Allergen from the mite Dermatophagoides farinae for diagnosis and treatment (Allergenum ex acaris Dermatophagoides farinae pro diagnostica et therapia)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspSolution for cutaneous scarification, prik-test and subcutaneous injection.
Composition:
The allergen is glycoprotein complexes isolated from Dermatophagoides farinae mites in their culture medium of 6000 PNU / ml in phosphate buffered saline.

Test - control fluid - phosphate buffered saline, pH from 6.75 to 7.25.

The composition of phosphate-buffered saline: sodium hydrophosphate - 0.56 mg; potassium dihydrogen phosphate 0.36 mg; sodium chloride - 5.0 mg; phenol (preservative) - 0,2-0,4%; water for injection - up to 1 ml.

The diluting liquid is a phosphate-buffered saline solution, the pH is from 6.75 to 7.25.

Composition per 1 ml: sodium hydrophosphate - 0.56 mg; potassium dihydrogen phosphate 0.36 mg; sodium chloride - 5.0 mg; phenol (preservative) - 0,2-0,4%; Polysorbate 80 (Tween-80) - 0.00005 ml; water for injection-up to 1 ml.

Note: PNU (protein nitrogen unit) is an international unit accepted for

expression of the concentration of protein nitrogen in allergens, equal to 0.00001 mg of protein nitrogen.
Description:
Allergen is a clear liquid from light yellow to intensely yellow.
Test - control liquid - a transparent colorless liquid.
Diluting liquid is a clear, colorless liquid.
Pharmacotherapeutic group:MIBP-allergen.
ATX: & nbsp
  • Allergens of house dust mite
    • Pharmacodynamics:Allergen causes a positive immediate local reaction of immediate type, when dermatology, flushing, hyperemia in persons having increased sensitivity to the Dermatophagoides farinae tick and causes desensitization (hyposensibilization) during specific immunotherapy.
    Indications:
    Allergen is intended for specific: diagnosis of hypersensitivity to the DermatopHagoides farinae mite and specific immunotherapy (aged 6 months to 60 years).

    For use only in medical and preventive institutions.

    Indication for treatment is determined by the allergist doctor on the basis of compliance of clinical manifestations of the disease, anamnesis, skin test data. When carrying out specific immunotherapy, children should be guided by the order of the Ministry of Health of the Russian Federation of 04.11.2002 "On improving allergic care for children in the Russian Federation."

    Treatment is carried out by an allergist doctor in an allergic room or a specialized department in the remission of the underlying disease.
    Contraindications:
    In order to identify contraindications, the doctor on the day of the dermatology prescribes the patient.

    Contraindications for diagnosis are:

    - exacerbation of an allergic disease;

    - acute and chronic skin diseases;

    - acute infectious diseases;

    - chronic diseases in the stage of decompensation;

    - exacerbation of mental illness;

    - oncological diseases;

    - immunopathological conditions and immunodeficiencies;

    - tuberculosis of any site in the period of exacerbation;

    - pregnancy and lactation;

    - cardiovascular. diseases in which complications are possible with the use of epinephrine;

    - any form of hormonal therapy, antihistamine therapy and bronchospasmolytic therapy, β-blockers.
    Pregnancy and lactation:
    Pregnancy and lactation are contraindications.

    Dosing and Administration:
    Allergen is used to diagnose skin (prik test or scarification) on the inner surface of the forearm at the same time with the test control fluid (negative skin reaction - absence of blistering, hyperemia) and histamine solution 0.01% (positive skin reaction - presence of blister, hyperemia); for treatment, the allergen is injected subcutaneously into the lateral area, the shoulder. The allergen products are prepared on a dilution liquid.

    Skin tests should be carried out not earlier than:

    - 1 week after tuberculin test;

    - 2 weeks after the use of inactivated vaccines and antihistamine drugs;

    - 4 weeks after the use of live vaccines;

    - 8-12 weeks after the use of BCG vaccines.

    Before carrying out skin tests and specific immunotherapy it is necessary:

    1. carefully read the markings on the bottles with the allergen, test-control liquid and dilution fluid (make sure that the shelf life of the drug has not expired, and the dose of activity indicated on the bottle corresponds to the scheme of application);

    2. check the integrity of the vials;

    3. check the physical properties of the drugs - drugs should not contain

    suspended particles, sediment;

    4. Make sure that the dose of administration is as accurate as possible.

    It is necessary to strictly follow the following rules of asepsis when recruiting an allergen, test-control liquid and dilution liquid in a syringe:

    1) disinfect alcohol-metal caps and rubber stoppers of vials;

    2) to collect the necessary amount of the drug in sterile syringes, piercing the rubber stopper with a sterile needle;

    3) do not dispose of the preparations unused during the working day from the syringe back into the vials.The started vial of the drug can be used within 3-4 months if the above aseptic rules are met.

