Roztvori do testuv provokaciinih Allergopharma

PATIENT INFORMATION LEAFLET

LEAFLET INCLUDED IN THE PACKAGING: USER INFORMATION

Allergopharma Provocation Test Solutions

Please read this leaflet carefully before using the medicine, as it contains

important information for the patient.
• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor. See section 4.

Table of contents of the leaflet:

• 1. What are Allergopharma Provocation Test Solutions and what are they used for
• 2. Important information before using Allergopharma Provocation Test Solutions
• 3. How to use Allergopharma Provocation Test Solutions
• 4. Possible side effects
• 5. How to store Allergopharma Provocation Test Solutions
• 6. Contents of the packaging and other information

1. What are Allergopharma Provocation Test Solutions and what are they used for

Provocation tests are used as an aid in the diagnosis of allergic diseases. The allergen contained
in the test solution reacts with specific allergenic IgE in the patient's mucous membranes. This
reaction leads to the release of mediators, particularly histamine from mast cells, which causes
an inflammatory reaction, increased mucus production, and smooth muscle contraction.
During the provocation test, increasing doses of the allergen are administered intranasally or intrabronchially.
Obtaining an allergic reaction indicates the clinical significance of the allergen and is important, for example,
in qualifying and monitoring the effects of specific immunotherapy.
Allergopharma Provocation Test Solutionsare used for the diagnosis of IgE-dependent allergic diseases (Type I according to the Gell and Coombs classification) by provoking the reaction of a positive allergen identified in a puncture test.

2. Important information before using Allergopharma Provocation Test Solutions

Allergopharma

When not to use Allergopharma Provocation Test Solutions

Allergopharma Provocation Test Solutions should not be used if the following conditions coexist:

severe diseases that significantly impair the patient's general condition,
high degree of sensitization (based on medical history and skin test reactions), as this increases the risk of a severe allergic reaction,
concomitant treatment with beta-adrenergic receptor blockers and angiotensin-converting enzyme inhibitors, as these weaken the effect of adrenaline,
pregnancy - due to the risk of anaphylactic reactions, which can lead to fetal hypoxia,
hypersensitivity (allergy) to any of the excipients.

Allergopharma Provocation Test Solutions should not be used for intrabronchial provocation testing if the following conditions coexist:

significant impairment of lung function, as the induction of an allergic reaction may lead to respiratory failure,
additional risk associated with indispensable treatment (e.g., cholinergic drugs),
increased airway hyperreactivity, as the allergic reaction may cause severe bronchospasm.

Allergopharma Provocation Test Solutions should not be used for intranasal provocation testing if the following conditions coexist:

acute inflammatory diseases of the nose and paranasal sinuses, as this increases the risk of a severe allergic reaction,
acute allergic reactions of the immediate type in other target organs.

Warnings and precautions

Before starting the use of Allergopharma Provocation Test Solutions, you should:

• discuss the degree of sensitization with your doctor. In highly sensitized patients, as well as in children and in the case of particularly active allergens, it is recommended to use a higher dilution of the allergen solution in the intranasal provocation test (e.g., 1:10) or to use more dilutions (e.g., 1:1000000, 1:10000000) in the intrabronchial provocation test. Before this test, it is recommended to prepare a rapidly acting bronchodilator for inhalation.
• pay attention to the inhalation technique. During intranasal provocation, deep inhalation of the allergen should be avoided. The patient should hold their breath during the administration of the allergen and then exhale through the nose.
• inform your doctor about any concomitant diseases, such as hypertension, coronary heart disease, arrhythmias, hyperthyroidism, as the use of adrenaline, which is recommended in case of adverse reactions to the medicinal product Allergopharma Provocation Test Solutions, is contraindicated in these cases.

All provocation tests, both intranasal and intrabronchial, should be performed during a period of minimal or no allergic symptoms.
Children and adolescents
Depending on the patient's condition, the intrabronchial provocation test can be performed from the age of 6, and the intranasal provocation test from the age of 3.

Allergopharma Provocation Test Solutions and other medicines

You should inform your doctor about all medicines you have taken recently, even those that are available without a prescription.
You should avoid administering medicines that affect the target organ during provocation. Antihistamines, steroids, mast cell stabilizers, and medicines with weak antihistaminic activity may cause false-negative results.
Whenever possible, these medicines should be discontinued before the test for a period corresponding to their duration of action specified by the manufacturer.

