Novo-helisen depot

Package leaflet: Information for the user

Novo-Helisen Depot
House dust mite allergen extracts
Injection suspension
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor.
• 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 you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Leaflet contents:

1. What Novo-Helisen Depot is and what it is used for
2. What you need to know 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 pack and other information

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

Novo-Helisen Depot is an allergen extract intended for desensitisation (specific immunotherapy).
During specific immunotherapy, increasing doses of a clinically relevant allergen causing an allergic reaction in the patient are administered by injection until an individual maximum dose is reached, which is then maintained as a maintenance dose.
The aim of this treatment is to alleviate clinical symptoms related to the specific allergen(s) and to reduce the need for symptomatic medication.
Novo-Helisen Depot is used in allergic conditions (IgE-mediated), such as allergic rhinitis, 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 above 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 predicted value despite appropriate pharmacological treatment;
• If the patient has permanent lung changes, e.g. pulmonary emphysema, bronchiectasis;
• If the patient has inflammatory or febrile diseases, severe acute or chronic conditions (e.g. malignancies, active tuberculosis);
• If clinically significant cardiovascular insufficiency has been diagnosed in the patient. In case of a severe allergic reaction after injection of Novo-Helisen Depot, adrenaline is used as emergency treatment. Patients with heart disease have an increased risk of adverse effects following adrenaline administration;
• If the patient has immunological disorders (severe systemic autoimmune diseases, immune complex-induced immunopathies, immunodeficiencies or multiple sclerosis, etc.);
• If the patient has previously experienced severe systemic reactions related to specific allergen immunotherapy;
• If the patient has severe psychiatric disorders.

Warnings and precautions
This medicinal product for subcutaneous allergen immunotherapy must be administered only by physicians, nurses, and medical personnel trained or experienced in allergy treatment. This particularly applies to the dose escalation regimen using a single concentration.
Before starting treatment with Novo-Helisen Depot, discuss with the 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 for glaucoma treatment);
• The patient is pregnant;
• Acute symptoms of illness are present (e.g. allergic symptoms or common cold);
• The patient has symptoms of bronchial asthma;
• The patient has received or is scheduled to receive vaccination.

The patient should inform the doctor about any changes in health status, such as infectious diseases or pregnancy, and discuss further management. If indicated, lung function tests (e.g. peak expiratory flow measurement) may be performed before injection in patients with bronchial asthma.
Inform the doctor whether the previous injection was well tolerated.
Before each injection, the doctor will determine the individual dose based on tolerance to the last administered dose and clinical history.
In case of severe allergic adverse reactions occurring during or after injection, the doctor may administer adrenaline as emergency treatment. It should be clarified in advance whether adrenaline treatment is feasible for the patient.
On the day of injection, strenuous activities such as sports or heavy physical work should be avoided. Alcohol consumption, sauna visits, and hot showers should also be avoided.
In case of planned vaccination against pathogens, an interval of at least 1 week should be maintained between the last injection of this medicinal product and the vaccination date. Treatment with this medicinal product is continued with the last administered dose 2 weeks after vaccination. Vaccinations that are urgently required (e.g. tetanus vaccination after injury) 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
Inform the doctor about all medicines currently or recently taken or used by the patient, as well as any medicines the patient plans to take or use.
No studies on drug interactions have been conducted.
Please keep in mind the following recommendations and discuss them with your doctor:

• Beta-blockers (medicines used in the treatment of high blood pressure or heart disease, and also as eye drops for glaucoma treatment) may be taken concurrently with Novo-Helisen Depot only after consultation with a doctor.
• ACE inhibitors (medicines used in the treatment of high blood pressure) may be taken concurrently with Novo-Helisen Depot only after consultation with a doctor.
• Concurrent treatment with medicines used for allergy treatment (e.g. antihistamines, corticosteroids, mast cell stabilizers) or medicines that partially act similarly to antiallergic drugs (e.g. certain sedatives, antiemetics, and antacids) may influence treatment with Novo-Helisen Depot. This may allow for tolerance of a higher dose of this medicine. If these medicines are discontinued, it may be necessary to reduce the dose of Novo-Helisen Depot.

During treatment with Novo-Helisen Depot, exposure to allergens causing allergy—particularly house dust mites—should be avoided as much as possible, especially on the day of administration. Other factors that may trigger allergic reactions should also be avoided.