    Setting of skin tests:

    Samples with allergen, test-control fluid and histamine solution 0.01% are placed on the skin of the inner surface of the forearm, the place of application is wiped with ethyl alcohol 70%. In sterile labeled syringes, a solution of histamine 0.01%, a test control fluid and an allergen are collected according to all aseptic rules (histamine solution 0.01% is prepared by diluting histamine dihydrochloride 0.1% -1 part and 9 parts sodium chloride solution 0.9 %, a solution of histamine 0.01% is suitable for 6 hours from the moment of preparation).

    Drugs are applied one drop (0.1 ml) to the disinfected skin at a distance of 30-40 mm from each other. Then, sterile scarifiers or injection needles, individual for each patient and for each drug, are applied through drops of drugs for one scratch up to 5 mm in length.

    When prik-test is performed with the help of separate sterile syringes, drops of histamine, test-control fluid, allergen are applied to the skin of the inner, forearm surfaces at a distance of 30-40 mm from each other.Through each drop, needles are injected, individual for each patient and for each drug.

    Skin reaction during scarification and prik test is taken into account after 15-20 minutes (the reaction lasts for 30-40 minutes) and recorded according to the attached scheme (immediate reaction). The dimensions of the blister are measured with a scale ruler (mm).

    The results of allergen skin tests are taken into account only in those cases when the test-control liquid gives a negative reaction, and a histamine solution of 0.01% gives a positive reaction.

    With doubtful results of skin tests, they can be repeated after 2-3 days (after the local reaction to the previous test subsides).

    Scheme of taking into account skin reactions

    Evaluation of reaction

    The size and nature of the reaction

    Negative


    Absence of blistering, hyperemia

    Positive

    one cross

    Blister 2-3 mm, hyperemia

    Positive

    two crosses

    Blister 4-5 mm, hyperemia

    Positive

    three crosses

    Blister 6-10 mm, hyperemia or blister 6-10 mm with pseudopodia, hyperemia

    Positive

    four crosses

    Blister more than 10 mm; hyperemia or blister more than 10 mm with pseudopodia, hyperemia

    Specific immunotherapy:
    Allergen is injected subcutaneously into the lateral region of the shoulder, at the border of the middle and lower third (12-15 cm above the elbow). Dilutions of the allergen are prepared on a diluting liquid. Dilutions of the allergen can be stored at a temperature of 2 to 10 ° C for not more than 1 month. For the preparation and use of the allergen in aseptic conditions for specific immunotherapy and the use of dilutions, the responsibility is borne by the doctor. The dilutions of the drug, the volume administered (dose) and the recommended scheme of application are given in the table.
    An approximate scheme of specific immunotherapy

    Breeding the allergen

    PNU/ ml

    Dose of the allergen, ml

    Interval between injections

    Note

    1:100000 , (10-5)

    0,06

    0,1

    0,2

    0,4

    0,8

    daily


    1:10000

    (10-4)

    0,6

    0,1

    0,2

    0,4

    0,8

    daily


    1:1000 (10-3)

    60

    0,1

    0,2

    0,4

    0,6

    0,8

    daily (or every other day)

    There may be local reactions in the form of itching hyperemia (at allergen 10 dilutions-3,10-2, 10-1), which runs through 1-24 hours. After the reaction subsides, it is recommended that the dose of injection be repeated before continuing treatment according to the scheme

    1:100 (10-2)

    60

    0,1

    0,2

    0,3

    0,4

    0,5

    0,6

    0,7

    0,8

    0,9

    in 1-2 days

    in 2 days


    1:10 (10-1)

    600

    0,1

    0,2

    0,3

    0,4

    0,5

    in 3 days

    from 1 time per week to 1 time per month

    The dose of the allergen is 0.5 ml in

    1:10 dilution

    spend 1 every 7 days 2-3 months or more after reaching the clinical effect. The course of maintenance immunotherapy can be carry out throughout the year: 1 time per month in a 1:10 dilution - 0.5 ml





    Side effects:
    When carrying out a specific diagnosis in a highly sensitive patient with an allergen, local (hyperemia, edema at the injection site) and general (hives, bronchospasm, exacerbation of the underlying disease, anaphylactic shock) reactions may appear.

    After each injection of the allergen, the patient should be observed by the doctor for at least 60 minutes. During this time, the doctor should note the skin reaction to the administration of the allergen and the general condition of the patient. In the event of remote reactions, the patient should immediately contact the medical institution and inform the doctor who conducted the allergy test.

    In the room where specific immunotherapy of patients is carried out, pharmacological preparations and tools for carrying out anti-shock therapy should be located.

    Assisting with general reactions and anaphylactic shock

    In cases where during the introduction of an allergen with a diagnostic or therapeutic purpose, the patient develops general weakness or agitation, anxiety, a feeling of heat throughout the body, redness of the face, rash, cough, shortness of breath, abdominal pain, the following treatment should be carried out:

    1: Immediately stop the injection of the allergen; lay the patient (head below the legs); Turn the head to the side, push the lower jaw, remove the existing dentures.

