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Dosage form: & nbsphypodermic solution
Composition:

Mixt allergoid is a dialyzed water-salt extract of protein-polysaccharide complexes - 10,000 PNU / ml *, extracted by extraction from pollen grains of alder sticky, birch hanging, hazel (common hazel) taken in equal proportions, treated with formaldehyde. Auxiliary substances: formaldehyde - not more than 0.14 mg; phosphate buffer solution - up to 1 ml.

The phosphate buffer solution contains (in 1 ml): sodium hydrogen phosphate dodecahydrate (equivalent to 6.0 mg sodium hydrophosphate) - 15.0 mg, potassium dihydrogen phosphate -2.16 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 Nitrogen Unit) - an international unit adopted to express the concentration of protein nitrogen in allergens, equal to 1x10 '5 mg of protein nitrogen.

Comes with mixed-allergoid release dilution fluid for allergoid.

The dilution liquid for the allergoid is 0.1 M phosphate buffer solution contains (in 1 ml): sodium hydrophosphate dodecahydrate (equivalent to 6.0 mg sodium hydrogen phosphate) -15.0 mg, potassium dihydrogen phosphate - 2.16 mg, water for injection - up to 1 ml.

Description:Mikst-allergoid is a transparent liquid from yellow to brown color.The diluent liquid for the allergoid is a colorless transparent liquid.
Pharmacotherapeutic group:MIBP is an allergen
ATX: & nbsp
  • Pollen allergens
  • Pharmacodynamics:

    Immunobiological properties. The main active ingredient of the preparation is a protein-polysaccharide complex extracted from a degreased mixture of alder alder pollen, birch hanging, hazel (common hazelnut) taken in equal proportions, and subjected to mild processing with formaldehyde. Such an effect leads to enlargement of the protein molecule of the mixt-allergoid and blocking part of allergenic determinants, as a result of which the drug has a reduced allergenicity, but retains the ability to cause a high therapeutic effect in patients sensitive to alder pollen, birch, hazel. This makes it possible to administer a higher maximum tolerated dose of the drug in a shorter period to the patient and significantly increase the total dose of units of protein nitrogen, in comparison with the doses for specific immunotherapy with the same allergens.

    Indications:

    Specific immunotherapy of adults and children from 5 years with allergic rhinoconjunctivitis, atopic bronchial asthma, atopic dermatitis, caused by a mixture of pollen of trees: alder sticky, birch hanging, hazel (common hazel).

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

    Contraindications:

    In order to identify contraindications, the doctor 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. Severe bronchial asthma, poorly controlled by pharmacological drugs (volume of forced expiration in 1 second less than 70% after adequate pharmacotherapy).

    7. Severe form of atopic eczema.

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

    9. Malignant neoplasms and blood diseases.

    10. Mental illness in the period of exacerbation.

    11. Systemic diseases of connective tissue.

    12. Children under 5 years.

    13. Pregnancy and lactation.

    14. Cardiovascular diseases, which may complicate the use of epinephrine (epinephrine).

    15. Therapy βadrenoblockers.

    Pregnancy and lactation:Contraindicated.
    Dosing and Administration:

    When carrying out specific immunotherapy, injections of mixed-allergic drugs are injected subcutaneously into the region of the lower third of the arm. The dilutions of the mixed allergoid are prepared using a diluent fluid for an allergoid. Dilutions mixed-allergoid store at a temperature of 2 to 8 ° C, the period of use is not more than 1 month.

    For the correct preparation and use of dilutions mixed an allergoid with the observance of asepsis is the responsibility of the allergist doctor. Specific immunotherapy is performed in the stage of remission of the underlying disease in the conditions of an allergological room or a specialized department of the hospital.

    Before the course of specific immunotherapy, it is mandatory to take skin tests with allergens from alder alder pollen, birch hanging, hazel (common hazel), confirming the patient's increased sensitivity.

    Dilution of the drug, the volume (dose) to be administered and the recommended scheme of application are given in the table.

    Dilutions mixed-allergoid

    PNU/ ml

    Dose (ml)

    Note

    1:10000

    1,0

    0,1

    0,3

    0,7

    Injections are made strictly subcutaneously in the region of the lower third of the shoulder. The first dilutions: 1: 10000, 1: 1000 are done daily or every other day.