Novo-Helisen Depot with food, drink, and alcohol
Alcohol should not be consumed on the day of injection.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
There is insufficient experience with the use of house dust mite allergen extracts in pregnant women.
Therefore, allergen immunotherapy is not recommended during pregnancy.
There are insufficient data available regarding breastfeeding mothers. Although it is unlikely that a breastfed infant would be at risk, the doctor will have to weigh the benefits against the risks during breastfeeding.
There are insufficient data on the effect of Novo-Helisen Depot on fertility.

Driving and operating machinery
Novo-Helisen Depot has no effect or negligible effect on the ability to drive and operate machinery, due to certain adverse effects mentioned in section 4. However, attention should be paid to this when driving, operating machinery, or working at heights without secure support.

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

3. How to use Novo-Helisen Depot

Recommended dose
A doctor trained or experienced in the treatment of allergies will determine the most appropriate treatment schedule for the patient and inform them of the intervals at which injections will be administered.
The doctor will also determine the appropriate dose. The individual dose depends, among other factors, 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 2 different phases: initial treatment and maintenance treatment.

Initial treatment (dose escalation)
Treatment should begin, whenever possible, during a symptom-free period.
The doctor may choose one of 3 different dosing schedules:

• standard dose escalation schedule (14 injections),
• dose escalation schedule for highly sensitive patients (23 injections),
• single-concentration dose escalation schedule (6 injections) ( Applies only to the allergen mixture: 708 Dermatophagoides farinae 50% + 725 Dermatophagoides pteronyssinus 50% ).

During initial treatment, the doctor will determine the maximum dose tolerated by the patient by gradually increasing the dose up to the individual maximum tolerated dose or the maximum recommended dose of the medicinal product.
Injections will be administered at regular intervals of 7 to 14 days until the individual maximum dose or the maximum recommended dose is reached.
If the interval between two injections is exceeded, the doctor may not be able to increase the dose according to the planned schedule. It is therefore important to always adhere to the scheduled injection dates and not interrupt initial treatment.
The single-concentration dose escalation should be performed exclusively 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 established the individual maximum dose during initial treatment or after reaching the maximum recommended dose of the medicinal product, maintenance treatment begins. Once the maximum dose is reached, the time intervals between injections are gradually extended so that injections are ultimately administered every 4 to 6 weeks. If the intended 6-week interval is exceeded, the doctor must reduce the next dose. The dose is then increased again over shorter intervals.
It is also important to always adhere to the scheduled injection dates and not interrupt maintenance treatment.
When starting a new batch of Novo-Helisen Depot, dose reduction is not necessary for house dust mite allergen extracts.

Use in children and adolescents
Allergen-specific immunotherapy (desensitization) is generally not performed in children under 5 years of age, as in this age group there is a greater likelihood of problems with acceptance and cooperation compared to adults.
In children and adolescents, the same initial and maintenance treatment schedules are used as in adults.

Method of administration
Novo-Helisen Depot is administered by subcutaneous injection by a doctor. The injection is given into the outer part of the upper arm, approximately one hand's width (of the patient) above the elbow. Doses of 0.5–1 mL may be divided and administered into both arms to improve tolerance. The doctor will shake the medicinal product well before use.
The patient must remain under medical supervision for at least 30 minutes after the injection. The doctor will ask the patient about their general condition. The observation period may be individually extended. In the event of adverse symptoms, even after the observation period, the patient should contact the doctor immediately.
The doctor may use two different desensitizing preparations. If both preparations are to be administered on the same day, at least a 30-minute interval between injections should be maintained. However, it is recommended that injections be given 2 to 3 days apart. Each preparation should be injected separately into the right and left arm.

Duration of treatment
The recommended duration of treatment is generally 3 years.

Use of a higher than recommended dose of Novo-Helisen Depot
Overdose may lead to allergic reactions and even anaphylactic shock. In such a case, the doctor will take necessary countermeasures. Typical symptoms are described in section 4, "Possible side effects."

Missed dose of Novo-Helisen Depot
It is important to always attend scheduled appointments to avoid compromising treatment success. If the patient misses a scheduled appointment, the treatment schedule may need to be adjusted. The patient should contact their doctor, who will advise on the appropriate course of action.

Discontinuation of Novo-Helisen Depot
This should be discussed with the doctor in advance. Premature discontinuation of treatment may result in a reduced therapeutic effect.
If there are any doubts regarding the use of this medicinal product, consult the doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
After administration of this medicine, the patient will be monitored for at least 30 minutes.
The physician will ask the patient about their general condition. It should be remembered that adverse reactions may also occur after this observation period. If any adverse symptoms occur, contact your doctor immediately.

