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Dosage form: & nbspSolution for dermal scarification, intradermal and subcutaneous administration.
Composition:

Allergen is a water-salt extract of protein-polysaccharide complexes - 10000 PNU/ ml *, isolated from the pollen of the quinoa by Tatar extraction in a neutral phosphate-buffered saline solution.

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

Note:

* PNU (protein N unit) - an international unit adopted to express the concentration of protein nitrogen in allergens, equal to the content 1x10-5 mg of protein nitrogen.

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

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

Diluting liquid - phosphate-buffered saline solution to which is added polysorbate 80, it contains (in 1 ml): sodium chloride - 5.0 mg sodium hydrogen phosphate dodecahydrate - 1.4 mg (equivalent to 0.56 mg of 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 fluid and diluent liquid are colorless transparent solutions.

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

    Immunobiological properties. The main active principle of pollen allergens is protein-polysaccharide complex, allowing to diagnose a patient with staged skin tests hypersensitivity to pollen Tatar quinoa and use it for immunotherapy of pollinosis.

    Indications:

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

    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, 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. An aggravation of an allergic disease.

    2. Acute infection.

    3. Chronic diseases in the stage of decompensation.

    4. Immunodeficiency conditions.

    5. Autoimmune diseases.

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

    7. Malignant neoplasms and blood diseases.

    8. Mental illness in the period of exacerbation.

    9. Systemic diseases of connective tissue.

    10. Pregnancy and lactation

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

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

    13. Therapy βadrenoblockers (for specific immunotherapy).

    14. Systemic glucocorticosteroid therapy, therapy β-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 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 a test-control fluid and with a 0.01% histamine solution, which was prepared by diluting 0.1% histamine dihydrochloride solution (1 part) sodium chloride solution 0.9% (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.A drop of the tested allergen is applied to the disinfected skin using a sterile syringe, a drop of test-control fluid 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 scarifying skin samples are put through the applied drops with a sterile scarification needle, two parallel scratches with a length of 5 mm are applied.

    When prik-tests are performed through the applied drops with a sterile injection needle, pierce the skin so that blood does not protrude, then the needle is removed, slightly lifting the skin.

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

    Intradermal samples are placed in cases where there are discrepancies in the data of clinical diagnostic methods and scarification tests.

    Intradermal tests are performed on the inner surface of the forearm. The skin is pulled by moving the finger downwards, the needle is inserted at an angle of 15 ° to the surface of the skin, 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 division, 0.02 ml of allergen and test-control liquid are strictly intradermally injected, a test with 0.01% histamine solution is put by the method of scarification.

    Evaluation of diagnostic skin tests.

    Local skin reaction during the formulation of scarifying 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 registration of scarifying skin samples, prik-tests.

    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 (for scarification tests).

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

    Positive

    +++

    Blister (papule) 6-10 mm, hyperemia or blister (papule) 6-10 mm with hyperemia and pseudopodia (for scarification tests). Blister (papule) 10-15 mm, surrounded by a zone of hyperemia with a diameter of more than 10 mm (for prik-tests)

    Positive

    ++++

    Blister (papule) more than 10 mm, hyperemia or blister (papule) more than 10 mm hyperemia with pseudopodia (for scarification tests). Blister (papule) more than 15 mm with pseudopodia, hyperemia with a diameter of more than 20 mm (for prik-tests)

    Doubtful

    + -

    Hyperemia without blistering

    Scheme of recording intradermal samples.

    Evaluation of reaction

    Degree of expression

    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 a sensitized patient with an 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 with pollinosis.

    Breeding

    Dose (ml)

    Notes

    allergen



    1

    2

    3

    10-5

    1:100000

    0.1 PNU / ml

    0,1

    0,2

    0,4

    0,8

    Specific immunotherapy is initiated after the diagnosis of atopic disease is not later than 3-4 months before the beginning of flowering and completed no later than 1.5 months before the commencement of the flowering plants.

    Injections are made strictly subcutaneously in the external the surface of the lower third of the shoulder. The first injections (when diluting the allergen 10-5, 10-4, 10-3) do daily or every other day injections (dilutions 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 flowering of trees and grasses. The period of use of the allergen after its dilution is 1 month.

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

    Contraindication for increasing the dose is a local reaction in the form of an infiltrate larger than 25 mm, 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

    1:100000

    1.0 PNU / ml

    0,1

    0,2

    0,4

    0,8

    10-3

    1:100000

    10 PNU / ml

    0,1

    0,2

    0,4

    0,8

    10-2

    1:100000

    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

    1:100000

    1000 PNU / ml

    0,1

    0,2

    0,3

    0,4

    0,5

    0,6

    0,7

    0,8

    0,9

    1,0

    Precautions for use.

    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 providing urgent assistance.

    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.

    Pre-hospital help with 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 allergen injection, if possible.

    3. 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).

    4. Apply an ice pack to the injection site.

    5. Enter 0.3-0.5 ml of a 0.1% solution of epinephrine (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.

    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 help with 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 slowly for a few minutes.

    2. If blood pressure does not stabilize, urgently begin intravenous drip injection 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%.

    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 enter 2.0 ml of a 2% solution of chloropyramine (1-12 months - 0.25 ml, 1-6 years 0.5 ml, 7-18 years -0.5-1 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. 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% of patients who have had anaphylactic shock, late allergic reactions are observed.

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

    Side effects:

    When introducing an allergen, local and general reactions are possible. In a number of cases, in highly sensitive patients with specific immunotherapy with an allergen, general reactions can occur that manifest symptoms of varying severity: from mild symptoms such as coughing, sneezing, headache, urticaria, edema of the face, 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 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.

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

    Skin tests and treatment with allergens 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 use simultaneously with the admission of ß-blockers. Possible simultaneous reception of symptomatic antiallergenic drugs for better tolerability of ASIT ß2-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.

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

    Not studied.

    Form release / dosage:Solution for cutaneous scarification, intradermal and subcutaneous administration, 10000 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: 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: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.
    Conditions of transportation.
    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 of fluids - 5 years. The drug with expired shelf life is not subject to application.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-000553
    Date of registration:09.07.2010 / 17.05.2013
    The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Manufacturer: & nbsp
    Information update date: & nbsp08.02.16
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