Polyoriks - instructions for use, doses, side effects, contraindications

*Component name*	Quantity in 1 dose (0.5 ml)
Active substances:
Inactivated poliovirus type 1 Inactivated poliovirus type 2 Inactivated poliovirus type 3	D-antigen in ELISA units: 40 units D-antigen in ELISA units: 8 units D-antigen in ELISA units: 32 units
Excipients:
2-phenoxyethanol	2.5 mg
Wednesday 199 (M199)*	5.23 mg
Formaldehyde	not more than 0.1 mg
Polysorbate 80	not more than 0.1 mg
Water for injections q.s. before	0.5 ml

*Composition of the medium 199 (M199):

calcium chloride dihydrate, iron nitrate nonahydrate, potassium chloride, potassium dihydrogen phosphate, magnesium sulfate heptahydrate, sodium chloride, sodium hydrogen carbonate, sodium hydrogen phosphate, L-alanine, L-arginine hydrochloride, L-aspartic acid, L-cysteine hydrochloride, L-cystine, L-glutamic acid, L-glutamine, glycine, L-histidine hydrochloride monohydrate, L-hydroxyproline, L-isoleucine, L-leucine, L-lysine hydrochloride, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, L-valine, ascorbic acid, alpha-tocopherol, biotin, calciferol, ka pantothenate, choline chloride, folic acid, inositol, menadione, nicotinic acid, nicotinamide, p-aminobenzoic acid, pyridoxal hydrochloride, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, retinol acetate, adenine, adenosine phosphate, adenosine sodium triphosphate, cholesterol, deoxyribose, glucose, glutathione, guanine hydrochloride, hypoxanthine, ribose, sodium acetate, thymine, polysorbate 80, uracil, xanthine.

Description:

Transparent colorless liquid without visible foreign matter.

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:

Vaccine Polyoriks® is a solution containing inactivated purified poliovirus types 1, 2 and 3, cultured on cells Vero and formaldehyde inactivated.

The vaccine meets all the requirements of the World Health Organization for the production of medical immunobiological drugs.

After the introduction of two doses of the vaccine in the primary vaccination, 97-100% of the vaccines showed antibodies to the three serotypes of the poliovirus. After the introduction of the third dose of the vaccine in the initial vaccination, antibodies to poliovirus were found in all vaccinated.

Indications:

- Hypersensitivity to any of the components of the vaccine;

- hypersensitivity reactions to the previous administration of inactivated polio vaccines.

Contraindications:The introduction of the PolyoriX® vaccine should be delayed in persons with acute febrile conditions caused, inter alia, by exacerbation of chronic diseases.

Pregnancy and lactation:

Adequate data on the use of the Polyoriks® vaccine in pregnancy and lactation are absent.

Dosing and Administration:

Method of administration

Vaccine Polyoriks® is administered by deep intramuscular injection. Children of the first year of life are given the vaccine in the upper-upper surface of the middle part of the thigh, the remaining age - in the deltoid muscle.

Before use, the vaccine should be visually checked for compliance with the above description and for the presence of foreign particles. If the vaccine does not correspond to the description or contains foreign matter, it should be destroyed.

Vaccination schedules

Single dose is 0.5 ml.

In accordance with the National Calendar of preventive vaccinations of the Russian Federation, the following vaccination course is recommended for the prevention of poliomyelitis: 3-4.5-6 months.

The first and second vaccinations are carried out with a vaccine to prevent poliomyelitis inactivated. The third vaccination is carried out with a vaccine for the prevention of poliomyelitis live.

Revaccination is carried out at 18, 20 months and 14 years with a vaccine for the prevention of poliomyelitis live.

Children born to mothers with HIV infection, children with HIV infection, children living in the children's homes, the third vaccination (6 months) and subsequent revaccinations are vaccinated for the prevention of inactivated poliomyelitis.

When using a live vaccine for the prevention of poliomyelitis should be guided by the instruction for its use.

Side effects:

Because of the simultaneous administration of other vaccines with the Polyoriks® vaccine, it is impossible to establish an accurate causal relationship between the occurrence of unwanted reactions and the use of the vaccine.

