Catalet c

Package leaflet: Information for the patient

Catalet C, injectable suspension
Mixture of allergoids from weed pollen
Induction therapy set: 25 JS*/ml, 250 JS/ml, 2 500 JS/ml
Maintenance therapy set: 5 000 JS/ml
*JS standardized unit
Please read this leaflet carefully 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, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

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

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

Catalet C is intended for desensitizing individuals allergic to weed pollens. The medicine is formulated as a suspension for injection in three increasing concentrations. Each concentration contains modified allergens (allergoids) derived from weed pollens. The treatment consists of systematically administering increasing doses of allergoid to induce a state of tolerance (lack of organism reaction to the allergen). This leads to alleviation or disappearance of allergic symptoms during weed pollen season. The effect of desensitization in reducing allergic symptoms has been confirmed in controlled clinical trials.
Catalet C is used for pre-seasonal and year-round desensitization (specific immunotherapy) in patients diagnosed with allergy to weed pollens. Immunotherapy with Catalet C is recommended for adults and children from the age of 6 years.
The dosing and desensitization regimen (immunotherapy) with Catalet C is determined exclusively by a specialist allergist doctor, who classifies patients into appropriate categories based on medical history, allergic symptoms, skin diagnostic tests, and/or levels of specific IgE antibodies.
An adequate desensitization effect is achieved after at least 3 treatment cycles (3 years) of immunotherapy.

2. Important information before using Catalet C

When not to use Catalet C:

• if the patient is allergic to any of the other ingredients of this medicine (listed in section 6)
• if the patient has:
• acute or chronic inflammatory conditions (the medicine may be used after resolution of the inflammatory state)
• severe immunological disease or immunodeficiency (excluding autoimmune diseases such as type I diabetes and multiple sclerosis, in which immunotherapy may have beneficial effects)
• malignant disease
• severe psychiatric disorder
• severe asthma resistant to pharmacological treatment and/or disease with irreversible bronchial obstruction (FEV1 below 70% of predicted value despite appropriate pharmacological treatment)
• severe cardiovascular disease that increases the risk of adverse reactions in case adrenaline administration becomes necessary
• organ insufficiency (liver, spleen, kidneys, thyroid)
• if the patient is taking beta-blockers (even locally)
• in case of poor patient cooperation
• in children under 5 years of age, except for specific indications.

Warnings and precautions

• immunotherapy with Catalet C should be administered by an allergologist specialist in a clinic equipped with anaphylactic shock emergency equipment
• before each administration of Catalet C, the patient must be thoroughly examined by a physician
• if adverse reactions occur after administration, the patient must immediately inform the physician
• the physician must exercise particular caution when administering Catalet C if adverse reactions described in section 4 occurred after the previous dose, or any other concerning reactions
• after injection, the patient must remain under medical supervision for at least one hour, with special attention paid to the occurrence of local and systemic adverse reactions. If adverse reactions occur, observation must be extended until symptoms resolve, or, if necessary, the physician may decide to hospitalize the patient
• for 24 hours after injection, the patient should avoid excessive physical exertion, alcohol consumption, and overheating (e.g. sauna, hot shower, sunbathing).

Biological preparations containing modified and adsorbed allergens rarely cause severe adverse reactions. However, it must be remembered that biological products are always potentially hazardous. In particularly sensitive patients, they may cause severe adverse reactions, including anaphylactic reactions, especially after overdose or intravenous administration.

Catalet C and other medicines

• do not use Catalet C if the patient is taking beta-blockers (even locally)
• concomitant use of antiallergic drugs such as antihistamines, cromones, or corticosteroids may modify (delay in time) the actual response to the medicine
• during allergen immunotherapy, only vaccinations absolutely necessary according to the National Immunization Program should be administered. Protective vaccination may be given one week after administration of Catalet C. After a protective vaccination, Catalet C may be administered after two weeks. The first dose after resuming immunotherapy should be half the last well-tolerated dose. If the immunotherapy interruption exceeds four weeks, treatment should be restarted with the initial dose. Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine.

Immunotherapy with Catalet C should not be initiated during pregnancy or breastfeeding. If treatment was started before conception, it may be continued under the supervision of the treating physician. Currently, there is insufficient well-documented data on the use of allergoid-based immunotherapy in pregnant and breastfeeding women. Therefore, the potential risk to the mother, fetus, or breastfed child is unknown.

Driving and operating machinery

Patients should not drive motor vehicles, operate any machinery, or use dangerous tools, as symptoms of fatigue may occur within 12 hours after each dose of Catalet C.

3. How to use Catalet C

Catalet C will be administered by a doctor or nurse as a deep subcutaneous injection.
Do not rub the injection site.
The medication can be used according to a pre-seasonal or year-round regimen.

Pre-seasonal desensitization schedule
Desensitization begins with the lowest doses, usually starting with concentration 1 containing
2.5–12.5 JU (0.1 ml or 0.5 ml). By gradually increasing the dose (concentration 2, concentration 3,
and concentration 4), the maximum dose well tolerated by the patient is reached, amounting to 5,000 JU
(1 ml of concentration 4). Immunotherapy should be initiated before the weed pollen season, during a symptom-free period.

Depending on the region, immunotherapy should be started early enough to achieve the maintenance dose two weeks before the onset of weed flowering. If the well-tolerated maintenance dose of 5,000 JU/ml is reached significantly earlier than two weeks before the weed pollen season, this dose should be repeated at two-week intervals.

