Purethal

Package Leaflet: Information for the Patient

PURETHAL Mixture of Plant Pollen Allergoids,
20,000 AUM
injection suspension

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 pack and other information

1. What is PURETHAL and what is it used for

PURETHAL is used for specific immunotherapy (desensitization) of IgE-dependent allergic reactions of inhalation origin, with symptoms of allergic rhinitis, allergic conjunctivitis, and allergic asthma.
The mechanism of action includes:

• modulation of T lymphocyte function
• production of IgG antibodies
• reduction of inflammatory cell reactivity.

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

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 one-second 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,
• 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,
• 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 allergy treatment.
You should consult a doctor, even if the following warnings refer to situations that have occurred in the past.
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 feeling of burning pain, 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, you should immediatelycontact your doctor.
During the pollen season, PURETHAL may only be used in patients who do not have allergic symptoms; if allergic symptoms occur during treatment in the pollen season, the next injection should be postponed until they resolve or treatment should be discontinued. During this time, 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.
You should not start desensitization during the pollen season!
You should avoid physical exertion (sports, heavy physical work) before and after each injection of the medicine.

PURETHAL and other medicines

You should 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, you should not use immunosuppressive medicines. Concurrent use of medicines that lower blood pressure (beta-adrenergic blockers and ACE inhibitors) may cause a very strong reaction, even at low 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 (using antihistamines, mast cell degranulation inhibitors, or corticosteroids), their reaction and sensitivity 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.
Bacterial and viral vaccines can be administered 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 vaccine, but no 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.
During pregnancy, you should not start treatment with PURETHAL. If such treatment has been started before pregnancy, it may be continued in consultation with the attending physician.

Breastfeeding

During breastfeeding, you should not start treatment with PURETHAL. If such 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. You should take this possibility into account before driving a vehicle or operating machines.

3. How to use PURETHAL

This medicine should always be used according to the doctor's recommendations. In case of doubts, you should consult a doctor.

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 carried out 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 a maximum dose of 0.5 ml (or lower, individually determined for the patient). Initial treatment is completed after administration of the largest dose.
Further procedure depends on the choice of treatment scheme, i.e., whether it will be shortened, pre-seasonal, or year-round immunotherapy.
Shortened immunotherapy may be completed after 6 injections at weekly intervals.
In adult patients, initial treatment with PURETHAL can be carried out according to an accelerated scheme (accelerated treatment) i.e., 3 injections at weekly intervals to achieve the maximum dose. After completion of this initial treatment, maintenance treatment can be continued.
Maintenance immunotherapy, pre-seasonal or year-round
After completion of initial treatment, injections are recommended every 14 days. If the patient tolerates them well, after the third injection in the 14-day cycle, the interval between subsequent injections can be extended to 4 weeks.
After 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 allergy.
Any decision to increase the dose of the medicine must be based on the assessment of the reaction to the last administered dose. Treatment can be continued with an increased dose 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

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:
edema, urticaria, or redness, and generalized, such as rhinitis, itching, and conjunctivitis, sneezing, throat irritation, or cough.

Severe side effects and procedure in case of their occurrence:

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, and in particular on the hands and soles of the feet
• wheezing, loud breathing, or difficulty breathing
• urticaria
• pale or grayish skin color
• rapid heart rate
• fainting or collapse

In case of occurrence of any of the warning signs, you should immediatelycontact your doctor.

The doctor will decide on the continuation of treatment with PURETHAL.

Other side effects that have been reported, but whose frequency 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 usually 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.
In the case of accelerated treatment in adults, severe side effects may occur. In clinical trials, patients reported mild to moderate side effects.
Children
No differences in the occurrence of side effects were observed between children and adults.
Side effects that were observed during treatment with PURETHAL are listed in the table below:

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform 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 to 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.
Suspension that has been frozen must not be used!
The medicine should be stored out of 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 specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the pack and other information

What PURETHAL contains

The active substances of the medicine are:
Grasses
Agrostis stolonifera
Anthoxanthum odoratum
Dactylis glomerata
Lolium perenne
Arrhenatherum elatius

Festuca rubra
Poa pratensis
Secale cereale
Holcus lanatus
Phleum pratense
Trees
Betula verrucosa
Alnus glutinosa
Corylus avellana
Grasses + Birch
Agrostis stolonifera
Anthoxanthum odoratum
Dactylis glomerata
Lolium perenne
Arrhenatherum elatius
Festuca rubra
Poa pratensis
Secale cereale
Holcus lanatus
Phleum pratense
Betula verrucosa
Grasses + Trees
Agrostis stolonifera
Anthoxanthum odoratum
Dactylis glomerata
Lolium perenne
Arrhenatherum elatius
Festuca rubra
Poa pratensis
Secale cereale
Holcus lanatus
Phleum pratense
Betula verrucosa
Alnus glutinosa
Corylus avellana
Other ingredients are: aluminum hydroxide, sodium chloride, phenol, water for injections

What PURETHAL looks like and contents of the pack

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

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, you should 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: