Allergovit

PACKAGE LEAFLET: INFORMATION FOR THE USER

ALLERGOVIT Pollen Allergoids
Injection suspension
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
Keep this leaflet, as you may need to read it again.
If you have any doubts, consult your doctor.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor. See section 4.
Contents of the leaflet

1. What ALLERGOVIT is and what it is 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 package and other information

1. What ALLERGOVIT is and what it is used for

ALLERGOVIT contains chemically modified allergenic extracts (so-called allergoids) from plant pollens.
The active substances are listed in the Register of Single Allergoids and Allergoid Mixtures of Plant Pollens that may be included in ALLERGOVIT.
The doctor administers the medicine by subcutaneous injection to reduce or eliminate allergic reactions caused by pollen triggering allergy symptoms. For this purpose, increasing doses of the allergens causing allergy are injected at appropriate time intervals. This treatment is called allergen immunotherapy (desensitization).
ALLERGOVIT is used for causal treatment of allergic conditions such as: allergic rhinitis, 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 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 (emphysema), bronchiectasis.
• If the patient has inflammatory or febrile diseases, severe acute or chronic illnesses (e.g. neoplastic diseases, active tuberculosis).
• If clinically significant cardiovascular insufficiency has been diagnosed in the patient. In case of severe allergic reaction (anaphylaxis) after injection of ALLERGOVIT, adrenaline is used as rescue medication. Patients with heart disease have an increased risk of adverse effects following adrenaline administration.
• If the patient suffers from immunological system disorders (autoimmune diseases, immune complex-induced immunopathies, immunodeficiencies or multiple sclerosis, etc.).
• If the patient has been diagnosed with severe psychiatric disorders.

Warnings and precautions
This medicinal product for subcutaneous allergen immunotherapy must be administered only by physicians, nurses, or medical personnel trained or experienced in allergy treatment. This particularly applies to the accelerated dose-increase regimen and the single-concentration dose-increase regimen.
Before starting treatment with ALLERGOVIT, discuss with the doctor if:

• The patient is being treated with ACE inhibitors due to high blood pressure.
• The patient is being treated with beta-blockers (medications 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 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.
The patient should inform the doctor whether the previous injection was well tolerated.
Before each injection, the doctor will determine the individual dose based on tolerance of the last administered dose and clinical history.
In case of severe allergic adverse reactions during or after injection, the doctor may administer adrenaline as rescue medication. 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 product should continue for 2 weeks after vaccination with the last administered dose. Vaccinations that are immediately necessary (e.g. tetanus vaccination after injury) may be given at any time.
Children and adolescents
Treatment with Allergovit is generally not recommended in children under 5 years of age.
ALLERGOVIT and other medicines
Inform the doctor about all medicines currently or recently used or planned to be used by the patient.
No studies on drug interactions have been conducted.
Please keep in mind the following recommendations and discuss them with the doctor:

• Concomitant treatment with medicines used in allergy treatment (e.g. antihistamines, corticosteroids, mast cell stabilizers) or medicines that partially act similarly to antiallergic drugs (e.g. certain sedatives, antiemetics, antacids) may influence treatment with ALLERGOVIT. In such cases, higher doses of this medicinal product may be tolerated. If these medications are discontinued, a reduction in the dose of ALLERGOVIT may be necessary.
• Beta-blockers (medications used in the treatment of high blood pressure or heart disease, as well as eye drops for glaucoma treatment) may be taken concomitantly with ALLERGOVIT only after consultation with the doctor.
• ACE inhibitors (medications used in the treatment of high blood pressure) may be taken concomitantly with ALLERGOVIT only after consultation with the doctor.

