Grippol^® Neo (Suspension) Instructions for Use

Marketing Authorization Holder

Petrovax Pharm, LLC (Russia)

ATC Code

J07BB (Anti-influenza vaccines)

Active Substances

Azoximer bromide (Rec.INN)

Inactivated influenza vaccine

Dosage Form

Grippol® Neo

Suspension for intramuscular and subcutaneous administration 0.5 ml/1 dose: amp. 5 pcs.

Dosage Form, Packaging, and Composition

* The antigenic composition of the vaccine is changed every year in accordance with the epidemic situation and WHO recommendations.

0.5 ml (1 dose) – ampoules (5) – plastic contour packaging (1) – cardboard packs.

Clinical-Pharmacological Group

Influenza vaccine for prophylaxis

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

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

The protective effect after vaccination usually occurs within 8-12 days, and immunity lasts up to 12 months.

Protective antibody titers to influenza viruses after vaccination of individuals of different ages are determined in 83-98% of vaccinated subjects.

The inclusion of the immunomodulator Polyoxidonium, which has a wide spectrum of immunopharmacological action, in the vaccine preparation ensures increased immunogenicity and stability of antigens, enhances immunological memory, significantly reduces the vaccination dose of antigens, and increases the body’s resistance to respiratory infections by correcting immune status.

Indications

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

The vaccine is especially indicated for:

1. Persons at high risk of developing complications in case of influenza disease

• Those frequently ill with acute respiratory infections, suffering from chronic somatic diseases: diseases and malformations of the central nervous, cardiovascular and bronchopulmonary systems, including bronchial asthma, chronic kidney diseases, diabetes mellitus, metabolic diseases, autoimmune diseases, chronic anemia, allergic diseases, including allergy to chicken egg protein, congenital or acquired immunodeficiency, HIV-infected;
• Elderly persons.

2. Persons who, by the nature of their profession, have a high risk of contracting influenza or infecting others

• Healthcare workers, employees of educational institutions, social services, transport, trade, police, military personnel, etc.

ICD codes

Dosage Regimen

Vaccination is carried out annually in the autumn-winter period. Vaccination is also possible at the beginning of the epidemic rise in influenza incidence.

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

For patients with immunodeficiency and those receiving immunosuppressive therapy, the vaccine may be administered twice at a dose of 0.5 ml with an interval of 4 weeks.

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

Adverse Reactions

The vaccine is a highly purified preparation and is well tolerated.

Local and general reactions to the vaccine administration are generally absent.

Rarely, reactions in the form of soreness, swelling and redness of the skin may develop at the injection site.

Some individuals may experience general reactions in the form of malaise, headache, and fever.

These reactions usually disappear on their own within 1-2 days.

Very rarely, as with any other vaccination, allergic reactions, myalgia, neuralgia, and neurological disorders may occur.

Contraindications

• Allergic reactions to the components of the vaccine.

Acute infectious and non-infectious diseases, exacerbation of chronic diseases are temporary contraindications for vaccination.

Routine vaccinations are carried out 2-4 weeks after recovery or during remission.

For non-severe acute respiratory viral infections, acute intestinal diseases and others, vaccinations are carried out immediately after the temperature normalizes.

Use in Pregnancy and Lactation

Experience with inactivated influenza vaccines shows that vaccination does not have a teratogenic or toxic effect on the fetus.

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.

Vaccination is safest in the second and third trimesters.

Breastfeeding is not a contraindication for vaccination.

Special Precautions

On the day of vaccination, the vaccinees should be examined by a doctor (paramedic) with mandatory thermometry.

Vaccination is not performed at a temperature above 37°C (98.6°F).

The drug in ampoules, vials, syringes with damaged integrity or labeling, with changed physical properties (color, transparency), with an expired shelf life, or with violated storage conditions is not suitable for use.

Do not administer intravenously!

The rooms where vaccination is carried out must have means for anti-shock therapy.

The vaccinated person must be under the supervision of a healthcare professional for 30 minutes after immunization.

Drug Interactions

Grippol^® Neo vaccine can be used simultaneously with other vaccines (except for anti-rabies vaccines).

In this case, contraindications to each of the vaccines used must be taken into account; the drugs should be administered into different parts of the body using different syringes.

The vaccine can be administered against the background of basic therapy for the underlying disease.

Vaccination of patients receiving immunosuppressive therapy may be less effective.

Storage Conditions

Store in a light-protected place at a temperature of 2 to 8°C (46.4°F), in accordance with SP 3.3.2.1248-03.

Keep out of reach of children!

Do not freeze!

The drug that has been frozen is not suitable for use.

Transportation by 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 (46.4°F) under conditions that exclude freezing.

Shelf Life

Shelf life – 1 year.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.