Universal reference book for medicines
Product name: ULTRAGRIVAK ® Vaccine influenza live (ULTRAGRIVAC)

Active substance: inactivated influenza vaccine (surface antigen)

Type: Vaccine for the prevention of influenza

Producer: NGO MIKROGEN (Russia)
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)

bird flu virus type A 10 7 EID 50

Excipients: stabilizer M-2 30.6 mg.

Solvent: water d / u - 1 ml.


EID 50 is the average embryonic infectious dose (a quantitative measure of the virulence of the causative agent of an infectious disease, expressed by the value of the infectious dose, which in this pathway causes disease in 50% of the experimental animals).

0.5 ml (1 dose) - ampoules glass (1) complete with a solvent 1 ml amp.
1 pc., A syringe with a needle in a contour non-jawed package and a nozzle Actuators-183.016 - packs of cardboard.
3 ml (6 doses) - ampoules glass (1) complete with a solvent 5 ml amp.
1 pc., A syringe with a needle in a contour non-jawed package and 6 nozzles Actuators-183.016 - packs of cardboard.
3 ml (6 doses) - ampoules glass (1) complete with a solvent 5 ml amp.
1 pc., A syringe with a needle and a nozzle. Actuators-183.016 - packings of cellular contour (1) - packs of cardboard.
0.5 ml (1 dose) - glass ampoules (2500) - cardboard boxes.

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 in humans against avian influenza A. The protective effect of the vaccine, as a rule, occurs 21 days after the second vaccination.

INDICATIONS

- Specific prevention of avian influenza in humans.

Vaccination is recommended for people aged 18 to 60 due to epidemiological indications.

DOSING MODE

The vaccine is administered intranasally 2 times at intervals of 10 days by means of a dispenser - dispenser (PD).

Immediately before vaccination, the contents of the ampoule are dissolved at room temperature in 0.5 ml of the solvent included in the vaccine kit.
The vaccine should be completely dissolved within 3 minutes. The dissolved preparation is a colorless, 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 the vaccine in the form of a finely divided mixture, a sterile syringe, a sterile needle and one disposable Actuators-183.016 disposable nozzle are used, which are included in the vaccine kit.
The spray tip is injected to a depth of 0.5 cm into the nasal passages, previously cleaned of mucus.
The grafted should be 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.
Method of use for vaccination:

1. Put the needle on the syringe, fill it with the solvent (water for injection) at room temperature, included in the vaccine kit, in a volume of 0.5 ml.

2. For dissolution, fill the opened ampoule with the vaccine with a solvent from the syringe.

3. After dissolution, fill the syringe with 0.5 ml (mark 20 on a scale of 80 units or mark 50 on a scale of 100 units).

4. Remove the needle and put on a snug detachable Acuators-183.016 nozzle (spray tip).

5. Bring the nozzle tip close to the nasal passage and squeeze the vaccine into each nasal passage of 0.25 ml with sharp pressure on the syringe plunger.

SIDE EFFECT

After vaccination for 4 days, 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% of the vaccinated. The duration of the temperature reaction should not exceed 3 days.
CONTRAINDICATIONS

- acute infectious and non-infectious diseases;

- chronic diseases in the stage of exacerbation or decompensation;

- hypersensitivity to chicken protein;

- a response or post-vaccination complication to previous administration of seasonal influenza vaccines;

- immunodeficiency status (primary), immunosuppression, malignant neoplasms;

- diseases of the nasopharynx in the acute stage;

- Pregnancy and the period of breastfeeding.

PREGNANCY AND LACTATION

Contraindicated in pregnancy, during lactation.

APPLICATION FOR CHILDREN

Vaccination is recommended for people aged 18 to 60 due to epidemiological indications.

APPLICATION IN ELDERLY PATIENTS

Vaccination is recommended for people aged 18 to 60 due to epidemiological indications.

SPECIAL INSTRUCTIONS

All persons subject to vaccinations 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.
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.
Precautionary measures

The grafted should be 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.
DRUG INTERACTION

Not installed.

TERMS OF RELEASE FROM PHARMACY

On prescription.

TERMS AND CONDITIONS OF STORAGE

Do not use the drug after the expiry date of the drug is not applicable.
The vaccine is stored and transported in accordance with SP 3.3.2.1248-03 at a temperature of 2 ° C to 8 ° C in a dry and inaccessible place for children. Freezing is not allowed. Transportation is allowed at a temperature of 9 ° C to 25 ° C for a period of not more than 10 days. Shelf life - 2 years.
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