Non-infectious allergens group plant pollen

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT Non-infectious Pollen Allergens

Composition:

Active substances: pollen allergens (Allergena e pollen):

1 ml of solution contains 10,000 PNU of allergen from white acacia pollen (Allergenum e pollen Robinia pseudoacacia),

1 ml of solution contains 10,000 PNU of allergen from ragweed pollen (Allergenum e pollen Ambrosia artemisiifolia),

1 ml of solution contains 10,000 PNU of allergen from birch pollen (Allergenum e pollen Betula),

1 ml of solution contains 10,000 PNU of allergen from black elderberry pollen (Allergenum e pollen Sambucus nigra),

1 ml of solution contains 10,000 PNU of allergen from willow pollen (Allergenum e pollen Salix sp.),

1 ml of solution contains 10,000 PNU of allergen from sticky alder pollen (Allergenum e pollen Alnus glutinosa),

1 ml of solution contains 10,000 PNU of allergen from walnut pollen (Allergenum e pollen Juglans regia),

1 ml of solution contains 10,000 PNU of allergen from common hornbeam pollen (Allergenum e pollen Carpinus betulus),

1 ml of solution contains 10,000 PNU of allergen from oak pollen (Allergenum e pollen Quercus),

1 ml of solution contains 10,000 PNU of allergen from orchard grass pollen (Allergenum e pollen Dactylis glomerata),

1 ml of solution contains 10,000 PNU of allergen from common buckwheat pollen (Allergenum e pollen Fagopyrum esculentum),

1 ml of solution contains 10,000 PNU of allergen from cultivated rye pollen (Allergenum e pollen Secale cereale),

1 ml of solution contains 10,000 PNU of allergen from horse chestnut pollen (Allergenum e pollen Aesculus hippocastanum),

1 ml of solution contains 10,000 PNU of allergen from box elder pollen (Allergenum e pollen Acer negundo),

1 ml of solution contains 10,000 PNU of allergen from cypress pollen (Allergenum e pollen Cypress),

1 ml of solution contains 10,000 PNU of allergen from meadow foxtail pollen (Allergenum e pollen Alopecurus pratensis),

1 ml of solution contains 10,000 PNU of allergen from meadow fescue pollen (Allergenum e pollen Festuca pratensis),

1 ml of solution contains 10,000 PNU of allergen from stinging nettle pollen (Allergenum e pollen Urtica dioica),

1 ml of solution contains 10,000 PNU of allergen from common corn pollen (Allergenum e pollen Zea mays),

1 ml of solution contains 10,000 PNU of allergen from dandelion pollen (Allergenum e pollen Taraxacum officinale),

1 ml of solution contains 10,000 PNU of allergen from common hazel pollen (Allergenum e pollen Corylus avellana),

1 ml of solution contains 10,000 PNU of allergen from heart-leaved linden pollen (Allergenum e pollen Tilia cordata),

1 ml of solution contains 10,000 PNU of allergen from orache pollen (Allergenum e pollen Artiplex),

1 ml of solution contains 10,000 PNU of allergen from perennial ryegrass pollen (Allergenum e pollen Lolium perenne),

1 ml of solution contains 10,000 PNU of allergen from plane tree pollen (Allergenum e pollen Platanus vulgaris),

1 ml of solution contains 10,000 PNU of allergen from creeping couch grass pollen (Allergenum e pollen Agropyrum repens),

1 ml of solution contains 10,000 PNU of allergen from greater plantain pollen (Allergenum e pollen Plantago major),

1 ml of solution contains 10,000 PNU of allergen from wormwood pollen (Allergenum e pollen Artemisia absinthium),

1 ml of solution contains 10,000 PNU of allergen from common mugwort pollen (Allergenum e pollen Artemisia vulgaris),

1 ml of solution contains 10,000 PNU of allergen from meadow foxtail grass pollen (Allergenum e pollen Agrostis vulgaris),

1 ml of solution contains 10,000 PNU of allergen from common wheat pollen (Allergenum e pollen Triticum aestivum),

1 ml of solution contains 10,000 PNU of allergen from common sunflower pollen (Allergenum e pollen Helianthus annuus),

1 ml of solution contains 10,000 PNU of allergen from Scots pine pollen (Allergenum e pollen Pinus silvestris),

1 ml of solution contains 10,000 PNU of allergen from bromegrass pollen (Allergenum e pollen Bromus),

1 ml of solution contains 10,000 PNU of allergen from timothy grass pollen (Allergenum e pollen Phleum pratense),

