French cure for birch allergies. Staloral "Birch pollen allergen"

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 completing the course 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:

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

Maintenance kit:

Purple bottles - 2 pcs.
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:

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. If pregnancy occurs during maintenance therapy, the possible benefits of ASIT are assessed based on the general condition of the patient.
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.
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:

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.
After the procedure, wash your hands thoroughly to avoid introducing allergen particles into your eyes.
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

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

Missing less than 7 days - ASIT is continued in the prescribed manner.
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.
Long-term pass requires specialist consultation.

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.

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.
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;

Manufacturers

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

Bed mites are a very common problem even today. No one is safe from their appearance in the house. It is impossible to see them with the naked eye, and it is difficult to get rid of such settlers. Almost always the appearance of such mites causes allergies in people. If the body reacts to the bed, it must be treated. A high-quality medicine for such allergies has appeared in pharmacies - staloral “Mite Allergen”. Let's look at this drug and reviews about it.

What kind of drug is this?

Staloral "Mite Allergen" is designed and created for the comfortable life of a person who has a terrible pest in their home - bed mites. Neighborhood with such a bloodsucker is often accompanied by allergies. If you notice symptoms such as itchy, patchy redness on the skin for no apparent reason, then the cause is truly invisible. This is a bed mite, which does not reach a quarter of a millimeter in size. The allergy is caused by his feces, and not bites, as most people think. They do not bite, but feed on dead human skin cells remaining on the bed. The protein contained in tick feces causes redness. Staloral "Mite Allergen" minimizes the sensitivity of the human body to mite allergens.

Why treat allergies?

Many who experience slight redness do not even think that it could be an allergic reaction. If there is no itching and small red spots on the skin do not bother you, most do not see a doctor. You need to contact us to diagnose or refute the manifestation of an allergy. In addition, redness may be associated with other skin diseases, such as fungus. In both cases, it is necessary to undergo a course of treatment. Allergies in the initial stages may not cause discomfort. If left untreated, it will develop into more severe forms and can cause swelling, suffocation and chronic bronchial asthma. Staloral "Mite Allergen" is a truly effective drug. Its action is aimed at alleviating symptoms and eliminating them completely.

Description of the drug

Staloral "Mite Allergen" has a liquid consistency. For convenient use, the bottle is equipped with a dispenser. The volume of the medicine is ten milliliters. There are two types of medication - initial and maintenance course. Only your doctor will determine which one you need, it depends on the stage of the disease. This drug is sold in sets. The initial course consists of three bottles of medicine: one of ten milliliters and two of three hundred, each bottle has its own dispenser, that is, there are three of them in the package. The supporter has two bottles of three hundred milliliters each and two dispensers.

Staloral "Mite Allergen": instructions

According to experts, the most effective treatment is in the early stages of the disease. There is no need to delay, wait until the allergy disappears on its own. Each of the kits of such a product as staloral “Mite Allergen” contains instructions, but the doctor can correct the scheme. If you have ever taken beta-blockers, you must tell your doctor about this.

Allergy treatment begins with an initial course. First of all, you need to use a small bottle - ten milliliters. It contains a low concentration of allergen extract, so you need to start with that. The drug is taken once a day before breakfast. Press the dispenser once, aiming it under your tongue. The drops must be kept there for two minutes and then swallowed. Then the dose is increased until it is normally tolerated by the person. When the small bottle runs out, open the one with three hundred milliliters, the intake follows the same scheme.

The initial course can last from nine days to three weeks, after which you need to start a maintenance course.

Support is provided individually for each person. It is adjusted by the doctor based on the characteristics of the body and the tolerability of the drug. Usually the scheme is as follows: the drug is taken every day before breakfast. Everything happens exactly as described above: the product is sprayed under the tongue, pressing the dispenser can be from four to eight. Or three times a week, eight presses on the dispenser, in the morning before breakfast.

If for some reason you stop using staloral, then remember:

missed a dose for less than a week - continue at the same dosage at which you started missing;
if you missed more than seven days, then you have to start over - one injection, and then increase the dosage.

Contraindications

Like all medications, this also has its contraindications:

Taking beta blockers, therapy in ophthalmology.
Immunodeficiency, immunocomplex and autoimmune diseases.
Bronchial asthma (severe or uncontrolled forms).
Oncological diseases.
Inflammation of the oral mucosa.
Intolerance to one or more ingredients of the drug.

Also, pregnant and lactating women should be treated with this drug with special caution. In these cases, it is not recommended to use the drug without a doctor's permission.

