Grippol Neo - instructions for use, dose, side effects, contraindications

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Dosage form: & nbsp

suspension for intramuscular and subcutaneous administration

Composition:One immunizing dose (0.5 ml) contains 5 μg hemagglutinin of epidemic-relevant strains of the influenza virus subtypes A (H1N1 and H3N2) and type B manufactured by Abbott Biolodicalts BV, the Netherlands and 500 μg of Polyoxidonium® immunoadjuvant in phosphate buffered saline.

Description:Colorless or yellowish tint slightly opalescent liquid.

Pharmacotherapeutic group:Vaccines

ATX: & nbsp

Influenza virus - purified antigen

Pharmacodynamics:

Vaccine Grippolous trivalent inactivated subunit adjuvant Grippol® Neo is a protective antigens (hemagglutinin and neuraminidase) isolated from Influenza A and B types of viruses grown in the mammalian kidney's transplantable mammalian cell line Madin-Darby Canine Kidney (MDCK) associated with a water-soluble high molecular weight immunoadiguant 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.

Does not contain preservative and ovalbumin.

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, the immunity persists up to 12 months.Protective titers of antibodies to influenza viruses after vaccinations 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 vaccination dose of antigens, increase the body's resistance to respiratory infections due to immune status corrections.

Indications:

Specific prevention of influenza in children from 3 years, adolescents and adults without age restriction.

Contingents to be vaccinated. The vaccine is especially shown:

1. Individuals with a high risk of complications in the event of an influenza:

- often ill with acute respiratory disease, suffering from chronic somatic diseases: diseases and malformations of the central nervous, cardiovascular and broncho-pulmonary systems, including bronchial asthma, chronic kidney diseases, diabetes mellitus. metabolic diseases, autoimmune diseases, chronic anemia, allergic diseases, including,with allergy to egg white protein, congenital or acquired immunodeficiency, HIV-infected;

- to the elderly.

2. Persons who are professionally at risk of getting influenza or are infected by others:

medical workers, employees of educational institutions, social services, transport, trade, militia, servicemen, etc.

Contraindications:

Allergic reactions to vaccine components.

- 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 remission. With non-severe acute respiratory viral infections, acute intestinal diseases, etc., vaccinations are carried out immediately after the normalization of the temperature.

Pregnancy and lactation:

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 vaccination is most safe in the second and third trimesters.

Breastfeeding is not a contraindication for vaccinations.

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.

The vaccine is given once in a dose of 0.5 ml intramuscularly or deeply subcutaneously in the upper third of the outer surface of the shoulder (in the deltoid muscle).

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

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

Precautionary measures

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 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 general reactions in the form of malaise, headache, fever.These reactions usually disappear on their own, after 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). 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 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 changes in physical properties (color, transparency), expired shelf life, violation of storage requirements.

Form release / dosage:

Suspension for intramuscular and subcutaneous administration.

Packaging:

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

For 1, 5 or 10 syringes in a contoured cell pack of a polyvinylchloride film, coated 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 each) 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.

For 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:

Transportation and storage conditions

Store in a dark place at a temperature of 2 to 8 ° C, in accordance with SP 3.3.2.1248-03.

Keep away from children!

Do not freeze! The drug, which has been frozen, is not subject to application. Transportation of all types of covered transport in accordance with SP 3.3.2.1248-03 in light-proof containers at a temperature of 2 to 8 ° C in conditions,excluding 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-006029/09

Date of registration:23.07.2009 / 18.07.2011

Expiration Date:Unlimited

The owner of the registration certificate:NPO PETROVAKS PHARM, LLC NPO PETROVAKS PHARM, LLC Russia

Manufacturer: & nbsp

NPO PETROVAKS PHARM, LLC Russia

Representation: & nbspNPO Petrovax Pharm Ltd. NPO Petrovax Pharm Ltd. Russia

Information update date: & nbsp10.05.2017

Illustrated instructions

Instructions

Grippol® Neo (Grippol® Neo)