Novo-helisen Depot

Leaflet attached to the packaging: information for the user

Novo-Helisen Depot

Dust mite allergen extracts

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. This treatment aims to alleviate clinical symptoms dependent on the given allergen(s) and reduce the use of symptomatic medications.
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 has hypersensitivity (allergy) 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 emphysema (pulmonary emphysema) or bronchiectasis (bronchial dilation);
• 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 a rescue 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, immunopathies induced by immune complexes, immunity deficiencies, or multiple sclerosis, etc.);

autoimmune diseases, immunopathies induced by immune complexes, immunity deficiencies, or multiple sclerosis, etc.);

• If the patient has experienced severe systemic reactions associated with 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 with training or experience in allergy treatment.
In particular, this applies to the dosage increase scheme with one concentration.
Before starting treatment with Novo-Helisen Depot, the patient should discuss with their doctor if:

• The patient is being treated with ACE inhibitors due to 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 for glaucoma treatment);
• The patient is pregnant;
• If there are acute symptoms of the disease (e.g., allergic symptoms or a cold);
• If the patient has symptoms of asthma;
• If the patient has received or is scheduled to receive a vaccination.

The patient should inform their doctor about any changes in their health, such as infectious diseases or pregnancy, and discuss further action. If indicated, a lung function test (e.g., measurement of peak expiratory flow) may be performed before injection 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 a rescue medication. It should be explained in advance whether adrenaline treatment is possible for the patient.
On the day of injection, the patient should avoid strenuous activities, such as sports or heavy physical work, and should also avoid consuming alcohol, visiting a sauna, and taking a hot shower.
In the case of scheduled vaccinationagainst pathogens, a minimum interval of 1 week should be maintained between the last injection of this medicine and the vaccination date. Treatment with this medicine is continued 2 weeks after the last administered dose. Vaccinations that are immediately necessary (e.g., against tetanus after an injury) may be given at any time.

Children and adolescents

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

Novo-Helisen Depot and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No studies on drug interactions have been conducted.
The following guidelines should be remembered and discussed with the doctor:

• Beta-blockers(medicines used to treat high blood pressure or heart disease, as well as eye drops for glaucoma treatment) 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 like antiallergic medicines (e.g., some sedatives, anti-nausea and anti-vomiting medicines, 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, contact with allergens causing allergy, such as dust mites, especially on the day of injection, should be avoided as much as possible. Other factors that may cause allergic reactions should also be avoided.

Novo-Helisen Depot with food, drink, and alcohol

On the day of injection, the patient should not drink alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
There is insufficient experience with the use of dust mite 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 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 no influence or negligible influence on the ability to drive and use machines, due to some of the effects listed in section 4. However, this should be taken into account 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 allergy treatment, will determine the most suitable treatment schedule for the patient and tell them at what time 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 (dosage increase)
Treatment should be started, if possible, during a symptom-free period.
The doctor may choose one of three different dosage schedules:

• standard dosage increase schedule (14 injections),
• dosage increase schedule for highly sensitive patients (23 injections),
• dosage increase schedule with one concentration (6 injections) (Only applies to the allergen mixture: 708 Dermatophagoides farinae50% + 725 Dermatophagoides pteronyssinus50%.

During 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 given 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 initial treatment.
Dosage increase with one concentration should only be performed by healthcare professionals with special experience in allergology, as clinical trials have shown a slightly higher risk of adverse reactions.
Maintenance treatment
After the doctor has determined the individual maximum dose during initial treatment or after reaching the maximum recommended dose of the medicine, maintenance treatment begins. After reaching the maximum dose, the time intervals between two injections are gradually increased, so that ultimately injections are given 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 at shorter intervals.
It is also essential to always follow the injection schedule and not interrupt maintenance treatment.
When starting a new series of Novo-Helisen Depot packaging, dose reduction is not necessary in the case of dust mite allergen extracts.

Use in children and adolescents

Specific allergen immunotherapy (desensitization) is not usually performed in children under 5 years of age, as there is a greater 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 given in 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 given in both arms to improve 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 injection. The doctor will ask the patient about their general condition. The observation period may be extended individually. In the event of side effects, the patient should contact their 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 injections. However, it is recommended that injections be given 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.

Overdose of Novo-Helisen Depot

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

Missed dose of Novo-Helisen Depot

The patient should always come to scheduled appointments, so that the success of the treatment is not jeopardized. If the patient forgets about the scheduled appointment, the treatment schedule may change. The patient should contact their doctor, who will explain how to proceed.

