STALORAL 10 IR/ml Solution

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is STALORAL and what is it used for
   1. Indications for use
3. Important information before taking STALORAL
   1. When not to take STALORAL
   2. Warnings and precautions
   3. STALORAL and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. STALORAL contains sodium
4. How to take STALORAL
   1. Basic treatment with dose increase
   2. Maintenance treatment - constant dose
   3. Duration of treatment
   4. Method of administration
   5. Activate the pump by pressing the plunger 5 times.
   6. Use in children
   7. Using a higher dose of STALORAL than recommended
   8. Missing a dose of STALORAL
   9. Stopping treatment with STALORAL
5. Possible side effects
   1. The following symptoms require immediate discontinuation of STALORAL and medical attention:
   2. The following additional side effects have been observed:
   3. Reporting side effects
6. How to store STALORAL
7. Package contents and other information
   1. What STALORAL contains
   2. What STALORAL looks like and what the package contains
   3. Marketing authorization holder and manufacturer
   4. Date of last update of the leaflet:
   5. STALORAL APPENDIX 1
   6. I. Plant-based allergen extracts
   7. Weeds
   8. Grasses
   9. Cereals
   10. Trees
   11. Tobacco
   12. Animals
   13. Insects
   14. III. House dust mite allergen extracts
   15. V. Mixtures of allergen extracts * of animal origin

Leaflet attached to the packaging: patient information

STALORALPlant-based allergen extracts
STALORALAnimal-based allergen extracts
STALORALHouse dust mite allergen extracts
STALORALFungal allergen extracts (mold fungi, dermatophytes, yeast)
STALORALMixtures of allergen extracts (plant-based, animal-based, mite, fungal)
Oral and sublingual solution
10; 100 IR/ml or 10; 100 IC/ml

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is STALORAL and what is it used for
• 2. Important information before taking STALORAL
• 3. How to take STALORAL
• 4. Possible side effects
• 5. How to store STALORAL
• 6. Package contents and other information

1. What is STALORAL and what is it used for

STALORAL is a specific immunotherapy medicine used in patients allergic to plant-based allergens (plant pollen), animal-based allergens, house dust mites, or fungi. A complete list of allergens is attached to this leaflet as Appendix 1.

Indications for use

Allergic diseases with seasonal or year-round symptoms, such as rhinitis (sneezing, runny nose, or itchy nose, stuffy nose), conjunctivitis (itchy and watery eyes), or asthma (mild or moderate) in adults and children (over 5 years old). The goal of treatment with STALORAL is to increase immunological tolerance to allergens and thus alleviate allergic reactions.

2. Important information before taking STALORAL

When not to take STALORAL

• if the patient has been found to be hypersensitive (allergic) to any of the other ingredients of this medicine (listed in section 6);
• if the patient has been found to have immune system disorders or diseases;
• if the patient has been found to have cancer;
• if the patient has been found to have severe or uncontrolled asthma;
• if the patient has been found to have oral thrush.

Only a doctor can determine if there are contraindications to taking the medicine.

Warnings and precautions

Before starting treatment, symptoms of allergy should be stabilized with appropriate symptomatic treatment if necessary.
Before starting treatment with STALORAL, the patient should inform their doctor or pharmacist:

• if the patient has severe clinical symptoms of allergy at the start of treatment - in this case, treatment should be postponed,
• if the patient has had other diseases recently or if the allergy has worsened recently,
• if the patient is to undergo oral surgery or have a tooth extracted. Treatment with STALORAL should be discontinued until the oral cavity has fully healed,
• if the patient has had eosinophilic esophagitis in the past,
• if the patient experiences severe or persistent abdominal pain, difficulty swallowing, or chest pain during treatment,
• if the patient is on a low-sodium diet, as the medicine contains sodium (see "STALORAL contains sodium chloride"),
• if the patient is taking beta-adrenergic blockers (including eye drops or ointments).

STALORAL and other medicines

The patient should tell their doctor about all medicines taken recently, including those available without a prescription.
Before starting treatment, the patient should inform their doctor:

• if the patient is taking certain antidepressants (tricyclic antidepressants or monoamine oxidase inhibitors - MAOIs), as there is a higher risk of side effects if epinephrine (prescribed in case of severe allergic reactions) is needed, even with a fatal outcome,
• if the patient is scheduled for preventive vaccination against infectious diseases. Vaccination can be performed without discontinuing treatment, but only after assessing the patient's overall health.

