Mikst-allergen from pollen of weeds and sunflower for diagnosis and treatment (Mixt-allergenum e herbis ruderalis et helianthi)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspsolution for cutaneous scarification, intradermal and subcutaneous administration
Composition:

Mixt-allergen is a water-salt extract of protein-polysaccharide complexes - 10,000 PNU / ml *, isolated from a mixture of pollen of weeds: ragweed ragweed, Tatarian quinoa, wormwood and sunflower annual, taken in equal proportions, extraction in neutral phosphate-salt buffer solution.

Phosphate-buffered saline contains (in 1 ml): sodium chloride - 5.0 mg, sodium hydrophosphate dodecahydrate (equivalent to 0.56 mg sodium hydrophosphate) - 1.4 mg, potassium dihydrogen phosphate - 0.36 mg, phenol (preservative) - 2,0 - 4,0 mg, water for injections - up to 1 ml. The concentration of these salts is calculated, in the finished product is not determined.

Note:

* PNU (Protein Nitrogen Unit) - an international unit adopted to express the concentration of protein nitrogen in allergens, equal to 1 x 10 '5 mg protein nitrogen.

In a set with mixt-allergen, test-control and dilution liquids are produced.

Test-control fluid-phosphate-buffered saline contains (in 1 ml): sodium chloride - 5.0 mg, sodium hydrophosphate dodecahydrate (equivalent to 0.56 mg sodium hydrophosphate) - 1.4 mg, potassium dihydrogen phosphate - 0.36 mg , phenol (preservative) - 2.0 - 4.0 mg, water for injection - up to 1 ml.

The diluting liquid - phosphate buffered saline, in which polysorbate-80 is added, contains (in 1 ml): sodium chloride - 5.0 mg, sodium hydrophosphate dodecahydrate (equivalent to 0.56 mg sodium hydrophosphate) - 1.4 mg, potassium dihydrogenphosphate 0.36 mg, phenol (preservative) 2.0 to 4.0 mg, polysorbate 80 to 0.005 μL, water for injection to 1 ml.

Description:

Mikst-allergen from pollen of weeds and sunflower is a transparent liquid from yellow to brown color. The test-control liquid and the diluent liquid are colorless transparent liquids.

Pharmacotherapeutic group:MIBP is an allergen
ATX: & nbsp
  • Allergens of grass pollen
    • Pharmacodynamics:Immunological properties. The main active principle of mixed-allergen is the protein-polysaccharide complex, which makes it possible to diagnose a hypersensitivity to the entire complex or a separate pollen species that is part of the mixed-allergen in the patient and to apply it for immunotherapy of pollinosis and atopic bronchial asthma.
    Indications:

    Specific diagnosis and specific immunotherapy of pollinosis and atopic bronchial asthma,caused by hypersensitivity to the pollen of weed grass: ragweed ambrosia, Tatar swans, wormwood and sunflower annual.

    Indications for diagnosis are clinical manifestations of the disease and history data.

    Indications for specific immunotherapy are determined by the allergist doctor on the basis of the history, clinical manifestations of the disease, the results of skin testing with a specific mixed-allergen, taking into account contraindications.

    Contraindications:

    In order to identify contraindications, the doctor on the day of setting allergic tests and on the day of specific immunotherapy conducts an examination of the patient.

    1. Exacerbation of an allergic disease.

    2. Acute infection.

    3. Chronic diseases in the stage of exacerbation and / or decompensation.

    4. Immune Deficiency Conditions.

    5. Autoimmune diseases.

    6. Tuberculosis of any localization in the period of exacerbation.

    7. Severe bronchial asthma, poorly controlled by pharmacological drugs (volume of forced expiration in 1 s less than 70% after adequate pharmacotherapy).

    8. Malignant neoplasms and blood diseases.

    9. Mental illness in the period of exacerbation.

    10.Systemic diseases of connective tissue.

