Allergens staloral are standardized European preparations for asitis. Staloral “Birch pollen allergen”: initial course, dosage regimen Indications: who is suitable for Staloral

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

Active ingredient:

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

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

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

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

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

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

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

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

Active forms of severe immunodeficiencies or autoimmune diseases;

Malignant neoplasms;

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

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

Beta blocker therapy.

Pregnancy and lactation:Pregnancy

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

ASIT should not be started during pregnancy.

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.

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

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

Doses and treatment regimen

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

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

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

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

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

Day

Dosage of the drug

Number of presses on the dispenser

Dose, IR

10 IR/ml

(bottle with blue cap)

300 IR/ml

(bottle with purple cap)

120

180

240

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

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

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

Mode of application

Before using the drug, make sure that:

The expiration date has not expired;

A bottle of the required dosage is used.

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

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

For first use, open the bottle as follows:

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

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

3) Remove the rubber plug.

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

5) Remove the purple protective ring.

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

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

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

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

Taking a break from taking the drug

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

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

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.

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

Keep out of the reach of children.

Best before date: 36 months.

Do not use after the expiration date.

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

Active substance

Birch pollen allergen

Dosage form

drops for oral administration

Manufacturer

Stallergen, France

Compound

sublingual drops

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

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

pharmachologic effect

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

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

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

Indications

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

Contraindications

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

Side effects

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

Local reactions:

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

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

General reactions are rare:

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

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

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

All side effects should be reported to your doctor.

Interaction

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

How to take, course of administration and dosage

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

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

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

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

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

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

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

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

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

3/ Remove the rubber plug.

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

5/ Remove the orange protective ring.

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

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

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

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

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

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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Every third patient of immunologists suffers from plant intolerance. One of the common allergens is pollen from deciduous trees: birch, alder, hazel, etc. The disease is manifested by lacrimation, redness of the eyes, or even the occurrence of laryngeal stenosis, accompanied by attacks of suffocation. You can cope with the signs of allergies using symptomatic therapy, but it is better to resort to ASIT, which allows you to get rid of the disease forever. To carry it out, 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 use allows you to reduce or completely eliminate hypersensitivity to specific compounds, thereby:

  • reduce the need for taking antihistamines and other drugs for symptomatic therapy;
  • 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 is excessive sensitivity to certain types of compounds.

After completion of treatment, remission lasts 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:

  • 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;
  • reducing the reactivity (ability to respond to environmental changes) of cells directly involved in the development of an allergic reaction;
  • strengthening the 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 pollen of deciduous trees with seasonal:

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

A type 1 allergic reaction is an immune response to the penetration of foreign particles of a certain amino acid composition into the body, and IgE antibodies are synthesized. This starts a chain reaction, resulting in the appearance of signs of allergies, which are characterized by a tendency to progress from minor disturbances to life-threatening conditions: Quincke's edema, bronchial asthma.

Release form

Staloral “Birch pollen allergen” can be purchased in different configurations. Starter set:

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

Maintenance kit:

  1. Purple bottles - 2 pcs.
  2. Dispensers - 2 pcs.

Advantages of the drug over subcutaneous injection of allergens

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

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

Allergy and the fight against it with ASIT - video

Who is Staloral suitable for?

Due to the peculiarities of the drug’s use, 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 unable to frequently visit a medical facility;
  • 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 pregnancy.
    2. If conception occurs during the first stage of therapy, use of the drug should be discontinued.
    3. When pregnancy occurs during maintenance therapy, the possible benefits of ASIT are assessed based on the general condition of the patient.
  2. Nursing women. There is 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 to children from 5 years of age.

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

Instructions

It is recommended to start taking the drug Staloral “Birch pollen allergen” no later than 2 or 3 months before the start of flowering of the plant to which the 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 conducting ASIT in subsequent years is considered.

Attention! The effectiveness of immunotherapy is much higher when it is started in the early stages of pathology development.

