10 ml contains:

Active ingredient: Allergen extract from birch pollen 10 IR/ml*, 300 IR/ml
Excipients: Sodium chloride 590 mg, glycerol 5800 mg, mannitol 200 mg, purified water up to 10 ml.

* IR/ml - Reactivity Index - biological unit of standardization.

Sublingual drops 10 IR/ml, 300 IR/ml.

10 ml of allergen containing 10 IR/ml and 300 IR/ml in glass bottles with a capacity of 14 ml, closed with rubber stoppers, rolled aluminum caps with plastic lids in blue (10 IR/ml) and violet (300 IR/ml).

The set consists of: 1 bottle with allergen 10 TS/ml, 2 bottles with allergen 300 TS/ml and three dispensers, or 2 bottles with allergen 300 TS/ml and two dispensers, or 5 bottles with allergen 300 TS/ml and five dispensers in a plastic box with instructions for use.

Description of the dosage form

Transparent solution from colorless to dark yellow.

pharmachologic effect

MIBP-allergen.

Instructions

Before using the drug, make sure that:

the expiration date has not expired;
a bottle of the required dosage is used.

The drug should be dripped directly under the tongue using a dispenser and kept in the sublingual area for 2 minutes, then swallowed.

To ensure the safety and integrity of the drug, the bottles are hermetically sealed with plastic caps and rolled with aluminum caps.

For first use, open the bottle as follows:

Tear off the colored plastic cap from the bottle.
Pull the metal ring to remove the aluminum cap completely.
Remove the rubber plug.
Remove the dispenser from the protective packaging. Place the bottle on a flat surface and, holding it firmly with one hand, snap the dispenser onto the bottle by pressing the top surface of the dispenser with the other hand.
Remove the purple protective ring.
Press the dispenser firmly 5 times over the sink. After five clicks, the dispenser dispenses the required amount of the drug.
Place the dispenser tip in your mouth under your tongue. Press the dispenser firmly as many times as prescribed by your doctor to obtain the required amount of the drug. Hold the drug under your tongue for 2 minutes.
After use, wipe the pipette tip and put on the protective ring. It is necessary to place the bottle with the dispenser in the refrigerator immediately after use.

For subsequent use, remove the protective ring and follow steps 7 and 8.

Indications for use Staloral birch pollen allergen

Allergen specific immunotherapy(ASIT) is indicated for patients with allergic reaction type 1 (IgE mediated), manifested in the form of rhinitis, conjunctivitis, rhinoconjunctivitis, mild or moderate form of bronchial asthma, with increased sensitivity to house dust mites (D. pteronyssinus, D. farinae).

Immunotherapy can be administered to adults and children from 5 years of age.

Contraindications for use Staloral birch pollen allergen

Increased sensitivity to any of excipients included in the composition of the drug;
Active forms of severe immunodeficiencies or autoimmune diseases;
Malignant neoplasms;
Uncontrollable or severe bronchial asthma(forced expiratory volume less than 70%);
Inflammatory diseases oral mucosa (erosive-ulcerative form of lichen planus, ulceration of the oral mucosa, mycoses of the oral mucosa);
Beta blocker therapy.

Staloral birch pollen allergen Use during pregnancy and children

Pregnancy

There are no clinical data on the use of the drug during pregnancy.

ASIT should not be started during pregnancy.

If pregnancy occurs during the first stage of treatment, therapy should be discontinued. If pregnancy occurs during maintenance therapy, the doctor should evaluate possible benefit ASIT, based on general condition patients.

No reports side effects when using ASIT in pregnant women.

Breast-feeding

There are no clinical data on the use of the drug during breastfeeding. Allocation data active substance With breast milk are missing. However, it is not recommended to start a course of ASIT during breastfeeding. The decision to continue a course of ASIT during breastfeeding should be made after assessing the risk-benefit ratio.

Staloral birch pollen allergen Side effects

Possible adverse reactions grouped by systems and organs and by frequency of occurrence: very often (≥1/10), often (≥1/100 to

Like any medicine STALORAL "Mite allergen" may cause adverse reactions in some patients.

During treatment, both local and general adverse reactions may occur. These reactions may occur at the beginning of therapy and later during treatment.

You should immediately stop taking the drug and consult a doctor if the following symptoms: severe allergic reactions with rapid development of symptoms such as severe itching or rash, difficulty breathing, abdominal pain, symptoms associated with falling blood pressure(dizziness, fainting).

Dose tolerance may vary depending on the patient's condition.

From the side of blood and lymphatic system: rarely - enlarged lymph nodes.

From the outside immune system: infrequently - hypersensitivity; rarely - serum sickness-type reactions.

From the outside nervous system: infrequently - paresthesia; rarely - headache.

From the side of the organ of vision: often - itching in the eyes; infrequently - conjunctivitis.

From the organ of hearing and labyrinthine disorders: often - itching of the ears.