    Subsequent dilutions: 1: 100 and 1: 10 with an interval of 3 days. If the patient tolerates injections of mixed-allergic drugs at a dose of 0.9 ml diluted 1:10, continue injections with undiluted mixed allergic (10,000 PNU/ ml) in increasing doses of 0.1 ml, 0.2 ml, 0.3 ml, 0.4 ml, etc. up to 1 ml with an interval of 7 days.

    In patients with high sensitivity, treatment is started at the doctor's discretion with a dilution of 1: 100,000 or 1: 1 million and lower dilutions.

    After each injection of a mixt-allergoid, the patient should be observed by the doctor for at least 60 minutes. During this time, the doctor observes the skin reaction at the site of injection of the mixed-allergoid and the general condition of the patient.

    The patient should be informed that he should urgently consult an allergist, if a general reaction or hyperergic reaction occurs at the injection site within 24 hours.

    Contraindication to increase the dose to the patient is a local reaction in the form of an infiltrate larger than 25 mm (emerged during the day at the injection site), the general reaction,exacerbation of the underlying disease. In these cases, the dose is reduced, and the intervals between injections are extended until good tolerability is established. Injections of mixed allergoid should be discontinued 1-2 weeks before the beginning of flowering of the corresponding plant species.

    1:1000

    10,0

    0,1

    0,3

    0,7

    1:100

    100

    0,1

    0,3

    0,5

    0,7

    1:10

    1000

    0,1

    0,3

    0,5

    0,7

    0,9

    Whole

    mikst-

    allergoid

    10000

    0,1

    0,2

    0,3

    0,4

    0,5

    0,6

    0,7

    0,8

    0,9

    1,0

    * The initial dose is determined by the method of allergometric titration.

    Side effects:

    With the introduction of mixed allergoids, local and general reactions are possible. In a number of cases, in highly sensitive patients with a specific immunotherapy with a mixed allergoid, general reactions may appear that manifest symptoms of varying severity: from moderately expressed coughs, sneezes, headaches, 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 a mixed allergoid, 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 the patient is carried out, there should be pharmacological preparations and tools for the provision of emergency care.

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

    Treatment mixed-allergoid 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 the use of P-blockers. Possible simultaneous reception of symptomatic drugs for the treatment of allergies for better tolerability of ASIT (Pr-adrenomimetics, corticosteroids, inhibitors of degranulation of mast cells, if necessary, further use of H1-antihistamines in the course of immunotherapy).

    It is possible to conduct a specific treatment at the same time with other allergenic and allergic allergens from domestic dust.

    Special instructions:

    Precautions for use.

    In particularly sensitive patients with specific immunotherapy, a systemic allergic reaction and anaphylactic shock can occur. In this regard, in the room where specific immunotherapy of patients is conducted, there should be pharmacological preparations and tools for emergency treatment.

    Assisting with general reactions and anaphylactic shock.

    When parenteral introduction of a mixed allergoid may develop an immediate reaction, including. 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 relapse for anaphylactic shock.

    1. Immediately stop the introduction of a mixed allergoid, lay the patient on the couch (head below the legs), turn the head to the side, push the lower jaw,remove existing dentures.

    2. Apply the tourniquet in place above the injection of the mixed allergoid, 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 rehoot 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 injection of norepinephrine (phenylephrine, dopamine) 0.2% 1.0-2.0 ml per 500 ml of 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 inject 2.0 ml of a 2% solution of chloropyramine (5-6 years - 0.5 ml, 7-18 years - 0.5-1.0 ml) or 0.1% klemastina (children 0,025 mg / kg / day for two injections).

    5. Symptomatic therapy according to indications. In bronchospasm, 10.0 ml of a 2.4% solution of aminophylline on a 0.9% sodium chloride solution is injected intravenously strontaneously (children 2 to 3 mg / kg). 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 subcutaneous administration, 10,000 PNU / ml.

    Packaging:

    For 5.0 ml in a vial; diluting liquid for allergoid for 4.5 ml in a vial. Issued in the kit: 1 bottle of mixed allergoid, 8 bottles of dilution fluid for an allergoid, 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.

    Transportation conditions. In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Freezing is not allowed.

    Shelf life:
    Mikst-allergoid - 2 years, diluting liquid for allergoid-5 years. The drug with expired shelf life is not subject to application.
    Terms of leave from pharmacies:On prescription
    Registration number:P N000873 / 01
    Date of registration:16.10.2008 / 03.12.2013
    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: & nbsp14.06.2018
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