As part of initial therapy, the bottle with the blue cap is used first. The allergen extract it contains has a reactivity index of 10 IR/ml. The drug dosage regimen for each patient is developed individually. It involves gradually increasing the dose up to 10 consecutive injections. Only after this do they move on to a bottle with a purple cap; the allergen activity in it is 300 IR/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 starter package of the drug Staloral “Birch pollen allergen” contains two types of bottles intended for initial and maintenance therapy

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

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

Features of use:

  1. The medicine is used from the morning before breakfast. It is dropped under the tongue and kept in the mouth for two minutes, then swallowed.
  2. After the procedure, wash your hands thoroughly to avoid introducing allergen particles into your eyes.
  3. To improve drug tolerability, patients, especially those with moderate bronchial asthma, are often prescribed additional symptomatic therapy, which consists of taking:
    1. H1-antihistamines (Diphenhydramine, Suprastin, Tavegil, Zyrtec, Telfast, Hydroxyzine, etc.)
    2. B 2-adrenergic agonists (Salbutamol, Fenoterol, Ventolin, Spiropent, Berotek, Clenbuterol, etc.
    3. Corticosteroids (Prednisolone, Medrol, Beclomethasone, Pulmicort, Rhinocort, Nazacort, etc.)
    4. Mast cell membrane stabilizers (Cromolyn, Nalkrom, etc.)

The drug is stored in the 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 bottle is always in an upright position.

First appointment

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

When switching to maintenance therapy, you should perform the steps in the same sequence, but with a bottle with a purple plastic cap.

Resumption of interrupted therapy

The medication is interrupted when:

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

After the inflammatory process subsides, therapy is resumed.

  1. Missing less than 7 days - ASIT is continued in the prescribed manner.
  2. If you miss more than a week, therapy should be started by administering 1 dose from a bottle with the same reactivity index that was used before stopping treatment, and methodically increase the number of presses until the optimal dose is reached.
  3. Long-term pass - specialist consultation is required.

Contraindications

The use of Staloral is contraindicated for:

  • hypersensitivity to any of the excipients included in the medication:
    • 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 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;
  • Nebilet;
  • Egilok, etc.

The drug is prescribed with great caution to patients taking:

  • tricyclic antidepressants:
    • Azafen;
    • Amitriptyline;
    • Fluoroacyzine, etc.
  • MAO inhibitors:
    • Isocarboxazid;
    • Phenelzine;
    • Bethol;
    • Metralindole;
    • Nialamid, etc.

When undergoing a course of 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 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 maximum dose of medication is well tolerated without exceeding it, and therefore without encountering allergy symptoms. Therefore, usually in such cases, serious adjustments to the immunotherapy regimen are not made. The question of the need to continue it is raised only when adverse reactions occur frequently. 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 saliva production;
    • nausea.
  2. Systemic reactions (rhinitis, urticaria, including generalized, conjunctivitis, asthma, Quincke's edema, anaphylaxis, laryngeal edema). Such violations are rare, but if they occur, you should immediately take antihistamines or corticosteroids and consult a doctor to make changes to the ASIT regimen or reconsider the possibility of its implementation.

For mild or moderate systemic reactions, it is usually recommended to return to the previous well-tolerated dose and maintain it for 2 days. After this, the build-up continues.

It is extremely rare for patients to experience:

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

Any adverse events that develop should be reported to your doctor.

Preventing allergies with Staloral

It is known that over time the disease begins to manifest itself with increasingly 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 status asthmaticus, etc. Therefore, all patients suffering from intolerance to pollen of deciduous trees of the Birch family are recommended as ASIT can be started earlier.

Analogues of the drug

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

  • alders;
  • hazel;
  • hornbeam

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

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

  • birch;
  • poplars;
  • elm;
  • oak;
  • maple

The drug Sevapharma “Early Spring Mixture” has a similar effect. It contains pollen extracts:

  • alders;
  • birch;
  • hornbeam;
  • hazel;
  • Antipolline Mixed trees

    Manufacturers

  1. The drugs Staloral “Birch pollen allergen” and Fostal are produced by the French pharmaceutical company JSC Stallergen.
  2. Antipollin "Mixt trees" is manufactured by Burli LLP (Kazakhstan).
  3. “Early Spring Mix” is produced in the Czech Republic by the company Sevafarma.