From the outside respiratory system, organs chest and mediastinum: often - irritation in the throat, swelling of the pharynx, blisters in the oropharynx, rhinitis, cough; uncommon - exacerbation of asthma, dyspnea, dysphonia, nasopharyngitis.

From the outside gastrointestinal tract: often - swelling of the lips, swelling of the tongue, itching in the mouth, swelling oral cavity, oral paresthesia, oral discomfort, stomatitis, dysfunction salivary glands, nausea, vomiting, abdominal pain, diarrhea; uncommon - pain in the mouth, gastritis, esophageal spasm.

From the skin and subcutaneous tissue: often - itching, redness; infrequently - urticaria; rarely - eczema.

From the outside musculoskeletal system And connective tissue: rarely - joint pain, muscle pain.

General disorders and disorders at the injection site: rarely - asthenia, increased body temperature.

Post-registration experience with use: dry lips, changes in taste, oropharyngeal edema, laryngeal edema, angioedema, dizziness, anaphylactic shock, eosinophilic esophagitis.

If you experience any of the side effects indicated in the instructions or notice any other side effects not listed in the instructions, tell your doctor.

Drug interactions

Possible simultaneous use with drugs for symptomatic treatment allergies ( antihistamines and/or nasal corticosteroids).

Caution should be exercised when prescribing and administering specific immunotherapy to patients taking tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs), since the use of epinephrine to relieve possible allergic reactions in such patients can lead to life-threatening adverse reactions.

Vaccination can be carried out without interruption in treatment only after consultation with a doctor.

Dosage Staloral birch pollen allergen

The effectiveness of ASIT is higher in cases where treatment is started at early stages diseases.

The safety and effectiveness of treatment in children under 5 years of age have not been established.

Doses and treatment regimen

The dosage of the drug and the treatment regimen are the same for all ages, but can be changed depending on the individual reactivity of the patient.

The attending physician adjusts the dosage and treatment regimen in accordance with possible symptomatic changes in the patient and individual response to the drug. It is advisable to start treatment no later than 2-3 months before the expected flowering season, and continue throughout the entire flowering period.

Treatment consists of two stages: initial therapy (increasing the dose) and maintenance therapy (taking a maintenance dose).

1. Initial therapy begins with a daily dose of the drug at a dosage of 10 IR/ml (bottle with a blue cap) with one click on the dispenser and gradually increase the dose to 5 clicks. One press of the dispenser is about 0.2 ml of the drug.

Next, they proceed to daily administration of the drug at a dosage of 300 IR/ml (bottle with a purple cap), starting with one press and gradually increasing the number of presses to the optimal (well tolerated by the patient). The first stage lasts 9 days. During this period it is achieved maximum dose, individual for each patient (from 2 to 4 presses daily of the drug at a dosage of 300 IR/ml), after which they move on to the second stage.

Maintenance therapy with a constant dose using the drug at a dosage of 300 IR/ml.

The optimal dose achieved in the first stage of initial therapy continues to be taken in the second stage of maintenance therapy.

The recommended dosage regimen is 2 to 4 presses on the dispenser daily or 4 presses 3 times a week. Daily dosing is preferred as it is associated with better adherence to treatment than 3 times a week.

Duration of treatment

Taking a break from taking the drug

If you miss taking the drug for less than one week, it is recommended to continue treatment without changes.

If there is a gap in taking the drug for more than one week, it is recommended to carry out treatment again with one click on the dispenser, using a bottle with the same dosage of the drug (as before the break), and then increase the number of clicks, according to the scheme of the initial stage of therapy, to an optimal well-tolerated dose.

Overdose

If the prescribed dose is exceeded, the risk of side effects and their severity increases, which requires symptomatic treatment.

Catad_pgroup Immunomodulators

Staloral Birch pollen allergen - instructions for use

INSTRUCTIONS for use

Registration number:

LSR-108339/10-180810
Tradename: STALORAL "Birch pollen allergen"
Dosage form:
sublingual drops

COMPOUND
Active ingredient: Allergen extract from birch pollen 10 IR/ml*, 300 IR/ml
Excipients: sodium chloride, glycerol, mannitol, purified water

* IR/ml - Reactivity Index – biological unit of standardization.

DESCRIPTION Transparent solution from colorless to dark yellow.

ATX code V01AA05

PHARMACOTHERAPEUTIC GROUP Tree pollen allergens

IMMUNOBIOLOGICAL PROPERTIES
The exact mechanism of action of the allergen during allergen-specific immunotherapy (ASIT) has not been fully studied. The following biological changes have been proven:

the appearance of specific antibodies (IgG4), which play the role of “blocking antibodies”;
decrease in the level of specific IgE in plasma;
decreased reactivity of cells involved in an allergic reaction;
increased activity of interaction between Th2 and Th1, leading to a positive change in the production of cytokines (decreased IL-4 and increased β-interferon), regulating the production of IgE.

Carrying out ASIT also inhibits the development of both the early and late phases of the immediate allergic reaction.

