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ASIT (allergen specific immunotherapy), today, is the only way to relieve a person of allergic symptoms for a long time. Using this method, you can reduce the body's sensitivity to many antigens. In the article we will analyze in detail how the drug Staloral is used in the treatment of allergies to birch pollen and dust mites.

What is ASIT?

Allergen specific therapy involves sensitizing the body to a substance that causes an increased reaction of the immune system.

Treatment is carried out as follows: a solution of the allergen, in a small concentration, is introduced into the patient’s body by injection or sublingual (sublingual) method for several years.

Thus, at the end of therapy, the person stops responding to the antigen. Consequently, the need for taking antiallergic drugs is reduced and the risk of progression of the disease to more severe forms is minimized.

As a rule, this therapy is carried out to relieve a person from the respiratory symptoms of hay fever: frequent sneezing, lacrimation, nasal congestion, bronchial asthma, etc.

Staloral: description of the drug

Staloral from Stallergenes are sublingual drops for ASIT made in France. According to the manufacturer, Staloral drops are a leader in the field of immunotherapy: they effectively relieve children and adults from seasonal allergies and other allergic conditions that are difficult to treat with medication.

Staloral from the biopharmaceutical company Stallergen, manufactured in France.

Since 2018, Staloral has been produced with a new dosing system. The dispenser now has a purple protective ring instead of an orange one. Therefore, before using the drop, you must carefully examine the bottle and study the instructions for use.

At the moment, Stallergen produces 2 types of the drug:

1. Staloral “Allergen of mites”;
2. Staloral “Birch pollen allergen”.

The drug is released in 10 ml glass bottles with a blue and purple cap. The set also includes dispensers for each bottle.

The blue cap is on the bottle, which has a concentration of the active substance of 10 TS/ml. While the substance content of the vial with a purple cap is 300 IR/ml. IR is an indicator that implies the concept of Reactivity Index.

Treatment is carried out in stages and is determined by an allergist. As a rule, the patient is prescribed:

• initial course, which involves gradually increasing the dosage until the optimal value is reached;
• maintenance course, which is the use of drops in the same dose.

It is worth knowing that ASIT is prescribed to children over 5 years of age. Carrying out the procedure at an earlier age is impossible, since the child, due to an immature immune system, may develop acute allergic reactions to the drug.

Release forms and storage rules

Staloral is sold only with a prescription from an allergist. Therefore, in order to cure allergies, it is necessary to consult a doctor, who, only after conducting a series of studies, will determine the dosage of the drug (number of presses).

When undergoing therapy, it is necessary to adhere to the storage conditions of the drug. The recommended storage temperature should be no more than 8 degrees Celsius. However, the manufacturer allows the bottle to be left at room temperature for several hours. An opened bottle can be stored for no more than 3 months. Otherwise, the effectiveness of the solution may be significantly reduced.

Staloral “Birch pollen allergen”: initial course

This set includes:

• 1 bottle with a blue cap;
• 2 bottles with a purple cap;
• 3 dispensers.

Staloral “Birch pollen allergen”: maintenance course

Set contains:

• 2 purple bottles;
• 2 dispensers.

Staloral "Mite allergen": initial course

The initial therapy kit contains:

• 1 blue bottle 10 IR/ml;
• 2 purple bottles Z00 IR/ml;
• 3 dispensers.

Staloral "Mite allergen": maintenance course

For maintenance therapy, a kit is required, including:

• 2 purple bottles of 300 IR/ml;
• 2 dispensers.

Staloral "Mite allergen"

On the packaging you can find the second name of the drug – “Household allergens”.

The main active ingredient is a solution of the allergen from Dermatophagoides pteronуssinus and Dermatophagoides farinae mites.

Instructions for use

Before using the drug, you must pay attention to the integrity of the packaging and expiration date. Only after making sure that everything is within normal limits should you begin treatment.

Procedure for using Staloral solution for the first time:

1. Remove the colored cap and metal cap from the bottle;
2. Remove the rubber plug;
3. Secure the dispenser: a characteristic click indicates its correct installation;
4. Remove the orange (purple) protective ring and, using five clicks, fill the dispenser with the drug;
5. Then, the required amount of the drug must be dropped under the tongue and wait for its absorption for 2 minutes. Staloral drops should be used daily, at the same time.
6. After use, the dispenser must be rinsed with warm water and the protective ring must be returned to its place.

Instructions for using Staloral.

Regimen for taking allergens Staloral

The dosage of the drug (number of presses) should be established by an allergist, since their values ​​may change depending on the body’s reaction, during pregnancy, etc.

