Allergen from pollen of a wormwood bitter

General characteristics. Structure:

Active ingredient: 10 000 PNU allergens from pollen of a wormwood bitter 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 wormwood bitter.

Indications for diagnosis are clinical displays of a disease and data of the anamnesis, and for an immunotherapy data of skin testing with offending allergen.

Route of administration and doses:

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

— 1 week after tuberkulinovy test;

— 2 weeks after use of the inactivated vaccines and therapy by antihistaminic drugs;

— 4 weeks after use of live vaccines;

— 8-12 weeks after use of vaccine BTsZh.

For the purpose of identification of contraindications the doctor in day of statement of allergy tests and in day of carrying out a specific immunotherapy performs inspection of the patient.

I.Специфическая diagnosis. Drug is used for statement of skin tests (scarification, the prik-test and vnutrikozhno).

Skin tests put once. At doubtful results 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.

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) of 0.9% solution of sodium chloride isotonic for injections (9 parts). Divorced solution of a histamine is good within 6 hours from the moment of preparation.

Skin tests put on the internal surface of a forearm or on back skin. About 15 tests with pollen allergens of various names are in one step allowed to carry out.

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 by alcohol with a sterile needle.

Skin of an internal surface of a forearm is wiped 70 ° with alcohol and allowed it to dry. By means of sterile syringes, separate for each allergen, apply drops of examinees of allergens, 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.

Through drug drops sterile scarifying or syringe needles, individual for each allergen and for each patient, put two parallel scratches 5 mm long (scarification) or carry out a skin prick on depth no more than 1 - 1.5 mm (prik-test).

If test on allergen gives negative reaction, and in the anamnesis is available data on hypersensitivity to this allergen or if it is necessary to carry out allergometrichesky titration for definition of an initial dose for carrying out a specific immunotherapy, put vnugrikozhny 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 and for each patient with 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.

Diagnosis by the test of a prick (prik-test) is carried out according to methodical recommendations of MZ USSR 10-11/20 of March 10, 1985.

Assessment of diagnostic skin tests. The result of diagnostic tests is considered in 15-20 min. (reaction of immediate type) 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 skin reactions (scarification, prik-test).

Reaction assessment	Symbols	Size and nature of reaction
Negative	-	Lack of a blister and hyperemia;
Positive	+	Blister of 2-3 mm, hyperemia;
Positive	++	Blister of 4-5 mm, hyperemia;
Positive	+++	Blister of 6-10 ml, hyperemia or blister of 6-10 mm with pseudopodiums, a hyperemia;
Positive	++++	Blister more than 10 mm, hyperemia or blister more than 10 mm with pseudopodiums, a hyperemia.

Scheme of the accounting of skin reactions (intradermal).

Reaction assessment	Symbols	Size and nature of reaction
Negative	-	The sizes are same, as well as in control.
Positive	+	The blister with a diameter of 4-7 mm surrounded with an erythema.
Positive	++	The blister of 8-14 mm in the diameter surrounded with a hyperemia.
Positive	+++	The blister of 15-20 mm in the diameter with pseudopodiums surrounded with a hyperemia.
Positive	++++	Blister more than 20 mm in the diameter with pseudopodiums and (or) a lymphangitis, and (or) additional blisters on the periphery and a bright erythema.

Ii.Spetsificheskaya immunotherapy. The specific immunotherapy is carried out when it is impossible to exclude contact of the sensibilized patient with allergen. 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. 

Allergen at a specific immunotherapy is entered subcutaneously. Other ways of administration of allergen in the medical purposes can be used only on the basis of the Methodical instructions approved by MZ of the Russian Federation. 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.   Detailed description of a technique specific it is presented to an immunotherapy in methodical letter of MZ USSR "Use of allergens noninfectious origin" A. D. Ado, See. Titova, Yu. A. Poroshin. Moscow. 1969.
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.

Use for children. When carrying out specific diagnosis and an immunotherapy children should be guided by the order MZ Russian Federation of 04.11.2002. "About improvement of the allergological help to children in the Russian Federation".

