Novo-helisen Depot

Leaflet attached to the packaging: information for the user

Novo-Helisen Depot

Animal allergen extracts (hair, epithelia, feathers)

Suspension for injection

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor.
• 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 tell their doctor or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Novo-Helisen Depot and what is it used for

Novo-Helisen Depot is an allergen extract intended for desensitization (specific immunotherapy).
During specific immunotherapy, increasingly larger doses of clinically significant allergens causing an allergic reaction in the patient are administered by injection to achieve an individual maximum dose, which is then administered as a maintenance dose. The treatment aims to alleviate clinical symptoms dependent on the given allergen(s) and reduce the consumption of symptomatic drugs.
Novo-Helisen Depot is used in allergic diseases (IgE-dependent), such as allergic rhinitis (hay fever), allergic conjunctivitis, allergic asthma, etc., caused by allergens that cannot be eliminated from the patient's environment.
Novo-Helisen Depot is used in adults, adolescents, and children over 5 years of age.

2. Important information before using Novo-Helisen Depot

When not to use Novo-Helisen Depot

• If the patient is hypersensitive (allergic) to any of the excipients listed in section 6;
• If the patient has uncontrolled asthma, i.e., FEV1 is below 70% of the expected value despite adequate pharmacotherapy;
• If the patient has permanent changes in the lungs, such as pulmonary emphysema (emphysema), bronchiectasis (bronchiectasis);
• If the patient has inflammatory or febrile diseases, severe acute or chronic conditions (e.g., cancer, active tuberculosis).
• If the patient has been diagnosed with significant cardiovascular system failure. In the event of a severe allergic reaction after injection of Novo-Helisen Depot, adrenaline is used as an emergency medication. In patients with heart disease, there is an increased risk of adverse reactions after administration of adrenaline;
• If the patient has been diagnosed with immune system disorders (severe systemic autoimmune diseases, immunologically induced immunopathies, immune deficiencies, or multiple sclerosis, etc.);

autoimmune diseases, immunologically induced immunopathies, immune deficiencies, or multiple sclerosis, etc.

• If the patient has experienced severe systemic reactions related to specific allergen immunotherapy in the past;
• If the patient has been diagnosed with severe mental disorders.

Warnings and precautions

This medicinal product for subcutaneous allergen immunotherapy should only be administered by doctors, nurses, and medical staff trained or experienced in the treatment of allergies.
Before starting treatment with Novo-Helisen Depot, you should discuss with your doctor if:

• The patient is being treated with ACE inhibitors for high blood pressure;
• The patient is being treated with beta-blockers (medicines used to treat high blood pressure or heart disease, or as eye drops to treat glaucoma);
• The patient is pregnant;
• There are acute symptoms of the disease (e.g., allergic symptoms or a cold);
• The patient has symptoms of asthma;
• The patient has been vaccinated or is scheduled to be vaccinated.

The patient should inform the doctor about any changes in their health, such as infectious diseases or pregnancy, and discuss further action. Before injection, a lung function test (e.g., measurement of peak expiratory flow) may be performed if the patient has asthma.
The doctor should be informed whether the previous injection was well tolerated.
Before each injection, the doctor will determine the individual dose based on the tolerance of the last dose administered and the medical history collected.
In the event of severe allergic reactions after injection or during it, the doctor may use adrenaline as an emergency medication. It should be explained in advance whether adrenaline treatment is possible for the patient.
On the day of injection, you should avoid strenuous activities, such as sports or heavy physical work. You should also avoid consuming alcohol, visiting a sauna, and taking a hot shower.
In the case of planned vaccinationagainst pathogens, an interval of at least 1 week should be maintained between the last injection of this medicine and the vaccination date. Treatment with this medicine is continued for 2 weeks after the last administered dose. Vaccinations that are immediately necessary (e.g., against tetanus after injuries) may be given at any time.

Children and adolescents

Treatment with Novo-Helisen Depot is generally not recommended for children under 5 years of age.

Novo-Helisen Depot and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
No drug interaction studies have been conducted.
You should remember the following instructions and discuss them with your doctor:

• Beta-blockers(medicines used to treat high blood pressure or heart disease, as well as eye drops to treat glaucoma) may be taken simultaneously with Novo-Helisen Depot only after consulting a doctor.
• ACE inhibitors(medicines used to treat high blood pressure) may be taken simultaneously with Novo-Helisen Depot only after consulting a doctor.
• Concomitant treatment with medicines used to treat allergies(e.g., antihistamines, corticosteroids, mast cell stabilizers) or medicines that partially act similarly to antiallergic medicines (e.g., some sedatives, antiemetics, and antacids) may affect treatment with Novo-Helisen Depot. It may then be possible to tolerate a higher dose of this medicine. If they are discontinued, it may be necessary to reduce the dose of Novo-Helisen Depot.