1 ml of solution contains 10,000 PNU of allergen from meadow bluegrass pollen (Allergenum e pollen Poa pratensis),

1 ml of solution contains 10,000 PNU of allergen from poplar pollen (Allergenum e pollen Populus),

1 ml of solution contains 10,000 PNU of allergen from cyclachaena pollen (Allergenum e pollen Cyclachaena xanthiifolia),

1 ml of solution contains 10,000 PNU of allergen from common bird cherry pollen (Allergenum e pollen Padus racemosa),

1 ml of solution contains 10,000 PNU of allergen from white mulberry pollen (Allergenum e pollen Morus alba),

1 ml of solution contains 10,000 PNU of allergen from black mulberry pollen (Allergenum e pollen Morus nigra),

1 ml of solution contains 10,000 PNU of allergen from horse sorrel pollen (Allergenum e pollen Rumex confertus),

1 ml of solution contains 10,000 PNU of allergen from common spruce pollen (Allergenum e pollen Picea abies),

1 ml of solution contains 10,000 PNU of allergen from common ash pollen (Allergenum e pollen Fraxinus excelsior),

1 ml of solution contains 10,000 PNU of allergen from common barley pollen (Allergenum e pollen Hordeum vulgare);

mixed pollen allergens (mixtures of the listed allergens taken in equal proportions, composition as follows) (Mixt-allergena e pollen):

1 ml of solution contains 10,000 PNU of mixed pollen allergen No. 1 (from birch, sticky alder, oak, common hazel pollen) (Mixt-allergenum e pollen No. 1 (Betula, Alnus glutinosa, Quercus, Corylus avellana));

1 ml of solution contains 10,000 PNU of mixed pollen allergen No. 2 (from orchard grass, meadow bluegrass, perennial ryegrass, meadow fescue, meadow foxtail pollen) (Mixt-allergenum e pollen No. 2 (Dactylis glomerata, Poa pratensis, Lolium perenne, Festuca pratensis, Alopecurus pratensis));

1 ml of solution contains 10,000 PNU of mixed pollen allergen No. 3 (from bromegrass, creeping couch grass, cultivated rye, timothy grass pollen) (Mixt-allergenum e pollen No. 3 (Bromus, Agropyrum repens, Secale cereale, Phleum pratense));

1 ml of solution contains 10,000 PNU of mixed pollen allergen No. 4 (from wormwood, ragweed, orache, common sunflower pollen) (Mixt-allergenum e pollen No. 4 (Artemisia absinthium, Ambrosia artemisiifolia, Artiplex, Helianthus annuus));

Excipients: sodium chloride, disodium phosphate dodecahydrate (sodium phosphate dibasic), potassium dihydrogen phosphate (potassium phosphate monobasic), phenol, water for injections.

1 vial contains 5 ml of allergen (10,000 PNU/ml).

Note: 1 PNU (Protein Nitrogen Unit) is an international unit accepted for determining the concentration of protein nitrogen in allergens, equivalent to 0.00001 mg of protein nitrogen.

Pharmaceutical form. Solution for injection.

Main physicochemical properties: clear liquids ranging in color from pale yellow to dark brown.

Pharmacotherapeutic group. Allergen extracts. Grass pollen allergens.
ATC code V01A A02.

Allergen extracts. Tree pollen allergens.
ATC code V01A A05.

Immunological and biological properties.

Pharmacodynamics.

Mechanism of action. The active component of plant pollen allergens is a protein-polysaccharide complex, which enables diagnosis of sensitization to the given allergen in patients when performing skin and provocation tests. If necessary, the preparation may be used for allergen-specific immunotherapy (AIT) in patients hypersensitive to the corresponding pollen allergens. The ability of allergen components to interact with specific IgE antibodies (reagins) in patients and to provoke a reaction in a sensitized organism determines the diagnostic potential of the preparation, while its multifactorial effect on the patient's immune system ensures the efficacy of allergen-specific immunotherapy (induction of tolerance to the corresponding allergens).

Allergen-specific immunotherapy exerts a therapeutic effect affecting all stages of the allergic process, including its immunological phase, leading to a shift in immune response from Th2-type to Th1-type, suppression of both early and late phases of IgE-mediated allergic reactions, inhibition of the cellular component of allergic inflammation, and reduction of non-specific tissue hyperreactivity.

