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Dosage form: & nbspSolution for subcutaneous administration.
Composition:

The allergoid is a water-salt extract of proteinopolysaccharide complexes - 10000 ± 2500 PNU / ml *, isolated from pollen of wormwood by bitter, processed 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.

Complete with an allergoid release dilution fluid for an allergic.

Diluting liquid - 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:Allergoid pollen wormwood 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
  • Allergens of grass pollen
  • Pharmacodynamics:Immunobiological properties. The main active principle of the preparation is a protein-polysaccharide complex extracted from the wormwood pollen bitter and subjected to mild processing with formaldehyde. This effect leads to enlargement of the protein molecule and blocking of a 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 pollen wormwood. 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 allergen.
    Indications:

    Specific immunotherapy of adults and children from 5 years with allergic rhinoconjunctivitis, atopic bronchial asthma, atopic dermatitis, susceptible to pollen wormwood.

    Indications for specific immunotherapy are determined by the allergist doctor on the basis of clinical manifestations of the disease, the history, 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 sec less than 70% after adequate pharmacotherapy).

    7. Severe form of atopic eczema.

    8. Tuberculosis of any site 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, in which complications from the use of adrenaline (epinephrine) are possible.

    15. Therapy with β-blockers.

    Pregnancy and lactation:Contraindicated.
    Dosing and Administration:

    With specific immunotherapy, allergic injections are administered subcutaneously to the lower third of the shoulder.Dilutions of the allergoid are prepared using a diluent fluid for an allergoid. Dilutions of the allergoid should be stored 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 of the allergic with observance of asepsis, the allergist doctor is responsible. 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.

    The dilutions of the drug, the volume administered (dose) and the recommended scheme of application are given in the table.
    Table. An approximate scheme of preseason specific immunotherapy. *

    Allergoid dilution

    PNU / ml

    Dose (ml)

    Note

    1

    2

    3

    4

    1:10 000

    1,0

    0,1

    Injections are made strictly subcutaneously in the region of the lower part of the shoulder. 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 allergoid injections at a dose of 0.9 ml of 1:10 dilution, continue injections with an undiluted allergoid: (10,000 PNU) at doses of 0.1 ml, 0.2 ml, 0.3 ml, 0.4 ml and t . 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: 1,000,000 and lower dilutions.

    After each injection, the patient's allergoid is observed in the office for at least 60 minutes. During this time, the doctor notes the skin reaction at the site of the allergoid injection 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 patient's dose is the 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 the allergoid should be discontinued 1-2 weeks before the beginning of flowering of the corresponding plant species.

    0,3

    0,7

    1:1 000

    10

    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

    Undivided

    10 000

    0,1

    0,2

    0,3

    0,4

    0,5

    0,6

    0,7

    0,8

    0,9

    1,0


    * a) The determination of the initial dose is carried out by the method of allergometric titration.

    b) In patients with high sensitivity (high degree of skin test), treatment begins at the discretion of the doctor, with a dilution of 1: 100,000 or 1: 1 million.

    Precautions for use.

    If, during the introduction of the allergoid or during follow-up for 60 minutes, the patient experiences general weakness or agitation, restlessness, a feeling of fever throughout the body, redness of the face, rash, cough, shortness of breath, abdominal pain, the following Events:

    Pre-hospital care for anaphylactic shock.

    1. Immediately stop the injection of the allergoid 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 allergoid injection, if possible.

    3. To the extremity free from the tourniquet, to conduct 0.3-0.5 ml of 0.1% solution of adrenaline (children 0.01 mg / kg, maximum to 0.3 mg, if necessary, the administration of these doses is repeated every 15 minutes (up to 3 times)) IM or IV with an interval of 10-20 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.

    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 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 slowly for a few 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 intravenously: 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% klemastin (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 (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 (i) in 1 ml.

    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.

    Side effects:

    When introducing an allergode, local and general reactions are possible. In a number of cases, in highly sensitive patients with specific immunotherapy, allergies can develop common reactions that manifest themselves with symptoms of varying severity: from moderately expressed - 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, 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 introduction of an allergoid 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:

    Treatment with an allergoid should be carried out no earlier than:

    - 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. Simultaneous reception of symptomatic drugs for the treatment of allergies is possible for better tolerability of ACHT (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 conduct a specific treatment with other pollen allergoids.

    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 vial of an allergoid, 8 vials of dilution fluid for an allergoid, 1 empty sterile vial in a pack of cardboard along with instructions for use.
    Storage conditions:

    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 0 C. Freezing is not allowed.

    Shelf life:Allergoid - 2 years, diluting the liquid for an allergoid - 5 years. The drug with expired shelf life is not subject to application.
    Terms of leave from pharmacies:On prescription
    Registration number:P N001539 / 01
    Date of registration:05.03.2009 / 18.04.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Manufacturer: & nbsp
    Information update date: & nbsp23.10.16
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