During treatment with Novo-Helisen Depot, you should avoid contact with allergens that cause allergies: animal origin, especially on the day of injection. You should also avoid other factors that may cause allergic reactions.

Novo-Helisen Depot with food, drink, and alcohol

You should not drink alcohol on the day of injection.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
There is insufficient experience with the use of animal allergen extracts in pregnant women.
Therefore, desensitization is not recommended during pregnancy.
There is insufficient data on breastfeeding mothers. Although it is unlikely that the breastfed infant will be at risk, the doctor will have to weigh the benefits and risks during breastfeeding.
There is insufficient data on the effect of Novo-Helisen Depot on fertility.

Driving and using machines

Novo-Helisen Depot has a minor influence on the ability to drive and use machines, as it may cause fatigue. You should pay attention to this when driving a vehicle, using machines, or working without safe support.

Novo-Helisen Depot contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 1.0 mL of the maximum dose (concentration 3), i.e., the medicine is considered "sodium-free".

3. How to use Novo-Helisen Depot

Recommended dose
The doctor, who is trained or experienced in the treatment of allergies, will determine the most suitable treatment schedule for the patient and tell them at what intervals they will receive injections.
The doctor will also determine the appropriate dose. The individual dose depends, among other things, on how well the patient tolerated the injection.
The maximum dose is 1.0 mL of concentration 3. The individual maximum dose may be lower.
Treatment consists of two different phases: initial treatment and maintenance treatment.
Initial treatment (dose escalation)
Treatment should be started as soon as possible during a symptom-free period.
The doctor may choose one of two different dosing schedules:

• standard dose escalation schedule (14 injections),
• dose escalation schedule for highly sensitive patients (23 injections).

During the initial treatment, the doctor will determine the maximum dose that the patient tolerates, regularly increasing the dose up to the maximum recommended dose of the medicine.
Injections will be administered at regular intervals of 7 to 14 days until the individual maximum dose or the maximum recommended dose of the medicine is reached.
If the interval between two injections is exceeded, the doctor may not be able to increase the dose according to the plan. Therefore, it is essential to always follow the injection schedule and not interrupt the initial treatment.
Maintenance treatment
After the doctor has determined the individual maximum dose during the initial treatment or after reaching the maximum recommended dose of the medicine, maintenance treatment begins. In the case of non-seasonal allergens, after reaching the maximum dose, the time intervals between two injections are gradually increased so that the injections are eventually administered at intervals of 4 to 6 weeks. If the planned interval of 6 weeks is exceeded, the doctor must reduce the next dose. Then the dose is increased again in shorter time intervals.
It is also essential to always follow the injection schedule and not interrupt the maintenance treatment.
When starting a new package of Novo-Helisen Depot, the doctor will reduce the dose. Then the dose will be increased again in intervals of 7 to 14 days.

Administration in children and adolescents

Specific allergen immunotherapy (desensitization) is not usually performed in children under 5 years of age, as there is a higher likelihood of acceptance and cooperation problems in this age group than in adults.
In children and adolescents, the same initial and maintenance treatment schedule is used as in adults.

Method of administration

Novo-Helisen Depot is injected subcutaneously by a doctor. The injection is performed on the outer part of the arm, about the width of the patient's hand above the elbow. Doses of 0.5-1 mL may be divided and administered in both arms to achieve better tolerance. The doctor will shake the medicine well before use.
The patient must remain under the doctor's supervision for at least 30 minutes after the injection. The doctor will ask the patient about their general condition. The observation period may be extended individually. In the event of side effects, you should contact the doctor immediately, even after the observation period.
The doctor may use two different preparations for desensitization. If both preparations are to be injected on the same day, a minimum interval of 30 minutes should be maintained between the injections. However, it is recommended that injections be administered at an interval of 2 to 3 days. Each time, the preparations are injected separately into the right and left arm.

Duration of treatment

The recommended duration of treatment is usually 3 years.

Use of a higher than recommended dose of Novo-Helisen Depot

Overdose may lead to allergic reactions, including anaphylactic shock. In such a case, the doctor will take the necessary measures. Typical symptoms can be found in section 4 "Possible side effects".