    11. Children under 5 years of age (for specific immunotherapy); up to 6 months. (for specific diagnostics).

    12. Pregnancy and lactation.

    13. Cardiovascular diseases, which can complicate the use of epinephrine (epinephrine) (for specific immunotherapy).

    14. Severe form of atopic eczema (for specific immunotherapy).

    15. Therapy βadrenoblockers (for specific immunotherapy).

    16. Systemic glucocorticosteroid therapy, therapy with P-adrenomimetics and antihistamines (for specific diagnostics).

    Pregnancy and lactation:Contraindicated.
    Dosing and Administration:

    I. Specific diagnostics.

    The preparation is used for setting up skin tests (scarification, prik-test and intradermally). Specific diagnostics, as a rule, are carried out simultaneously with other pollen allergens. During one procedure, up to 15 samples with different pollen allergens are allowed, except for allergens of plant species included in the mixt-allergen. For 2-3 days before the setting of skin tests, antihistamines should be canceled.With doubtful results of skin tests, they can be repeated two days after the local reaction to the previous samples subsided. In case of a positive result, skin tests with pollen allergens can be repeated no more than once a month.

    A patient with an increased sensitivity to at least one of the allergens that make up the mixst-allergen from pollen of weeds and sunflower, an immediate-type reaction of a kind appears (positive result). The question of the necessity of setting skin tests with individual monoallergens, which are part of the mixt-allergen, is decided by the allergist doctor.

    The skin test is performed with a mixt-allergen containing 10,000 PNU / ml. In patients with a high degree of sensitization, it is possible to apply the drug at a concentration of 5000 PNU / ml. If there is no reaction to the skin test at a concentration of 10,000 PNU / ml, it is switched to its intradermal administration at a dose of 0.02 ml at a concentration of 1000 PNU / ml. The preparation is diluted with a diluting liquid.

    Setting skarification skin tests, prik-tests.

    Scarification skin tests, prik-tests put on the inner surface of the forearm or, if necessary, on the skin of the back.

    Simultaneously with the mixt-allergen, skin tests with test-control fluid and with 0.01% histamine solution are prepared, which is prepared by diluting 0.1% of histamine dihydrochloride solution (1 part) of sodium chloride with a solution of 0.9% (9 parts), positive reaction to which no less than "+" indicates the presence of sufficient reactivity of the skin. The diluted solution of histamine is suitable for 6 hours from the moment of preparation.

    The metal cap of vials (with mixed-allergen, test-control liquid) is wiped with alcohol. Remove the central cap of the cap using a sterile forceps, and pierce the rubber stopper, pretreated with 70% ethyl alcohol, with a sterile needle.

    The skin of the inner surface of the forearm is wiped with 70% ethyl alcohol and allowed to dry. A drop of the test mix-allergen, a drop of test-control fluid and a drop of 0.01% histamine solution at a distance (30 ± 10) mm from each other are applied to the disinfected skin with a sterile syringe. Mixt-allergen, typed in a syringe, can not be poured back into the vial.

    When setting skarifikatsionnyh skin tests through drops of applied solutions with sterile scarifiers or injection needles, two parallel scratches with a length of 5 mm are applied.

    When prik-tests are applied through droplets of applied solutions with sterile injecting needles, shortened or with the depth stop of the prick or needles for prik-test (lancets), the skin is injected to a depth of 1.0-1.5 mm. When using injection needles, the skin is pierced at an angle of 45 ° so that blood does not protrude; then the needle is removed, slightly lifting the skin.

    After 15-20 minutes, sterile cotton swabs "drip" the drops of applied solutions at the site of scratches or puncture of the skin (a cotton swab should be separate for each drop of applied solutions) and take into account the skin reaction.

    Injection of intradermal samples.

    Intradermal tests are set in cases where the scarification skin test gives a negative reaction, and a history of susceptibility to susceptibility to plant pollen included in the mix allergen and / or if allergometric titration is necessary before the initiation of specific immunotherapy.

    Intradermal tests are performed on the inner surface of the forearm. The skin is pulled downward by moving the finger downwards, the needle is inserted at an angle of 15 ° to the surface of the skin, and it must be ensured that the needle hole is completely hidden in the epidermis, the needle must be thin with a short point.

    Sterile, individual for mixed-allergen and test-control fluid, marked with syringes with a scale of 0.02 ml, strictly intracutaneously injected 0.02 ml of mixed-allergen and test-control fluid, a sample with 0.01% histamine is put by the method of scarification . Mixt-allergen, typed in a syringe, can not be poured back into the vial.