Symptomatic treatment (e.g., antihistamines and/or nasal corticosteroids) may be used concurrently with STALORAL.

Pregnancy and breastfeeding

Pregnant or breastfeeding women, or those planning to become pregnant, should consult their doctor or pharmacist before taking this medicine.
There is no experience with the use of STALORAL in pregnant or breastfeeding women, so immunotherapy should not be initiated in pregnant or breastfeeding women unless the doctor considers it necessary.
Women who become pregnant or start breastfeeding during treatment with this medicine should consult their doctor about continuing treatment.

Driving and using machines

There are no contraindications to driving or operating machinery while taking STALORAL.

STALORAL contains sodium

In the case of patients on a low-sodium diet, the presence of sodium chloride in the medicine should be taken into account (one vial, i.e., 10 ml of solution, contains 590 mg of sodium chloride). See "Warnings and precautions".

3. How to take STALORAL

This medicine should always be taken according to the doctor's instructions. In case of doubts, consult a doctor or pharmacist.
Specific immunotherapy is most effective when started in the early stages of the disease.
The dose size does not depend on age but on the individual patient's reactivity.
In the case of seasonal allergy, treatment should be started before the pollen season and continued until the end of the pollen season.
In the case of year-round allergy, treatment should be continued throughout the year.
Treatment is divided into two stages:

• basic treatment - with gradual dose increase
• maintenance treatment - with a constant dose.

Before each administration of the medicine, the patient should carefully check the information on the packaging and ensure that it matches the doctor's prescription (recipe): the patient's name, the composition and concentration of the medicine, as well as the expiration date of the medicine.

Basic treatment with dose increase

The medicine is taken daily, with the dose increased every day until the maintenance dose is reached according to the following scheme:
The above dosage scheme should be considered as a guideline and example of treatment. Treatment may be modified depending on the patient's condition and their reaction to treatment.

Maintenance treatment - constant dose

The maximum well-tolerated dose should be taken daily or 3 times a week.

Duration of treatment

Usually, desensitization treatment is used for 3 to 5 years.
The doctor will reassess treatment in case of no significant improvement in symptoms after one year (year-round allergy) or after the first pollen season (seasonal allergy).

Method of administration

To ensure safe use of the medicine, the doctor's instructions should be strictly followed.
STALORAL is administered sublingually.
The medicine should be taken during the day to an empty mouth, without food and drink.
Before each use of the medicine, the patient should check the expiration date and ensure that the used vial matches the doctor's prescription (recipe)
The patient should use the dosing pump mechanism to administer the appropriate amount of solution directly into the mouth under the tongue.
Wait 2 minutes before swallowing the solution.
The doctor may prescribe a different dosage regimen depending on the patient's condition and their reaction to treatment.
STALORAL should be administered to children by adults.
Information about the first use of the medicine:
For safety reasons and to ensure that the vial remains intact, the vials are hermetically sealed with plastic and aluminum caps.
The patient should always check if the medicine matches the one prescribed by the doctor. In case of doubts, consult a doctor.
It is extremely important to read the instructions for using the dosing pump carefully. If necessary, ask the doctor for detailed explanations.

When using the medicine for the first time, follow these steps:

• 1. Remove the plastic, colored part of the cap.
• 2. Pull the metal tab and completely remove the aluminum cap.
• 3. Remove the gray cork.

• 4. Remove the dosing pump from the plastic cover. Place the vial on a flat surface and, holding it firmly with one hand, press the pump firmly onto the vial.
• 5. Remove the purple protective ring.
• 6.

Activate the pump by pressing the plunger 5 times.

Discard the solution that comes out.
The dosing pump measures 1 full dose of the medicine only after 5 presses.

• 7. Place the tip of the dosing pump in the mouth, directly under the tongue.
• 8. Press the plunger with a smooth motion until it stops. Use the finger that can press the hardest.
• 9. Release the pressure on the plunger completely. Make sure to maintain a 2-second interval between presses.
• 10. Repeat the above procedure until the prescribed number of presses is reached. Keep the solution under the tongue for 2 minutes and swallow.
• 11. After use, clean the tip of the dosing pump and put on the protective ring.