Missing a dose of Novo-Helisen Depot

You should always come to scheduled appointments, so that the success of the treatment is not jeopardized. If you miss a scheduled appointment, the treatment schedule may change. You should contact the doctor, who will explain how to proceed.

Stopping the use of Novo-Helisen Depot

This should be discussed with the doctor in advance. In the event of premature termination of treatment, the therapeutic effect may be weakened.
In case of any 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.
After injection of this medicine, the patient will be monitored for at least 30 minutes.
The doctor will ask the patient about their general condition. You should remember that side effects may occur even after this observation period. In the event of side effects, you should contact the doctor immediately.
Important side effects and measures

If symptoms of intolerance occur during injection, the doctor will immediately stop the injection.
Reactions at the injection site (e.g., redness, itching, swelling) and systemic reactions (e.g., shortness of breath, itching all over the body, redness all over the body) may occur.
Severe allergic reactions, including anaphylactic shock, may occur. Anaphylactic reactions, including anaphylactic shock, may occur within a few seconds to a few minutes after injection. Typical warning signs are itching, feeling of heaton and under the tongue and in the throat, shortness of breath, itching or burning of the hands and (or) soles of the feet, hives all over the body, itching, drop in blood pressure, dizziness, malaise. You should immediatelyinform the medical staff if you notice these symptoms.
The doctor must have an emergency kit available for immediate use when the patient is being treated with this medicine. If anaphylactic shock occurs, the patient must be under medical observation for 24 hours.
Post-marketing data
The following list provides an overview of side effects reported spontaneously after the marketing of Novo-Helisen Depot containing animal allergen extracts. Due to the small number of reports, the frequency of side effects cannot be estimated based on the available data.
At the injection site: redness, itching, swelling, reaction at the injection site;
Other side effects: anaphylactic reaction, anaphylactic shock, cold sweats, altered state of consciousness, headache, anxiety, loss of consciousness, rapid heartbeat (tachycardia), blue discoloration of the skin and lips (cyanosis), redness, high blood pressure, low blood pressure, chest discomfort, asthma, bronchospasm, cough, shortness of breath, wheezing, cerebral hypoxia, allergic conjunctivitis, allergic rhinitis, conjunctivitis, rhinitis, weakness, malaise, fatigue, feeling of a foreign body, joint pain, muscle pain, hemiparesis, dry mouth, difficulty swallowing, angioedema, redness, itching, rash, wound pain, urticaria

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides:
Jerozolimskie Avenue 181 C,
02-222 Warsaw,
phone: 22 49-21-301,
fax: 22 49 21-309.
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Novo-Helisen Depot

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 after "EXP".
Store in a refrigerator (2 °C-8 °C).

Do not freeze!

The shelf life after opening the vial is 12 months. However, the medicine should not be used after the expiry date stated on the carton and vial.
Do not use this medicine if you notice any sediment.
You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Novo-Helisen Depot contains

Novo-Helisen Depot contains animal allergen extracts, house dust mites, and mold fungi.
The composition of the medicine is selected individually, depending on the patient's spectrum of allergy and in accordance with the attached list. The names of individual allergens and their percentage share are indicated on the packaging.
Standardization is carried out in PNU (protein nitrogen units).
Concentration 1 contains 25 PNU/mL
Concentration 2 contains 250 PNU/mL
Concentration 3 contains 2500 PNU/mL
Other ingredients of the medicine are:aluminum hydroxide, sodium chloride, sodium bicarbonate, phenol, water for injections

What Novo-Helisen Depot looks like and what the packaging contains

The medicine is a suspension and, after shaking, shows distinct turbidity.
Depending on the starting material and concentration of the suspension, they are varied and sometimes intensely colored.

Pack sizes:

• Packaging containing 1 vial of 4.5 mL of concentration 1, 1 vial of 4.5 mL of concentration 2, 1 vial of 4.5 mL of concentration 3,
• Packaging containing 1 vial of 4.5 mL of concentration 3,
• Packaging containing 2 vials of 4.5 mL of concentration 3,
• Packaging containing 1 vial of 9.5 mL of concentration 3.

