Staloral birch allergen maintenance course. Staloral "birch pollen allergen" - instructions for use, doses, side effects, contraindications, price, where to buy - geotar medicinal reference book

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

To prevent such seasonal diseases, there is medicinal product 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 relief allergic symptoms, and in some cases, complete relief of unpleasant symptoms, which allows the allergy sufferer to be completely relieved of the disease.

When passing full course therapy and compliance with all 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:

1. Elementary. At this stage, the dosage of the drug is increased to the desired level.
2. 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 initial stage treatment, and 2 purple vials for the maintenance phase.

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

At the moment, the principle of action of allergens when carrying out immune therapy not fully explored. Only the following biological modifications in the human body are considered reliable:

1. Appear specific antibodies, which play a blocking role.
2. The level of specific immunoglobulin decreases in blood plasma.
3. Cell reactivity decreases, which are involved in creating allergic reactions.
4. 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-ulcerative lichen, mycosis or other inflammations of the mucous membrane oral cavity severe form;
• immunodeficiencies or autoimmune diseases;
• bronchial asthma 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 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 daily consumption of the blue cap allergen. In this case, the volume of medicine 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 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:

1. Before using the medicine, you should make sure it is suitability(not expired).
2. Make sure making the right choice bottle.
3. You should take the medicine in the morning, before eating.
4. 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 stool 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 may occur or anaphylactic shock. In this case, you need to refuse ASIT treatment.

In case of manifestation negative reactions body, a patient with an allergy 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 at the moment final stage treatment, then the allergist must evaluate the primary benefits of the drug. That is, the antiallergic drug should bring much more benefit to a pregnant woman than harm.

When carrying out various scientific research, 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 is not excluded complex application Staloral with antihistamines or nasal corticosteroids. 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 medical supplies, can lead to fatal side effects.

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

Precautions

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

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

Select the section Allergic diseases Symptoms and manifestations of allergies Diagnosis of allergies Treatment of allergies Pregnant and lactating Children and allergies Hypoallergenic life Allergy calendar

The goal of therapy is to transition the disease to a more light form, partial or even complete disappearance of allergy symptoms. A complete cure is also possible. of this disease.

Cochrane Collaboration - international non-profit organization, collaborating with WHO, in its research confirmed the consistency and effectiveness of the ASIT method.

With accurate identification of the allergen causing the allergy, timely initiation of ASIT and complete passage course in compliance with all doctor’s instructions, the frequency of manifestations of persistent positive result treatment rate reaches 80%.

Please note that it is important to carry out treatment under the supervision of a doctor! More about ASIT.

Description of drugs Staloral

Photo: Appearance packaging and dispenser

The drugs are produced by the French pharmaceutical company STALLERGENES, specializing in drugs used in ASIT. Sometimes the Abbott Healthcare company is indicated in the “manufacturer” column, but today they no longer produce this drug. The supplier in Russia, or rather the representative company, is Stallergen Vostok.

Allergy vaccines being developed:

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

Treatment includes two parts: initial and maintenance courses. At the initial stage, the dosage of the allergen is raised to a certain level, which is maintained throughout the maintenance course.

Please note

ASIT can be performed on children aged 5 years and older.

Release form and storage rules

The drug is available in 10 ml bottles, closed with a rubber stopper, which is secured with metal caps with a plastic lid.

1. Colored blue, indicating a concentration of 10 IR/ml;
2. In purple color indicating a concentration of 300 TS/ml.

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

Stored in a dark place at a temperature of 2-8°C. Shelf life 3 years.

When ordering the product, you may be faced with the question: Staloral 2 and 3 - is there a difference? Staloral 3 is initial course drug, and 2 - a course of maintenance therapy.

Why is it important to comply with storage conditions?

Improper storage of the allergen “Staloral” leads to the fact that the drug loses its effectiveness. In this regard, before starting therapy, carefully read the instructions for storing the drug (from 2 to 8 degrees, out of the reach of children). Also make sure that you are using the correct concentration of the product and that it is not expired.

It is recommended to store the drug in medical institution, however, this certainly makes it difficult to take.

The editors of the portal asked the manufacturer a question about keeping the drug at room temperature. We received this response:

“It is undesirable to violate the instructions and rules for storing drugs. If the drug has been at room temperature for several hours, its further use is permissible.”

Staloral "Mite allergen"

The product contains an allergen based on the patented Stalmite APF culture developed by Stallergen.