In clinical trials, 1,105 children received 2323 doses of the Polyoriks® vaccine. Most of the adverse events were mild and short. The most common adverse events observed after vaccination were anxiety and irritability, recorded in 30.2% and 28.9% of cases, respectively.

Undesirable reactions assessed by researchers as at least possibly related to vaccination are listed below, depending on the anatomical and physiological classification and frequency of occurrence. Frequency of occurrence is defined as follows: Often (≥1/10), often (≥1 / 100 and <1/10), infrequently (≥1 / 1,000 and <1/100), rarely (≥1 / 10,000 and <1/1 000), rarely (<1/10 000, including individual cases). Frequency categories were formed on the basis of clinical studies of the drug and post-registration surveillance.

Clinical Trials Data

From the nervous system

Often: drowsiness, irritability, anxiety, pathological crying.

From the gastrointestinal tract

Often: diarrhea, vomiting.

From the side of metabolism and nutrition

Often: loss of appetite.

Local and general reactions

Often: soreness, redness and swelling at the injection site; fever.

Post-registration data

From the immune system

allergic reactions, including anaphylactic and anaphylactoid reactions.

Overdose:

No cases of overdose have been reported.

Interaction:

The vaccines (except BCG and BCG-M) used in the National calendar of preventive vaccinations in Russia can be administered at intervals of 1 month or simultaneously in different parts of the body with different syringes.

Special instructions:

As with other injectable vaccines, appropriate conditions must be met during the introduction of the Polyoriks® vaccine to help with the development of an anaphylactic reaction and to monitor the vaccine within 20 minutes after the introduction of the vaccine.

After vaccination, or sometimes in front of it, fainting or severe weakness is possible as a psychological reaction to injection.Before vaccination it is important to make sure that the patient does not get injured in the event of a syncope.

Before vaccination, the history of the child should be studied, paying attention to the previous administration of vaccines and the associated occurrence of adverse reactions, as well as to conduct an examination.

Acute infectious and non-infectious diseases, exacerbation of chronic diseases are temporary contraindications for vaccination. Scheduled vaccinations are carried out 2-4 weeks after recovery or during the period of convalescence or remission.

With mild ARVI, acute intestinal diseases and other vaccinations are carried out immediately after the normalization of temperature.

When a vaccine is administered to patients with impairments from the immune system as a result of the course of immunosuppressive therapy, a genetic defect or HIV infection, an adequate immune response may not be achieved.

Since the Polyoriks® vaccine may contain trace amounts of neomycin and polymyxin used in the manufacturing process and are almost completely removable, patients with a hypersensitivity to these antibiotics should be cautioned in the history.

Polyiorix® should be used with caution in patients with thrombocytopenia and disorders of the coagulation system, since intramuscular administration of the vaccine can lead to bleeding.

It is necessary to take into account the potential risk of apnea and the need to monitor respiratory function for 48-72 hours during the course of primary vaccination of children born prematurely (<28 weeks gestation) and especially children with respiratory distress syndrome. Vaccination in such cases is advisable to be performed in a hospital. Prematurely born children are vaccinated when they achieve stabilization with adequate weight gain.

Polyoriks® should not be administered intravenously under any circumstances.

Form release / dosage:

Solution for intramuscular injection, 0.5 ml / dose.

Packaging:

For 0.5 ml (1 dose) in a bottle of neutral glass type I (EF) with a capacity of 3 ml with a self-adhesive label, sealed with a plug of synthetic butyl rubber and an aluminum cap for running in, equipped with a protective plastic snap-off lid.

For 1, 10 or 100 vials, together with the appropriate number of instructions for use (1 pc. Or 10 pcs.) In a cardboard bundle.

Storage conditions:

Store at a temperature of 2 to 8 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date stated on the package.

Expiration date is the last day of the month indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-006668/09

Date of registration:20.08.2009

The owner of the registration certificate:GlaxoSmithKline Trading, ZAO GlaxoSmithKline Trading, ZAO Russia

Manufacturer: & nbsp

SMITKLYAIN BICHEM-BIOMED Russia

GlaxoSmithKline Biologicals, s.a. Belgium

Representation: & nbspGlaxoSmithKline Trading, ZAOGlaxoSmithKline Trading, ZAO

Information update date: & nbsp20.12.2015

Illustrated instructions

Instructions

Polyoriks® (Poliorix®)