Grippol® plus [Influenza trivalent inactivated polymer-subunit vaccine] (Grippol plus)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceVaccine for the prevention of influenza [inactivated] + Azoxime bromideVaccine for the prevention of influenza [inactivated] + Azoxime bromide
Dosage form: & nbsp

suspension for intramuscular and subcutaneous administration

Composition:In 1 dose (0.5 ml) contains:

Active components:

Antigen of influenza virus type

A (H1N1)* with a hemagglutinin content of 5 μg

Antigen of influenza virus type

A (H3N2)* with a hemagglutinin content of 5 μg

Antigen of influenza virus type AT* with a hemagglutinin content of 5 μg

Polyoxidonium® (Azoxime bromide) - 500 μg

Auxiliary components:

Phosphate buffered saline solution up to 0.5 ml

Does not contain a preservative.

* The strains of influenza antigens are in line with WHO recommendations for the current epidemic season.

Description:Colorless or yellowish tint slightly opalescent liquid.
Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp

J.07.B.B.02   Influenza virus - purified antigen

J.07.B   Vaccines for the prevention of viral infections

Pharmacodynamics:
Characteristics of the preparation.
The vaccine is a protective antigen (hemagglutinin and neuraminidase) isolated from purified influenza A and B viruses grown in 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.
Pharmacokinetics:

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, including in the elderly.Protective titers of antibodies to influenza viruses after vaccination of persons of different ages are determined in 75-95% of vaccinated people.

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

Indications:

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

Contingents to be vaccinated. The vaccine is especially shown:

- Persons with a high risk of complications in the case of influenza:

over 60 years of age; children of preschool age, schoolchildren; adults and children who often suffer from acute respiratory diseases, suffering from chronic physical illnesses, including: diseases and malformations of the central nervous, cardiovascular and broncho-pulmonary systems, bronchial asthma, chronic kidney disease, diabetes mellitus, metabolic diseases, autoimmune diseases,allergic diseases (except for allergies to chicken proteins); chronic anemia, congenital or acquired immunodeficiency, HIV-infected;

- Persons, by profession, having a high risk of getting the flu or getting infected by other people:

medical workers, employees of educational institutions, social services, transport, trade, police, servicemen, etc.
Contraindications:

Allergic reactions to chicken protein and vaccine components.

Allergic reactions to previously administered influenza vaccines.

Acute feverish 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).

Pregnancy and lactation:

Preclinical studies have shown that the vaccine influenza inactivated polymer-subunit does not have embryotoxic and teratogenic effects. 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 vaccination is most safe in the second and third trimesters.

Breastfeeding is not a contraindication for vaccination.

Dosing and Administration:

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 intramuscularly or deeply subcutaneously in the upper third of the outer surface of the shoulder (in the deltoid muscle), children of younger age - in the anterolateral hip surface intramuscularly.

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 given once in a dose of 0.5 ml.

Earlier, not a flu and unvaccinated children, the vaccine can be injected twice with an interval of 3-4 weeks.

Patients with immunodeficiency and receiving immunosuppressive therapy it is possible to administer the vaccine twice in 0.5 ml at intervals of 3-4 weeks.

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 up and slowly pressing the piston.

For immunization of children, which shows the introduction of 0.25 ml (half dose) of vaccine necessary to remove half of the contents of the syringe by pushing the plunger to special risks marked on the syringe body, or to label red color applied to the label region, and enter the the remaining 0.25 ml.

Autopsy ampoules and vials, and the procedure of vaccination is carried out under strict aseptic and antiseptic rules: before opening the ampoule knife neck of the ampoule or vial stopper is rubbed with cotton wool soaked in 70% ethyl alcohol, opened ampoule or puncture needle rubber stopper of the vial, gaining vaccine of 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.

Precautions for use.

Do not administer intravenously. 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.

Side effects:

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

Frequent (> 1/100, <1/10). Local reactions in the form of pain, hyperemia, compaction and swelling at the injection site. General reactions: malaise, weakness, low-grade fever.

Infrequent (> 1/1000, <1/100). Common reactions in the form of a slight runny nose, sore throat, headache and fever above subfebrile.

These reactions usually pass independently for 1-2 days.

Rare (> 1/10000, <1/1000). Allergic reactions, including 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 physician of any adverse reactions expressed or not indicated in this manual.

Overdose:

Cases of overdose are not registered.

Interaction:

The Grippol® Plus vaccine can be used concomitantly with the inactivated and live vaccines of the National Preventative Vaccine Calendar (excluding BCG and BCG-M) and inactivated vaccines of the vaccination vaccination schedule for epidemic indications (with the exception of anti-rabies vaccines).In this case, contraindications to each of the vaccines used must 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 (corticosteroids, cytotoxic drugs, radiotherapy) may be less effective.

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 carried out.

The preparation 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 requirements for storage conditions.

It is prohibited to administer the vaccine intravenously.

Effect on the ability to drive transp. cf. and fur:

Grippol® Plus does not affect the ability to drive a car or operate machinery and machinery.

Form release / dosage:

Suspension for intramuscular and subcutaneous administration.

Packaging:

For 0.5 ml (1 dose) in disposable syringes or in ampoules or vials, hermetically sealed with rubber stoppers and crimped with aluminum caps.

For 1, 5 or 10 syringes in a contiguous cell pack of a polyvinyl chloride 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 along with instructions for use. For 5 ampoules or vials in a contoured cell pack of a polyvinyl chloride film. For 1 or 2 contour mesh packages in a pack of cardboard together with instructions for use.

Or 5 or 10 ampoules or vials without a contour cell package are placed in a pack of cardboard along with the instructions for use.

Storage conditions:

Store in a dark place at a temperature of 2 ° C to 8 ° C.

Keep away from children!

Do not freeze! The drug, which has been frozen, is not subject to application.

Conditions of transportation.

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

Shelf life:

1 year. The drug with expired shelf life is not subject to application.

Terms of leave from pharmacies:On prescription
Registration number:LSR-006981/08
Date of registration:01.09.2008 / 02.02.2016
Expiration Date:Unlimited
The owner of the registration certificate:NPO PETROVAKS PHARM, LLC NPO PETROVAKS PHARM, LLC Russia
Manufacturer: & nbsp
Representation: & nbspNPO Petrovax Pharm Ltd. NPO Petrovax Pharm Ltd. Russia
Information update date: & nbsp10.05.2017
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