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Dosage form: & nbsphypodermic solution
Composition:

Mixt-allergoid is a dialyzed water-salt extract of protein-polysaccharide complexes - 10000±2500 PNU *, extracted by extraction from the pollen grains of the hedgehog, the fescue meadow, timothy grass, taken in equal proportions, processed with formaldehyde. Excipients; formaldehyde - not more than 0.14 mg; phosphate buffer solution - up to 1 ml.

The phosphate buffer solution contains (in 1 ml): sodium hydrophosphate 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 the content of 1x10-5 mg of protein nitrogen.

Comes with mixed-allergoid release dilution fluid for allergoid.

Brewing liquid for allergoid - 0,1 M 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.

Description:

Mixt-allergoid is a clear liquid from yellow to brown.

Brewing liquid for allergoid is a colorless transparent liquid.

Pharmacotherapeutic group:MIBP is an allergen
ATX: & nbsp
  • Allergens of grass pollen
  • Pharmacodynamics:Immunobiological properties. The active ingredient of the preparation is a protein-polysaccharide complex extracted from a defatted mixture of pollen from the hedgehog, fescue meadow grass, timothy grass, taken in equal proportions, and subjected to mild processing with formaldehyde. This effect leads to enlargement of the protein molecule of the mixt-allergoid and blocking part of the 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. This makes it possible to administer to a patient in a shorter period of a higher maximum tolerated dose of a mixed allergoid and significantly increase the total dose received by a patient with a course of increasing and maintaining doses than in immunotherapy with a corresponding allergen.
    Indications:

    Specific immunotherapy of pollinosis and atopic bronchial asthma caused by a mixture of pollen meadow grasses: hedgehogs, meadow fescue, timothy grass.

    Indications for treatment are clinical manifestations of the disease, history data, skin test data with a specific mixt-allergen.

    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 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 exacerbation and / or decompensation.

    4. Immunodeficiency conditions.

    5. Autoimmune diseases.

    6. Severe form of atopic eczema.

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

    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.

    12. Pregnancy and lactation.

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

    14. Therapy βadrenoblockers.

    Pregnancy and lactation:

    Contraindicated.

    Dosing and Administration:

    When carrying out specific immunotherapy, injections of mixed-allergic drugs are administered subcutaneously. For the preparation and use of dilutions of the mixed allergoid in aseptic conditions, the responsibility is borne by the allergist doctor. Mixt-allergoid dilute dilution fluid for allergoid.

    Mikst-allergoid injected subcutaneously into the lower third of the shoulder. The dilution of the drug, the volume administered, and the recommended application schedule are given at table. Treatment is conducted in an allergological room in the remission of the underlying disease.

    Before the course of specific immunotherapy, it is mandatory to take skin tests with allergens from the pollock of the hedgehog, the fescue meadow grass, timothy grass, which confirm 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.

    Table. An approximate scheme of preseason specific immunotherapy.

    Dilutions mikst-allergoid

    PNU/ ml

    Dose (ml)

    Note

    1:10000

    1,0

    0,1

    0,3

    0,7

    Specific immunotherapy is initiated after the diagnosis of atopic disease is not later than 3-4 months before the beginning of flowering of the corresponding types of meadow grasses.

    Injections are made subcutaneously in the lower region third of the shoulder. First dilutions: 1: 10000, 1: 1000 are done daily or every other day. Subsequent breeding: 1:100 and 1:10 with an interval of 3 days. If the patient tolerates injections of mixed-allergic in a dose of 0.9 ml timesled1:10, it is necessary to continue injections with an undiluted mixed-allergoid: (10000 PNU) in 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 initiated at the discretion of the doctor, with dilution 1:100,000 or 1: 1 million and lower dilutions.

    After each injection of the mixed allergoid, the patient is observed in the office for 40-60 minutes. During this time, the doctor observes the reaction of the skin 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 there are within 24 hours a general reaction or a hyperergic reaction at the injection site.

    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 allergoids should be discontinued 1-2 weeks before the flowering of the corresponding meadow grass species is started.

    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

    Side effects:

    With the introduction of mixed allergoids, local and general reactions are possible.

    In a number of cases, in high-sensitivity patients with a specific immunotherapy with a mixed allergoid, general reactions can occur that manifest symptoms of varying severity: from mild cough, sneezing, headache, urticaria, edema of the face, conjunctivitis, rhinitis, bronchospasm, exacerbation of the underlying disease to anaphylactic 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 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 office, where specific hypo-sensitization of patients is carried out, there should be pharmacological preparations and tools for 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 use simultaneously with the use of β-blockers.

    Possible simultaneous reception of symptomatic antiallergic drugs (H1-antigistamine drugs, β2adrenomimetics, corticosteroids, inhibitors of mast cell degranulation) for better tolerability of ASIT.

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

    Special instructions:

    In cases where during the introduction of a mixed allergoid the patient develops general weakness or agitation, anxiety, a feeling of heat throughout the body, redness of the face, rash, cough, shortness of breath, abdominal pain, the following measures should be taken.

    Prehospital care for anaphylactic shock

    1. Immediately stop the introduction of the mixed allergoid pollen hedgehog, fescue, timothy, put the patient on the couch (head below the legs), head to the side, push the lower jaw, remove the existing dentures.

    2. Apply the tourniquet in place above the allergoid injection, 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 for injection 0.9%).

    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.

    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 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% 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 5% glucose solution for infusion or sodium chloride solution for injection 0.9%.

    3. Intravenously injected 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 (1-12 months - 0.25 ml, 1-6 years - 0.5 ml, 7-18 years - 0.5-1 ml) or 0, 1% Clemastin (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 solution of sodium chloride for injection 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-adrenoblockers showed additional administration of salbutamol and / or glucagon in / in 1 ml.

    8. In 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% patients who have experienced anaphylactic shock, there are late allergic reactions.

    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.

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

    Not studied.

    Form release / dosage:A solution for subcutaneous administration, 10000 PNU / ml.
    Packaging:

    For 5.0 ml in a vial; diluting liquid of 4.5 ml in a vial.

    Available in the kit: 1 vial of mixed allergoid, 8 vials of dilution fluid for allergoid, 1 empty sterile vial 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 N000872 / 01
    Date of registration:20.11.2008 / 13.01.2014
    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: & nbsp16.02.2016
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