Important adverse reactions and countermeasures
If intolerance symptoms occur during injection, the physician will immediately stop the injection.
Reactions at the injection site (e.g. redness, itching, swelling) as well as systemic reactions (e.g. shortness of breath, generalized itching, generalized redness) may occur.
Severe allergic reactions, up to anaphylactic shock, may occur. Anaphylactic reactions, including anaphylactic shock, may occur within seconds to minutes after injection. Typical warning symptoms include itching and a sensation of warmth on and under the tongue and in the throat, shortness of breath, itching or burning of the palms and (or) soles of the feet, generalized urticaria, pruritus, drop in blood pressure, dizziness, and malaise. The medical staff must be informed immediately if the patient notices any of these symptoms.
The physician must have an emergency anaphylaxis kit immediately available when the patient is being treated with this medicine. If an allergic (anaphylactic) shock occurs, the patient must remain under medical supervision for 24 hours.

Standard dose-escalation regimen
Frequent (may affect up to 1 in 10 people)
At the injection site: redness, hypersensitivity, induration, swelling (edema), nodule, itching, rash, urticaria;
Other frequent adverse reactions: swelling, redness, itching, rash, urticaria, asthma, cough

Uncommon (may affect up to 1 in 100 people)
At the injection site: skin discoloration (spot), nodule, pain, reaction at the site of administration, sensation of warmth;
Other uncommon adverse reactions: hypersensitivity, dizziness, headache, allergic conjunctivitis, eye irritation, eye pain, eye itching, allergic rhinitis, sinusitis, pallor, dyspnea, pulmonary function disorder (decreased FEV1 value), chest discomfort, cold sweats, tightness sensation, dry throat, throat irritation, pharyngitis, oral and throat pain, laryngeal edema, nasal obstruction, nasal discharge (rhinorrhea), lip itching, abdominal pain, lower abdominal pain, joint pain, neck pain, back pain, allergic dermatitis, atopic dermatitis, drug eruption, maculopapular rash, skin reaction, weakness, malaise, pain, fever, foreign body sensation, swelling of arms and (or) legs (peripheral edema), granuloma

Children and adolescents
The safety profile in children and adolescents treated with Novo-Helisen Depot containing house dust mite allergen extract using the standard dose-escalation regimen is comparable to that in adults. No different adverse reactions are expected in these age groups.

Single-concentration dose-escalation regimen
Adverse reactions may occur more frequently with the single-concentration dose-escalation regimen compared to the standard dose-escalation regimen. Furthermore, adverse reactions with the single-concentration dose-escalation regimen may occur earlier during the dose-escalation phase than with the standard dose-escalation regimen. The severity of systemic allergic reactions was not increased compared to the standard dose-escalation regimen.

Very frequent (may affect more than 1 in 10 people)
At the injection site: redness, itching, swelling, pain

Frequent (may affect up to 1 in 10 people)
At the injection site: induration, swelling, nodule, rash
Other frequent adverse reactions: anaphylactic reaction, hypersensitivity, dyspnea, pulmonary function disorder (decreased FEV1 value), cough, oral and throat pain, rhinorrhea (nasal discharge), weakness, fatigue, somnolence, motor performance disturbances, sinus headache, joint pain, pain in hands and (or) feet, redness

Children and adolescents
The safety profile in children and adolescents treated with Novo-Helisen Depot containing house dust mite allergen extract using the single-concentration dose-escalation regimen is comparable to that in adults. No different adverse reactions are expected in these age groups.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C,
02-222 Warsaw,
tel.: 22 49-21-301,
fax: 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 provide more information on the safety of the medicine.

5. How to store Novo-Helisen Depot

Keep this medicine 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 must not be used after
the expiry date indicated on the carton and vial.
Do not use this medicine if you notice any particles.
Ask your pharmacist how to dispose of medicines no longer required.
Doing so helps protect the environment.

