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

Mixed-allergen is an aqueous saline extract belkovopolisaharidnyh complexes - 10,000 PNU / ml *, isolated from a mixture of pollen of meadow grass (cocksfoot, fire direct, foxtail meadow, Poa pratensis, Festuca pratensis, quack grass, perennial ryegrass, timothy grass in equal ratios) by extraction in a neutral phosphate-buffered saline solution.

Phosphate buffered saline contains (in 1 ml): sodium chloride - 5.0 mg Sodium hydrogen phosphate dodecahydrate (equivalent to 0.56 mg of sodium dihydrogen phosphate) - 1.4 mg, of potassium dihydrogenphosphate - 0.36 mg phenol (preservative) - 2,0-4,0 mg, water for injections - 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.

In a set with mixt-allergen, test-control and dilution liquids are produced.

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

The diluting liquid - phosphate buffered saline, in which polysorbate-80 is added, contains (in 1 ml): sodium chloride - 5.0 mg, sodium hydrophosphate dodecahydrate (equivalent to 0.56 mg sodium hydrophosphate) - 1.4 mg, 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:Mikst-allergen from pollen of meadow grasses is a transparent liquid from yellow to brown color. The test-control liquid and the diluent liquid are colorless transparent liquids.
Pharmacotherapeutic group:MIBP is an allergen
Pharmacodynamics:Immunobiological properties. The main active ingredient of the mixt-allergen is the protein-polysaccharide complex, which makes it possible to diagnose a hypersensitivity to the entire complex, or a particular kind of pollen, which is part of the mixt-allergen, and apply it to immunotherapy for pollinosis and atopic bronchial asthma.
Indications:

Specific diagnostics and specific immunotherapy of pollinosis and atopic bronchial asthma caused by hypersensitivity to pollen of meadow grasses (timothy grass, hedgehog,ryegrass pasture, bonfire straight, fescue fescue, wild grass creeping, foxtail meadow, bluegrass meadow).

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 with a specific mixed-allergen, 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. 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. Tuberculosis of any localization in the period of exacerbation.

7. Severe bronchial asthma, poorly controlled by pharmacological drugs (volume of forced expiration in 1 sec less than 70% after adequate pharmacotherapy).

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 of age (for specific immunotherapy); up to 6 months (for specific diagnosis).

12. Pregnancy and lactation.

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

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

15. Therapy with β-adrenoblockers (for specific immunotherapy).

16. Systemic glucocorticosteroid therapy, therapy with 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 different pollen allergens are allowed, except for allergens of plant species included in the mixt-allergen. For 2-3 days before the setting of skin tests, antihistamines should be canceled.With doubtful results of skin tests, they can be repeated two days after the local reaction to the previous samples subsided. In case of a positive result, skin tests with pollen allergens can be repeated no more than once a month.

A patient with an increased sensitivity to at least one of the allergens that make up the mixt-allergen from the pollen of meadow grasses, an immediate-type reaction of the type appears (positive result). The question of the necessity of setting skin tests with individual monoallergens that are part of the mixed-allergen is decided by the allergist doctor.

The skin test is performed with a mixt-allergen containing 10,000 PNU / ml. In patients with a high degree of sensitization, it is possible to apply the drug at a concentration of 5000 PNU / ml. In the absence of a reaction to the skin test at a concentration of 10,000 PNU / ml, it is switched to its intradermal administration at a dose of 0.02 ml at a concentration of 1000 PNU / ml. The preparation is diluted with a diluting liquid.

Setting skarification skin tests, prik-tests.

Scarification skin tests, prik-tests put on the inner surface of the forearm or, if necessary, on the skin of the back.

Simultaneously with the mixt-allergen, skin tests with test-control fluid and with 0.01% histamine solution are prepared, which is prepared by diluting 0.1% of histamine dihydrochloride solution (1 part) of sodium chloride with a solution of 0.9% (9 parts), positive reaction to which no less than "+" indicates the presence of sufficient reactivity of the skin. The diluted solution of histamine is suitable for 6 hours from the moment of preparation.

The metal cap of vials (with mixed-allergen, test-control liquid) is wiped 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 test mix-allergen, a drop of test-control fluid and a drop of 0.01% histamine solution at a distance (30 ± 10) mm from each other are applied to the disinfected skin with a sterile syringe. Mixt-allergen, typed in a syringe, can not be poured back into the vial.

When setting skarifikatsionnyh skin tests through drops of applied solutions with sterile scarifiers or injection needles, two parallel scratches with a length of 5 mm are applied.

When prik-tests are applied through droplets of applied solutions with sterile injecting needles, shortened or with the depth stop of the prick or needles for prik-test (lancets), the skin is injected to a depth of 1.0-1.5 mm. When using injection needles, the skin is pierced at an angle of 45 ° so that blood does not protrude; then the needle is removed, slightly lifting the skin.

After 15-20 minutes, sterile cotton swabs "drip" the drops of applied solutions at the site of scratches or puncture of the skin (a cotton swab should be separate for each drop of applied solutions) and take into account the skin reaction.

Injection of intradermal samples.

Intradermal tests are set in cases where the scarification skin test gives a negative reaction, and a history of susceptibility to the pollen of plants that is part of the mixt-allergen and / or if it is necessary to perform allergometric titration before the start of specific immunotherapy.

