Purethal

Leaflet attached to the packaging: patient information

PURETHAL single allergoids of plant pollen,

20,000 AUM/ml
suspension for injection

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is PURETHAL and what is it used for

PURETHAL is used for specific immunotherapy (desensitization) of IgE-dependent inhalant allergies, with symptoms of allergic rhinitis, allergic conjunctivitis, and asthma with an allergic background.
The mechanism of action includes:

• modulation of T lymphocyte function (shift from Th2 to Th1 dominance)
• production of IgG antibodies
• reduction of mediator-releasing cell reactivity.

Diagnosis should be based on a detailed medical history confirming the occurrence of hypersensitivity reactions in the patient to birch pollen.

2. Important information before using PURETHAL

When not to use PURETHAL

• if the patient is hypersensitive (allergic) to any of the other components of this medicine (listed in section 6),
• if the patient has reduced immunity (e.g., due to immunosuppressive medication),
• if the patient has an autoimmune disease (e.g., rheumatoid disease),
• if the patient has severe asthma, especially with a forced expiratory volume (FEV) consistently below 70% of the expected value or glucocorticoid-dependent asthma,
• if the patient has heart failure, is being treated with beta-adrenergic blockers or ACE inhibitors (angiotensin-converting enzyme inhibitors),
• if the patient has a contraindication to the use of adrenaline (e.g., hyperthyroidism),
• if the patient has active tuberculosis,
• if the patient has cancer,
• if the patient has severe mental disorders, impaired contact with the patient, or non-compliance with the doctor's recommendations,
• in children under 5 years of age,
• during pregnancy. If treatment has been started before pregnancy, it may be continued in consultation with the attending physician.

Warnings and precautions

This medicine should only be prescribed and administered by specialist allergists with experience in treating allergies.
Consult a doctor, even if the following warnings relate to past situations.
In rare cases, after injection of this medicine, a severe systemic reaction (wheezing, shortness of breath, Quincke's edema, generalized urticaria) may occur, and in extreme cases, anaphylactic shock may occur.
Typical warning signs are: a burning sensation, itching, a feeling of heat on or under the tongue, in the throat, on the hands, and soles of the feet.
If any of these symptoms occur, immediatelycontact a doctor.
During the pollen season, PURETHAL may only be used in patients who do not have allergy symptoms; if allergy symptoms occur during treatment in the pollen season, the next injection should be postponed until they resolve or treatment should be discontinued. In this case, the interval between injections is extended, which should be taken into account when continuing treatment. The decision to administer the next dose is made by the doctor.
Do not start desensitization during the pollen season!
Avoid physical exertion (sports, heavy physical work) before and after each injection of the medicine.

PURETHAL and other medicines

Inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
During desensitization, do not use immunosuppressive medicines. Concurrent use of blood pressure-lowering medicines (beta-adrenergic blockers and ACE inhibitors) may cause a very strong reaction even at small doses of the medicine.
Additional exposure to external allergens or other harmful substances may lower the tolerance threshold (regarding use during the pollen season, see: Warnings and precautions).
If the patient is also using symptomatic anti-allergic treatment (with antihistamines, mast cell degranulation inhibitors, or corticosteroids), their reaction to previously well-tolerated doses of the medicine may change. Moreover, in this case, skin sensitivity may change, and skin tests performed during this period may give false, unreliable results.
Vaccinations against bacterial and viral infections can be performed no earlier than 7 days after the last injection of PURETHAL (except in life-saving situations). The next injection of the medicine can be administered only after the complete resolution of the reaction to the vaccination, but not earlier than 14 days after vaccination.

Pregnancy and breastfeeding

Pregnancy

Currently, there are no adequately documented data on the use of allergoid desensitization in pregnant women. The potential risk to the mother and fetus is unknown.
Do not start treatment with PURETHAL during pregnancy. If treatment has been started before pregnancy, it may be continued in consultation with the attending physician.

Breastfeeding

Do not start treatment with PURETHAL during breastfeeding. If treatment has been started before pregnancy, it may be continued in consultation with the attending physician.

Driving and using machines

In very rare cases, a feeling of mild fatigue may occur. This possibility should be taken into account before driving or operating machines.

