drowsiness, agitation, short-term convulsions, febrile convulsions, irritability in the first hours or days after vaccination (short-term), headache, transient mild paresthesia (especially in the extremities) in the first 14 days after vaccination (in extremely rare cases, convulsions may may occur later than the specified time, but after 7 days there is no evidence of a connection between seizures and vaccination);
- data from clinical studies: increase in body temperature to 38.5–39.5 °C, normalizing within 24–48 hours after vaccination/re-vaccination with the drug.
The safety profile of Imovax Polio is virtually consistent across different ages, given the relative frequency of adverse events and the fact that few events are specific to a given age (eg, seizures in infants and children 2 to 11 years of age, arthralgia/myalgia in adults and teenagers). Due to the simultaneous administration of other vaccines with the Imovax Polio vaccine, it is impossible to establish an exact cause-and-effect relationship between the occurrence of adverse events and the use of the vaccine.
In very premature babies (born at 28 weeks or earlier), cases of lengthening of the time intervals between respiratory movements may be observed in the period 2-3 days after vaccination.
In case of undesirable reactions not listed in these instructions, it is recommended to consult a specialist.
Overdose
There is no information on overdose of Imovax Polio.
special instructions
Impact on the ability to drive vehicles and complex mechanisms
The effect of Imovax Polio on the ability to drive vehicles and engage in other potentially hazardous activities has not been studied.
Use during pregnancy and lactation
There is no reliable data on the use of the vaccine during pregnancy. During animal studies, sufficient data were not obtained on the effect of the drug on pregnancy, childbirth and postnatal development, as well as the development of the embryo and fetus. Potential risk unknown.
According to the instructions, Imovax Polio can be used during pregnancy if necessary. The lactation period is not a contraindication to vaccination.
Drug interactions
Simultaneous administration of Imovax Polio with different syringes into different parts of the body with other vaccines of the National Preventive Vaccination Calendar (except for BCG-M and BCG vaccines) is allowed.
Do not mix the vaccine in the same syringe with other vaccines or medications.
Analogs
Analogues of Imovax Polio are: BiVac Polio, Polimilex, Poliorix.
Terms and conditions of storage
Store away from light, at a temperature of 2 to 8 ° C, do not freeze. Keep away from children.
Shelf life – 3 years.