How to take Staloral should be decided by the doctor, since the regimen can be prescribed on an individual basis, taking into account the characteristics of the patient’s body.

Then, upon reaching a dose of 8 presses from the purple bottle (that is, on the 12th day of treatment), the second stage of maintenance therapy begins.

On average, treatment with Staloral allergens for house dust mites takes 3 years, after which a significant improvement in the patient’s condition is observed.

Continuation of treatment in case of interruption

Due to various life circumstances, a person may intentionally or accidentally skip taking the drug. Below we will look at what to do when you stop taking allergens for a period of several days or more.

• If the patient missed taking the drug for less than 1 week, then the dose can be resumed with the same dosage at which the pause was made.
• If the break lasted from 7 to 30 days, treatment begins with one press of the dispenser on the required bottle (10 or 300 TS/ml), and then, gradually, reaches the maximum allowable rate specified by the doctor.
• If you take a longer break from treatment, you should consult an allergist.

Staloral "Birch pollen allergen"

In the spring, many people begin to experience serious malaise associated with birch flowering. Therefore, in order to alleviate this painful condition, allergists suggest taking an effective course of allergy treatment with the drug Staloral.

The birch pollen allergen has cross-reactivity with antigens of other trees of this family: alder, hazel, etc. Therefore, a solution of birch allergen is often used in medical practice to treat hay fever caused by the flowering of these trees.

ASIT therapy is an effective method of getting rid of seasonal allergies. However, it is worth starting treatment several months before the birch or other trees begin to bloom.

It is not recommended to treat hay fever with drops under the tongue in the spring, as the load on the body increases significantly and the risk of acute allergic reactions increases.

Instructions for use Staloral “Birch Pollen” is identical to mite allergens and is described above.

Initial course of treatment

Initial therapy lasts from 7 to 21 days: the exact period must be determined by the attending physician. According to the treatment regimen indicated on the manufacturer’s official website, the course begins with one click on the blue bottle dispenser (10 IR/ml). Over time, the dosage should reach 10 presses.

After the first course, they switch to using a purple bottle containing a solution of 300 TS/ml. Application begins with one drop of the allergen and is gradually increased to 4-8 drops.

Maintenance course

Maintenance therapy can be carried out in two variations. The estimated period of therapy is 4 years. The first version involves daily use of 4-8 drops. The second is 8 presses 3 times a week.

Efficiency of allergens Staloral

Many people are interested in the question of how long after ASIT therapy the results last. There is no single answer to this question, since treatment takes into account many factors: how many years a person has lived with allergies, how timely the course of therapy began, what particular substance caused unpleasant symptoms, etc.

In general, a three-year course of allergy treatment with Staloral shows its effectiveness in more than 80% of cases. The positive result lasts for 5–10 years from the date of completion of therapy.

The effectiveness and maintenance of the result depend on how responsibly the person approached treatment: he followed the prescribed dosage and the recommendations of the attending physician.

Why is taking drops better than injections?

The sublingual (sublingual) method of introducing allergens has identical effectiveness as when administered subcutaneously. Moreover, the use of drops is the safest method than injections, since the absorption of the drug occurs more slowly.

Initiation of therapy under the supervision of an allergist.

Also, self-administration of Staloral frees a person from many years of visiting the clinic. And children who endure injections with stress undergo ASIT therapy much more calmly.

Side effects

During treatment with Staloral sublingual drops, a solution of allergens is used. As a result, allergic reactions are the most common side effect. The thing is that the body can react sharply to the introduction of antigens into the body, so the patient is recommended to always have an antihistamine with him.

Other manifestations that may occur during the course of therapy include:

• swelling of the oral cavity: swelling of the tongue, lips, pharynx;
• loss of taste and smell, dry mouth;
• sore or tingling throat;
• itching of the eyelids, redness of the eyes;
• rhinitis, lacrimation, frequent sneezing;
• nausea, vomiting, stomach pain, diarrhea;
• cough, wheezing, chest pain;
• burning sensation, itching, skin rash;
• headache, migraine;

If the above symptoms occur, you should urgently seek medical help and stop treatment.

Indications: who is suitable for Staloral

Indications for use are:

• allergic rhinitis, conjunctivitis;
• allergic bronchial asthma;
• Quincke's edema;
• various skin rashes of an allergic nature;
• seasonal allergies, hay fever.

The use of allergens Staloral is contraindicated in the following cases:

• individual intolerance to medicinal components;
• exacerbation of bronchial asthma;
• autoimmune diseases;
• oncology;
• inflammatory processes of the oral mucosa;
• children under 5 years of age;
• the presence of eosinophilic esophagitis;
• combined use with beta-blockers or tricyclic antidepressants.