Stopping treatment with Novo-Helisen Depot

This should be discussed with the doctor in advance. If treatment is stopped prematurely, the therapeutic effect may be weakened.
In case of any doubts related to the use of this medicine, the patient should consult their 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. It should be remembered that side effects may occur even after this observation period. In the event of side effects, the patient should contact their 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 up to 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. The patient should immediatelyinform the medical staff if they 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 supervision for 24 hours.
Standard dosage increase schedule
Frequent (may affect up to 1 in 10 people)
At the injection site: redness, hypersensitivity, induration, swelling (edema), nodule, itching, rash, hives;
Other frequent side effects: swelling, redness, itching, rash, hives, asthma, cough
Uncommon (may affect up to 1 in 100 people)
At the injection site: skin color change (spot), nodule, pain, reaction at the injection site, feeling of heat;
Other uncommon side effects: hypersensitivity, dizziness, headache, allergic conjunctivitis, eye irritation, eye pain, itching of the eyes, allergic rhinitis, sinusitis, pallor, shortness of breath, lung function disorder (reduced FEV1 value), chest discomfort, cold sweats, feeling of choking, throat dryness, throat irritation, pharyngitis, oral and pharyngeal pain, laryngeal edema, nasal congestion, runny nose (rhinitis), lip itching, abdominal pain, lower abdominal pain, joint pain, neck pain, back pain, allergic skin rash, atopic dermatitis, drug rash, rash, skin reaction, weakness, malaise, pain, fever, feeling of a foreign body, swelling of the arms and (or) legs (peripheral edema), granuloma
Children and adolescents
The safety profile in children and adolescents treated with Novo-Helisen Depot containing dust mite allergen extract using the standard dosage increase schedule is comparable to the safety profile in adults. In these age groups, no other side effects are expected.
Dosage increase schedule with one concentration
Side effects may occur more frequently when using the dosage increase schedule with one concentration compared to the standard dosage increase schedule. Additionally, side effects in the dosage increase schedule with one concentration may occur earlier during the dosage increase period than during the standard dosage increase schedule. The severity of systemic allergic reactions was not increased compared to the standard dosage increase schedule.
Very common (may affect more than 1 in 10 people)
At the injection site: redness, itching, swelling, pain
Common (may affect up to 1 in 10 people)
At the injection site: induration, swelling, nodule, rash
Other common side effects: anaphylactic reaction, hypersensitivity, shortness of breath, lung function disorder (reduced FEV1 value), cough, oral and pharyngeal pain, runny nose (rhinitis), weakness, fatigue, drowsiness, motor disorders, sinus headache, joint pain, arm and (or) leg pain, redness
Children and adolescents
The safety profile in children and adolescents treated with Novo-Helisen Depot containing dust mite allergen extract using the dosage increase schedule with one concentration is comparable to the safety profile in adults. In these age groups, no other side effects are expected.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
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.
Reporting side effects 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 sediment.
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 allergen extracts of animal origin, 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 given on the packaging.
Standardization is carried out in TU (therapeutic units) or PNU (protein nitrogen units).
Concentration 1 contains 50 TU/mL or 7.5 PNU/mL
Concentration 2 contains 500 TU/mL or 75 PNU/mL
Concentration 3 contains 5000 TU/mL or 750 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 contents of the packaging

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: [email protected]
To obtain more detailed information, please contact the representative of the marketing authorization holder:
SUN-FARM Sp. z o.o.
Dolna Street 21
05-092 Łomianki
Phone: 22 350 66 69
Fax: 22 350 77 03

Date of last revision of the leaflet:

SCHEMAT DAWKOWANIA

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

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

Initial treatment:

Initial treatment:

Maintenance treatment:

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

Dust mite allergen extracts:
a) single
708 Dermatophagoides farinae
725 Dermatophagoides pteronyssinus
b) mixtures
708 Dermatophagoides farinae50% + 725 Dermatophagoides pteronyssinus50%

Information intended only for healthcare professionals:

This medicinal product for subcutaneous allergen immunotherapy may only be administered by doctors, nurses, and healthcare professionals with training or experience in allergy treatment.
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 supervision for 24 hours. National and international guidelines for the treatment of anaphylaxis should be taken into account.

Special warnings and precautions for use

In the event of side effects during injection, administration of the product should be stopped immediately.
Products for allergen immunotherapy (desensitization) should only be prescribed and used by doctors, nurses, and medical staff with training or experience in allergy treatment. When using the dosage increase schedule with one concentration, more frequent side effects can be expected during initial treatment compared to the standard dosage increase schedule (see section 4.8). Therapy according to the dosage increase schedule with one concentration should only be performed by doctors, nurses, and medical staff particularlyexperienced in allergology.
On the day of injection, the patient must not have acute symptoms of the disease (such as allergic symptoms, e.g., allergic rhinitis, allergic conjunctivitis, cold), and especially not asthma symptoms.
Before each injection, patients should 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 (e.g., by measuring peak expiratory flow) should be assessed if necessary.
The dose for each injection should be determined individually based on previous tolerance and current medical history.