Pregnancy, breastfeeding, and fertility

There is a lack of sufficient experience with the use of Allergopharma Provocation Test Solutions during pregnancy and breastfeeding.
Provocation tests should not be performed during pregnancy (due to the risk of anaphylactic reactions).
Performing a provocation test is unlikely to pose any risk to a breastfed child; however, in each case, the risk and benefits of performing the test should be individually assessed.

Driving and using machines

The effect of performing provocation tests on these activities is unknown.

3. How to use Allergopharma Provocation Test Solutions

Recommended dose

Intrabronchial provocation test

Depending on the type of device, 1-2 ml of the solution is introduced into the nebulizer, and the patient inhales a portion of this volume each time. The recommended concentration of the allergen depends on: the type of allergen, the degree of sensitization of the patient, and the reactivity of the airways. The provocation starts with the lowest concentration and is repeated with increasing dilutions until a positive reaction is obtained or the undiluted solution is administered. Recommended dilutions of the test solution with physiological saline:

• 1. provocation: 1:10,000 (or even lower concentration in highly sensitized patients)
• 2. provocation: 1:1000
• 3. provocation: 1:100
• 4. provocation: 1:10
• 5. provocation: undiluted test solution.

Intranasal provocation test

• Spray method: Administer the test solution with a volume of 0.04-0.05 ml using a spray device.
• Tuberculin syringe method: 0.05 ml (2 drops of the test solution) is administered using a tuberculin syringe to the surface of the lower nasal turbinate.

Method of administration
To dissolve the powder, 5 ml of sterile solvent should be drawn up with a sterile needle and syringe and injected into the vial with the powder. The powder should be thoroughly mixed until it is completely dissolved. The resulting solution is ready for the test. The dissolution date should be noted on the label.
Dilutions of the test solution are prepared by adding physiological saline.
In the case of the intranasal provocation test using the "spray" method, the cap and screw cap should be removed, and the spray device should be attached (with a plastic protective cover). Only single allergens are tested (mixtures: grasses and grass/cereals are treated as single allergens).

Intrabronchial provocation test

One allergen is administered per day. Increasing concentrations of the allergen should be used at 2-3 hour intervals until a positive test result is obtained or the undiluted solution is administered. Due to the physiological daily rhythm, the provocation should be performed in the morning hours.
Before the actual provocation, the patient should be instructed to inhale a physiological saline solution (negative control) to establish baseline values for the test result and to demonstrate non-specific reactions. Then, the test solution is sprayed. The inhalation should be stopped immediatelyafter the first mild clinical symptoms appear. Lung function parameters are usually measured directly after the end of inhalation and after 10 and 20 minutes.
A late reaction may occur up to 24 hours after inhalation of the test solution, with maximum severity after about 4-12 hours. During this period, the patient should be monitored and have access to medical examination.

Intranasal provocation test

Up to two allergens can be administered per day, and each allergen can be used in several concentrations. The test with the second allergen can only be performed if the reaction to the first allergen was not stronger than the reaction to the negative control. Each test must be preceded by a negative control test with physiological saline solution (negative control) to demonstrate non-specific reactions and establish a baseline value for further measurements. After determining the nostril with better patency, the initial rhinomanometric measurement is performed, and the negative control solution is administered on that side. After 15 minutes, a control measurement is performed on that side. If no significant change in nasal patency is found in the control measurement, the allergen provocation is performed on that side. After 15 minutes, the effect of the provocation is recorded by performing a measurement or assessing the severity of the reaction. In the case of a negative reaction, the measurement is repeated after 30 minutes. In the case of house dust mite and mold allergens, an additional measurement is performed after 45 minutes if the reaction is negative. The intranasal provocation test can be evaluated based on the severity of symptoms such as nasal congestion, discharge, irritation, and symptoms from other organs, as well as rhinomanometrically (demonstrating nasal congestion by measuring nasal resistance). The provocation test is considered positive if the airflow decreases by at least 40% compared to the control test. In the case of a negative test result or uncertain cases, the intranasal provocation with the same allergen can be repeated the next day.
Spray method– After dissolving the powder, the spray device should be attached and the nasal tip should be attached. A new nasal tip should be used for each patient and each allergen. The device should be pumped several times so that the liquid enters the dosing mechanism. The patient should be asked to blow their nose, tilt their head back, take a deep breath, and then hold their breath. By pressing the nasal tip, the control solution or test solution is sprayed onto the surface of the lower nasal turbinate. Then, the patient should perform a quick exhalation through the nose. After the test, the dosing nozzle should be removed, and the protective screw cap should be put back on.
Tuberculin syringe method– The test solution or control solution should be applied to the surface of the lower nasal turbinate using a tuberculin syringe.
In the case of administration of a higher dose of Allergopharma Provocation Test Solutionsthan recommended, an exacerbation of allergic symptoms may occur (see section 4. Possible side effects). Symptomatic medicines (e.g., antihistamines, bronchodilators) should be used, and the doctor should be contacted immediately.

