Allergovit

PATIENT INFORMATION LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE USER

ALLERGOVIT Plant Pollen Allergoids

Suspension for injection

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.
 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 any not listed in this leaflet, please inform your doctor. See section 4.
Table of contents of the leaflet

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

1. What is ALLERGOVIT and what is it used for

ALLERGOVIT contains chemically modified allergen extracts (so-called allergoids) of plant pollen. The active substances are listed in the List of individual allergoids and mixtures of plant pollen allergoids that may be included in ALLERGOVIT.
The doctor injects the medicine under the patient's skin to reduce or eliminate allergic reactions caused by pollen that trigger allergy symptoms. For this purpose, increasingly larger doses of allergens that cause allergies are injected at appropriate intervals. This treatment is called allergen immunotherapy (desensitization).
ALLERGOVIT is used to treat the causes of allergic diseases such as allergic rhinitis (hay fever), allergic conjunctivitis, allergic rhinoconjunctivitis and/or allergic bronchial asthma, caused by exposure to specific plant pollen allergens.

2. Important information before using ALLERGOVIT

When not to use ALLERGOVIT

• 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 appropriate pharmacotherapy.
• If the patient has chronic changes in the lungs, such as emphysema (pulmonary emphysema), 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 a clinically significant cardiovascular system failure. In case of a severe allergic reaction (anaphylaxis) after injection of ALLERGOVIT, 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 suffers from immune system disorders (autoimmune diseases, immunopathies induced by immune complexes, immune deficiencies or multiple sclerosis, etc.).
• If the patient has severe mental disorders.

Warnings and precautions

This medicinal product for subcutaneous allergen immunotherapy should only be administered by doctors, nurses and medical staff who have been trained or have experience in treating allergies. In particular, this applies to the accelerated dose escalation scheme and the dose escalation scheme from one concentration.
Before starting treatment with ALLERGOVIT, 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 in the form of eye drops for glaucoma treatment).
• The patient is pregnant.
• There are acute symptoms of the disease (e.g. allergic symptoms or a cold).
• The patient has symptoms of bronchial asthma.
• The patient has been vaccinated or is scheduled for vaccination.

The patient should inform the doctor about any changes in their health, such as infectious diseases or pregnancy, and discuss further action with them. Before injection, a lung function test (e.g. measurement of peak expiratory flow) may be performed if the patient has bronchial 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 case 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, strenuous activities, such as sports or heavy physical work, should be avoided. Alcohol consumption, sauna visits, and hot showers should also be avoided.
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 vaccination with the last administered dose. Vaccinations that are immediately necessary (e.g. against tetanus after injuries) can be given at any time.
Children and adolescents
Treatment with Allergovit is generally not recommended for children under 5 years of age.

ALLERGOVIT and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
No studies on drug interactions have been conducted.
Remember the following instructions and discuss them with your 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 ALLERGOVIT. 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 ALLERGOVIT.
• Beta-blockers(medicines used to treat high blood pressure or heart disease, as well as eye drops for glaucoma treatment) may be taken concomitantly with ALLERGOVIT only after consulting a doctor.
• ACE inhibitors(medicines used to treat high blood pressure) may be taken concomitantly with ALLERGOVIT only after consulting a doctor.

During treatment with ALLERGOVIT, contact with plant pollen allergens should be avoided as much as possible, especially on the day of injection. Other allergens that may cause allergic reactions should also be avoided.

ALLERGOVIT with food, drink, and alcohol

On the day of injection, do not drink alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before using this medicine.
There is insufficient data on the use of Allergovit during pregnancy. Therefore, treatment with Allergovit 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 Allergovit on fertility.

Driving and using machines

This medicine may affect your ability to drive or use machines, as it can cause fatigue.

ALLERGOVIT contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 0.8 ml of maximum concentration A, which means it is essentially "sodium-free".

3. How to use ALLERGOVIT

Recommended dose

The doctor, who is trained or experienced in treating allergies, will determine the most suitable treatment schedule for the patient and tell them when they will receive the 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 0.6 ml of concentration B. The individual maximum dose may be lower.
There are 2 different phases of treatment, "initial treatment" and "maintenance treatment".