The list of allergens is updated daily. Most modern drugs block the allergic reaction. Medicine has stepped forward and allergy sufferers have the opportunity to purchase medications that can relieve allergies, rather than alleviate symptoms. Allergen Staloral is one of the modern and effective means of combating this disease.

What is Staloral and what effect does it have on the human body?

Staloral is a drug for allergen-specific immunotherapy. The point of therapy is to reduce sensitivity to stimuli. Therapy with the allergen Staloral requires a lot of time. During this period, the body develops a normal response to stimuli.

After completing the course, the allergy becomes mild or completely ceases to appear.

If, during diagnosis, specialists accurately determined that the allergen is birch or mites, and the patient did not violate the rules for taking the drug, then the percentage of complete cure increases.

As a result of the drug’s effect on the body, changes occur:

  1. The cells that are involved in the development of allergies become less reactive.
  2. The LgE level drops.
  3. Antibodies appear in the body, which stop the synthesis of substances as a result of the appearance of allergens.
  4. The cells that are responsible for suppressing allergic reactions actively interact.

Types of vaccines: release form, composition, description, indications for use

Staloral was developed in France. Now the company “Stallergen Vostok” is engaged in deliveries. There are two allergy vaccines:

  1. Staloral "Mite allergen".
  2. Staloral "Birch pollen allergen".

The medicine is in 10 ml bottles. They are tightly closed with rubber and metal caps.

Staloral drops “Birch pollen allergen” are designed to reduce the reaction to birch pollen. According to research, Staloral is highly effective and protects against allergens.

  • birch pollen allergen extract;
  • sodium chloride;
  • glycerol;
  • water;
  • D-Mannitol.

Indications: allergic rhinitis, conjunctivitis and asthma, which are provoked by birch pollen.

“House dust mite allergen” Staloral is a means to reduce the body’s reaction to mites. Its composition is similar, but the active ingredient is an allergen extract from mites.

The drug is sold only by prescription in case of an allergic reaction to mites in the form of redness, rhinitis, itching.

Instructions for the use of allergens of the Staloral group “house dust mites” and “birch pollen”

Before taking the drug for the first time, you need to make sure that the packaging is intact and check the expiration date. You must follow the rules of use that are prescribed in the instructions. Do not take the medicine on an empty stomach. It needs to be inserted under the tongue and kept there for about 2 minutes.

Use in childhood

Children's bodies are more susceptible to allergens. This raises the question of whether therapy can be performed on children.

According to the instructions, children under 5 years of age should not take the drug.

After five years, the dosage is prescribed by the doctor, but basically it does not differ from that for adults. Sublingual administration of the drug should be supervised by adults.

Courses of therapy and exact dosage of drugs

To achieve the maximum effect of the course, you must follow the dosage rules. Therapy is divided into two stages:

  1. Initial cycle.
  2. Supportive.

To make it convenient for the patient to navigate the dosages and follow the instructions, manufacturers produce allergens in two bottles: in the blue bottle the concentration is 10 IR/ml, and in the purple bottle 300 IR/ml.

Initial cycle of treatment with birch pollen allergen

The duration of this cycle is from 9 to 21 days. The first dose consists of 1 press, then their number increases to 10. Concentration - 10 IR/ml.

Maintenance course

At this stage, the treatment algorithm is slightly different: you need to take the medicine 4-8 times daily. The second option is 8 presses on the dispenser three times every seven days.

Initial treatment cycle for house dust mite allergen

Treatment begins with a blue bottle. It takes 1 press per day, then the dose is increased. Then a vial of 300 TS/ml is applied. The duration of treatment is from 9 days to three weeks.

Maintenance course

For the maintenance course, an individual dosage regimen is selected. Every day make 4-8 clicks on the dispenser.

