No overdose cases have been reported.
allergic reactions to chicken protein and vaccine components, including thiomersal contained in multi-dose vials,
allergic reactions to previously administered influenza vaccines,
severe reaction (temperature above 40 °C, edema and hyperemia at the injection site over 8 cm in diameter) or complications from previous administration of influenza vaccines in the anamnesis,
acute febrile conditions or exacerbation of a chronic disease (vaccination is carried out after recovery or during remission),
mild acute respiratory infections, acute intestinal diseases (vaccination is carried out after normalization of temperature),
pregnancy period (when using a vaccine containing the preservative thiomersal),
age up to 18 years.
With caution: in the offices where vaccination is carried out, it is necessary to have anti-shock therapy, the vaccinated person should be under the supervision of a medical worker for 30 minutes after immunization, should not be administered intravenously.
Grippol® Quadrivalent influenza vaccine quadrivalent inactivated subunit adjuvant can be used simultaneously with inactivated and live vaccines of the national calendar of preventive vaccinations (with the exception of BCG and BCG-M) and inactivated vaccines of the calendar of preventive vaccinations for epidemic indications (with the exception of anti-rabies). At the same time, contraindications to each of the vaccines used should be taken into account, the 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 disease that is being vaccinated. Vaccination of patients receiving immunosuppressive therapy (corticosteroids, cytostatic drugs, radiotherapy) may be less effective.
Colorless or slightly opalescent liquid with a yellowish tinge.
The vaccine is a highly purified drug and is well tolerated.
The frequency of adverse reactions reported in clinical trials is presented in accordance with the WHO classification.
The frequency of adverse reactions according to the WHO classification: very often (≥1/10), often (≥1/100 and <1/10), infrequently (≥1/1000 and <1/100), rarely (≥1/10000 and <1/1000), very rarely (<1/10000).
From the blood and lymphatic system: rarely-enlarged lymph nodes.
From the nervous system: often-a headache.
From the respiratory system, chest and mediastinal organs: often-runny nose, redness of the throat, infrequently-sore throat.
From the musculoskeletal system and connective tissue: infrequently-myalgia, arthralgia.
General disorders and disorders at the injection site: general disorders: often-malaise, local disorders: very often-pain, redness, formation of seals (infiltration) and swelling at the injection site, often-itching at the injection site.
Laboratory and instrumental data: infrequently-an increase in body temperature.
Most reactions usually go away on their own within 2-3 days.
Despite the lack of clinical data, it is impossible to exclude the possibility of developing neurological disorders and allergic reactions characteristic of influenza vaccines (including immediate reactions to chicken protein and other components of the vaccine).
The patient should be informed of the need to inform the doctor about any expressed or not specified in this description of adverse reactions.
According to the recipe-a package containing 1 syringe.
Medical and preventive institutions-a package containing 5 or 10 syringes, 1, 20 or 50 fl.
On the day of vaccination, the vaccinated should be examined by a doctor (paramedic) with mandatory thermometry. At temperatures above 37 °C, vaccination is not carried out.
The drug is not suitable for use in syringes with impaired integrity or labeling, with a change in physical properties (color, transparency), with an expired expiration date, violation of the requirements for storage conditions.
Failure to follow the technique of taking doses from a multi-dose bottle may affect the properties of the drug. For this reason, the manufacturer is responsible for its quality for 24 hours after the first sampling procedure only if stored in the refrigerator in accordance with the manufacturer's recommendations.
Multi-dose vials of Grippol® Quadrivalent contains a small amount of thiomersal as a preservative, which can cause an allergic reaction.
Influence on the ability to drive vehicles, mechanisms. Does not affect.
Specific prevention of influenza in people aged 18 to 60 years.
The vaccine is particularly indicated:
- persons with a high risk of complications in the case of influenza: over 60 years of age, often suffering from acute respiratory infections, suffering from chronic somatic diseases, including diseases and malformations of the central nervous, cardiovascular and bronchopulmonary systems, bronchial asthma, chronic kidney diseases, diabetes, metabolic diseases, autoimmune diseases, allergic diseases (except for allergies to chicken proteins), chronic anemia, congenital or acquired immunodeficiency, HIV-infected,
- persons who, by their profession, have a high risk of contracting influenza or infecting other persons with it (medical workers, citizens subject to conscription for military service, employees of educational institutions, social services, transport, trade, police, employees of poultry enterprises, military personnel).