4. Possible side effects

Intrabronchial provocation test

The intrabronchial provocation test may cause an asthma attack, and in this case, a bronchodilator should be used. In the place where the test is performed, treatment for severe asthma attacks must be ensured.

Intranasal provocation test

An excessive reaction of the nasal mucosa can be controlled by administering local antihistamines or nasal decongestants. In rare cases, distant symptoms (conjunctival reactions, palate itching, coughing) may occur.
In extreme cases, provocation tests may cause a severe allergic reaction (anaphylactic shock). Anaphylactic shock may develop within a few seconds or minutes after the administration of the allergen. Typical warning signs are: itching and a feeling of heat in the tongue, under the tongue, in the throat, as well as itching of the palms and soles.
Anaphylaxis kitand an adrenaline syringe should always be prepared for immediate use during the tests.
In the treatment of anaphylactic reactions, the attached scheme “Procedure in emergency situations during provocation tests”should be used.
After the administration of the test solution, the patient should be monitored for at least 30 minutes, and then examined by a doctor.
It should be kept in mind that side effects may occur even after several hours after the administration of the allergen (very rarely). In uncertain cases, especially in the case of systemic reactions, the patient should contact their doctor immediately.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the doctor should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181 C, 02-222 Warszawa, Tel. +48 22 49 21 301, Fax +48 22 49 21 309, e-mail: [email protected]. By reporting side effects, more information can be collected on the safety of the use of the medicine.

5. How to store Allergopharma Provocation Test Solutions

Store in a refrigerator (2°C - 8°C).
Do not freeze.
Store in a place inaccessible and invisible to children.
Do not use Allergopharma Provocation Test Solutions after the expiry date stated on the packaging.

6. Contents of the packaging and other information

What Allergopharma Provocation Test Solutions contain

Allergopharma Provocation Test Solutions contain allergenic extracts of plant, animal, fungal, and yeast origin, as well as house dust mites, pollen, and food.
The allergens are in the form of a powder and must be completely dissolved before use.
The names of the allergens and their concentrations after dissolution of the powder in 5 ml of solvent are stated on the labels of the test vials.
The activity and concentration of the allergens are expressed in: SBU - standardized biological units; BU - biological units; PNU - protein nitrogen units, or %w/v - weight-to-volume units. List of allergens and concentrations - Appendix 1. The provocation test solutions are characterized by analysis of their physicochemical and immunological properties, including the quantitative assessment of selected major allergens.

• The packaging contains: vials with powder and vials with solvent, each 5 ml, and/or a vial with negative control solution, 5 ml, with a screwed-on spray device and/or spray devices and nasal tips, as ordered, according to Appendix 1.

Other ingredients of the medicine:

Powder
mannitol
Solvent
sodium chloride
sodium bicarbonate
phenol
water for injections
Negative control solution:
sodium chloride
phenol
purified water

What Allergopharma Provocation Test Solutions look like and what the packaging contains

Due to the natural coloration of the starting material for extraction, the test solutions may have different colorations.
The packaging contains:
Vials with powder and vials with solvent, each 5 ml, and/or a vial with negative control solution, 5 ml, with a screwed-on spray device and/or spray devices and nasal tips, as ordered, according to Appendix 1.