Initial treatment (dose escalation)

During the initial treatment, the doctor will determine the maximum dose that the patient can tolerate, up to the maximum recommended dose of the medicine, regularly increasing the dose.

Adults

The doctor may choose one of 3 different dosing schedules:

• 1. Standard dose escalation schedulewith 7 injections
• 2. Accelerated dose escalation schedulewith 4 injections (only for ALLERGOVIT grass and cereal pollen allergens and tree pollen allergens)

• 3. Single concentration dose escalation schedulewith 3 injections (only for ALLERGOVIT grass and cereal pollen allergens) Standarddose escalation schedulemust be started before the pollen season and completed 1 week before the start of the pollen season. In the case of ALLERGOVIT grass and cereal pollen allergens, it is also possible to start the initial treatment during the pollen season (all year round) in the first year of therapy. Accelerated dose escalation schedulemust be started before the pollen season and completed 1 week before the start of the pollen season. The accelerated dose escalation schedule can only be used for ALLERGOVIT grass and cereal pollen allergens and tree pollen allergens (see List of individual allergoids and mixtures of allergoids). Single concentration dose escalation schedulemust be started before the pollen season and completed 1 week before the start of the pollen season. The single concentration dose escalation schedule can only be used for ALLERGOVIT grass and cereal pollen allergens (see List of individual allergoids and mixtures of allergoids). To achieve optimal treatment efficacy using the accelerated dose escalation schedule and the single concentration schedule, it is recommended to continue treatment before the pollen season with at least 2 maintenance dose injections. The patient will receive injections at regular intervals of 7 to 14 days until they reach their individual maximum dose or the maximum recommended dose of the medicine. 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 keep the injection appointments and not interrupt the initial treatment.

Children and adolescents

Treatment with Allergovit is generally not recommended for children under 5 years of age.
For children aged 5 and over and adolescents, the doctor may choose one of 2 schedules:

• 1. Standard dose escalation schedulewith 7 injections
• 2. Single concentration dose escalation schedulewith 3 injections (only for ALLERGOVIT grass and cereal pollen allergens) The single concentration dose escalation schedule can only be used for grass and cereal pollen allergens ALLERGOVIT. Initial treatment in children and adolescents should only be started before the pollen season and completed 1 week before the start of the pollen season. To achieve optimal treatment efficacy using the single concentration dose escalation schedule, it is recommended to continue treatment before the pollen season with at least 2 maintenance dose injections. The patient will receive injections at regular intervals of 7 to 14 days until they reach their individual maximum dose or the maximum recommended dose of the medicine. 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 keep the injection appointments 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, there are 2 possible treatment options:

• Treatment is continued until about 1 week before the start of the pollen season. In the next year, treatment is started again, using the appropriate dose escalation schedule before the pollen season.
• Treatment is continued throughout the year. In children and adolescents during the pollen season, it is necessary to reduce the dose for all preparations. In adults, dose reduction during the pollen season is only necessary for preparations containing weed pollen. After reaching the maximum dose, the time intervals between injections are gradually increased, so that the patient eventually receives injections at intervals of 4 to 8 weeks. If the planned interval of 8 weeks is exceeded, the doctor must reduce the next dose. Then the dose is increased again in shorter intervals. It is also essential to always keep the injection appointments and not interrupt the maintenance treatment.

Use in children and adolescents

Treatment with ALLERGOVIT is generally not recommended for children under 5 years of age.
Initial treatment in children aged 5 and over and adolescents may only be started before the pollen season, according to the standard dosing schedule or the single concentration dosing schedule (single concentration dose escalation schedule only for ALLERGOVIT grass and cereal pollen allergens). Then the doctor will start maintenance treatment. During the pollen season, the doctor will reduce the individual maintenance treatment dose.

Method of administration

ALLERGOVIT is injected under the skin 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.
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 individually extended to 2 hours.
In case of side effects, the patient should immediately contact the doctor.
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 duration of treatment is usually 3 years.
The outcome of therapy depends, among other things, on the dose achieved during therapy.