Side effects

The drug must be taken correctly, follow the instructions, and avoid overdose. With a large dose, abdominal pain, diarrhea, nausea, itching and burning in the mouth, and swelling may occur. If these symptoms are the result of an overdose, then in the near future they will disappear on their own, without treatment. If they appear after each dose of the drug (even if the dose is small), then you need to contact a specialist and consult with him about the advisability of continuing treatment.

Staloral and children

An allergy to bed mites can develop not only in adults, but also in children. Children's skin is more sensitive to allergens. Many people have a question: can children take Staloral? It is possible, the dosage is the same as for adults, it can be adjusted by a specialist. If the patient is a child, then it is necessary to monitor the correct intake. Children may accidentally take a large dose, hold the drops under their tongue for too little time, and choke. The drug should only be taken under the supervision of an adult.

Staloral "Mite Allergen": price, where to buy

Many who have been prescribed this drug are hesitant to buy it because of the cost. The most expensive is staloral “Mite Allergen. Beginning course." The price of this drug reaches seven and a half thousand rubles! The supporter is cheaper - up to five thousand. If you are prescribed this drug and you decide to buy it, then keep in mind that you need to purchase both kits: the initial kit and the staloral “Mite Allergen. Supporting course." St. Petersburg is a huge metropolis; this city has a large number of pharmacies. In order not to go around them all in search of this drug, you can go online to the “Pharmacies in Russia” help desk. On this portal you will see a search engine in which you will need to enter the name of the medicine. Based on the results of the search, a number of names and addresses of pharmacies where this drug is available will open, and current prices for staloral “Mite Allergen” are indicated. St. Petersburg and other cities recently learned about this drug, so not all pharmacies may have it in stock. So it will be more convenient to use such a search engine. This system will also allow you to save money, because the prices for the medicine in each pharmacy will also be displayed.

10 ml contains:

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

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

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

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

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

Description of the dosage form

Transparent solution from colorless to dark yellow.

pharmachologic effect

MIBP-allergen.

Instructions

Before using the drug, make sure that:

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

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

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

For first use, open the bottle as follows:

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

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

Indications for use Staloral birch pollen allergen

Allergen-specific immunotherapy (ASIT) is indicated for patients with 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.

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

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

Release form

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

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

pharmachologic effect

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

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

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

Indications for use

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.

Directions for use and doses

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

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

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

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

Treatment consists of two stages: initial and maintenance therapy.

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

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

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

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

Duration of treatment

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

Taking the drug:

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

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

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

For first use, open the bottle as follows:

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

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

Taking a break from taking the drug

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

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

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

Contraindications

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

special instructions

ASIT should not be started during pregnancy.

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

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

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

Storage conditions

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

Many people suffer from unpleasant allergic reactions caused by tick bites and birch pollen.

To prevent such seasonal diseases, there is a drug called Staloral, which is a birch pollen allergen.

Staloral is a series of standardized European drugs that are aimed at allergen-specific immune therapy (ASIT).

Basic information about the medicine

Treatment with such drugs is based on alleviation of allergic symptoms, and in some cases, complete relief of unpleasant symptoms, which allows the allergy sufferer to be completely relieved of the disease.

When completing the full course of therapy and following all the doctor’s prescriptions, a positive outcome (complete cure) from the use of ASIT is observed in 80% of patients.

The manufacturer of Staloral drugs is a French company that specializes in the production of products used in ASIT.

This company produces allergens against mites and birch pollen.

Therapy with such drugs occurs in two stages:

Elementary. At this stage, the dosage of the drug is increased to the desired level.
Supportive. When the maximum dosage is increased, the entire treatment course is maintained at the same level.

Composition and release form of the drug

Allergens are produced in 10-milligram glass vials, which are closed with a rubber stopper with metal clips and a plastic cap. Depending on the concentration, the drug cap has the following shades:

concentration of 10 reactivity indices per milligram (IR/ml) - colored bluish;
concentration 300IR/ml – colored purple.

The package contains 2 bottles (blue and purple) for the initial stage of treatment, and 2 purple bottles for the maintenance stage.

The product is available in the form of sublingual drops.

Birch pollen allergen consists of:

birch pollen extract (active ingredient);
sodium chloride;
glycerol;
mannitol;
purified water.

Staloral for tick bite allergies contains:

allergen concentrate from mites (active ingredient);
sodium chloride;
glycerol;
d-mannitol;
purified water.