Caution is advised

• 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, contraindications to the use of adrenaline must be taken into account.
On the day of injection, the patient should avoid strenuous activities(physical exertion, alcohol consumption, sauna, hot shower, etc.), as they may exacerbate allergic reactions.
In the case of scheduled vaccinationagainst pathogens, a minimum interval of 1 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 an injury) can be given regardless of the phase of allergen immunotherapy. Desensitization is continued 2 weeks after the last administered dose.
The medicinal product contains less than 1 mmol of sodium (23 mg) per 1 mL of the maximum dose (concentration 3), and is therefore considered "sodium-free".

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 use or administration of the medicinal product
Accidental intravascular injection should be strictly avoided (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 their doctor immediately if they experience side effects, even after the observation period.
Doses of 0.5-1 mL may be divided and given in both arms to improve tolerance.
In the case of concomitant therapywith two allergen immunotherapy products, a minimum interval of 30 minutesshould be maintained between injections. The second injection should only be given after it has been established that the first injection did not cause a side effect. Concomitant therapyshould only be performed according to the standard dosage increase schedule(Table 1) or the dosage increase schedule for highly sensitive patients(Table 2). To avoid the effect of accumulation, a 2-3 day interval between two injections is recommended. Additionally, it is recommended to administer each allergen extract in a separate arm.
The outcome of treatment depends, among other things, on achieving the individual maximum dose, which must not be exceeded (see dosing).
When continuing treatment with a new packaging with a new batch number, dose reduction is not necessary.
If the composition of the allergens is changed, treatment should be restarted with the lowest concentration. This also applies if specific immunotherapy was previously performed using a different product (also sublingual or subcutaneous).
Instructions for preparing the medicinal product before administration - see section 6.6.
The recommended treatment duration is usually 3 years.

Dosage

Dosage must be individualized; the recommended dosages in the dosage schedules serve only 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 should be remembered that regular dosage increaseis necessary. 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 procedures are proposed:

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

The decision to continue treatment must be made based on the course and severity of allergic reactions!
Treatment with Novo-Helisen Depot consists of two phases: initial treatment and maintenance treatment.

Initial Treatment (Dose Increase)

Treatment begins during a period with the least severe symptoms.
Initial treatment can be carried out according to one of three dose increase schemes:

• standard dose increase scheme (14 injections) (Table 1),
• dose increase scheme for highly sensitive patients (23 injections) (Table 2),
• single concentration dose increase scheme (6 injections) (Table 3).

Table 1 Standard Dose Increase Scheme

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 Increase Scheme 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

3

Red Label

Concentration

Dose

mL
0.7
0.8
0.9
1.0
Dose increase, especially in highly sensitive patients, must be done gradually until reaching the individual tolerance limit. This constitutes 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.

Table 3 Single Concentration Dose Increase Scheme

Concentration

Dose

mL
0.05
0.1
0.2
0.4
0.6
1.0
The single concentration dose increase scheme can only be used for the Novo-Helisen Depot product with the composition: 708 Dermatophagoides farinae 50% + 725 Dermatophagoides pteronyssinus 50%.
It has been shown that single concentration dose increase is associated with a slightly higher risk of adverse reactions. Additionally, adverse reactions occur earlier with single concentration dose increase than with the standard dose increase scheme. Therefore, it should only be performed by doctors, nurses, and medical staff particularly experienced in allergy treatment (see section 4.4 of the SmPC).
During dose increase, injections are administered at intervals of 7 to 14 days. If the recommended interval between doses is extended, treatment should be continued according to the following scheme (Table 4).

Table 4 Dose Modification in Case of Extended Interval Between Doses During Treatment

3

Red Label of Initial

Interval from Last Injection Dose Modification

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

Maintenance Treatment

Maintenance treatment can be carried out 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 extended to 4 to 6 weeks.
If the interval between maintenance doses is extended, treatment should be continued according to the following scheme (Table 5):

Table 5 Dose Modification in Case of Extended Interval During Maintenance Treatment

Interval from Last Injection Dose Modification

Children and Adolescents

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

Important Information for the Patient Regarding Dosage can be Found in Section 3 "How to Use the Medication

Novo-Helisen Depot”.