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

It is a water-salt extract of protein-polysaccharide complexes isolated from plant pollen by extraction with phosphate-buffered saline solution.

A drug contains in 1 ml: an allergen from pollen of alder glue - 10000 PNU; Excipients: phosphate-buffered saline solution - up to 1 ml. Phosphate buffered saline contains: sodium chloride 5.0 mg, disodium hydrophosphate dodecahydrate 1.4 mg (equivalent to 0.56 mg disodium hydrogen phosphate), potassium dihydrogen phosphate 0.36 mg, phenol (preservative) 2.0 grams, 4.0 mg, water for injection - up to 1 ml.

In a set with an allergen, test-control and dilution fluids are produced.

Test-control liquid - phosphate buffered saline contains (in 1 ml): sodium chloride - 5.0 mg, disodium hydrophosphate dodecahydrate - 1.4 mg (equivalent to 0.56 mg disodium hydrogen phosphate), potassium dihydrogen phosphate 0.36 mg, phenol (preservative ) - 2,0-4,0 mg, water for injections - up to 1 ml.

Dilution liquid - phosphate buffered saline solution, in which polysorbate-80 is added, contains: sodium chloride - 5.0 mg, disodium hydrogen phosphate dodecahydrate 1.4 mg (equivalent to 0.56 mg disodium hydrogen phosphate), potassium dihydrogen phosphate 0.36 mg, phenol (preservative) 2.0-4.0 mg, polysorbate 80 0.005 μl, water for injection up to 1 ml.

Description:Allergen is a clear liquid from yellow to brown.
Test-control liquid and diluent fluid are colorless transparent liquids.
Pharmacotherapeutic group:MIBP is an allergen
ATX: & nbsp
  • Pollen allergens
  • Pharmacodynamics:Immunobiological properties
    The main active principle of pollen allergens is the protein-polysaccharide complex, which makes it possible to diagnose a hypersensitivity to this type of plant pollens in the case of a skin test and apply it to immunotherapy for pollinosis.
    Indications:

    Specific diagnosis and treatment of pollinosis, atopic bronchial asthma, caused by hypersensitivity to alder alder pollen.

    Indications for diagnosis are clinical manifestations 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, 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.

    Contraindications for specific diagnostics:

    1. An aggravation of an allergic disease.

    2. Acute infection.

    3. Chronic diseases in the stage of decompensation.

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

    5. Systemic diseases of connective tissue.

    6. Systemic glucocorticosteroid therapy, therapy β-adrenomimetics and antihistamines.

    Contraindications for specific immunotherapy:

    1. An aggravation of an allergic disease.

    2. Severe form of atopic eczema.

    3. Autoimmune diseases.

    4. Immunodeficiency conditions.

    5. Acute infection.

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

    7. Malignant neoplasms and blood diseases.

    8. Chronic diseases in the stage of decompensation.

    9. Cardiovascular diseases.

    10. Pregnancy and lactation.

    11. Mental illness in the period of exacerbation.

    12. Systemic glucocorticosteroid therapy, therapy β-adrenomimetics and antihistamines.

    Pregnancy and lactation:

    Not investigated.

    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 pollen allergens of various denominations are allowed to be carried out.

    Skin tests are placed on the inner surface of the forearm or, if necessary, on the skin of the back.

    Simultaneously with the allergen, dermal samples were made with test-control fluid and with a 0.01% histamine solution, which was prepared by diluting 0.1% histamine dihydrochloride solution (1 part) with 0.9% sodium chloride solution for injection (9 parts). A diluted solution of histamine is suitable for 6 hours from the time of preparation.

    A metal cap of vials (with allergens or test-control liquid) is rubbed 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. On the disinfected skin, a drop of the tested allergen is applied using a sterile syringe,a drop of test-control liquid and a drop of 0.01% histamine solution at a distance (30 ± 10) mm from each other. Allergen, typed in a syringe, can not be poured back into the vial.

    When setting skarification skin tests through the applied drops with a sterile scarification needle, two parallel scratches with a length of 5 mm are applied.

    When prik-tests are made through the applied drops with a sterile injectable needle, a skin prick is carried out to a depth of not more than 1-1.5 mm.

