Grippol plus (azoximer bromide)

Grippol plus (azoximer bromide) Medicine

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Contraindications

allergic reactions to chicken protein and vaccine components,

allergic reactions to early-administered influenza vaccines,

acute febrile conditions or exacerbation of a chronic disease (vaccination is carried out after recovery or during remission),

mild acute respiratory infections, acute intestinal diseases (vaccination is carried out after normalization of temperature).

Incompatibilities

Grippol vaccine® plus can be used simultaneously with inactivated and live vaccines of the National Calendar of Preventive vaccinations (with the exception of BCG and BCG-M) and inactivated vaccines of the calendar of preventive vaccinations for epidemic indications (with the exception of anti-rabies). At the same time, contraindications to each of the vaccines used should be taken into account, the 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 (corticosteroids, cytotoxic drugs, radiotherapy) may be less effective.

Pharmaceutical form

Colorless or slightly opalescent liquid with a yellowish tinge.

Undesirable effects

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

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

Local reactions: soreness, hyperemia, tightness and swelling at the injection site.

General reactions: malaise, weakness, subfebrile fever.

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

General reactions: mild runny nose, sore throat, headache, fever above subfebrile.

These reactions usually pass independently within 1-2 days.

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

Allergic reactions: including the immediate type.

Very rare (>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 doctor about any adverse reactions expressed or not specified in these instructions.

Pharmacy sales terms

By prescription.

Special instructions

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

The drug is not suitable for use in ampoules, vials, syringes with impaired integrity or labeling, with changes in physical properties (color, transparency), with an expired expiration date, violation of the requirements for storage conditions.

Influence on the ability to drive a car or control machines and mechanisms. Grippol® plus, it does not affect the ability to drive a car or control machines and mechanisms.

Transportation. It can be transported by all types of indoor transport in light-tight containers at a temperature of 2 to 8 °C, in conditions that exclude freezing. It is allowed to transport at a temperature of up to 25 °C for 6 hours.

Therapeutic indications

Specific prevention of influenza in children from 6 months of age, adolescents and adults without age restriction.

The vaccine is particularly indicated in the following cases:

persons with a high risk of complications in the case of influenza: over 60 years of age, preschool children, schoolchildren, adults and children who often suffer from acute respiratory infections, suffering from chronic somatic diseases, including diseases and malformations of the central nervous system, cardiovascular and bronchopulmonary systems (including bronchial asthma), chronic kidney diseases, diabetes, metabolic diseases, autoimmune diseases, allergic diseases (except for allergies to chicken protein), chronic anemia, congenital or acquired immunodeficiency, HIV-infected,

persons who have a high risk of contracting the flu or infecting others by their occupation: including medical workers, employees of educational institutions, social services, transport, trade, police, and military personnel.

Pharmacotherapeutic group

  • Vaccines, serums, phages, and toxoids in combination

Special precautions for storage

In a dry place, protected from light, at a temperature of 2-8 °C (do not freeze). The drug that has been frozen is not subject to use.

Keep out of reach of children.

Shelf life of the drug Grippol® plus [Influenza vaccine trivalent inactivated polymer-subunit]1 год.

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

Nature and contents of container

Suspension for I / m and p/c administration 1 dose (0.5 ml)
active substance:  
Hemagglutinin of epidemiologically relevant influenza virus strains produced by Abbott Biologicals B. V., the Netherlands  
subtype A (H1N1) 5 mcg
subtype A (H3N2) 5 mcg
type B 5 mcg
immunoadjuvant Polyoxidonium® (in phosphate-salt buffer) 500 mcg
Release form

Suspension for intramuscular and subcutaneous administration. 0.5 ml (1 dose) in single-use syringes or in ampoules or vials, hermetically sealed with rubber stoppers and compressed with aluminum caps. 1, 5 or 10 syringes in a contour cell package made of PVC film covered with aluminum foil with a polymer coating or laminated paper with a polymer coating. 1 (containing 1 or 5 or 10 syringes) or 2 (containing 5 syringes) contour packages in a cardboard pack.

5 amp each. or vials in a contoured cell packaging made of PVC film. 1 or 2 contour cell packages in a pack of cardboard or 5 or 10 amp. or vials without contour cell packaging are placed in a cardboard pack.

Fertility, pregnancy and lactation

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

The decision to vaccinate pregnant women should be made by a doctor individually, taking into account the risk of influenza infection and possible complications of influenza infection. The safest vaccination is in the second and third trimesters.

Breast-feeding is not a contraindication for vaccination.

Nosological classification (ICD-10)

  • Z25. 1 The need for influenza immunization

Dosage (Posology) and method of administration

V / m, p / k. Vaccination is carried out annually in the autumn-winter period. Vaccination is possible at the beginning of the epidemic rise in the incidence of influenza.

Children over 3 years of age, adolescents and adults are given the vaccine in/m or deep p/c in the upper third of the outer surface of the shoulder (in the deltoid muscle), in young children - in the anterolateral surface of the thigh in/m.

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

Children over 36 months and adults the vaccine is administered once in a dose of 0.5 ml.

Previously not ill with influenza and unvaccinated children may be 2-fold administration of the vaccine at intervals of 3-4 weeks.

Patients with immunodeficiency and receiving immunosuppressive therapy it is possible to administer the vaccine 2 times in 0.5 ml with an interval of 3-4 weeks.

Before use, the vaccine should be kept at room temperature and shaken well. Remove the protective cover from the needle and remove the air from the syringe by holding it in a vertical position with the needle up and slowly pressing the plunger.

To immunize children who are indicated for the administration of 0.25 ml (1/2 dose) of the vaccine, it is necessary to remove half of the contents of the syringe by pressing the plunger to the special mark marked on the body of the syringe, or to the red mark applied to the edge of the label, and inject the remaining 0.25 ml.

The opening of ampoules and vials and the vaccination procedure is carried out in strict compliance with the rules of asepsis and antiseptics: before opening, the ampoule knife, the neck of the ampoule or the stopper of the bottle is wiped with cotton wool moistened with 70% ethyl alcohol, the ampoule is opened or the rubber stopper of the bottle is pierced with a needle, the vaccine is collected in a single-use syringe and excess air is removed from the syringe. Alcohol is rubbed on the skin at the injection site. The drug is not stored in an open ampoule or bottle.

ATC - Anatomical and therapeutic chemical classification

J07BB02 Influenza virus inactivated cleaved or surface antigen