Catalet t

Package leaflet: information for the patient

Catalet T, suspension for injection
Grass pollen allergoid mixture
Initiation treatment set: 25 JS*/ml, 250 JS/ml, 2 500 JS/ml
Maintenance treatment set: 10 000 JS/ml
*JS standardized unit
Please read carefully this leaflet 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 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 the same.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

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

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

Catalet T is intended for desensitizing individuals allergic to grass pollen. The medicine is a suspension for injection, available in three increasing concentrations. Each concentration contains modified allergens (allergoids) derived from grass pollen. 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 grass pollen season. The effect of desensitization in reducing allergic symptoms has been confirmed by controlled clinical trials.
Catalet T is used for pre-seasonal and year-round desensitization (specific immunotherapy) in patients with diagnosed allergy to grass pollen. Immunotherapy with Catalet T is recommended for adults and children from the age of 6 years.
The dosing and desensitization regimen (immunotherapy) with Catalet T is determined exclusively by an allergist specialist, who qualifies 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 before using Catalet T

When not to use Catalet T:

• 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 exerts beneficial effects)
• malignant neoplastic 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-blocking agents (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 T should be administered by an allergology specialist in a clinic equipped with an anaphylaxis emergency kit
• before each administration of Catalet T, the patient must be thoroughly examined by a physician
• if adverse reactions occur after administration of the medicine, the patient should immediately inform the physician
• the physician should exercise particular caution when administering Catalet T if adverse reactions described in section 4 occurred after the previous dose, or any other concerning reactions
• 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; if necessary, the physician may decide to hospitalize the patient
• for 24 hours after the injection, the patient should avoid excessive physical exertion, alcohol consumption, and overheating (e.g. sauna, hot shower, sunbathing).

Medicinal products 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 T and other medicines

• do not use Catalet T if the patient is taking beta-blocking agents (even locally)
• concomitant use of antiallergic drugs, e.g. antihistamines, cromones, corticosteroids, may modify (delay in time) the actual reaction to the medicine
• during allergen immunotherapy, only vaccinations absolutely necessary according to the Vaccination Schedule should be performed. Protective vaccination may be administered one week after administration of Catalet T. After a protective vaccination, Catalet T may be administered after two weeks. The first dose after resuming immunotherapy should be half the last well-tolerated dose. If the break in immunotherapy exceeds four weeks, treatment should be restarted with the first administered 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 might be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.

Immunotherapy with Catalet T should not be initiated during pregnancy or breastfeeding. If such 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 allergoid-based immunotherapy in pregnant or 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 any machinery or use dangerous tools, as symptoms of fatigue may occur within 12 hours after each administered dose of Catalet T.

3. How to use Catalet T

Catalet T 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 schedule.

Pre-seasonal desensitization schedule
Desensitization starts with the lowest doses, usually with concentration 1 containing 2.5–12.5 JE (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 10,000 JE (1 ml of concentration 4). Immunotherapy should be initiated before the grass pollen season, during a symptom-free period.

Depending on the region, immunotherapy should be started at such a time to achieve the maintenance dose two weeks before the onset of grass flowering. If the well-tolerated maintenance dose of 10,000 JE/ml is reached significantly earlier than two weeks before the grass 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 schedule.
Each year during the pollen season, reduce the dose relative to the last previously administered, well-tolerated preseason dose, 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 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, and continue immunotherapy every 4 weeks until the beginning of the next pollen season.

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

• 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) at 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 preseasonal schedule, in subsequent years treatment may be initiated with slightly higher doses than in the preceding year.
The above schedules are general guidelines only. The physician, if necessary, should modify them according to the patient's response.

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

Interrupting treatment with Catalet T
If the interruption of desensitization exceeds 4 weeks, desensitization should be restarted from the initial 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 in everyone.

Frequency unknown (frequency cannot be determined from available data):

• allergic reaction, anaphylactic shock
• atopic dermatitis
• urticaria, swelling
• burning sensation in 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 drug 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, 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 up to 6 weeks or longer and resolve spontaneously. In case 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, systemic adverse reactions occur after administration of Catalet T.

Reporting of adverse reactions

If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet, inform your physician, 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 aforementioned Department}, e-mail: [email protected].

Reporting adverse reactions enables further safety information on the medicinal product to be collected.

5. How to store Catalet T

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, discard it.
Keep the vials in the outer packaging to protect from light.

6. Contents of the pack and other information

What Catalet T contains
The active substance is a mixture of allergoids derived from the pollen of the following grass species:
Latin name                                             Common name
Alopecurus pratensis                                  meadow foxtail
Anthoxanthum odoratum                          sweet vernal grass
Arrhenatherum elatius                              tall oat-grass
Dactylis glomerata                                    orchard grass
Festuca pratensis                                     meadow fescue
Holcus lanatus                                          velvet grass
Lolium perenne                                         perennial ryegrass
Phleum pratense                                       timothy grass
Poa sp.                                                       meadow-grass
Secale cereale                                           rye
The other ingredients (excipients) are: phenol, sodium chloride, disodium phosphate dodecahydrate,
sodium dihydrogen phosphate dihydrate, water for injections, aluminium hydroxide.

What Catalet T looks like and contents of the pack
Catalet T, concentration 1 is a milky suspension,
Catalet T, concentration 2 is a creamy milky suspension,
Catalet T, concentration 3 is a light brown suspension,
Catalet T, concentration 4 is a brown suspension.
The pack contains vial(s) closed with a rubber stopper.

Basic treatment set:
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

Maintenance treatment set:
1 vial (concentration 4) – 2 ml
Concentration 4 – 10,000 BU/ml

Marketing Authorisation Holder and Manufacturer
Institute of BioTechnology of Sera 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 healthcare professionals

Administration of Catalet T
Shake the vial well before use to obtain a uniform suspension. The product should be visually inspected for the presence of 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 T 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 T should be conducted by an allergology specialist in a medical office equipped with emergency anaphylaxis treatment equipment.
Do not mix the medicinal product with other medicinal products, as compatibility studies have not been performed.