Roztvori do testuv punktovih

PATIENT INFORMATION LEAFLET

LEAFLET INCLUDED WITH THE PACKAGING: USER INFORMATION

Point-of-Care Test Solutions

It is essential to carefully read the contents of this leaflet before using the medication, as it contains

important information for the patient.
• The leaflet should be kept for future reference.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, they should inform their doctor. See section 4.

Table of Contents:

• 1. What are Point-of-Care Test Solutions and what are they used for
• 2. Important information before using Point-of-Care Test Solutions
• 3. How to use Point-of-Care Test Solutions
• 4. Possible side effects
• 5. How to store Point-of-Care Test Solutions
• 6. Package contents and other information

1. What are Point-of-Care Test Solutions and what are they used for

The product is intended exclusively for diagnostic purposes.
Point-of-Care Test Solutions are allergen extracts and control solutions intended for the diagnosis of IgE-dependent allergic diseases, such as allergic rhinitis and conjunctivitis, allergic asthma, certain forms of atopic dermatitis, allergic urticaria, and food allergies.

2. Important information before using Point-of-Care Test Solutions

When not to use Point-of-Care Test Solutions

• If the patient has severe, generalized diseases due to an increased risk of adverse reactions.
• If the patient has skin lesions in the area to be used for testing, as there is a risk of exacerbation and incorrect interpretation of test results.
• If the patient is being treated with beta-adrenergic receptor blockers (beta-blockers) (as they weaken the response to adrenaline administered in case of adverse reactions) and ACE inhibitors (as they increase the decrease in blood pressure in case of anaphylactic reactions).
• If the patient is allergic to any of the excipients.

Warnings and precautions

Before starting the use of Point-of-Care Test Solutions, the patient should:

• inform the doctor about pregnancy, as there is a risk of anaphylactic reaction (severe allergic reaction) during the use of the product, which can lead to fetal hypoxia;
• inform the doctor about concomitant diseases, such as hypertension, coronary heart disease, arrhythmias, hyperthyroidism, as the use of adrenaline recommended in case of adverse reactions to the medicinal product Point-of-Care Test Solutions is contraindicated.

It is recommended to perform tests during a symptom-free period or with minimal clinical symptoms.
Children and adolescents
Point-of-Care Test Solutions can be performed in children from the age of one, depending on the child's condition, but are usually not performed before the age of four.

Point-of-Care Test Solutions and other medications

The patient should inform the doctor or pharmacist about all medications currently being taken, including those available without a prescription.
Concomitant use of antihistamines, steroids, or medications with antihistamine side effects may result in false-negative test results. The doctor will determine which medications should be discontinued before using Point-of-Care Test Solutions.
Natural exposure to the allergen should be avoided.

Pregnancy, breastfeeding, and fertility

There is insufficient experience with skin testing during pregnancy and lactation.
Whenever possible, skin tests should not be performed during pregnancy (due to the risk of anaphylactic reactions).
Although there is probably no risk to breastfed infants, the risk-benefit ratio should be considered on an individual basis.

Driving and operating machinery

The effect of point-of-care skin testing on these activities is unknown.

3. How to use Point-of-Care Test Solutions

Method of administration

• 1. The tests are performed on the inner part of the forearm, which the patient rests loosely on a table.
• 2. Special skin preparation is not necessary. In extreme temperatures, the patient should wait for a while to acclimate to the room temperature. If the skin is cleaned with water, ethanol, etc., the patient should wait at least 2 minutes for the skin's normal blood flow to return.
• 3. Two control tests should be performed simultaneously to check the patient's individual skin reactivity: a) negative control test with the solvent present in the allergen extract, and b) positive control test with a histamine solution.
• 4. A drop of the test solution is placed on the marked skin area using a pipette. For hygiene reasons, the pipette should not touch the skin. The distance between the applied drops should be approximately 4 cm.
• 5. The skin is pricked vertically with a needle or lancet within the applied drop (standard prick test). The needle or lancet can be directed at an acute angle and, after pricking, the blade can be slightly lifted to allow a small amount of the solution to enter the skin (modified prick test). Bleeding should be avoided.
• 6. Excess solution should be removed after 5-10 minutes in case of a mild reaction, and immediately after a strong reaction occurs.
• 7. The test results should be read after approximately 10-20 minutes (during which time the reaction should be observed).
• 8. A positive reaction is a pale yellow blister (edema) with a bright red halo (erythema). The reaction is considered positive if the blister diameter is ≥ 3 mm. The negative control solution should not cause a reaction (blister diameter 0 mm). The reaction can be evaluated based on the following scheme:

 = no blister (like negative control solution),
(+) = blister diameter <3 mm,
+ = blister diameter ≥ 3 - <4 mm,
++ = blister diameter ≥ 4 - <5 mm,
+++ = blister diameter ≥ 5 – <6 mm,
++++ = blister diameter ≥ 6 mm.
If a reaction occurs after the negative control solution, the test result cannot be unequivocally evaluated due to increased skin reactivity. This should be taken into account when interpreting the reactions to allergen extracts. Ideally, the test should be repeated at a later time. If the blister diameter after the negative control solution exceeds 2 mm, the test is not reliable.