INDICATIONS FOR USE
Allergen specific immunotherapy (ASIT) for patients with allergic reaction type 1 (IgE mediated), suffering from rhinitis, conjunctivitis, mild or moderate form of seasonal bronchial asthma, and hypersensitivity to birch pollen.
Immunotherapy can be administered to adults and children from 5 years of age.

CONTRAINDICATIONS

Hypersensitivity to one of the excipients (see list of excipients);
Autoimmune diseases, immune complex diseases, immunodeficiencies;
Malignant neoplasms;
Uncontrolled or severe asthma (forced expiratory volume< 70 %);
Beta blocker therapy (including local therapy in ophthalmology);
Severe inflammatory diseases of the oral mucosa, for example, erosive-ulcerative form of lichen planus, mycoses.

METHOD OF APPLICATION AND DOSAGE
The effectiveness of ASIT is higher in cases where treatment is started in the early stages of the disease.
Dosage and treatment regimen
The dosage of the drug and the scheme of its use are the same for all ages, but can be changed depending on the individual reactivity of the patient.
The attending physician adjusts the dosage and treatment regimen in accordance with possible symptomatic changes in the patient and individual response to the drug.
It is advisable to start treatment no later than 2-3 months before the expected flowering season and continue throughout the entire flowering period.
Treatment consists of two stages: initial and maintenance therapy.
1. Initial therapy begins with a daily dose of the drug at a concentration of 10 IR/ml (blue bottle cap) with one click on the dispenser and gradually increases the daily dosage to 10 clicks. One press of the dispenser is about 0.1 ml of the drug.
Next, they proceed to daily administration of the drug at a concentration of 300 IR/ml (purple bottle cap), starting with one press and gradually increasing the number of presses to the optimal (well tolerated by the patient). The first stage can last 9 - 21 days. During this period, the maximum dosage is reached, individual for each patient (from 4 to 8 presses daily of the drug with a concentration of 300 IR/ml), after which they proceed to the second stage.

2. Maintenance therapy with a constant dose using a vial of concentration 300 IR/ml.
The optimal dose achieved in the first stage of initial therapy continues to be taken in the second stage of maintenance therapy.
Recommended dosage regimen: from 4 to 8 presses on the dispenser daily or 8 presses 3 times a week.

Duration of treatment
Allergen specific immunotherapy is recommended to be carried out in the above two-stage courses (2-3 months before the expected flowering season until the end of the season) for 3-5 years.
If, after treatment, improvement does not occur during the first flowering season, the feasibility of ASIT should be reconsidered.

Mode of application
Before taking the drug, make sure that:

the expiration date has not expired;
a bottle of the required concentration is used.

It is recommended to take the drug in the morning before breakfast.
The drug should be dropped directly under the tongue and held for 2 minutes, then swallowed.
Children are recommended to use the drug with the help of adults.

To ensure the safety and integrity of the drug, the bottles are hermetically sealed with plastic caps and rolled with aluminum caps.

For first use, open the bottle as follows:
1/ Tear off the colored plastic cap from the bottle.

2/ Pull the metal ring to remove the aluminum cap completely.

3/ Remove the rubber plug.

4/ Remove the dispenser from the plastic packaging. Holding the bottle firmly with one hand, with the other hand, pressing firmly on the top flat surface of the dispenser, snap it onto the bottle.

5/ Remove the orange protective ring.

6/ Press the dispenser firmly 5 times over the sink. After five clicks, the dispenser dispenses the required amount of the drug.

7/ Place the dispenser tip in your mouth under your tongue. Press the dispenser firmly as many times as prescribed by your doctor to obtain the required amount of the drug. Hold the liquid under your tongue for 2 minutes.

8/ After use, wipe the pipette tip and put on the protective ring.

For subsequent use, remove the protective ring and follow steps 7 and 8.

Taking a break from taking the drug
If you skip taking the drug for a long time, you should consult your doctor.
If you miss taking the drug for less than one week, it is recommended to continue treatment without changes.
If the gap in taking the drug was more than one week at the initial stage or during maintenance therapy, it is recommended to carry out treatment again with one click on the dispenser, using the same concentration of the drug (as before the break), and then increase the number of clicks, according to the scheme of the initial stage of therapy to the optimal well-tolerated dose.

SIDE EFFECTS
Carrying out ASIT can cause adverse reactions, both local and general.
The dosage and treatment regimen may be revised by the attending physician in case of an individual reaction or changes in the general condition of the patient.

Local reactions:

oral: itching in the mouth, swelling, discomfort in the mouth and throat, disruption of the salivary glands (increased salivation or dry mouth);
gastroenterological reactions: abdominal pain, nausea, diarrhea.

Usually these symptoms go away quickly, and there is no need to change the dosage or treatment regimen. When frequent occurrence symptoms, the possibility of continuing therapy should be reconsidered.

General reactions rarely appear:

rhinitis, conjunctivitis, asthma, urticaria require symptomatic treatment with H1-antagonists, beta-2 mimetics or corticosteroids (orally). The physician should reconsider the dosage and treatment regimen or the possibility of continuing ASIT.
in extremely rare cases, generalized urticaria, angioedema, laryngeal edema, severe asthma, anaphylactic shock are possible, which requires the abolition of ASIT.