    Evaluation of diagnostic skin tests.

    The local skin reaction during the formulation of scarifying skin tests, prik-tests are taken into account after 15-20 minutes, intradermal tests - after 20 minutes in the absence of reaction to the test control fluid and in the presence of a positive sample for histamine (not less than "+") (Table. 1).

    Table 1

    Scheme of accounting for scarification skin tests, prik-tests

    Evaluation of reaction

    Degree of severity of reaction *

    The size and nature of the reaction

    Negative


    Absence of blister (papules), hyperemia with dimensions both in control with test-control fluid

    Doubtful

    +

    Absence of blister (papules), hyperemia with sizes exceeding those in control with test-control fluid

    Positive

    +

    Wheal (papule) 2-3 mm, only noticeable when the skin stretching is congestion (for prick tests);

    Blister (papule) 3-5 mm, visible only when stretching the skin, hyperemia (for prik-tests)

    Positive

    ++

    Blister (papule) 4-5 mm, hyperemia (for scarification tests);

    Blister (papule) 5-10 mm, hyperemia (for prik-tests)

    Positive

    +++

    Blister (papule) 6-10 mm, hyperemia or blister (papule) 6-10 mm with pseudopodia, hyperemia (for scarification tests); Blister (papule) 10-15 mm, hyperemia (for prik-tests)

    Positive

    ++++

    Blister (papule) more than 10 mm, hyperemia or blister (papule) more than 10 mm with pseudopodia, hyperemia (for scarification tests); Blister (papule) more than 15 mm with pseudopodia, hyperemia (for prik-tests)

    Negative

    -

    Dimensions are the same as in the control

    Doubtful

    +

    At the test site, the blister dissolves more slowly than in the control

    Positive

    +

    Blister (papule) 4-7 mm in diameter, surrounded by hyperemia

    Positive

    -n-

    Blister (papule) 8-14 mm in diameter, surrounded by hyperemia

    Positive

    +++

    Blister (papule) 15-20 mm in diameter with pseudopodia, surrounded by hyperemia

    Positive

    -H- + 4-

    Blister (papule) more than 20 mm in diameter with pseudopodia and (or) erythema around (additional blisters around the periphery of pink or bright red)

    Note:

    * Degree of severity of reaction:

    - Negative;

    + Doubtful;

    + Weakly positive;

    ++ Positive;

    +++ Sharply positive;

    ++++ Very sharply positive.

    II. Specific immunotherapy.

    Specific immunotherapy is carried out in those cases when it is impossible to exclude the contact of the sensitized patient with the mixt-allergen.

    The mixed-allergen immunotherapy is administered to patients who have been sensitized to all types of pollen that is part of the complex preparation.

    Immunotherapy starts with a dose 10 times lower than the one that caused a minimal positive reaction with intradermal administration.

    Mixt-allergen with specific immunotherapy is administered subcutaneously.

    For the correct preparation and use of dilutions of the mixt-allergen with the observance of asepsis, the responsibility is borne by the allergist doctor.

    The dilutions of the drug, the volume administered (dose) and the recommended scheme of application are given in Table. 2.

    table 2

    An approximate scheme of specific immunotherapy for pollinosis

    Breeding the allergen

    Dose (ml)

    Notes

    1

    2

    3

    10-5

    1:100000

    0,1 PNU/ ml

    0,1

    0,2

    0,4

    0,8

    Specific immunotherapy begin no later than after the diagnosis of atopic disease,

    than for 3-4 months.before flowering and complete

    later than 1.5 months. before the flowering of plants.

    Injections are made strictly subcutaneously in the lower region

    third of the shoulder. The first injections (with the dilution of the mixt-

    allergen 10-5, 10-4, 10-3) are done daily or through

    day, subsequent injections (dilutions 10-2, 10-1) - from

    an interval of 7-10 days. The dose of mixt-allergen is 0.9-1.0 ml

    in breeding 10-1 repeat at intervals of 5-7 days until

    the beginning of flowering plants. Term of use of a mixt-

    allergen after its dilution -1 month.