Staloral during pregnancy and lactation

If pregnancy occurs during therapy, treatment may not be interrupted, but only after the approval of the attending physician.

When breastfeeding, starting a course of ASIT is not recommended. To undergo treatment, you should wait until you finish breastfeeding.

Analogues of Staloral

Below we will look at drugs that can be used as analogues of Staloral.

Analogues of Staloral “Birch pollen allergen”

Phostal, manufacturer Stallergenes, France. The drug is intended for subcutaneous use only.

Deciding whether Fostal or Staloral is better is an appointment with an allergist, after weighing all the pros and cons. The main difference between drugs is the method of introducing allergens. Fostal is used only in the form of injections.

Microgen: hanging birch pollen allergen.

It is a Russian analogue of Staloral. The product contains 1 bottle of allergen and 7 bottles of dilution liquid. One of the positive aspects is the cost of the medicine, which is significantly lower than the foreign one, Staloral, and is about 2,500 thousand rubles.

Sevafarma, Czech-made allergens. Sublingual drops with antigens from pollen of the birch, ash and willow families.
Antipollin, Kazakhstan. One of the analogues, produced in the form of tablets.

It is a mix of spring trees: the Birch family, as well as poplar, maple, oak.

Analogues of Staloral "Mite allergen"

Alustal, Stallergen, France.

Used only as injections. Contains allergens from Dermatophagoides mites: pteronуssinus and farinae.

Lais Dermatophagoides, made in Italy.

It is a tablet of mite allergens D. pteronуssinus and D. farinae for ASIT.

Sevapharma, Czech Republic. The drug for sublingual ASIT consists of house dust mite allergens.
Biomed, Russia. Allergens of ticks D. farinae and D. pteronуssinus for injection use.
Antipollin, Republic of Kazakhstan. Tablets from tick antigens D. Farinae and D. Pteronуssinus.

Where to buy Staloral: pharmacies, cost

Staloral "Birch pollen allergen" and "Mite allergen" can be purchased in Moscow in the following pharmacies:

• AdonisPharm;
• GorPharma;
• Diapharm;
• Doctor Stoletov;
• ZDOROV.ru;
• Lekamed;
• Neopharmacy;
• NEOPHARM;
• Nova Vita;
• Ozerki in Medvedkovo;
• Samson-Pharma;

The cost of the initial course of birch allergens is: 5600 – 8000 rubles. The price of maintenance therapy varies from 5200 to 11880 rubles.

The cost of the initial course of treatment with house dust mite allergens: 2695 – 7490 rubles. Approximate price of the maintenance course: 3575 – 8320 rubles.

In the regions, Staloral may not be available, so it is worth using the delivery service.

Allergens Staloral: reviews

Natalya, 24 years old, Ryazan. Tired of the symptoms of hay fever, I decided to be treated with Staloral “Birch Pollen”. I was attracted by the convenient use of drops, because I didn’t want to go to the hospital regularly. I have been undergoing ASIT for the second year now and I feel much better in the spring.

Artem, 57 years old, Moscow. When I was 30, I started having allergies. After a long examination, it was discovered that the symptoms were caused by dust. I heard from friends that there is a remedy that can help me get rid of my illness. As a result, having found out everything, I took a course of treatment with Staloral “Ticks”. It was not possible to completely cure the allergy, but the severe cough has subsided and I feel better than before.

Svetlana, 46 years old, Omsk. My 12 year old daughter suffered from an allergy to birch and alder pollen. We didn’t want the symptoms to worsen and subsequently turn into asthma, so the allergist recommended taking a course of allergen-specific immunotherapy. I can say that the treatment is not cheap at all, but the most important thing is that it is effective. Now the annual allergic rhinitis and itchy eyes no longer bother my daughter.

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.

Pharmacological action

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:

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 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 type 1 allergic reaction (IgE mediated), manifested in the form of rhinitis, conjunctivitis, rhinoconjunctivitis, mild or moderate forms of bronchial asthma, and 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

• 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.

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 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

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.

Staloral birch pollen allergen Side effects

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

Like any medicine, STALORAL "Mite 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: infrequently - 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.

From the organ of hearing and labyrinthine 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; infrequently - 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 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 the symptomatic treatment of 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 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.

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 taking the drug daily 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.

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
Trade name: 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 %);
• 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.

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.