If for some reason you had to suspend the course of therapy, then you need to know a few rules for its restoration:

  1. If the duration of the interruption did not exceed 1 week, then therapy can be continued from the interrupted dosage.
  2. If you miss more than 7 days, you need to start with 1-press doses with the desired concentration, gradually increasing it to the maximum tolerated dose.
  3. Recovery after a long absence should be under the supervision of a specialist.

Contraindications

Before starting the course, you should make sure that there are no contraindications or sensitivity to some components of the medication.

When the use of the drug is contraindicated:

  • with intolerance to mannitol and glycerol;
  • in the presence of a tumor;
  • in inflammatory processes;
  • for asthma in severe forms;
  • for mental disorders;
  • for autoimmune diseases.

Interaction of allergens with other drugs

It is prohibited to use Staloral simultaneously with adrenergic blockers. You cannot carry out the course while using antidepressants and inhibitors.

The use of Staloral drops for pregnant and nursing mothers

When carrying a child, doctors do not prescribe therapy with Staloral. If conception has already occurred during the initial course, then it is stopped. During the maintenance course, you must consult a doctor before further treatment.

It is not recommended to take the course while breastfeeding.

But there is no clinical data on the use of vaccines during this period.

Overdose and side effects

If there is at least one side effect, the doctor reduces the dose of the medicine, and in special cases prescribes hospitalization. Despite the effectiveness of vaccines, they have many unwanted side effects:

  1. Weakness, fatigue.
  2. Insomnia and other sleep disorders.
  3. Headache.
  4. Asthma.
  5. Quincke's edema.
  6. Abdominal pain.
  7. Nausea.
  8. Stomach upsets.
  9. Swelling, itching, burning.

Rules for storing Staloral drugs and why is it important to follow them?

If storage rules are not followed, Staloral loses its effectiveness. Do not use the medicine after the expiration date, or violate the storage temperature conditions. Normal temperature is 2-8 degrees.

Step-by-step steps for opening the bottle the first time you use it

Before the first dose, it is important to open the bottle correctly and understand the principle of its operation. There are several steps you need to follow:

  1. The bottle is tightly closed with a lid and secured with a cap. Before first use, you must carefully remove the lid and remove the plug. After attaching the dispenser, it is snapped into place. The orange ring is removed from the dispenser. Next you need to click on it 5 times.
  2. The advantage of Staloral is that it is used sublingually. The dispenser must be placed under the tongue and pressed the required number of times. Do not swallow the medicine for 2 minutes.
  3. After use, the dispenser must be cleaned and the ring must be put on.

Analogues of allergens of the Staloral series

Not every pharmacy can provide a wide selection of drugs for ASIT. If it was not possible to purchase Staloral or the pricing policy does not allow this, then you can turn to analogues. At the same time, “Birch pollen allergen” and “Mite allergen” have different substitutes. How to replace Staloral “Birch pollen allergen”:

  1. Microgen is a cheap analogue.
  2. Sevapharma is a substitute that has a similar composition to Staloral and is taken sublingually.
  3. Antipollin tablets.

Analogues of "Mite Allergen":

  1. Alustal for injection under the skin.
  2. Biomed for injection.

Where are the drugs sold? Their pricing policy?

Patients have the opportunity to buy Staloral not only in city pharmacies, but also in online stores, where they can leave a review. The price of the drug is high. 1 course of treatment will cost 6-8 thousand rubles. If the treatment consists of two courses, then, accordingly, from 12 thousand rubles. It is worth noting that the price is justified by the quality, because long-term treatment allows you to forget about allergies.

Staloral is a drug that helps get rid of allergies. The medicine does not mask the symptoms of the disease, but treats it. After a course of therapy, the body is less sensitive to allergens. To be effective, you must follow the dosage rules for Staloral, which are contained in the instructions for use.

10 ml contains:

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

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

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

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

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

Description of the dosage form

Transparent solution from colorless to dark yellow.

pharmachologic effect

MIBP-allergen.

Instructions

Before using the drug, make sure that:

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

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

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

For first use, open the bottle as follows:

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

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.