BiVac polio (polio vaccine oral, divalent, live attenuated 1, 3 types) (BiVac polio (polio vaccine oral, divalent, live attenuated 1, 3 types))

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceVaccine for the prevention of poliomyelitisVaccine for the prevention of poliomyelitis
Dosage form: & nbsporal solution
Composition:

1 dose (0.2 ml - 4 drops) contains:

Active component: poliomyelitis virus, attenuated Sabin type 1 type not less than 106,0 TCDs50, 3 types of at least 105,5 TCDs50 infectious units (IE) of the virus, expressed in tissue cytopathogenic doses (TTSTS50);

Excipients: magnesium chloride 0.018 g; kanamycin 30 μg.

Description:

Transparent liquid from yellowish-red to pink-crimson, without sediment, without visible foreign inclusions.

Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp

J.07.B.F   Vaccines for the prevention of poliomyelitis

J.07.B.F.03   The virus of poliomyelitis is trivalent inactivated

Pharmacodynamics:

Immunological properties

The vaccine is a preparation from attenuated Sabin strains of the poliomyelitis virus 1, 3 types grown on the primary culture of kidney cells of African green monkeys or on a primary culture of kidney cells of African green monkeys with one passage on the transplantable cell culture line Vero, and contains two types of virus (divalent vaccine) in the form of a solution with 0.5% lactalbumin hydrolyzate in Earl's solution. The vaccine creates a stable immunity to the virus of poliomyelitis of 1.3 types in (90-95)% of grafted.

Indications:

Active prevention of poliomyelitis.

Contraindications:

- Neurological disorders accompanying previous vaccination with oral poliomyelitis vaccine;

- immunodeficiency status (primary), malignant neoplasms, immunosuppression (vaccinations are given no earlier than 3 months after the end of the course of therapy);

- Pregnancy;

- hypersensitivity to any component of the vaccine;

- severe reaction (temperature above 40 ° C) or complication of previous administration of the drug;

- acute infectious or non-infectious diseases, exacerbation of chronic diseases - vaccinations are carried out 2-4 weeks after recovery or remission. For non-severe acute respiratory viral infections, acute intestinal diseases, grafts are carried out after normalizing the temperature.

Pregnancy and lactation:

Use during pregnancy is contraindicated.

The possibility and peculiarity of the medical use of the vaccine for women during breastfeeding has not been studied.

Dosing and Administration:

Attention! The vaccine is intended for oral use only.

The vaccine is applied to 4 drops per reception. Vaccination dose of the vaccine is instilled into the mouth of the dropper or pipette attached to the bottle 1 hour before meals. Drink the vaccine with water or some other liquid, and eat or drink within an hour after vaccination is not allowed.

In accordance with the current version of the National Calendar of Prophylactic Vaccines, the first and second polio vaccination is administered to children with a vaccine for inactivated (IPV) poliomyelitis prevention, in accordance with the instruction for the use of IPV.

The third vaccination and subsequent revaccinations against poliomyelitis are administered to children with a vaccine for the prevention of live oral poliomyelitis (PVV).

The first three vaccinations are the vaccination course.

Inoculations

Vaccination

Revaccination

IPV

PPV

PPV

1

2

3*

4*

5*

6*

Age of child

3 months

4,5 months

6 months

18 months

20 months

14 years

* Children born to mothers with HIV infection, children with HIV infection, children staying in the children's homes - the third vaccination and subsequent revaccinations against poliomyelitis are carried out by the IPV vaccine for the prevention of poliomyelitis (inactivated).

Older children who were not vaccinated against poliomyelitis within the established time limits, routine immunization is carried out according to the same scheme (first and second vaccination - IPV, third vaccination and subsequent booster vaccinations - PPV).

In accordance with the current edition of the calendar of preventive vaccinations for epidemic indications, vaccination againstPoliomyelitis according to epidemic indications is carried out by oral poliomyelitis vaccine. When registering a case of poliomyelitis caused by wild poliovirus, the isolation of wild poliovirus in human biological samples or from environmental objects carries out mandatory vaccination to the following categories of citizens (contacts in poliomyelitis outbreaks, including those caused by wild poliovirus (or with suspected disease):

- children from 3 months to 18 years - once;

- medical workers - once;

- children arriving from poliomyelitis-endemic countries (regions), from 3 months to 15 years - once (with reliable data on previous vaccinations) or three times (in the absence of them);

- persons without a specific place of residence (if detected) from 3 months to 15 years - once (with reliable data on previous vaccinations) or three times (in their absence);

- persons who come in contact with those who arrived from endemic (unfavorable) poliomyelitis countries (regions), from 3 months of life without age restriction - once;

- persons working with live poliovirus, with materials infected (potentially infected) with the wild poliovirus, without age limitation, once in employment.

Features of the drug at the first admission

Features of the drug at the first reception was not observed.

Actions of the doctor and the patient if one or several doses are missed

The prolongation of the intervals between vaccinations is allowed in exceptional cases, in the presence of medical contraindications, shortening of the intervals between the first three vaccinations is not allowed.