During treatment with ALLERGOVIT, exposure to pollen causing allergy should be avoided as much as possible, especially on the day of administration. Other allergy-triggering factors that may provoke allergic reactions should also be avoided.
ALLERGOVIT with food, drink and alcohol
Alcohol should not be consumed on the day of injection.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult the doctor before using this medicinal product.
There are insufficient data on the use of Allergovit during pregnancy. Therefore, treatment with Allergovit is not recommended during pregnancy.
There are insufficient data on breastfeeding mothers. Although it is unlikely that a breastfed infant would be exposed to risk, the doctor will have to weigh the benefits and risks during breastfeeding.
There are insufficient data on the effect of Allergovit on fertility.
Driving and operating machinery
This medicinal product may affect the ability to drive and operate machinery due to possible fatigue.
ALLERGOVIT contains sodium
This medicinal product contains less than 1 mmol (23 mg) of sodium per 0.8 ml of maximum dose of concentration A, meaning it is essentially "sodium-free".

3. How to use ALLERGOVIT
Recommended dose
The doctor, trained or experienced in allergy treatment, will determine the most appropriate treatment regimen for the patient and inform about the intervals at which the patient will receive injections. The doctor will also specify the appropriate dose.
The individual dose depends, among other factors, on how well the patient tolerated the previous injection.
The maximum dose is 0.6 ml of concentration B. The individual maximum dose may be lower.
There are two different treatment phases: "initial treatment" and "maintenance treatment".

Initial treatment (dose escalation)
During initial treatment, the doctor will determine the maximum dose the patient can tolerate, gradually increasing the dose up to the recommended maximum dose of the medicinal product.
Adults
The doctor may choose one of three different dosing regimens:

1. Standard dose-escalation regimen with 7 injections
2. Accelerated dose-escalation regimen with 4 injections (only for ALLERGOVIT grass and cereal pollen allergens and tree pollen allergens)
3. Single-concentration dose-escalation regimen with 3 injections (only for ALLERGOVIT grass and cereal pollen allergens)

The standard dose-escalation regimen must be started before the pollen season and should be completed one week before the start of the pollen season. For ALLERGOVIT grass and cereal, initiating the induction treatment during the pollen season (year-round) is also possible in the first year of therapy.
The accelerated dose-escalation regimen must be started before the pollen season and should be completed one week before the start of the pollen season. The accelerated dose-escalation regimen may only be used for ALLERGOVIT grass and cereal and tree pollen allergens (see List of individual allergoids and allergoid mixtures).
The single-concentration dose-escalation regimen must be started before the pollen season and should be completed one week before the start of the pollen season. The single-concentration dose-escalation regimen may only be used for ALLERGOVIT grass and cereal (see List of individual allergoids and allergoid mixtures).
To achieve optimal treatment efficacy using the accelerated dose-escalation regimen and the single-concentration regimen, continuation of treatment before the pollen season with at least 2 maintenance dose injections is recommended. The patient will receive injections at regular intervals of 7 to 14 days until reaching their individual maximum dose or the recommended maximum dose of the medicinal product. If the interval between two injections is exceeded, the doctor may not be able to increase the dose according to plan. Therefore, it is important to always keep scheduled injection appointments and not interrupt initial treatment.

Children and adolescents
Treatment with Allergovit is generally not recommended in children under 5 years of age. For children aged 5 years and adolescents, the doctor may choose one of two regimens:

1. Standard dose-escalation regimen with 7 injections
2. Single-concentration dose-escalation regimen with 3 injections (only for ALLERGOVIT grass and cereal)

The single-concentration dose-escalation regimen may only be used for ALLERGOVIT grass and cereal pollen allergens. Induction treatment in children and adolescents should begin exclusively before the pollen season and be completed one week before the start of the pollen season. To achieve optimal treatment efficacy using the single-concentration dose-escalation regimen, continuation of treatment before the pollen season with at least 2 maintenance dose injections is recommended. The patient will receive injections at regular intervals of 7 to 14 days until reaching their individual maximum dose or the recommended maximum dose of the medicinal product. If the interval between two injections is exceeded, the doctor may not be able to increase the dose according to plan. Therefore, it is important to always keep scheduled injection appointments and not interrupt initial treatment.

Maintenance treatment
After the doctor has determined the individual maximum dose during initial treatment or after reaching the recommended maximum dose of the medicinal product, two treatment options are available:

• Treatment continues until approximately 1 week before the start of the plant pollen season. In the following year, treatment should be restarted, using the appropriate dose-escalation regimen before the pollen season.