Pharmacokinetics and mechanism of action

To date, the principle of action of allergens in immune therapy has not been fully studied. Only the following biological modifications in the human body are considered reliable:

Appear specific antibodies, which play a blocking role.
The level of specific immunoglobulin decreases in blood plasma.
Cell reactivity decreases, which are involved in creating allergic reactions.
P cell interaction activity increases, which leads to fundamental changes in cytokine products, which, in turn, regulate the production of immunoglobulin.

Indications

This medication is intended for adults and children over five years of age who suffer from the following allergic diseases:

allergic effects of the first type, when the immunoglobulin class is mediated;
rhinitis;
conjunctivitis;
, light and medium shape;
hypersensitivity to mites or house dust.

Allergen contraindications

This antiallergic drug device is strictly contraindicated for persons who have hypersensitivity to the auxiliary elements that are part of this antiallergic drug (glycerol, mannitol, sodium chloride).

erosive and ulcerative lichen, mycosis or other severe inflammations of the oral mucosa;
immunodeficiencies or autoimmune diseases;
bronchial asthma of severe or uncontrolled form, that is, when the volume of initiated inspiration is less than seventy percent;
children under five years of age.

Detailed instructions for use

Regardless of the patient’s age, the regimen for using the allergen and its dosage is the same. An exception may be the individual reaction of a person to this drug.

Before using this medicine, you should obtain detailed advice from an allergy doctor, who, in turn, will be able to prescribe the necessary therapy, indicating doses and their subsequent adjustment.

Treatment is usually prescribed two to three months before the expected onset of an allergic reaction.

The very first step is the initial stage of treatment, which begins with the daily use of the blue cap allergen. In this case, the volume of medication on the first day of administration should not be more than one click on the dispenser.

Subsequent use of the antiallergic drug is carried out on the basis that the number of days is equal to the number of presses on the dispenser, that is, the number of presses increases every day.

When the number of presses is ten, you should move on to the bottle with a purple cap. In this case, the regimen is similar to the previous one. Only here is the optimal volume of medication selected that will be well tolerated by the patient.

The initial stage lasts from nine to twenty days (it all depends on the body’s reaction to the allergen). It is during this period that the maximum volume of the drug is reached, which also depends on the human body and can range from four to eight pumps of the purple cap vaccine.

The doctor prescribes the duration of treatment individually for each patient, usually the period of immunotherapy is about three to five years, two to three months of using the medicine annually (usually taken before the flowering of various plants, that is, in the spring).

Directions for using the drug:

Before using the medicine, you should make sure it is suitability(not expired).
Make sure choosing the right bottle.
You should take the medicine in the first half of the day, before eating.
Allergen drips under the tongue and lingers there for two minutes, after which it can be swallowed.

Overdose

In case of overdose, the risk of manifestation or intensification of side effects increases, which are eliminated by symptomatic therapy.

Side effects

The use of Staloral can cause both general and local side effects in humans. These include:

irritation, itching and other sensations of discomfort in the oral cavity;
increased salivation or, conversely, dry mouth;
cutting abdominal pain, loose stools and nausea;
the occurrence of allergy symptoms that require immediate symptomatic intervention, as well as a review of the ASIT treatment regimen and dosage;
in rare cases, severe bronchial asthma or anaphylactic shock may occur. In this case, you need to refuse ASIT treatment.

In case of negative reactions of the body, an allergy patient should urgently consult his doctor.

Possibility of use during pregnancy and lactation

If a woman becomes pregnant at the initial stage of therapy, then the treatment started should be stopped. And if pregnancy occurs during the final stage of treatment, then the allergist must give an assessment of the primary benefit of the drug. That is, an antiallergic drug should bring much more benefit to a pregnant woman than harm.

When conducting various scientific studies, no side effects or harm were found when consuming allergens for pregnant and lactating women. There is also no information about the harm of the drug to the fetus.

Interaction with other drugs

The possibility of combined use of Staloral with antihistamines or nasal corticosteroids cannot be ruled out. This combination of drugs is usually prescribed for the symptomatic treatment of allergic reactions.

Particular caution must be exercised when simultaneous administration of this allergen in combination with tricyclic antidepressants and monoamine oxidase inhibitors. Since this combination of medications can lead to fatal side effects.

When taking an allergen, various vaccinations are allowed only with the permission of the attending physician.

Precautionary measures

The following special instructions must be observed when taking this medicine:

Patients undergoing treatment with Staloral should have on hand other antiallergic, sympathomimetic, antihistamine and corticosteroid drugs for immediate relief of possible allergic reactions.
If negative reactions occur, it is necessary consult your doctor immediately.
In case of manifestation inflammatory reactions in the oral cavity, you need to stop treatment until inflammation is completely eliminated.