At a temperature of 2-8 °C (do not freeze).
Keep out of reach of children.
Shelf life of the drug Grippol® Quadrivalent Influenza vaccine tetravalent inactivated subunit adjuvant1 год.Do not use after the expiration date indicated on the package.
| Solution for intramuscular and subcutaneous administration | 1 dose (0.5 ml) |
| active ingredients: | |
| influenza A (H) virus antigen1N1) * with hemagglutinin content | 5 mcg |
| influenza A (H) virus antigen3N2) * with hemagglutinin content | 5 mcg |
| influenza B virus antigen (line Yamagata) * with hemagglutinin content | 5 mcg |
| influenza B virus antigen (line Victoria) * with hemagglutinin content | 5 mcg |
| Polyoxidonium®, substance-lyophilizate** (azoximer bromide) | 500 mcg |
| excipients: phosphate-salt buffer solution (consisting of potassium chloride, potassium dihydrophosphate, disodium hydrophosphate dihydrate, sodium chloride, water for injection), preservative thiomersal (only for a multi-dose bottle-10 doses, 5 ml per bottle) | |
| * Influenza virus antigen strains-in accordance with WHO recommendations for the current epidemic season for the Northern Hemisphere, | |
| ** In terms of the active substance (azoximer bromide), excipients-mannitol, povidone | |
| note: in influenza virus antigens, triton X-100 may be present as an auxiliary substance |
Solution for intravenous and subcutaneous administration. 0.5 ml (1 dose) in single-use syringes made of glass.
5 ml (10 doses) each with a preservative in glass vials, hermetically sealed with rubber stoppers and compressed with aluminum caps.
1, 5 or 10 syringes in a contour cell package made of PVC film covered with aluminum foil with a polymer coating.
1 (containing 1 or 5 syringes or 10 syringes) or 2 (containing 5 syringes) contour cell packages are placed in a pack of cardboard. 1 fl. is placed in a pack of cardboard.
20 or 50 fl. are placed in a pack of cardboard with a cardboard insert.
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. The safest vaccination is in the second and third trimesters.
Breast-feeding is not a contraindication for vaccination.
In/m or deep p/c in the upper third of the outer surface of the shoulder (in the deltoid muscle).
Vaccination is carried out annually in the autumn-winter period. Vaccination is possible at the beginning of the epidemic rise in the incidence of influenza.
Dosage for adults: 0.5 ml once.
In patients with immunodeficiency and receiving immunosuppressive therapy, the vaccine can be administered twice, 0.5 ml at intervals of 3-4 weeks.
Before use, the vaccine should be kept at room temperature and shaken well.
When using the syringe, remove the protective cover from the needle and remove the air from the syringe by holding it in a vertical position with the needle up and slowly pressing the plunger.
The opening of a multi-dose bottle is carried out in strict compliance with the rules of asepsis and antiseptics. Before opening the bottle, the outer surface of its stopper is wiped with cotton wool moistened with 70% ethyl alcohol, the vaccine is collected in a single-use syringe and excess air is removed from the syringe. For each dose taken, a new sterile syringe with a new sterile needle should be used for each patient. In the intervals between the intake of doses and no later than 5 minutes after the last intake, the bottle must be placed in the refrigerator (but not in the freezer) for storage at a temperature of 2 to 8 °C. The drug in an opened multi-dose bottle can be used during the working day, subject to proper storage rules
A partially used multi-dose vial must be destroyed immediately if the sterility of the vaccine intake cannot be guaranteed, if contamination is likely or exists, if there is a change in appearance, or if there are foreign impurities.
The vaccine in a multi-dose bottle should be stored for the entire shelf life in accordance with the manufacturer's recommendations specified in the instructions for use. After use, all vaccine residues and packaging must be disposed of in a safe manner in accordance with local requirements.
J07BB02 Influenza virus inactivated cleaved or surface antigen