Rare side effects not related to Ig-E mediator reactions:

asthenia, headache;
exacerbation of preclinical atopic eczema;
delayed reactions of the serum sickness type with arthralgia, myalgia, urticaria, nausea, adenopathy, fever, which requires the abolition of ASIT.

All side effects should be reported to your doctor.

OVERDOSE
If the prescribed dose is exceeded, the risk of side effects increases, which requires symptomatic treatment.

DRUG INTERACTIONS
Do not use simultaneously with beta-blockers.
Available simultaneous administration with symptomatic antiallergic drugs (H1-antihistamines, beta-2 mimetics, corticoids, degranulation inhibitors mast cells) for better tolerability of ASIT.

PREGNANCY AND BREASTFEEDING
Pregnancy
ASIT should not be started during pregnancy.
If pregnancy occurs during the first stage of treatment, therapy should be discontinued. If pregnancy occurs during the period of maintenance therapy, the doctor should assess the possible benefits of ASIT based on the general condition of the patient.
No side effects have been reported with the use of ASIT in pregnant women.
Breast-feeding
It is not recommended to start a course of ASIT during breastfeeding.
If a woman continues to perform ASIT during lactation, no adverse symptoms or reactions in children are expected.
There are no clinical data on the use of the drug during lactation.

WARNINGS AND PRECAUTIONS
If necessary, before starting ASIT, allergy symptoms should be stabilized with appropriate therapy.
Patients undergoing ASIT should always carry medications to relieve allergy symptoms, such as corticosteroids, sympathomimetic drugs and antihistamines.
You should consult a doctor immediately if you experience severe itching palms, arms, soles of the feet, urticaria, swelling of the lips, larynx, accompanied by difficulty swallowing, breathing, change in voice. In these cases, your doctor may recommend taking epinephrine. In patients taking tricyclic antidepressants, monoamine oxidase inhibitors, the risk of side effects of epinephrine increases, including death. This circumstance should be taken into account when prescribing ASIT.
At inflammatory processes in the oral cavity (mycoses, aphthae, gum damage, tooth extraction/loss or surgical intervention) therapy should be interrupted until inflammation is completely cured (at least for 7 days).
During the ASIT course, vaccination may be carried out after consultation with a doctor.
For patients, especially children, on a diet with reduced salt intake, it should be taken into account that the drug contains sodium chloride (one press of the dispenser is about 0.1 ml of the drug containing 5.9 mg of sodium chloride).
When traveling, make sure that the bottle is in an upright position. The bottle should be in a box with a protective ring on the dispenser. The bottle should be placed in the refrigerator as soon as possible.

RELEASE FORM
10 ml of allergen containing 10 IR/ml and 300 IR/ml in glass bottles with a capacity of 14 ml closed with rubber stoppers, rolled aluminum caps with plastic lids in blue (10 IR/ml) and violet (300 IR/ml).
The kit consists of: 1 bottle with allergen 10 IR/ml, 2 bottles with allergen 300 IR/ml and three dispensers or 2 bottles with allergen 300 IR/ml and two dispensers in a plastic box with instructions for use.

STORAGE AND TRANSPORTATION CONDITIONS
Store and transport at temperatures from 2 to 8 °C.
Keep out of the reach of children.

BEST BEFORE DATE 36 months. Do not use after expiration date.

CONDITIONS OF VACATION FROM PHARMACIES On prescription.

All claims regarding the quality of the drug should be sent to:
FGUN GISK named after L.A. Tarasevich Rospotrebnadzor
119002, Moscow, Sivtsev Vrazhek lane, 41
and to the manufacturer.

Active substance

Birch pollen allergen

Dosage form

drops for oral administration

Manufacturer

Stallergen, France

Compound

sublingual drops

Active ingredient: Allergen extract from birch pollen 10 IR/ml*, 300 IR/ml
Excipients: sodium chloride, glycerol, mannitol, purified water

* IR/ml - Reactivity Index – biological unit of standardization.

pharmachologic effect

The exact mechanism of action of the allergen during allergen-specific immunotherapy (ASIT) has not been fully studied. The following biological changes have been proven:

the appearance of specific antibodies (IgG4), which play the role of “blocking antibodies”;
decrease in the level of specific IgE in plasma;
decreased reactivity of cells involved in an allergic reaction;
increased activity of interaction between Th2 and Th1, leading to a positive change in the production of cytokines (decreased IL-4 and increased β-interferon), regulating the production of IgE.

Carrying out ASIT also inhibits the development of both the early and late phases of the immediate allergic reaction.

Indications

Allergen specific immunotherapy (ASIT) for patients with allergic reaction type 1 (IgE mediated), suffering from rhinitis, conjunctivitis, mild or moderate form of seasonal bronchial asthma, and hypersensitivity to birch pollen.
Immunotherapy can be administered to adults and children from 5 years of age.

