Hal allergy prick test

Package leaflet: Information for the patient

HAL Allergy Prick Test
Solution for skin prick tests
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or nurse. See section 4.

Table of contents
1. What HAL Allergy Prick Test is and what it is used for
2. Important information before using HAL Allergy Prick Test
3. How to use HAL Allergy Prick Test
4. Possible side effects
5. How to store HAL Allergy Prick Test
6. Contents of the pack and other information

1. What HAL Allergy Prick Test is and what it is used for
HAL Allergy Prick Test is intended solely for diagnostic purposes. It is used to determine which allergens the patient is sensitized to. HAL Allergy Prick Test contains allergens such as grass pollen, tree pollen, weed pollen, house dust mites, mould fungi, animal epithelia, and food allergens. Drops of the allergen solution are applied to the skin, which is then pricked. In allergic patients, this causes redness and swelling. To correctly assess whether sensitization is present, prick tests are performed using both Positive Control for HAL Allergy Prick Test and Negative Control for HAL Allergy Prick Test. The positive control should elicit a skin reaction, while the negative control usually does not provoke a reaction.

2. Important information before using HAL Allergy Prick Test

When not to use HAL Allergy Prick Test

• If the patient suffers from serious conditions impairing general health.
• If the skin on the area to be tested is damaged.
• If severe, acute allergic symptoms are present.
• If the patient is being treated with immunosuppressive drugs.
• If the patient is being treated with beta-adrenergic receptor blockers.
• In children under 5 years of age.
• If the patient has known hypersensitivity (allergy) to any of the other components of this medicine (listed in section 6).

Warnings and precautions
After testing, do not rub or scratch the test sites.
Before starting HAL Allergy Prick Test, discuss it with your doctor or nurse.

Children
HAL Allergy Prick Test must not be used in children under 5 years of age.

HAL Allergy Prick Test and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
It is important that the doctor knows if the patient is taking symptomatic antiallergic drugs such as antihistamines, mast cell degranulation inhibitors, or corticosteroids. After consulting with the doctor, the patient should not take these drugs within 48 hours before performing the intradermal test. It is important that the doctor knows if the patient is taking long-acting antihistamines, as these may affect test results up to 8 weeks after the last dose. The patient may continue using inhaled corticosteroids and low-dose corticosteroids.
Inform the doctor if the patient is taking beta-adrenergic receptor blockers. These drugs may interfere with the treatment of adverse reactions.

Pregnancy and breastfeeding
Pregnancy
Skin prick tests should be avoided during pregnancy.

Breastfeeding
Skin prick tests may be performed during breastfeeding.

Driving and operating machinery
No effects of HAL Allergy Prick Test on the ability to drive or operate machinery have been observed to date.

3. How to use HAL Allergy Prick Test.

This medicinal product should always be used as directed by a physician. If in doubt, consult a doctor or pharmacist.
The tests are performed on the skin of the inner forearm or on the back. No special skin preparation is required. If the skin surface is cleaned with water, alcohol, etc., it is necessary to wait 2 minutes before performing the test.
Several allergen solutions are usually tested simultaneously, together with a positive control (histamine) and a negative control (diluent).
Using a pipette, a drop of each test solution is applied separately onto designated points on the skin. The distance between the points should be at least 4 centimeters.
Skin prick is performed using a sterile needle or lancet through the drop of the test solution. A new needle or lancet must be used for each solution.
The result is read after approximately 15 to 20 minutes.
A positive reaction consists of a wheal surrounded by a red flare. A positive reaction is determined based on the skin response to the two control solutions.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

| System organ class | Frequency of occurrence | Adverse reactions | |------------------------|-------------------------------|------------------------| | Immune system disorders | Rare (in 1 to 10 patients per 10,000) | Anaphylactic shock (typical symptoms preceding anaphylactic shock include: burning or itching sensation on or under the tongue and in the throat, and particularly on the palms and soles). | | Skin and subcutaneous tissue disorders | Very rare (less than 1 in 10,000) | Quincke's edema (angioedema).
Rare (in 1 to 10 patients per 10,000) | Allergic conjunctivitis, mucosal irritation, urticaria, swelling around the injection site exceeding 12 cm in diameter. | | Respiratory, thoracic and mediastinal disorders | | Bronchospasm (which may occur immediately or several hours after skin prick tests), laryngeal edema. | | General disorders and administration site conditions | Very rare (less than 1 in 10,000) | Feeling of fatigue.
Rare (in 1 to 10 patients per 10,000) | Exacerbation of patient-specific allergic symptoms (such as eye irritation, rhinitis, cough) or atopic eczema. |

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps to gather further information on the safety of the medicine.

5. How to store HAL Allergy Prick Test

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after: Expiry
date. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.
Store in a refrigerator (2°C – 8°C). Do not freeze.

6. Contents of the pack and other information

What HAL Allergy Prick Test contains
Allergen extracts according to Annex No. 1, at concentrations expressed in Allergy Units/ml (AU/ml).
Positive control: histamine dihydrochloride
Other components are:
Allergen extracts: aminocaproic acid; disodium phosphate dihydrate; sodium dihydrogen phosphate dihydrate; human albumin; phenol; glycerol; water for injections.
Positive control: sodium chloride; sodium hydrogen carbonate; glycerol; phenol; water for injections.
Negative control: disodium phosphate dihydrate; sodium dihydrogen phosphate dihydrate; aminocaproic acid; human albumin; glycerol; phenol; water for injections.

What HAL Allergy Prick Test looks like and contents of the pack
Vials containing 3 ml of allergen extracts + one vial containing 3 ml of positive control solution + one vial containing 3 ml of negative control solution, according to the order based on Annex No. 1.
Vials made of coloured glass of type I with a capacity of 5 ml, fitted with bromobutyl rubber stoppers and polypropylene dropper pipettes with polypropylene caps,
or
vials made of colourless glass of type I with a capacity of 6 ml, fitted with bromobutyl rubber stoppers sealed with an aluminium ring and polypropylene cap, together with polypropylene droppers supplied separately in laminated sachets. The dropper, sterile packed in a laminated sachet, may be used exclusively with the HAL Allergy Prick Test.
Packs may vary in presentation.

Marketing Authorisation Holder and Manufacturer
HAL Allergy B.V.
J.H. Oortweg 15
Leiden, The Netherlands

For further information, please contact the local representative of the Marketing Authorisation Holder:
Hal Allergy Sp. z o.o.
ul. Rumiana 65
02-956 Warsaw, Poland
Tel: 0-22 858 16 14
Fax: 0-22 858 16 15

Annex No. 1
Hal Allergy Prick Test
LIST OF ALERGENS
Single allergens

Allergen extract mixtures