Overdose of ALLERGOVIT

Overdose can 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 ALLERGOVIT

Always attend 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. Contact the doctor, who will explain how to proceed.

Stopping ALLERGOVIT treatment

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, consult a doctor.

4. Possible side effects

Like all medicines, ALLERGOVIT 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. Remember that side effects can also occur after this observation period. In case of side effects, contact the doctor immediately.

Important side effects and measures

If intolerance symptoms occur during injection, the doctor will immediately stop the injection.
Reactions at the injection site (e.g. redness, itching, swelling) and reactions affecting the whole body (e.g. shortness of breath, itching all over the body, redness all over the body) may occur.
Severe allergic reactions up to anaphylactic shockcan occur.
Anaphylactic reactions, including anaphylactic shock, can 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 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 anaphylaxis kit available for immediate use when the patient is being treated with this medicine. If anaphylactic shock occurs, the patient must be medically monitored for 24 hours.
Delayed local reactions can also occur several hours after injection.

Side effects for ALLERGOVIT Grass and Cereal Pollen:

Standard dose escalation schedule

Very common (may affect more than 1 in 10 people)
At the injection site: redness, itching, swelling
Common (may affect up to 1 in 10 people)
At the injection site: pain, reaction, blisters (hives), warmth
Other common side effects: headache
Uncommon (may affect up to 1 in 100 people)
At the injection site: discomfort, rash, skin changes (ulceration), bruise (hematoma), bleeding (hemorrhage), hypersensitivity, reduced sensitivity (hypoesthesia), hardening, swelling (edema), sensory disturbances (paresthesia), granuloma
Other uncommon side effects: anaphylactic reaction, dizziness, conjunctival edema, allergic conjunctivitis, itching eyes, redness of the eyes, eyelid swelling, gastrointestinal disorders, lip swelling, nausea, itching in the mouth, malaise, pain, swelling of the hands and/or feet (peripheral edema), fever, fatigue, rhinitis, nasal congestion, increased blood pressure, impaired lung function (reduced FEV1 value), joint pain, arm and/or leg pain, migraine, drowsiness, asthma, cough, shortness of breath, croup, allergic rhinitis, diarrhea, vomiting, swallowing disorders, skin and subcutaneous tissue swelling (angioedema), facial swelling (facial edema), feeling of heat, cold sweats, rash, redness, itching, hives, bruise (hematoma), lymphedema, decreased blood pressure when changing position quickly (orthostatic hypotension)
Children and adolescents
The safety profile in children and adolescents is comparable to the safety profile in adults.
No other hazards are expected in these age groups.
Accelerated dose escalation schedule
Very common (may affect more than 1 in 10 people)
At the injection site: swelling, redness, itching, pain
Common (may affect up to 1 in 10 people)
At the injection site: discomfort, sensory disturbances (paresthesia), warmth, bruise (hematoma), reduced sensitivity (hypoesthesia), hardening, rash, hives
Other common side effects: anaphylactic reaction, chest discomfort, impaired lung function, headache, shortness of breath, hives
Children and adolescents
No data are available for the accelerated dose escalation schedule (4 injections, concentrations A and B).
Single concentration dose escalation schedule
Very common (may affect more than 1 in 10 people)
At the injection site: redness, itching, swelling
Common (may affect up to 1 in 10 people)
At the injection site: discomfort, bleeding (hemorrhage), pain, blisters (hives), warmth
Other common side effects: rapid heartbeat (tachycardia), itching eyes, diarrhea, malaise, swelling, allergic rhinitis, impaired lung function (reduced FEV1 value), arm and/or leg pain, headache, restlessness, asthma, shortness of breath, cough, stuffy nose, sore throat, hoarseness, allergic dermatitis, rash, redness, itching, hives
Children and adolescents
The safety profile in children and adolescents is comparable to the safety profile in adults.
No other hazards are expected in these age groups.

