Catalet T

Leaflet attached to the packaging: patient information

Catalet T,suspension for injection
Mixture of grass pollen allergoids
Basic treatment set:25 SU*/ml, 250 SU/ml, 2,500 SU/ml
Maintenance treatment set:10,000 SU/ml
*SU standard unit
It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient

• It is necessary to keep this leaflet, so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to you for a specific reason. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

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

Catalet T is intended for desensitization of individuals with grass pollen allergy. The medicine is in the form of a suspension for injection in three increasing concentrations. Each concentration contains modified allergens (allergoids) derived from grass pollen. The treatment involves the systematic administration of increasing doses of the allergoid 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 effect of desensitization on reducing allergic symptoms has been confirmed by controlled clinical trials.
Catalet T is used for preseasonal and year-round desensitization (specific immunotherapy) in patients with confirmed grass pollen allergy. Immunotherapy with Catalet T is recommended for adults and children from 6 years of age.
Dosing and method of desensitization (immunotherapy) with Catalet T are determined exclusively by a specialist allergist, qualifying patients for the appropriate category based on medical history, allergic symptoms, skin diagnostic tests, and/or levels of specific IgE antibodies.
Adequate desensitization effect is achieved after at least 3 cycles (3 years) of immunotherapy.

2. Important information before using Catalet T

When not to use Catalet T:

• 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 condition (the medicine may be used after the inflammatory condition has subsided)
• severe immunological disease or immunodeficiency (with the exception of autoimmune diseases, such as type 1 diabetes and multiple sclerosis, where immunotherapy has a beneficial effect)
• cancer
• severe mental illness
• severe asthma resistant to pharmacological treatment and/or disease with irreversible airway obstruction (FEV1 below 70% of the expected value with appropriate pharmacological treatment)
• severe cardiovascular disease, which increases the risk of side effects in case of adrenaline administration
• organ failure (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, with the exception of specified indications.

Warnings and precautions

• immunotherapy with Catalet T should be carried out by a specialist allergist in a office equipped with an emergency kit
• before each administration of Catalet T, the patient should be thoroughly examined by a doctor
• if side effects occur after administration of the medicine, the patient should immediately inform their doctor
• the doctor should exercise particular caution when administering Catalet T if side effects occurred after the previous dose of the medicine or any other worrying reactions
• after the injection, the patient should remain under medical supervision for at least one hour, paying particular attention to the occurrence of local and general side effects. In case of side effects, observation should be extended until they disappear or, if necessary, the doctor may decide to hospitalize the patient
• for 24 hours after the injection, the patient should avoid excessive physical exertion, drinking alcohol, and overheating (e.g., sauna, hot shower, sunbathing).

Medicines containing modified and adsorbed allergens rarely cause severe side effects. However, it should be taken into account that biological products are always potentially hazardous. In particularly sensitive patients, they may cause severe side effects, 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-blockers (even locally)
• concomitant use of antiallergic medicines, such as antihistamines, cromones, corticosteroids, may modify (shift in time) the actual reaction to the medicine
• during immunotherapy, only absolutely necessary vaccinations should be performed in accordance with the Vaccination Program. After administration of Catalet T, vaccination can be performed after one week. After vaccination, Catalet T can be administered after two weeks. The first dose of resumed immunotherapy should be half the size of the last well-tolerated dose. If the break in immunotherapy is longer than 4 weeks, immunotherapy should be started from the first administered dose. The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as about medicines they plan to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects 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 Catalet T 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 allergoid desensitization in pregnant and breastfeeding women. The potential risk to the mother and fetus or breastfed child is therefore unknown.

Driving and using machines

Do not drive vehicles, operate any mechanical devices, or use dangerous tools, as fatigue may occur up to 12 hours after each 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.
Do not massage the injection site.
The medicine can be used in a preseasonal and year-round scheme.

Preseasonal desensitization scheme

Desensitization starts from the lowest doses, usually from a concentration of 1containing 2.5-12.5 SU (0.1 ml or 0.5 ml). Through gradual dose increase (concentrations 2, 3, and 4), the maximum dose, well-tolerated by the patient, is achieved, amounting to 10,000 SU (1 ml of concentration 4). Immunotherapy should be started before the grass pollen season, during the symptom-free period.
Depending on the region, it is recommended to start immunotherapy at a time that allows achieving the maintenance dose two weeks before the grass pollen season. If good tolerance of the 10,000 SU/ml (maintenance) dose is achieved much earlier than two weeks before the pollen season, it is recommended to repeat this dose at two-week intervals.

Year-round desensitization scheme

Year-round desensitization scheme

In the first year, treatment should be started according to the preseasonal desensitization scheme.
In each year of desensitization, during the pollen season, the dose should be reduced compared to the last dose well-tolerated before the pollen season, in the following manner:

• 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.