It is allowed to shorten the interval between the third and fourth vaccinations to 3 months if the intervals between the first three vaccinations were lengthened.

Side effects:

The following criteria for assessing incidence of adverse events were used: infrequently (≥ 1/1000 to <1/100), rarely (≥ 1/10000 to <1/1000), very rarely (<1/10000).

Reactions (except for immediate allergic reactions in the first few hours after vaccination) usually can not occur before the 4th day and more than 30 days after the introduction of the vaccine.

Rarely - Nonspecific symptoms: fever, vomiting, headache, not necessarily associated with taking an oral polio vaccine.

Rarely - Individual vaccines may experience allergic reactions in the form of urticaria or Quincke edema.

Single cases - both in vaccinated and in persons contacting with vaccinated - the emergence of vaccine-associated paralytic poliomyelitis (VAPP). For the prevention of VAPP, the first two vaccinations against poliomyelitis are carried out with the IPV vaccine.

Overdose:

Overdosing does not lead to undesirable consequences.

Interaction:

Vaccinations against poliomyelitis are allowed to be administered on the same day as DTP vaccine (ADS or ADS-M toxoid), simultaneous administration of poliovirus vaccine with other preparations of the National calendar of preventive vaccinations is allowed.

Immunosuppressors can reduce the immune response to vaccination with an oral poliomyelitis vaccine, promote the multiplication of vaccine viruses, and increase the timing of vaccine viruses with feces.

Special instructions:

All persons to whom preventive vaccinations should be given should be examined by a physician (paramedic).

In children's organized groups it is necessary to plan vaccination against poliomyelitis for all children in the group at the same time.

It is necessary to separate children not vaccinated against poliomyelitis from newly vaccinated PPV for a period not less than 60 calendar days from the moment of vaccination.

To limit the circulation of the vaccine virus among the people surrounding the vaccinated, the personal hygiene rules of the child should be observed after vaccination (a separate bed, a pot, bed linens, clothing and the need to isolate the vaccinated child in the family from immunodeficiency patients).

In families where there are non-vaccinated children - by age (newborns) or having contraindications to vaccinations against poliomyelitis, IPV vaccine should be used to immunize children belonging to the target groups.

All vaccinations against poliomyelitis are recorded in the prescribed registration forms with the name of the preparation, the date of vaccination, the dose, the number of the series, the response to the vaccination.

Unused vaccine from the opened vial can be stored no more than 2 days at a temperature of 2 to 8 ° C in a vial tightly closed with a dropper or rubber stopper. The drug in a vial with broken integrity, marking, as well as changing its physical properties (color, transparency, etc.), with expired shelf life, in violation of the conditions of transportation and storage is not suitable for use.

Precautions for use

The vaccine should not be administered parenterally!

In the case of vomiting or diarrhea at the time of vaccine administration or immediately after administration, a repeated dose of the vaccine may be administered after the disappearance of these symptoms.

In case of the forthcoming planned operation, vaccinations should be carried out no later than 1 month before the operation. In case of urgent intervention for emergency indicators, immunization should not be carried out earlier than through 3-4 weeks after the operation.

In connection with the potential risk of apnea in preterm infants (less than 28 weeks) and in children with a history of respiratory insufficiency, it is necessary to carry out constant monitoring of respiratory activity due to the possibility of apnea within 48-72 hours.

Effect on the ability to drive transp. cf. and fur:

Does not affect the ability to drive vehicles and perform work that requires an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Solution for oral administration, 0.2 ml / dose.
Packaging:

By 2.0 ml (10 doses) in the vial.

10 bottles together with the instructions for use are placed in a pack of cardboard.

Storage conditions:

In accordance with SP 3.3.2.2329-08 (changes and additions to SP 3.3.2.1248-03) the vaccine is stored: at the 1 level of the "cold chain" - at a temperature of minus 20 ° C and lower,when transporting the vaccine in the temperature regime from 2 to 8 ° C, it is possible to re-freeze it to minus 20 ° C (at level 2 of the "cold chain"). At the 3 rd and 4 th levels of the cold chain, the vaccine is stored at a temperature of 2 to 8 ° C.

Keep out of the reach of children.

Transportation conditions

In accordance with SP 3.3.2.2329-08 at a temperature of 2 to 8 ° C.

Shelf life:

2 years at a temperature of minus 20 ° C and lower,

6 months at a temperature of 2 to 8 ° C.

Terms of leave from pharmacies:For hospitals
Registration number:LP-003511
Date of registration:18.03.2016 / 27.12.2016
Expiration Date:18.03.2021
The owner of the registration certificate:The enterprise for the production of bacterial and viral preparations of the Institute of Poliomyelitis and Viral Encephalitis. M.P.Chumakov RAMS FSUE The enterprise for the production of bacterial and viral preparations of the Institute of Poliomyelitis and Viral Encephalitis. M.P.Chumakov RAMS FSUE Russia
Manufacturer: & nbsp
Information update date: & nbsp25.01.2017
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