Perosall d

Package leaflet: information for the patient

Perosall D, solution for sublingual use.
Tree pollen allergen mixture.
Induction treatment set: 10 SQ*/1 ml, 100 SQ/1 ml, 1,000 SQ/1 ml, 5,000 SQ/1 ml
Maintenance treatment set: 5,000 SQ/1 ml
Custom order set: 1 SQ/1 ml
*SQ standardized unit
Read the entire leaflet carefully before using the medicine, because it contains important information for the patient.

• Keep this leaflet for possible future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

1. What Perosall D is and what it is used for

Perosall D is intended for desensitizing individuals allergic to tree pollen. The medicine is in the form of a solution for sublingual use, available in four increasing concentrations. Each solution contains a mixture of allergens derived from tree pollen. The treatment consists of systematically administering increasing doses of allergens to induce immune tolerance (lack of organism reaction to the allergen). This leads to alleviation or disappearance of allergic symptoms during tree pollination season.
The decision on initiating sublingual immunotherapy is made exclusively by an allergist specialist, based on medical history, allergic symptoms, skin diagnostic tests, and/or levels of specific IgE antibodies.

2. Information before using Perosall D

When not to use Perosall D:

• if the patient is allergic to any of the excipients listed in section 6
• if the patient has been diagnosed with an autoimmune disease
• if the patient has been diagnosed with a malignant neoplastic disease
• if the patient has been diagnosed with active tuberculosis
• if the patient is undergoing chronic treatment with beta-adrenolytics (e.g. due to coronary artery disease, severe hypertension)
• in patients with clinically evident severe immunodeficiency
• in cases of lack of patient cooperation
• in patients with acute infectious diseases accompanied by fever (desensitization may be resumed 5–7 days after resolution of the infection, following consultation with an allergist)
• during exacerbations of chronic infections (desensitization may be resumed 5–7 days after the exacerbation has subsided, following consultation with an allergist)
• in patients with unstable cardiovascular diseases, e.g. unstable coronary artery disease (requiring periodic use of beta-adrenolytics or ACE inhibitors)
• in patients with severe, unstable asthma – with spirometry measurements showing FEV1 below 70% of predicted value
• in patients with severe atopic dermatitis during an exacerbation.

Warnings and precautions

• if any adverse reactions occur, the physician should be informed immediately
• on the day of taking the medication, avoid excessive physical exertion, alcohol consumption, and overheating (e.g. sauna, hot shower, sunbathing).

Children

• do not use Perosall D in children under 5 years of age.

Perosall D and other medicines

• concomitant use of antiallergic drugs, such as antihistamines, cromones, or corticosteroids, may modify (delay in time) the actual reaction to the medication
• if allergen-specific immunotherapy (specific desensitization) and vaccination according to the National Immunization Program are planned simultaneously, immunotherapy should be initiated after vaccination
• if maintenance doses and vaccination according to the National Immunization Program are scheduled at the same time, vaccination should be administered between consecutive maintenance doses, and immunotherapy should continue according to the schedule (do not administer immunotherapy and vaccines on the same day).

You should inform your doctor or pharmacist about all medicines currently used or
recently used, as well as any medicines you plan to take.
Perosall D with food and drink
The medicine should be taken on an empty stomach, at least 15 minutes before a meal.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
a child, she should consult a doctor before using this medicine.
During pregnancy and breastfeeding, treatment with Perosall D should not be initiated. If
treatment has already been started before conception, it may be continued
in consultation with the treating physician. Currently, there are insufficiently documented
data on the use of allergen immunotherapy in pregnant women. Therefore, the potential risk to
the mother and fetus is unknown.
Driving and operating machinery
Perosall D does not affect the ability to drive motor vehicles or operate machinery.

3. How to use Perosall D

Perosall D should be used before the pollen season, before allergy symptoms appear.
Administer on an empty stomach, at least 15 minutes before a meal. Tilt the head slightly backward and place the recommended number of drops under the tongue. The bottle automatically dispenses drops when tilted, thanks to the special design of the dropper. A caregiver may administer the medication to a child.
Treatment consists of two phases:

• Initial treatment – gradual dose increase
• Maintenance treatment – fixed dose

Initial treatment
Unless otherwise advised by a physician, the medicine should be taken daily, increasing the dose by one drop each day until reaching the maximum maintenance dose of 10 drops of concentration 4, according to the following schedule:

Initial treatment schedule
Concentration 1 – 10 JS/ml                     Concentration 2 – 100 JS/ml
Day  Number of drops                        Day  Number of drops
1    1                                  11   1
2    2                                  12   2
3    3                                  13   3
4    4                                  14   4
5    5                                  15   5
6    6                                  16   6
7    7                                  17   7
8    8                                  18   8
9    9                                  19   9
10   10                                 20   10

Concentration 3 – 1,000 JS/ml                 Concentration 4 – 5,000 JS/ml
Day  Number of drops                        Day  Number of drops
21   1                                 31   2
22   2                                 32   4
23   3                                 33   6
24   4                                 34   8
25   5                                 35   10
26   6
27   7
28   8
29   9
30   10

The above dosing schedule should be considered a guideline and example of treatment. The physician may modify the schedule depending on the patient's condition and response to treatment.

