Staloral birch pollen allergen. Staloral "birch pollen allergen" - instructions for use, doses, side effects, contraindications, price, where to buy

10 ml contains:

  • Active ingredient: Birch pollen allergen extract 10 TS/ml*, 300 TS/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 TS/ml, 300 TS/ml.

10 ml of the allergen with a content of 10 TS/ml and 300 TS/ml in 14 ml glass bottles, closed with rubber stoppers, sealed with aluminum caps with blue (10 TS/ml) and violet (300 TS/ml) plastic caps.

The kit consists of: 1 allergen bottle 10 TS/ml, 2 allergen bottles 300 TS/ml and three dispensers or 2 allergen bottles 300 TS ml and two dispensers or 5 allergen bottles 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.

Instruction

Before using the drug, make sure that:

  • the expiration date has not expired;
  • the vial of the required dosage is used.

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

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

When using for the first time, open the vial as follows:

  1. Tear off the colored plastic cap from the bottle.
  2. Pull on the metal ring, removing the aluminum cap completely.
  3. Remove the rubber stopper.
  4. Remove the dispenser from the protective packaging. Place the vial on a flat surface and, holding it firmly with one hand, snap the dispenser onto the vial by pressing the top surface of the dispenser with the other hand.
  5. Remove the purple protective ring.
  6. Firmly press the dispenser 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. Firmly press the dispenser as many times as the doctor has prescribed for you to get the right amount of the drug. Hold the drug under the tongue for 2 minutes.
  8. After use, wipe the pipette tip and put on the protective ring. It is necessary to place the vial with the dispenser on 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, with increased sensitivity to house dust mites (D. pteronyssinus, D. farinae).

Immunotherapy can be carried out for adults and children from 5 years of age.

Contraindications to the use of Staloral birch pollen allergen

  • Hypersensitivity to any of the excipients that make up 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 and ulcerative form of lichen planus, ulceration of the oral mucosa, mycosis of the oral mucosa);
  • Therapy with beta-blockers.

Staloral birch pollen allergen Use in 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 physician should evaluate the possible benefit 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 are no data on the excretion of the active substance in breast milk. However, it is not recommended to start ASIT during breastfeeding. The decision to continue the course of ASIT during breastfeeding should be taken after assessing the risk-benefit ratio.

Staloral birch pollen allergen Side effects

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

Like all medicines, 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 in the course of 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).

Tolerability of the dose of the drug may vary depending on the patient's condition.

In case of adverse reactions, 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.

On the part of the blood and lymphatic system: rarely - an increase in lymph nodes.

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

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

On the part of the organ of vision: often - itching in the eyes; infrequently - conjunctivitis.

On the part of the organ of hearing and labyrinth disorders: often - itching of the ears.

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

From the gastrointestinal tract: often - swelling of the lips, swelling of the tongue, itching in the oral cavity, 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; infrequently - pain in the oral cavity, gastritis, spasm of the esophagus.

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, fever.

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

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

drug interaction

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

Caution should be exercised when prescribing and conducting specific immunotherapy in 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 a break in treatment only after consulting a doctor.

Dosage of 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 efficacy 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 may 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 the 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 (dose increase) and maintenance therapy (maintenance dose).

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

Then they proceed to the daily intake of the drug at a dosage of 300 TS / 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 injections daily of the drug at a dosage of 300 TS / ml), after which they proceed to the second stage.

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

The optimal dose reached at the first stage of initial therapy is continued at the second stage of maintenance therapy.

The recommended dosage regimen is 2 to 4 pumps per day or 4 pumps 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

Break in taking the drug

If the gap in taking the drug was less than one week, it is recommended to continue treatment without changes.

If the gap in taking the drug was more than one week, it is recommended to treat again with one click on the dispenser, using a vial 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 the optimal well-tolerated dose.

Overdose

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

String(10) "error stat"

ASIT (allergen-specific immunotherapy), today, is the only way to rid 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 Staloral is used in the treatment of allergies to birch pollen and dust mites.

