BiVak polio
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Terms and conditions of storage
BiVak polio - oral poliomyelitis vaccine, bivalent, live attenuated 1, 3 types.
Release form and composition
Dosage form - solution for oral administration: transparent liquid from pink-raspberry to yellowish-red color, without sediment and visible foreign inclusions [2 ml (10 doses) in a vial, in a cardboard box 10 vials].
1 dose contains:
- active substance: poliomyelitis virus, attenuated Sabin strains of type 1 - at least 10 to 6 degrees TCD 50 (tissue cytopathogenic doses) and type 3 - at least 10 to 5.5 degrees TCD 50 infectious units (IE) of the virus;
- auxiliary components: kanamycin, magnesium chloride.
Indications for use
The use of BiVac polio is indicated for the active prevention of poliomyelitis.
Contraindications
- neurological disorders that occurred during previous vaccination with oral polio vaccine;
- severe reaction, including an increase in body temperature above 40 ° C, complications from a previous vaccine intake;
- period of acute non-infectious and infectious diseases or exacerbation of chronic pathologies;
- primary (congenital) immunodeficiency state;
- immunosuppression;
- malignant neoplasms;
- period of pregnancy;
- hypersensitivity to vaccine components.
The safety of using the vaccine in women during breastfeeding has not been established.
Method of administration and dosage
The vaccine is intended exclusively for oral use!
The inoculation dose is 4 drops (0.2 ml), they are instilled into the patient's mouth using a pipette or a dropper attached to the bottle. It is not allowed to drink or eat for one hour after the procedure.
The first and second vaccination against poliomyelitis for children is given with inactivated polio vaccine (IPV) for prophylaxis, according to the relevant instructions for the use of IPV.
The third vaccination and subsequent revaccinations against poliomyelitis are given to children with a live oral poliomyelitis vaccine (PPV).
The vaccination course consists of the first three vaccinations:
- first: at the age of 3 months of life - IPV;
- the second: at 4.5 months - IPV;
- third: at 6 months - PPV.
Revaccination against poliomyelitis is carried out in accordance with the calendar of preventive vaccinations in 3 stages: at the age of 18 and 20 months, then at 14 years old.
Exceptions to the general rules for vaccination and revaccination are foster children, children with HIV infection or those born to HIV-infected mothers. The third vaccination and subsequent revaccinations against poliomyelitis for this category of children should be given IPV.
If routine immunization of a child begins at the age of three months, it is also carried out according to the established scheme.
If a case of poliomyelitis caused by wild poliovirus isolated in human bioassays or from environmental objects is registered, vaccination is mandatory. The categories of citizens who are contact persons in the outbreak of poliomyelitis (or if a disease is suspected), including those caused by wild poliovirus, are subject to additional single vaccination. These include:
- children from 3 months to 18 years old;
- medical workers;
- children from 3 months to 15 years old, who arrived from countries or regions unfavorable for poliomyelitis (in the absence of reliable data on previous vaccinations, three times vaccination is indicated);
- children from 3 months to 15 years old without a fixed place of residence (in the absence of reliable data on previous vaccinations, triple vaccination is indicated);
- persons from 3 months of age and older who have contact with people who have arrived from countries or regions affected by poliomyelitis;
- persons of no age limit working with materials potentially infected with wild poliomyelitis virus or live poliovirus - upon hiring.
The intervals between the first three vaccinations must not be allowed to be reduced.
In the presence of medical contraindications, in exceptional cases, it is allowed to lengthen the intervals between vaccinations. If the interval between the first three vaccinations is extended, the date of the fourth vaccination can be postponed 3 months earlier.
Side effects
In the first few hours after taking BiVak polio, an immediate allergic reaction may develop.
After the introduction of the vaccine, as a rule, in the period from the fifth to the thirtieth day, the following reactions may appear:
- rarely: nonspecific symptoms - vomiting, fever, headache (connection with taking the vaccine is not necessary);
- very rare: allergic reactions (Quincke's edema, urticaria);
- isolated cases: in vaccinated and in persons in contact with vaccinated - the occurrence of vaccine-associated paralytic poliomyelitis (VAPP).
special instructions
Before vaccination, the patient should be examined by a pediatrician or general practitioner.
In child care settings, it is necessary to plan for polio immunization for all children in the group at the same time.
Do not allow unvaccinated children to come into contact with vaccinated PPVs within 60 calendar days from the date of vaccination.
Strict personal hygiene is required after vaccination to restrict the circulation of the vaccine virus. First of all, it is necessary to isolate family members with immunodeficiency from the vaccinated child. The child should be provided with a separate bed, potty, linens and clothing.
IPV should be used to immunize a child belonging to the target groups, in whose family there are still unvaccinated children (by age or with contraindications to vaccination against poliomyelitis).
Vaccinations against poliomyelitis must be registered in the established registration forms, which indicate the name of the drug, date of vaccination, dose, batch number, reaction to vaccination.
After opening, the vaccine in a tightly closed vial is suitable for use for no more than 48 hours at a storage temperature of 2-8 ° C.
Do not use the drug from a bottle with impaired integrity and labeling, with visible changes in its physical properties.
If the patient has vomiting or diarrhea during or immediately after taking the vaccine, a second dose of the vaccine can be taken after the condition has returned to normal.
Accidental excess of the dose does not cause undesirable consequences.
It is impossible to vaccinate later than 4 weeks before the planned operation and earlier than 3-4 weeks after the emergency surgery.
With a history of respiratory failure and premature infants (less than 28 weeks) while taking BiVak polio, there is a high risk of apnea. Therefore, this category of children during the first 48–72 hours after vaccination must be constantly monitored for respiratory activity.
To reduce the risk of developing VAPP, the first 2 vaccinations are given with the IPV vaccine.
After an exacerbation of chronic pathologies or acute non-infectious and infectious diseases, the vaccine can only be taken 2-4 weeks after remission or complete recovery.
In milder forms of acute respiratory viral infections, in acute intestinal diseases, vaccination is carried out after the temperature has returned to normal.
With immunosuppression, vaccination can be carried out only 12 weeks after the end of the course of treatment.
Drug interactions
On one day with the use of BiVak polio, it is allowed to vaccinate with an adsorbed diphtheria-tetanus-pertussis vaccine (DTP vaccine) or adsorbed diphtheria-tetanus vaccine (DTP and ADS-M toxoid). In addition, the introduction of polio vaccine is allowed simultaneously with other drugs on the National Vaccination Calendar.
Immunosuppressive drugs can reduce the immune response to polio vaccine, promote the multiplication of vaccine viruses, and increase the clearance time for vaccine viruses in feces.
Terms and conditions of storage
Keep out of the reach of children.
Store at minus 20 ° C and below, transport at 2-8 ° C with subsequent freezing.
Shelf life: at a storage temperature of minus 20 ° C and below - 24 months, 2–8 ° C - 6 months.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
