Allergen from pollen of a herd grass meadow

General characteristics. Structure:

Active ingredient: 10 000 PNU allergens from pollen of a herd grass meadow in 1 ml of solution for diagnosis and treatment.

Excipients: sodium phosphate, disubstituted, 12-water, potassium phosphate, monosubstituted, sodium chloride, phenol (preservative), water for injections.

Pharmacological properties:

Pharmacodynamics. The main effective agent of pollen allergens is proteinaceous полисахаридный the complex allowing to diagnose for the patient at statement of skin tests hypersensitivity to this type of pollen of plants and to apply it to an immunotherapy of pollinoses.

Indications to use:

— specific diagnosis and treatment of the pollinoses, atopic bronchial asthma caused by hypersensitivity to pollen of a herd grass meadow.

Indications for diagnosis are clinical displays of a disease and data of the anamnesis.

Indications for carrying out a specific immunotherapy are defined by the allergologist on the basis of data of the anamnesis, clinical displays of a disease, results of skin testing, taking into account contraindications.

Route of administration and doses:

I. Specific diagnosis. Drug is used for statement of skin tests (scarification, the prik-test and vnutrikozhno). Specific diagnosis is carried out, as a rule, along with other pollen allergens. During one procedure about 15 tests with pollen allergens of various names are allowed to carry out.

Skin tests put on the internal surface of a forearm or, if necessary, on back skin. Along with allergen carry out statement of skin tests with test and control liquid and from 0.01% solution of a histamine which is prepared by cultivation of 0,1% of solution of a histamine of dihydrochloride (1 part) chloride sodium solution for injections of 0.9% (9 parts). Divorced solution of a histamine is good during 6 h from the moment of preparation.

The metal cap of bottles (with allergens or test and control liquid) is wiped with alcohol. Delete with sterile tweezers the central cover of a cap, and puncture the rubber bung which is previously processed 70% by alcohol with a sterile needle.

Skin of an internal surface of a forearm is wiped by 70% with alcohol and allow it to dry. By means of the sterile syringe apply a drop of the examinee of allergen, a drop of test and control liquid and a drop of 0.01% of solution of a histamine on the disinfected skin at distance (30±10) mm from each other. The allergen gathered in the syringe cannot be poured out back in a bottle.

At statement of scarifying skin tests through the put drops put with a sterile scarifying needle two parallel scratches 5 mm long.

At statement of prik-tests through the put drops carry out by a sterile syringe needle a skin prick on depth no more than 1-1.5 mm.

At the expressed skin reaction carry out selection of a safe initial medical dose for what use a method of allergometrichesky titration.

Vnugrikozhny tests are put when there are discrepancies in data of clinical diagnostic methods and scarifying tests.

Intracutaneous tests carry out on the internal surface of a forearm. Skin is pulled the movement of a finger from top to bottom, the needle is entered at an angle 15 ° to the surface of skin, at the same time it is necessary to watch that the needle opening completely disappeared in epidermis, the needle has to be thin with a short edge.

Sterile, individual for each allergen, the marked syringes with a scale of division of 0.02 ml, strictly vnutrikozhno enter 0.02 ml of allergen and test and control liquid, a histamine put test from 0.01% by a scarification method.

Assessment of diagnostic skin tests. Local reaction of skin at statement of scarifying skin tests, prik-tests is considered in 15-20 min., and intracutaneous tests in 20 min. in the absence of reaction to test and control liquid and in the presence of positive test on a histamine.

Scheme of the accounting of scarifying skin tests.

Reaction assessment	Reaction degree of manifestation *	Size and nature of reaction
Negative	-	Lack of a blister (papule) and hyperemia, the sizes as in control with test and control liquid
Positive	+	The blister (papule) of 2-3 mm with a hyperemia, is swept up only at a skin tension
Positive	++	The blister (papule) of 4-5 mm surrounded with a hyperemia is swept up without skin tension
Positive	+++	Blister (papule) of 6-10 mm, hyperemia or blister (papule) of 6-10 mm with a hyperemia and pseudopodiums
Positive	++++	Blister (papule) more than 10 mm, a hyperemia or a blister (papule) more than 10 mm a hyperemia with pseudopodiums
Doubtful	+ -	Hyperemia without blister

Scheme of the accounting of prik-tests.

Reaction assessment	Reaction degree of manifestation *	Size and nature of reaction
Negative	-	Lack of a blister (papule) and hyperemia, the sizes as in control with test and control liquid
Positive	+	The blister (papule) of 3-5 mm with a hyperemia to 10 mm, is swept up only at a skin tension
Positive	++	The blister (papule) of 5-10 mm surrounded with a zone of a hyperemia with a diameter of 5-10 mm
Positive	+++	The blister (papule) of 10-15 mm surrounded with a zone of a hyperemia with a diameter more than 10 mm
Positive	++++	Blister (papule) more than 15 mm with psevdpodiya, a hyperemia with a diameter more than 20 mm
Doubtful	+ -	Hyperemia without blister

Scheme of the accounting of intracutaneous tests.