During allergen-specific immunotherapy, the following changes occur: increased production of blocking antibodies, reduced release of allergy mediators, increased activity of suppressor cells and mechanisms; increased number of IL-2 producing cells, enhanced function of Th1 helper lymphocytes and reduced Th2 response, shift of CD4+ cells from Th2 to Th1 phenotype, increased functional activity of T-lymphocytes, enhanced function of isotype-specific T-suppressors, regulation of IgE induction by idiotypic antibodies, and reduced reactivity of mediator-producing cells.

Pharmacokinetics.

Not studied. The action of the preparation is due to the combined effect of its protein components, making pharmacokinetic studies impossible, as individual components cannot be traced using markers or bioassays. For the same reasons, metabolites of the preparation cannot be identified.

Clinical characteristics.

Indications.

Specific diagnosis of allergic diseases by detecting sensitization to plant pollen allergens and allergen-specific immunotherapy for hypersensitivity to pollen allergens.

Specific diagnosis of allergic diseases

For diagnostic purposes, the preparations are used to perform skin tests by the prick test method (scarification test and provocation tests may also be performed).

Allergen-specific immunotherapy of allergic diseases

Allergen-specific immunotherapy for hypersensitivity to pollen allergens is performed in patients in whom sensitization to these allergens has been confirmed by skin testing.

Allergen-specific immunotherapy is indicated when:

• IgE-mediated nature of the disease has been confirmed;
• the disease has a prolonged course with pronounced clinical manifestations;
• there is clear confirmation of the role of plant pollen allergens;
• complete allergen elimination is not possible;
• the necessary standardized allergens are available.

Contraindications.

To identify contraindications, the physician examines the patient on the day of performing skin tests or initiating allergen-specific immunotherapy (AIT).

Contraindications for skin testing with allergens

Age under 1 year for prick test and under 3 years for scarification test; exacerbation of the allergic disease being diagnosed; skin pathology at the test site (e.g., eczema); acute respiratory infections with elevated body temperature; chronic diseases in decompensation phase; active tuberculosis regardless of localization; acute phase of psychiatric disorders; systemic diseases (collagenoses) and oncological diseases.

Pregnancy is a contraindication for skin testing (see section "Use during pregnancy or breastfeeding").

The use of beta-adrenergic antagonists (beta-blockers) is a risk factor for the development of anaphylactic reactions.

Contraindications for allergen-specific immunotherapy (AIT)

Severe immunopathological conditions and immunodeficiencies (including HIV); oncological diseases; severe psychiatric disorders; acute infections and chronic infections in exacerbation phase; elevated body temperature (above 38.5 °C); infectious diseases (viral hepatitis, tuberculosis); uncontrolled bronchial asthma (FEV1 less than 70% despite adequate pharmacotherapy, including severe forms of bronchial asthma); asthma exacerbation within 3 days prior to dose administration; cardiovascular diseases where complications may arise with adrenaline (epinephrine) use; use of beta-adrenergic antagonists (beta-blockers), including topical forms, and ACE inhibitors (for treatment of hypertension or ischemic heart disease); severe cardiovascular diseases; history of anaphylactic shock during previous AIT; age under 5 years (for subcutaneous AIT); diabetes mellitus; uncontrolled thyrotoxicosis; myocardial infarction within the past year; active autoimmune diseases; pregnancy and breastfeeding (see section "Use during pregnancy or breastfeeding"); physical exertion immediately after dose administration; hypersensitivity to excipients of the medicinal product.

Special precautions.

No special warnings or precautions are required when using allergen preparations.

Any unused medicinal product or waste material must be disposed of in accordance with local requirements.

Interaction with other medicinal products and other forms of interaction.

Specific diagnosis of allergic diseases

The use of antihistamines and glucocorticosteroids affects the reliability of skin tests with allergens (reduces papule size up to complete absence).

The use of H2 histamine receptor blockers, cromoglicate, corticosteroids in doses up to 15 mg of prednisolone, and theophylline derivatives does not affect the results of allergy testing. A possible effect may occur with topical application of steroid ointments. Beta-blockers may enhance skin reactions.

Allergen-specific immunotherapy of allergic diseases

AIT should not be performed during treatment with antibiotics, cytostatics, or immunobiological agents. It may be combined with medications used for the treatment of allergic diseases (non-sedating antihistamines, cromones, bronchodilators, topical glucocorticosteroids, anti-leukotriene agents).

Do not use simultaneously with beta-blockers.

Food intake does not affect allergen diagnosis or therapy.

Special precautions.