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 mixed-allergen and test-control fluid, marked syringes with a scale of 0.02 ml, strictly intracutaneously injected 0.02 ml of mixed-allergen and test-control fluid, a sample with 0.01% histamine solution is put scarification. Mixt-allergen, typed in a syringe, can not be poured back into the vial.

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, 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 (not less than "+") (Table 1 ).

Table 1. Scheme of accounting for scarification skin tests, prik-tests.

Evaluation of reaction

Power

severity of reaction *

The size and nature of the reaction

Negative

Absence of a blister (papules), hyperemia with dimensions as in control with a test-control fluid.

Doubtful

±

Absence of blister (papules), hyperemia with sizes exceeding those in control with test-control fluid.

Positive

+

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

Positive

++

Blister (papule) 4-5 mm, hyperemia (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 pseudopodia, hyperemia (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 with pseudopodia, hyperemia (for scarification tests). Blister (papule) more than 15 mm with pseudopodia, hyperemia with a diameter of more than 20 mm (for prik-tests)

Scheme of recording intradermal samples.

Evaluation of reaction

Power

severity of reaction *

The size and nature of the reaction

Negative

-

Dimensions are the same as in the control

Doubtful

±

At the test site, the blister dissolves more slowly than 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)

Note:

* Degree of severity of reaction:

- Negative;

± Doubtful;

+ Weakly positive;

++ Positive;

+++ Sharply positive;

++++ Very sharply positive.

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 mixt-allergen.

The mixed-allergen immunotherapy is administered to patients who have been sensitized to all types of pollen that is part of the complex preparation.

Immunotherapy starts with a dose 10 times lower than the one that caused a minimal positive reaction, with intradermal injection.

Mixt-allergen with specific immunotherapy is administered subcutaneously.

For the correct preparation and use of dilutions of the mixt-allergen with the observance of asepsis, the responsibility is borne by the allergist doctor.

Dilutions of the drug, the volume administered (dose) and the recommended scheme of application are given in Table 2.

Table 2. An example scheme of specific immunotherapy in pollinosis.

Breeding

Dose

Notes

allergen

(ml)

1

2

3

10-5

0,1

Specific immunotherapy is started after

1:100000

0,2

diagnosis of atopic disease no later than

0,1 PNU/ ml

0,4

than 3-4 months before the beginning of flowering and complete

0,8

later than 1.5 months before the beginning of flowering plants.

10-4

0,1

Injections are made strictly subcutaneously in the lower region

1:10000

0,2

third of the shoulder. The first injections (with the dilution of the mixt-

1,0 PNU/ ml

0,4

Allergen 10-5, 10-4, 10-3) do daily or through

0,8

day, subsequent injections (dilutions 10-2, 10-1) - from

10-3

0,1

an interval of 7-10 days. The dose of mixt-allergen is 0.9-1.0 ml

1:1000

0,2

in breeding 10-1 repeat at intervals of 5-7 days until

10 PNU/ ml

0,4

the beginning of flowering plants. Term of use of a mixt-

0,8

allergen after its dilution - 1 months.

10-2

0,1

After each injection of the patient's mixed-allergen

1:100

0,2

observe in the office for at least 60 minutes. Doctor notes

100 PNU/ ml

0,3

reaction of the skin at the site of injection of the mixt-allergen and

0,4

general condition of the patient.

0,5

Contraindication for increasing the dose is

0,6

local reaction in the form of an infiltrate larger than

0,7

25 mm, which occurred during the day at the injection site,

0,8

general reaction of the organism, exacerbation of the main

0,9

disease. In these cases, the dose is reduced,

1,0

intervals between injections are extended until

10-1

odes

good tolerance will be established.

1:10

0,2

1000 PNU/ ml

0,3

0,4

0,5

0,6

0,7

0,8

0,9

1,0

Precautions for use.

In particularly sensitive patients, a systemic allergic reaction and anaphylactic shock can 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 treatment.

Assisting with general reactions and anaphylactic shock.

After the introduction of the mixt-allergen from the pollen of meadow grasses, the symptoms of clinical manifestations of hypersensitivity to the mixt-allergen may develop. With parenteral administration of mixed-allergen, the development of an immediate-type reaction is possible, 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 care for anaphylactic shock.

1. Immediately stop the injection of the mixed 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 to the site above the injection of the mixt-allergen, 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 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 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 (children of 6-12 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. 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.

Side effects:

When a mixed-allergen is administered, local and general reactions are possible. In a number of cases, in highly sensitive patients with a specific immunotherapy with a mixt-allergen, general reactions can occur that manifest themselves in symptoms of varying degrees of severity: from moderately expressed cough, sneezing, headache, urticaria, edema of the face, conjunctivitis, rhinitis, bronchospasm,exacerbation of the underlying disease before anaphylactic shock in rare cases. Local reactions are expressed by education at the site of administration of edema, hyperemia.

After each injection of mixed-allergen, 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 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 a mixt-allergen 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. Simultaneous reception of symptomatic drugs for the treatment of allergies is possible for better tolerability of ASIT 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 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, 10,000 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: 2 vials of mixed allergen, 7 bottles of dilution liquid, 1 vial of test-control liquid 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 0 C. Freezing is not allowed.

Shelf life:Mixt-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:P N001534 / 01
Date of registration:18.11.2008 / 08.11.2012
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: & nbsp08.06.2018
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