    2. Apply the tourniquet above the injection site (every 10 minutes, the tourniquet should be loosened for 1-2 minutes).

    3. In the limb, free from the tourniquet, 0.3-0.5 ml of epinephrine solution 0.1% is injected subcutaneously.

    1. Administer 0.1% eepiephry or Iorepinephritis 0.2% subcutaneously or intramuscularly at a dose of 0.01 ml / kg (children 0.15-0.3 ml, adolescents and adults 0.3-0.5 ml) at intervals of 10-15 minutes. The multiplicity and dose of injected epinephrine depends on the severity of the reaction and the numbers of blood pressure. In severe anaphylactic shock, the epinephrine solution must be administered intravenously in 20 ml of a 40% glucose solution. The total dose of 0.1% epinephrine solution should not exceed 2 ml (children 1 ml).

    It should be remembered that repeated administration of small doses of epinephrine is more effective than a single dose of a large dose.

    2. If the patient's condition does not improve, then sympathomimetic is administered intravenously in 10 ml of sodium chloride solution 0,9% (0,01 ml / kg of epinephrine solution 0,1% or solution of norepinifrine 0,2%, or 0,1-0, 3 ml phenylephrine solution 1%). Simultaneously, intramuscularly injected any of the antihistamines in the age dosage.

    3. Intramuscularly or intravenously, inject glucocorticosteroid drugs: prednisolone 60-120 mg (children 40-100 mg), dexamethasone - 8-16 mg (children 4-8 mg).

    4. Intramuscularly inject 2.0 ml (children 0.5-1.5 ml) of the suprastin solution 2.5%.

    5. With the development of bronchospasm intravenously injected aminophylline in a dose of 4 mg / kg per 10-20 ml of 0.9% sodium chloride solution or inhalation through nebulizer ipratropium bromide + fenoteropa or budesonide (intrapia bromide + fenoterop to children under 6 years 5-10 drops per 2 ml of sodium chloride solution 0,9%, for adolescents and adults 20 drops for 2 ml of sodium chloride solution 0,9%; budesonide Children-250 μg per 2 ml of sodium chloride solution 0,9%, adolescents and adults 500 μg per 2 ml of sodium chloride solution 0,9%).

    6. Cardiac glycosides, respiratory analeptics (strophanthine, etazole hydrochloride) are administered according to the indications.

    7. If necessary, suck off mucus from the respiratory tract, vomit and perform oxygen therapy.

    8. In case of acute edema of the larynx, intubation or tracheotomy is indicated. Disturbance of breathing and its stopping require intravenous slow administration of lobeline (a solution of 1% in a dose of 0.1-0.3 ml) or cytisine (0.1-0.5 ml), carrying out artificial ventilation.

    Help with anaphylactic shock should be provided promptly.Otherwise, death may occur from cardiac arrest or breathing.

    All patients with anaphylactic shock are hospitalized. Transportation of patients is made after removal from the threatening state by the resuscitation team, tk. in the course of evacuation, a repeated drop in blood pressure and the development of collapse are possible. After anaphylactic shock, the patient should be observed and examined in a hospital for 10-15 days because of the danger of a two-phase shock current.
    Interaction:
    Before the application of skin tests, the following preparations should be canceled: 1 week of tuberculin test, 2 weeks inactivated vaccines and antihistamines, 4 weeks of live vaccine use, 8 to 12 weeks use of BCG vaccines.

    Simultaneous use of β-blockers by patients and the use of allergens can increase sensitization to allergens.
    Effect on the ability to drive transp. cf. and fur:Not found.
    Form release / dosage:
    Solution for cutaneous scarification, prik-test and subcutaneous injection; 6000 PNU / ml.
    Packaging:
    4.5 ml of the allergen (solution for cutaneous scarification, prik-test and subcutaneous injection, 6000 PNU / ml), 4.5 ml of test-control fluid and dilution liquid in glass bottles, sealed with rubber stoppers and rolled with aluminum caps.

    Issued in the kit. The kit consists of one vial with an allergen, one vial with test-control fluid and eight vials with dilution liquid, placed in one pack of cardboard. In the pack insert instruction for use.
    Storage conditions:
    Store in a dark place at a temperature of 2 to 10 ° C. Keep out of the reach of children.
    Shelf life:
    Allergen - 2 years, test-control fluid - 5 years, dilution fluid - 5 years.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-000844
    Date of registration:11.10.2011/24.12.2015
    Date of cancellation:2016-10-11
    The owner of the registration certificate:BIOMED them. I.I.Mechnikova, OJSC BIOMED them. I.I.Mechnikova, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp19.03.2016
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