MonoGriple Neo (MonoGrippol Neo)

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: & nbspsuspension for intramuscular and subcutaneous administration
Composition:One immunizing dose (0.5 ml) contains 5 μg hemagglutinin of a pandemic strain of the influenza virus type A (HiNi) produced by Abbott Biolodicals BV, the Netherlands and 500 μg of Polyoxidonium immunoadjuvant in a phosphate buffered saline solution.
Description:Colorless or yellowish tint slightly opalescent liquid.
Pharmacotherapeutic group:Vaccines
ATX: & nbsp

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

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

Pharmacodynamics:

Immunobiological properties

The vaccine causes the formation of a high level of specific immunity against pandemic influenza.

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

Indications:

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

Contingents to be vaccinated. The vaccine is especially shown:

1. Persons with a high risk of complications in case of flu;

- 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 disease, diabetes, metabolic diseases, autoimmune diseases, chronic anemia, allergic diseases , including allergies to the egg white protein,congenital or acquired immunodeficiency, HIV-infected;

- to the elderly.

2. Persons who have a high risk of influenza or other persons who are classified as having a profession:

- 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 remission. With mild ARVI, acute intestinal diseases and other vaccinations are carried out immediately after the normalization of 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 vaccination.

Dosing and Administration:

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

The vaccine is given 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 region):

- children from 7 years, adolescents and adults only once;

- children from 3 to 6 years - twice with an interval of at least 21 days.

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. At the injection site, reactions may 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 in 1-2 days. Very rarely, as with any other vaccination, there may be allergic reactions, myalgia, neuralgia, neurological disorders.

Interaction:

The MonoGripol Neo vaccine can be used concomitantly with other inactivated vaccines (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 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 drug is not suitable for use in syringes with broken integrity or marking, with changing physical properties (color, transparency), expired shelf life, violation of storage requirements.

Form release / dosage:

Suspension for intramuscular and subcutaneous injection of 0.5 ml (1 dose).

Packaging:MonoGripol Neo (Influenza monovalent activated subunit adjuvant vaccine) suspension for intramuscular and subcutaneous injection of 0.5 ml (1 dose) into sterile injectable disposable syringes with a capacity of 1 ml with a glued needle and protective cap.

1 syringe per circuit pack of PVC film, foil-coated aluminum with a polymer coating, or paper laminated with a polymer coating. 1 contour mesh package in a pack of cardboard together with instructions for use. It is allowed to apply the instructions for use in the required quantity to the group package.

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 by all types of covered transport in accordance with SP 3.3.2.1248-03 in light tight 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.

Shelf life:

1,5 years. The drug is not expired.

Terms of leave from pharmacies:On prescription
Registration number:LSR-008177/09
Date of registration:16.10.2009 / 18.07.2011
Expiration Date:Unlimited
The owner of the registration certificate:FC PETROVAKS, LLC FC PETROVAKS, LLC Russia
Manufacturer: & nbsp
Representation: & nbspFC PETROVAKS, LLCFC PETROVAKS, LLC
Information update date: & nbsp13.06.2018
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