For subsequent uses, remove the protective ring and repeat the steps starting from point 7.

Use in children

Allergen immunotherapy is not recommended for children under 5 years old.

Using a higher dose of STALORAL than recommended

Inform the doctor or pharmacist immediately.
If a higher dose than recommended is used, the risk of side effects increases, including systemic reactions or severe local reactions.

Missing a dose of STALORAL

It is recommended to take the medicine in the usual dose the next day.
Do not take a double dose to make up for a missed dose.
If several consecutive doses are missed, consult the doctor who prescribed the treatment to determine a new treatment schedule.

Stopping treatment with STALORAL

If treatment with STALORAL is discontinued for less than a week, treatment can be continued with the last dose. If treatment is discontinued for more than a week, consult the doctor.
In case of any further doubts about taking this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, STALORAL can cause side effects, although not everybody gets them.
During treatment with STALORAL, the patient will be exposed to substances that can cause allergic reactions at the injection site and/or symptoms that can affect the whole body.
Such reactions can occur at the start of treatment or later, during treatment.

The following symptoms require immediate discontinuation of STALORAL and medical attention:

Severe allergic reaction with rapid onset of symptoms, which affects the whole body, such as intense itching or rash, difficulty breathing, abdominal pain, or symptoms related to low blood pressure, such as dizziness, malaise.
Tolerance to a given dose may change over time depending on the patient's health and environment.
In case of side effects, consult the doctor, who may change the treatment schedule.
The doctor may prescribe pre-treatment with antiallergic medicines to reduce the frequency and severity of side effects.

The following additional side effects have been observed:

Frequent (affecting less than 1 in 10 patients)
Mouth disorders (e.g., swelling, discomfort, tingling, itching, numbness, blisters, ulcers), tongue swelling, throat discomfort or pain or swelling or irritation, nasal congestion (stuffy nose, runny nose, sneezing, itchy nose, discomfort in the nose), cough, salivary gland disorders, itchy eyes, itchy ears, nausea, vomiting, abdominal pain, diarrhea, skin redness or itching.
Uncommon (affecting less than 1 in 100 patients)
Eye disorders (redness, irritation, tearing), herpes, hoarseness, breathing difficulties, asthma, hives, atypical skin allergy symptoms (burning, tingling, pricking), gastritis, esophageal spasm.
Rare (affecting less than 1 in 1000 patients)
Headache, eczema, joint pain, muscle pain, weakness, enlarged lymph nodes, fever.
Additionally, the following side effects have been reported:
Taste disorders, dry mouth, dizziness, facial swelling, severe allergic reactions, esophagitis.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, inform the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. 22 49 21 301, fax 22 49 21 309, e-mail: [email protected].
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store STALORAL

Before opening: Store in a refrigerator (2°C - 8°C).
After first opening: Store in a refrigerator (2°C - 8°C) for up to 30 days.
During transport, the vials should always be carried in a vertical position.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiration date stated on the carton after the "EXP" date and more than 30 days after first opening. The expiration date refers to the last day of the given 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.

6. Package contents and other information

What STALORAL contains

The active substance of the medicine is allergen extracts or their mixtures in combination with mannitol. The amount of mannitol does not exceed 40 mg/ml.
1 vial (10 ml) of solution contains allergen extracts (according to Appendix 1) at a concentration of:
10; 100 IR*/ml (standardized allergen extract)
or
10; 100 IC**/ml (non-standardized allergen extract)
The qualitative composition of the active substance can be individually selected for the patient within the range of allergens listed in Appendix 1.
*/**) The activity of the relevant allergen expressed in IR/ml or IC/ml is given on the label.

• Other ingredients are: sodium chloride, glycerol, purified water.