Contraindications

Hypersensitivity to one of the excipients (see list of excipients);
Autoimmune diseases, immune complex diseases, immunodeficiencies;
Malignant neoplasms;
Uncontrolled or severe asthma (forced expiratory volume
Therapy with beta-blockers (including local therapy in ophthalmology);
Severe inflammatory diseases of the oral mucosa, for example, erosive-ulcerative form of lichen planus, mycoses.

Side effects

Carrying out ASIT can cause adverse reactions, both local and general.
The dosage and treatment regimen may be revised by the attending physician in case of an individual reaction or changes in the general condition of the patient.

Local reactions:

oral: itching in the mouth, swelling, discomfort in the mouth and throat, disruption of the salivary glands (increased salivation or dry mouth);
gastroenterological reactions: abdominal pain, nausea, diarrhea.

Usually these symptoms go away quickly, and there is no need to change the dosage or treatment regimen. If symptoms occur frequently, the possibility of continuing therapy should be reconsidered.

General reactions are rare:

rhinitis, conjunctivitis, asthma, urticaria require symptomatic treatment with H1-antagonists, beta-2 mimetics or corticosteroids (orally). The physician should reconsider the dosage and treatment regimen or the possibility of continuing ASIT.
in extremely rare cases, generalized urticaria, angioedema, laryngeal edema, severe asthma, anaphylactic shock are possible, which requires the abolition of ASIT.

Rare side effects not related to Ig-E mediator reactions:

asthenia, headache;
exacerbation of preclinical atopic eczema;
delayed reactions of the serum sickness type with arthralgia, myalgia, urticaria, nausea, adenopathy, fever, which requires the abolition of ASIT.

All side effects should be reported to your doctor.

Interaction

Do not use simultaneously with beta-blockers.
Possible simultaneous use with symptomatic antiallergic drugs (H1-antihistamines, beta-2 mimetics, corticoids, mast cell degranulation inhibitors) for better tolerability of ASIT.

How to take, course of administration and dosage

The effectiveness of ASIT is higher in cases where treatment is started in the early stages of the disease.
Dosage and treatment regimen
The dosage of the drug and the scheme of its use are the same for all ages, but can be changed depending on the individual reactivity of the patient.
The attending physician adjusts the dosage and treatment regimen in accordance with possible symptomatic changes in the patient and individual response to the drug.
It is advisable to start treatment no later than 2-3 months before the expected flowering season and continue throughout the entire flowering period.
Treatment consists of two stages: initial and maintenance therapy.
1. Initial therapy begins with a daily dose of the drug at a concentration of 10 IR/ml (blue bottle cap) with one click on the dispenser and gradually increases the daily dosage to 10 clicks. One press of the dispenser is about 0.1 ml of the drug.
Next, they proceed to daily administration of the drug at a concentration of 300 IR/ml (purple bottle cap), starting with one press and gradually increasing the number of presses to the optimal (well tolerated by the patient). The first stage can last 9 - 21 days. During this period, the maximum dosage is reached, individual for each patient (from 4 to 8 presses daily of the drug with a concentration of 300 IR/ml), after which they proceed to the second stage.

Duration of treatment
Allergen specific immunotherapy is recommended to be carried out in the above two-stage courses (2-3 months before the expected flowering season until the end of the season) for 3-5 years.
If, after treatment, improvement does not occur during the first flowering season, the feasibility of ASIT should be reconsidered.

Mode of application
Before taking the drug, make sure that:

the expiration date has not expired;
a bottle of the required concentration is used.

To ensure the safety and integrity of the drug, the bottles are hermetically sealed with plastic caps and rolled with aluminum caps.

For first use, open the bottle as follows:
1/ Tear off the colored plastic cap from the bottle.

2/ Pull the metal ring to remove the aluminum cap completely.

3/ Remove the rubber plug.

4/ Remove the dispenser from the plastic packaging. Holding the bottle firmly with one hand, with the other hand, pressing firmly on the top flat surface of the dispenser, snap it onto the bottle.

5/ Remove the orange protective ring.

6/ Press the dispenser firmly 5 times over the sink. After five clicks, the dispenser dispenses the required amount of the drug.

8/ After use, wipe the pipette tip and put on the protective ring.

For subsequent use, remove the protective ring and follow steps 7 and 8.

Taking a break from taking the drug
If you skip taking the drug for a long time, you should consult your doctor.
If you miss taking the drug for less than one week, it is recommended to continue treatment without changes.
If the gap in taking the drug was more than one week at the initial stage or during maintenance therapy, it is recommended to carry out treatment again with one click on the dispenser, using the same concentration of the drug (as before the break), and then increase the number of clicks, according to the scheme of the initial stage of therapy to the optimal well-tolerated dose.

Overdose

If the prescribed dose is exceeded, the risk of side effects increases, which requires symptomatic treatment. Staloral Birch allergen, maintenance course, 10 ml bottle 5 pcs. . Constant use Staloral Birch allergen, maintenance course, 10 ml bottle 5 pcs..