What is ASIT?

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

Treatment is carried out as follows: an allergen solution, in a small concentration, is injected 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 disease progression 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, watery eyes, nasal congestion, bronchial asthma, etc.

Staloral: description of the drug

Staloral from Stallergenes are sublingual drops for ASIT French production. 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 "Stallerzhen", manufacturer France.

Since 2018, Staloral has been produced with a new dosing system. Now on the dispenser instead of the orange protective ring is purple. Therefore, before using a drop, you must carefully consider the vial and study the instructions for use.

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

  1. Staloral "Allergen of mites" (Staloral "Allergen of mites");
  2. Staloral "Birch pollen allergen" (Staloral "Birch pollen allergen").

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

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

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

  • the initial course, which involves a gradual increase in 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 for children over 5 years old. It is impossible to carry out the procedure at an earlier age, since the child, due to a weak immune system, may develop acute allergic reactions to the drug.

Forms of release and storage rules

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

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 at room temperature for several hours. The opened bottle is stored 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

The set contains:

  • 2 purple bottles;
  • 2 dispensers.

Staloral "Allergen mites": initial course

The initial therapy kit contains:

  • 1 blue vial 10 TS/ml;
  • 2 purple bottles 300 TS/ml;
  • 3 dispensers.

Staloral "Allergen mites": maintenance course

Maintenance therapy requires a kit that includes:

  • 2 purple vials of 300 TS/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 an allergen solution from the mites Dermatophagoides pteronussinus and Dermatophagoides farinae.

Instructions for use

Before using the drug, you need to pay attention to the integrity of the package and the expiration date. Only after making sure that everything is within the normal range, you should start treatment.

The procedure for the first use of the solution Staloral:

  1. Remove the colored cap and metal cap from the bottle;
  2. Remove the rubber stopper;
  3. Fix the dispenser: a characteristic click indicates its correct installation;
  4. Remove the orange (purple) protective ring and with five clicks, fill the dispenser with the drug;
  5. Then, the right amount of the drug must be dripped under the tongue and wait for it to be absorbed 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.

Scheme of taking allergens Staloral

The dosage of the drug (the number of clicks) should be set by an allergist, since their values ​​\u200b\u200bmay change depending on the reaction of the body, during pregnancy, etc.


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

Then, upon reaching a dose of 8 clicks 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 from house dust mites takes 3 years, after which there is a significant improvement in the patient's condition.

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 consider what to do when allergens have been stopped for a period of several days or more.

  • If the patient missed taking the drug for less than 1 week, then you can resume taking 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 vial (10 or 300 TS / ml), and then, gradually, they reach the maximum allowable rate indicated by the doctor.
  • With a longer break in treatment, it is necessary to seek advice from an allergist.

Staloral "Birch pollen allergen"

In the spring, many people begin to experience a serious illness associated with birch blossoms. Therefore, in order to alleviate this painful condition, allergists are invited to undergo an effective course of allergy treatment with Staloral.

The birch pollen allergen has cross-reactivity with antigens of other trees of this family: alder, hazel, etc. Therefore, birch allergen solution is often used in medical practice to treat pollinosis 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 a few months before the start of flowering of birch or other trees.

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 tick allergens and is described above.

Initial course of treatment

Initial therapy lasts from 7 to 21 days: the exact period should be established by the attending physician. According to the treatment regimen indicated on the official website of the manufacturer, the course starts with one click on the blue vial dispenser (10 TS / ml). Over time, the dosage should reach 10 clicks.

After the first course, they switch to the purple vial containing a solution of 300 TS/ml. The application begins with one drop of the allergen and gradually increases to 4-8 drops.

Support course

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

The effectiveness of allergens Staloral

Many people are interested in the question of how long after ASIT therapy the result is preserved. There is no single answer to this question, since many factors are taken into account in the treatment: how many years a person lived with an allergy, how timely the course of therapy began, which 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. A positive result is maintained for 5-10 years from the end of therapy.


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

Why is taking a drop better than injections?

The sublingual (sublingual) method of introducing allergens has the same efficiency as with their subcutaneous administration. Moreover, the use of a drop is the safest method than injections, since the absorption of the drug is slower.


Start 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 tolerate injections with stress are much calmer in the course of ASIT therapy.

Side effects

During treatment with Staloral sublingual drops, an allergen solution 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 advised to always carry 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 in the 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 rashes;
  • headache, migraine;

In the event of the above symptoms, it is necessary to urgently seek medical help and stop treatment.

Indications: who is suitable for Staloral

Indications for use are:

  • allergic rhinitis, conjunctivitis;
  • allergic bronchial asthma;
  • angioedema;
  • 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's age up to 5 years;
  • the presence of eosinophilic esophagitis;
  • co-administration with beta-blockers or tricyclic antidepressants.

Staloral during pregnancy and lactation

In the event that pregnancy occurs during therapy, treatment can 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 the end of breastfeeding.

Analogues Staloral

Below we consider the drugs that can be used analogue of Staloral.

Staloral analogues "Birch pollen allergen"


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

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


Microgen: An allergen of the pollen of the hanging birch.

Represents the Russian analogue of Staloral. The composition of the product includes 1 bottle of allergen and 7 bottles of diluting liquid. Of the positive aspects, the cost of the drug can be noted, which is significantly lower than the foreign Staloral and is about 2,500 thousand rubles.


Sevapharma, Czech allergens. Sublingual drops with pollen antigens 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 "Alustal", Stallergen, France.

It is used only in the form of injections. Contains Dermatophagoides mite allergens: pteronussinus and farinae.


Lays Dermatophagoides, made in Italy.

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

Sevapharma, Czech Republic. The drug for sublingual ASIT, consists of allergens from house dust mites.
Biomed, Russia. D. farinae and D. pteronussinus tick allergens for injection use.
Antipollin, Republic of Kazakhstan. Tablets from the antigens of the mite D. Farinae and D. Pteronussinus.

Where to buy Staloral: pharmacies, cost

Staloral "Birch Pollen Allergen" and "Mite Allergen" can be bought in Moscow at the following pharmacies:

  • AdonisPharm;
  • GorPharma;
  • Diaspharm;
  • Doctor Stoletov;
  • ZDOROV.ru;
  • Lekamed;
  • Neoapteka;
  • NEOPHARM;
  • Nova Vita;
  • Lakes 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. Estimated price of the supporting course: 3575 - 8320 rubles.

In the regions, Staloral may not be available, so you should use the delivery service.

Allergens Staloral: reviews

Natalia, 24 years old, Ryazan. Tired of the symptoms of hay fever, I decided to treat with Staloral "Birch Pollen". I was attracted by the convenient use of the drop, because I didn’t feel like going 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. At the age of 30, I started having allergies. After a long examination, it was found that the symptoms were caused by dust. From friends I heard that there is such a remedy that can help me get rid of my ailment. As a result, having found out everything, I underwent a course of treatment with Staloral "Ticks". It was not possible to completely cure the allergy, but the strong cough receded, I feel better than before.

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

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

Active ingredient:

Birch pollen allergen extract 10 TS/mL*, 300 TS/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) is not fully understood.

ASIT leads to a change in the immune response of T-lymphocytes, followed by an 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. The secondary and possibly later immune response is an immune deviation with a change in the immune response of specific T cells.

Indications: 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 bronchial asthma of a seasonal nature, with increased sensitivity to birch pollen.

Immunotherapy can be carried out for adults and children from 5 years of age.

Contraindications:- Hypersensitivity to any of the excipients that make up 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 and ulcerative form of lichen planus, ulceration of the oral mucosa, mycosis of the oral mucosa);

Therapy with beta-blockers.

Pregnancy and lactation: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, then therapy should be discontinued. If pregnancy occurs during the period of maintenance therapy, the physician should evaluate the possible benefit 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 are no data on the excretion of the active substance in breast milk. However, it is not recommended to start ASIT during breastfeeding. The decision to continue the course of ASIT during breastfeeding should be taken after assessing the risk-benefit ratio.

