Aliostal

Package Leaflet: Information for the User

ALYOSTAL,solution for skin prick tests, 100 IR/ml or 100 IC/ml
Extracts of allergens – diagnostic allergens for skin prick tests

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor.
• If you experience any side effects, including any not listed in this package leaflet, inform your doctor. See section 4.

Diagnostic product for use only by qualified medical personnel.

Table of Contents of the Package Leaflet

• 1. What is ALYOSTAL and what is it used for
• 2. Important information before using ALYOSTAL
• 3. How to use ALYOSTAL
• 4. Possible side effects
• 5. How to store ALYOSTAL
• 6. Contents of the package and other information

1. WHAT IS ALYOSTAL AND WHAT IS IT USED FOR

ALYOSTAL is intended exclusively for diagnostic purposes.
Skin prick tests with ALYOSTAL are performed to diagnose the causes of allergic diseases in children, adolescents, and adults.

2. IMPORTANT INFORMATION BEFORE USING ALYOSTAL

When not to use ALYOSTAL

• if the patient is allergic to any of the other ingredients listed in section 6.

Warnings and precautions

Before starting treatment with ALYOSTAL, inform your doctor or nurse:

• if the patient is taking beta-blockers (beta-adrenergic blockers) in any form (even eye drops) or certain antidepressants (tricyclic antidepressants or monoamine oxidase inhibitors - MAOIs). See section "ALYOSTAL and other medicines"
• if the patient has had a fever or a clinically confirmed asthma attack and/or a peak expiratory flow rate measurement, the doctor will consider what actions to take
• if the patient does not feel well, the doctor will decide on the timing of the tests
• if the patient has had an acute phase of an allergic disease, the doctor will postpone the tests
• if the patient has skin diseases. The doctor will postpone the tests to avoid obtaining unassessable test results or exacerbating existing skin diseases
• if the patient has conditions such as dermographism, urticaria, atopic dermatitis, eczema, or psoriasis
• if a lymph node has been removed from one armpit, as skin prick tests should be performed on the other forearm.

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Inform your doctor immediately if you experience any systemic allergic symptoms during the skin prick tests (e.g., intense itching of the hands and soles of the feet, urticaria, swelling of the lips or throat leading to difficulty swallowing, breathing, or voice changes, nausea, and vomiting). See section 4. Possible side effects.
ALYOSTAL should not be used in children under 4 years of age. Use in children from 1 year of age may be considered by a doctor with caution.

ALYOSTAL and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Before performing skin prick tests, inform your doctor:

• if you are taking antihistamines or corticosteroids. These medicines may significantly reduce the response to the skin prick test. Your doctor will inform you about the proper procedure
• if you are taking beta-blockers. Your doctor will assess the risk associated with taking these medicines, as they may hinder the treatment of possible allergic reactions
• if you are taking certain antidepressants (tricyclic antidepressants or monoamine oxidase inhibitors - MAOIs), as the risk of side effects may increase in case epinephrine needs to be used in the event of severe allergic reactions (with possible fatal consequences).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before undergoing an ALYOSTAL diagnostic test.
Pregnancy
There are no clinical data on the use of ALYOSTAL in pregnant women.
Skin allergy tests are generally not performed in pregnant women, as they may expose the pregnant woman to the risk of generalized allergic reactions.
Breastfeeding
Skin tests can be performed during breastfeeding.
There are no clinical data on the use of ALYOSTAL during breastfeeding.

Driving and using machines

ALYOSTAL does not affect driving or using machines.