    After each injection of the patient's mixed-allergen

    observe in the office for at least 60 minutes. Doctor notes

    reaction of the skin at the site of injection of the mixt-allergen and

    general condition of the patient.

    Contraindication for increasing the dose is a local reaction in the form of an infiltrate larger than

    25 mm, which occurred during the day at the injection site,

    general reaction of the body, exacerbation of the underlying disease. In these cases, the dose is reduced,

    intervals between injections are extended until

    good tolerance will be established.

    10-4

    1:10000

    1,0 PNU/ ml

    0,1

    0,2

    0,4

    0,8

    10-3

    1:1000

    10 PNU/ ml

    0,1

    0,2

    0,4

    0,8

    10-2

    1:100

    100 PNU/ ml

    0,1

    0,2

    0,3

    0,4

    0,5

    0,6

    0,7

    0,8

    0,9

    1,0

    10-1

    1:10

    1000 PNU/ ml

    0,1

    0,2

    0,3

    0,4

    0,5

    0,6

    0,7

    0,8

    0,9

    1,0
    Side effects:

    When a mixed-allergen is administered, local and general reactions are possible. In a number of cases, in highly sensitive patients with a specific immunotherapy with a mixt-allergen, general reactions may appear,which are manifested by symptoms of varying severity: from moderately expressed - coughing, sneezing, headache, urticaria, facial edema, conjunctivitis, rhinitis, bronchospasm, exacerbation of the underlying disease to anaphylactic shock in rare cases. Local reactions are expressed by education at the site of administration of edema, hyperemia.

    After each injection of mixed-allergen, the patient should be observed by an allergist for at least 60 minutes. During this time the doctor should note the reaction of the skin to the administration of the drug and the general condition of the patient. On remote reactions the patient should inform the doctor. In the room where specific immunotherapy of patients is carried out, pharmacological preparations and tools for emergency care should be located.

    Overdose:If the prescribed dose is exceeded, the risk of side effects increases, which requires symptomatic treatment.
    Interaction:

    Skin tests and treatment with a mixt-allergen should be carried out not earlier than through:

    -1 week after tuberculin test;

    -1 month after vaccination with inactivated vaccines;

    - 3 months after vaccination with live vaccines (both viral and bacterial, including BCG vaccine).

    Do not apply simultaneously with reception βadrenoblockers. Simultaneous reception of symptomatic drugs for the treatment of allergies is possible for better tolerability of ASIT (β2-adrenomimetikov, corticosteroids, inhibitors of degranulation of mast cells, if necessary later in the course of immunotherapy, it is possible to use H1-antihistamines).

    It is possible to use other names simultaneously with pollen allergens.

    Special instructions:

    Precautions for use.

    In particularly sensitive patients, a systemic allergic reaction and anaphylactic shock can occur. In this regard, in the office, where specific diagnostics and specific immunotherapy of patients are carried out, there should be pharmacological preparations and tools for emergency treatment.

    Assisting with general reactions and anaphylactic shock.

    After the introduction of the mixt-allergen from the pollen of weeds and sunflower, the symptoms of clinical manifestations of hypersensitivity to the mixt-allergen may develop. With parenteral administration of mixed-allergen, the development of an immediate-type reaction is possible, incl.anaphylaxis, which manifests itself in the form of urticaria and vascular edema, laryngeal edema, shortness of breath and suffocation. These symptoms often occur after feeling generalized itching, burning sensation, skin flushing, and a sense of fear of death.

    As a result of anaphylactic shock, non-occuring bronchospasm, asphyxia due to edema of the upper respiratory tract, and collapse can develop.

    In this case, urgent medical measures are required.

    Pre-hospital care for anaphylactic shock.

    1. Immediately stop the injection of the mixed allergen that caused the reaction, put the patient on the couch (head below the legs), turn the head to the side, push the lower jaw, remove the existing dentures.