• 9. Allergen mixtures are only used for screening tests. In case of a positive reaction, the tests should be repeated with individual allergens. (Usually, individual allergens are not tested in the case of grass and grass/cereal mixtures).

After applying the test solutions, the patient should remain under observation for at least 30 minutes, after which the doctor should assess the patient's condition.

4. Possible side effects

Like all medications, Point-of-Care Test Solutions can cause side effects, although they do not occur in every patient.
In highly sensitive patients, severe local reactions may occur. In such cases, a topical steroid cream or an oral antihistamine can be administered.
In rare cases, generalized reactions may occur, sometimes with a severe course (up to anaphylactic shock). Anaphylactic shock can occur a few seconds or minutes after exposure to the allergen, often even before the onset of local reaction. Symptoms preceding anaphylactic shock include burning, itching, and a feeling of heat on or under the tongue, in the throat, and especially on the hands or soles of the feet. These symptoms should be reported to the doctor immediately.
During the tests, the doctor has an emergency kit with a ready-to-use adrenaline syringe.
In extremely rare cases, adverse reactions may occur even several hours after exposure to the allergen; in case of doubt, and especially in case of generalized reactions, the patient should contact the doctor immediately.
Guidelines for the treatment of anaphylactic reactions are included in the attached scheme. The doctor may modify them depending on the patient's condition.

Reporting side effects

If any adverse reactions occur, including those not listed in the leaflet, the patient should inform their doctor. Adverse reactions can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222, Warsaw, Tel. +48 22 492 13 01, Fax: +48 22 49 21 309, e-mail: [email protected]. By reporting adverse reactions, more information can be collected on the safety of the medication.

5. How to store Point-of-Care Test Solutions

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

6. Package contents and other information

What are Point-of-Care Test Solutions

The active substances are: plant allergen extracts, mite extracts, animal dander, mold and yeast extracts, and food extracts. The list and concentration of allergens can be found in Annex 1 and Annex 2.
The active substance of the positive control solution is histamine dihydrochloride.
The activity and concentration of allergens are expressed in: SBU - standardized biological units; BU - biological units; PNU - protein nitrogen units.
Other ingredients are: sodium chloride, phenol, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, glycerol, water for injection - for allergen extracts listed in Annex 1 or sodium chloride, phenol, glycerol, water for injection - for allergen extracts listed in Annex 2.

What Point-of-Care 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 varying coloration.
The packaging contains bottles with allergen extracts of 3 ml each and (or bottles with) positive control solution of 3 ml each (or) bottles with negative control solution of 3 ml each, according to individual orders based on Annex 1 or Annex 2.

Responsible entity and manufacturer

Allergopharma GmbH & Co. KG
Hermann-Koerner-Str. 52-54
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:10.2024

Annex 1 to the patient leaflet

• list of allergens for point-of-care tests containing phosphate buffer in their composition

Plant allergen extracts (plant pollen)

101 Hornbeam
50,000 BU/ml
106 Nettle
50,000 SBU/ml
108 White birch
50,000 SBU/ml
110 Beech
50,000 BU/ml
114 English oak
50,000 BU/ml
115 Alder
50,000 BU/ml
116 Ash
50,000 BU/ml
121 Barley
50,000 BU/ml
123 Parietaria officinalis
50,000 SBU/ml
126 Oat
50,000 BU/ml
129 Hazel
50,000 BU/ml
142 Lime
50,000 BU/ml
143 Dandelion
50,000 BU/ml
151 Olive tree
50,000 BU/ml
152 Poplar
50,000 BU/ml
154 Ragweed
50,000 BU/ml
158 Rye
50,000 SBU/ml
168 Elm
50,000 BU/ml
169 Plantain
50,000 SBU/ml
170 Willow
50,000 BU/ml
173 Wheat
50,000 BU/ml

Mite allergen extracts

708 Dermatophagoides farinae
50,000 BU/ml
725 Dermatophagoides pteronyssinus 50,000 SBU/ml

Mixtures of plant allergen extracts

006 Grasses 100% 50,000 SBU/ml

133 Cocksfoot
140 Meadow fescue
157 English ryegrass
177 Meadow timothy
178 Meadow foxtail
179 Meadow brome
in equal parts

015 Grasses/cereals 100% 100,000 BU/ml

006 Grasses
55%
121 Barley
10%
126 Oat
10%
158 Rye
15%
173 Wheat
10%

Annex 2 to the patient leaflet

• list of allergens for point-of-care tests not containing phosphate buffer in their composition

Plant allergen extracts (plant pollen)

100 Maple
50,000 BU/ml
109 Nettle
50,000 BU/ml
111 Hornbeam
50,000 BU/ml
119 Fat hen
50,000 BU/ml
133 Cocksfoot
50,000 BU/ml
135 Bermuda grass
50,000 BU/ml
140 Meadow fescue
50,000 BU/ml
147 Maize
50,000 BU/ml
153 Eastern plane
50,000 BU/ml
157 English ryegrass
50,000 BU/ml
177 Meadow timothy
50,000 BU/ml
178 Meadow foxtail
50,000 BU/ml
179 Meadow brome
50,000 BU/ml

