Vaccine poliomyelitis oral 1, 2 and 3 types (Vaccinum poliomyelitidis perorale typus 1, 2, 3)

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:

In one inoculation dose (0.1 ml - 2 drops) the preparation contains:

Active ingredient: Polio virus, attenuated Sabin strains

1 type - not less than 106,0 TCDs50

2 type - not less than 105,0 TTCs50

3 type - not less than 105,8 TTCs50

infectious units (IE) of the virus, expressed in tissue cytopathogenic doses (TCDs50).

Excipients: Magnesium chloride - 0,009 g - stabilizer; kanamycin - 15 mcg - preservative.

In one inoculation dose (0.2 ml - 4 drops), the preparation contains:

Active ingredient: Polio virus, attenuated Sabin strains

1 type - not less than 106,0 TCDs50

2 type - not less than 105,0 TTCs50

3 type - not less than 105,5 TTCs50

infectious units (IE) of the virus, expressed in tissue cytopathogenic doses (TCDs50).

Excipients: Magnesium chloride - 0.018 g - stabilizer; kanamycin - 30 mcg - preservative.

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:

The polio vaccine oral is a preparation from attenuated Sabin strains of the poliomyelitis virus 1, 2, 3 types grown on the primary culture of kidney cells of African green monkeys or on the primary culture of kidney cells of African green monkeys with one passage on the transplanted cell culture of the line Vero in the form of a solution with 0.5% lactalbumin hydrolyzate in Earl's solution.

The vaccine creates a permanent immunity to poliovirus 1, 2, 3 types of (90-95)% vaccinated.

Indications:

Active prevention of poliomyelitis.

Contraindications:

1. Neurological disorders accompanying previous vaccination with oral poliomyelitis vaccine;

2. Immunodeficiency status (primary), malignant neoplasms, immunosuppression (vaccinations are given no earlier than 6 months after the end of the course of therapy);

3. Scheduled vaccination is postponed until the end of acute manifestations of the disease and exacerbation of chronic diseases. With mild ARVI, acute intestinal diseases, etc., vaccinations are carried out immediately after the normalization of temperature.

Pregnancy and lactation:

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

Dosing and Administration:

Attention: the vaccine is intended for oral use only.

The vaccine is used 2 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.

As a possible vaccination scheme, the scheme of vaccinations against poliomyelitis in Russia is given below.

In accordance with the current National Calendar of Prophylactic Inoculations, the first and second vaccination against poliomyelitis is carried out with a vaccine against poliomyelitis inactivated (IPV), in accordance with the instruction for the use of IPV.

The third vaccination and subsequent revaccinations against poliomyelitis are administered to children with poliomyelitis oral vaccine (PPV) at the age specified by the National Calendar of Prophylactic Inoculations.

The first three vaccinations are the vaccination course.

Inoculations

Vaccination (IPV)

Revaccination (PPV)

1

2

3*

4*

5*

6*

age

3 months

4,5 months

6 months

18 months

20 months

14 years

* Children born to mothers with HIV, children with HIV, children staying in the homes of the child - the third vaccination and subsequent revaccinations against polio are carried out by IPV vaccine for the prevention of poliomyelitis inactivated,

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 possible to shorten the interval between the third and fourth vaccinations to 3 months, if the intervals between the first three vaccinations have been extended.

Vaccination against poliomyelitis according to epidemic indications is carried out by oral poliomyelitis vaccine.

The contingent of persons subject to vaccination for epidemic indications, the timing, order and frequency of vaccinations are established in each specific case, taking into account the characteristics of the epidemic process of poliomyelitis and in accordance with the current calendar of preventive vaccinations for epidemiological indications:

contact persons in the outbreaks of poliomyelitis, including those caused by wild poliovirus (or with suspected disease):

- children from 3 months to 18 years - once;

- medical workers - once;

- children who have arrived from poliomyelitis-endemic countries (regions), from 3 months to 15 years - once (with reliable data on previous vaccinations) or three times (in their absence);

- 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 came 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) wild poliomyelitis virus, without age limitation - once when hired.

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.

Precautions for use

It is necessary to notify parents in advance about the day of the forthcoming preventive vaccinations to children.

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. If necessary, the vaccine is allowed to be collected with a sterile syringe by puncturing the rubber plug while observing the aseptic rules. In this case, the vaccine, which remained in the vial and did not change the physical properties, can be used up to the end of the shelf life.

The preparation is not suitable for use in a vial with broken integrity, marking, and also when its physical properties (color, transparency, etc.) change, if the expiration date has elapsed, if transportation and storage conditions are violated.

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.

Side effects:

Side effects on the introduction of the vaccine are practically absent.

Individual vaccinated, predisposed to allergic reactions, extremely rarely there may be allergic complications in the form of a rash like hives or Quincke edema.

Extreme rarity in vaccinated as well as in persons who are in contact with vaccinated persons is the occurrence of vaccine-associated paralytic poliomyelitis (VAPP).

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

Overdose:

Overdosing does not lead to undesirable consequences.

Interaction:

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

Special instructions:

Scheduled vaccination of children with chronic diseases exacerbation is postponed until full recovery.

Effect on the ability to drive transp. cf. and fur:The vaccine on the ability to drive vehicles is not affected.
Form release / dosage:Solution for oral administration, 0.1 ml / dose and 0.2 ml / dose.
Packaging:

To 2.0 ml in the vial.

In a pack of cardboard box 10 bottles of vaccine and instructions for use are placed.

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 level 1 "cold chain" - at a temperature of minus 20 ° C and below, during transportation of 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:

At a temperature of minus 20 ° C and lower - 2 years, at a temperature of 2 to 8 ° C - 6 months.

A vaccine with expired shelf life is not subject to application.
Terms of leave from pharmacies:For hospitals
Registration number:P N000181 / 01
Date of registration:14.01.2011 / 02.06.2015
Expiration Date:Unlimited
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: & nbsp12.01.2017
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