Perosall t13

Package leaflet: Information for the patient

Perosall T13, solution for sublingual use.
Grass pollen allergen mixture.
Initiation treatment set: 10 SU*/1 ml, 100 SU/1 ml, 1,000 SU/1 ml, 5,000 SU/1 ml
Maintenance treatment set: 5,000 SU/1 ml
Custom order set: 1 SU/1 ml
*SU = standardized unit
Read the entire leaflet before using the medicine, as it contains important information for the patient

• Keep this leaflet for 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. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Perosall T13 is and what it is used for
2. Important information before using Perosall T13
3. How to use Perosall T13
4. Possible side effects
5. How to store Perosall T13
6. Contents of the package and other information

1. What Perosall T13 is and what it is used for

Perosall T13 is intended for desensitizing individuals allergic to grass pollen. The medicine is available as a solution for sublingual use in four increasing concentrations. Each solution contains a mixture of allergens derived from grass pollen. The treatment consists of the systematic administration of gradually 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 grass 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 T13

When not to use Perosall T13:

• 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 neoplastic disease
• if the patient has been diagnosed with tuberculosis
• if the patient is undergoing continuous treatment with beta-adrenolytics (e.g. during cardiovascular disease, in cases of severe hypertension)
• in patients with clinically evident severe immunodeficiency
• in case 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 end of the exacerbation, following consultation with an allergist)
• in patients with unstable cardiovascular diseases, e.g. unstable angina (requiring periodic use of beta-adrenolytics or ACE inhibitors)
• in patients with severe, unstable asthma – with spirometry measurements showing FEV1 below 70% of the predicted value
• in patients with severe atopic dermatitis during exacerbation.

Warnings and precautions

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

Children

• Perosall T13 must not be used in children under 5 years of age.

Perosall T13 and other medicines

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

Tell your doctor or pharmacist if you are taking, have recently taken, or plan to take any other medicines.

Perosall T13 and 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 become pregnant, she should consult a doctor before using this medicine.

During pregnancy and breastfeeding, treatment with Perosall T13 should not be initiated. If treatment has already been started before conception, it may be continued in consultation with the attending physician. Currently, there are no adequately documented data on the use of allergen immunotherapy in pregnant women. Therefore, the potential risk for the mother and fetus is unknown.

Driving and operating machinery

The medicine does not affect the ability to drive motor vehicles or operate machinery.

3. How to use Perosall T13

Perosall T13 should be used before the pollen season begins, before allergy symptoms appear.
Administer on an empty stomach, at least 15 minutes before a meal. Tilt the head slightly backward and administer the recommended number of drops under the tongue. The bottle automatically dispenses drops due to the special design of the dropper when tilted. A caregiver may administer the medication to a child.

Treatment consists of two phases:

• Maintenance treatment – constant dose.

Initial treatment
Unless otherwise directed by a physician, the medication 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,

reduce the dose by using fewer drops or a lower concentration for at least 3 days. Then resume increasing 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 plant 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.

Check the expiry date stated on the packaging before using Perosall T13.

Taking more than the recommended dose of Perosall T13
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 has been taken, seek immediate medical advice from a physician or pharmacist.

Missed dose of Perosall T13
Take the last prescribed dose as soon as possible, then continue treatment according to the schedule.

Interrupting use of Perosall T13
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 provoke allergic symptoms).
If the interruption lasts longer than 4 weeks, treatment should be restarted from concentration 1.

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

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

4. Possible adverse reactions

Like any medicinal product, this medicine may cause adverse reactions, although not in every individual.
To date, within the framework of spontaneous monitoring, no adverse reactions have been reported following administration of Perosall T13. However, it should be remembered that sublingual immunotherapy, like any administration of biological preparations, carries a risk of local and systemic adverse reactions.
Frequency unknown (frequency cannot be estimated from available data):

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

These symptoms are most often transient and resolve spontaneously.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, medical advice should be sought from 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 also be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 safety information regarding the use of the medicine.

5. How to store Perosall T13 medicine

Keep this medicine out of 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 T13 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 T13 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 immunotherapy seasons.

6. Contents of the packaging and other information

What Perosall T13 contains
The active substance is a mixture of allergens from the pollen of the following grass species:
Latin name                                     Common name
Secale cereale                                     rye
Agrostis alba                                       meadow bent
Alopecurus pratensis                          meadow foxtail
Anthoxanthum odoratum                  sweet vernal grass
Apera spica-venti                               windgrass
Arrhenatherum elatius                       false oat-grass
Cynosurus cristatus                            dog's-tail
Dactylis glomerata                             cocksfoot
Festuca pratensis                               meadow fescue
Holcus lanatus                                    velvet grass
Lolium perenne                                   perennial ryegrass
Phleum pratense                                timothy grass
Poa sp.                                               meadow-grass

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

What Perosall T13 looks like and contents of the pack
Initial treatment set:
4 vials of 10 ml each (concentrations 1–4)
Concentration 1 – 10 BU/ml
Concentration 2 – 100 BU/ml
Concentration 3 – 1,000 BU/ml
Concentration 4 – 5,000 BU/ml

Maintenance treatment set:
1 vial of 10 ml (concentration 4)
Concentration 4 – 5,000 BU/ml

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

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

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

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