• Treatment continues throughout the year. In children and adolescents during the plant pollen season, dose reduction is required for all preparations. In adults, dose reduction during the pollen season is required only for preparations containing weed pollen. After reaching the maximum dose, the intervals between subsequent injections are gradually extended so that eventually the patient receives injections every 4 to 8 weeks. If the intended 8-week interval is exceeded, the doctor must reduce the next dose. The dose is then increased again at shorter intervals. It is also important to always keep scheduled injection appointments and not interrupt maintenance treatment.

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

Method of administration
ALLERGOVIT is administered subcutaneously by a doctor. The injection is given into the outer aspect of the upper arm, approximately one hand's width (of the patient) above the elbow. The doctor should shake the medicinal product well before use. The patient must remain under medical supervision for at least 30 minutes after injection. The doctor will inquire about the patient's general condition. The observation period may be individually extended up to 2 hours. In case of adverse symptoms, even after the observation period, immediate contact with the doctor is required. The doctor may use two different allergen extracts for desensitization. If both preparations are to be injected on the same day, at least a 30-minute interval between injections should be maintained. However, it is recommended that injections be administered 2 to 3 days apart. Each time, the preparations should be injected separately into the right and left arms.

Duration of treatment
The duration of treatment is generally 3 years. The treatment outcome depends, among other factors, on the cumulative dose achieved during therapy.

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

Missed dose of ALLERGOVIT
Patients should 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 the doctor, who will advise on the appropriate course of action.

Stopping treatment with ALLERGOVIT
This should be discussed with the doctor beforehand. Premature discontinuation of treatment may result in reduced therapeutic effect. In case of any doubts regarding the use of this medicinal product, consult the doctor.

4. Possible adverse reactions

Like all medicines, ALLERGOVIT may cause adverse reactions, although not everyone experiences 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 noted that adverse reactions may also occur after this observation period. If any adverse symptoms occur, contact a doctor immediately.

Important adverse reactions and countermeasures
If intolerance symptoms occur during injection, the doctor 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 signs 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, itching, 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 readily available for immediate use when the patient is being treated with this medicine. If an allergic shock occurs, the patient must be medically monitored for 24 hours.
Delayed local reactions may also occur several hours after injection.

Adverse reactions for ALLERGOVIT Grass and Cereal:
Standard dose escalation regimen
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 (urticaria), warmth
Other common adverse reactions: headache

Uncommon (may affect up to 1 in 100 people):
At the injection site: discomfort, rash, skin lesions (erosion), bruising (haematoma), bleeding (haemorrhage), hypersensitivity, decreased sensitivity (hypoesthesia), induration, swelling (oedema), sensory disturbances (paraesthesia), granuloma
Other uncommon adverse reactions: anaphylactic reaction, dizziness, eyelid oedema, allergic conjunctivitis, eye itching, eye redness, eyelid swelling, gastrointestinal disturbances, lip oedema, nausea, oral cavity itching, malaise, pain, hand and/or leg swelling (peripheral oedema), fever, fatigue, rhinopharyngitis, rhinitis, increased blood pressure, impaired lung function (decreased FEV1), joint pain, shoulder and/or leg pain, migraine, somnolence, asthma, cough, dyspnoea, nasal congestion, pain in the mouth and throat area, runny nose, sneezing, throat irritation, respiratory sound (wheezing), neurodermatitis (atopic dermatitis), generalized redness, cutaneous granuloma, itching, rash, blisters (urticaria), bruising (haematoma), lymphatic oedema, orthostatic hypotension (drop in blood pressure upon rapid change in position)

Children and adolescents
The safety profile in children and adolescents is comparable to that in adults.
No additional risks are expected in these age groups.

Accelerated dose escalation regimen
Very common (may affect more than 1 in 10 people):
At the injection site: redness, swelling

Common (may affect up to 1 in 10 people):
At the injection site: discomfort, itching, blisters (urticaria), warmth
Other common adverse reactions: anaphylactic reaction, chest discomfort, impaired lung function, headache, dyspnoea, blisters (urticaria)

Children and adolescents
No data available for the accelerated dose escalation regimen (4 injections, concentration A and B).

