Vaccinum poliomyelitidis perorale typus 1, 2, 3 (Solution) Instructions for Use

Marketing Authorization Holder

Fncirip Named After M.P. Chumakov Ran, Fsbsi (Russia)

ATC Code

J07BF02 (Poliovirus — trivalent for oral administration)

Active Substance

Poliomyelitis vaccine live (oral)

Poliomyelitis vaccine live (oral) (Ph.Eur. European Pharmacopoeia)

Dosage Forms

	Vaccinum poliomyelitidis perorale typus 1, 2, 3	Solution for oral administration 0.1 ml (1 dose): fl. 2 ml (20 doses) 10 pcs.
		Solution for oral administration 0.2 ml (1 dose): fl. 2 ml (10 doses) 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for oral administration transparent, from yellowish-red to pinkish-raspberry in color, without sediment, without visible foreign inclusions.

Excipients : magnesium chloride – 0.018 g (stabilizer), kanamycin – 30 mcg (preservative).

2 ml (10 doses) – bottles (1) – carton packs.
2 ml (10 doses) – bottles (10) – carton packs.

Clinical-Pharmacological Group

Vaccine for the prevention of poliomyelitis

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

The oral poliomyelitis vaccine is a preparation from attenuated Sabin strains of poliovirus types 1, 2, and 3, grown on a primary culture of African green monkey kidney cells or on a primary culture of African green monkey kidney cells with one passage on a continuous cell line Vero culture in the form of a solution with 0.5% lactalbumin hydrolysate in Earle’s solution.

The vaccine induces lasting immunity to poliovirus types 1, 2, and 3 in 90-95% of vaccinated individuals.

Indications

• Active prevention of poliomyelitis.

ICD codes

Dosage Regimen

The vaccine is intended for oral use only.

The vaccine is administered as 4 drops per dose. The vaccination dose of the vaccine is instilled into the mouth using the dropper or pipette supplied with the bottle, 1 hour before a meal. It is not allowed to drink the vaccine with water or any other liquid, nor to eat or drink within one hour after vaccination.

In accordance with Order of the Ministry of Health and Social Development of the Russian Federation No. 673 dated October 30, 2007, on amendments and additions to Order No. 229 of June 27, 2001, “On the National Calendar of Preventive Vaccinations and the Calendar of Preventive Vaccinations for Epidemic Indications,” vaccination against poliomyelitis is carried out with inactivated poliomyelitis vaccine (IPV) three times for all children in their first year of life, in accordance with the instructions for use of the latter.

The first three vaccinations constitute the vaccination course.

Revaccination is carried out with the oral poliomyelitis vaccine three times, at the age established by the National Calendar of Preventive Vaccinations.

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

Reduction of the interval between the third and fourth vaccinations to 3 months is allowed if the intervals between the first three vaccinations were extended. Children arriving in a given area without documentation of vaccinations performed are subject to three-time vaccination. Subsequent vaccinations for these children are carried out according to their age.

Vaccinations for epidemic indications are carried out in the event of poliomyelitis cases in a childcare facility or locality.

The contingent of persons subject to vaccination for epidemic indications and the frequency of vaccinations are established in each specific case, taking into account the characteristics of the poliomyelitis epidemic process. Subsequently, routine scheduled vaccinations against poliomyelitis are carried out at the established times.

All vaccinations against poliomyelitis are recorded in the established record-keeping forms, indicating the name of the preparation, date of vaccination, dose, batch number, and reaction to the vaccination.

Adverse Reactions

Adverse reactions to the vaccine administration are practically absent.

In isolated vaccinated individuals predisposed to allergic reactions, allergic complications such as urticaria-like rash or angioedema may occur extremely rarely.

The occurrence of vaccine-associated paralytic poliomyelitis (VAPP) is extremely rare, both in vaccinated individuals and in persons in contact with the vaccinated.

To limit the circulation of the vaccine virus among persons surrounding the vaccinated individual, parents should be explained the necessity of observing the child’s personal hygiene rules after vaccination (separate bed, potty, separate bed linen and clothing from other children, and the need for isolation of the vaccinated child in the family from persons with immunodeficiency).

Contraindications

• Neurological disorders that accompanied previous vaccination with oral poliomyelitis vaccine;
• Immunodeficiency state (primary), malignant neoplasms, immunosuppression (vaccinations are carried out no earlier than 6 months after the end of the course of therapy);
• Routine vaccination is postponed until the acute manifestations of the disease subside and chronic diseases are in remission. For non-severe acute respiratory viral infections, acute intestinal and other diseases, vaccinations are carried out immediately after temperature normalization.

Use in Pregnancy and Lactation

The possibility and specifics of medical use of the vaccine in pregnant women and women during breastfeeding have not been studied.

Special Precautions

Parents should be informed in advance about the day of upcoming preventive vaccinations for children.

Routine vaccination of children experiencing an exacerbation of chronic diseases is postponed until complete recovery.

Unused vaccine from an opened vial can be stored for no more than 2 days at a temperature of 2°C (35.6°F) to 8°C (46.4°F) in a vial tightly closed with a dropper or rubber stopper. If necessary, it is permitted to draw the vaccine with a sterile syringe by puncturing the rubber stopper while observing aseptic rules. In this case, the vaccine remaining in the vial and not changed in its physical properties can be used until the expiration date.

The preparation in a vial with damaged integrity, labeling, as well as with altered physical properties (color, transparency, etc.), expired shelf life, or violated transportation and storage conditions is not suitable for use.

Effect on the ability to drive vehicles and mechanisms

The vaccine does not affect the ability to drive vehicles.

Overdose

Overdose does not lead to undesirable consequences.

Drug Interactions

Vaccinations against poliomyelitis are allowed to be carried out on the same day as vaccination with DTP vaccine (ADS or ADS-M toxoid); simultaneous administration of the poliomyelitis vaccine with other drugs of the National Calendar of Preventive Vaccinations is allowed.

Storage Conditions

Store in accordance with SP 3.3.2.2329-08 at a temperature of minus 20°C (68°F) and below or at a temperature of 2°C (35.6°F) to 8°C (46.4°F). Keep out of reach of children.

Transport in accordance with SP 3.3.2.2329-08 at a temperature of 2°C (35.6°F) to 8°C (46.4°F). Repeated freezing down to minus 20°C (68°F) is allowed.

Shelf Life

Shelf life at a temperature of minus 20°C (68°F) and below – 2 years, at a temperature of 2°C (35.6°F) to 8°C (46.4°F) – 6 months. The vaccine with an expired shelf life must not be used.

Dispensing Status

For therapeutic-prophylactic and sanitary-prophylactic institutions.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.