Side effects for ALLERGOVIT Tree Pollen:

Standard dose escalation schedule

Very common (may affect more than 1 in 10 people)
At the injection site: redness, itching, swelling, reaction
Common (may affect up to 1 in 10 people)
At the injection site: pain, warmth, granuloma
Other common side effects: rhinitis, conjunctivitis, headache, itching eyes, sneezing, wheezing
Uncommon (may affect up to 1 in 100 people)
At the injection site: rash, bruise (hematoma), sensory disturbances (paresthesia)
Other uncommon side effects: anaphylactic reaction, hypersensitivity reaction, sleep disturbances, dizziness, sensory disturbances (paresthesia), eye irritation, eyelid swelling, rapid heartbeat, asthma, cough, increased respiratory secretions, itching nose, sore throat, itching mouth, glossodynia, rash, allergic dermatitis, exacerbation of dermatitis, itching, discomfort
Children and adolescents
The safety profile in children and adolescents is comparable to the safety profile in adults.
No other hazards are expected in these age groups.
Accelerated dose escalation schedule
Very common (may affect more than 1 in 10 people)
At the injection site: swelling, redness, itching, pain
Common (may affect up to 1 in 10 people)
At the injection site: warmth, sensory disturbances (paresthesia), discomfort, bruise (hematoma), reduced sensitivity (hypoesthesia), hardening, rash, hives
Other common side effects: increased salivation, hypersensitivity, arm and/or leg pain, headache, allergic rhinitis, stuffy nose
Children and adolescents
No data are available for the accelerated dose escalation schedule (4 injections, concentrations A and B).

Post-marketing data

Side effects for ALLERGOVIT Weed Pollen:

(Frequency not known: cannot be estimated from available data)
At the injection site: swelling, bruise (hematoma), nodules, swelling (edema), pain, reaction, blisters (hives), blisters
Other side effects: anaphylactic reaction, anaphylactic shock, allergic conjunctivitis, eyelid swelling, mydriasis, increased appetite, weight gain, restlessness, dizziness, fainting, sensory disturbances (paresthesia), loss of consciousness, tremor, cyanosis, palpitations, rapid heartbeat, chest discomfort, decreased blood pressure, increased blood pressure, asthma, cough, wheezing, croup, allergic rhinitis, diarrhea, vomiting, swallowing disorders, skin and subcutaneous tissue swelling (angioedema), facial swelling, feeling of heat, cold sweats, rash, redness, itching, hives, swelling of the hands and/or feet, weakness, urinary incontinence
Children and adolescents
The safety profile in children and adolescents is comparable to the safety profile in adults.
No other hazards are expected in these age groups.

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181 C
02-222 Warsaw
Phone: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ALLERGOVIT

Store out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the month stated.
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 stated on the carton and container.
Do not use this medicine if you notice any sediment.
Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What ALLERGOVIT contains

ALLERGOVIT contains plant pollen allergoids in depot form. They are produced by physical and chemical modification of the allergen. The composition of the medicine is individually selected depending on the patient's spectrum of sensitization, in accordance with the attached list. The names of individual allergoids and their percentage share are given on the packaging.
The standardization of allergoids is carried out in TU (therapeutic units).
Concentration A contains 1,000 TU/ml
Concentration B contains 10,000 TU/ml
Other ingredients of the medicine are: aluminum hydroxide, sodium chloride, sodium bicarbonate, phenol, water for injections.

What ALLERGOVIT looks like and contents of the pack

Suspension for injection for subcutaneous use
Sterile
The liquid in the vials must show a clearly recognizable turbidity after shaking. Due to the natural coloration of the source material of the allergens and depending on the concentration, the intensity of the colorationof the preparations may vary.
Pack sizes
Two pack sizes are available, containing:
1 vial of concentration A and 1 vial of concentration B
1 vial of concentration B
They are supplied in additional outer packaging containing 10 needles and 10 syringes. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Allergopharma GmbH & Co. KG
Hermann-Koerner-Str. 52
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 21,
05-092 Łomianki
Phone: 22 350 66 69
Fax: 22 350 77 03
Date of last revision of the leaflet:12.2022

Information intended for healthcare professionals only:

This medicinal product for subcutaneous allergen immunotherapy may only be administered by doctors, nurses, and medical staff who have been trained or have experience in treating allergies.
In the event of severe local or systemic reactions or anaphylaxis, the treating physician must have an anaphylaxis kit and must have experience in treating anaphylactic reactions. In the event of anaphylactic shock, patients must be monitored by a doctor for 24 hours. National guidelines for the treatment of anaphylaxis should be taken into account.