    At the expressed skin reaction selection of safe initial medical dose for what use a method of allergometric titration is spent.

    Intradermal tests Are put in those cases when there are discrepancies in the data of clinical methods of diagnostics and scarification tests.

    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 each allergen labeled syringes with a scale of 0.02 ml,Strictly intradermally injected with 0.02 ml of the allergen and test-control liquid, a sample with 0.01% histamine is put by the method of scarification.

    Evaluation of diagnostic skin tests

    Local skin reaction during the formulation of scarification skin tests, prik-tests are taken into account after 15-20 minutes, and 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.

    Scheme of accounting for scarification skin samples

    Evaluation reactions

    Power severity of reaction *

    The size and nature of the reaction

    Negative

    -

    Absence of blister (papules) and hyperemia, as in control with test test fluid

    Positive

    +

    Blister (papule) 2-3 mm with hyperemia, visible only when stretching the skin

    Positive

    ++

    Blister (papule) 4-5 mm, surrounded by hyperemia, is noticeable without stretching the skin

    Positive

    +++

    Blister (papule) 6-10 mm, hyperemia or blister (papule) 6-10 mm with hyperemia and pseudopodia

    Positive

    ++++

    Blister (papule) more than 10 mm, hyperemia or blister (papule) more than 10 mm of hyperemia with pseudopodia

    Doubtful

    ±

    Hyperemia without blistering

    The scheme of accounting for prik-tests

    Evaluation of reaction

    Degree of severity of reaction *

    The size and nature of the reaction

    Negative

    -

    Absence of blister (papules) and hyperemia, as in control with test test fluid

    Positive

    +

    Blister (papule) 3-5 mm with hyperemia up to 10 mm, visible only when stretching the skin

    Positive

    ++

    Blister (papule) 5-10 mm, surrounded by a zone of hyperemia with a diameter of 5-10 mm

    Positive

    +++

    Blister (papule) 10-15 mm, surrounded by a zone of hyperemia with a diameter of more than 10 mm

    Positive

    ++++

    Blister (papule) more than 15 mm with pseudopodia, hyperemia with a diameter of more than 20 mm

    Doubtful

    ±

    Hyperemia without blistering

    Scheme of recording intradermal samples

    Evaluation of reaction

    Degree of severity of reaction *

    The size and nature of the reaction

    Negative

    -

    Dimensions are the same as in the control

    Positive

    +

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

    Positive

    ++

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

    Positive

    +++

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

    Positive

    ++++

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

    Doubtful

    ±

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

    Note:

    * Degree of severity of reaction:

    - Negative;

    + Weakly positive;

    ++ Positive;

    +++ Sharply positive;

    ++++ Very sharply positive;

    ± Doubtful.

    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 allergen. Allergen for specific immunotherapy is administered subcutaneously.

    For the preparation and use of dilutions of the allergen in aseptic conditions, the responsibility is borne by the allergist doctor.

    An approximate scheme of specific immunotherapy for pollinosis

    Breedingallergen

    Dose (ml)

    Notes

    1

    2

    3

    10-5

    1:100000

    0.1 PNU / ml

    0,1

    0,2

    0,4

    0,8

    Specific immunotherapy begins after diagnosis of atopic disease no later than 3-4 months before the beginning of flowering and is completed no later than 1.5 months before the beginning of flowering of plants.

    Injections are made strictly subcutaneously in the region of the lower third of the shoulder. The first injection (when diluting the allergen 10-5, 10-4, 10-3) are done daily or every other day, subsequent injections (dilutions of 10-2, 10-1) - with an interval of 7-10 days. The dose of the allergen is 0.9-1.0 ml in dilution 10-1 repeat with an interval of 5-7 days before the beginning of flowering of plants. The period of use of the allergen after its dilution is 1 month.

    After each injection of the patient's allergen, the patient is observed in the office for at least 60 minutes. The doctor notes the skin reaction at the site of the allergen injection and the general condition of the patient.

    Contraindication to increase the dose is a local reaction in the form of an infiltrate larger than 25 mm, arising during the day at the injection site, the general reaction of the body, the aggravation of the underlying disease. In these cases, the dose is reduced, the intervals between injections are extended until good tolerability is 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 introducing an allergen, local and general reactions are possible.