3. HOW TO USE ALYOSTAL

ALYOSTAL can only be used by trained healthcare professionals who will inform the patient about the procedure and rules for performing skin prick tests.
Diagnostictests are performedon the medial surface of the forearm. The patient should place their relaxed arm on the table.
The skin where the tests will be performed should be cleaned and disinfected with alcohol and dried.
One drop of each skin test solution will be applied to the skin at a suitable distance from each other.
After applying the drop of solution, the skin will be pricked with a Stallerpoint needle.
A new sterile needle for single use must be used for each solution.
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A positive and negative control test should be performed under the same conditions to assess skin reactivity.
The skin reaction appears within 20 minutes of performing the prick. A positive result is the appearance of a blister (edema) with or without redness (erythema).
The doctor or nurse will read the results, outline each skin reaction, and optionally copy the boundaries of the reaction onto adhesive tape.
The patient should remain under medical supervision for at least 30 minutes after performing the skin prick tests.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During the performance of the test with ALYOSTAL, patients are exposed to allergens, which can cause allergic reactions at the prick site and/or systemic symptoms.
The patient should inform the doctor immediately if they experience intense itching or rash, difficulty breathing, abdominal pain, or symptoms related to a drop in blood pressure, such as dizziness, malaise, as these symptoms may herald severe allergic reactions.
The patient's tolerance to allergens may change over time, depending on the patient's health and environment.
The following side effects were observed in clinical trials:
Uncommon (affecting less than 1 in 100 patients)
Itching
After marketing, the following side effects have been spontaneously reported, and their frequency cannot be estimated (frequency not known):

• local reactions: pain, swelling, redness, urticaria
• generalized allergic reactions: anaphylactic reactions

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 provide more information on the safety of this medicine.
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5. HOW TO STORE ALYOSTAL

Keep out of sight and reach of children.
ALYOSTAL should be stored in a refrigerator (2°C - 8°C). Do not use ALYOSTAL after the expiry date (EXP) stated on the packaging (vial label).

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What ALYOSTAL contains

The active substance is allergen extracts at a concentration of 100 IR/ml or 100 IC/ml (according to Annex 1) in combination with mannitol. The amount of mannitol does not exceed 40 mg/ml.
Excipients: glycerol, sodium chloride, phenol, water for injections
The negative control solution contains: glycerol, sodium chloride, phenol, water for injections.
The positive control solution contains: histamine dihydrochloride, glycerol, sodium chloride, phenol, water for injections.

What ALYOSTAL looks like and what the package contains

ALYOSTAL is a clear, colorless solution in Type I glass vials with a plastic cap and dropper.
One vial (3 ml) of solution contains:

• a single standardized allergen extract or a mixture of standardized allergen extracts
• a single non-standardized allergen extract or a mixture of non-standardized allergen extracts

The list of allergens registered in Poland is in Annex 1.
The package contains:
vials with allergen extracts of 3 ml + one vial with positive control solution of 3 ml + one vial with negative control solution of 3 ml.

Marketing authorization holder and manufacturer

STALLERGENES
6 rue Alexis de Tocqueville, 92160 ANTONY, France
For more information, contact the representative of the marketing authorization holder:
STALLERGENES Sp. z o.o.
phone: 22 620 29 98
Date of last revision of the package leaflet: 12/2023
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ANNEX

NR 1

I. Plant-based allergen extracts

Weeds

605 Mugwort ( Artemisia vulgaris)
IR/ml
604 Ragweed ( Ambrosia elatior)
IR/ml

Trees

609 Black alder ( Alnus glutinosa)
IR/ml
615 White birch ( Betula alba)
IR/ml
649 Hazel ( Corylus avellana)
IR/ml
651 European olive ( Olea europea)
IR/ml

ALYOSTAL

II. Animal-based allergen extracts

Animals

507 Cat
IR/ml
509 Dog
IC/ml

III. House dust mite allergen extracts

314 Dermatophagoides farinae
IR/ml
315 Dermatophagoides pteronyssinus
IR/ml

VI. Mixtures of plant-based allergen extracts * grasses

688 5 grasses- (orchard grass, meadow fescue, perennial ryegrass, sweet vernal grass, timothy grass)
IR/ml
* molds
400 Alternaria( alternata, longipes)
IC/ml
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