MonoVac polio type 2 (polio vaccine, oral, monovalent, live attenuated type 2) - instructions for use, dose, side effects, contraindications

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Dosage form: & nbsporal solution

Composition:

1 dose (0.2 ml - 4 drops) contains:

Active substance: poliovirus, attenuated Sabin strain type 2 - not less than 10^5,0 TCDs₅₀ infectious units (IE) of the virus, expressed in tissue cytopathogenic doses (TCD₅₀);

Excipients: magnesium chloride - 0.018 g; kanamycin - 30 mcg.

Description:

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

Pharmacotherapeutic group:MIBP vaccine

ATX: & nbsp

Vaccines for the prevention of poliomyelitis

Pharmacodynamics:

Immunological properties

The vaccine is a preparation from an attenuated Sabin strain of a type 2 poliomyelitis virus grown on a 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 a transplantable cell culture line Vero, and contains one type of virus (monovalent vaccine) in the form of a solution with 0.5% hydrolyzate lactalbumin in Earl's solution. The vaccine creates a permanent immunity to poliomyelitis virus type 2 in 90-95% of the vaccinated.

Pharmacokinetics:

After oral administration of the vaccine, the vaccine strain of the virus replicates in the intestine and excreted in the feces for 4-6 weeks. The immune response induced by the vaccine virus is similar to the immune response induced by a natural infection. As a result, the body produces antibodies, including the secretory immunoglobulin A in the small intestine. Local immunity is important for the prevention of poliovirus infection.

Indications:

Active prevention of poliomyelitis according to epidemic indications.

Contraindications:

- neurological disorders accompanying previous vaccination with oral poliomyelitis vaccine;

- immunodeficiency (primary) cancer, immunosuppression (grafting is carried out not earlier than 3 months after completion of therapy.);

- pregnancy;

- hypersensitivity to any component of the vaccine;

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

- acute infectious or non-infectious diseases, aggravation of chronic diseases (vaccination performed after 2-4 weeks of 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 used only for epidemic indications!

The vaccine is applied to 4 drops per reception. Vaccination dose of the vaccine is instilled into the mouth of the lid attached to the bottle with a dropper or pipette 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.

Vaccination is carried out in the case of isolation of vaccine-based or wild poliovirus type 2 from any material (human bioassay or environmental objects) in accordance with the current edition of the Schedule of preventive vaccinations for epidemic indications and only by the decision of the Chief State Sanitary Doctor of the Russian Federation, which determines the categories and age of citizens , subject to vaccination,order and frequency of its conduct.

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. When prompt surgery for emergency indications, immunization should not be performed earlier than 3-4 weeks after surgery.

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 in connection with the possibility of occurrence of apnea within 48-72 hours.

Features of the drug at the first admission

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

Side effects:

The following criteria were used to estimate the incidence of adverse events: infrequently (≥ 1/1000 to <1/100), rarely (≥ 1/10000 to <1/1000), very rarely (<1/10000). Reactions (except for allergic reactions of the immediate type in the first fewhours after vaccination), as a rule, can not appear 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's edema.

Single cases - both in vaccinated and in persons in contact with vaccinated - the emergence of vaccine-associated paralytic poliomyelitis (VAPP).

Overdose:

The potential risk of overdose has not been studied.

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 oral poliomyelitis vaccine 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, inactivated poliomyelitis vaccine (IPV) 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 ° C to +8 ° C inclusive 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.

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.

Packaging:

By 2.0 ml (10 doses) in the vial. In a pack of cardboard contains 10 bottles with instructions for use.

Storage conditions:

In accordance with SP 3.3.2.3332-16, vaccine storage is possible at the 1 and 2 levels of the "cold chain" at a temperature of minus 20 ° C and below or at a temperature of +2 ° C to +8 ° C inclusive; when transporting the vaccine at a temperature of +2 ° C to +8 ° C inclusive, it is then possible to re-freeze it to a temperature of minus 20 ° C or lower. At the third and fourth levels of the cold chain, the vaccine is stored in the refrigerator at a temperature of +2 ° C to +8 ° C inclusive.

Transport conditions: in accordance with SG1 3.3.2.3332-16 at temperatures from +2 ° C to +8 ° C inclusive.

Keep out of the reach of children.

Shelf life:

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

6 months at a temperature from +2 ° С to +8 ° С inclusive.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:For hospitals

Registration number:LP-004115

Date of registration:01.02.2017

Expiration Date:01.02.2022

The owner of the registration certificate:FNCIPRI im. Chumakov Institute of the Russian Academy of Sciences, FGBNUFNCIPRI im. Chumakov Institute of the Russian Academy of Sciences, FGBNU Russia

Manufacturer: & nbsp

FNCIPRI im. Chumakov Institute of the Russian Academy of Sciences, FGBNU Russia

Information update date: & nbsp13.02.2017

Illustrated instructions

Instructions

MonoVac polio type 2 (polio vaccine, oral, monovalent, live attenuated type 2) (MonoVak polio type 2)