Doses should be administered at 4-week intervals during the pollen season.
After the pollen season, the dose should be gradually increased at 1-week intervals until the full maintenance dose (1 ml) or the highest dose well-tolerated by the patient is achieved, and immunotherapy should be continued every 4 weeks until the start of the next pollen season.

EXAMPLE DOSING

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

• in the 1st year of immunotherapy, 0.2 ml should be administered during the pollen season, every 4 weeks. After the pollen season, the dose should be gradually increased at 1-week intervals - 0.4 ml; 0.6 ml; 0.8 ml; 1 ml
• in the 2nd year of immunotherapy, 0.3 ml should be administered during the pollen season, every 4 weeks. After the pollen season, the dose should be gradually increased at 1-week intervals - 0.6 ml; 0.8 ml; 1 ml
• in the 3rd year of immunotherapy, 0.4 ml should be administered during the pollen season, every 4 weeks. After the pollen season, the dose should be gradually increased at 1-week 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 increases during the desensitization cycle are only possible if the last dose was well-tolerated.
The dose should not exceed 1 ml.
The medicine should only be administered in the prepared concentrations.
Immunotherapy should be carried out for a period of 3-5 years.
In the case of desensitization only in the preseasonal scheme, in subsequent years, treatment can be started from slightly higher doses than in the previous year.
The presented schemes are only general guidelines. The doctor, if necessary, should modify them depending on the patient's reaction.

Taking a higher dose of Catalet T than recommended

Local and general side effects 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 of the medicine than recommended, you should immediately consult a doctor or pharmacist.

Discontinuation of Catalet T

If the break in desensitization is longer than 4 weeks, desensitization should be started from the first administered dose. In case of any further doubts related to the use of this medicine, you should consult a doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• allergic reaction, anaphylactic shock
• atopic rash
• urticaria, angioedema
• eye burning
• sneezing, coughing
• wheezing, chest tightness
• flushing, redness at the injection site (sometimes angioedema at the injection site) with a diameter of 5-10 cm, which usually does not require treatment. Local early side effects may occur up to 20 minutes after injection of the medicine, and late local side effects may occur on the day of injection or in subsequent days
• subcutaneous, painful nodules at the injection site, so-called granulomas, which appear two to three weeks after injection. The above side effect is related to the presence of aluminum hydroxide in the product. Subcutaneous nodules persist for up to 6 weeks or longer and disappear spontaneously. In case of multiple subcutaneous granulomas, it is recommended to discontinue immunotherapy. The decision is made by the attending physician
• fever.

The doctor discontinues immunotherapy if severe, general side effects occur after administration of Catalet T.

Reporting side effects

If side effects occur, including any side effects 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 Medicinal Products, 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 medicine.

5. How to store Catalet T

The medicine should be stored 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; in case of freezing, the medicine is destroyed.
Store the vials in the outer packaging to protect from light.

6. Contents of the packaging and other information

What Catalet T contains

The active substance of the medicine 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
cocksfoot
Festuca pratensis
meadow fescue
Holcus lanatus
creeping soft grass
Lolium perenne
perennial ryegrass
Phleum pratense
timothy grass
Poasp.
bluegrass
Secale cereale
rye
The other ingredients (excipients) are: phenol, sodium chloride, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injections, aluminum hydroxide.

What Catalet T looks like and what the packaging contains

Catalet T, concentration 1 is a milky suspension,
Catalet T, concentration 2 is a milky suspension with a creamy tint,
Catalet T, concentration 3 is a light brown suspension,
Catalet T, concentration 4 is a brown suspension.
The packaging contains a vial/vials closed with a rubber stopper.

Basic treatment set:

3 vials (concentrations 1-3) of 2 ml each
Concentration 1- 25 SU/ml
Concentration 2- 250 SU/ml
Concentration 3- 2,500 SU/ml
Maintenance treatment set:
1 vial (concentration 4) of 2 ml
Concentration 4- 10,000 SU/ml

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 revision of the leaflet:

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Information intended exclusively for healthcare professionals

Administration of Catalet T

Before use, shake the vial to obtain a uniform suspension. It should be visually assessed whether the medicine contains any foreign particles and/or whether any changes have occurred in its appearance. If any changes are observed, the medicine should not be used.
After the first opening of the vial, Catalet T can be stored for a maximum of 4 weeks in a refrigerator (2°C - 8°C) within the validity period of the medicine.
The medicine should be administered deep subcutaneously without massaging the injection site.
Immunotherapy with Catalet T should be carried out by a specialist allergist in an office equipped with an emergency kit.
The medicinal product should not be mixed with other medicinal products, as compatibility tests have not been performed.