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Dosage form: & nbspsuspension for cutaneous scarification application
Composition:

1 dose (one drop) (0.05 ml) contains:

Active substances:

- Allergen tularemia [suspension of tularemia microbes of the vaccine strain Francisella tularensis 15 lines of NIIEG, killed by heating, in 0.9% solution of sodium chloride] - 5x108 microbial cells.

Excipients:

- Glycerin - 3% (calculated concentration).

The ampoule contains 20 dermal doses.

Description:

Homogeneous suspension of white color with grayish or yellowish tinge, without foreign inclusions, with sedimentation divided into two layers: upper - colorless transparent liquid, lower - sediment of white with grayish or yellowish tint, easily broken when shaken.

Pharmacotherapeutic group:MIBP is an allergen
ATX: & nbsp
  • Other allergens
  • Pharmacodynamics:Characteristics of the preparation
    The preparation is a suspension of tularemia microbes of the vaccine strain Francisella tularensis 15 lines of NIIEG, killed by heating, in a 0.9% solution of sodium chloride.
    Immunological properties
    The allergen used to set up an allergic test causes a local specific reaction (hyperemia, infiltration) in patients or vaccinated people when the drug is administered by scarification.
    Indications:

    Definition of specific immunity and diagnosis of tularemia.

    Contraindications:

    - Hypersensitivity to tularemia allergen;

    - Presence of contraindications to the introduction of the drug "Tularemia live vaccine";

    - Hyperthermia.

    In order to identify contraindications, the doctor (or paramedic) on the day of sampling conducts an examination and a questioning of the patient with obligatory thermometry and an appropriate laboratory examination, if necessary.

    Pregnancy and lactation:

    Application in pregnancy and lactation has not been studied. The use of the drug is allowed only for life indications, taking into account the possible benefits for the mother and the risk to the fetus or the child.

    Dosing and Administration:

    Method of application - Skin - scarification (by 0,05 ml).

    An allergic test is placed on the outer surface of the middle third of the left shoulder. The skin at the site of application of the allergen is pretreated with 70% ethyl alcohol.

    Opening of ampoules and the procedure for administering the drug are carried out with strict adherence to aseptic and antiseptic rules. An opened ampoule with an allergen, preserved in accordance with the rules of asepsis, can be used within 2 hours.

    Before using the ampoule with the drug should be shaken several times until the liquid containing it becomes evenly turbid.One drop of the drug 0.05 ml (1 dose) with a 1 ml syringe with a thin needle is applied to dried skin after treatment. The osprivivivatelnym pen through the applied drop make on the skin two parallel incisions, the distance between which is 2-3 mm, the length is 8-10 mm. Then the drop is rubbed into the notches by the flat side of the ospivyvatelnogo pen for 30 seconds. The incisions should not be excessively deep or, on the contrary, very shallow. After their application, blood should appear in the form of dewdrops.

    Incorporation of reaction results

    After 24 hours, redness and swelling around the notches appear, reaching a maximum after 48-72 hours. After that, it gradually fades, disappearing completely by 7-10-12 days. At the place of incisions, by this time, only trace marks remain. In rare cases, vesicles appear on the line of incisions, disappearing after 2-3 days.

    The results are monitored by the doctor after 48 hours for a skin reaction in the form of hyperemia and edema (infiltration) at the site of application of the drug. To assess its intensity, determine the reactive area of ​​the skin, along the border of hyperemia, measure it across the incisions made.

    The reaction is considered positive in the presence of hyperemia and infiltration of the skin not less than 0.5 cm.

    Negative reaction consider the absence of cutaneous manifestations, the development of hyperemia without infiltration or the presence of hyperemia and infiltration less than 0.5 cm.

    The administration of the tularemia allergen is recorded in the prescribed registration forms with the name of the preparation, the date of administration, the dose, the name of the manufacturer, the serial number, the reaction to the administration.

    Precautions for use

    Given the possibility of developing an anaphylactic shock in certain highly sensitive individuals, the subject should be under medical supervision for at least 30 minutes. Sample sites should be provided with anti-shock therapy.
    Side effects:

    After setting the allergic test in 20-30 minutes at the site of the allergen injection, allergic reactions of the immediate type can occur in the form of an edema (infiltration), hyperemia and soreness of the skin.

    In persons highly sensitized to tularemia antigen, it is possible to develop a general reaction (fever, headache, chills, malaise), sometimes lymphadenitis, joint pain, tenderness at the site of the allergen, an increase in temperature (up to 38 ° C).

    The patient should be warned about the possibility of developing side effects not listed in the instructions.

    Overdose:Not installed.
    Interaction:

    CATEGORALLY IS PROHIBITED to conduct an allergy test simultaneously with the introduction of the vaccine.

    Special instructions:

    Do not allow the injection of an allergen and the reception of patients in the same room.

    Categorically, subcutaneous or intradermal injection of the drug is prohibited.

    The allergen is not to be used, the integrity of the package is damaged, with changed physical properties (foreign impurities, insoluble flakes), with expired shelf life, if storage conditions are violated.

    Effect on the ability to drive transp. cf. and fur:No information.
    Form release / dosage:Suspension for cutaneous scarification application, 20 doses / ml.
    Packaging:

    1 ml (20 cutaneous doses) in the ampoule.

    For 10 ampoules in a cardboard pack, along with instructions for use and a knife ampoule.

    Storage conditions:
    In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C in a place inaccessible to children.
    Transportation conditions
    In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C.
    Shelf life:2 years.
    The drug with expired shelf life is not subject to application.
    Terms of leave from pharmacies:For hospitals
    Registration number:LSR-009941/08
    Date of registration:12.12.2008 / 30.01.2014
    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: & nbsp14.02.2016
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