Perosall c

Patient Information Leaflet

Perosall C, oral solution for sublingual use.
Mixture of weed pollen allergens.
Induction 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
Custom order set: 1 JS/1 ml
*JS = standardized unit
Please 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 or questions, 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 appear identical.
• If you experience any adverse effects, including those not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of Contents:

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

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

Perosall C is intended for desensitizing individuals allergic to weed pollens. The medicine is available as an oral solution for sublingual use in four increasing concentrations. Each solution contains a mixture of allergens derived from weed pollens. The treatment involves the regular 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 weed pollen season.

The decision on initiating sublingual desensitization therapy is made exclusively by an allergist specialist, based on medical history, clinical symptoms, skin diagnostic tests, and/or levels of specific IgE antibodies.

2. Information before using Perosall C

When not to use Perosall C:

• 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 continuous treatment with beta-adrenolytics (e.g. due to coronary artery disease, 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 exacerbation of chronic infections (desensitization may be resumed 5–7 days after the end of exacerbation, 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 exacerbation.

Warnings and precautions

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

Children

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

Perosall C 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 (basic treatment) 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 vaccinations on the same day).

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Perosall C 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 her doctor before using this medicine.

During pregnancy and breastfeeding, treatment with Perosall C should not be initiated. If such treatment has already been started before conception, it may be continued in consultation with the attending 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

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

3. How to use Perosall C

Perosall C 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 apply 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 medicine to a child.

Treatment consists of two phases:

• Induction (build-up) phase – gradual dose increase
• Maintenance phase – fixed dose

Induction phase
Unless otherwise directed 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:

Induction 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 per day according to the induction treatment schedule.

Maintenance phase
The maximum individual dose of concentration 4, well tolerated by the patient, should be administered twice weekly. Treatment should be completed 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.

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

Accidental overdose of Perosall C
Local and systemic adverse reactions may occur, including anaphylactic shock, manifested by sudden drop in blood pressure and loss of consciousness.
In case of accidental overdose, seek immediate medical advice from a doctor or pharmacist.

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

Interrupting Perosall C treatment
If the induction phase has been interrupted for more than 2 weeks, resume treatment with half of the last 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 case of infection or exacerbation of chronic conditions (see 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 questions regarding the use of this medicine or interruption of treatment, consult your allergist.

4. Possible adverse reactions

Like all medicines, this medicinal product 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 C. However, it should be remembered that sublingual immunotherapy, as with 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):

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

These symptoms are most often 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 Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products {current address, telephone and fax numbers of the Department} e-mail: [email protected] .
By reporting adverse reactions, more information on the safety of this medicinal product can be collected.

5. How to store Perosall C

Keep the 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, discard it.
After first opening, the bottle with concentration 4 of Perosall C 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 C may be stored
for a maximum of 10 days in the refrigerator (2°C - 8°C) within the medicine's shelf life.
An opened, unused medicine must not be used in subsequent allergy seasons.

6. Contents of the package and other information

What Perosall C contains
The active substance is a mixture of allergens from pollen of the following weed species:
Latin name Common name
Artemisia sp. mugwort
Chenopodium album lamb's quarters
Plantago lanceolata ribwort plantain
Rumex acetosa common sorrel

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

What Perosall C looks like and contents of the pack
Basic 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 dropper cap 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 of Sera and Vaccines 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]