Marketing authorization holder and manufacturer

Allergopharma GmbH & Co. KG
Hermann-Koerner-Str. 52-54
21465 Reinbek
Germany
Phone: +49 40 / 72765-0
Fax: +49 40 / 7227713
Email: info@allergopharma.com
To obtain more detailed information, you should contact the representative of the marketing authorization holder:
SUN-FARM Sp. z o.o.
Dolna 21
05-092 Łomianki
Phone: 22 350 66 69
Fax: 22 350 77 03

Date of last revision of the leaflet:

DOSAGE SCHEME

Before use, read the patient leaflet! Do not exceed the individual maximum dose! Patient............................................................................................

Batch number....................................................................................................................

Initial treatment:

Maintenance treatment:

List of allergen extracts that may be part of Novo-Helisen Depot

Animal allergen extracts (hair and epithelia of animals, feathers):
304 Hamster hair
306 Dog hair
308 Rabbit hair
309 Cat hair
311 Guinea pig hair 314 Horse hair
317 Cow hair
318 Sheep's wool
321 Parrot feathers

Information intended only for healthcare professionals:

This medicinal product for subcutaneous allergen immunotherapy may only be administered by doctors, nurses, and healthcare professionals trained or experienced in the treatment of allergies.
In the event of severe local or systemic reactions or anaphylaxis during treatment with Novo-Helisen Depot, the attending physician must have an emergency kit available. In the event of anaphylactic shock, patients must be under medical observation for 24 hours.
Post-marketing data
The following list provides an overview of side effects reported spontaneously after the marketing of Novo-Helisen Depot containing animal allergen extracts. Due to the small number of reports, the frequency of side effects cannot be estimated based on the available data.
At the injection site: redness, itching, swelling, reaction at the injection site;
Other side effects: anaphylactic reaction, anaphylactic shock, cold sweats, altered state of consciousness, headache, anxiety, loss of consciousness, rapid heartbeat (tachycardia), blue discoloration of the skin and lips (cyanosis), redness, high blood pressure, low blood pressure, chest discomfort, asthma, bronchospasm, cough, shortness of breath, wheezing, cerebral hypoxia, allergic conjunctivitis, allergic rhinitis, conjunctivitis, rhinitis, weakness, malaise, fatigue, feeling of a foreign body, joint pain, muscle pain, hemiparesis, dry mouth, difficulty swallowing, angioedema, redness, itching, rash, wound pain, urticaria

Special warnings and precautions for use

In the event of side effects during injection, the administration of the product should be stopped immediately.
Immunotherapy products (desensitization) should only be prescribed and used by doctors, nurses, and healthcare professionals trained or experienced in the treatment of allergies.
On the day of injection, the patient should not have acute symptoms of the disease (such as allergic symptoms, e.g., allergic rhinitis, allergic conjunctivitis, cold).
Before each injection, patients should be encouraged to inform their doctor about any changes in their health, such as infectious diseases or pregnancy, and whether the last dose was well tolerated.
In the case of asthmatics, lung function should be assessed if necessary (e.g., by measuring peak expiratory flow).
The dose for each injection should be determined individually based on previous tolerance and current medical history.

Particular caution is recommended

• in patients treated with ACE inhibitors (see also section 4.5),
• in patients treated with beta-blockers (local, systemic, see also section 4.5),
• during pregnancy (see section 4.6).

Given that adrenalineis recommended for the treatment of severe allergic reactions, the contraindications for the use of adrenaline should be taken into account.
On the day of injection, you should avoid strenuous activities(physical exertion, alcohol consumption, sauna, hot shower, etc.), as they may exacerbate allergic reactions.
In the case of planned vaccination, an interval of at least one week should be maintained between the last injection of the allergen extract and the vaccination date. Vaccination should therefore be performed during maintenance treatment. Vaccination for urgent reasons (e.g., against tetanus after injuries) may be given regardless of the phase of allergen immunotherapy. Immunotherapy is continued for 2 weeks after the last administered dose.

Identifiability

To improve the identifiability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.

Method of administration

Precautions to be taken before handling or administering the medicinal product
Avoid accidental intravascular injection (aspirate!).
Subcutaneous injection should be performed on the outer aspect of the arm, about the width of the patient's hand above the elbow.
After each injection, the patient must be observed for at least 30 minutes, after which their condition should be assessed by the doctor. The observation period may be extended individually. Side effects may occur even after the observation period.
The patient should be instructed to contact the treating doctor or their medical staff immediately in the event of side effects, even after the observation period.
Doses of 0.5-1 mL may be divided and administered in both arms to achieve better tolerance.
In the case of concurrent therapy with two allergen immunotherapy products, a minimum interval of 30 minutesshould be maintained between injections. The second injection should only be performed after it has been established that the first injection did not cause a side effect. Concurrent therapyshould only be performed according to the standard dose escalation schedule(Table 1) or the dose escalation schedule for highly sensitive patients(Table 2). To avoid a cumulative effect, an interval of 2 to 3 days is recommended between two injections. Additionally, it is recommended to administer each allergen extract in a separate arm.