3. How to use PURETHAL

This medicine should always be used as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Using PURETHAL in children

In children and adolescents between 5 and 18 years of age, the same dose as in adults is recommended.
Treatment with PURETHAL can be performed before the pollen season or throughout the year.
Treatment usually starts with a dose of 0.05 ml (first injection), and then the doses are gradually increased at weekly intervals to achieve the maximum dose of 0.5 ml (or lower, individually determined for the patient). Initial treatment is completed after administration of the largest tolerated dose.
Further management depends on the choice of treatment regimen, i.e., whether it will be shortened, preseasonal, or year-round immunotherapy.
Shortened immunotherapy can be completed after 8 injections at weekly intervals, within 7 weeks (contents of 1 vial).
In adult patients, initial treatment with PURETHAL can be performed according to an accelerated schedule (accelerated treatment), i.e., 3 injections at weekly intervals to achieve the maximum dose. After completing this initial treatment, maintenance treatment can be continued.
Maintenance immunotherapy, preseasonal or year-round
After completing the initial treatment, injections are recommended every 14 days. If the patient tolerates the treatment well, after the third injection in the 14-day cycle, the interval between subsequent injections can be extended to 4 weeks.
When starting a new vial, there is no need to reduce the dose.
The above recommendations for use should be considered only as a guideline and example of treatment with PURETHAL. The attending physician may recommend a different dosage based on the assessment of the patient's degree of hypersensitivity.
Any decision to increase the dose of the medicine must be based on the assessment of the reaction to the last administered dose. Treatment with an increased dose can be continued if no side effects have occurred and the allergic reaction has not worsened after administration of the last dose.
Regarding the use of plant pollen extracts during the pollen season, see section 2. Important information before using PURETHAL.

• 2. Important information before using PURETHAL.

Duration of immunotherapy

A full and lasting effect of treatment is achieved after 3-5 years of using PURETHAL.

4. Possible side effects

Like all medicines, PURETHAL can cause side effects, although not everybody gets them.
In connection with the use of PURETHAL, local or general (affecting the whole body) allergic reactions may occur. Local allergic reactions may be mild or moderate, such as swelling, urticaria, or redness, and generalized, such as rhinitis, itching, and conjunctivitis, sneezing, throat irritation, or cough.

Severe side effects:

In rare cases, anaphylactic shock may occur. Typical warning signs are:

• a feeling of heat or itching on (or) under the tongue and in the throat, especially on the hands and soles of the feet
• wheezing, loud breathing, or difficulty breathing
• urticaria
• pale or grayish skin color
• rapid heartbeat
• fainting or collapse

In case of any of these warning signs, immediatelycontact a doctor.
The doctor will decide on the continuation of treatment with PURETHAL.

Laboratory tests

Other side effects that have been reported, with frequencies that cannot be determined based on available data, include asthma, skin rash, transient skin hardening, rapid breathing, itching, nausea, abdominal pain, fever, weakness.
Side effects may occur soon after injection, so the patient should be observed for 30 minutes after administration of the medicine. However, delayed allergic reactions may occur even several hours after administration of the medicine.
After using PURETHAL in adults according to an accelerated schedule, side effects may be more severe. In patients in clinical trials, these side effects were mild to moderate.
Side effects observed during clinical trials of PURETHAL are listed in the table below:

Children
No differences in the incidence of side effects were observed between children and adults.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store PURETHAL

Store in a refrigerator (2°C – 8°C).
Do not freeze.
Suspensions that have been frozen must not be used!
Keep the medicine out of the sight and reach of children!
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What PURETHAL contains

• The active substance of the medicine is single allergoids of plant pollen; 1 ml of suspension contains: Birch pollen allergoid (Betula verrucosa) 20,000 AUM
• -The other ingredients are : aluminum hydroxide, sodium chloride, phenol, water for injections

What PURETHAL looks like and contents of the packaging

A type I glass vial with a bromobutyl rubber stopper and a 1 ml polypropylene syringe with a 26G1/2 needle in a cardboard box.
1 vial with 3 ml of suspension and 8 syringes with needles

Marketing authorization holder and manufacturer

HAL Allergy B.V.
J.H. Oortweg 15, 2333 CH Leiden
P.O. Box 1204 2302 BE Leiden
Netherlands
To obtain more detailed information, please contact the representative of the marketing authorization holder
Centrofarm Sp. z o.o.
Leszczynowa 1
05-092 Kiełpin, Łomianki
Tel: +48 691 810 590

Date of last revision of the leaflet: