Composition, form of production and packaging
Lyophilizate for the preparation of a solution for intranasal administration 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
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.
INDICATIONS
- active prevention of influenza in adults without age limitation and in children from the age of 3 years.
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
Vaccination is carried out once in the autumn-winter period annually.
The vaccine is administered intranasally with the aid of a dispenser - dispenser (RD). Immediately before the vaccinations begin, the contents of the ampoule are dissolved in 0.5 ml of the solvent.
The vaccine should dissolve within 3 minutes. Dissolved drug - a clear or slightly opalescent liquid. 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 per each nasal opening.
To administer a single-dose vaccine, a single-use dispenser (RD) is used.
The dispenser-dispenser consists of a sterile syringe with a scale of divisions of 40 and 100 units (in the volume ratio of the scale are identical), a sterile needle and one removable spray nozzle to create a finely dispersed suspension.
Method of use for vaccination
1. Put the needle on the syringe, fill it with a solvent (water for injection) in a volume of 0.5 ml of room temperature.
2. To dilute the vaccine, fill the opened ampoule with water from the syringe.
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. Dissolved vaccine should be used within 30 minutes.
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 for 4 days are possible: 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 should not exceed 3 days.
CONTRAINDICATIONS
- acute infectious and non-infectious diseases are temporary contraindications for vaccination (inoculation is carried out 2-4 weeks after recovery, with non-severe acute respiratory viral infections, acute intestinal diseases, etc., inoculation after normalization of temperature);
- chronic diseases in the phase of exacerbation or decompensation;
- Hypersensitivity to chicken protein;
- reaction or postvaccinal complication of the previous introduction;
- immunodeficiency state (primary), immunosuppression;
- malignant neoplasms;
- rhinitis;
- Pregnancy.
PREGNANCY AND LACTATION
The drug is contraindicated in pregnancy.
APPLICATION FOR FUNCTIONS OF THE LIVER
Chronic diseases in the stage of exacerbation or decompensation are contraindications for vaccination.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Chronic diseases in the stage of exacerbation or decompensation are contraindications for vaccination.
APPLICATION FOR CHILDREN
It is used in children from 3 years.
APPLICATION IN ELDERLY PATIENTS
Possible application for indications.
SPECIAL INSTRUCTIONS
All persons subject to inoculations should be examined by a physician (paramedic), taking into account the history 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.
OVERDOSE
Data on the overdose of UltavacВ® vaccine are not available.
DRUG INTERACTION
Within 2 days after vaccination, the use of any drugs administered intranasally is not recommended.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The vaccine is stored and transported in accordance with SP 3.3.2.1248-03 at a temperature of 2 В° to 8 В° C in a dry and inaccessible place for children. Freezing is not allowed. Transportation is allowed at a temperature of 9 В° to 25 В° C for a period not exceeding 10 days. Shelf life - 1 year. After the expiration date, the drug is not applicable.