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

The safety and efficacy 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 may 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 the 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 (dose increase) and maintenance therapy (maintenance dose).

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

Then they proceed to the daily intake of the drug at a dosage of 300 TS / 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 injections daily of the drug at a dosage of 300 TS / ml), after which they proceed to the second stage.

Day

Dosage of the drug

The number of clicks on the dispenser

Dose, IR

10 TS/ml

(bottle with blue cap)

300 TS/ml

(bottle with purple cap)

120

180

240

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

The optimal dose reached at the first stage of initial therapy is continued at the second stage of maintenance therapy.

The recommended dosage regimen is 2 to 4 pumps per day or 4 pumps 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

Mode of application

Before using the drug, make sure that:

The expiration date has not expired;

The vial of the required dosage is used.

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

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

When using for the first time, open the vial 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 vial on a flat surface and, holding it firmly with one hand, snap the dispenser onto the vial 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. Firmly press the dispenser as many times as the doctor has prescribed for you to get the right amount of the drug. Hold the drug under the tongue for 2 minutes.

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

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

Break in taking the drug

If the gap in taking the drug was less than one week, it is recommended to continue treatment without changes.

If the gap in taking the drug was more than one week, it is recommended to treat again with one click on the dispenser, using a vial 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 the optimal well-tolerated dose.

Side effects:Possible adverse reactions are grouped by systems and organs 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 all medicines, STALORAL Birch Pollen 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 in the course of 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).

Tolerability of the dose of the drug may vary depending on the patient's condition.

In case of adverse reactions, 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 - an increase in lymph nodes. From the immune system: infrequently - hypersensitivity; rarely - reactions of the type of serum sickness.

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

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

On the part of the organ of hearing and labyrinth disorders: often - itching of the ears.

From the respiratory system, chest organs and mediastinum: often - irritation in the throat, swelling of the pharynx, blisters in the oropharynx, rhinitis, cough; infrequently - 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; infrequently - pain in the oral cavity, gastritis, spasm of the esophagus.

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, fever.

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

If you have any of the side effects listed in the instructions or you 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: Perhaps simultaneous use with drugs for the symptomatic treatment of allergies (antihistamines and / or nasal corticosteroids).

Caution should be exercised when prescribing and conducting specific immunotherapy in 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 a break in treatment only after consulting a doctor.

Special instructions:Patients should inform the physician of any comorbidities or if a current allergic disease worsens.

If necessary, allergy symptoms should be stabilized with appropriate therapy before starting ASIT. Treatment should be delayed in the presence of severe clinical symptoms of an allergic disease 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 administered with caution to patients taking tricyclic antidepressants, 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 a complete cure. Cases of eosinophilic esophagitis associated with sublingual immunotherapy have been reported. If severe or persistent upper gastrointestinal symptoms occur during treatment with STALORAL Birch Pollen Allergen, including swallowing problems or chest pain, treatment with STALORAL Birch Pollen Allergen should be discontinued and a doctor should be consulted. Treatment can be resumed only after consulting a doctor.

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

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

Influence on the ability to drive transport. cf. and fur.:The drug does not affect the ability to drive vehicles and mechanisms. Release form / dosage:Sublingual drops 10 TS/ml, 300 TS/ml. Package: 10 ml of the allergen with a content of 10 TS/ml and 300 TS/ml in 14 ml glass bottles, closed with rubber stoppers, sealed with aluminum caps with blue (10 TS/ml) and violet (300 TS/ml) plastic caps.

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

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 Date of registration: 18.08.2010 / 04.10.2016 Expiration date: Perpetual Registration certificate holder: Stallerzhen, AO

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 bronchial asthma of a seasonal nature, with increased sensitivity to birch pollen. Immunotherapy can be carried out for adults and children from 5 years of age.

