Mix allergen from Dermatophagoides pteronyssinus mite and house dust for diagnosis and treatment (Mix-allergen of dermatophagoides pteronyssinus tick and house dust for diagnosis and treatment)

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Dosage form: & nbspsolution for cutaneous scarification, intradermal and subcutaneous administration
Composition:

Allergen is a glycoprotein complexes isolated from mites Dermatophagoides pteronyssinus in their cultivation environment 10000 PNU/ ml in phosphate-buffered saline.

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

The composition of the phosphate buffered saline solution: 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.

Dilution liquid - phosphate buffered saline, pH 6.75 to 7.25.

Composition per 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 N unit) - an international unit adopted to express the concentration of protein nitrogen in allergens, equal to the content of 0.00001 mg of protein nitrogen.

Description:

Allergen - Clear liquid from light yellow to yellow or from light brown to brown.

Test-control liquid - Clear, colorless liquid.

Dilution liquid - Clear, colorless liquid.

Pharmacotherapeutic group:MIBP is an allergen
ATX: & nbsp
  • Other allergens
  • Pharmacodynamics:

    Allergen causes a positive local reaction of an immediate type in the setting of skin tests in the form of blistering, hyperemia in persons having increased sensitivity to mites Dermatophagoides pteronyssinus and home dust and causes desensitization (hyposensitization) during specific immunotherapy.

    Indications:

    Allergen is intended for specific diagnosis of hypersensitivity to mites Dermatophagoides pteronyssinus and home dust 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, which may complicate the use of adrenaline;

    - 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 region of the shoulder.Dilutions of the allergen are prepared on a diluting 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 fluid and diluting liquid (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 preparations - preparations 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 with 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 (a histamine solution of 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 using individual sterile syringes, drops of histamine, test-control fluid, allergen are applied to the skin of the inner surface of the forearm 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 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 the conditions of aseptic day of 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

    Dilution of 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)

    6

    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 (with dilutions of the allergen (10-3, 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

    -

    -

    -

    -

    The dose of the allergen 0.5 ml in the dilution 1:10

    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 0.5 ml in 1:10 dilution is carried out once every 7 days for 2-3 months or more after reaching the clinical effect.

    The course of maintenance immunotherapy can be carried out throughout the year: once a month at a dilution of 1:10 - 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 (urticaria, 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 at least 60 min. 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 allergic 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 experiences general weakness or agitation,anxiety, a feeling of heat throughout the body, redness of the face, rash, cough, shortness of breath, abdominal pain, it is necessary to carry out the following medical measures.

    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.

    4. To conduct the splitting in 5-6 points and infiltration of the injection site - 0.3-0.5 ml of epinephrine solution 0.1% with 4.5 ml of sodium chloride solution 0.9%.

    5. Place ice or a heating pad with cold water at the injection site for 15 minutes.

    If points 1-5 are fulfilled and there is no effect:

    1. Introduce epinephrine 0.1% or norepinephrine 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 sodium chloride solution 0,9%, adolescents and adults 500 μg per 2 ml 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 carry out 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 production of skin tests, the following drugs should be canceled: for 1 week, a tuberculin test, for 2 weeks, the use of inactivated vaccines and antihistamines, for 4 weeks the use of live vaccines, for 8-12 weeks use of BCG vaccines.

    Simultaneous use by patients β-adrenoconstituents and the use of allergens can increase sensitization to allergens.

    Special instructions:

    The use of the drug by children and adults with chronic diseases is described in detail in the paragraph "Method of administration and dose".

    Effect on the ability to drive transp. cf. and fur:Not found.
    Form release / dosage:A solution for cutaneous scarification, prik-test and subcutaneous injection, 10000 PNU/ ml
    Packaging:

    4.5 ml allergen (solution for cutaneous scarification, prik-test and subcutaneous injection, 10000 PNU/ ml), 4.5 ml test-control fluid and dilution fluid in glass bottles, ukuporennyh rubber stoppers and zavaltsovannyh 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:For hospitals
    Registration number:LP-000841
    Date of registration:11.10.2011
    Expiration Date:11.10.2016
    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: & nbsp08.06.2018
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