Description
Pharmacological action
The vaccine causes the formation of a high level of specific immunity against influenza. The protective effect after vaccination, as a rule, occurs after 8-12 days and lasts up to 12 months, including in the elderly. Protective titers of antibodies to influenza viruses after vaccination of people of different ages are determined in 75-95% of those vaccinated.
The inclusion of the Polyoxidonium ® immunomodulator, which has a wide range of immunopharmacological effects, in the vaccine preparation, provides an increase in the immunogenicity and stability of antigens, improves immunological memory, significantly reduces the vaccination dose of antigens, and increases the body’s resistance to other infections by correcting the immune status.
Indications
Specific prophylaxis of influenza in children from 6 months of age, adolescents and adults with no age limit.
The contingents to be vaccinated. The vaccine is especially indicated: For people at high risk of complications from influenza: older than 60 years of age for preschool children,
schoolchildren, adults and children often suffering from acute respiratory infections, suffering from chronic somatic diseases, including diseases and malformations of the central nervous system, cardiac vascular and broncho-pulmonary systems, bronchial asthma, chronic kidney diseases, diabetes, metabolic diseases, autoimmune diseases, allergic diseases (except for allergy to chicken proteins), chronic anemia, congenital or acquired immunodeficiency, HIV-infected
Persons by profession who are at high risk of contracting the flu or contracting other persons: health workers, educational workers, social services, transport, trade , police, military personnel, etc.
Contraindications
Allergic reactions to chicken protein and components of the
vaccine Allergic reactions to previously administered flu vaccines
Acute febrile illness or exacerbation of a chronic disease. (Vaccination is carried out after recovery or during remission)
Light ARVI, acute intestinal diseases (vaccination is carried out after normalization of temperature).
Special instructions
On the day of vaccination, vaccinees should be examined by a doctor (paramedic) with mandatory thermometry. At temperatures above 37.0 ° C, vaccination is not carried out.
The drug is not suitable for use in ampoules, vials, syringe doses with impaired integrity or labeling, with a change in physical properties (color, transparency), with an expired Expiration, violation of the requirements for storage conditions.
The vaccine is not allowed to be administered intravenously
Influence on the ability to drive a car, or the operation of machines and mechanisms
Influenza ® does not affect the ability to drive a car, or control machines and mechanisms.
Composition
In one dose (0.5 ml) contains:
Active ingredients:
Influenza virus antigen type
A (N1H1) * with hemmaglutin content – 5 Ñg
Influenza virus antigen type
A (N3N2) * with hemmagglutinin – 5 Ñg
Influenza virus type B *
g with ® (Azoximera bromide) – 500 mcg
Auxiliary components:
Phosphate-buffered saline – up to 0.5 ml.
does not contain a preservative.
* Influenza virus antigen strains – as recommended by the WHO for the current epidemic season.
Dosage and administration
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.
Children over 3 years old, for adolescents and adults, the vaccine is administered intramuscularly or deeply subcutaneously in the upper third of the outer surface of the shoulder (in the deltoid muscle), for young children – in the anterolateral thigh surface intramuscularly.
For children from 6 to 35 months old, 0.25 ml twice, with an interval of 3-4 weeks.
For children older than 36 months and adults, the vaccine is administered once at a dose of 0.5 ml.
Previously unaffected influenza and unvaccinated children, the vaccine may be administered twice with an interval of 3-4 weeks.
Patients with immunodeficiency and receiving immunosuppressive therapy may receive the vaccine twice in 0.5 ml with an interval of 3-4 weeks.
Before use, the vaccine should be kept at room temperature and shaken well. Remove the protective cap from the needle and remove air from the syringe, holding it upright with the needle up and slowly pressing the piston.
To immunize children who are shown to be given 0.25 ml (1/2 dose) of the vaccine, half the contents of the syringe must be removed by pushing the plunger down to the special risk marked on the syringe body or until a red mark is printed on the edge of the label, and Inject the remaining 0.25 ml.
Opening of ampoules and vials and the vaccination procedure is carried out under strict aseptic and antiseptic rules: before opening, the ampoule knife, the neck of the ampoule, or the cork of the vial are wiped with cotton wool dampened with 70% ethyl alcohol, the vial is opened, or the rubber cork of the vial is punctured with a needle, disposable syringe and remove excess air from the syringe. Wipe the skin with alcohol at the injection site. The drug is in an open ampoule, or vial is not subject to storage.
Side effects
The vaccine is a highly purified preparation, well tolerated by children and adults.
Frequent (> 1/100 <1/10). Local reactions in the form of pain, hyperemia, compaction and edema at the injection site. General reactions: malaise, weakness, low-grade fever Infrequent (> 1/1000 <1/100) General reactions in the form of a runny nose, sore throat, headache and fever above subfebrile These reactions usually go away on their own within 1-2 days. Rare (> 1/10000 <1/1000) Allergic reactions, including the immediate type Very rare (> 1/10000)
From the nervous system: neuralgia, paresthesia, neurological disorders
from the musculoskeletal system: myalgia
The patient should be informed of the need to inform the doctor of any adverse reactions expressed or not indicated in these instructions
Storage conditions
Store in a dark place at a temperature of 2 ° C to 8 ° C.
Keep out of the reach of children!
Do not freeze! The drug, subjected to freezing, is not subject to use.
Shelf life
1 year. An expired drug is not to be used.
Active ingredient
Budesonide, Azoximer bromide
lekarstvennaja form
suspensions for