Single-concentration dose escalation regimen
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 (haemorrhage), pain, blisters (urticaria), warmth
Other common adverse reactions: increased heart rate (tachycardia), eye itching, diarrhoea, malaise, oedema, (allergic) rhinitis, impaired lung function (decreased FEV1), shoulder and/or leg pain, headache, restlessness, asthma, shortness of breath, runny nose, sneezing, throat tightness, allergic dermatitis, rash, redness, blisters (urticaria)

Children and adolescents
The safety profile in children and adolescents is comparable to that in adults.
No additional risks are expected in these age groups.

Adverse reactions for tree pollen allergens ALLERGOVIT:
Standard dose escalation regimen
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 adverse reactions: rhinitis, conjunctivitis, headache, eye itching, sneezing, additional respiratory sound (wheezing), fatigue

Uncommon (may affect up to 1 in 100 people):
At the injection site: rash, bruising (haematoma), sensory disturbances (paraesthesiae), blisters (urticaria)
Other uncommon adverse reactions: anaphylactic reaction, hypersensitivity reaction, sleep disturbances, dizziness, sensory disturbances (paraesthesiae), eye irritation, eyelid oedema, palpitations, asthma, cough, increased upper respiratory tract secretion, nasal itching, throat irritation, oral cavity itching, tongue pain (glossodynia), rash, neurodermatitis, exacerbation of dermatitis, itching, discomfort

Children and adolescents
The safety profile in children and adolescents is comparable to that in adults.
No additional risks are expected in these age groups.

Accelerated dose escalation regimen
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 (paraesthesiae), discomfort, bruising (haematoma), decreased sensitivity (hypoesthesia), induration, rash, blisters (urticaria)
Other common adverse reactions: increased salivation, hypersensitivity, hand and/or leg pain, headache, allergic rhinitis, runny nose

Children and adolescents
No data available for the accelerated dose escalation regimen (4 injections, concentration A and B).

Post-marketing data
Adverse reactions for weed pollen allergens ALLERGOVIT:
Standard dose escalation regimen
(Frequency unknown: cannot be estimated based on available data)
At the injection site: swelling, bruising (haematoma), nodules, oedema (swelling), pain, reaction, blisters (urticaria), vesicles
Other adverse reactions: anaphylactic reaction, anaphylactic shock, (allergic) conjunctivitis, eyelid oedema, pupil dilation (mydriasis), increased appetite, weight gain, restlessness, dizziness, fainting (syncope), sensory disturbances (paraesthesiae), loss of consciousness, tremor, cyanosis (skin and lip blueness), palpitations, tachycardia, chest discomfort, drop in blood pressure, increased blood pressure, asthma, cough, shortness of breath, pseudocroup, allergic rhinitis, diarrhoea, vomiting, swallowing difficulties, skin and subcutaneous oedema (angioedema), facial swelling (facial oedema), sensation of warmth, cold sweats, rash, redness, itching, generalized skin eruption, blisters (urticaria), hand and/or foot swelling, oedema (swelling) of hands and/or feet, weakness, urinary bladder weakness

Children and adolescents
The safety profile in children and adolescents is comparable to that in adults.
No additional risks 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 or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 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 this medicine.

5. How to store ALLERGOVIT
Keep 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 stated month.
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 particles or flakes are visible.
Ask your pharmacist how to dispose of medicines no longer required. Doing so helps protect the environment.

6. Contents of the pack and other information

What ALLERGOVIT contains
ALLERGOVIT contains depot-form pollen allergoids. These are obtained through
physicochemical modification of the allergen. The composition of the medicinal product is individually selected according to
the patient's sensitization profile, as specified in the attached list. The names of individual allergoids and their
percentage content are indicated on the packaging.
Allergoid standardization is expressed in TU (therapeutic units).
Concentration A contains 1,000 TU/ml
Concentration B contains 10,000 TU/ml
Other ingredients are: aluminium 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 clearly recognizable turbidity upon shaking. Due to the natural
colouration of the source material of allergens and depending on concentration, the intensity of
colouration of 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 outer packaging containing 10 needles and 10 syringes. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Allergopharma GmbH & Co. KG
Hermann-Koerner-Str. 52
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
Tel. 22 350 66 69
Fax 22 350 77 03

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
allergy.
In the event of severe local or systemic reactions or anaphylaxis, the treating physician must have access to an anaphylactic shock kit and must have appropriate experience in managing anaphylactic reactions. In case of anaphylactic shock, patients must be monitored by a physician for 24 hours. National 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) must be prescribed and used exclusively by physicians, nurses, and medical personnel trained or experienced in allergy treatment.
When using accelerated dose-increase regimens or a single-concentration dose-increase regimen, more frequent adverse reactions may be expected during initial treatment compared to the standard regimen (see SmPC section 4.8).
Therapy using accelerated regimens or a single-concentration regimen should be conducted only by physicians, nurses, and medical personnel with special expertise in allergology.
On the day of injection, the patient must not have acute symptoms of illness (such as allergic symptoms, e.g. allergic rhinitis, conjunctivitis, colds) and particularly must not have asthmatic symptoms. In asthmatic patients, lung function should be assessed when indicated (e.g. by measuring peak expiratory flow).
Particular caution is recommended:

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

Prior to each injection, patients should be encouraged to inform the physician of any changes in health status, such as infectious diseases or pregnancy, and whether the previous dose was well tolerated.
Based on prior tolerance and medical history, the dose for each injection must be individually determined.
Since adrenaline is recommended for the treatment of severe allergic adverse 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 planned vaccination is required, a minimum interval of one week should be maintained between the last injection of ALLERGOVIT and the vaccination date.
Vaccinations should therefore be scheduled during the maintenance phase, between allergen vaccine injections given at 4-week intervals. Vaccinations for life-threatening indications (e.g. tetanus after injury) may be administered regardless of the phase of allergen immunotherapy. Desensitization resumes 2 weeks after vaccination using the last administered dose.
The medicinal product contains less than 1 mmol of sodium (23 mg) in 0.8 ml (concentration A), and is therefore considered "sodium-free".
Traceability
To improve traceability of biological medicinal products, the name and batch number of the administered product should be clearly documented.
Method of administration
Precautions to be taken before 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 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, observation time may be extended up to 2 hours. Adverse reactions may also occur after the observation period.
Patients must be instructed to contact the treating physician or medical staff if any adverse reactions occur, even after the observation period.
When conducting concomitant therapy with two allergen immunotherapy products on the same day, a minimum interval of 30 minutes between injections must be maintained. The second injection must not be administered unless the first injection was well tolerated without side effects. Concomitant therapy must be conducted only according to the standard dose-increase regimen (Table 2). A 2–3 day interval between injections is recommended to avoid cumulative effects. It is recommended that different allergen extracts always be injected separately into the right and left arms.
It is not necessary to reduce the first dose from a new package of the maintenance treatment set.
If the composition of the vaccine is changed, therapy must be restarted from the lowest dose. This also applies if prior desensitization was performed with another product (including oral or sublingual formulations).
Before use, the vial must be shaken vigorously to obtain a uniform suspension.
Instructions for preparation of the medicinal product prior to administration – see SmPC section 6.6.
Treatment outcome depends, among other factors, on the cumulative dose.
The recommended duration of treatment is generally 3 years.
Dosage
Dosage must be individually adjusted; dosage recommendations provided in the dosing schedules serve only as guidance. Dosage 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 be increased only if the previously administered dose was well tolerated. Otherwise, the last administered dose should be maintained or reduced.
The following approach may serve as a guide:

• severe local reaction: repeat the last well-tolerated dose or reduce the last dose by one level,
• mild to moderate generalized reaction: in case of mild generalized reaction, step back one dose in the schedule; in case of moderate generalized reaction, step back two doses or, if necessary, restart therapy from concentration A according to the standard dose-increase regimen (see Table 2),
• severe generalized reaction: restart therapy from the lowest dose of concentration A according to the standard dose-increase regimen (see Table 2).