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Active ingredient: Allergen extract from birch pollen 10 IR/ml, 300 IR/ml.

Excipients: sodium chloride, glycerol, mannitol, purified water.

Release form

10 ml of allergen containing 10 IR/ml and 300 IR/ml in glass bottles with a capacity of 14 ml closed with rubber stoppers, rolled aluminum caps with plastic lids in blue (10 IR/ml) and violet (300 IR/ml).

The kit consists of: 1 bottle with allergen 10 IR/ml, 2 bottles with allergen 300 IR/ml and three dispensers or 2 bottles with allergen 300 IR/ml and two dispensers in a plastic box with instructions for use.

pharmachologic effect

The exact mechanism of action of the allergen during allergen-specific immunotherapy (ASIT) has not been fully studied. The following biological changes have been proven:

the appearance of specific antibodies (IgG4), which play the role of “blocking antibodies”;
decrease in the level of specific IgE in plasma;
decreased reactivity of cells involved in an allergic reaction;
increased activity of interaction between Th2 and Th1, leading to a positive change in the production of cytokines (decreased IL-4 and increased β-interferon), regulating the production of IgE.

Carrying out ASIT also inhibits the development of both the early and late phases of the immediate allergic reaction.

Indications for use

Immunotherapy can be administered to adults and children from 5 years of age.

Directions for use and doses

The effectiveness of ASIT is higher in cases where treatment is started in the early stages of the disease.

The dosage of the drug and the scheme of its use are the same for all ages, but can be changed depending on the individual reactivity of the patient.

The attending physician adjusts the dosage and treatment regimen in accordance with possible symptomatic changes in the patient and individual response to the drug.

It is advisable to start treatment no later than 2-3 months before the expected flowering season and continue throughout the entire flowering period.

Treatment consists of two stages: initial and maintenance therapy.

1. Initial therapy begins with a daily dose of the drug at a concentration of 10 IR/ml (blue bottle cap) with one click on the dispenser and gradually increases the daily dosage to 10 clicks. One press of the dispenser is about 0.1 ml of the drug.

Next, they proceed to daily administration of the drug at a concentration of 300 IR/ml (purple bottle cap), starting with one press and gradually increasing the number of presses to the optimal (well tolerated by the patient). The first stage can last 9 - 21 days. During this period, the maximum dosage is reached, individual for each patient (from 4 to 8 presses daily of the drug with a concentration of 300 IR/ml), after which they proceed to the second stage.

2. Maintenance therapy with a constant dose using a vial of concentration 300 IR/ml.

The optimal dose achieved in the first stage of initial therapy continues to be taken in the second stage of maintenance therapy.

Duration of treatment

If, after treatment, improvement does not occur during the first flowering season, the feasibility of ASIT should be reconsidered.

Taking the drug:

Before taking the drug, make sure that: the expiration date has not expired and the bottle of the required concentration is used.

The drug should be dropped directly under the tongue and held for 2 minutes, then swallowed.

To ensure the safety and integrity of the drug, the bottles are hermetically sealed with plastic caps and rolled with aluminum caps.

For first use, open the bottle as follows:

Tear off the colored plastic cap from the bottle.
Pull the metal ring to remove the aluminum cap completely.
Remove the rubber plug.
Remove the dispenser from the plastic packaging. Holding the bottle firmly with one hand, with the other hand, pressing firmly on the top flat surface of the dispenser, snap it onto the bottle.
Remove the orange protective ring.
Press the dispenser firmly 5 times over the sink. After five clicks, the dispenser dispenses the required amount of the drug.
Place the dispenser tip in your mouth under your tongue. Press the dispenser firmly as many times as prescribed by your doctor to obtain the required amount of the drug. Hold the liquid under your tongue for 2 minutes.
After use, wipe the pipette tip and put on the protective ring.

For subsequent use, remove the protective ring and follow steps 7 and 8.

Taking a break from taking the drug

If you skip taking the drug for a long time, you should consult your doctor.

If you miss taking the drug for less than one week, it is recommended to continue treatment without changes.

If the gap in taking the drug was more than one week at the initial stage or during maintenance therapy, it is recommended to carry out treatment again with one click on the dispenser, using the same concentration of the drug (as before the break), and then increase the number of clicks, according to the scheme of the initial stage of therapy to the optimal well-tolerated dose.

Contraindications

Hypersensitivity to one of the excipients (see list of excipients);
Autoimmune diseases, immune complex diseases, immunodeficiencies;
Malignant neoplasms;
Uncontrolled or severe asthma (forced expiratory volume< 70 %);
Therapy with beta-blockers (including local therapy in ophthalmology);
Severe inflammatory diseases of the oral mucosa, for example, erosive-ulcerative form of lichen planus, mycoses.

special instructions

ASIT should not be started during pregnancy.

If pregnancy occurs during the first stage of treatment, therapy should be discontinued. If pregnancy occurs during the period of maintenance therapy, the doctor should assess the possible benefits of ASIT based on the general condition of the patient.