Responsible entity and manufacturer

Allergopharma GmbH & Co. KG
Hermann-Koerner-Str. 52
D-21465 Reinbek
Germany
Tel. +49 40 / 727 65-0
Fax +49 40 / 722 77 13
e-mail: [email protected]
To obtain more detailed information, please contact the representative of the responsible entity:
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
Tel. 22 350 66 69
Fax 22 350 77 03
Date of last update of the leaflet:01.2024

Appendix 1 to the patient information leaflet: allergenic extracts for provocation tests

Plant allergenic extracts (pollen)

101 Hornbeam

• 5000 BU/ml 106 Nettle 5000 SBU/ml 108 White birch 5000 SBU/ml 109 Nettle 5000 BU/ml 110 Beech 5000 BU/ml 114 English oak 5000 BU/ml 115 Alder 5000 BU/ml 116 Ash 5000 BU/ml 121 Barley 5000 BU/ml 126 Oats 5000 BU/ml 129 Hazel 5000 BU/ml 132 Blackthorn 5000 BU/ml 142 Lime 5000 BU/ml 143 Dandelion 5000 BU/ml 151 Olive tree 5000 BU/ml 152 Poplar 5000 BU/ml 153 Eastern plane 5000 BU/ml 156 Ragweed 5000 BU/ml 158 Rye 5000 SBU/ml 161 Sorrel 5000 BU/ml 168 Elm 5000 BU/ml 169 Plantain 5000 SBU/ml 170 Willow 5000 BU/ml 173 Wheat 5000 BU/ml 177 Meadow fescue 5000 BU/ml

Animal allergenic extracts (animal hair and dander, feathers)

304 Chinchilla fur

• 5000 BU/ml 306 Dog hair 5000 BU/ml 308 Rabbit hair 5000 BU/ml 309 Cat hair 5000 SBU/ml 311 Guinea pig hair 5000 BU/ml 314 Horse hair 5000 BU/ml 317 Cow hair 5000 BU/ml 318 Sheep's wool 5000 BU/ml 321 Parrot feathers 5000 BU/ml

Mite allergenic extracts

708 Dermatophagoides farinae

• 5000 BU/ml 725 Dermatophagoides pteronyssinus 5000 SBU/ml 728 Acarus siro 5000 BU/ml 729 Lepidoglyphus destructor 5000 BU/ml 730 Tyrophagus putrescentiae 5000 BU/ml

Food allergenic extracts

588 Barley flour

• 1000 PNU/ml 589 Barley flour 1000 PNU/ml 590 Oat flour 1000 PNU/ml 592 Corn flour 400 PNU/ml 593 Corn flour 800 PNU/ml 595 Rye flour 1600 PNU/ml 596 Rye flour 1600 PNU/ml 599 Wheat flour 1600 PNU/ml 600 Wheat flour 1600 PNU/ml

Fungal and yeast allergenic extracts

400 Alternaria tenuis

• 5000 SBU/ml 401 Aspergillus fumigatus 5000 BU/ml 402 Botrytis cinerea 5000 BU/ml 405 Cladosporium herbarum 5000 BU/ml 406 Curvularia lunata 5000 BU/ml 407 Fusarium moniliforme 5000 BU/ml 408 Helminthosporium halodes 5000 BU/ml 410 Mucor mucedo 5000 BU/ml 412 Penicillium notatum 5000 BU/ml 413 Pullularia pullulans 5000 BU/ml 414 Rhizopus nigricans 5000 BU/ml 416 Serpula lacrymans 5000 BU/ml

Mixtures of plant allergenic extracts

006 Grasses 100%

• - 5000 SBU/ml133 Cocksfoot 140 Meadow grass 157 English ryegrass 177 Meadow fescue 178 Meadow foxtail 179 Meadow bluegrass in equal parts

015 Grasses/cereals 100%

• - 5000 BU/ml006 Grasses 55% 121 Barley 10% 126 Oats 10% 158 Rye 15% 173 Wheat 10%

014 Weeds

• - 5000 BU/ml106 Nettle 109 Nettle 143 Dandelion 169 Plantain in equal parts

012 Trees I

• - 5000 BU/ml115 Alder 129 Hazel 152 Poplar 168 Elm 170 Willow in equal parts

013 Trees II

• - 5000 BU/ml108 White birch 110 Beech 114 English oak 153 Eastern plane in equal parts

901 Negative control solution

Procedure in emergency situations during provocation tests

This scheme serves only as a general guideline; the procedure should be adjusted according to the patient's clinical condition.