Allergen from pollen of a birch trailing

General characteristics. Structure:

Active ingredient: 10000 PNU/ml * water-salt extract proteinaceous полисахаридных the complexes allocated from pollen of a birch trailing with extraction in neutral phosphatic and salt buffered solution.

Excipients: the phosphatic and salt buffered solution containing: sodium chloride, hydrophosphate sodium dodecahydrate (0,56 mg of sodium of hydrophosphate are equivalent), potassium dihydrophosphate, phenol (preservative), water for injections. Concentration of the listed salts settlement, in ready drug is not defined.

Note: * PNU (proteinnitrogenunit) – the international unit accepted for expression of concentration of protein nitrogen in allergens equal to the content of 1х10 - 5 mg of protein nitrogen.

Complete with allergen produce the test and control and parting liquids. Test and control liquid – phosphatic and salt buffered solution contains: sodium chloride, hydrophosphate sodium dodecahydrate (0,56 mg of sodium of hydrophosphate are equivalent), potassium dihydrophosphate, phenol (preservative), water for injections.

The parting liquid – phosphatic and salt buffered solution to which polysorbate-80 is added contains: sodium chloride, hydrophosphate sodium dodecahydrate (0,56 mg of sodium of hydrophosphate are equivalent), potassium dihydrophosphate, phenol (preservative), polysorbate-80, water for injections.

Pharmacological properties:

Pharmacodynamics. The main effective agent of allergen is proteinaceous полисахаридный the complex allowing to diagnose for the patient at statement of skin tests hypersensitivity to pollen of a birch trailing and to apply it to an immunotherapy of pollinoses and atopic bronchial asthma.

Indications to use:

Specific diagnosis and specific immunotherapy of the pollinoses and atopic bronchial asthma caused by hypersensitivity to pollen of a birch trailing.

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. In 2-3 days prior to statement of skin tests antihistaminic drugs have to be cancelled. 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 a positive take, skin tests with pollen allergens can be repeated not more often than once a month.

Statement of scarifying skin tests, prik-tests. Scarifying skin tests, prik-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 a histamine of dihydrochloride of solution (1 part) of chloride sodium solution of 0,9% (9 parts), positive reaction to which not less "+" demonstrates existence of sufficient reactivity of skin. Divorced solution of a histamine is good during 6 h from the moment of preparation.

The metal cap of bottles (with allergen, 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 drops of the applied solutions put with sterile scarificators or syringe needles two parallel scratches 5 mm long.

At statement of prik-tests through drops of the applied solutions the sterile syringe needles shortened or with the limiter of depth of a prick or needles (lancets) make a skin prick on depth of 1,0-1,5 mm for the prik-test. When using syringe needles skin is pierced at an angle ⁴⁵⁰ so that blood did not act; then the needle is taken out, slightly raising skin.

In 15-20 min. "blot" with sterile cotton plugs drops of the applied solutions in the place of scratches or a puncture of skin (the cotton plug has to be separate for each drop of the applied solutions) and consider reaction of skin.

Statement of intracutaneous tests. Intracutaneous tests put in those cases if scarifying skin test gives negative reaction, and according to the anamnesis there is a suspicion on hypersensitivity to pollen of a birch trailing and/or if carrying out allergometrichesky titration before a specific immunotherapy is necessary.

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 ^15o 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 allergen and test and control liquid, 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, solution of a histamine put test from 0,01% by a scarification method. The allergen gathered in the syringe cannot be poured out back in a bottle.

Assessment of diagnostic skin tests. Local reaction of skin at statement of scarifying skin tests, prik-tests is considered in 15-20 min., 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 (not less "+") (Table 1).

Table 1. Scheme of the accounting of scarifying skin tests, prik-tests. 

Reaction assessment	Reaction degree of manifestation *	Size and nature of reaction
Negative	–	Lack of a blister (papule), hyperemia with sizes as in control with test and control liquid
Doubtful	±	Lack of a blister (papule), hyperemia with the sizes exceeding those in control with test and control liquid
Positive	+	The blister (papule) of 2-3 mm, is swept up only at a skin tension, a hyperemia (for scarifying tests); The blister (papule) of 3-5 mm, is swept up only at a skin tension, a hyperemia (for prik-tests)
Positive	++	Blister (papule) of 4-5 mm, hyperemia (for scarifying tests); Blister (papule) of 5-10 mm, hyperemia (for prik-tests)
Positive	+++	Blister (papule) of 6-10 mm, hyperemia or blister (papule) of 6-10 mm with pseudopodiums, a hyperemia (for scarifying tests); Blister (papule) of 10-15 mm, hyperemia (for prik-tests)
Positive	++++	Blister (papule) more than 10 mm, a hyperemia or a blister (papule) more than 10 mm with pseudopodiums, a hyperemia (for scarifying tests); Blister (papule) more than 15 mm with pseudopodiums, a hyperemia (for prik-tests)

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
Doubtful	+	In the place of test the blister resolves more slowly, than 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)

 Note: 

 * Degree of expressiveness of reaction: 

– Negative; 

 + Doubtful; 

 + Slabopolozhitelny; 

 ++ Positive; 

 +++ Sharply positive; 

 ++++ Very sharply positive. 