The decision to continue therapy must be based on the course and severity of allergic reactions!
Treatment with the medicinal product ALLERGOVIT consists of two phases: initial treatment and maintenance treatment.
ADULTS
Initial treatment (dose escalation)
Initial treatment in adult patients may follow one of three dose-escalation regimens:

1. Standard dose-escalation regimen (7 injections), see Table 1
2. Accelerated dose-escalation regimen (4 injections), see Table 2 (only for grass/cereal and tree pollen allergens)
3. Single-concentration dose-escalation regimen (3 injections), see Table 3 (only for grass/cereal pollen allergens)

Table 1 Standard dose-escalation regimen (7 injections)
Dosing: Allergen dose:
Concentration
ml TU
0.1
0.2 200
A
(light blue striped label) 0.4 400
0.8 800
0.15 1500
B
0.3 3000
(dark blue label)
0.6 6000
Initial treatment according to the standard dose-escalation regimen should begin pre-seasonally.
Initial treatment with ALLERGOVIT containing grass and cereal pollen allergoids may also be initiated during the pollen season (regardless of time of year) in the first year of treatment.
Table 2 Accelerated dose-escalation regimen (4 injections)
Dosing: Allergen dose:
Concentration
ml TU
A 0.2 200
(light blue striped label)
0.6 600
B 0.2 2000
(dark blue label)
0.6 6000
Initial treatment according to the accelerated dose-escalation regimen should begin pre-seasonally. This regimen may be used only for ALLERGOVIT products containing grass/cereal or tree pollen allergens (see List of individual allergoids and allergoid mixtures).
Table 3 Single-concentration dose-escalation regimen (3 injections)
Dosing: Allergen dose:
Concentration
ml TU
0.1 1000
B
0.3 3000
(dark blue label)
0.6 6000
Initial treatment according to the single-concentration dose-escalation regimen should begin pre-seasonally. This regimen may be used only for ALLERGOVIT products containing grass/cereal pollen allergens (see List of individual allergoids and allergoid mixtures).
Pre-seasonal initial treatment should be completed one week before the start of the pollen season.
Dosing regimens presented in Table 3 and Table 4 should be used only by physicians, nurses, and medical personnel with special expertise in allergy treatment (see section 4.4).
To achieve optimal treatment efficacy when using the accelerated dose-escalation regimen or the single-concentration regimen, continuation of treatment before the pollen season with at least two maintenance doses is recommended.
During dose escalation, injections are administered at intervals of 7 to 14 days. If the recommended interval between doses is prolonged, treatment should continue according to the following regimen:
Table 4 Dose modification in case of prolonged interval between doses during initial treatment

Pre-seasonal treatment is initiated each year with the lowest dose of the appropriate dosing schedule.
The maximum dose is 0.6 ml of concentration B, and this must never be exceeded. The individual maximum dose for a given patient may be lower.

Maintenance treatment
Maintenance treatment may be administered year-round or pre-seasonally each year.
The first dose of maintenance treatment is administered 14 days after reaching the individual maximum dose (usually 0.6 ml of concentration B) during the initial treatment phase. Subsequently, the interval between injections is gradually extended to 4–8 weeks.

Pre-seasonal treatment is initiated each year with the lowest dose according to the applied dosing schedule and continued until one week before the expected start of the pollen season.

In year-round therapy, maintenance doses are administered throughout the year, including during the pollen season, at intervals of 4 to 8 weeks. Dose reduction during the pollen season is not necessary for grass and cereal pollen allergens as well as tree allergens.

For other allergens (weed pollen), dose reduction is required due to lack of safety data regarding maintenance treatment in adults without dose reduction. During the pollen season, the achieved maximum dose should be reduced by two dose steps according to the standard dosing schedule (Table 1), administered at 2-week intervals. Subsequently, the interval between injections may 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 reached again. The intervals between maintenance doses should then be gradually extended to 4–8 weeks.

