Perosall T13

Leaflet included in the packaging: patient information

Perosall T13,solution for sublingual use.
Mixture of grass pollen allergens.
Basic treatment set:10 JS*/1 ml, 100 JS/1 ml, 1,000 JS/1 ml, 5,000 JS/1 ml
Maintenance treatment set:5,000 JS/1 ml
Set for individual orders:1 JS/1 ml
*JS standard unit
You should 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 necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you for a specific person. Do not pass it on to others. The medicine may harm another person, even if their disease symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Perosall T13 and what is it 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 packaging and other information.

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

Perosall T13 is intended for desensitization of individuals with grass pollen allergy. The medicine is in the form of a solution for sublingual use in four increasing concentrations. Each solution contains a mixture of allergens derived from grass pollen. The treatment involves the systematic administration of increasing doses of allergens to induce a state of tolerance (lack of reaction to the allergen). This leads to the alleviation or disappearance of allergy symptoms during the grass pollen season.
The decision to undergo sublingual desensitization is made exclusively by a specialist allergist, based on the patient's history, allergic symptoms, skin diagnostic tests, and/or the level of specific IgE antibodies.

2. Important 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 malignant disease
• if the patient has been diagnosed with tuberculosis
• if the patient is constantly being treated with beta-adrenergic blockers (e.g., during coronary artery disease, with high blood pressure)
• in patients with clinically apparent severe immunodeficiency
• in case of lack of cooperation from the patient
• in patients with acute infectious diseases with fever (desensitization can be resumed after 5-7 days after the infection has subsided, after consultation with an allergist)
• during exacerbation of chronic infections (desensitization can be resumed after 5-7 days after the exacerbation has subsided, after consultation with an allergist)
• in patients with unstable cardiovascular diseases, e.g., unstable coronary artery disease (requiring periodic use of beta-adrenergic blockers or ACE inhibitors)
• in patients with severe, unstable asthma - with spirometry measurements - FEV1 below 70% of the normal value
• in patients with severe atopic dermatitis in exacerbation.

Warnings and precautions

• if adverse reactions occur, the patient should immediately inform their doctor
• on the day of taking the medicine, the patient should avoid excessive effort, drinking alcohol, and overheating (e.g., sauna, hot shower, sunbathing).

Children

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

Perosall T13 and other medicines

• concomitant use of anti-allergic medicines, e.g., antihistamines, cromones, corticosteroids, may modify (shift in time) the actual reaction to the medicine
• if desensitization (basic treatment) and vaccination are planned at the same time, according to the Vaccination Program, desensitization should be started after vaccination
• if maintenance doses and vaccination are planned at the same time, according to the Vaccination Program, vaccination should be performed between maintenance doses and desensitization should be continued according to the scheme (do not use desensitization and protective vaccinations on the same day).

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Perosall T13 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, or thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
During pregnancy and breastfeeding, therapy with Perosall T13 should not be initiated. If such treatment has been started before pregnancy, it may be continued in agreement with the attending physician. Currently, there is a lack of sufficiently documented data on the use of allergen desensitization in pregnant women. The potential risk to the mother and fetus is therefore unknown.

Driving vehicles and operating machinery

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

3. How to use Perosall T13

Perosall T13 should be used before the pollen season, before the onset of allergy symptoms.
Take on an empty stomach, at least 15 minutes before a meal. Tilt your head back slightly and put the recommended number of drops under your tongue. The bottle, after being tilted, automatically doses the drops thanks to the appropriate design of the dropper. A child can be given the medicine by a caregiver.
The treatment is divided into two stages:

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

Basic treatment

Unless the doctor recommends otherwise, the medicine is used daily, with the dose increased by one drop every day until the highest maintenance dose, i.e., 10 drops of concentration 4, is reached, according to the following scheme:

Basic treatment scheme

Concentration 1- 10 JS/ml
Concentration 2- 100 JS/ml
Day
Number of drops
Day
Number of drops
1
2
3
4
5
6
7
8
9
10
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
1
2
3
4
5
6
7
8
9
10
Concentration 3- 1,000 JS/ml
Concentration 4- 5,000 JS/ml
Day
Number of drops
Day
Number of drops
21
22
23
24
25
26
27
28
29
30
1
2
3
4
5
6
7
8
9
10
31
32
33
34
35
2
4
6
8
10
The above dosing scheme should be considered as a guideline and example of treatment. The doctor may modify the scheme depending on the patient's condition and their reaction to the treatment.
In case of allergic symptoms such as:

• swelling of the eye and face area, runny nose, conjunctivitis,
• breathing difficulties, swallowing, the dose should be reduced, using fewer drops or a lower concentration, for at least 3 days. Then, the dose should be increased by one drop daily, according to the basic treatment scheme.