Animal allergen extracts (animal dander)

304 Guinea pig dander
10,000 BU/ml
306 Dog dander
10,000 BU/ml
308 Rabbit dander
10,000 BU/ml
309 Cat dander
50,000 SBU/ml
311 Hamster dander
10,000 BU/ml
314 Horse dander
10,000 BU/ml
317 Cow dander
10,000 BU/ml
319 Pig dander
10,000 BU/ml

Mite allergen extracts

728 Acarus siro
50,000 BU/ml
729 Lepidoglyphus destructor
50,000 BU/ml
730 Tyrophagus putrescentiae
50,000 BU/ml

Food allergen extracts

500 Duck meat
5,000 PNU/ml
501 Lamb
5,000 PNU/ml
503 Chicken meat
5,000 PNU/ml
505 Turkey meat
5,000 PNU/ml
506 Beef
5,000 PNU/ml
507 Pork
5,000 PNU/ml
509 Eel
5,000 PNU/ml
510 Trout
5,000 PNU/ml
511 Halibut
5,000 PNU/ml
513 Cod
5,000 PNU/ml
514 Carp
5,000 PNU/ml
515 Salmon
5,000 PNU/ml
520 Sole
5,000 PNU/ml
522 Tuna
5,000 PNU/ml
526 Crab
5,000 PNU/ml
527 Lobster
5,000 PNU/ml
528 Mussels
2,500 PNU/ml
529 Shrimp
5,000 PNU/ml
530 Pineapple
2,500 PNU/ml
532 Orange
1,000 PNU/ml
533 Banana
500 PNU/ml
538 Peanuts
5,000 PNU/ml
541 Grapefruit
500 PNU/ml
542 Walnut
5,000 PNU/ml
546 Clementine
1,000 PNU/ml
549 Bell pepper
1,000 PNU/ml
553 Tomato
1,000 PNU/ml
555 Grapes
500 PNU/ml
559 Cauliflower
1,000 PNU/ml
563 Potato
5,000 PNU/ml
574 Asparagus
2,500 PNU/ml
576 Spinach
1,000 PNU/ml
581 Barley flour
5,000 PNU/ml
590 Oat flour
5,000 PNU/ml
593 Corn flour
5,000 PNU/ml
596 Rye flour
5,000 PNU/ml
599 Wheat flour
5,000 PNU/ml
601 Cow's milk
5,000 PNU/ml
604 Chicken egg (whole)
5,000 PNU/ml
610 Chicken egg (white)
5,000 PNU/ml
611 Chicken egg (yolk)
5,000 PNU/ml
612 Goose meat
5,000 PNU/ml
620 Anise
25,000 PNU/ml
624 Chamomile
25,000 PNU/ml
632 Bell pepper
25,000 PNU/ml
637 Celery
25,000 PNU/ml

Mold allergen extracts

400 Alternaria tenuis
10,000 SBU/ml
401 Aspergillus fumigatus
10,000 BU/ml
402 Botrytis cinerea
10,000 BU/ml
405 Cladosporium herbarum
10,000 BU/ml
407 Fusarium moniliforme
10,000 BU/ml
408 Helminthosporium halodes
10,000 BU/ml
410 Mucor mucedo
10,000 BU/ml
412 Penicillium notatum
10,000 BU/ml
413 Pullularia pullulans
10,000 BU/ml
414 Rhizopus nigricans
10,000 BU/ml
416 Serpula lacrymans
10,000 BU/ml

Mixtures of plant allergen extracts

014 Weeds 100,000 BU/ml

106 Nettle
109 Nettle
143 Dandelion
169 Plantain
in equal parts

012 Trees I 100,000 BU/ml

115 Alder
129 Hazel
152 Poplar
168 Elm
170 Willow
in equal parts

013 Trees II 100,000 BU/ml

108 White birch
110 Beech
114 English oak
153 Eastern plane
in equal parts

Mixtures of mold allergen extracts

044 Molds I 20,000 BU/ml

400 Alternaria tenuis
402 Botrytis cinerea
405 Cladosporium herbarum
406 Curvularia lunata
407 Fusarium moniliforme
408 Helminthosporium
in equal parts

045 Molds II 20,000 BU/ml

401 Aspergillus fumigatus
410 Mucor mucedo
412 Penicillium notatum
413 Pullularia pullulans
414 Rhizopus nigricans
416 Serpula lacrymans
in equal parts

Mixtures of food allergen extracts

050 Meats I 5,000 PNU/ml

501 Lamb
506 Beef
507 Pork
in equal parts

059 Meats II 5,000 PNU/ml

500 Duck
503 Chicken
505 Turkey
612 Goose
in equal parts

Control solutions

901 Negative control solution – physiological saline solution
902 Positive control solution – histamine solution
Immediate treatment of anaphylactic conditions