If the interval between maintenance doses is prolonged, treatment should be continued according to the following scheme:

Table 5 Dose modification in case of prolonged intervals between injections during maintenance
treatment:

CHILDREN AND ADOLESCENTS
Initial treatment (dose escalation)
Children under 5 years of age are generally not suitable candidates for immunotherapy due to a higher likelihood of difficulties with cooperation and treatment adherence in this age group compared to adults.

The efficacy and safety of ALLERGOVIT Grass Mix 6 in children over 5 years of age and adolescents have been established in clinical trials.

Limited data are available for children over 5 years of age for ALLERGOVIT products containing tree and weed pollen allergens. These data are insufficient to confirm efficacy; however, safety data do not indicate a greater risk in terms of the occurrence and frequency of potential adverse reactions compared to adults.

Initial treatment in children over 5 years of age and adolescents can be conducted according to 2 regimens:

1. Standard dose escalation regimen (7 injections), see Table 1
2. Single-concentration dose escalation regimen (3 injections), see Table 3 (only for grass and cereal pollen allergens)

The single-concentration dose escalation regimen in children and adolescents may only be used for the ALLERGOVIT product containing grass and cereal pollen allergens. This single-concentration dose escalation regimen should only be administered by physicians, nurses, and medical personnel with extensive experience in allergy treatment (see SmPC section 4.4).

Initial treatment in children and adolescents must be initiated only pre-seasonally and should be completed one week before the start of the pollen season. To achieve optimal treatment efficacy using the single-concentration dose escalation regimen, continuation of treatment pre-seasonally with at least 2 maintenance dose injections is recommended.

During dose escalation, injections are administered at intervals of 7 to 14 days. If the recommended interval between doses is exceeded, treatment should be continued according to the regimen in Table 4.

Pre-seasonal therapy should be started each year from the lowest dose.

The maximum dose is 0.6 ml of concentration B, and this must never be exceeded. The individual maximum dose for a given patient may be lower.

Maintenance treatment
Maintenance treatment can be administered year-round or pre-seasonally each subsequent year.

The first maintenance dose is given 14 days after reaching the individual maximum dose (usually 0.6 ml of concentration B) during initial treatment. Subsequently, the interval between injections is gradually extended to 4–8 weeks.

Pre-seasonal treatment is initiated each year from the lowest dose according to the applied dosing regimen and continued until one week before the expected start of the pollen season.

In year-round therapy, dose reduction during the pollen season is required, as there are no 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 a 2-week interval; thereafter, the interval between injections may be gradually extended to 4–8 weeks.

After the pollen season, the reduced dose should be gradually increased again according to the appropriate dosing schedule at 2-week intervals until the maximum dose is re-established.

Intervals between maintenance doses should then be gradually extended to 4–8 weeks.

If the interval between maintenance doses is prolonged, treatment should be continued according to the regimen in Table 5.

Important patient information regarding dosing and administration is provided in section 3 "How to use ALLERGOVIT".

Dosing guidelines
Standard dose escalation regimen (7 injections) for ALLERGOVIT preparations for all age groups (children, adolescents, adults):
All instructions contained in the package leaflet must be strictly followed!
The individual maximum dose must not be exceeded!

Medicinal product:
Patient:
Initial treatment (including re-escalation in pre-seasonal therapy in subsequent years)

Dosing guidelines
Accelerated dose escalation schedule (4 injections) for grass and cereal pollen allergens
ALLERGOVIT and tree pollen allergens ALLERGOVIT (for use in adults only):
All instructions contained in the package leaflet must be strictly followed!
The individual maximum dose must not be exceeded!
Medicinal product:
Patient:
Initial treatment (including re-escalation of dose in pre-seasonal therapy in the following year)

Patient:
Maintenance treatment

Dosing guidelines
Single concentration dose escalation regimen (3 injections) for ALLERGOVIT grass and cereal vaccine for
all age groups (children, adolescents, adults):
All instructions contained in the package leaflet must be strictly followed!
The individual maximum dose must not be exceeded!
Medicinal product:
Patient:
Initial treatment (including re-escalation in preseasonal therapy in subsequent years)

Patient:
Maintenance treatment