Skin tests and allergen-specific immunotherapy (ASIT) must be prescribed exclusively by an allergist or pediatric allergist experienced in the management of allergic diseases and who has undergone specialized training, including emergency management of anaphylaxis. These procedures must be performed under the physician’s supervision in an allergology office or inpatient setting.

Skin tests with allergens and ASIT are performed only after the physician has obtained written informed consent from the patient!

Specific diagnosis of allergic diseases

Indications for skin testing with allergens include patient history and clinical and laboratory findings.

Skin tests are applied to the inner surface of the forearm, spaced (30 ± 10) mm apart, or on the skin of the back. Up to 30 tests may be performed simultaneously when using the prick test method, or up to 15 when using the scarification method. Skin testing with allergens by the prick test method is not recommended in children under 1 year of age, and by the scarification method in children under 3 years of age. The number of allergen skin tests (using the prick test method) in children should not exceed the numerical value of their age (for scarification, this number should be half that value).

Skin tests are performed using allergens containing 10,000 PNU per 1 mL. For patients with a high degree of sensitization, a preparation with a concentration of 5,000 PNU per 1 mL should be used.

Testing patients with pollinosis during the flowering season of causative allergens should be performed with caution, as increased levels of the relevant allergen in the environment may exacerbate allergic symptoms. Therefore, unless absolutely necessary, skin testing should be postponed until after the pollen season ends.

Temporary contraindications for skin testing include the use of antihistamines (up to 10 days), systemic glucocorticosteroids (up to 14 days), or topical glucocorticosteroid creams applied to the skin area where testing is to be performed (up to 30 days). Due to the large number of medications used in the treatment of allergic diseases and the emergence of new drugs, these time intervals are approximate and may vary depending on the specific medication used by the patient. Therefore, skin tests with allergens should only be performed after a positive skin reaction to histamine has been restored!

Allergen-specific immunotherapy for allergic diseases

ASIT with plant pollen allergens is performed in patients who have been diagnosed with sensitization to these allergens via skin testing. During ASIT, allergens are administered subcutaneously into the outer third of the upper arm (in the groove between the deltoid and triceps muscles). Other routes of allergen administration for therapeutic purposes may only be used based on regulatory documents (relevant instructions, protocols, standards, or methodological recommendations) approved by the Ministry of Health of Ukraine. The allergist is responsible for the preparation of allergen dilutions under aseptic conditions for ASIT and for the use of prepared dilutions.

ASIT regimens may vary—from accelerated to slow. This instruction provides a standard ASIT regimen for adults and children. The decision to use alternative regimens is made by the allergist based on the patient’s condition, age, necessity of ASIT, and the etiology of the allergic disease. Typically, ASIT is initiated after allergometric titration (by performing prick tests or intradermal injections of serial allergen dilutions to determine the lowest concentration that elicits a skin reaction). ASIT is initiated at a dose 10 times lower than the concentration that induces a skin reaction. If a skin reaction is observed to a group of allergens, the allergist must determine which specific allergen(s) should be used for ASIT. ASIT with allergen mixtures containing more than four components is considered undesirable.

Systemic allergic reactions and anaphylactic shock may occur during skin testing and ASIT, particularly in highly sensitive patients. After allergen injection, the patient must remain under the allergist’s supervision for at least 30 minutes. Every office performing ASIT must have an emergency kit available for the management of anaphylaxis.

In the event of anaphylactic reactions, allergen administration must be immediately discontinued, and emergency medical management for anaphylactic shock in children and adults, as approved by the order of the Ministry of Health of Ukraine, must be initiated.

Relative or temporary contraindications for ASIT

Age over 55 years; skin diseases; chronic infectious diseases; weakly positive skin tests with allergens; ineffectiveness of previous ASIT (if performed); exacerbation of the primary allergic disease; exacerbation of any concomitant disease; any intercurrent illness in an acute phase; use of monoamine oxidase inhibitors (MAOIs) in combination with sympathomimetics; vaccination (see section "Vaccination").

Limitations for ASIT use

Insufficient patient understanding of the necessity of ASIT or poor patient compliance; long duration of allergic disease (10 years or more); delayed positive skin reactions to allergens; presence of non-specific hyperreactivity; epidermal allergy; sensitization to food, drug, or chemical allergens; high sensitivity to 5 or more allergens.

Vaccination

Vaccination is not performed during the first phase (dose escalation phase) of ASIT.