Reaction assessment	Reaction degree of manifestation *	Size and nature of reaction
Negative	-	The sizes are same, as well as in control
Positive	+	The blister (papule) with a diameter of 4-7 mm surrounded with a hyperemia
Positive	++	The blister (papule) of 8-14 mm in the diameter surrounded with a hyperemia
Positive	+++	The blister (papule) of 15-20 mm in the diameter with pseudopodiums surrounded with a hyperemia
Positive	++++	Blister (papule) more than 20 mm in the diameter with pseudopodiums and (or) an erythema around (additional blisters on the periphery of pink or bright red color)
Doubtful	+-	In the place of test the blister resolves more slowly, than in control

Note:

* Reaction degree of manifestation:

- Negative;

+ Slabopolozhitelny;

++ Positive;

+++ Sharply positive;

++++ Very sharply positive;

+ - Doubtful.

II. Specific immunotherapy. The specific immunotherapy is carried out when it is impossible to exclude contact of the sensibilized patient with allergen. Allergen at a specific immunotherapy is entered subcutaneously. For preparation and use of cultivations of allergen in the conditions of an asepsis responsibility is born by the allergologist.

The approximate scheme of a specific immunotherapy at pollinoses.

Allergen cultivation	Dose (ml)	Notes
1	2	3
10-5 1:100000 1.0 PNU/ml	0.1 0.2 0.4 0.8	The specific immunotherapy is begun not later, than in 1,5 months prior to blossoming. Injections do subcutaneously to the area lower thirds of a shoulder. The first injections (at cultivation allergen 10-5, 10-4, 10-3) do daily or every other day, the subsequent injections (cultivations 10-2, 10-1) - with an interval of 7-10 days. Allergen dose 0.9-1.0 the ml in cultivation 10-1 is repeated with interval of 5-7 days prior to blossoming of trees and herbs. Allergen use term later its cultivations - 1 month.   After each injection of allergen of the patient observe in an office within 30 min. Doctor notes reaction of skin on site of introduction allergen and general condition of the patient.   Contraindication for increase in a dose is local reaction in the form of infiltrate the size more than 25 mm, general reaction of an organism, aggravation basic disease. In these cases a dose reduce, intervals between injections extend until good is established portability.
10-4 1:100000 1.0 PNU/ml	0.1 0.2 0.4 0.8
10-3 1:100000 1.0 PNU/ml	0.1 0.2 0.4 0.8
10-2 1:100000 1.0 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 1.0 PNU/ml	0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0

Features of use:

Use at pregnancy and feeding by a breast. The immunotherapy is contraindicated at pregnancy and a lactation.

Special instructions. At doubtful results of skin tests they can be repeated in 2 days after subsiding of local reaction to the previous tests. In case of positive takes, it is allowed to repeat skin tests with pollen allergens not more often than once a month.

Especially sensitive patients can have a system allergic reaction and an acute anaphylaxis. In this regard, in an office where specific diagnosis and a specific immunotherapy of patients is carried out, there have to be pharmacological drugs and tools for rendering acute management.

Assistance at reactions of the general type and an acute anaphylaxis. After administration of allergen symptoms of clinical manifestations of hypersensitivity to allergen can develop. At parenteral administration of allergen development of reaction of immediate type, including an anaphylaxis which is shown in the form of a small tortoiseshell and vascular hypostasis, hypostasis of a throat, the complicated breath and suffocation is possible. These symptoms often arise after feeling of a generalized itch, burning sensation, a hyperemia of integuments, and also feelings of fear of death.

In the investigation of an acute anaphylaxis not stopped bronchospasm, the asphyxia caused by hypostasis of upper respiratory tracts and a collapse can develop.

In this case urgent medical actions are required. The pre-hospital help at an acute anaphylaxis.

1. To immediately stop administration of the allergen which caused reaction, to lay the patient on a couch (the head lower than legs), to turn the head aside, to put forward a mandible, to remove the available dentures.

2. To impose a plait into place above administration of allergen if it is possible.

3. To cut away the place of an injection of 0,3-0,5 ml of solution of adrenaline (to dissolve with 1 ml of 0,1% of solution of adrenaline in 3-5 ml of sodium of chloride of solution for injections 0,9%).

4. To the place of an injection to put a bubble with ice.

5. To enter 0,3-0,5 ml of 0,1% of solution of adrenaline (children of 0,05-0,1 ml/year of life) in oil or in/in at an interval of 5-10 minutes. Frequency rate and a dose of the entered adrenaline depends on weight of shock and indicators of arterial pressure. The general dose of adrenaline should not exceed 1 ml of 0,1% of solution. Repeated introduction of small doses of adrenaline is more effective, than single introduction of a high dose.

6. To provide access of fresh air or to give oxygen. At disturbance of a respiratory rhythm or its difficulty to carry out the artificial ventilation of the lungs (AVL).

7. To urgently call the doctor, the resuscitation crew at the same time is called.

Before arrival of resuscitation crew it is necessary to provide medical care and to carry out constant control behind hemodynamic indicators and a condition of the function of external respiration (FER).

The hospital help at an acute anaphylaxis.