Directions for use
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 miss 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. If symptoms occur frequently, 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.
Possible simultaneous use with symptomatic antiallergic drugs (H1-antihistamines, beta-2 mimetics, corticoids, mast cell degranulation inhibitors) 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 immediately consult a doctor if you experience severe itching of the palms, arms, soles of your feet, urticaria, swelling of the lips, larynx, accompanied by difficulty swallowing, breathing, or 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.
In case of inflammatory processes in the oral cavity (mycoses, aphthae, gum damage, tooth extraction/loss or surgery), therapy should be interrupted until the 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 with 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 According to the recipe.

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.

Allergen-specific immunotherapy is an effective method for treating allergies. It is used in the treatment of diseases based on sensitivity to pollen or household allergens. The mechanism of action is associated with the introduction of an allergen to the patient. Its dose increases during the first stage of therapy, but remains constant during the second. When using this treatment method, after completing the course of therapy, there is a decrease or complete absence of symptoms of the disease when the patient comes into contact with the causative allergen.

• Show all

  Release form and conditions of release from pharmacies

  Available in the form of sublingual drops in a 10 ml glass bottle. Manufacturer - Stallergen, France. The basis of the drug is an allergen extract from birch pollen. Allergen concentration 10 IR/ml or 300 IR/ml (IR - reactivity index. The concept is used to standardize allergens). The bottles are tightly closed with rubber stoppers; on top of the stoppers there are aluminum caps with blue and purple plastic lids. The colors of the caps correspond to the dosage of the allergen: blue - 10 TS/ml, purple - 300 TS/ml. It must be remembered that one bottle of the drug contains 590 mg of sodium chloride (in 10 ml of the drug). This fact must be taken into account when a course of ASIT is planned in patients on a salt-restricted diet, mainly in children.

  Kit options:

  • 1 bottle with allergen dilution 10 IR/ml, 2 bottles of 300 IR/ml and 3 dispensers;
  • 2 bottles with allergen 300 IR/ml and 2 dispensers;
  • 5 bottles with allergen 300 IR/ml and 5 dispensers with instructions for use.

  Each kit contains instructions for use. The drug is dispensed from pharmacies strictly according to prescription. When using it, it is necessary to strictly follow the storage requirements: temperature from 2 to 8 ° C, the bottles must be in an upright position, and there must be a protective ring on the dispenser. If storage conditions are not observed, the drug may become unusable.

  Administration of the drug under the tongue (sublingually) is not inferior in effectiveness to the injection method of ASIT. This method also helps to develop better tolerance to allergens. Therapy is most effective if treatment begins at the initial stage of the disease. The effectiveness and safety of this drug in children under 5 years of age have not been studied.

  

  Possible side effects

  During treatment, both at the beginning of therapy and in the future, side effects may occur.

  If acute allergic reactions occur with difficulty breathing, difficulty swallowing, severe itching, rash, abdominal pain, dizziness or fainting, you should immediately consult a doctor.

  Also, during therapy, there may be an increase in peripheral lymph nodes, hypersensitivity reactions, serum sickness-type reactions, headache, paresthesia, itching, conjunctivitis, swelling of the lips, tongue, cough, rhinitis, stomatitis, discomfort in the mouth, changes in work salivary glands, diarrhea, nausea, vomiting, increased stool frequency, gastritis, esophageal spasm, urticaria, eczema, muscle and joint pain, weakness, increased body temperature, dry lips, change in taste. During therapy, side effects may occur that are not indicated in the instructions. Patients should immediately inform their doctor about the occurrence of any concomitant diseases, undesirable effects, or if the underlying disease worsens.

  If necessary, before performing ASIT, it is necessary to improve control over the allergic disease by adjusting the drug therapy taken by the patient. If severe allergy symptoms are noted before starting treatment, the start of the course should be postponed until the patient's condition improves. For this purpose, hormonal drugs, histamine receptor blockers and β2-blockers are used.

  The drug does not affect the ability to drive vehicles.

  The drug is not used in cases :

  • hypersensitivity to substances included in the drug;
  • severe mental disorders;
  • lack of patient compliance with the treatment regimen;
  • diseases whose complications may be associated with the use of adrenaline (epinephrine);
  • active forms of severe immunodeficiencies or autoimmune diseases;
  • malignant neoplasms;
  • uncontrolled or severe form of bronchial asthma (forced expiratory volume less than 70%);
  • inflammatory diseases of the oral mucosa;
  • infectious diseases;
  • carriage of hepatitis B and C viruses;
  • therapy with drugs from the beta blocker group (Atenolol, Betaxolol, etc.).