No side effects have been reported with the use of ASIT in pregnant women.

If a woman continues to perform ASIT during lactation, no adverse symptoms or reactions in children are expected.

There are no clinical data on the use of the drug during lactation.

Storage conditions

Store and transport at temperatures from 2 to 8°C. Keep out of the reach of children.

Dosage form: Sublingual drops. Compound: 10 ml contains:

Active ingredient:

Allergen extract from birch pollen 10 IR/ml*, 300 IR/ml Excipients:

sodium chloride 590 mg, glycerol 5800 mg, mannitol 200 mg, purified water up to 10 ml.

* IR/ml - Reactivity Index - biological unit of standardization.

Description: Transparent solution from colorless to dark yellow. Pharmacotherapeutic group: MIBP-allergen. Pharmacodynamics:The exact mechanism of action of the allergen during allergen-specific immunotherapy (ASIT) has not been fully studied.

ASIT leads to a change in the immune response of T lymphocytes with a subsequent increase in the level of specific antibodies (IgG 4 and/or IgG 1 and, in some cases, IgA) and a decrease in the level of specific IgE. A secondary and possibly later immune response is immune deviation with a change in the immune response of specific T cells.

Indications: Allergen-specific immunotherapy (ASIT) is indicated for patients with allergic reaction type 1 (IgE mediated), manifested in the form of rhinitis, conjunctivitis, rhinoconjunctivitis, mild or moderate form of seasonal bronchial asthma, and with increased sensitivity to birch pollen.

Immunotherapy can be administered to adults and children from 5 years of age.

Contraindications:- Hypersensitivity to any of the excipients included in the drug;

Active forms of severe immunodeficiencies or autoimmune diseases;

Malignant neoplasms;

Uncontrolled or severe bronchial asthma (forced expiratory volume less than 70%);

Inflammatory diseases of the oral mucosa (erosive-ulcerative form of lichen planus, ulceration of the oral mucosa, mycoses of the oral mucosa);

Beta blocker therapy.

Pregnancy and lactation:Pregnancy

There are no clinical data on the use of the drug during pregnancy.

ASIT should not be started during pregnancy.

No side effects have been reported with the use of ASIT in pregnant women.

Breast-feeding

There are no clinical data on the use of the drug during breastfeeding. There is no data on the release of the active substance into breast milk. However, it is not recommended to start a course of ASIT during breastfeeding. The decision to continue a course of ASIT during breastfeeding should be made after assessing the risk-benefit ratio.

Directions for use and dosage:The effectiveness of ASIT is higher in cases where treatment is started in the early stages of the disease.

The safety and effectiveness of treatment in children under 5 years of age have not been established.

Doses and treatment regimen

The dosage of the drug and the treatment regimen are the same for all ages, but can be changed depending on the individual reactivity of the patient.

Treatment consists of two stages: initial therapy (increasing the dose) and maintenance therapy (taking a maintenance dose).

Next, they proceed to daily administration of the drug at a dosage of 300 IR/ml (bottle with a purple cap), starting with one press and gradually increasing the number of presses to the optimal (well tolerated by the patient). The first stage lasts 9 days. During this period, the maximum dose is reached, individual for each patient (from 2 to 4 presses daily of the drug at a dosage of 300 IR/ml), after which they proceed to the second stage.

Day	Dosage of the drug	Number of presses on the dispenser	Dose, IR
	10 IR/ml (bottle with blue cap)




	300 IR/ml (bottle with purple cap)
			120
			180
			240

2. Maintenance therapy with a constant dose using the drug at a dosage of 300 IR/ml.

The optimal dose achieved in the first stage of initial therapy continues to be taken in the second stage of maintenance therapy.

Duration of treatment

Mode of application

Before using the drug, make sure that:

The expiration date has not expired;

A bottle of the required dosage is used.

The drug should be dripped directly under the tongue using a dispenser and kept in the sublingual area for 2 minutes, then swallowed.

To ensure the safety and integrity of the drug, the bottles are hermetically sealed with plastic caps and rolled with aluminum caps.

For first use, open the bottle as follows:

1) Tear off the colored plastic cap from the bottle.

2) Pull the metal ring to remove the aluminum cap completely.

3) Remove the rubber plug.

4) Remove the dispenser from the protective packaging. Place the bottle on a flat surface and, holding it firmly with one hand, snap the dispenser onto the bottle by pressing the top surface of the dispenser with the other hand.

5) Remove the purple protective ring.

6) Press the dispenser firmly 5 times over the sink. After five clicks, the dispenser dispenses the required amount of the drug.

7) Place the dispenser tip in your mouth under your tongue. Press the dispenser firmly as many times as prescribed by your doctor to obtain the required amount of the drug. Hold the drug under your tongue for 2 minutes.

8) After use, wipe the dispenser tip and put on the protective ring. It is necessary to place the bottle with the dispenser in the refrigerator immediately after use.

For subsequent use, remove the protective ring and follow steps 7 and 8.

Taking a break from taking the drug

If you miss taking the drug for less than one week, it is recommended to continue treatment without changes.