Characteristics of “Mite Allergen”
Active ingredient	Allergen extract from mites Dermatophagoides pteronyssinus and Dermatophagoides farinae in a 50/50 ratio.	Photo: Packaging of the drug Staloral “Mite Allergen” (can be enlarged)
Additional substances	sodium chloride, glycerol, D-Mannitol, purified water.
Nonproprietary name	Household allergens

The drug is sold by prescription.

Instructions for use of allergens Staloral

Information about the new effective dispenser Staloral

It is necessary to make sure that the product has not expired, the packaging is intact, and a bottle with a solution of the required concentration has been selected.

1. Remove the plastic cap from the bottle, then remove the metal cap, remove the stopper, attach the dispenser and, pressing on it from above, snap it onto the bottle. Then remove the orange ring of the dispenser, which is pressed 5 times to fill with the solution.
2. When using, the tip of the dispenser is placed under the tongue, the dispenser is pressed several times, in accordance with the dosage. The drug is kept under the tongue for two minutes.
3. After use, the dispenser is wiped clean and the orange safety ring is put on it.

Dosage of allergens Staloral

The dosage does not depend on the patient’s age, but can be adjusted by the attending physician depending on the individual response to the drug.

Upon reaching the optimal, i.e. The maximum dosage that is well tolerated by the patient, corresponding to approximately 4-8 presses at a concentration of 300 IR/ml, begins the second stage - a course of support. On at this stage To administer the optimal dose, in addition to the scheme of four to eight presses every day, it is also possible to use the scheme of eight presses three times a week.

Rules for resuming interrupted therapy

Sometimes it may be necessary to temporarily interrupt the course of taking the drug. For example, in case of illness.

1. When missing less than 1 week. it is possible to continue treatment with the current dosage.
2. The pass lasted longer than 1 week. - administration begins with one click and a concentration corresponding to the concentration used before the break (10 or 300 units), and is adjusted to the maximum acceptable dose according to the dosage regimen.
3. At long absence A doctor's consultation is required.

Staloral "Mite allergen" - initial course

Staloral "Mite Allergen" - maintenance course

The composition includes two 300 IR/ml bottles and two dispensers.

Storing the allergen in a medical facility is encouraged, but this certainly makes taking it more difficult.

Staloral "Birch pollen allergen"

Allergens from representatives of the Birch family are highly cross-reactive. Therefore, as studies show, the ASIT procedure using birch pollen extract provides high protection against the effects of pollen from other members of the family (hazel, hornbeam, alder, etc.).

The effectiveness of the product has been proven clinical studies, the drugs are manufactured in accordance with all European requirements.

Characteristics of “Birch pollen allergen”
Active ingredient	Birch pollen allergen extract	Photo: Packaging of the drug Staloral “Birch Pollen” (can be enlarged)
Additional substances	Sodium chloride, glycerol, D-Mannitol, purified water
Nonproprietary name	Tree pollen allergens

Used for ASIT in patients with immediate hypersensitivity to birch pollen, suffering from:

• rhinitis;
• conjunctivitis;
• mild or moderate form of seasonal asthma;

The method of application is similar to that of Staloral “Mite Allergen”.

Available in the form of an initial course and a support course.

Staloral “Birch pollen allergen” – initial course

Dose escalation scheme for ASIT with Staloral birch

Consists of one 10 ml bottle of 10 TS/ml, two 10 ml bottles of 300 TS/ml and three dispensers.

Initial therapy may last from 9 days to 3 weeks. They're starting therapeutic measures with 1 click on the dispenser and gradually increase to the maximum (10 clicks). The concentration of the drug in this case is 10 IR/ml (cover blue color). The volume of the drug from one press is 0.1 ml.

The next point is the transition to taking the drug with a concentration of 300 IR/ml (purple cap). Treatment begins with one click on the dispenser and is increased to 4-8 (depending on how well the patient tolerates the drug).

Staloral "Birch pollen allergen" - maintenance course

Includes two 300 IR/ml bottles and two dispensers. Prescription drug.

After the optimal dose has been determined at the initial stage, they proceed to maintenance treatment. The treatment algorithm is as follows: daily from 4 to 8 presses or 8 presses on the dispenser three times a week. This two-stage treatment is carried out over a period of three to five years.

If the therapy turns out to be ineffective, the question is decided: is it advisable to carry out ASIT or not.

Side effects

Before a person signs consent to conduct ASIT, the doctor is obliged to explain to him all the intricacies of the process, and also remember to mention that it is impossible to guarantee the effect. Moreover, development side effects during procedures - not so uncommon. The allergen Staloral, be it birch or any other, can cause side effects.