Special instructions. Assistance at reactions of the general type and an acute anaphylaxis. In cases if during administration of allergen with the diagnostic or medical purpose the patient has the general weakness or excitement, concern, feeling of heat in all body, face reddening, rash, cough, the complicated breath, abdominal pains, it is necessary to hold the following events:

First pre-medical aid. To immediately stop administration of allergen; to lay the patient (the head is lower than legs) to turn the head aside, to put forward a mandible, to remove the removed dentures.

1. If allergen was entered into an extremity, to impose a plait above an injection site for 25 min.

2. To cut away the place of an injection of 0.3-0.5 ml of 0,1% of solution of adrenaline from 4.5 ml of 0.9% of solution of chloride sodium.

3. To the place of an injection to put ice or a hot-water bottle with cold water for 10-15 min.

4. In an extremity, free from a plait to enter subcutaneously or intramusculary 0.3-0.5 ml of 0.1% of solution of adrenaline (children of 0.15-0.3 ml).

5. To urgently call the doctor.

First medical assistance. If points 1-5 are implemented and there is no effect, follows:

1. To enter subcutaneously or intramusculary 0.3-0.5 ml (children of 0.15-0.3 ml) of 0.1% of solution of bucketed adrenaline of 5-10 min. Frequency rate and a dose of the entered adrenaline depends on weight of reaction and indicators of arterial pressure. At a heavy acute anaphylaxis solution of adrenaline needs to be entered intravenously into 20 ml of 0.9% of solution of chloride sodium. The general dose of adrenaline should not exceed 2 ml (children of 1 ml) of 0.1% of solution. It is necessary to remember that repeated introduction of small doses of adrenaline is more effective, than single introductions of a high dose.

2. If arterial pressure is not stabilized, it is necessary to begin urgently intravenous drop administration of noradrenaline (or a phenylephine hydrochloride) 0.2-1.0 - 2.0 ml on 500.0 ml of 0.9% of solution of chloride sodium.

3. Intramusculary or intravenously struyno to administer the glucocorticosteroid drugs: Prednisolonum of 60-120 mg (children of 40-100 mg), dexamethasone of 8-16 mg (children of 4-8 mg) or hydrocortisone succinate or гемисукцинат 125-250 mg (children of 25-125 mg).

4. To intramusculary enter 2.0 ml (children of 0.5-1.5 ml) of solution of tavegil of 0.1% or Suprastinum of 2.5%.

5. At a bronchospasm 10.0 ml (children of 2-3 ml) of 2.4% of solution of an Euphyllinum for 0.9% - number solution of chloride sodium are intravenously entered.

6. Cardiac glycosides, respiratory analeptics (strophanthin, Korglykonum, Cordiaminum) are entered according to indications.

7. If necessary it is necessary to suck away slime from respiratory tracts, emetic masses and to carry out an oxygenotherapy.

All patients with an acute anaphylaxis are subject to hospitalization. Transportation of patients is made after removal from the menacing state by resuscitation crew since during evacuation perhaps repeated falling of arterial pressure and development of a collapse.

Doses of the administered drugs and tactics of the doctor are defined by a clinical picture, but in all cases it is necessary, first of all administration of adrenaline, glucocorticoids, antihistaminic drugs.

Administration of antihistaminic drugs of a fenotiazinovy row (Pipolphenum, isopromethazine, etc.) and drugs of calcium is not recommended.

Use in pediatrics. When carrying out specific diagnosis and an immunotherapy children should be guided by the order MZ Russian Federation of 04.11.2002. "About improvement of the allergological help to children in the Russian Federation".

Side effects:

Reaction to introduction. Local reaction to allergen arises in 15-20 min. (reaction of immediate type). Duration of local reaction is from 30 to 40 min.

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.

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;
— hormonal therapy, therapy by antihistaminic drugs and bronkhospazmolitika.

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 aggravation period;
— hormonal therapy, therapy by antihistaminic drugs and bronkhospazmolitika.

Storage conditions:

Allergens store according to the joint venture 3.3.2.1248-03 in dry, protected from light and the place, unavailable to children, at a temperature from 4 °C to 8 °C. Transportation is carried out according to the joint venture 3.3.2.1248-03 at a temperature from 4 °C to 8 °C. 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.