6. Contents of the package and other information

What Novo-Helisen Depot contains
Novo-Helisen Depot contains allergenic extracts of animal origin, house dust mites, and mould fungi.
The composition of the medicinal product is individually selected according to the patient's sensitization profile and as specified in the attached list. The names of individual allergens and their percentage content are indicated on the packaging.
Standardization is expressed 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 are: aluminium hydroxide, sodium chloride, sodium bicarbonate, phenol, water for injections
What Novo-Helisen Depot looks like and contents of the pack
The medicinal product is a suspension which, after shaking, shows visible turbidity.
Depending on the starting material and concentration, suspensions may vary in color and are sometimes intensely colored.
Pack sizes:

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

Marketing Authorisation Holder and Manufacturer
Allergopharma GmbH & Co. KG
Hermann-Koerner-Str. 52-54
21465 Reinbek
Germany
Tel. +49 40 / 72765-0
Fax +49 40 / 7227713
e-mail: [email protected]
For further information, please contact the representative of the Marketing Authorisation Holder:
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
Poland
Tel. 22 350 66 69
Fax 22 350 77 03
DOSING SCHEDULE
Before administration, read the patient leaflet carefully! Do not exceed the individual maximum dose!
Patient.....................................................................................................................................
Batch number........................................................................................................................
Initial treatment:

Initial treatment:

Maintenance treatment:

List of allergen extracts that may be included in the Novo-Helisen Depot product
House dust mite allergen extracts:
a) single extracts
708 Dermatophagoides farinae
725 Dermatophagoides pteronyssinus
b) mixtures
708 Dermatophagoides farinae 50% + 725 Dermatophagoides pteronyssinus 50%

Information intended exclusively for healthcare professionals:

This medicinal product for subcutaneous allergen immunotherapy must be administered only by
physicians, nurses, and healthcare personnel 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 treating physician must have access to an emergency anaphylaxis kit. In case of anaphylactic shock,
patients must be monitored by a physician for 24 hours. National and international guidelines on the
management of anaphylaxis should be taken into account.
Special warnings and precautions for use
If adverse reactions occur during injection, administration of the product must be immediately discontinued.
Allergen immunotherapy products (desensitization) should be prescribed and used only by physicians,
nurses, and healthcare professionals trained or experienced in allergy treatment. When using the single-concentration dose escalation regimen, more frequent adverse effects may be expected during initial treatment compared to the standard regimen (see section 4.8 of the SmPC). The single-concentration dose escalation regimen should be conducted only by physicians, nurses, and healthcare professionals particularly experienced in allergology.
On the day of injection, the patient must not have acute symptoms of illness (such as allergic symptoms, e.g.
allergic rhinitis, allergic conjunctivitis, cold) and, in particular, asthmatic symptoms.
Before each injection, patients should be encouraged to inform the physician about any changes in their
health status, such as infectious diseases or pregnancy, and whether the last administered dose was well tolerated.
In patients with asthma, lung function should be assessed when necessary (e.g. by measuring peak expiratory
flow).
The dose for each injection must be individually determined based on previous tolerance and current
medical history.
Particular caution is advised

• in patients treated with angiotensin-converting enzyme (ACE) inhibitors (see also section 4.5 of the SmPC),
• in patients treated with beta-blockers (local or systemic, see also section 4.5 of the SmPC),
• during pregnancy (see section 4.6 of the SmPC).

Since adrenaline is recommended for the treatment of severe allergic reactions, contraindications to
adrenaline use must be considered.
On the day of injection, strenuous activities (physical exertion, alcohol consumption, sauna, hot shower, etc.)
should be avoided, as they may exacerbate allergic reactions.
If a vaccination is planned, a minimum interval of one week should be maintained between the last allergen
extract injection and the vaccination date. Vaccination should therefore be scheduled during the maintenance
phase. Life-saving vaccinations (e.g. tetanus after injury) may be administered regardless of the phase of
allergen immunotherapy. Desensitization therapy is continued two weeks after vaccination with the last administered dose.
The medicinal product contains less than 1 mmol of sodium (23 mg) per 1 mL of maximum dose (concentration 3), thus it is considered "sodium-free".
Traceability
To improve traceability of biological medicinal products, the name and batch number of the administered product must be clearly documented.
Method of administration
Precautions to be taken prior to use or administration of the medicinal product
Intravascular injection must be strictly avoided (aspirate before injection!).
Subcutaneous injection should be administered on the extensor side of the upper arm, approximately one hand's width (of the patient) above the elbow.
After each injection, the patient must be observed for at least 30 minutes, after which their condition must be evaluated by a physician. In individual cases, the observation period may be extended.
Adverse reactions may also occur after the observation period.
Patients should be instructed to contact their treating physician or medical staff immediately if adverse reactions occur, even after the observation period.
Doses of 0.5–1 mL may be divided and administered into both arms to improve tolerance.
When conducting concomitant therapy with two allergen immunotherapy products on the same day, a minimum interval of 30 minutes must be maintained between injections. The second injection may only be administered after confirming that the first injection did not cause an adverse reaction. Concomitant therapy must be conducted only according to the standard dose escalation regimen (Table 1) or the dose escalation regimen for highly sensitive patients (Table 2). To avoid cumulative effects, a 2–3 day interval between the two injections is recommended. Additionally, each allergen extract should be administered into a separate arm.
Treatment outcome depends, among other factors, on achieving the individual maximum dose, which must not be exceeded (see dosing).
When continuing treatment with a new package bearing a new batch number, dose reduction is not necessary.
If the allergen composition is changed, treatment must be restarted from the lowest concentration. This also applies if previous specific immunotherapy was conducted with another product (including oral or sublingual).
Instructions for preparation of the medicinal product prior to administration – see section 6.6 of the SmPC.
The recommended duration of treatment is generally 3 years.
Dosing
Dosing must be individually adjusted; dosing recommendations provided in the regimens serve only as guidance. Dosing must be adapted according to the individual course of therapy. The patient's individual sensitivity level is determined based on a thorough medical history and diagnostic testing (skin test results).
Regular dose escalation must be ensured. The dose may only be increased if the last administered dose was well tolerated. Otherwise, the last dose should be maintained or reduced.
In case of local or systemic reactions after administration of the medicinal product, the following procedures are recommended:

• 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 regimen (see Table 1) or the dose escalation regimen for highly sensitive patients (see Table 2).
• Severe systemic reaction: restart treatment with concentration 1 according to the standard dose escalation regimen (see Table 1) or the dose escalation regimen for highly sensitive patients (see Table 2).

The decision to continue treatment must be based on the course and severity of allergic reactions!
Novo-Helisen Depot therapy consists of two phases: initial treatment and maintenance treatment.
Initial treatment (dose escalation)
Treatment should begin during a period with minimal symptom expression.
Initial treatment may be conducted according to one of three dose escalation regimens:

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

Table 1 Standard dose escalation regimen
Dose
Concentration
mL
1 0.1
Green 0.2
label 0.4
0.8
0.1
2
0.2
Orange
0.4
label
0.8
0.1
3 0.2
Red 0.4
label 0.6
0.8
1.0
Table 2 Dose escalation regimen for highly sensitive patients
Dose
Concentration
mL
0.05
0.1
1
Green 0.2
label 0.4
0.6
0.8
0.05
0.1
2
0.2
Orange
0.4
label
0.6
0.8
0.05
0.1
3 0.2
Red 0.3
label 0.4
0.5
0.6
Dose
Concentration
mL
0.7
0.8
0.9
1.0
Dose escalation, especially in highly sensitive patients, must be performed gradually until reaching the individual tolerance threshold. 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 escalation regimen
Dose
Concentration
mL
0.05
0.1
3 0.2
Red label 0.4
0.6
1.0
The single-concentration dose escalation regimen may be used exclusively 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 escalation is associated with a slightly higher risk of adverse reactions. Moreover, adverse reactions occur earlier with single-concentration dose escalation compared to the standard dose escalation regimen. Therefore, it should be performed only by physicians, nurses, and healthcare professionals particularly experienced in allergy treatment (see section 4.4 of the SmPC).
During dose escalation, injections are administered at intervals of 7 to 14 days. If the recommended interval between doses is prolonged, treatment should be continued according to the following regimen (Table 4).
Table 4 Dose modification in case of prolonged interval between doses during initial treatment
Interval since last injection Dose modification

2 weeks Reduce by one dose level in the applied regimen
4 weeks Restart initial treatment from the lowest dose according to the appropriate dosing regimen
Maintenance treatment
Maintenance treatment may be conducted continuously (year-round).
The first maintenance dose is administered 14 days after reaching the individual maximum dose (usually 1.0 mL of concentration 3) during initial treatment. Subsequently, the interval between injections is gradually extended to 4 to 6 weeks.
If the interval between maintenance doses is prolonged, treatment should be continued according to the following regimen (Table 5):
Table 5 Dose modification in case of prolonged interval during maintenance treatment
Interval since last injection Dose modification

Children and adolescents
Children under the age of 5 are generally not suitable candidates for immunotherapy (desensitization) due
to a higher likelihood of cooperation and treatment acceptance issues in this age group compared to adults.
In children over the age of 5 and in adolescents, clinical data are limited and insufficient to confirm efficacy and safety; however, clinical safety data do not indicate a higher risk than in adults.
In children and adolescents, the same initial and maintenance treatment regimen is used as in adults.
Important patient information regarding dosing can be found in section 3 “How to use Novo-Helisen Depot”.