Orniflu (OrniFlu)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspsuspensions for intramuscular injection
Composition:
In 1 dose (0.5 ml) of the vaccine contains haemagglutinin of the avian influenza virus type A serotype HsN! - (15 ± 2,2) μg, aluminum hydroxide - (0,475 + 0,075) mg. Preservative - thiomersal (merthiolate) - (50 ± 7.5) μg.
The antigenic composition of the vaccine varies according to the epidemic situation, the recommendations of the WHO and / or the Commission on influenza vaccine and diagnostic strains.
Description:

The preparation is a suspension of white color without foreign inclusions, separated upon settling on a clear supernatant and a loose sediment completely shattered by shaking.

Pharmacotherapeutic group:Vaccines
ATX: & nbsp
  • Influenza virus - inactivated whole virus
    • Pharmacodynamics:

    Immunobiological properties.

    The vaccine causes the formation of specific immunity in humans against avian influenza.

    After the second vaccination on days 21-28, the vaccine should cause an increase in homologous antibodies in sera 4 and more times at least 50%. vaccinated.

    Indications:

    Specific prevention of avian influenza in people aged 18-60 years on epidemic indications.

    Contraindications:

    1. Acute infectious and non-infectious diseases, chronic diseases in the acute stage - vaccinations are carried out not earlier than a month after recovery (remission). For non-severe acute respiratory viral infections, acute intestinal diseases, vaccination is carried out after normalizing the temperature.

    2. Hypersensitivity to chicken protein.

    3. Systemic diseases of connective tissue.

    4. Diseases of the adrenal glands.

    5. Hereditary, degenerative and progredient diseases of the nervous system. The possibility of vaccination of persons suffering from chronic diseases not listed in the list of contraindications is determined by the attending physician based on the patient's condition.

    All persons subject to inoculations should be examined by a doctor taking into account anamnestic data. On the day of vaccination, the vaccinated should be examined by a physician with mandatory thermometry. At a temperature above 37 ° C vaccinations are not carried out. The doctor is responsible for the correct administration of the vaccine.

    Pregnancy and lactation:

    Clinical studies have not been conducted.

    Dosing and Administration:

    Vaccination is carried out twice with an interval of 4 weeks.

    The vaccine is given intramuscularly, before you inject the ampoule with the drug, shake until a homogeneous suspension is obtained.

    The drug is not suitable for use in ampoules with broken integrity or marking, with expired shelf life, improper storage.

    Opening of ampoules and the vaccination procedure are carried out with strict adherence to aseptic and antiseptic rules.The drug in the opened ampoule is not subject to storage.

    The vaccination is recorded in the prescribed registration forms with the date of administration of the drug, dose, serial number and name of the manufacturer.

    Precautionary measures.

    Do not administer intravenously. In the offices where the vaccination is carried out, it is necessary to have medicines for anti-shock measures and relief of anaphylactic reaction.

    The vaccinated should be monitored by a health worker within 30 minutes after immunization.

    Side effects:

    Local and general reactions to the introduction of the vaccine are largely absent. Rarely at the injection site, there may be reactions in the form of soreness, redness and swelling of the skin. Individuals may have general reactions in the form of increased fatigue, headache, dizziness, subfebrile temperature, runny nose, pharyngitis, coughing, arthralgia, myalgia, nausea. These reactions usually disappear on their own in 1-3 days. In extremely rare cases with high individual sensitivity, allergic reactions can be observed.

    Interaction:

    The vaccine can be administered against the background of basic therapy of the underlying disease.The vaccine can be used concomitantly with other inactivated vaccines. This should take into account contraindications to each of the vaccines used, the drugs must be injected into different parts of the body with different syringes.

    Form release / dosage:

    Suspensions for intramuscular injection.

    Packaging:

    In ampoules of 0.5 ml (1 dose).

    By 1; 5 or 10 ampoules in a pack of cardboard together with an ampoule knife or scarifier and instructions for use, or in a contoured cell packaging made of a polyvinyl chloride film.

    1 (1, 5 or 10 ampoules) or 2 (5 ampoules) contoured unpacked packages in a pack of cardboard with an ampoule knife or scarifier and instructions for use.

    When packing ampoules with a break ring or a broken point for opening, the ampoule knife (scarifier) ​​is not put.

    Storage conditions:

    The drug is stored in a place inaccessible to children and transported in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Freezing is not allowed.

    Shelf life:1 year. The drug with expired shelf life is not subject to application.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-001481/09
    Date of registration:03.03.2009 / 04.10.2013
    Expiration Date:Unlimited
    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: & nbsp12.06.2017
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