Universal reference book for medicines
Name of the preparation: VACCINE POLYOMYELITIS PERORAL 1, 2, 3 TYPES (VACCINUM POLIOMYELITIDIS PERORALE TYPUS 1, 2, 3)

Active substance: poliomyelitis vaccine live (oral)

Type: Vaccine for the prevention of poliomyelitis

Manufacturer: PIPVE them.
M.P. Chumakova RAMS FSUE (Russia)
Composition, form of production and packaging
The solution for oral administration is
transparent, from yellowish-red to pinkish-crimson, without sediment, without visible foreign inclusions.

1 dose (0.2 ml)

attenuated Sabin strains of poliomyelitis virus type 1 no less than 10 6 TC 50

attenuated Sabin strains of poliomyelitis virus type 2 not less than 10 5 TCD 50

attenuated Sabin strains of poliomyelitis virus type 3 not less than 10 5.5 TCD 50

Excipients: magnesium chloride - 0.018 g (stabilizer), kanamycin - 30 μg (preservative).

2 ml (10 doses) - bottles (1) - packs of cardboard.

2 ml (10 doses) - bottles (10) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

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 a transplantable Vero cell culture as a solution with 0.5% of lactalbumin hydrolyzate in Earle's solution.

The vaccine creates a stable immunity to the poliovirus of types 1, 2, 3, in 90-95% of the vaccinated.

INDICATIONS

- active prevention of poliomyelitis.

DOSING MODE

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 Order of the Ministry of Health of the Russian Federation No. 673 of 30 October 2007 on the introduction of changes and additions to the order of the Ministry of Health of the Russian Federation dated 27.06.01 No. 229 "On the National Calendar of preventive vaccinations and the calendar of preventive vaccinations for epidemiological indications," vaccination against poliomyelitis is carried out with an inactivated polio vaccine (IPV) three times to all children of the first year of life in accordance with the instruction for the application of the latter.

The first three vaccinations are the vaccination course.

Revaccination is carried out by polio vaccine 3 times, at the age set by the National Calendar of preventive vaccinations.

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

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 were extended.
Children who arrived in this area without a document on vaccinations carried out are subject to a three-time vaccination. Follow-up vaccinations for these children are carried out in accordance with age.
Vaccination for epidemics should be carried out in case of the occurrence of poliomyelitis in a children's institution, a settlement.

The contingent of persons subject to vaccination according to epidemiological indications and the multiplicity of vaccinations are established in each specific case, taking into account the specific features of the epidemic process of poliomyelitis.
In the following, regular routine vaccinations against poliomyelitis are carried out on time.
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 EFFECT

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).

CONTRAINDICATIONS

- neurological disorders accompanying previous vaccination with oral polio vaccine;

- Immune Deficiency (primary), malignant neoplasms, immunosuppression (vaccinations are given no earlier than 6 months after the end of the course of therapy);

- routine vaccination is postponed until the end of acute manifestations of the disease and exacerbation of chronic diseases.
With mild ARVI, acute intestinal and other diseases, vaccinations are carried out immediately after the temperature is normalized.
PREGNANCY AND LACTATION

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

SPECIAL INSTRUCTIONS

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

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

Unused vaccine from the opened bottle can be stored for 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.

Impact on the ability to drive vehicles and manage mechanisms

The vaccine on the ability to drive vehicles is not affected.

OVERDOSE

Overdosing does not lead to undesirable consequences.

DRUG 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.

TERMS OF RELEASE FROM PHARMACY

For treatment and preventive and sanitary facilities.

TERMS AND CONDITIONS OF STORAGE

Store in accordance with SP 3.3.2.2329-08 at a temperature of minus 20 ° C and below or at a temperature of 2 ° to 8 ° C.
Keep out of the reach of children.
Transport in accordance with SP 3.3.2.2329-08 at a temperature of 2 ° to 8 ° C.
Repeated freezing to minus 20 ° C is allowed.
Shelf life at a temperature of minus 20 ° C and below - 2 years, at a temperature of 2 ° to 8 ° C - 6 months.
A vaccine with expired shelf life is not subject to application.
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