Contraindications Staloral "Birch pollen allergen" sublingual drops 300IR/ml 10ml (maintenance therapy)

Hypersensitivity to any of the excipients that make up 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 and ulcerative form of lichen planus, ulceration of the oral mucosa, mycosis of the oral mucosa). Therapy with beta-blockers. Use during pregnancy and during breastfeeding. 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 physician should evaluate the possible benefit 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 are no data on the excretion of the active substance in breast milk. However, it is not recommended to start ASIT during breastfeeding. The decision to continue the course of ASIT during breastfeeding should be taken after assessing the risk-benefit ratio. The safety and efficacy of treatment in children under 5 years of age have not been established.

Method of application and dosage Staloral "Birch pollen allergen" sublingual drops 300IR/ml 10ml (maintenance therapy)

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 treatment regimen are the same for all ages, but may be changed depending on the individual reactivity of the patient. It is advisable to start treatment no later than 2-3 months before the expected flowering season, and continue throughout the entire flowering period. The attending physician adjusts the dosage and treatment regimen in accordance with possible symptomatic changes in the patient and the individual response to the drug. Treatment consists of two stages: initial therapy (dose increase) and maintenance therapy (maintenance dose). Initial therapy begins with a daily intake of the drug at a dosage of 10 TS / ml (vial with a blue cap) with one click on the dispenser and gradually increase the dose to 5 clicks. One click on the dispenser is about 0.2 ml of the drug. Then they proceed to the daily intake of the drug at a dosage of 300 TS / 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 injections daily of the drug at a dosage of 300 TS / ml), after which they proceed to the second stage. Recommended scheme for the initial course of ASIT: Day - Dosage pre-ta - Number of clicks on the dispenser - Dose, TS 1 10 TS / ml (bottle with a blue cap) 1 2 2 2 4 3 3 6 4 4 8 5 5 10 6 300 TS/mL (bottle with purple cap) 1 60 7 2 120 8 3 180 9 4 240 Maintenance therapy at a constant dose using the drug at a dosage of 300 TS/mL. The optimal dose reached at the first stage of initial therapy is continued at the second stage of maintenance therapy. The recommended dosage regimen is 2 to 4 pumps per day or 4 pumps 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. Allergen-specific immunotherapy is recommended for 3-5 years. If during the treatment the improvement did not occur during the first flowering season, the feasibility of ASIT should be reconsidered. The drug is recommended to be taken on an empty stomach during the day. The drug should be dripped directly into the tongue using a dispenser and kept in the sublingual region for 2 minutes, then swallowed. Children are advised to use the drug with the help of adults. To ensure the safety and preservation of the drug, the vials are hermetically sealed with plastic caps and rolled with aluminum caps. When using for the first time, open the vial as follows: 1. Tear off the colored plastic cap from the vial. 2. Pull on the metal ring to completely remove the aluminum cap. 3. Remove the rubber plug. 4. Remove the dispenser from the protective packaging. Place the vial on a flat surface and, holding it firmly with one hand, snap the dispenser onto the vial 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. Firmly press the dispenser as many times as the doctor has prescribed for you to get the right amount of the drug. Hold the drug under the tongue for 2 minutes. 8. After use, wipe the pipette tip and put on the protective ring. It is necessary to place the vial with the dispenser on in the refrigerator immediately after use. For subsequent use, remove the protective ring and follow steps 7 and 8. Break in taking the drug. If the gap in taking the drug was less than one week, it is recommended to continue treatment without changes. If the gap in taking the drug was more than one week, it is recommended to treat again with one click on the dispenser, using a vial 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 the optimal well-tolerated dose.

Every third patient of immunologists suffers from plant intolerance. One of the most common allergens is the pollen of deciduous trees: birch, alder, hazel, etc. The disease is manifested by lacrimation, reddening of the eyes, or even the occurrence of stenosis of the larynx, accompanied by attacks of suffocation. You can cope with the signs of allergies with the help of symptomatic therapy, but it is better to resort to ASIT, which allows you to get rid of the disease forever. For its implementation, the drug Staloral "Birch pollen allergen" is used.

