Instruction for use: Grippol plus

Dosage form: Suspension for intramuscular and subcutaneous administration

Active substance: Vaccinum ad prophylaxim grippi inactivatum + Azoximeri bromidum

ATX

J07BB02 Influenza virus inactivated cleavage or surface antigen

Pharmacological group

Vaccines, serums, phages and toxoids in combinations

The nosological classification (ICD-10)

Z25.1 The need for immunization against influenza

Composition

Suspension for IM and SC administration 1 dose (0.5 ml)

active substance: Haemagglutinin epidemically relevant strains of the influenza virus produced by Abbott Biolodicals BV, the Netherlands

Subtype A (H1N1) 5 mkg

Subtype A (H3N2) 5 mkg

Type B 5 mkg

Immunoadjuvant Polyoxidonium® (in phosphate-buffered saline) 500 mkg

Description of dosage form

Colorless or yellowish tint slightly opalescent liquid.

Characteristic

Vaccine influenza trivalent inactivated subunit polymer is a protective antigens (haemagglutinin and neuraminidase) isolated from purified influenza viruses of types A and B grown on chick embryos associated with a water-soluble high molecular weight immunoadjuvant N-oxidized derivative of poly-1,4-ethylene-piperazine (Polyoxidonium ®, INN - azoxime bromide). The antigenic composition of the vaccine changes every year in accordance with the epidemic situation and WHO recommendations. Does not contain a preservative.

Pharmachologic effect

Mode of action - Immunostimulating.

Pharmacological (immunobiological) properties

The vaccine causes the formation of a high level of specific immunity against influenza. The protective effect after vaccination, as a rule, comes in 8-12 days and lasts up to 12 months, incl. And in the elderly. Protective titers of antibodies to influenza viruses after vaccination of persons of different ages are defined in 75-95% of vaccinated.

The inclusion in the vaccine preparation of the immunomodulator Polyoxidonium, which has a broad spectrum of immunopharmacological action, provides an increase in immunogenicity and stability of antigens, allows to increase immunological memory, significantly reduce the vaccine dose of antigens, and increase the resistance of the organism to other infections by correcting the immune status.

Indications for the Grippol plus

The vaccine causes the formation of a high level of specific immunity against influenza. The protective effect after vaccination, as a rule, comes in 8-12 days and lasts up to 12 months, incl. And in the elderly. Protective titers of antibodies to influenza viruses after vaccination of persons of different ages are defined in 75-95% of vaccinated.

The inclusion in the vaccine preparation of the immunomodulator Polyoxidonium, which has a broad spectrum of immunopharmacological action, provides an increase in immunogenicity and stability of antigens, allows to increase immunological memory, significantly reduce the vaccine dose of antigens, and increase the resistance of the organism to other infections by correcting the immune status.

Contraindications

Allergic reactions to chicken protein and vaccine components;

Allergic reactions to early-onset influenza vaccines;

Acute febrile conditions or exacerbation of a chronic disease (vaccination is performed after recovery or during remission);

Not severe ARVI, acute intestinal diseases (vaccination is carried out after normalization of temperature).

Application of pregnancy and breastfeeding

Preclinical studies have shown that the vaccine influenza inactivated polymer-subunit does not have embryotoxic and teratogenic effects.

The decision to vaccinate pregnant women should be taken by the doctor individually, taking into account the risk of infection with influenza and possible complications of influenza infection. The most safe vaccination in the II and III trimesters.

Breastfeeding is not a contraindication for vaccination.

Side effects

The vaccine is highly purified and well tolerated by children and adults.

Often (> 1/100, <1/10)

Local reactions: soreness, hyperemia, compaction and edema at the site of injection.

General reactions: malaise, weakness, low-grade fever.

Infrequently (> 1/1000, <1/100)

Common reactions: slight runny nose, sore throat, headache, fever above subfebrile.

These reactions usually pass independently for 1-2 days.

Rarely (> 1/10000, <1/1000)

Allergic reactions: incl. Immediate type.

Very rarely (> 1/10000)

From the nervous system: neuralgia, paresthesia, neurological disorders.

From the musculoskeletal system: myalgia.

The patient should be informed of the need to inform the physician of any adverse reactions expressed or not indicated in this manual.

Interaction

The Grippol® Plus vaccine can be used concomitantly with the inactivated and live vaccines of the National Preventative Vaccine Calendar (except for BCG and BCG-M) and inactivated vaccines of the vaccination vaccination schedule for epidemic indications (except rabies). This should take into account contraindications to each of the vaccines used, the drugs must be injected into different parts of the body with different syringes.