Maintenance treatment

The maximum, individual, well-tolerated dose of concentration 4should be used 2 times a week. The treatment should be ended 2-3 weeks before the pollen season.
Note:
In the case of patients who are particularly sensitive to pollen allergens, treatment can be started with concentration 0- 1 JS/ml, which is prepared on individual order.

Before using Perosall T13, check the expiration date on the packaging.

Taking a higher dose of Perosall T13 than recommended

Local and general adverse reactions may occur, including anaphylactic shock, the symptoms of which are: sudden blood pressure drop and loss of consciousness.
In case of taking a higher dose than recommended, the patient should immediately consult a doctor or pharmacist.

Missing a dose of Perosall T13

The patient should take the last used dose and then continue the treatment according to the scheme.

Stopping the use of Perosall T13

If the basic treatment is interrupted for more than 2 weeks, it should be resumed using half of the last used and well-tolerated dose (a dose that does not cause allergic symptoms). In case of a longer interruption than 4 weeks, the treatment should be started from concentration 1.
Desensitization may be interrupted in case of infection or exacerbation of chronic infections (in accordance with section 2 of the leaflet). Desensitization can be resumed after 5-7 days after the infection/exacerbation has subsided, after consultation with an allergist.
In case of any further doubts related to the use of this medicine and interruption of treatment, the patient should consult an allergist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
To date, in the course of spontaneous monitoring, no adverse reactions have been reported after the use of Perosall T13. However, it should be remembered that sublingual immunotherapy, like the administration of other biological preparations, carries the risk of adverse reactions, both local and general.

Frequency not known (frequency cannot be estimated from the available data):

• intensification of conjunctivitis
• intensification of rhinitis, exacerbation of asthma
• gastrointestinal disorders, abdominal pain, diarrhea
• generalized urticaria, generalized skin itching
• itching in the throat, burning in the mouth, lip swelling.

These symptoms are usually short-term and resolve on their own.
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, the patient should consult their doctor or pharmacist.

Reporting side effects

If any adverse reactions occur, including any adverse reactions not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products {current address, phone number, and fax of the above Department} e-mail: [email protected].
Thanks to the reporting of side effects, more information can be collected on the safety of the use of the medicine.

5. How to store Perosall T13

The medicine should be stored in a place invisible and inaccessible to children.
Do not use this medicine after the expiration date stated on the bottle.
Store in a refrigerator (2°C - 8°C).
Do not freeze. In case of freezing, the medicine should be destroyed.
After the first opening, the bottle with concentration 4of Perosall T13 can be stored for a maximum of 5 days in a refrigerator (2°C - 8°C) within the validity period of the medicine.
After the first opening, bottles with concentrations 0-3of Perosall T13 can be stored for a maximum of 10 days in a refrigerator (2°C - 8°C) within the validity period of the medicine.
Opened, unused medicine should not be used in subsequent desensitization seasons.

6. Contents of the packaging and other information

What Perosall T13 contains

The active substance of the medicine is a mixture of grass pollen allergens of the following species:

Latin name Common name

Secale cereale
rye
Agrostis alba
red top
Alopecurus pratensis
meadow foxtail
Anthoxanthum odoratum
sweet vernal grass
Apera spica venti
loose silky bent
Arrhenatherum elatius
tall oat grass
Cynosurus cristatus
crested dog's tail
Dactylis glomerata
cocksfoot
Festuca pratensis
meadow fescue
Holcus lanatus
creeping soft grass
Lolium perenne
perennial ryegrass
Phleum pratense
timothy grass
Poasp.
bluegrass
The other ingredients (excipients) are: glycerol, sodium chloride, disodium phosphate dodecahydrate, potassium dihydrogen phosphate, water for injections.

What Perosall T13 looks like and what the packaging contains

Basic treatment set:

4 bottles of 10 ml (concentrations 1-4)
Concentration 1- 10 JS/ml
Concentration 2- 100 JS/ml
Concentration 3- 1,000 JS/ml
Concentration 4- 5,000 JS/ml

Maintenance treatment set:

1 bottle of 10 ml (concentration 4)
Concentration 4- 5,000 JS/ml

Set for individual orders:

1 bottle of 10 ml (concentration 0)
Concentration 0- 1 JS/ml
10 ml solution in a bottle, closed with a polypropylene and polyethylene dropper, in a cardboard box.
To obtain more detailed information, you should contact the representative of the marketing authorization holder.

Marketing authorization holder and manufacturer

Biomed S.A.
Sosnowa Avenue 8
30-224 Krakow
Phone: +48 12 37 69 200
Fax: +48 12 37 69 205
e-mail: [email protected]

Date of last update of the leaflet: