Catalet d

Package leaflet: Information for the patient

Catalet D, suspension for injection
Mixture of tree pollen allergoids
Induction therapy set: 25 JS*/ml, 250 JS/ml, 2 500 JS/ml
Maintenance therapy set: 5 000 JS/ml
*JS standardized unit
Read this leaflet carefully before using the medicine, as it contains important information for the patient

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

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

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

Catalet D is intended for desensitizing individuals allergic to tree pollens. The medicine is formulated as a suspension for injection in three increasing concentrations. Each concentration contains modified allergens (allergoids) derived from tree 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 tree pollen season. The effect of desensitization in reducing allergic symptoms has been confirmed by controlled clinical trials.

Catalet D is used for preseasonal and year-round desensitization (specific immunotherapy) in patients diagnosed with allergy to tree pollens. Immunotherapy with Catalet D is recommended for adults and children from the age of 6 years.

The dosage and method of desensitization (immunotherapy) with Catalet D are determined exclusively by an allergist specialist, who classifies patients into the appropriate category 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. Information important before using Catalet D

When not to use Catalet D:

• if the patient is allergic to any of the other components 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 has 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 which 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 administered)
• in case of poor patient cooperation
• in children under 5 years of age, except for specific indications.

Warnings and precautions

• immunotherapy with Catalet D should be administered by an allergist specialist in a clinic equipped with emergency anaphylaxis treatment kit
• before each administration of Catalet D, the patient should be thoroughly examined by a physician
• if adverse reactions occur after administration, the patient should immediately inform the physician
• the physician should exercise particular caution when administering Catalet D if adverse reactions described in section 4 or any other concerning reactions occurred after the previous dose
• after injection, the patient should 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 should 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).

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

Catalet D and other medicines

• do not use Catalet D 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 allergoid desensitization treatment, only vaccinations absolutely necessary according to the National Immunization Program should be performed. Protective vaccination may be administered one week after administration of Catalet D. After a protective vaccination, Catalet D may be administered two weeks later. The first dose after resuming desensitization should be half the last well-tolerated dose. If the interruption in desensitization 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, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.

Desensitization treatment with allergoids should not be initiated during pregnancy or breastfeeding. If such treatment has already been started before conception, it may be continued under the supervision of the attending physician. Currently, there are insufficiently documented data regarding the use of allergoid desensitization in pregnant and breastfeeding women. Therefore, the potential risk to the mother, fetus, or breastfed infant is unknown.

Driving and operating machinery

Do not drive vehicles or operate machinery or use dangerous tools, as symptoms of fatigue may occur within 12 hours after each dose of Catalet D.

3. How to use Catalet D

Catalet D will be administered by a doctor or nurse as a deep subcutaneous injection.
The injection site should not be rubbed.
The medicine can be used according to a pre-seasonal or year-round regimen.

Pre-seasonal desensitization schedule
Desensitization starts with the lowest doses, usually with concentration 1 containing
2.5–12.5 JS (0.1 ml or 0.5 ml). By gradually increasing the dose (concentration 2, concentration 3,
and concentration 4), the maximum, well-tolerated dose is reached, amounting to 5,000 JS
(1 ml of concentration 4). Immunotherapy should be initiated before the tree 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 tree blooming. If the patient achieves good tolerance to the maintenance dose of 5,000 JS/ml significantly earlier than two weeks before the tree 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 pre-seasonal desensitization schedule.
Each year during allergen immunotherapy, reduce the dose during pollen season relative to the last previously administered dose that was well tolerated before the pollen season, as follows:

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

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

• In the 1st year of immunotherapy: administer 0.2 ml every 4 weeks during pollen season. After 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 pollen season. After 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 pollen season. After 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 start of the next pollen season.
Dose escalation during the desensitization cycle is only permitted 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 continued for a period of 3–5 years.
In cases where desensitization is performed only according to the pre-seasonal schedule, treatment in subsequent years may be initiated with slightly higher doses than in the preceding year.
The above schedules are general guidelines only. The physician may modify them as necessary depending on the patient's response.

Accidental overdose of Catalet D
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 accidental overdose, seek immediate medical advice from a physician or pharmacist.

Discontinuation of Catalet D
If the interruption in desensitization exceeds 4 weeks, desensitization should be restarted from the initial 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 estimated from the available data):

• allergic reaction, anaphylactic shock
• atopic eczema
• urticaria, swelling
• burning sensation in the 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, which usually does 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 the following days
• subcutaneous, itchy nodules at the injection site, so-called granulomas, which become apparent 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 up to 6 weeks or longer and resolve spontaneously. If multiple subcutaneous nodules/granulomas are observed, discontinuation of immunotherapy is recommended. The decision is made by the physician supervising the desensitization treatment
• fever.

The physician will discontinue immunotherapy if severe, systemic adverse reactions occur after administration of Catalet D.
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 number of the aforementioned Department}, e-mail: [email protected].
Reporting adverse reactions enables further safety information regarding the use of the medicine to be collected.

5. How to store Catalet D

Keep the 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 the medicine freezes, dispose of it.
Keep vials in the outer packaging to protect from light.

6. Contents of the package and other information

What Catalet D contains
The active substance of the medicinal product is a mixture of allergoids derived 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: phenol, sodium chloride, disodium phosphate dodecahydrate,
sodium dihydrogen phosphate dihydrate, water for injections, aluminium hydroxide.

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

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

Set for initial 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 Immunobiologicals 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]

Information intended exclusively for medical professionals

Administration of Catalet D
Shake the vial well before use to obtain a uniform suspension. The medicinal product 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, Catalet D 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 D should be administered by an allergology specialist in a clinic equipped with an anaphylaxis treatment kit.
Do not mix the medicinal product with other medicinal products, as compatibility studies have not been performed.