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Dosage form: & nbspsolution for prik-test and dermalscarifying application
Composition:

A drug is a protein-polysaccharide complex from cow's milk, 10000 PNU/ ml in a phosphate buffered saline solution.

Test-control liquid - phosphate buffered saline, pH from 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.

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 - a clear or slightly opalescent liquid from colorless to light brown in color.

Test-control liquid - Clear, colorless liquid.

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

    Allergen causes a positive local reaction of an immediate type when dermatology is performed in the form of a blister, hyperemia in persons having increased sensitivity to cow's milk.

    Indications:

    Specific diagnosis of hypersensitivity to cow's milk.

    For use only in medical and preventive institutions.

    Treatment is carried out by an allergist doctor in an allergic room or a specialized department in the remission of the underlying disease.

    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 Russian M3 order of 04.11.2002 "On improving allergic care for children in the Russian Federation."

    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, βadrenoblockers.

    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).

    Before carrying out skin tests it is necessary:

    1) carefully read the label on the bottles with the allergen and test-control fluid, which indicates the name of the manufacturer, the name of the drug, the volume in milliliters, the content PNU in 1 ml, serial number, date of issue, expiry date;

    2) check the integrity of the vials;

    3) check the physical properties of the drugs - the preparations should not contain suspended particles, sediment.

    Skin tests should be carried out not earlier than:

    - 1 week after tuberculin test;

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

    - 4 weeks after the use of live vaccines;

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

    It is necessary to strictly follow the following rules of asepsis when typing the allergen and test-control liquid into the syringe:

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

    2) Collect the required amount of the drug in sterile syringes, piercing the rubber stopper with a sterile needle;

    3) Do not pour unused during the working day preparations 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.

    Staging of skin tests

    Samples with allergen, test-control fluid and histamine solution 0.01% are performed simultaneously on the skin of the inner surface of the forearm, the site 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, with sterile scarifiers or injection needles, individual for each patient and for each drug, scratches up to 5 mm long are applied through drops of drugs.

    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, the needle is injected individually 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.

    When. doubtful results of skin tests they can be repeated after 2-3 days (after the local reaction to the previous testing 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

    Side effects:

    When conducting skin tests in highly sensitive patients with the introduction of 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 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 allergic test.

    In the office, where a specific diagnosis of patients, there should be pharmacological drugs and tools for antishock therapy.

    Assisting with general reactions and anaphylactic shock:

    In cases where during the introduction of an allergen with a diagnostic purpose the patient develops general weakness or agitation, anxiety, a feeling of fever throughout the body, redness of the face, a 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, you need to loosen the tourniquet 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. Carry out splitting in 5-6 points and infiltration of injection site - 0.3-0.5 ml of epinephrine 0.1% solution with 4.5 ml of sodium chloride solution 0.9%.

    5. Apply ice or a hot water bottle to the injection site with cold water 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 0.9% sodium chloride solution (0.01 ml / kg epinephrine 0.1 solution% or norepinifrine solution 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 injected glucocorticoid preparations: 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 sodium chloride solution 0.9% or inhalation through the 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 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:

    Prior to the placement 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 carrying out the prick test and the cutaneous scarification application, 10000 PNU / ml.
    Packaging:

    For 4.5 ml of the allergen (solution for prik-test and cutaneous scarification, 10000 PNU/ ml) and 4.5 ml of test-control 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 and one vial with test-control fluid, placed in one pack of cardboard. In the pack insert instruction for use.

    Storage conditions:

    In a place protected from light and out of reach of children, at a temperature of 2 to 10 ° C.

    Shelf life:

    Allergen - 2 years, test-control fluid - 5 years.

    Terms of leave from pharmacies:For hospitals
    Registration number:P N000950 / 01
    Date of registration:11.08.2011
    The owner of the registration certificate:BIOMED them. I.I.Mechnikova, OJSC BIOMED them. I.I.Mechnikova, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp22.03.2016
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