Of course, the most likely undesirable consequences are allergic reactions that go beyond the body's adaptation to the allergen.

Review of the treatment of allergies in a child with birch allergen - it is possible that things have only gotten worse (source - vk.com/topic-87598739_34026451)

Side effects can be local or general. The first category includes:

• feeling of itching and discomfort in the mouth, throat;
• increased or decreased salivation;
• abdominal pain;
• nausea;
• vomit;
• loose stool.

Positive feedback about the drug "Mite Allergen" (source: otzovik.com/review_388769.html)

The general ones are manifested by the following phenomena:

• cough;
• runny nose;
• hives;
• asthmatic phenomena;
• severe phenomena - anaphylaxis, Quincke's edema.

It is extremely rare that consequences such as:

• headache;
• weakness, lethargy, decreased performance;
• chills;
• skin disorders;
• fever, muscle pain, nausea, swollen lymph nodes.

If the latter group of symptoms develops, ASIT must be discontinued.

Many people believe that subcutaneous immunotherapy is more effective than sublingual immunotherapy, but this is not true. It has been clinically proven:

1. both methods are significantly more effective than placebo;
2. the effectiveness of both methods is almost the same;
3. sublingual therapy is safer.

The prescription of the drug is often dictated by the characteristics of its use. Sublingual ASIT is recommended for patients:

• ready to take the drug consistently and daily;
• children afraid of injections;
• for allergy sufferers who do not have the opportunity to visit the medical center frequently. institution;
• patients who were not suitable for subcutaneous ASIT due to the development of systemic reactions.

1. During periods of pregnancy and lactation;
2. Children under 5 years old.

Contraindications

First of all, taking allergens Staloral is contraindicated for people suffering from intolerance to its auxiliary components:

• glycerol;
• sodium chloride;
• mannitol

Also should not be taken for:

• autoimmune diseases;
• malignant tumors;
• immunodeficiencies;
• mental disorders;
• severe forms of asthma;
• acute diseases;
• inflammatory diseases of the oral cavity.

You cannot use Staloral while taking beta-blockers:

With caution - while taking antidepressants and MAO inhibitors:

It is important to notify your doctor about the medications you are taking.

Analogs of drugs Staloral

Like any other product, there are analogues of Staloral allergens.

Staloral "Birch pollen allergen" - analogues:

Analogue	Characteristic	Photo
Fostal “Birch pollen allergens”, JSC Stallergen (France)	Stallergenes is also available but is intended for subcutaneous administration. The active ingredient is extracts of alder, hornbeam, birch and hazel pollen.	Photo: Fostal - a standardized drug from Stallergence for subcutaneous ASIT
Microgen: hanging birch pollen allergen	Refers to cheap analogues of Staloral. It is a water-salt extract of protein-polysaccharide complexes isolated from hanging birch pollen.
Sevafarma (Czech Republic) “Early spring mixture”	The most “exact analogue”: a preparation made from birch pollen from the Czech company Sevapharma. It is taken sublingually (under the tongue), like Staloral. It is a water-salt extract from a mixture of pollen of alder, birch, hornbeam, hazel, ash and willow.
Mix of trees No. 1 and No. 2. Antipollin, manufactured in Kazakhstan, Burli LLP	Available in tablet form. Mix 1: birch, alder, hazel, hornbeam. Mix 2: poplar, elm, maple, birch, oak.

For the mite allergen from Staloral, there are slightly fewer analogues:

Analogue	Characteristic	Photo
Alustal "House dust mite allergen", JSC Stallergen (France)	Preparation for subcutaneous administration produced by Stallergence. Includes allergen extract from mites Dermatophagoides pteronyssinus, Dermatophagoides farinae.
Lais Dermatophagoides, Lofarma (Italy)	Available in tablet form for sublingual administration. Allergens: D. pteronyssinus, D. farinae
Allergen “Mixture of ticks”, “Sevapharma” (Czech Republic)	Includes allergens: Acarus siro, D. farinae, D. pteronyssinus. Available in the form of drops.
Mite allergen; Mixed allergen from a mite. JSC "Biomed" (RF)	Designed for injection. There are several drugs with different compositions: Mite allergens: D. farinae, D. pteronyssinus. Mixed allergens: mite allergen + house dust allergen
Antipollin. Mixed ticks, “Burli” (Kazakhstan)	Available in tablet form. Contains mite allergen extract (D. Farinae, D. Pteronyssinus)

The question of which remedy is better - Staloral, Alustal, Fostal or, for example, Sevafarma - should be decided exclusively by a doctor. The difference is in the method of application (for example, Alustal and Fostal are substances for injection, and the other two are for sublingual administration).

