Purethal

Patient Information Leaflet

PURETHAL single pollen allergoids,
20,000 AUM/ml
injection suspension
Please read this leaflet carefully before using this 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, please consult your doctor or pharmacist.
• 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 any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Leaflet Contents:

1. What PURETHAL is and what it is used for
2. Important information before using PURETHAL
3. How to use PURETHAL
4. Possible side effects
5. How to store PURETHAL
6. Package contents and other information

1. What PURETHAL is and what it is used for

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

• Modulation of T-lymphocyte function (shift from Th2 to Th1 dominance)
• Induction of IgG antibodies
• Reduction of mediator-releasing cell reactivity

Diagnosis should be based on a detailed medical history confirming the patient's hypersensitivity reaction 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 ingredients of this medicine (listed in section 6),
• if the patient has reduced immunity (e.g. due to immunosuppressive drugs),
• if the patient has an autoimmune disease (e.g. rheumatic disease),
• if the patient has severe asthma, particularly with FEV (one-second forced expiratory volume) persistently below 70% of predicted value, or glucocorticosteroid-dependent asthma,
• if the patient has cardiovascular insufficiency, or is being treated with β-blockers or ACE inhibitors (angiotensin-converting enzyme inhibitors),
• if the patient has contraindications to adrenaline (e.g. hyperthyroidism),
• if active tuberculosis has been diagnosed in the patient,
• if the patient has a malignant disease,
• if the patient has serious psychiatric disorders, impaired communication, or non-compliance with medical advice,
• in children under 5 years of age,
• during pregnancy. If treatment was initiated before pregnancy, it may be continued in consultation with the attending physician.

Warnings and precautions
This medicine should be prescribed and administered only by specialist allergologists experienced in allergy treatment.
Consult your doctor, even if the warnings below refer to conditions that occurred in the past.
In rare cases, administration of this medicine may lead to a severe systemic reaction (wheezing, shortness of breath, Quincke's angioedema, generalized urticaria), and in extreme cases, anaphylactic shock may occur.
Typical warning symptoms include: burning pain, itching, sensation of heat on or under the tongue, in the throat, on the palms and soles.
If any of these symptoms occur, contact your doctor immediately.
During pollen season, PURETHAL may be administered only to patients who are not experiencing allergic symptoms; if allergic symptoms occur during treatment in pollen season, the next injection should be postponed until symptoms resolve or treatment should be discontinued. During this time, the interval between injections is prolonged, which should be taken into account when continuing treatment. The decision on administering the next dose is made by the physician.
Allergen immunotherapy should not be initiated during pollen season!
Physical exertion (sports, heavy physical work) should be avoided before and after each injection of the medicine.

PURETHAL and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines planned for use.
Immunosuppressive drugs should not be used during allergen immunotherapy. Concurrent use of antihypertensive drugs (beta-blockers and ACE inhibitors) may cause a very strong reaction, even after small doses of the medicine.
Additional exposure to external allergens or other harmful substances may lower the tolerance threshold (for use during pollen season, see: Warnings and precautions).
If symptomatic anti-allergic treatment (using antihistamines, mast cell degranulation inhibitors, or corticosteroids) is simultaneously administered, the patient's reaction to previously well-tolerated doses of the medicine may change. Moreover, skin sensitivity may be altered, and skin tests performed during this period may yield false, unreliable results.
Live bacterial or viral vaccinations should not be administered earlier than 7 days after the last injection of PURETHAL (except in life-threatening situations). The next injection of PURETHAL may be given only after complete resolution of the reaction to vaccination, but never earlier than 14 days after vaccination.

Pregnancy and breastfeeding
Pregnancy
Currently, there are no adequately documented data on the use of allergoid immunotherapy in pregnant women. The potential risk to the mother and fetus is unknown.
Initiating treatment with PURETHAL during pregnancy is not recommended. If treatment was started before pregnancy, it may be continued in consultation with the attending physician.

Breastfeeding
During breastfeeding, initiation of treatment with PURETHAL is not recommended. If treatment was started before pregnancy, it may be continued in consultation with the attending physician.

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

3. How to use PURETHAL
This medicine should always be used as prescribed by the doctor. In case of doubt, consult your doctor or pharmacist.