It is recommended to perform routine vaccination one month before the start of ASIT or, if possible, to postpone vaccination until after completion of the primary ASIT course. For long-term ASIT (continuous treatment for 3 or more years), vaccination may be performed during the maintenance phase under the following conditions:

• Allergen injections and prophylactic vaccinations should not be administered on the same day;
  • vaccination should be performed no earlier than 2–3 weeks after allergen injection;
  • if no adverse reactions occur after vaccine administration, the next allergen injection may be given no earlier than:
• 2 weeks after administration of inactivated vaccines;
• 4 weeks after administration of live vaccines;
• 8–12 weeks after administration of the BCG vaccine;
• 1 week after a tuberculin skin test.

In such cases, ASIT should be resumed using the same allergen dilution that was used prior to vaccination.

Skin tests with allergens may be performed 10–15 days before vaccination or 1.5–2 months after administration of vaccine preparations.

The medicinal product contains potassium and sodium compounds; however, the content is less than 1 mmol (39 mg) per dose of potassium and 1 mmol (23 mg) per dose of sodium, which allows the product to be considered practically free of potassium and sodium.

Use during pregnancy or breastfeeding.

Pregnancy is a contraindication for skin testing and ASIT (see section "Contraindications") due to the risk of systemic allergic reactions, which may cause uterine contractions, and the potential need for epinephrine (adrenaline), which may lead to constriction of the umbilical artery.

Treatment should not be initiated during pregnancy. If pregnancy occurs during ASIT, continuation of allergen administration must be determined jointly by the allergist and the obstetrician-gynecologist, considering the potential risk to mother and fetus in case of systemic allergic reaction or anaphylactic shock. It is recommended to discontinue ASIT if pregnancy occurs during the dose escalation phase. ASIT may be continued if pregnancy occurs during the maintenance phase.

ASIT should not be initiated during breastfeeding.

Ability to influence the speed of reactions while driving or operating machinery.

Allergen preparations do not affect the ability to drive or operate machinery.

Method of Administration and Dosage

Technique for Performing Skin Allergy Tests with Allergens

Skin tests are administered on the inner surface of the forearm or on the skin of the back.

Allergens, allergen diluent (negative control), and 0.01% histamine dihydrochloride solution for skin diagnosis of allergic diseases (positive control) are used under aseptic conditions. After disinfecting the skin with 70% ethyl alcohol, apply one drop each of the allergen, allergen diluent, and 0.01% histamine dihydrochloride solution for skin diagnosis of allergic diseases onto the skin using sterile dropper caps (see instructions for medical use).

Prick Test. Using sterile disposable lancets for prick testing—individual for each patient and each preparation—puncture the skin through each drop of allergen, allergen diluent, and 0.01% histamine dihydrochloride solution for skin diagnosis of allergic diseases, until the lancet's stopper limits further penetration.

Scarification Test. Using sterile scarifiers—individual for each patient and each preparation—make scratches through the drops of allergen, allergen diluent, and 0.01% histamine dihydrochloride solution for skin diagnosis of allergic diseases, with scratches no longer than 5 mm.

Evaluation of Skin Test Results

Skin test results are evaluated after 15–20 minutes (immediate-type reaction). The skin reaction to histamine should be positive (typically a wheal with a diameter of 3–5 mm forms); if the histamine skin reaction is negative, allergen (or mixed allergen) tests are not considered valid. The skin reaction to the diluent should be negative; if a positive reaction occurs to the diluent, the allergen (or mixed allergen) test result is disregarded.

Skin Test Evaluation Scheme

Types of allergic reactions	Prick test		Scarification test
	Wheal size, mm
Negative	0	0
Doubtful	1–2	up to 3
Positive	3–7	3–10
Strongly positive	8–12	11–15
Hyperergic	13 and larger	16 and larger

Allergen-specific immunotherapy (AIT) procedure technique

The potential risk of developing severe allergic reactions and/or delayed systemic reactions during AIT, as well as the management plan in such cases, must be thoroughly discussed with patients.

During AIT, allergens are administered subcutaneously to patients in the outer third of the upper arm (in the groove between the deltoid and triceps muscles).

The interval between allergen doses during AIT is determined by the allergist physician. It may range from 1 day to 1 week or longer.

After allergen injection, the patient must remain under the supervision of the allergist physician for at least 30 minutes!

