Catalet D

Leaflet included in the packaging: patient information

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to you by a doctor for a specific person. 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 undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

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

Catalet D is intended for desensitization of individuals with an allergy to tree pollen. The medicine is in the form of a suspension for injection in three increasing concentrations. Each concentration contains modified allergens (allergoids) derived from tree pollen. The treatment involves the systematic administration of increasing doses of the allergoid to induce a state of tolerance (no reaction of the body to the allergen). This leads to the alleviation or disappearance of allergy symptoms during tree pollen season. The effect of desensitization on reducing allergic symptoms has been confirmed by controlled clinical trials.
Catalet D is used for preseasonal and year-round desensitization (specific immunotherapy) in patients with confirmed allergy to tree pollen. Immunotherapy with Catalet D is recommended for adults and children from 6 years of age.
Dosing and method of desensitization (immunotherapy) with Catalet D 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 D

When not to use Catalet D:

• 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 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 undesirable effects in case of adrenaline administration
• organ failure (liver, spleen, kidney, 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 D should be carried out by a specialist allergist in a office equipped with an emergency kit
• before each administration of Catalet D, the patient should be thoroughly examined by a doctor
• if undesirable effects occur after administration of the medicine, the patient should immediately inform their doctor
• the doctor should exercise particular caution when administering Catalet D if undesirable effects or any other concerning reactions occurred after the previous dose of the medicine
• 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 undesirable effects. In case of undesirable effects, observation should be extended until they subside or, if necessary, the doctor may decide on hospitalization
• for 24 hours after the 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 undesirable effects. However, it should be taken into account that biological products are always potentially hazardous. In particularly sensitive patients, they may cause severe undesirable effects, 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 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 D, vaccination can be performed after one week. After vaccination, Catalet D 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, or thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
During pregnancy and breastfeeding, do not start therapy with Catalet D. 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 administered 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.
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 dose of concentration 1containing 2.5-12.5 JS (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 5,000 JS (1 ml of concentration 4). Immunotherapy should be started before the tree 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 tree pollen season. If good tolerance of the 5,000 JS/ml (maintenance) dose is achieved much earlier than two weeks before the tree pollen season, it is recommended to repeat this dose at two-week intervals.

Preseasonal 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 well-tolerated dose 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 the pollen season, use 4-week intervals between doses.
After the pollen season, gradually increase the dose at 1-week intervals until the full maintenance dose (1 ml) or the highest well-tolerated dose is achieved, and continue immunotherapy every 4 weeks until the start of the next pollen season.

EXAMPLE OF DOSING

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

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

Administer the full maintenance dose (1 ml) of concentration 4 or lower (the highest dose well-tolerated by the patient) every 4 weeks until the start of the next pollen season.
Dose escalation during the desensitization cycle is only possible if the last dose was well-tolerated.
Do not exceed the dose of 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 provided schemes are only general guidelines. The doctor, if necessary, should modify them depending on the patient's reaction.

Taking a higher dose of Catalet D than recommended

Local and general undesirable effects may occur, including anaphylactic shock, with symptoms such as sudden blood pressure drop and loss of consciousness.
In case of taking a higher dose of the medicine than recommended, immediately consult a doctor or pharmacist.

Discontinuation of Catalet D

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, consult a doctor.

4. Possible undesirable effects

Like all medicines, this medicine can cause undesirable 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
• swelling, 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 undesirable effects may occur up to 20 minutes after injection of the medicine, and late local undesirable effects may occur on the day of injection or in the following days
• subcutaneous, painful nodules at the injection site, so-called granulomas, which appear 2-3 weeks after injection. The above undesirable effect is related to the presence of aluminum hydroxide in the product. Subcutaneous nodules persist for up to 6 weeks or longer and resolve 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 undesirable effects occur after administration of Catalet D.

Reporting undesirable effects

If any undesirable effects occur, including any possible undesirable effects not mentioned in the leaflet, inform your doctor, pharmacist, or nurse.
Undesirable effects can be reported directly to the Department of Adverse Reaction Monitoring of the 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].
Reporting undesirable effects helps to gather more information on the safety of the medicine.

5. How to store Catalet D

Keep the medicine out of the 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 D contains

The active substance of the medicine is a mixture of allergoids derived from the pollen of the following tree species:
Latin name
Common name
Alnussp.
alder
Betulasp.
birch
Corylus avellana
common hazel
The other ingredients (excipients) are: phenol, sodium chloride, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injections, aluminum hydroxide.

What Catalet D looks like and what the packaging contains

Catalet D, concentration 1 is a milky suspension,
Catalet D, concentration 2 is a milky suspension with a creamy tint,
Catalet D, concentration 3 is a light brown suspension,
Catalet D, 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 JS/ml
Concentration 2- 250 JS/ml
Concentration 3- 2,500 JS/ml
Maintenance treatment set:
1 vial (concentration 4) of 2 ml
Concentration 4- 5,000 JS/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 the last update of the leaflet:

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Information intended exclusively for medical professionals

Administration of Catalet D

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