Solutions for point tests

PACKAGE LEAFLET: INFORMATION FOR THE USER

Roztwory do testów punktowych
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor. See section 4.
Table of contents:

1. What Roztwory do testów punktowych are and what they are used for
2. Important information before using Roztwory do testów punktowych
3. How to use Roztwory do testów punktowych
4. Possible side effects
5. How to store Roztwory do testów punktowych
6. Contents of the pack and other information

1. What Roztwory do testów punktowych are and what they are used for

The product is intended for diagnostic use only.
Roztwory do testów punktowych are allergen solutions and control solutions intended for the diagnosis of IgE-mediated allergic diseases, such as allergic rhinitis and conjunctivitis, allergic asthma, certain forms of atopic dermatitis, allergic urticaria, and food allergy.

2. Important information before using Point Test Solutions

When not to use Point Test Solutions

• If the patient has been diagnosed with severe, generalized diseases due to an increased risk of adverse reactions.
• If the patient has skin disorders in the area intended for testing, as there is a risk of exacerbating the condition and obtaining inaccurate test results.
• If the patient is being treated with beta-adrenergic receptor blockers (beta-blockers) (because they reduce the response to adrenaline administered in case of adverse reactions) or ACE inhibitors (because they may worsen arterial hypotension during an anaphylactic reaction).
• If the patient is allergic to any of the excipients.

Warnings and precautions
Before starting the use of Point Test Solutions, the patient should:

• Inform the physician about pregnancy, as there is a risk of an anaphylactic reaction (severe allergic reaction) during testing, which may lead to fetal hypoxia;
• Inform the physician about concomitant diseases such as hypertension, ischemic heart disease, cardiac arrhythmias, or hyperthyroidism, as the use of adrenaline—recommended in case of adverse reactions to Point Test Solutions—is contraindicated in these conditions.

Testing is recommended during symptom-free periods or when clinical symptoms are mild.
Children and adolescents
Skin prick testing in children is possible after the age of one year, depending on the child's health condition, but generally should not be performed before the fourth year of life.
Interaction of Point Test Solutions with other medicinal products
Inform the physician or pharmacist about all medicinal products currently used or recently used, including those available without a prescription.
Concomitant use of antiallergic drugs such as antihistamines, corticosteroids, or drugs with antihistaminic side effects may lead to false-negative results. The physician will determine which medications should be discontinued prior to administration of Point Test Solutions.
Avoid natural exposure to allergens during testing.
Pregnancy, breastfeeding, and fertility
There is insufficient experience with skin prick testing during pregnancy and lactation.
Skin testing should be avoided during pregnancy whenever possible due to the risk of anaphylactic reactions.
Although there is likely no risk to breastfed infants, the risk-benefit ratio should be evaluated individually in each case.
Driving and operating machinery
The effect of skin prick testing on the ability to drive or operate machinery is unknown.

3. How to use Point Test Solutions

Method of administration

1. The inner surface of the forearm is used for testing, with the patient's arm resting loosely on a table.
2. Special skin preparation is not necessary. In case of extreme outdoor temperatures, wait a while to allow acclimatization to room temperature. If the skin is cleaned with water, ethyl alcohol, etc., wait at least 2 minutes until normal skin perfusion returns.
3. Two control tests should be performed simultaneously to assess the individual skin reactivity of the patient: a) a negative control test with the solvent present in the allergen extract, b) a positive control test with a histamine solution.
4. A drop of the test solution is applied to the marked site on the skin using a pipette. For hygienic reasons, the pipette should not touch the skin. The distance between the drops should be approximately 4 cm.
5. The skin is pricked vertically with a needle or lancet within the area of the applied drop (standard prick test). Alternatively, the needle or lancet may be directed at a sharp angle, and after pricking, the tip may be slightly lifted to allow a small amount of 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 mild reaction, or immediately if a strong reaction occurs.
7. Results of the prick tests should be read approximately 10–20 minutes after application (during this time, the reaction should be observed).
8. A positive reaction is characterized by a pale yellow wheal (swelling) surrounded by a bright red flare (erythema). The reaction is considered positive when the wheal diameter is ≥ 3 mm. The negative control solution should not elicit any reaction (wheal diameter 0 mm). The reaction can be graded according to the following scale:

 = no wheal (as in the negative control),
(+) = wheal with diameter < 3 mm,

• = wheal with diameter ≥ 3 - < 4 mm,
  ++ = wheal with diameter ≥ 4 - < 5 mm,
  +++ = wheal with diameter ≥ 5 – < 6 mm,
  ++++ = wheal with diameter ≥ 6 mm.
  If a reaction occurs after the negative control solution, the test result cannot be definitively evaluated due to increased skin reactivity. This should be taken into account when interpreting reactions to allergen solutions. Ideally, the test should be repeated at a later date. If the wheal diameter after the negative control exceeds 2 mm, the test is invalid.

9. Allergen mixtures are intended only for screening purposes. In case of a positive reaction, testing should be repeated with individual allergens. (Individual allergens are generally not tested in the case of grass mixtures and grass/cereal mixtures).