Dosage

Dosage must be individualized; the recommended dosages in the dosing schedules may only serve as guidelines. Dosage must be adapted to the individual course of therapy. The individual degree of sensitivity of the patient is determined based on a thorough medical history and diagnosis (test reaction result).
It is essential to regularly increase the dose. The dose can only be increased if the last dose was well tolerated. Otherwise, the last dose used should be maintained or reduced.
In the event of side effects during injection of the medicinal product, the following procedure is proposed:

• Severe local reaction:repeat the last well-tolerated dose or reduce the last dose by one level.
• Mild systemic reaction:reduce the last dose by one level.
• Moderate systemic reaction: reduce the last dose by two levels or, if necessary, restart treatment with concentration 1 according to the standard dose escalation schedule (see Table 1) or the dose escalation schedule for highly sensitive patients (see Table 2).
• Severe systemic reaction:restart treatment with concentration 1 according to the standard dose escalation schedule (see Table 1) or the dose escalation schedule for highly sensitive patients (see Table 2).

Treatment with Novo-Helisen Depot consists of two phases: initial treatment and maintenance treatment.

Initial treatment (dose escalation)

Treatment should be started as soon as possible during a symptom-free period.
Initial treatment can be performed according to one of two dose escalation schedules:

• standard dose escalation schedule (14 injections) (Table 1),
• dose escalation schedule for highly sensitive patients (23 injections) (Table 2).

Table 1 Standard dose escalation schedule

Concentration

Dose

mL

1

Green label

0.1
0.2
0.4
0.8
0.1
0.2
0.4
0.8

2

Orange label

0.1
0.2
0.4
0.6
0.8
1.0

Table 2 Dose escalation schedule for highly sensitive patients

3

Red label

Concentration

Dose

mL
0.05
0.1
0.2
0.4
0.6
0.8

1

Green label

0.05
0.1
0.2
0.4
0.6
0.8

2

Orange label

0.05
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0

3

Red label

Dose escalation, especially in highly sensitive patients, must be done gradually until the individual tolerance limit is reached. This is the individual maximum dose, which must not be exceeded. The maximum dose is 1.0 mL of concentration 3. The individual maximum dose for a given patient may be lower.
Dose escalation is performed at intervals of 7 to 14 days. If the recommended interval between doses is exceeded, treatment should be continued according to the following schedule (Table 3):

Table 3 Modification of the dose in case of exceeding the interval between doses during initial treatment

Interval since the last injection Modification of the dose

>2 weeks
Reduction by one dose in the applied dosing schedule
>4 weeks
Start initial treatment from the lowest dose of the applicable dosing schedule

Maintenance treatment

Maintenance treatment can be performed continuously (year-round).
The first dose of maintenance treatment is administered 14 days after reaching the individual maximum dose (usually 1.0 mL of concentration 3) during initial treatment, then the interval between injections is gradually increased to 4 to 6 weeks.
If the interval between maintenance doses is exceeded, treatment should be continued according to the following schedule (Table 4):

Table 4 Modification of the dose in case of exceeding the interval during maintenance treatment

Interval since the last injection Modification of the dose

>6 to 8 weeks
Reduction by 1 dose according to the applicable dosing schedule
Then gradual increase to the individual maximum dose according to the schedule at intervals of 7-14 days.
>8 weeks
5% of the last tolerated dose
Then gradual increase to the individual maximum dose according to the schedule at intervals of 7-14 days.
52 weeks
Start dose escalation from the lowest dose according to the applicable dosing schedule

Children and adolescents

Children under 5 years of age are not usually candidates for immunotherapy (desensitization) due to a higher likelihood of cooperation and acceptance problems in this age group than in adults.
In children over 5 years of age and adolescents, clinical data are limited and insufficient to confirm efficacy and safety, but clinical safety data do not indicate a higher risk than in adults.
In children and adolescents, the same initial and maintenance treatment schedule is used as in adults.

Important information for the patient regarding dosing can be found in section 3 "How to use Novo-Helisen Depot".