According to research by O.M. Kurbacheva, there is no significant difference. The only question is convenience (frequency of visiting the doctor, sensations during administration) and acceptability for each patient individually. It cannot be said that one of the drugs listed above causes side effects more often than another.

Purchasing the drug - how much it costs and where to buy

Prices for sublingual allergens for ASIT “Staloral”

Purchasing the allergen Staloral is not an easy task. Firstly, imports of the drug to Russia are rare; Staloral is difficult to find in pharmacies in the country. Transportation of the drug to our country was suspended at the end of spring 2016. However, in June, a batch of “allergenic vaccine” was brought to the Russian Federation, and it was subject to certification for 3 months. The first delivery to pharmacies took place in September, the next one in October of this year.

Do not forget to visit the website of the official representative - Stallergen Vostok

On it you can find up-to-date information about drug supplies to Russia and company news.

In 2016, delivery of Staloral allergens is expected in November, the bottles will be equipped with a new dispenser.

Where can I order Staloral? Firstly, when favorable conditions it can be purchased at a pharmacy.

Photo: Mother's review of the use of the allergen Staloral for a child with allergies. Pros and cons of the drug in her opinion (can be increased)

So, in Moscow these are the following points:

• pharmacy on the territory of the Sechenov Hospital;
• Samson-Pharma pharmacy;
• Health Formula pharmacy.

In the northern capital of Russia ( full list pharmacies and addresses V help desk ECMI):

• Ava-Peter Pharm pharmacy;
• City Farm Pharmacy;
• Biotechnotronik pharmacy.

Online pharmacies:

• Farmprostor pharmacy: farmprostor.ru
• pharmacy Ver.ru: www.wer.ru

Read more about possible places to purchase allergens for ASIT in next article

The drug Staloral also has distributors

The official one is “ Trading House Allergen”(www.allergen.ru). This portal supplies medical products pharmacies, hospitals and other organizations. However, there is also the possibility of a private order - upon prior application to the pharmacy (list of cities in which there are points cooperating with the company).

In addition, in social network“VKontakte” is sales group for drugs Staloral and Sevapharma: vk.com/sevafarma. To trust or not to trust this resource is everyone’s business. However, it has established itself by publishing reliable information and linking only to the official websites of manufacturers.

It is strictly not recommended to purchase an “allergen vaccine” by hand.

Despite the fact that it is cheaper, no one can guarantee that the medicine is genuine (no cases of counterfeiting have been registered, but anything can happen), that it has not been opened and that all storage conditions have been observed.

If you order medicine from Europe (in some countries it is sold according to Russian prescriptions), then the question arises of how to transport Staloral. It has very narrow temperature limits for storage, so trust transportation transport company risky. However, the drugs Staloral “Ambrosia” and Staloral “Weeds” are not supplied to Russia at all, so it makes sense to look for a way to safely deliver allergens from other countries.

Are Staloral and alcohol compatible?

There is no evidence that alcohol somehow affects the absorption of the drug. However, abstinence from alcohol for the entire period of treatment is a recommendation from allergists, which it is advisable to follow. Alcoholic drinks themselves are highly allergenic; moreover, there is no accurate data on the absence of distortion of the body's reaction to an allergen in a state of alcoholic intoxication.

How long does Staloral birch pollen allergen last?

Due to possible supply disruptions, it will be useful to know how long a package of the drug lasts. In 1 press - 0.1 ml of the drug.

Usually the allergen is taken from February 1 to May 31. According to patient reviews, 1 bottle with a concentration of 300 IR/ml lasts for 3-4 weeks (depending on the tolerability of the drug and the number of drops taken). It is also worth considering that Staloral should not be taken during illness.

Positive review of Staloral, but according to an allergist, it doesn’t help everyone

Trade name: STALORAL “Birch pollen allergen”
Dosage form:
sublingual drops

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

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

DESCRIPTION Transparent solution from colorless to dark yellow.

ATX code V01AA05

PHARMACOTHERAPEUTIC GROUP Tree pollen allergens

IMMUNOBIOLOGICAL PROPERTIES
The exact mechanism of action of the allergen during allergen-specific immunotherapy (ASIT) has not been fully studied. The following biological changes have been proven: the appearance of specific antibodies (IgG4), which play the role of “blocking antibodies”;
decrease in the level of specific IgE in plasma;
decreased reactivity of cells involved in an allergic reaction;
increased activity of interaction between Th2 and Th1, leading to a positive change in the production of cytokines (decreased IL-4 and increased β-interferon) that regulate IgE production.