  ASIT is not started during pregnancy and during breastfeeding. If pregnancy occurs during the first stage of therapy, the course should be completed. When pregnancy occurs during the second stage of therapy, the benefits of ASIT are assessed based on the patient’s condition. No side effects were reported during treatment in pregnant women. There are no data on the use of allergen-specific immunotherapy during breastfeeding and the excretion of the drug in breast milk.

  

  Interactions with drugs

  Conducting a course of ASIT is possible simultaneously with the use of histamine receptor blockers and/or local glucocorticosteroids.

  For patients undergoing planned therapy with tricyclic antidepressants (Amitriptyline, Sarotene Retard, etc.) and monoamine oxidase inhibitors (iproniazide, nialamide), ASIT is carried out with extreme caution, since the use of epinephrine for emergency treatment of allergic reactions can cause life-threatening reactions. side effects.

  

  Vaccination

  Without interrupting the course of therapy, vaccination is carried out only after consultation with the attending physician. It is better to carry out planned vaccination a month before the start of the course of therapy or postpone it until after completion of ASIT. At the dose-escalation stage, vaccination is not carried out. At the second stage of ASIT, its implementation is possible subject to the following conditions:

  • ASIT and vaccination are not carried out on the same day;
  • To carry out vaccination at stage 2 of ASIT, a break in taking the allergen is required 3 days before and for 10-14 days after vaccination.

  Before use, please ensure that:

  • the expiration date has not been exceeded;
  • the required bottle (dosage) is used.
  • It is better to take on an empty stomach throughout the day;
  • apply exactly under the tongue using a dispenser and hold, without swallowing, for two minutes;
  • It is recommended to apply to children with the help of adults.

  Algorithm for opening a bottle of the drug for the first use:

  1. 1. Remove the colored plastic cover.
  2. 2. Remove the aluminum cap by pulling the metal ring.
  3. 3. Remove the rubber plug.
  4. 4. Having first removed the new dispenser from the individual packaging, secure it to the bottle. To do this, you need to place the bottle on a hard, flat surface, fix it tightly with one hand, and install the dispenser with the other, pressing your hand on its upper part.
  5. 5. Remove the protective ring.
  6. 6. Next, you need to press the dispenser 5 times, after which it will dispense the required amount of the drug.
  7. 7. Place the dispenser tip in the mouth directly in the area under the tongue. Press the dispenser the required number of times to receive the prescribed dose of the drug. Hold the drug for 2 minutes.
  8. 8. After administering the medicine, clean the dispenser tip and attach the protective ring back.

  Regimen and dosage

  Dosage regimens and treatment with this drug are the same for all age categories, but changes can be made depending on the patient’s tolerability and level of sensitivity to this medication. Adjustment of the drug administration regimen by the attending physician occurs depending on the patient’s tolerability of therapy. It is best to start the course before flowering, about two or three months, and continue throughout the entire period. Courses of allergen-specific immunotherapy are recommended at least 3-5 years contract. If, after a course of treatment during the first flowering season, the patient does not notice an improvement in the condition and a decrease in the severity of the symptoms of the underlying disease, one should reconsider the indications again and decide on the need for ASIT.

  

  Treatment consists of: an initial course (increasing the dose) and a maintenance course (taking a maintenance dose):

  1. 1. It is customary to begin increasing the dose by taking the drug daily from a bottle with a blue cap (dosage 10 TS/ml). Start with one click on the dispenser and gradually increase the number of clicks to five. One click on the dispenser - about 0.2 ml of the drug. This is followed by daily administration of the drug from a vial with a purple cap (dosage 300 TS/ml), also starting with one press and gradually increasing to a well-tolerated amount. The dose escalation phase lasts 9 days. During the initial period, an individual maximum dose is achieved for each - from 2 to 4 presses daily, a dosage of 300 IR/ml (purple bottle). When the maximum dose is reached, they proceed to maintenance therapy (second stage of therapy).
  2. 2. Maintenance therapy with a constant dose. Use a dosage of 300 TS/ml (purple bottle). The individual maximum dose that was achieved in the first stage of therapy is continued. It is recommended to take the drug according to the scheme - from 2 to 4 clicks on the dispenser daily or 4 clicks 3 times a week from a purple bottle.

  A regimen with daily dosing of the drug is more effective, since it is associated with a more responsible approach to treatment than taking the drug 3 times a week:

  Therapy day	Drug dose	Number of clicks	Dose, IR
  1		1	2
  2	10 TS/ml bottle with blue cap	2	4
  3	10 TS/ml bottle with blue cap	3	6
  4	10 TS/ml bottle with blue cap	4	8
  5

Active ingredient

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.

Pharmacological action

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.

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.

Directions for use
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 miss 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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