Use of PURETHAL in children
In children and adolescents aged between 5 and 18 years, the same dose as in adults is recommended.
Treatment with PURETHAL can be administered before pollen season or throughout the year.
Treatment usually starts with a dose of 0.05 ml (first injection), then doses are gradually increased at weekly intervals until reaching the maximum dose of 0.5 ml (or a lower dose individually determined for the patient). Initial treatment is completed after administration of the highest tolerated dose.
Further management depends on the chosen treatment regimen, i.e. whether it will be accelerated, pre-seasonal, or year-round immunotherapy.
Accelerated immunotherapy may be completed after 8 injections at weekly intervals within 7 weeks (contents of 1 vial).
In adult patients, initial treatment with PURETHAL may be conducted according to an accelerated schedule (rush therapy), i.e. 3 injections at weekly intervals to reach the maximum dose. After completion of this initial treatment, maintenance therapy may be continued.

Maintenance immunotherapy (pre-seasonal or year-round)
After completion of initial treatment, injections every 14 days are recommended. If the patient tolerates the treatment well, after the third injection in the 14-day cycle, the interval between subsequent injections may 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 guidance and examples of PURETHAL treatment. The attending physician may recommend a different dosing schedule based on assessment of the patient's degree of sensitization.
Any decision to increase the dose must be based on evaluation of the reaction to the last administered dose. Treatment with an increased dose may be continued if no adverse reactions occurred and no worsening of allergic reaction was observed after the last dose.
For information on use of allergen extracts from plant pollens during pollen season, see section

2. Important information before using PURETHAL.

Duration of immunotherapy
A full and lasting therapeutic effect is achieved after 3–5 years of treatment with PURETHAL.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Allergic reactions, either local or systemic (affecting the whole body), may occur following administration of PURETHAL. Local allergic reactions may be mild or moderate, such as swelling, hives, or redness, and systemic reactions such as rhinitis, itching, eye inflammation, sneezing, throat irritation, or cough.

Severe adverse symptoms:
In rare cases, anaphylactic shock may occur. Typical warning signs include:

• sensation of warmth or itching on (or) under the tongue and in the throat, particularly on the palms and soles
• wheezing, noisy breathing, or difficulty breathing
• hives
• pale or greyish skin color
• rapid heartbeat
• fainting or collapse

If any of these warning symptoms occur, contact a doctor immediately.
The doctor will decide whether treatment with PURETHAL should continue.

Other adverse reactions that have been reported, for which frequency cannot be determined from available data, include asthma, skin rash, transient subcutaneous induration, rapid breathing, skin itching, nausea, abdominal pain, fever, and fatigue.

Adverse reactions may occur shortly after administration; therefore, the patient should be observed for 30 minutes after dosing. However, delayed allergic reactions may occur several hours after administration.

When PURETHAL was administered to adults according to an accelerated regimen, adverse reactions may be more pronounced. In clinical trials, these adverse reactions were generally mild to moderate in severity.

Adverse reactions observed during clinical trials of PURETHAL are listed in the table below:

Children
No differences in the occurrence of adverse reactions between children and adults have been observed.
Reporting of adverse reactions
If any adverse reactions occur, including any 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 at the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Purethal

Store in a refrigerator (2°C – 8°C).
Do not freeze.
Do not use the suspension if it has been frozen!
Keep the medicine out of the sight and reach of children!
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Medicines must 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 is single pollen allergoids. 1 ml of suspension contains:
  Birch pollen allergoid (Betula verrucosa) 20,000 AUM
• The other components are: aluminium hydroxide, sodium chloride, phenol, water for injections

What Purethal looks like and contents of the pack
A type I glass vial with a bromobutyl rubber stopper and 1 ml polypropylene syringes with 26G1/2 needles in a cardboard box.
1 vial with 3 ml of suspension and 8 syringes with needles.

Marketing Authorisation Holder and Manufacturer
HAL Allergy B.V.
J.H. Oortweg 15, 2333 CH Leiden
P.O. Box 1204 2302 BE Leiden
The Netherlands

For further information, please contact the representative of the Marketing Authorisation Holder:
Centrofarm Sp. z o.o.
Leszczynowa 1
05-092 Kiełpin, Łomianki
Tel: +48 691 810 590