Hal Allergi Prick Test

Leaflet attached to the packaging: patient information

HAL Allergy Prick Test

Solution for skin prick tests

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet

1. What is HAL Allergy Prick Test and what is it 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 packaging and other information

1. What is HAL Allergy Prick Test and what is it used for

HAL Allergy Prick Test is intended exclusively for diagnostic purposes. It is used to determine which substances causing allergic reactions (allergens) the patient is sensitized to. HAL Allergy Prick Test contains allergens such as grass pollen, tree pollen, weed pollen, mites, mold fungi, animal dander, 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 properly evaluate whether sensitization occurs, prick tests are performed using Positive Control for HAL Allergy Prick Test, as well as Negative Control for HAL Allergy Prick Test. The positive control should cause a skin reaction, while the negative control usually does not cause 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 diseases that impair their general condition.
• If the skin on the side being tested is damaged.
• If severe, acute symptoms of allergy occur.
• 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 been found to be hypersensitive (allergic) to any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

After performing the tests, do not rub or scratch the test areas.
Before starting to use HAL Allergy Prick Test, you should discuss it with your doctor or nurse.

Children

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

HAL Allergy Prick Test and other medicines

You should tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
It is important for the doctor to know that the patient is using symptomatic anti-allergic medicines, such as antihistamines, mast cell degranulation inhibitors, or corticosteroids. After consulting with the doctor, the patient should not take these medicines within 48 hours before performing the skin test. It is important for the doctor to know that the patient is using long-acting antihistamines, as these medicines may affect the test results up to 8 weeks after their last intake. The patient may continue to take inhaled corticosteroids and low-dose corticosteroids.
You should tell your doctor about taking beta-adrenergic receptor blockers. These medicines may make it difficult to treat side effects.

Pregnancy and breastfeeding

Pregnancy

Prick skin tests should be avoided during pregnancy.

Breastfeeding

Prick tests can be performed during breastfeeding.

Driving and using machines

So far, no effect of using HAL Allergy Prick Test on the ability to drive and use machines has been found.

3. How to use HAL Allergy Prick Test

This medicine should always be used in accordance with the doctor's recommendations. If you have any doubts, you should consult a doctor or pharmacist.
Tests are performed on the skin on the inner side of the forearm or on the back. Special skin preparation is not necessary. If the skin surface is cleaned with water, alcohol, etc., you should wait 2 minutes before performing the test.
Usually, several allergen solutions are tested at the same time, along with a positive control (histamine) and a negative control (diluent).
Using a pipette, a drop of each test solution is applied separately to points on the skin that have been previously marked. The distance between the points should be at least 4 centimeters.
The skin is pricked using a sterile needle or lancet through the drop of test solution. A new needle or lancet is used for each solution.
The result is read after about 15 to 20 minutes.
A positive reaction involves the appearance of a blister surrounded by a red border on the skin. A positive reaction is determined based on the skin reaction to the two control solutions.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Classification of systems and organs

Frequency of occurrence

Side effects

Immune system disorders
Anaphylactic shock (typical symptoms preceding anaphylactic shock include:
a burning sensation or itching on or under the tongue and in the throat, and in particular on the hands and soles of the feet).
Skin and subcutaneous tissue disorders
Rare (in 1 to 10 patients out of 10,000)
Quincke's edema.
Allergic conjunctivitis, rhinitis, urticaria, swelling around the injection site with a diameter exceeding 12 cm.
Respiratory, thoracic, and mediastinal disorders
Very rare (less than 1 in 10,000)
Rare (in 1 to 10 patients out of 10,000)
Bronchospasm (may occur immediately or after several hours after using the prick tests), laryngeal edema.
General disorders and administration site conditions
Feeling of fatigue.
Exacerbation of allergic symptoms specific to the patient (such as burning eyes, runny nose, cough) or atopic eczema.
Very rare (less than 1 in 10,000)
Rare (in 1 to 10 patients out of 10,000)
If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store HAL Allergy Prick Test

The medicine should be stored out of 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 specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
Store in a refrigerator (2°C – 8°C). Do not freeze.

6. Contents of the packaging and other information

What HAL Allergy Prick Test contains

Allergen extracts in accordance with Annex 1, with concentrations expressed in Allergy Units/ml (AU/ml).
Positive control:
histamine dihydrochloride

Other ingredients are:

Allergen extracts:
aminocaproic acid; sodium dihydrogen phosphate dihydrate; disodium phosphate dihydrate; human albumin; phenol; glycerol; water for injections.
Positive control: sodium chloride; sodium bicarbonate; 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 what the packaging contains
Vials with allergen extracts of 3 ml + vial with positive control solution of 3 ml + vial with negative control solution of 3 ml, according to the order based on Annex 1.
Vials made of type I colored glass with a capacity of 5 ml with a bromobutyl rubber stopper with a polypropylene pipette and a polypropylene screw cap
or
vials made of type I clear glass with a capacity of 6 ml with a bromobutyl rubber stopper secured with an aluminum ring and a polypropylene cap with attached polypropylene droppers in laminated bags. The dropper, sterilized in a laminated bag, can only be used with the HAL Allergy Prick Test. The packaging may vary.

Marketing authorization holder and manufacturer

HAL Allergy B.V.
J.H. Oortweg 15
Leiden, Netherlands
To obtain more detailed information, you should contact the representative of the marketing authorization holder
Hal Allergy Sp. z o. o.
ul. Rumiana 65
02-956 Warsaw
Tel: 0-22 858 16 14
Fax: 0-22 858 16 15

Date of last update of the leaflet:

Annex 1

Hal Allergy Prick Test

LIST OF ALLERGENS

Single allergens

Mixtures of allergen extracts