Grippol^® plus (Suspension) Instructions for Use

Marketing Authorization Holder

Petrovax Pharm NPO, LLC (Russia)

Contact Information

Petrovax Pharm NPO, LLC (Russia)

ATC Code

J07BB (Anti-influenza vaccines)

Active Substances

Azoximer bromide (Rec.INN registered by WHO)

Inactivated influenza vaccine (Grouping name)

Dosage Form

Grippol® plus

Intramuscular and subcutaneous suspension 0.5 ml/1 dose: syringes 1, 5 or 10 pcs., amp. 5 or 10 pcs., bottle 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Suspension for intramuscular and subcutaneous administration in the form of a colorless or slightly yellowish, slightly opalescent liquid.

* strains of influenza virus antigens – in accordance with WHO recommendations for the current epidemic season.

Excipients: phosphate-saline buffer solution – up to 0.5 ml.
Does not contain a preservative.

0.5 ml – disposable syringes (1) – contour cell packs (1) – cardboard boxes.
0.5 ml – disposable syringes (5) – contour cell packs (1) – cardboard boxes.
0.5 ml – disposable syringes (5) – contour cell packs (2) – cardboard boxes.
0.5 ml – disposable syringes (10) – contour cell packs (1) – cardboard boxes.
0.5 ml – ampoules (5) – contour cell packs (1) – cardboard boxes.
0.5 ml – ampoules (5) – contour cell packs (2) – cardboard boxes.
0.5 ml – ampoules (5) – cardboard boxes.
0.5 ml – ampoules (10) – cardboard boxes.
0.5 ml – bottles (5) – contour cell packs (1) – cardboard boxes.
0.5 ml – bottles (5) – contour cell packs (2) – cardboard boxes.
0.5 ml – bottles (5) – cardboard boxes.
0.5 ml – bottles (10) – cardboard boxes.

Clinical-Pharmacological Group

Influenza vaccine for prophylaxis

Pharmacotherapeutic Group

Vaccines; viral vaccines; influenza vaccines

Pharmacological Action

The trivalent inactivated polymer-subunit influenza vaccine consists of protective antigens (hemagglutinin and neuraminidase) isolated from purified influenza viruses type A and B, grown in chicken embryos, and conjugated with a water-soluble high-molecular-weight immuno-adjuvant N-oxidized derivative of poly-1,4-ethylenepiperazine (Azoximer bromide).

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 lasts up to 12 months, including in the elderly. Protective antibody titers to influenza viruses after vaccination of individuals of different ages are determined in 75-95% of vaccinated subjects.

The inclusion of the immunomodulator azoximer bromide, which has a broad spectrum of immunopharmacological action, into 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 other infections by correcting immune status.

Indications

Specific prophylaxis of influenza in children from 6 months of age, adolescents and adults without age limit.

The vaccine is especially indicated for individuals at high risk of developing complications in case of influenza

• Over 60 years of age, preschool children, schoolchildren;
• Adults and children who frequently suffer from acute respiratory infections, who have chronic somatic diseases, including diseases and malformations of the central nervous system, cardiovascular and bronchopulmonary systems, bronchial asthma, chronic kidney diseases, diabetes mellitus, metabolic diseases, autoimmune diseases, allergic diseases (except allergy to chicken protein), chronic anemia, congenital or acquired immunodeficiency, HIV-infected individuals;

The vaccine is also indicated for individuals who, by the nature of their profession, have a high risk of contracting influenza or infecting others, including

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

ICD codes

Dosage Regimen

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

Children over 3 years of age, adolescents and adults are administered the vaccine intramuscularly or deep subcutaneously into the upper third of the outer surface of the shoulder (into the deltoid muscle). Young children are administered the vaccine intramuscularly into the anterolateral surface of the thigh.

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

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

Children who have not previously had influenza and have not been vaccinated may be administered the vaccine twice with an interval of 3-4 weeks.

Patients with immunodeficiency and those receiving immunosuppressive therapy may be administered the vaccine twice at 0.5 ml with an interval of 3-4 weeks.

Vaccine administration rules

Before use, the vaccine should be brought to room temperature and shaken well. Remove the protective cap from the needle and remove air from the syringe by holding it vertically with the needle up and slowly pressing the plunger.

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

The opening of ampoules and vials and the vaccination procedure are carried out in strict compliance with the rules of asepsis and antisepsis: before opening, the ampoule knife, the neck of the ampoule or the vial stopper are wiped with cotton wool moistened with 70% ethyl alcohol, the ampoule is opened or the rubber stopper of the vial is pierced with a needle, the vaccine is drawn into a disposable syringe and excess air is removed from the syringe. The skin at the injection site is wiped with alcohol. The drug in an opened ampoule or vial is not subject to storage.

Adverse Reactions

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

The frequency of adverse reactions is defined as follows: common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000), very rare (<1/10,000).

Local reactions common – pain, redness, induration and swelling at the injection site.

General reactions common – malaise, weakness, subfebrile temperature; uncommon – mild runny nose, sore throat, headache and fever above subfebrile (these reactions usually resolve on their own within 1-2 days); rare – allergic reactions, including immediate type.

From the nervous system very rare – neuralgia, paresthesia, neurological disorders.

From the musculoskeletal system very rare – myalgia.

The patient should be informed of the need to report to the doctor any pronounced or unlisted adverse reactions.

Contraindications

• Allergic reactions to chicken protein and vaccine components;
• Allergic reactions to previously administered influenza vaccines;
• Acute febrile conditions or exacerbation of a chronic disease (vaccination is carried out after recovery or during remission);
• Non-severe acute respiratory viral infections, acute intestinal diseases (vaccination is carried out after temperature normalization).

Use in Pregnancy and Lactation

Preclinical studies have shown that the inactivated polymer-subunit influenza vaccine does not have embryotoxic or teratogenic effects.

The decision to vaccinate pregnant women is made by the 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 of pregnancy.

Breastfeeding is not a contraindication for vaccination.

Special Precautions

On the day of vaccination, the vaccinees must be examined by a doctor (paramedic) with mandatory thermometry. Vaccination is not carried out 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.

It is prohibited to administer the vaccine intravenously.

Rooms where vaccination is carried out must have anti-shock therapy means.

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

Effect on ability to drive vehicles and mechanisms

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

Overdose

Cases of overdose of Grippol^® plus vaccine have not been reported.

Drug Interactions

Grippol^® plus can be used simultaneously with inactivated and live vaccines of the National Calendar of Preventive Vaccinations (except for BCG and BCG-M) and inactivated vaccines of the Calendar of Preventive Vaccinations for Epidemic Indications (except for anti-rabies). In this case, contraindications to each of the vaccines used should be taken into account; the drugs should be administered into different parts of the body with different syringes.

The vaccine can be administered against the background of basic therapy for the underlying disease. Vaccination of patients receiving immunosuppressive therapy (corticosteroids, cytotoxic drugs, radiotherapy) may be less effective.

Storage Conditions

The drug should be stored out of the reach of children, in a dry, light-protected place at a temperature from 2°C (35.6°F) to 8°C (46.4°F); do not freeze. The drug that has been frozen is not suitable for use.

Shelf Life

Shelf life – 1 year.

The vaccine is transported in a dry, light-protected place at a temperature from 2°C (35.6°F) to 8°C (46.4°F) under conditions that exclude freezing. Transportation at a temperature not exceeding 25°C (77°F) for no more than 24 hours is allowed.

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.