II. Specific immunotherapy. 

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

The immunotherapy is begun with a dose by 10 times smaller, than that which caused the minimum positive reaction, at intradermal introduction. 

Allergen at a specific immunotherapy is entered subcutaneously. 

For correctness of preparation and use of cultivations of allergen with observance of an asepsis the otvetyostvennost is born by the allergologist. 

Drug cultivations, the entered volume (dose) and the recommended scheme of use are given in table 2. 

Table 2. The approximate scheme of a specific immunotherapy at pollinoses. 

Allergen cultivation	Dose (ml)	Notes
1	2	3
10-5  1:100000  0,1 PNU/ml	0,1 0,2 0,4 0,8	The specific immunotherapy is begun after diagnosing of an atopic disease not later than 3-4 months prior to blossoming and completed not later than 1,5 months prior to blossoming of plants.  Injections do strictly subcutaneously to the area of the lower third of a shoulder. The first injections (at cultivation of 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. The dose of allergen of 0,9-1,0 ml in cultivation 10-1 is repeated with an interval of 5 - 7 days prior to blossoming of plants. The term of use of allergen after its cultivation - 1 month.  After each injection of allergen of the patient observe in an office not less than 60 min. The doctor notes reaction of skin on site of administration of allergen and the general condition of the patient.  Contraindication for increase in a dose is the local reaction in the form of infiltrate more than 25 mm in size which arose within a day on site injections, the general reaction of an organism, an aggravation of a basic disease. In these cases the dose is reduced, intervals between injections extend until good tolerance is established.
10-4  1:10000  1,0 PNU/ml	0,1 0,2 0,4 0,8
10-3  1:1000  10 PNU/ml	0,1 0,2 0,4 0,8
10-2  1:100  100 PNU/ml	0,1 0,2 0,3 0,4 0,5 0,6 0,7 0,8 0,9 1,0
10-1  1:10  1000 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:

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.

Use at pregnancy and during breastfeeding. Contraindicated.

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.

After each injection of allergen the patient 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 drug and the general condition of the patient. The patient has to inform the doctor on the remote reactions. 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 allergen should be carried out not earlier than through:
- 1 week after tuberkulinovy test;
- 1 month after vaccination by the inactivated vaccines;
- 3 months after inoculations live vaccines (both virus, and bacterial, including vaccine BTsZh).

Not to apply along with reception of β-adrenoblockers..........

The concomitant use of symptomatic drugs for treatment of an allergy for the best portability of ASIT is possible (β2-адреномиметиков, corticosteroids, inhibitors of degranulation of mast cells, in case of need further during an immunotherapy use of H1 - antihistaminic drugs is possible).

Perhaps simultaneous use with pollen allergens of other names.

Contraindications:

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.

1. Exacerbation of an allergic disease.
2. Acute infections.
3. Chronic diseases in a stage of an aggravation and/or a decompensation.
4. Immunodeficiency.
5. Autoimmune diseases.
6. Tuberculosis of any localization in the period of an aggravation.
7. The heavy bronchial asthma which is badly controlled by pharmacological drugs (the volume of the forced exhalation for 1 sec. less than 70% after carrying out adequate pharmacotherapy).
8. Malignant new growths and diseases of blood.
9. Mental diseases in the period of an aggravation.
10. General diseases of connecting fabric.
11. Children's age up to 5 years (for a specific immunotherapy); up to 6 months (for specific diagnosis).
12. Pregnancy and period of a lactation.
13. Cardiovascular diseases at which complications when using adrenaline (Epinephrinum) are possible (for a specific immunotherapy).
14. A severe form of atopic eczema (for a specific immunotherapy).
15. Therapy by β-adrenoblockers ((((((((((for a specific immunotherapy).
16. System glucocorticosteroid therapy, therapy of a β-adrenomimetikama and antihistaminic drugs (for specific diagnosis).

Storage conditions:

In the place protected from light, at a temperature of 2-10 °C and humidity no more than 60%. To store in the place, unavailable to children. A period of validity - 2 years.

Issue conditions:

According to the recipe

Packaging:

Solution for cutaneous scarifying drawing, intradermal and hypodermic introduction, 10000 PNU/ml on 5,0 ml in a bottle; test and control liquid on 4,5 ml in a bottle; the parting liquid on 4,5 ml in a bottle. Is issued in a set: 1 bottles of allergen, 7 bottles of the parting liquid, 1 bottle of test and control liquid, 1 empty sterile bottle in a pack cardboard together with the application instruction.