ASIT drug: Staloral "Birch pollen allergen"

Allergen-specific immunotherapy (ASIT) is a method of treating all kinds of allergic diseases, the essence of which is the regular introduction into the patient's body of small, but constantly increasing doses of a substance that causes conjunctivitis, urticaria, etc. Since ASIT affects the causes of the development of pathology, it the application allows to reduce or completely eliminate hypersensitivity to specific compounds, thereby:

  • reduce the need for taking antihistamines and other symptomatic drugs;
  • prevent the transition of mild clinical manifestations, for example, a runny nose, into severe forms of allergies - bronchial asthma;
  • reduce the risk of developing sensitization to other substances.

Sensitization - excessive sensitivity to compounds of a certain kind.

After completion of the course of treatment, remission persists for at least 3-5 years.

To combat intolerance to pollen from deciduous trees of the Birch family, the standardized drug Staloral "Birch pollen allergen" is used. The drug is intended for seasonal therapy and sublingual administration, that is, instillation under the tongue. Although the true mechanism of action of ASIT has not yet been fully established, it has been proven that the use of the drug leads to:

  • the production of specific antibodies that prevent the synthesis of others, including those produced in response to an allergen entering the body;
  • a drop in the level of lgE in the blood;
  • a decrease in reactivity (the ability to respond to environmental changes) of cells directly involved in the development of an allergic reaction;
  • increased interaction between T-helper types 1 and 2 (cells responsible for the development of the inflammatory process), which leads to their neutralization, since they inhibit each other's production.

The drug is prescribed to patients suffering from type 1 allergic reactions to the pollen of deciduous trees with seasonal:

  • rhinitis;
  • conjunctivitis;
  • mild or moderate forms of bronchial asthma.

An allergic reaction of type 1 is an immune response to the penetration of foreign particles of a certain amino acid composition into the body, while lgE antibodies are synthesized. This sets off a chain reaction, resulting in the appearance of signs of allergy, which is characterized by a tendency to progress from minor disorders to life-threatening conditions: Quincke's edema, bronchial asthma.

Release form

Staloral "Birch pollen allergen" can be purchased in different configurations. Starter kit:

  1. Vials:
    • blue - 1 pc.;
    • purple - 1 pc.
  2. Dispensers - 3 pcs.

Maintenance kit:

  1. Violet bottles - 2 pcs.
  2. Dispensers - 2 pcs.

The advantages of the drug over the introduction of allergens subcutaneously

  • subcutaneous and sublingual methods have a pronounced effectiveness compared to placebo (a compound that does not have any medicinal properties, but has some therapeutic effect due to the patient's confidence in its effectiveness);
  • both methods of introducing the allergen are practically equivalent in efficiency;
  • the sublingual method has a higher safety profile.

Thus, instillation of allergens under the tongue is an effective and safe method of conducting ASIT, which is in no way inferior to injection, and in some situations even surpasses it.

Allergy and the fight against it by the forces of ASIT - video

Who is Staloral suitable for?

Due to the peculiarities of the use of the drug, it is prescribed:

  • patients with a high level of responsibility, since the medication must be taken daily;
  • children who are afraid of injections;
  • patients who do not want or are not able to visit a medical institution often;
  • patients who underwent a course of subcutaneous ASIT, but were forced to abandon it due to the development of systemic (general) reactions of the body.

However, there are special categories of allergy sufferers:

  1. Pregnant women.
    1. It is not recommended to start ASIT during the period of gestation.
    2. If conception occurred during the first stage of therapy, the use of the drug should be discontinued.
    3. When pregnancy occurs during maintenance therapy, the possible benefit of ASIT is assessed based on the general condition of the patient.
  2. Lactating women. There are no data on the use of ASIT during lactation, however, the development of any undesirable consequences in babies whose mothers received Staloral during breastfeeding is unlikely.
  3. Children. Staloral is prescribed for children from 5 years of age.

