Composition, form of production and packaging
Lyophilizate for the preparation of a solution for intranasal administration in the form of amorphous white mass.
1 dose (0.5 ml)
influenza virus reassortant type A (strains H 1 N 1 and H 3 N 2 ) not less than 10 6.9 EID 50
influenza virus reassortant type B not less than 10 6.4 EID 50
Excipients: stabilizer M-2 (sucrose-15 mg, lactose-6 mg, glycine-3 mg, sodium glutamate-3 mg, tris-hydroxymethylaminomethane-0.3 mg, sodium chloride-0.3 mg, gelatin-3 mg).
Solvent: water d / u - 1 ml.
0.5 ml (1 dose) - glass ampoules (1) complete with solvent (1 pc.) And disposable dispenser - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
The vaccine causes the formation of specific immunity against influenza types A and B.
The protective effect of the vaccine, as a rule, comes in 3 weeks after vaccination and lasts 10-12 months.
PHARMACOKINETICS
No data.
INDICATIONS
- active prevention of influenza in adults without age limit and in children from the age of 3 years.
Vaccination is carried out once in the autumn-winter period annually.
Vaccination is primarily recommended for people with a high risk of complications and persons of a profession with a high risk of influenza or other persons: people over 60 years old, people with chronic physical illnesses, often ill with ARI; preschool children, schoolchildren, medical workers, workers in the service sector, transport, educational institutions.
DOSING MODE
The vaccine is administered intranasally with a single-use dispenser (PD).
Immediately before the introduction of the vaccine, the contents of the ampoule are dissolved at room temperature in 0.5 ml of the solvent supplied with the preparation. The vaccine should dissolve within 3 minutes.
Dissolved drug - a clear or slightly opalescent colorless liquid. Dissolved vaccine should be used within 30 minutes.
It is not suitable to use the drug in ampoules with broken integrity, marking, as well as changing its physical properties (color, transparency), with improper storage.
The vaccine is injected into the nasal passages at a rate of 0.25 ml in each nasal passage.
The single-use dispenser dispenser consists of a sterile syringe with a scale of divisions of 40 and 100 units, a sterile needle and one removable spray nozzle to create a finely dispersed suspension.
Note
In the volume ratio of the scale are identical
Method of use for vaccination:
1. Put the needle on the syringe, fill it with a room temperature solvent in a volume of 0.5 ml.
2. Insert the solvent from the syringe into the opened ampoule with the vaccine.
3. After dissolving, fill the syringe with the preparation in the volume of 0.25 ml (the mark 10 on the scale of 40 units or 25 on the scale of 100 units).
4. Remove the needle and fit the spray nozzle tightly.
5. Bring the spray nozzle close to the nasal passage and squeeze the vaccine into the nasal passage with a sharp push on the syringe plunger.
6. Remove the nozzle-sprayer, put on the needle and fill the syringe with the drug remaining in the ampoule (0.25 ml).
7. Remove the needle, re-tighten the nozzle and inject the drug into the other nasal passage in accordance with paragraph 5.
The spray nozzle is injected at a depth of 0.5 cm into the nasal passages, previously cleaned of mucus. The graft is in a sitting position with a slightly upturned head.After vaccine administration, the vaccine should remain in a sitting position with a slightly upturned head for 1 minute.
The subsequent vaccinations can be carried out by any influenza vaccine in the autumn-winter period of the following year in accordance with the instruction for the use of the drug.
SIDE EFFECT
After vaccination, some vaccinated people may appear: an increase in temperature to 37.5 В° C, malaise, headache, minor catarrhal phenomena. The presence of reactions with an increase in temperature above 37.5 В° C is not more than 2% of the vaccinated. The duration of the temperature reaction and catarrhal phenomena should not exceed 3 days.
CONTRAINDICATIONS
- acute infectious and non-infectious diseases are temporary contraindications for vaccination.
Vaccination is carried out 2-4 weeks after recovery. For non-severe acute respiratory viral infections, acute intestinal diseases, etc., inoculation is carried out after normalizing the temperature.
- chronic diseases in the stage of exacerbation or decompensation;
- allergic reactions to chicken protein and other components of the vaccine;
- Adverse reaction (s) or post-vaccination complication to previous administration of vaccines for the prevention of influenza;
- immunodeficiency states, immunosuppression, malignant neoplasms;
- rhinitis;
- Pregnancy.
All persons subject to vaccination should be examined by a physician (paramedic), taking into account anamnestic data. On the day of vaccination, the vaccinated should be examined by a physician (paramedic) with obligatory thermometry. At a temperature above 37 В° C vaccinations are not carried out. The doctor (paramedic) is responsible for the correct appointment of the vaccine. The vaccine is recorded in the prescribed registration forms with the date, the manufacturer of the drug, the serial number, the reaction to the vaccination.
PREGNANCY AND LACTATION
Use during pregnancy is contraindicated.
APPLICATION FOR CHILDREN
It is used in children from 3 years.
APPLICATION IN ELDERLY PATIENTS
Possible application for indications.
SPECIAL INSTRUCTIONS
Impact on the ability to drive vehicles and manage mechanisms
No information.
OVERDOSE
Cases of overdose are not established.
DRUG INTERACTION
It is not recommended after the vaccination to use within 2 days any drugs administered intranasally.
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 В° C. Freezing is not allowed. Keep out of the reach of children. Shelf life - 1 year.
Transportation conditions
In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 В° C. Transportation is allowed at a temperature of 9 to 25 В° C for not more than 10 days.