Special warnings and precautions for use

In the event of adverse reactions during injection, administration of the product should be stopped immediately.
Allergen immunotherapy preparations (desensitization) should only be prescribed and used by doctors, nurses, and medical staff who have been trained or have experience in treating allergies.
When using the accelerated dose escalation schedule and the single concentration dose escalation schedule, more frequent adverse reactions can be expected during the initial treatment compared to the standard schedule (see SPC section 4.8).
Treatment according to the accelerated schedule and the single concentration schedule should only be carried out by doctors, nurses, and medical staff who are particularly experienced 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, conjunctivitis, cold) and, in particular, asthmatic symptoms. In the case of asthmatics, lung function (e.g. by measuring peak expiratory flow) should be assessed if necessary.
Particular caution is recommended:

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

Before each injection, patients should be encouraged to inform the doctor about any changes in their health, such as infectious diseases or pregnancy, and discuss further action with them. Based on the previous tolerance and the medical history collected, the individual dose should be determined for each injection.
Given that adrenaline is recommended for the treatment of severe allergic reactions, contraindications to the use of adrenaline must be taken into account.
On the day of injection, strenuous activities (physical exertion, alcohol consumption, sauna, hot shower, etc.) should be avoided, as they may exacerbate allergic reactions.
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. Vaccinations should therefore be performed during maintenance treatment, between allergen vaccine injections given at 4-week intervals. Vaccinations that are immediately necessary (e.g. against tetanus after injuries) can be given regardless of the phase of allergen immunotherapy. Desensitization is continued for 2 weeks after vaccination with the last administered dose.
The medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml of concentration A, which means it is essentially "sodium-free".

Identifiability

To improve the identifiability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.
Administration
Precautions to be taken before using or administering the medicinal product.
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 monitored for at least 30 minutes, after which their condition should be assessed by the doctor. The observation period may be individually extended to 2 hours. Side effects can also occur after the observation period.
Patients should be instructed to contact the treating doctor or their medical staff in case of side effects, even after the observation period.
In the case of concomitant therapywith 2 allergen immunotherapy products, a minimum interval of 30 minutesshould be maintained between injections. The second injection should not be given unless the first injection was well tolerated without side effects. Concomitant therapyshould only be carried out according to the standard dose escalation schedule. It is recommended to maintain a 2-3 day interval between injections to avoid the cumulative effect. It is recommended that different allergen extracts are always injected separately into the right and left arm.
Nodose reduction is required for the first dose from a new packageof the maintenance treatment set.
In the event of a change in the composition of the vaccine, treatment should be restarted from the lowest dose.
This also applies in the case of previous desensitization with another product (also sublingual or subcutaneous).
Before use, the vial should be shaken vigorously to obtain a uniform suspension.
Instructions for preparation of the medicinal product before administration - see SPC section 6.6.
Treatment outcomedepends, among other things, on the cumulative dose.
The recommended treatment duration is usually 3 years.
Dosing
Dosing must be individualized; the recommended dosing schedules may only serve as a guide. Dosing 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 administered was well tolerated. Otherwise, the last dose used should be maintained or reduced.

• severe local reaction: repeat the last well-tolerated dose or reduce the last dose by 1 level,
• mild to moderate generalized reaction: in the case of a mild generalized reaction, go back 1 dose in the dosing schedule, in the case of a moderate generalized reaction, go back 2 doses or, if necessary, start treatment from concentration A according to the standard schedule (see Table 2).
• severe generalized reaction: restart therapy from the smallest dose of concentration A according to the standard dose escalation schedule (see Table 2).

The decision to continue treatment must be made based on the course and severity of allergic reactions!
Treatment with ALLERGOVIT involves two phases: initial treatment and maintenance treatment.