Standard protocol for allergen-specific immunotherapy

Allergen dilution	PNU per 1 ml	Dose (ml)					Frequency of administration
10-6 (1:1,000,000)	0.01	0.1	0.2	0.4	0.6	0.8	daily
10-5 (1:100,000)	0.1	0.1	0.2	0.4	0.6	0.8	daily
10-4 (1:10,000)	1.0	0.1	0.2	0.4	0.6	0.8	every 1–2 days
10-3 (1:1,000)	10.0	0.1	0.2	0.4	0.6	0.8	every 1–2 days
10-2 (1:100)	100.0	from 0.1 to 1.0 in increments of 0.1					every 2–3 days
10-1 (1:10)	1000.0	from 0.1 to 1.0 in increments of 0.1					1–2 times per week

The standard protocol for conducting AIT in children corresponds to the protocol for adults.

The duration of AIT is determined by the allergist. Usually, the maximum effect of AIT develops within 1–2 years after initiation. The optimal duration of AIT is considered to be 3–5 years. If AIT shows no effect within one year, it should be discontinued.

Children.

Skin testing with allergens using the prick test method is not recommended in children under 1 year of age, and using the scarification method is not recommended in children under 3 years of age.

For children, the number of allergen tests (by prick test method) should not exceed the numerical value of their age (for scarification – half that number).

Allergen-specific immunotherapy (subcutaneous) is not recommended in children under 5 years of age. Allergen-specific treatment in children is generally conducted according to the standard protocol; accelerated (rush) immunotherapy protocols (AIT) are not recommended.

When conducting allergen-specific immunotherapy in children, current orders of the Ministry of Health of Ukraine must be followed.

Overdose.

Specific diagnosis of allergic diseases

Cases of allergen preparation overdose during skin testing are unknown.

Allergen-specific immunotherapy of allergic diseases

Exceeding the dose of administered allergens during allergen-specific immunotherapy may lead to the occurrence of systemic and local adverse reactions in the patient.

Side effects.

Side effects are usually associated with violations of the rules for conducting skin testing and allergen-specific immunotherapy: incorrect performance of skin prick tests, performing skin tests on infected skin, exceeding the dose of allergens, errors in preparing allergen solutions for allergen-specific immunotherapy (AIT), administration of treatment by untrained personnel, incorrect technique of allergen administration, direct intravascular injection of allergens, conducting AIT during undiagnosed intercurrent infection, lack of monitoring of vital signs before allergen administration (arterial pressure, pulse, baseline spirometry parameters, etc.).

Potential side effects may develop 10 minutes or more after allergen injection and may manifest as:

• Disorders of the respiratory system, thoracic organs, and mediastinum: cough, dyspnea, bronchospasm, sneezing, nasal congestion, and pruritus;
• Disorders of the skin and subcutaneous tissue: rash, facial flushing, urticaria, edema, pruritus;
• Gastrointestinal disorders: abdominal pain;
• Nervous system disorders: headache, somnolence;
• Psychiatric disorders: excitement;
• Eye disorders: eye redness, lacrimation;
• Musculoskeletal and connective tissue disorders: arthralgia;
• Immune system disorders: anaphylactic reactions;
• General disorders and administration site reactions: general weakness, elevated body temperature, sensation of warmth throughout the body, pain and pruritus at the injection site, formation of a papule, swelling, and hyperemia at the injection site. Local reactions usually resolve spontaneously or require application of cold to the injection site.

Reporting of suspected adverse reactions.

Reporting of adverse reactions after drug registration is of great importance.
This enables continuous monitoring of the benefit-risk balance associated with the use of the medicinal product. Healthcare professionals are required to report any adverse reactions through the national reporting system.

Shelf life.

2 years.

The shelf life of allergens in vials with dropper caps used for skin testing and stored in a refrigerator is 1 year, but not exceeding the total shelf life indicated on the vial. The shelf life of allergens after dilution is 1 month; when diluted to concentrations between 0.01 and 1000 PNU/mL, the shelf life is 1 week.

Storage conditions.

Store in a light-protected place at a temperature of 2 to 8 °C. Do not freeze.
Keep out of reach of children.

Packaging.

5 mL of allergen in glass vials.

As a kit in a cardboard box containing 1 vial of allergen – 5 mL (10000 PNU/mL), 1 sterile dropper cap.

An instruction leaflet for medical use is included in each box.

Prescription status. By prescription only.

Manufacturer.

LLC "Immunolog", Ukraine.

Manufacturer's location and address of its place of business.

5 Dmytro Mayborody Street, Vinnytsia, Vinnytsia Oblast, 21036, Ukraine.