What STALORAL looks like and what the package contains

STALORAL is a clear, colorless or yellow-brown solution, depending on the type of allergen and its concentration.
The basic treatment kit contains:
2 vials of 10 ml (concentration 10 IR/ml or 10 IC/ml; concentration 100 IR/ml or 100 IC/ml) and 2 dosing pumps.
blue cap concentration: 10 IR/ml or 10 IC/ml
red cap
concentration: 100 IR/ml or 100 IC/ml
The maintenance treatment kit contains:
2 vials of 10 ml (concentration 100 IR/ml or 100 IC/ml) - red caps.
2 dosing pumps.

Marketing authorization holder and manufacturer

STALLERGENES
6, rue Alexis de Tocqueville
92160 Antony, France
To obtain more detailed information, contact the representative of the marketing authorization holder in Poland:
STALLERGENES Sp. z o.o.
tel. 22 620 29 98

Date of last update of the leaflet:

STALORAL APPENDIX 1

I. Plant-based allergen extracts

Weeds

641 Alfalfa (Medicago sativa)
IC/ml
664 Dandelion (Taraxacum vulgare)
IC/ml
623 Fat hen (Chenopodium album)
IC/ml
673 Goldenrod (Solidago canadensis)
IC/ml
636 Hop (Humulus lupulus)
IC/ml
605 Mugwort (Artemisia vulgaris)
IR/ml
646 Black mustard (Brassica nigra)
IC/ml
654 Nettle (Urtica dioica)
IC/ml
643 Oxeye daisy (Chrysanthemum leucanthemum)
IC/ml
665 Plantain (Plantago)
IC/ml
604 Ragweed (Ambrosia elatior)
IR/ml
625 Oilseed rape (Brassica oleifera)
IC/ml
710 Russian thistle (Salsola kali)
IC/ml
655 Sorrel (Rumex acetosa)
IC/ml
678 Sunflower (Helianthus annus)
IC/ml
657 Parietaria officinalis
IR/ml

Grasses

601 Red fescue (Festuca rubra)
IC/ml
705 Bermuda grass (Cynodon dactylon)
IR/ml
627 Orchard grass (Dactylis glomerata)
IR/ml
624 Quackgrass (Agropyron repens)
IC/ml
630 Meadow fescue (Festuca elatior)
IC/ml
658 Meadow grass (Poa pratensis)
IR/ml
638 Perennial ryegrass (Lolium perenne)
IR/ml
631 Sweet vernal grass (Anthoxanthum odoratum)
IR/ml
661 Timothy grass (Phleum pratense)
IR/ml
637 Yorkshire fog (Holcus lanatus)
IC/ml

Cereals

652 Barley (Hordeum vulgare)
IC/ml
642 Corn (Zea mays)
IC/ml
610 Oat (Avena sativa)
IC/ml
671 Rye (Secale cereale)
IR/ml
614 Wheat (Triticum vulgare)
IC/ml
106 Wheat flour
IC/ml

Trees

609 Alder (Alnus glutinosa)
IR/ml
632 Ash (Fraxinus excelsior)
IC/ml
635 Beech (Fagus sylvatica)
IC/ml
615 Birch (Betula alba)
IR/ml
620 Chestnut (Castanea vulgaris)
IC/ml
626 Cypress (Cupressus sempervirens)
IC/ml
675 Elder (Sambucus nigra)
IC/ml
653 Elm (Ulmus campestris)
IC/ml
667 Black locust (Robinia pseudoacacia)
IC/ml
649 Hazel (Corylus avellana)
IR/ml
619 Hornbeam (Carpinus betulus)
IR/ml
644 Horse chestnut (Aesculus hippocastanum)
IC/ml
634 Juniper (Juniperus communis)
IC/ml
677 Lime (Tilia platyphyllos)
IC/ml
629 Sycamore (Acer pseudoplatanus)
IC/ml
645 Silver fir (Abies alba)
IC/ml
647 White mulberry (Morus alba)
IC/ml
621 English oak (Quercus robur)
IC/ml
651 Olive (Olea europea)
IR/ml
662 Scots pine (Pinus sylvestris)
IC/ml
666 Plane tree (Platanus vulgaris)
IC/ml
659 White poplar (Populus alba)
IC/ml
680 Privet (Ligustrum vulgare)
IC/ml
650 Walnut (Juglans regia)
IC/ml
669 Goat willow (Salix caprea)
IC/ml