    In some cases, in highly sensitive patients with specific immunotherapy, an allergen may appear general reactionsWhich develop over 10-40 minutes after injection and the allergen are manifested symptoms of varying severity, from moderately expressed - coughing, sneezing, headaches, hives, swelling of the face, conjunctivitis, rhinitis, bronchospasm, exacerbation of underlying disease to anaphylactic shock in rare cases.

    Local Reactions expressed by education at the site of administration of edema, hyperemia, occur after 15-20 minutes and last for 30 to 40 minutes.

    After each injection of the allergen, the patient should be observed by an allergist 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. 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.

    Interaction:

    Skin tests and treatment with allergens should be carried out through:

    - 1 week after tuberculin test;

    - 2 weeks after the use of inactivated vaccines;

    - 4 weeks after the use of live vaccines;

    - not earlier than 8-12 weeks after BCG vaccine application;

    - for 3-5 days, the elimination of glucocorticosteroids and antihistamines of the first generation is required;

    - for 4 weeks - antihistamine preparations of the second generation.

    Special instructions:

    In case of doubtful results of skin tests, they can be repeated 2 days after the local response to the previous samples subsided. In case of positive results, it is allowed to repeat skin tests with pollen allergens no more than once a month.

    In particularly sensitive patients, a systemic allergic reaction and anaphylactic shock may 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 care.

    Assisting with general reactions and anaphylactic shock

    After the introduction of the allergen, symptoms of clinical manifestations of hypersensitivity to the allergen may develop. With parenteral administration of an allergen, it is possible to develop an immediate-type reaction, 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.

    Prehospital care for anaphylactic shock

    1. Immediately stop the introduction of the 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 allergen, if possible.

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

    4. Apply an ice pack to the injection site.

    5. Enter 0.3-0.5 ml of 0.1% solution of adrenaline (children 0.05-0.1 ml / year of life) in / m or IV with an interval of 5-10 minutes. The multiplicity and dose of adrenaline administered depends on the severity of the shock and blood pressure. The total dose of epinephrine should not exceed 1 ml of 0.1% solution. Repeated administration of small doses of epinephrine is more effective than single administration of a large dose.

    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.

    Hospital care for anaphylactic shock

    1. In the extremely serious condition of the patient and with severe violations of hemodynamics, slowly inject 5 ml of 0.01 ml% solution of adrenaline, when the effect is achieved, the administration is stopped. Children 0.1 ml / kg 0.01% r-ra slowly for several minutes.

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

    3. Intravenously struino enter glucocorticosteroids: prednisolone 60-180 mg (children 5 mg / kg), dexamethasone - 8-20 mg (children 0,3-0,6 mg / kg), 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 enter 2.0 ml of a 2% solution of chloropyramine (children 0.1-0.15 ml / year of life) or 0.1% klemastina.

    5. Symptomatic therapy according to indications. When bronchospasm is injected intravenously, 10.0 ml of a 2.4% solution of aminophylline on a 0.9% sodium chloride solution for injections (children 1 ml / year of life). If necessary, enter cardiac glycosides, respiratory analeptics.

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

    7. Patients receiving β-adrenoceptor blockers, additional administration of salbutamol and / or glucagon to / in 1 ml 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 % patients who have experienced anaphylactic shock, there are late allergic reactions.

    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.

    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).

    Effect on the ability to drive transp. cf. and fur:

    Not described.

    Form release / dosage:Solution for cutaneous scarification, intradermal and subcutaneous administration, 10000 PNU/ ml.
    Packaging:Solution for dermal scarification, intradermal and subcutaneous administration - 5.0 ml in the vial; test-control liquid - 4.5 ml in the vial; diluent fluid - 4.5 ml in a vial.
    Issued in the kit: 1 bottle of allergen, 7 bottles of dilution fluid, 1 bottle of test-control fluid, 1 empty sterile bottle in a pack of cardboard along with instructions for use.

    Storage conditions:

    Allergens are stored 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 FROM.

    Transportation are carried out in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Freezing is not allowed.

    Shelf life:

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

    The drug with expired shelf life is not subject to application.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-000566
    Date of registration:25.06.2010
    Date of cancellation:2013-06-25
    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: & nbsp30.03.2016
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