Pre-seasonal desensitization schedule

Year-Round Desensitization Schedule
In the first year, treatment should be initiated according to the preseasonal desensitization scheme.
Each year of desensitization, during the pollen season, reduce the dose to the following percentage of the last previously administered and well-tolerated preseason dose:

• in the 1st year of immunotherapy – to 20% of the volume
• in the 2nd year of immunotherapy – to 30% of the volume
• in the 3rd year of immunotherapy – to 40% of the volume

During the pollen season, administer doses at 4-week intervals.
After the pollen season, gradually increase the dose at weekly intervals until reaching the full maintenance dose (1 ml) or the highest dose well tolerated, then continue immunotherapy every 4 weeks until the start of the next pollen season.

EXAMPLE DOSING
If the last administered dose before the pollen season was 1 ml:

• In the 1st year of immunotherapy: administer 0.2 ml every 4 weeks during the pollen season. After the pollen season, gradually increase the dose at weekly intervals: 0.4 ml, 0.6 ml, 0.8 ml, 1 ml.
• In the 2nd year of immunotherapy: administer 0.3 ml every 4 weeks during the pollen season. After the pollen season, gradually increase the dose at weekly intervals: 0.6 ml, 0.8 ml, 1 ml.
• In the 3rd year of immunotherapy: administer 0.4 ml every 4 weeks during the pollen season. After the pollen season, gradually increase the dose at weekly intervals: 0.8 ml, 1 ml.

The full maintenance dose (1 ml) of concentration 4 or lower (the highest dose well tolerated by the patient) should be administered every 4 weeks until the beginning of the next pollen season.
Dose escalation during the desensitization cycle is only possible if the previous dose was well tolerated.
The dose of 1 ml must not be exceeded.
The medicinal product must be administered only in the prepared concentrations.
Immunotherapy should be conducted for a period of 3–5 years.
In cases of desensitization using only the preseasonal scheme, in subsequent years treatment may be initiated at slightly higher doses than in the previous year.
The above schemes are only general guidelines. The physician should modify them as necessary depending on the patient's response.

Taking a higher than recommended dose of Catalet C
Local and systemic adverse reactions may occur, including anaphylactic shock, with symptoms such as sudden drop in blood pressure and loss of consciousness.
In case of ingestion of a higher than recommended dose of the medicinal product, seek immediate medical advice from a physician or pharmacist.

Discontinuation of Catalet C treatment
If the desensitization interruption lasts longer than 4 weeks, desensitization should be restarted from the first administered dose. In case of any further doubts regarding the use of this medicinal product, consult a physician.

4. Possible adverse reactions

Like any medicine, this medicinal product may cause adverse reactions, although not everyone experiences them.
Frequency unknown (frequency cannot be determined from available data):

• allergic reaction, anaphylactic shock
• atopic dermatitis
• urticaria, swelling
• burning eyes
• sneezing, cough
• wheezing, chest tightness
• itching, redness at the injection site (sometimes swelling at the injection site) with a diameter of 5–10 cm, usually do not require treatment. Local early adverse reactions may occur within 20 minutes after injection, while late local adverse reactions may appear on the day of injection or in subsequent days
• subcutaneous, itchy nodules at the injection site, so-called granulomas, appearing two to three weeks after injection. The above adverse reaction is associated with the presence of aluminium hydroxide in the product. Subcutaneous nodules may persist for 6 weeks or longer and resolve spontaneously. In case of detection of multiple subcutaneous nodules/granulomas, immunotherapy should be discontinued. The decision is made by the physician supervising the desensitization
• fever.

The physician will discontinue immunotherapy if severe general adverse reactions occur after administration of Catalet C.
Reporting of adverse reactions
If any adverse symptoms 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 of 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].
Reporting of adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store Catalet C

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the vial.
Store in a refrigerator (2°C - 8°C).
Do not freeze; if frozen, the medicine must be discarded.
Keep the vials in the outer packaging to protect from light.

6. Contents of the package and other information

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

The other ingredients (excipients) are: phenol, sodium chloride, disodium phosphate dodecahydrate,
sodium dihydrogen phosphate dihydrate, water for injections, aluminium hydroxide.

What Catalet C looks like and contents of the pack
Catalet C, concentration 1 is a milky suspension,
Catalet C, concentration 2 is a creamy milky suspension,
Catalet C, concentration 3 is a light brown suspension,
Catalet C, concentration 4 is a brown suspension.

The pack contains vial(s) sealed with a rubber stopper.

Set for basic treatment:
3 vials (concentrations 1–3) of 2 ml each
Concentration 1 – 25 BU/ml
Concentration 2 – 250 BU/ml
Concentration 3 – 2,500 BU/ml

Set for maintenance treatment:
1 vial (concentration 4) – 2 ml
Concentration 4 – 5,000 BU/ml

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

Information intended exclusively for medical professionals

Administration of Catalet C
Before use, shake the vial to obtain a uniform suspension. The solution should be inspected visually for any foreign particles and/or any changes in appearance. If any changes are observed, the medicinal product must not be used.
After first opening the vial, Catalet C may be stored for up to 4 weeks in a refrigerator (2°C - 8°C) within the product's shelf life.
Administer the medicinal product by deep subcutaneous injection, without rubbing the injection site.
Immunotherapy with Catalet C should be conducted by an allergology specialist in a medical office equipped with an anaphylaxis emergency kit.
Do not mix this medicinal product with other medicinal products, as compatibility studies have not been performed.