    2. Apply the tourniquet in place above the injection of the mixt-allergen, if possible.

    3. Add 0.3-0.5 ml of 0.1% adrenaline solution intramuscularly (IM) or intravenously (IV) to the limb-free limb (children 0.01 mg / kg, maximum to 0, 3 mg). If necessary, the administration of these doses is repeated at intervals of 10-20 minutes. The total dose of epinephrine should not exceed 1 ml of 0.1% solution. The multiplicity and dose of adrenaline administered depends on the severity of the shock and blood pressure.Repeated administration of small doses of epinephrine is more effective than single administration of a large dose.

    4. Finish the injection site with 0.3-0.5 ml of adrenaline solution (1 ml of 0.1% solution of epinephrine diluted in 3-5 ml of sodium chloride solution for injection 0.9%).

    5. Apply an ice pack to the injection site.

    6. Provide access to fresh air or give oxygen. If the rhythm of breathing is disturbed or if it is difficult, perform artificial ventilation (IVL).

    7. Urgent call the doctor, simultaneously called the resuscitation team.

    Before the arrival of the resuscitation team, it is necessary to provide medical care and carry out constant monitoring of hemodynamic parameters and the state of the function of external respiration (FVD).

    Hospital care for anaphylactic shock.

    1. In extremely severe condition of the patient and with severe hemodynamic disorders, 5 ml of 0.01% solution of epinephrine are injected slowly into IV, when the effect is achieved, the administration is terminated. Children 0.1 ml / kg 0.01% solution injected slowly for several minutes.

    2. If blood pressure (BP) does not stabilize, urgently begin intravenous drip norepinephrine (phenylephrine,dopamine) 0.2% 1.0-2.0 ml per 500 ml 5% glucose solution for infusion or sodium chloride solution 0.9%.

    3. Intravenously inject glucocorticosteroids: prednisolone - 60-180 mg (children 5 mg / kg) or dexamethasone - 8-20 mg (children 0,3-0,6 mg / kg), or hydrocortisone - 200-400 mg (children 4-8 mg / kg). As of the introduction of hormones, repeat and continue at least 4-6 days to prevent allergic reactions by immunocomplex or delayed type.

    4. Only with the stabilization of blood pressure intramuscularly to enter 2.0 ml of a 2% solution of chloropyramine (children 6-12 months - 0.25 ml, 1-6 years - 0.5 ml, 7-18 years - 0.5-1, 0 ml) or 0.1% clemastine (children 0,025 mg / kg / day for two injections).

    5. Symptomatic therapy according to indications. At bronhospazme 10.0 ml of a 2.4% solution of aminophylline on sodium chloride solution 0.9% (2-3 mg / kg for children) is injected intravenously. If necessary, enter cardiac glycosides, respiratory analeptics.

    6. If necessary, suck from the respiratory tract accumulated secret and vomit, begin oxygen therapy.

    7. In case of acute edema of the larynx, intubation or tracheotomy is indicated.

    All patients with anaphylactic shock are subject to compulsory admission for a period of at least 10 days in order to continue monitoring and treatment, In 2-5% of patients who have had anaphylactic shock, late allergic reactions are observed.

    Doses of drugs administered and the tactics of the doctor are determined by the clinical picture, but in all cases it is necessary, first of all, the introduction of adrenaline, glucocorticosteroid preparations. The administration of preparations of phenothiazine series and calcium preparations is contraindicated.

    Effect on the ability to drive transp. cf. and fur:Not studied.
    Form release / dosage:Solution for cutaneous scarification, intradermal and subcutaneous administration, 10,000 PNU / ml.
    Packaging:

    For 5.0 ml in a vial; test-control liquid of 4.5 ml in a vial; diluting liquid of 4.5 ml in a vial. Issued in the kit: 2 vials of mixed allergen, 7 bottles of dilution liquid, 1 vial of test-control liquid in a pack of cardboard along with instructions for use.

    Storage conditions:In accordance with SP 3.3.2.1248-03 in a place protected from light and inaccessible to children at a temperature of 2 to 8 ° C. Freezing is not allowed.
    Shelf life:Mixt-allergen - 2 years, test-control and dilution of fluids - 5 years. The drug with expired shelf life is not subject to application.
    Terms of leave from pharmacies:On prescription
    Registration number:P N001537 / 01
    Date of registration:19.11.2008 / 29.03.2018
    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: & nbsp13.06.2018
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