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 bronchial asthma of a seasonal nature, having increased sensitivity to birch pollen.
Immunotherapy can be administered to adults and children from 5 years of age.

CONTRAINDICATIONS

Hypersensitivity to one of the excipients(see list of excipients);
Autoimmune diseases, immune complex diseases, immunodeficiencies;
Malignant neoplasms;
Uncontrolled or severe asthma (forced expiratory volume< 70 %);
Beta blocker therapy (including local therapy in ophthalmology);
Heavy inflammatory diseases oral mucosa, for example, erosive-ulcerative form of lichen planus, mycoses.
METHOD OF APPLICATION AND DOSAGE
The effectiveness of ASIT is higher in cases where treatment is started at early stages diseases.

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

Directions for use
Before taking the drug, make sure that:

the expiration date has not expired;
a bottle of the required concentration is used.
It is recommended to take the drug in the morning before breakfast.
The drug should be dropped directly under the tongue and held for 2 minutes, then swallowed.
Children are recommended to use the drug with the help of adults.

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

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

SIDE EFFECTS
Carrying out ASIT may cause adverse reactions both local and general.
The dosage and treatment regimen may be revised by your doctor in case of individual reaction or changes in general condition patient.

Local reactions:

oral: itching in the mouth, swelling, discomfort in the mouth and throat, dysfunction 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. In case frequent occurrence symptoms, the possibility of continuing therapy should be reconsidered.

General reactions are rare:

rhinitis, conjunctivitis, asthma, urticaria require symptomatic treatment H1-antagonists, beta-2 mimetics or corticosteroids (oral). The physician should reconsider the dosage and treatment regimen or the possibility of continuing ASIT.
in extremely rare cases, generalized urticaria, angioedema, laryngeal edema, severe asthma, anaphylactic shock are possible, which requires the abolition of ASIT.
Rare side effects not related to Ig-E mediator reactions:

asthenia, headache;
exacerbation of preclinical atopic eczema;
delayed reactions of the serum sickness type with arthralgia, myalgia, urticaria, nausea, adenopathy, fever, which requires the abolition of ASIT.
All side effects should be reported to your doctor.

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

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

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

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

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

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

SHELF LIFE 36 months. Do not use after expiration date.

CONDITIONS FOR DISCHARGE FROM PHARMACIES By prescription.

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, its use can reduce or completely eliminate increased sensitivity to specific compounds, thus most:

• reduce the need for taking antihistamines and other drugs for symptomatic therapy;
• prevent lung transition clinical manifestations, for example, runny nose, in severe forms 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 of deciduous trees of the Birch family, a standardized medicine Staloral "Birch pollen allergen". 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 reactivity (ability to respond to changes environment) 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 tend to progress from minor violations 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 has no medicinal properties, but providing some 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 effective and safe way conducting 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 different high level 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 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. If pregnancy occurs during maintenance therapy, an assessment is made possible benefits ASIT 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 while breastfeeding, it 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 significantly higher when it is started on early stages development of pathology.

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 tolerability of the drug, patients, especially with moderate bronchial asthma, are often prescribed additional symptomatic therapy, consisting in receiving:
   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 put it on open bottle, pressing firmly on it from above. 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:

• execution 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 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 the occurrence of unwanted 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 to understand what maximum dose The medication is well tolerated, without exceeding it, and therefore without encountering allergy symptoms, it is impossible. 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:

• headaches;
• , 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 more and more seriously 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 preparations Staloral “Birch pollen allergen” and Fostal are produced by the French pharmaceutical company JSC Stallerzhen.
2. Antipollin "Mixt trees" is manufactured by Burli LLP (Kazakhstan).
3. “Early Spring Mix” is produced in the Czech Republic by Sevafarma.

Active ingredient

Birch pollen allergen

Dosage form

drops for oral administration

Manufacturer

Stallergen, France

Compound

sublingual drops

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

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

Pharmacological action

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

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

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

Indications

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

Contraindications

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

Side effects

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

Local reactions:

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

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

General reactions are rare:

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

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

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

All side effects should be reported to your doctor.

Interaction

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

How to take, course of administration and dosage

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

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

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

Directions for use
Before taking the drug, make sure that:

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

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

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

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

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

3/ Remove the rubber plug.

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

5/ Remove the orange protective ring.

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

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

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

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

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

Overdose

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

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