1 dose of the drug contains 5.9 mg of NaCl, which must be taken into account in patients on a diet with reduced salt intake.

Instruction

It is recommended to start taking Staloral "Birch Pollen Allergen" no later than 2 or 3 months before the start of flowering of a plant whose pollen is allergic, and continue until the end of this period. Treatment is repeated annually for 3-5 years. If after the first course of immunotherapy the intensity of clinical manifestations does not decrease, the rationality of ASIT in subsequent years is considered.

Attention! The effectiveness of immunotherapy is much higher at the beginning of its implementation in the early stages of the development of pathology.

As part of the initial therapy, the bottle with the blue cap is used first. The allergen extract contained in it has a reactivity index of 10 IR / ml. The regimen for taking the drug for each patient is developed individually. It involves a gradual increase in dose up to 10 consecutive injections. Only after that they pass to a vial with a purple cap, the activity of the allergen in it is 300 TS / ml. Treatment is continued, gradually increasing the dose, stopping at the maximum, normally tolerated by the patient. As a rule, it is 4-8 injections.

The starting package of the drug Staloral "Birch pollen allergen" contains two types of vials intended for initial and maintenance therapy

For maintenance therapy, only a vial with a purple cap is used. The drug is administered daily.

Important! Amendments to the number of injections are made purely individually, and solely on the basis of the patient's response to the medication.

Usage features:

  1. The medicine is used from morning to breakfast. It is buried under the tongue and kept in the mouth for two minutes, then swallowed.
  2. After the procedure, wash your hands thoroughly so as not to bring particles of the allergen into the eyes.
  3. To improve the tolerability of the drug, often patients, especially those with moderate bronchial asthma, are prescribed additional symptomatic therapy, which consists in taking:
    1. H1-antihistamines (Diphenhydramine, Suprastin, Tavegil, Zyrtec, Telfast, Hydroxyzine, etc.)
    2. Β 2 -agonists (Salbutamol, Fenoterol, Ventolin, Spiropent, Berotek, Clenbuterol, etc.
    3. Corticosteroids (Prednisolone, Medrol, Beclomethasone, Pulmicort, Rhinocort, Nazacort, etc.)
    4. Mast cell membrane stabilizers (Cromoline, Nalcrom, etc.)

The drug is stored in a refrigerator at a temperature of 2-8°C. If it is necessary to transport the medicine, use special bags and make sure that the opened vial is constantly in an upright position.

First reception

  1. Remove the blue plastic cap from the initial therapy vial.
  2. Remove the metal cap by pulling on the protruding ring.
  3. Pull out the rubber stopper.
  4. Remove the dispenser and put it on the open bottle, pressing it firmly from above. A characteristic click indicates fixation.
  5. Remove the orange fuse.
  6. Make 5 strong pressures over any container to achieve dosing accuracy.
  7. Place the tip of the dispenser under the tongue and firmly press it as many times as prescribed by the doctor.
  8. Wipe the tip and put on the fuse.

When switching to maintenance therapy, you should follow the same steps, but with a vial that has a purple plastic cap.

Resuming interrupted therapy

The drug is interrupted when:

  • performing surgical interventions on the oral cavity, including tooth extraction;
  • afte;
  • serious damage to the gums, in particular periodontitis and gingivitis;
  • mycoses of the oral cavity;
  • loss of teeth.

After the inflammatory process subsides, therapy is resumed.

  1. Pass less than 7 days - ASIT continues in the prescribed manner.
  2. Missing more than a week - therapy should be started with the introduction of 1 dose from the vial with the same reactivity index that was used before the suspension of treatment, and methodically increase the number of clicks until the optimal dose is reached.
  3. Long pass - expert advice required.

Contraindications

The use of Staloral is contraindicated in:

  • hypersensitivity to any of the excipients that make up the drug:
    • glycerol;
    • sodium chloride;
    • mannitol.
  • autoimmune diseases;
  • severe mental disorders;
  • immunodeficiencies of any origin, including after chemotherapy, etc.;
  • malignant neoplasms;
  • severe forms of bronchial asthma;
  • acute diseases, especially those accompanied by fever;
  • serious inflammatory processes in the oral cavity, in particular those observed in infectious diseases.