Tobacco

904 Tobacco (leaves)
IC/ml
II. Animal-based allergen extracts(dander, epithelia, insects)

Animals

507 Cat
IR/ml
509 Dog
IC/ml
508 Goat
IC/ml
510 Guinea pig
IC/ml
511 Hamster
IC/ml
516 Horse
IC/ml
512 Rabbit
IC/ml
505 Wool
IC/ml

Insects

301 Cockroach
IC/ml
303 Grain weevil
IC/ml
310 Horsefly
IC/ml
307 Mosquito
IC/ml

III. House dust mite allergen extracts

325 Acarus siro
IC/ml
314 Dermatophagoides farinae
IR/ml
315 Dermatophagoides pteronyssinus
IR/ml
326 Euroglyphus maynei
IC/ml
324 Glycyphagus domesticus
IC/ml
317 Lepidoglyphus destructor
IC/ml
318 Tyrophagus putrescentiae
IC/ml
IV. Fungal allergen extracts(mold fungi, yeast, dermatophytes)
402 Botrytis cinerea
IC/ml
403 Candida albicans
IC/ml
407 Chaetomium globosum
IC/ml
409 Epicoccum
IC/ml
410 Epidermophyton
IC/ml
411 Fusarium
IC/ml
413 Helminthosporium
IC/ml
447 Merulius lacrymans
IC/ml
417 Mucor racemosus
IC/ml
425 Pullularia pullulans
IC/ml
426 Rhizopus nigricans
IC/ml
432 Stemphylium botryosum
IC/ml
435 Trichophyton
IC/ml
405 Trichothecium roseum (Cephalothecium)
IC/ml

V. Mixtures of allergen extracts * of animal origin

506 Feather mixture (duck, goose, chicken)
IC/ml
* of plant origin
a) weeds
719 Mixture I - Compositae (Goldenrod, Dandelion, Lampourde, Ox-eye-daisy) IC/ml
714 Mixture II - Chenopodiaceae (Fat hen, Rough pigweed)
IC/ml
706 Mixture III - Weed mixtures (Alfalfa, Red clover, Mustard, Nettle, Sorrel) IC/ml
b) grasses
701 3 grasses- (Orchard grass, Perennial ryegrass, Timothy grass)
IR/ml
688 5 grasses- (Orchard grass, Meadow grass, Perennial ryegrass, Sweet vernal grass, Timothy grass)
IR/ml
689 12 grasses- (Red fescue, Bermuda grass, Bromus, Orchard grass, Meadow fescue, Meadow grass, Perennial ryegrass, Sweet vernal grass, Timothy grass, Wild oat, Yorkshire fog)
IR/ml
690 5 grasses/4 cereals- (Orchard grass, Meadow grass, Perennial ryegrass, Sweet vernal grass, Timothy grass)/(Barley, Corn, Oat, Wheat)
IR/ml
687 4 cereals- (Barley, Corn, Oat, Wheat)
IR/ml
c) trees
702 Betulaceae (Alder, Birch, Hazel, Hornbeam)
IR/ml
696 Fagaceae (Beech, Chestnut, Oak)
IC/ml
716 Cupressaceae (Cypress, Juniper)
IC/ml
715 Oleaceae (Ash, Olive, Privet)
IC/ml
717 Salicaceae (Poplar, Willow)
IC/ml
718 Tree mixture (Sycamore, Horse chestnut, Plane tree, Black locust, Lime)
IC/ml
917 Woodworker's dust (Oak, Beech, Cherry, Pine)
IC/ml
* house dust mites
350 D. pteronyssinus + D. farinae
IR/ml
330 Storage mite (Acarus siro, Glycyphagus domesticus, Lepidoglyphus destructor, Tyrophagus putrescentiae)
IC/ml
* fungi
400 Alternaria (Alternatalongipes)
IC/ml
414 Cladosporium (Cladosporoides, herbarum)
IC/ml
401 Aspergillus (Fumigatus, nidulans, niger)
IC/ml
422 Penicillium (Digitatum, expansum, notatum)
IC/ml
445 Yeast mixture (Saccharomyces cerevisiae, minor)
IC/ml
446 Smut mixture (Ustilago avenae, tritici, holci, zeae)
IC/ml