Instruction for use: Grippol Neo

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 and release form

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

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

Subtype A (H1N1) 5 μg

Subtype A (H3N2) 5 μg

Type B 5 μg

Immunoadjuvant Polyoxidonium® 500 μg

Phosphate-buffered saline to 0.5 ml

Does not contain a preservative and ovalbumin

0.5 ml (1 dose) in a disposable syringe; In the contour cell pack 1 syringe; In a pack of cardboard 1 package.

Description of dosage form

Colorless or yellowish tint slightly opalescent liquid.

Characteristic

The influenza trivalent inactivated subunit adjuvant vaccine is a protective antigens (haemagglutinin and neuraminidase) isolated from influenza A and B influenza viruses grown in the transplantable mammalian Madin-Darby Canine Kidney kidney cell line (MDCK) associated with the water-soluble high molecular weight immunoadiguvant Polyoxidonium® (INN - Azoxime bromide). The antigenic composition of the vaccine changes every year in accordance with the epidemic situation and the recommendations of the WHO and the EU for the current epidemic season.

Pharmachologic effect

Mode of action - Immunostimulating.

Pharmacodynamics

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. Protective titers of antibodies to influenza viruses after vaccination of persons of different ages are determined in 83-98% 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, increase the resistance of the organism to acute respiratory viral infection by correcting the immune status.

Indications for the Grippol Neo

Specific prevention of influenza in children from the age of three, adolescents and adults without age restriction.

Contingents to be vaccinated. The vaccine is especially shown:

1. Persons with a high risk of complications in the event of a flu virus:

Often ill with ARI, suffering from chronic physical illnesses, incl. Diseases and malformations of the central nervous system, cardiovascular and broncho-pulmonary systems (including bronchial asthma), chronic kidney diseases; Diabetes mellitus, metabolic diseases, autoimmune diseases, allergic diseases (including allergy to chicken protein); Chronic anemia, congenital or acquired immunodeficiency; HIV-infected;

To the elderly.

2. Persons who have a high risk of illness or other persons who are infected by it: health workers, employees of educational institutions, social services, transport, trade, police, servicemen, etc.

Contraindications

Allergic reactions to vaccine components;

Acute infectious and non-infectious diseases, exacerbation of chronic diseases are temporary contraindications for vaccination (planned vaccinations are carried out 2-4 weeks after recovery or during remission).

For non-severe acute respiratory viral infections, acute intestinal diseases, etc., vaccination is carried out immediately after the temperature is normalized.

Application of pregnancy and breastfeeding

Experience with the use of influenza inactivated vaccines shows that vaccination does not have a teratogenic or toxic effect on the fetus. The decision on vaccination of pregnant women should be taken by a 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. Local and general reactions to vaccine administration are generally not available.

Rarely at the injection site, reactions can develop in the form of soreness, swelling and redness of the skin. Individuals may have common reactions in the form of malaise, headache, fever. These reactions usually disappear on their own in 1-2 days. Very rarely, as with any other vaccination, there may be allergic reactions, myalgia, neuralgia, neurological disorders.

Interaction

The vaccine Grippol® Neo can be used concomitantly with other vaccines (with the exception of anti-rabies vaccines). Contraindications to each of the vaccines used should be taken into account; Drugs should 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 may be less effective.

Dosing and Administration

IM or SC (deep) in the upper third of the outer surface of the shoulder (in the deltoid muscle) in a dose of 0.5 ml once.

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.

Before use, the vaccine should be allowed to reach room temperature and shaken well.

Patients with immunodeficiency and receiving immunosuppressive therapy can enter the vaccine twice in 0.5 ml with an interval of 4 weeks.

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 37.0 ° C, vaccination is not performed.

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

Transportation - all types of covered transport in accordance with SP 3.3.2.1248-03 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.

Complaints on the discrepancy of the preparation in terms of quality, physical properties, packing, packing with the obligatory indication of the serial number and the date of manufacture, should be sent to the manufacturing company LLC FC "PETROVAKS" and to the State Research Institute for Standardization and Control of Medical Biological Preparations. L.A. Tarasevich Rospotrebnadzor.

About cases of increased reactogenicity or the development of post-vaccination complications should be reported by phone (fax) to the State Research Institute for Standardization and Control of Medical Biological Preparations. L.A. Tarasevich (LA Taraskevich GISK) with subsequent submission of medical documentation to the address: 119002, Moscow

Conditions of supply of pharmacies

On prescription.

Storage conditions of the drug Grippol Neo

In the dark place at a temperature of 2-8 ° C (do not freeze).

Keep out of the reach of children.

The shelf life of the drug Grippol Neo

1 year.

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