Ultravac® All-Vivo Influenza Vaccine (Ultravac live allantoic influenza vaccine)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceVaccine for the prevention of influenza [live]Vaccine for the prevention of influenza [live]
Dosage form: & nbspLyophilizate for the preparation of a solution for intranasal administration.
Composition:

One inoculation dose (0.5 ml) contains:

Active substances:

· reassortant influenza virus subtypes A /HjNi/ and A/H3N2/ - not less than 106,9 EID50;

· reassortant influenza virus type B - no less than 106,4 EID50.

Excipients:

· stabilizer M-2: sucrose - 15 mg, lactose monohydrate - 6 mg, glycine - 3 mg, sodium glutamate monohydrate - 3 mg, trometamol - 0.3 mg, sodium chloride - 0.3 mg, gelatin - 3 mg.

Description:Amorphous mass of white color.
Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp

J.07.B.B   Vaccine for the prevention of influenza

J.07.B   Vaccines for the prevention of viral infections

Pharmacodynamics:

Immunological properties.

The vaccine causes the formation of specific immunity against influenza types A and B.

The protective effect of the vaccine, as a rule, occurs 3 weeks after vaccination and remains 10-12 months.

Indications:

Active prevention of influenza in adults without age limit and in children from 3 years of age.

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 with a high occupational risk

diseases of the flu or infection of others: persons over 60 years old, persons suffering from chronic physical illnesses, who are often ill with ARI; preschool children, schoolchildren, medical workers, workers in the service sector, transport, educational institutions.

Contraindications:

1. 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.

2. Chronic diseases in the stage of exacerbation or decompensation.

3. Allergic reactions to chicken protein and other components of the vaccine.

4. Adverse reaction (s) or post-vaccination complication to previous administration of vaccines for the prevention of influenza.

5. Immunodeficiency states, immunosuppression, malignant neoplasms.

6. Rhinitis.

7. 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 ° 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:

The use is contraindicated.

Dosing and Administration:

The vaccine is administered intranasally with a single-use dispenser (RD).

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 nozzle-dispenser to create a finely dispersed suspension.

Note

* The volume ratio of the scale is identical

Method nVaccination:

1. Put the needle on the syringe, fill it with a room temperature solvent in a volume of 0.5 ml.

2. Add the solvent from the syringe to the opened ampoule with the vaccine.

3. After dissolving, fill the syringe with the drug in a volume of 0.25 ml (a mark of 10 on a scale of 40 units or a mark of 25 on a scale of 100 units).

4. Remove the needle and put on the spray nozzle.

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 spray nozzle and insert the drug into the other nasal passage inaccordance with paragraph 5.

The spray nozzle is injected to 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 effects:

After vaccination, some vaccinated people may have: an increase in temperature to 37.5 ° C, malaise, headache, minor catarrhal phenomena. The presence of reactions with an increase in temperature above 37.5 ° C is not more than 2 % vaccinated. The duration of the temperature reaction and catarrhal phenomena should not exceed 3 days.

Overdose:

Cases of overdose are not established.

Interaction:

It is not recommended after the vaccination to use within 2 days any drugs administered intranasally.

Effect on the ability to drive transp. cf. and fur:

No information.

Form release / dosage:

Lyophilizate for the preparation of a solution for intranasal administration of 1 dose (0.5 ml).

Packaging:1 ampoule with a vaccine, 1 ampoule with a solvent, 1 disposable dispenser, consisting of a syringe, a needle and a removable nozzle (nozzle-sprayer for nasal use of drugs of a vertical type), instructions for use in a pack of cardboard box.
Storage conditions:

Storage conditions. AT accordance with the JV 3.3.2.1248-03 at a temperature from 2 up to 8 ° С. Freezing is not allowed. Keep out of the reach of children.

Conditions of transportation. AT according to SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Transportation is allowed at a temperature of 9 to 25 ° C for not more than 10 days.

Shelf life:

1 year. After the expiration date, the drug is not applicable.

Terms of leave from pharmacies:On prescription
Registration number:P N003224 / 01
Date of registration:04.06.2009
The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
Manufacturer: & nbsp
Representation: & nbspMICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
Information update date: & nbsp27.03.2013
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