In addition, Staloral "Birch Pollen Allergen" cannot be used while taking β-blockers:

  • Atenolol;
  • propranolol;
  • Tenormil;
  • Anaprilin;
  • Lokren;
  • Metocard;
  • Concor;
  • Corvitol;
  • Biprolol;
  • Vasocardin;
  • metoprolol;
  • non-ticket;
  • Egilok, etc.

With great care, the drug is prescribed to patients taking:

  • tricyclic antidepressants:
    • Azaphen;
    • Amitriptyline;
    • Fluoracizine, etc.
  • MAO inhibitors:
    • Isocarboxazid;
    • Phenelzine;
    • Befol;
    • Metralindol;
    • Nialamide, etc.

When undergoing immunotherapy, vaccination is possible, but the doctor must be aware that the patient is taking Staloral.

Possible side effects

Taking the drug may be accompanied by the occurrence of undesirable effects, especially if the recommended dose is exceeded.

  1. local reactions. They quickly disappear on their own and, in general, are an integral part of the treatment, because it is impossible to understand what the maximum dose of the drug is well tolerated without exceeding it, and therefore without encountering allergy symptoms. Therefore, usually in such cases, serious adjustments are not made to the immunotherapy regimen. The question of the need to continue it is raised only with the frequent manifestation of undesirable reactions. These include:
    • itching and swelling of the lips or mucous membrane under the tongue;
    • burning sensation or discomfort in the mouth and throat;
    • diarrhea;
    • stomach ache;
    • excessive salivation or, conversely, insufficient production of saliva;
    • nausea.
  2. Systemic reactions (rhinitis, urticaria, including generalized, conjunctivitis, asthma, angioedema, anaphylaxis, laryngeal edema). Such disorders are rare, but when they appear, you should immediately take antihistamines or corticosteroids and contact your doctor to make changes to the ASIT regimen or reconsider the possibility of conducting it.

For mild or moderate systemic reactions, it is usually recommended to return to the previous well-tolerated dose and stick to it for 2 days. After that, the extension continues.

Very rarely, patients experience:

  • headache;
  • manifesting:
    • increased fatigue;
    • mood instability;
    • sleep disorders;
    • exhaustion.
  • exacerbation of skin diseases.

All developing adverse events should be reported to the doctor.

Allergy prevention with Staloral

It is known that over time, the disease begins to manifest itself with more and more serious and dangerous symptoms. Staloral "Birch pollen allergen" can be used to prevent the progression of hay fever, for example, from rhinitis to bronchial asthma or from mild forms of bronchial asthma to the development of asthmatic status, etc. Therefore, all patients suffering from intolerance to pollen from deciduous trees of the Birch family are recommended as you can start ASIT earlier.

Drug analogues

An analogue of the drug Staloral "Birch pollen allergen" is Fostal "Tree pollen allergen", which includes an extract of pollen not only from birch, but also from other representatives of this family:

  • alder;
  • hazel;
  • hornbeam.

Unlike Staloral, Fostal is intended for subcutaneous administration. However, the effectiveness of both drugs is the same.

Also recently, a line of drugs Antipollin appeared on the Russian market. Mixed trees contain allergens:

  • birches;
  • poplars;
  • elm;
  • oak;
  • maple.

The drug Sevapharma "Early Spring Mix" has a similar effect. It contains pollen extracts:

  • alder;
  • birches;
  • hornbeam;
  • hazel;
  • Antipollin Mixed Trees

    Manufacturers

  1. Preparations Staloral "Birch Pollen Allergen" and Fostal are produced by the French pharmaceutical company JSC Stallergen.
  2. Antipollin "Mixed Trees" is manufactured by Burli LLP (Kazakhstan).
  3. "Spring mixture early" is produced in the Czech Republic by Sevafarma.
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