1. At critical condition of the patient and at the expressed disturbances of a hemodynamics enter 0,01% of solution of adrenaline into slowly 5 ml, at achievement of effect stop introduction. To children of 0,1 ml/kg of 0,01% of solution slowly within several minutes.

2. If the ABP is not stabilized, to urgently begin intravenous drop administration of Norepinephrinum (Phenylephrinum, a dopamine) of 0,2% 1,0-2,0 ml for 500 ml of 5% of solution of glucose for infusions or sodium of chloride of solution for injections of 0,9%.

3. Intravenously struyno to enter glucocorticosteroids: Prednisolonum - 60-180 mg (children of 5 mg/kg), dexamethasone - 8-20 mg (children of 0.3-0.6 mg/kg), a hydrocortisone - 200-400 mg (children of 4-8 mg/kg). On a state administration of hormones is repeated and continued not less than 4-6 days for prevention of allergic reactions on the immunocomplex or slowed-down type.

4. Only at stabilization of the ABP intramusculary to enter 2.0 ml of 2% of solution of Chloropyraminum (children of 0.1-0.15 ml/year of life) or 0.1% of Clemastinum.

5. Symptomatic therapy according to indications. At a bronchospasm 10,0 ml of 2,4% of solution of Aminophyllinum on chloride sodium solution for injections of 0.9% (children of 1 ml/year of life) are intravenously struyno entered. If necessary cardiac glycosides, respiratory analeptics are entered.

6. If necessary suck away the accumulated secret and emetic masses from respiratory tracts, begin an oxygenotherapy.

7. Additional administration of salbutamol and/or a glucagon in/in 1 ml is shown to the patients receiving beta adrenoblockers.

8. At acute hypostasis of a throat the intubation or tracheotomy is shown.

All patients with an acute anaphylaxis are subject to obligatory hospitalization for the term of not less than 10 days for the purpose of continuation of observation and treatment since at 2-5% of the patients who transferred an acute anaphylaxis late allergic reactions are observed.

Doses of the entered drugs and tactics of the doctor are defined by a clinical picture, but in all cases administration of adrenaline, glucocorticosteroid drugs is necessary, first of all. Administration of drugs of a fenotiazinovy row and drugs of calcium contraindicated.

Influence on ability to manage vehicles, mechanisms. It is not described.

Side effects:

At administration of allergen local and general reactions are possible. In some cases highly sensitive patients at a specific immunotherapy allergen can have general reactions which are shown by symptoms of various degrees of severity: from moderately expressed - cough, sneezing, a headache, a small tortoiseshell, a face edema, a konjyuktivit, rhinitis, a bronchospasm, an aggravation of a basic disease to an acute anaphylaxis in rare instances.

Local reactions are expressed by education in an injection site of hypostasis, a hyperemia, arise in 15-20 minutes and continue from 30 to 40 minutes.

After each injection of allergen of the patient it has to be observed by the allergologist not less than 60 min. During this time the doctor has to note reaction of skin to administration of allergen and the general condition of the patient. Has to inform the doctor on the remote reactions of the patient. In an office where the specific immunotherapy of patients is carried out, there have to be pharmacological drugs and tools for rendering acute management.

Interaction with other medicines:

Skin tests and treatment by allergens should be carried out through:

- 1 week after tuberkulinovy test;

- 2 weeks after use of the inactivated vaccines;

- 4 weeks after use of live vaccines;

- not earlier than in 8-12 weeks after use of vaccine BTsZh;

- in 3-5 days cancellation of glucocorticosteroids and antihistaminic drugs I of generation, in 4 weeks - antihistaminic drugs II of generation is required.

Contraindications:

Contraindications for carrying out specific diagnosis:

— exacerbation of an allergic disease;
— acute infections;
— chronic diseases in a decompensation stage;
— tuberculosis of any localization in the period of an aggravation;
— general diseases of connecting fabric;
— system glucocorticosteroid therapy, therapy (beta-adrenergic agonists and antihistaminic drugs.

Contraindications for carrying out a specific immunotherapy:

— exacerbation of an allergic disease;
— severe form of atopic eczema;
— autoimmune diseases;
— immunodeficiency;
— acute infections;
— tuberculosis of any localization in the period of an aggravation;
— malignant new growths and diseases of blood;
— chronic diseases in a decompensation stage;
— cardiovascular diseases;
— pregnancy and period of a lactation;
— mental diseases in the period of an aggravation;
— system glucocorticosteroid therapy, therapy by beta-adrenergic agonists and antihistaminic drugs.

Storage conditions:

Allergens store according to the joint venture 3.3.2.1248-03 in protected from light and the place, unavailable to children, at a temperature from 2 to 8 °C. Freezing is not allowed. Transportation is carried out according to the joint venture 3.3.2.1248-03 at a temperature from 2 to 8 °C. Freezing is not allowed. An allergen period of validity - 2 years, the test and control and parting liquids - 5 years.

Issue conditions:

According to the recipe

Packaging:

5 ml - bottles glass (1) complete with test and control liquid of 4.5 ml фл. (1 piece), the parting liquid of 4.5 ml фл. (7 pieces) and empty sterile фл. (1 piece) - packs cardboard.