If allergic symptoms occur, such as:

• swelling around the eyes and face, rhinitis, conjunctivitis,
• difficulty breathing or swallowing,

the dose should be reduced by using fewer drops or a lower concentration for at least 3 days. Then, increase the dose by one drop daily according to the initial treatment schedule.

Maintenance treatment
The maximum individual dose of concentration 4, well tolerated by the patient, should be administered twice weekly. Treatment should be discontinued 2–3 weeks before the start of the pollen season.

Note:
For patients particularly sensitive to pollen allergens, treatment may be initiated with concentration 0 – 1 JS/ml, which is prepared upon individual request.

Before using Perosall D, check the expiry date stated on the packaging.

Taking more than the recommended dose of Perosall D
Local and systemic adverse reactions may occur, including anaphylactic shock, with symptoms such as sudden drop in blood pressure and loss of consciousness.
If an overdose is taken, seek immediate medical advice from a doctor or pharmacist.

Missed dose of Perosall D
Take the last used dose as soon as possible, then continue treatment according to the schedule.

Interrupting treatment with Perosall D
If initial treatment has been interrupted for longer than 2 weeks, resume treatment with half of the last administered and well-tolerated dose (a dose that did not cause allergic symptoms). If the interruption lasts longer than 4 weeks, treatment should be restarted from concentration 1.

Discontinuation of desensitization may occur in cases of infection or exacerbation of chronic diseases (as described in section 2 of the leaflet). Desensitization may be resumed 5–7 days after resolution of the infection/exacerbation, following consultation with an allergist.

If you have any further doubts regarding the use of this medicine or interruption of treatment, consult your allergist.

4. Possible adverse reactions

Like any medicinal product, this medicine may cause adverse reactions, although not everyone experiences them.
To date, in the context of spontaneous monitoring, no adverse reactions have been reported following the use of Perosall D.
However, it should be remembered that sublingual immunotherapy, as with the administration of any other biological preparations, carries a risk of local and systemic adverse reactions.
Frequency unknown (frequency cannot be estimated from the available data):

• worsening of conjunctivitis
• worsening of rhinitis, exacerbation of asthma
• gastrointestinal disturbances, abdominal pain, diarrhoea
• generalized urticaria, generalized skin itching
• throat itching, burning sensation in the oral cavity, lip swelling

These symptoms are usually transient and resolve spontaneously.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a physician or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products {current address, telephone and fax numbers of the aforementioned Department}, e-mail: [email protected].
Reporting adverse reactions enables further collection of information on the safety of using this medicine.

5. How to store Perosall D

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle.
Store in a refrigerator (2°C - 8°C).
Do not freeze. If the medicine freezes, it must be discarded.
After first opening, the bottle with concentration 4 of Perosall D may be stored
for a maximum of 5 days in the refrigerator (2°C - 8°C), within the medicine's shelf life.
After first opening, bottles with concentrations 0-3 of Perosall D may be stored
for a maximum of 10 days in the refrigerator (2°C - 8°C), within the medicine's shelf life.
Opened, unused medicine must not be used in subsequent allergy seasons.

6. Contents of the pack and other information

What Perosall D contains
The active substance in the medicinal product is a mixture of allergens from pollen of the following tree species:
Latin name Common name
Alnus sp. alder
Betula sp. birch
Corylus avellana common hazel

The other components (excipients) are: glycerol, sodium chloride, disodium phosphate dodecahydrate, potassium dihydrogen phosphate, water for injections.

What Perosall D looks like and contents of the pack
Set for initial treatment:
4 vials of 10 ml each (concentrations 1–4)
Concentration 1 – 10 JU/ml
Concentration 2 – 100 JU/ml
Concentration 3 – 1,000 JU/ml
Concentration 4 – 5,000 JU/ml

Set for maintenance treatment:
1 vial of 10 ml (concentration 4)
Concentration 4 – 5,000 JU/ml

Set for individual orders:
1 vial of 10 ml (concentration 0)
Concentration 0 – 1 JU/ml

10 ml solution in a vial closed with a dropper cap made of polypropylene and polyethylene, packed in a cardboard box.

For further detailed information, please contact the responsible entity's representative.

Marketing Authorisation Holder and Manufacturer
Institute of Biotechnology and Vaccine Sera BIOMED Joint Stock Company
Al. Sosnowa 8
30-224 Kraków
Tel.: +48 12 37 69 200
Fax: +48 12 37 69 205
e-mail: [email protected]