The vaccine can be administered against the background of basic therapy of the underlying disease.

Vaccination of patients receiving immunosuppressive therapy (corticosteroids, cytotoxic drugs, radiotherapy) may be less effective.

Dosing and Administration

IV, SC. Vaccination is carried out annually in the autumn-winter period. It is possible to vaccinate at the beginning of an epidemic rise in the incidence of influenza.

Children older than 3 years, adolescents and adults are given a vaccine in / m or deep in the upper third of the outer surface of the shoulder (in the deltoid muscle); Children of younger age - in anterolateral surface of femur in / m.

Children from 6 to 35 months inclusive - 0.25 ml twice with an interval of 3-4 weeks.

Children older than 36 months and adults are given a single dose of vaccine in a dose of 0.5 ml.

Previously, not sick with the flu and unvaccinated children, a 2-fold administration of the vaccine with an interval of 3-4 weeks is possible.

Patients with immunodeficiency and receiving immunosuppressive therapy may receive a 2-fold injection of 0.5 ml each at 3-4-week intervals.

Before use, the vaccine should be allowed to reach room temperature and shaken well. Remove the protective cap from the needle and remove air from the syringe by holding it upright with a needle and slowly pressing the piston.

To immunize children who are treated with 0.25 ml (1/2 dose) of the vaccine, it is necessary to remove half of the contents of the syringe by pressing the piston to a special risk marked on the syringe body, or to a red label on the label edge, and enter The remaining 0.25 ml.

Opening of ampoules and vials and the vaccination procedure are carried out with strict adherence to aseptic and antiseptic rules: before opening, the ampoule knife, ampoule neck or bottle stopper should be wiped with cotton wool soaked with 70% ethyl alcohol, open the ampoule or pierce the rubber stopper of the vial with a needle, and inject the vaccine into a disposable syringe And remove excess air from the syringe. Alcohol rubs the skin at the injection site. The drug in the opened ampoule or vial is not subject to storage.

Precautionary measures

Do not enter IV.

In the offices where the vaccination is carried out, it is necessary to have anti-shock therapy.

The vaccinated should be monitored by a health worker within 30 minutes after immunization.

Special instructions

On the day of vaccination, the vaccinated should be examined by a physician (paramedic) with obligatory thermometry. At a temperature above 37 ° C vaccination is not carried out.

The drug is not suitable for use in ampoules, vials, syringes with broken integrity or marking, with a change in physical properties (color, transparency), expired shelf life, violation of storage requirements.

Impact on the ability to drive a car or control cars and mechanisms. Grippol® Plus does not affect the ability to drive a car or operate machinery and machinery.

Transportation. Can be transported by all types of covered transport in lightproof containers at a temperature of 2 to 8 ° C, in conditions that exclude freezing. Transportation is allowed at temperatures up to 25 ° C for 6 hours.

Release form

Suspension for intramuscular and subcutaneous administration. For 0.5 ml (1 dose) in disposable syringes or in ampoules or vials sealed with rubber stoppers and crimped with aluminum caps. For 1, 5 or 10 syringes in a contoured cell pack of a PVC film coated with aluminum foil with a polymer coating or paper laminated with a polymer coating. 1 (containing 1 or 5 or 10 syringes) or 2 (containing 5 syringes) contour packs in a pack of cardboard.

At 5 amp. Or bottles in the outline of the cell packaging of PVC film. For 1 or 2 contour mesh packaging in a pack of cardboard or 5 or 10 amp. Or vials without a contour cell package are placed in a cardboard package.

Manufacturer

OOO NPO Petrovax Pharm. 142143, Russia

Complaints on the quality of the preparation for physical properties, packaging, and information on cases of increased reactogenicity or development of postvaccinal complications with mandatory indication of the serial number and the date of manufacture, followed by the submission of medical documentation, should be sent to the manufacturing company OOO NPO Petrovax Pharm and to the address " FGBU GISK them. L.A. Tarasevich "of the Ministry of Health of Russia: 119002, Moscow

Conditions of supply of pharmacies

On prescription.

Storage conditions of the drug Grippol plus

In the dark place at a temperature of 2-8 ° C (do not freeze). The drug, which has been frozen, is not subject to application.

Keep out of the reach of children.

The shelf life of the drug Grippol plus

1 year.

Do not use beyond the expiration date printed on the package.