ADULTS

Initial treatment (dose escalation)

Initial treatment in adult patients can be carried out according to one of 3 dose escalation schedules.

• 1. Standard dose escalation schedule(7 injections), see Table 1
• 2. Accelerated dose escalation schedule(4 injections), see Table 2 ( onlyfor grass and cereal pollen allergens and tree pollen allergens)
• 3. Single concentration dose escalation schedule(3 injections), see Table 3 ( onlyfor grass and cereal pollen allergens)

Table 1 Standard dose escalation schedule (7 injections)

Concentration Dosing: Dose of allergen:

ml

TU

0.1
100
0.2
200

A

(light blue label with stripes)
0.4
400
0.8
800
0.15
1500

B

(dark blue label)
0.3
3000
0.6
6000
Initial treatment according to the standard dose escalation schedule starts pre-seasonally.
Initial treatment with ALLERGOVIT containing grass and cereal pollen allergoidscan also be started during the pollen season (regardless of the time of year) in the first year of therapy.

Table 2 Accelerated dose escalation schedule (4 injections)

Concentration Dosing: Dose of allergen:

TU

A

(light blue label with stripes)
ml
0.2
200
0.6
600
0.2
2000

B

(dark blue label)
0.6
6000
Initial treatment according to the accelerated dose escalation schedule starts pre-seasonally. This schedule can only be used for ALLERGOVIT containing grass and cereal pollen allergens or tree pollen allergens (see List of individual allergoids and mixtures of allergoids).

Table 3 Single concentration dose escalation schedule (3 injections)

Concentration Dosing: Dose of allergen:

ml

TU

0.1
1000

B

(dark blue label)
0.3
3000
0.6
6000
Initial treatment according to the single concentration dose escalation schedule starts pre-seasonally. This schedule can only be used for ALLERGOVIT containing grass and cereal pollen allergens (see List of individual allergoids and mixtures of allergoids).
Initial treatment given pre-seasonally should be completed 1 week before the start of the pollen season.
The dosing schedules presented in Table 3 and Table 4 should only be used by doctors, nurses, and medical staff who are particularly experienced in treating allergies (see section 4.4).
To achieve optimal treatment efficacy using the accelerated dose escalation schedule and the single concentration schedule, it is recommended to continue treatment before the pollen season with at least 2 maintenance dose injections.
During dose escalation, injections are given 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 4 Dose Modification in Case of Prolonged Interval Between Doses During Initial Treatment

Pre-seasonal therapy is started every year from the lowest dose of the appropriate dosing schedule.
The maximum dose is 0.6 ml of concentration Band should never be exceeded. The individual maximum dose for a given patient may be lower.

Maintenance Treatment

Maintenance treatment can be carried out all year round or pre-seasonally in each subsequent year.
The first dose of maintenance treatment is administered 14 days after achieving the individual maximum dose (usually 0.6 ml of concentration B) during initial treatment, then the interval between injections is gradually extended to 4 - 8 weeks.
Pre-seasonal treatment starts every year from the lowest dose according to the applied dosing schedule. It is continued until 1 week before the expected start of the pollen season.
In year-round therapy, maintenance doses are administered throughout the year, also during the pollen season, at intervals of 4 to 8 weeks. Dose reduction during the pollen season is not necessary in the case of grass and cereal pollen allergens as well as tree pollen.
For other allergens (weed pollen), dose reduction is required because there is a lack of data on the safety of maintenance treatment in adults without dose reduction. During the pollen season, the achieved maximum dose should be reduced by two doses according to the standard dosing schedule (Table 1) and administered at 2-week intervals, then the interval between injections can be gradually extended to 4 - 8 weeks.
After the pollen season, the reduced dose should be gradually increased according to the standard dosing schedule at 2-week intervals until the maximum dose is re-achieved.
The intervals between maintenance doses should then be gradually extended to 4 - 8 weeks.
If the interval between maintenance doses is extended, treatment should be continued according to the following schedule:

Table 5 Dose Modification in Case of Prolonged Interval Between Injections During Maintenance Treatment:

CHILDREN AND ADOLESCENTS

Initial Treatment (Dose Increase)

Children under 5 years of age are not usually suitable candidates for immunotherapy due to a higher likelihood of cooperation and acceptance problems in this age group.
Efficacy and safety in children over 5 years of age and in adolescents have been established in clinical trials of the ALLERGOVIT mixture 6 grasses product.
For the ALLERGOVIT product containing tree and weed pollen allergens, limited data are available for children over 5 years of age. These data are not sufficient to confirm efficacy, but safety data do not indicate a higher risk than in adults in terms of the occurrence and frequency of possible adverse reactions.
Initial treatment in children over 5 years of age and in adolescents can be carried out according to 2 schedules.

• 1. Standard dose increase schedule(7 injections), see Table 1
• 2. Single concentration dose increase schedule(3 injections), see Table 3 ( onlyfor grass and cereal pollen allergens) The single concentration dose increase schedule in children and adolescents can only be used for the ALLERGOVIT product containing grass and cereal pollen allergens. The single concentration dose increase schedule should only be used by doctors, nurses, and medical staff with extensive experience in allergy treatment (see SPC section 4.4). Initial treatment in children and adolescents can only be started pre-seasonally and must be completed 1 week before the start of the pollen season. To achieve optimal treatment efficacy using the single concentration dose increase schedule, it is recommended to continue treatment before the pollen season with at least 2

injections of the maintenance dose.
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 schedule in Table 4.
Pre-seasonal therapy is started every year from the lowest dose.
The maximum dose is 0.6 ml of concentration Band should never be exceeded. The individual maximum dose for a given patient may be lower.

Maintenance Treatment

Maintenance treatment can be carried out all year round or pre-seasonally in each subsequent year.
The first dose of maintenance treatment is administered 14 days after achieving the individual maximum dose (usually 0.6 ml of concentration B) during initial treatment, then the interval between injections is gradually extended to 4 - 8 weeks.
Pre-seasonal treatment starts every year from the lowest dose according to the applied dosing schedule. It is continued until 1 week before the expected start of the pollen season.
In year-round therapy, dose reduction during the pollen season is necessary because there is a lack of data on the safety of maintenance treatment in children and adolescents without dose reduction.
During the pollen season, the achieved maximum dose should be reduced by two doses according to the appropriate dosing schedule and administered at 2-week intervals, then the interval between injections can be gradually extended to 4 - 8 weeks.
After the pollen season, the reduced dose should be gradually increased according to the appropriate dosing schedule at 2-week intervals until the maximum dose is re-achieved.
The intervals between maintenance doses should then be gradually extended to 4 - 8 weeks.
If the interval between maintenance doses is extended, treatment should be continued according to the schedule contained in Table 5.

Important Information for the Patient Regarding Dosage and Administration is Provided in Section 3 "How to Use the ALLERGOVIT Medication".

Dosage Guidelines
Standard dose increase schedule (7 injections) for ALLERGOVIT products for all age groups (children, adolescents, adults):
Follow all instructions contained in the leaflet attached to the packaging!
Do not exceed the individual maximum dose!
Product:
Patient:
Initial treatment (including repeated dose increase in pre-seasonal therapy in the next year)

Dosage Guidelines
Accelerated dose increase schedule (4 injections) for grass and cereal pollen allergens ALLERGOVIT and tree pollen allergens ALLERGOVIT (only for use in adults):
Follow all instructions contained in the leaflet attached to the packaging!
Do not exceed the individual maximum dose!
Product:
Patient:
Initial treatment (including repeated dose increase in pre-seasonal therapy in the next year)

Patient:

Maintenance Treatment

Dosage Guidelines
Single concentration dose increase schedule (3 injections) for ALLERGOVIT grass and cereal pollen for all age groups (children, adolescents, adults):
Follow all instructions contained in the leaflet attached to the packaging!
Do not exceed the individual maximum dose!
Product:
Patient:
Initial treatment (including repeated dose increase in pre-seasonal therapy in the next year)

Patient:

Maintenance Treatment