Side effects:Possible adverse reactions are grouped by system and organ and by frequency of occurrence: very often (≥1/10), often (≥1/100 to<1/10), нечасто (≥1/1000 до <1/100), редко (≥1/10000 до <1/1000), очень редко (<1 /10000).

Like any medicine, STALORAL "Birch pollen allergen" can cause adverse reactions in some patients.

During treatment, both local and general adverse reactions may occur. These reactions may occur at the beginning of therapy and later during treatment.

You should immediately stop taking the drug and consult a doctor if the following symptoms appear: severe allergic reactions with rapid development of symptoms such as severe itching or rash, difficulty breathing, abdominal pain, symptoms associated with a drop in blood pressure (dizziness, fainting).

Dose tolerance may vary depending on the patient's condition.

If adverse reactions occur, you should consult a doctor to review therapy. It is possible to carry out preliminary treatment with antiallergic drugs that reduce the frequency and severity of adverse reactions. From the blood and lymphatic system: rarely - enlarged lymph nodes. From the immune system: uncommon - hypersensitivity; rarely - serum sickness-type reactions.

From the nervous system: infrequently - paresthesia; rarely - headache.

From the side of the organ of vision: often - itching in the eyes; infrequently - conjunctivitis.

Hearing and labyrinth disorders: often - itching of the ears.

From the respiratory system, chest and mediastinal organs: often - irritation in the throat, swelling of the pharynx, blisters in the oropharynx, rhinitis, cough; uncommon - exacerbation of asthma, dyspnea, dysphonia, nasopharyngitis.

From the gastrointestinal tract: often - swelling of the lips, swelling of the tongue, itching in the mouth, swelling of the oral cavity, paresthesia of the oral cavity, discomfort in the mouth, stomatitis, disruption of the salivary glands, nausea, vomiting, abdominal pain, diarrhea; uncommon - pain in the mouth, gastritis, esophageal spasm.

From the skin and subcutaneous tissue: often - itching, redness; uncommon - urticaria; rarely - eczema.

From the musculoskeletal system and connective tissue: rarely - joint pain, muscle pain.

General disorders and disorders at the injection site: rarely - asthenia, increased body temperature.

Post-registration experience: dry lips, changes in taste, oropharyngeal edema, laryngeal edema, angioedema, dizziness, anaphylactic shock, eosinophilic esophagitis.

If you experience any of the side effects indicated in the instructions or notice any other side effects not listed in the instructions, tell your doctor.

Overdose: If the prescribed dose is exceeded, the risk of side effects and their severity increases, which requires symptomatic treatment. Interaction: Possible simultaneous use with drugs for the symptomatic treatment of allergies (antihistamines and/or nasal corticosteroids).

Vaccination can be carried out without interruption in treatment only after consultation with a doctor.

Special instructions:Patients should inform the doctor of any concomitant diseases or if the current allergic disease worsens.

If necessary, before starting AS IT, allergy symptoms should be stabilized with appropriate therapy. Treatment should be delayed if severe clinical symptoms of an allergic disease are present at the time of initial drug therapy.

If allergic symptoms occur, it is necessary to use drugs such as glucocorticosteroids, antihistamines and β2-agonists.

ASIT should be prescribed with caution to patients taking tricyclic antidepressants and MAO inhibitors.

In case of inflammatory processes in the oral cavity (mycoses, aphthae, damage to the oral mucosa, tooth loss or surgical operations in the oral cavity, including tooth extraction), drug therapy should be interrupted until complete recovery. Cases of eosinophilic esophagitis associated with sublingual immunotherapy have been reported. If, during treatment with STALORAL "Birch Pollen Allergen", severe or persistent symptoms from the upper digestive system occur, including difficulty swallowing or chest pain, therapy with STALORAL "Birch Pollen Allergen" should be interrupted and consult a doctor. Treatment can be resumed only after consulting a doctor.

1 bottle of the drug contains 590 mg of sodium chloride (in 10 ml of the drug). This should be taken into account in patients on a low-salt diet, especially in children.

When traveling, make sure that the bottle is in an upright position. The bottle should be in a box with a protective ring on the dispenser.

Impact on the ability to drive vehicles. Wed and fur.:The drug does not affect the ability to drive vehicles and machinery. Release form/dosage:Sublingual drops 10 IR/ml, 300 IR/ml. Package: 10 ml of allergen containing 10 IR/ml and 300 IR/ml in glass bottles with a capacity of 14 ml, closed with rubber stoppers, rolled aluminum caps with plastic lids in blue (10 IR/ml) and violet (300 IR/ml).

Storage conditions:Store at a temperature of 2 to 8 °C.

Keep out of the reach of children.

Best before date: 36 months.

Do not use after the expiration date.

Conditions for dispensing from pharmacies: On prescription Registration number: LSR-008339/10 Registration date: 18.08.2010 / 04.10.2016 Expiration date: Indefinite Owner of the Registration Certificate: Stallerzhen, JSC