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

4. Possible adverse reactions

Like all medicines, Roztwory do testów punktowych may cause adverse reactions, although not
everyone will experience them.
In highly sensitive patients, pronounced local reactions may occur. If necessary, a topical steroid cream
can then be applied or an oral antihistamine administered.
In isolated cases, generalized reactions may occur, sometimes severe (including anaphylactic shock).
Anaphylactic shock may occur several seconds or minutes after exposure to the allergen, often even
before the onset of a local reaction. Prodromal symptoms of anaphylactic shock include burning,
itching, and a sensation of heat on or under the tongue, in the throat, and particularly on the palms or
soles of the feet. These symptoms should be reported to the physician immediately.
During testing, the physician has access to an emergency anaphylaxis kit containing a pre-filled
syringe of adrenaline ready for administration.
In exceptionally rare cases, adverse reactions may occur even several hours after allergen exposure;
in case of doubt, and especially if generalized reactions occur, the patient should contact a physician
immediately.
Guidelines for the treatment of anaphylactic reactions are included in the enclosed scheme.
The physician may modify them depending on the patient's condition.
Reporting adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform the
physician. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug
Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, Tel. +48 22 492 13 01, Fax: +48 22 492 13 09, e-mail:
[email protected]. Reporting adverse reactions allows the collection of additional information on the
safety of the medicine's use.

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

Keep out of the reach and sight of children.
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Do not use Point-of-Care Test Solutions after the expiry date stated on the packaging.

6. Contents of the packaging and other information

What Roztwory do testów punktowych contain
The active substances are: allergenic extracts from plant pollens, mites, animal epithelia,
mould fungi and yeasts, as well as food allergens. The list and concentration of allergens are given in
Annex 1 and Annex 2.
The active substance in the positive control solution is histamine dihydrochloride.
Allergen activity and concentration are expressed as: SBU – standardized biological units;
BU – biological units; PNU – protein nitrogen units.
Other ingredients include: sodium chloride, phenol, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, glycerol, water for injections – for allergenic extracts listed in Annex 1; or sodium chloride, phenol, glycerol, water for injections – for allergenic extracts listed in Annex 2.

What Roztwory do testów punktowych look like and contents of the packaging
Due to the natural colouring of the starting material used for extraction, test solutions may vary in appearance.
The packaging contains vials of allergenic extracts at 3 ml each and (or vials) of positive control solution at 3 ml (or) vials of negative control solution at 3 ml, according to individual orders based on Annex 1 or Annex 2.

Marketing Authorisation Holder 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]
For more detailed information, please contact the representative of the Marketing Authorisation Holder:
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
Tel. 22 350 66 69
Fax 22 350 77 03

Annex No. 1 to the Patient Leaflet

• List of allergens for prick tests containing phosphate buffer in the formulation

Plant-derived allergenic extracts (plant pollens)
101 Alder 50,000 BU/ml
106 Common mugwort 50,000 SBU/ml
108 White birch 50,000 SBU/ml
110 Beech 50,000 BU/ml
114 Pedunculate 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 50,000 BU/ml
152 Poplar 50,000 BU/ml
154 Ambrosia artemisiifolia 50,000 BU/ml
158 Rye 50,000 SBU/ml
168 Elm 50,000 BU/ml
169 Plantain lanceolata 50,000 SBU/ml
170 Willow 50,000 BU/ml
173 Wheat 50,000 BU/ml

Allergenic extracts from mites
708 Dermatophagoides farinae 50,000 BU/ml
725 Dermatophagoides pteronyssinus 50,000 SBU/ml

Mixtures of plant-derived allergenic extracts
006 Grasses 100% 50,000 SBU/ml
133 Meadow fescue
140 Common reed
157 English ryegrass
177 Timothy grass
178 Meadow fescue
179 Meadow fescue
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 No. 2 to the Patient Leaflet

• List of allergens for prick tests not containing phosphate buffer in the formulation

Plant-derived allergenic extracts (plant pollens)
100 Maple 50,000 BU/ml
109 Nettle 50,000 BU/ml
111 Hornbeam 50,000 BU/ml
119 Kochia 50,000 BU/ml
133 Meadow fescue 50,000 BU/ml
135 Bermuda grass 50,000 BU/ml
140 Common reed 50,000 BU/ml
147 Maize 50,000 BU/ml
153 Oriental plane 50,000 BU/ml
157 English ryegrass 50,000 BU/ml
177 Timothy grass 50,000 BU/ml
178 Meadow fescue 50,000 BU/ml
179 Meadow fescue 50,000 BU/ml

Animal-derived allergenic extracts (animal hair and epithelia)
304 Hamster hair 10,000 BU/ml
306 Dog hair 10,000 BU/ml
308 Rabbit hair 10,000 BU/ml
309 Cat hair 50,000 SBU/ml
311 Guinea pig hair 10,000 BU/ml
314 Horse hair 10,000 BU/ml
317 Cow hair 10,000 BU/ml
319 Pig hair 10,000 BU/ml

Allergenic extracts from mites
728 Acarus siro 50,000 BU/ml
729 Lepidoglyphus destructor 50,000 BU/ml
730 Tyrophagus putrescentiae 50,000 BU/ml

Food allergenic 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 Lobster 5,000 PNU/ml
530 Pineapple 2,500 PNU/ml
532 Orange 1,000 PNU/ml
533 Banana 500 PNU/ml
538 Peanut 5,000 PNU/ml
541 Grapefruit 500 PNU/ml
542 Hazelnut 5,000 PNU/ml
546 Clementine 1,000 PNU/ml
549 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 Pea 5,000 PNU/ml
589 Barley flour 5,000 PNU/ml
590 Oat flour 5,000 PNU/ml
593 Maize 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 Whole hen's egg 5,000 PNU/ml
610 Hen's egg white 5,000 PNU/ml
611 Hen's 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 Paprika 25,000 PNU/ml
637 Celery 25,000 PNU/ml

Allergenic extracts from mould fungi
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-derived allergenic extracts
014 Weeds 100,000 BU/ml
106 Common mugwort
109 Nettle
143 Dandelion
169 Plantain lanceolata
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 Pedunculate oak
153 Oriental plane
in equal parts

Mixtures of allergenic extracts from mould fungi
044 Moulds 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 Moulds 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 allergenic 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 reactions