Steeloral "Birch Pollen Allergen" - Instructions For Use, Initial Course

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Steeloral "Birch pollen allergen"

Steeloral "Birch pollen allergen": instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. Drug interactions
12. 12. Analogs
13. 13. Terms and conditions of storage
14. 14. Terms of dispensing from pharmacies
15. 15. Reviews
16. 16. Price in pharmacies

Latin name: Staloral "Allergen of betula pollinis"

ATX code: V01AA05

Active ingredient: tree pollen allergens

Manufacturer: Stallerzhen S. A. (Stallergenes SA) (France)

Description and photo update: 2020-09-01

Staloral “Birch pollen allergen” is an MIBP (medical immunobiological preparation) used for allergen-specific immunotherapy (ASIT) in cases of severe human hypersensitivity to tree pollen.

Release form and composition

Dosage form - sublingual drops: clear liquid from colorless to dark yellow [10 ml of solution at a dosage of 10 IR / ml * or 300 IR / ml in glass vials with a capacity of 14 ml, sealed with rubber stoppers, sealed with aluminum caps plastic caps (for a dosage of 10 IR / ml - a blue plastic cap, for a dosage of 300 IR / ml - a purple plastic cap); 1 of 3 sets is enclosed in a plastic box together with instructions for use of Staloral "Birch pollen allergen": for initial therapy - 1 bottle at a dosage of 10 IR / ml + 2 bottles at a dosage of 300 IR / ml + 3 dispensers; for maintenance therapy - 2 bottles at a dosage of 300 IR ml + 2 dispensers or 5 bottles at a dosage of 300 IR / ml + 5 dispensers].

10 ml of sublingual drops contain:

• active substance: birch pollen allergen extract - 10 or 300 IR / ml;
• auxiliary components: mannitol - 200 mg; glycerol - 5800 mg; sodium chloride - 590 mg; purified water - up to 10 ml.

* IR / ml - biological standardization unit, where IR - Reactivity Index.

Pharmacological properties

Pharmacodynamics

To date, the exact mechanism of action of the allergen from birch pollen during ASIT has not been fully studied.

ASIT changes the immune response of T-lymphocytes with a subsequent increase in the level of specific antibodies [immunoglobulins of subclass G4 (IgG ₄) and / or subclass G1 (IgG ₁), and in some cases subclass A (IgA)] and a decrease in the content of specific total immunoglobulins E (IgE). A secondary and probably later immune response is immune deviation with a modification of the immune response of specific T-lymphocytes.

Indications for use

Staloral "Birch pollen allergen" is recommended for ASIT patients with hypersensitivity to birch pollen, manifested by an allergic reaction of type 1 (IgE mediated), the symptoms of which are rhinitis, conjunctivitis, rhinoconjunctivitis, mild to moderate seasonal asthma.

Contraindications

• severe immunodeficiency states or active autoimmune diseases;
• uncontrolled or severe bronchial asthma with forced expiratory volume <70%;
• malignant neoplasms;
• ulceration, mycoses or erosive and ulcerative form of lichen planus of the oral mucosa, other inflammatory diseases of the oral mucosa;
• pregnancy, lactation;
• children under 5 years of age;
• simultaneous use with beta blockers;
• hypersensitivity to any of the auxiliary components in Staloral "Birch pollen allergen".

Steeloral "Birch pollen allergen", instructions for use: method and dosage

Sublingual drops Staloral "Birch pollen Allergen" are applied by instillation with a dispenser directly under the tongue, after which they are kept in the sublingual area for 2 minutes and then swallowed. The drug is recommended to be taken during the day on an empty stomach.

Children apply drops with the help of adults.

ASIT is more effective when treatment is started in the early stages of the disease.

Immunotherapy can be given to adults and children over 5 years of age using the same dosage regimen for all ages. A change in the therapy regimen can be made only depending on the patient's individual reactivity.

Correction of the dosage regimen and treatment regimen is carried out by the attending physician taking into account possible symptomatic changes in the patient and the individual reaction to Staloral "Birch pollen allergen". It is advisable to start taking the drug no later than a few months (2-3) before the beginning of the flowering season, and to continue therapy throughout the flowering time.

The complete therapeutic course includes two stages:

1. Initial therapy is the dose escalation period.
2. Supportive therapy - taking the drug in a dose sufficient to maintain the therapeutic effect.

Treatment begins with daily intake of drops of Staloral "Birch pollen allergen" from a bottle with a blue cap at a dosage of 10 IR / ml, with 1 press on the dispenser, gradually increasing the dose to 5 pressures. With one press of the dispenser, the patient receives about 0.2 ml of solution.

At the end of the 5-day period, they switch to taking daily drops from a bottle with a purple cap at a dosage of 300 IR / ml. Begin with one press on the dispenser, gradually increasing the number of pressures to the optimum, providing the patient with a well-tolerated dose.

The total duration of the first stage is 9 days. During this period, the maximum dose should be reached. It is individual for each patient and is daily from 2 to 4 pressures (120–240 doses of IR).

Recommended scheme of the initial course Staloral "Birch pollen allergen":

• 1st day, 10 IR / ml (bottle with blue cap): 1 press - 2 doses of IR;
• 2nd day, 10 IR / ml (bottle with blue cap): 2 presses - 4 doses of IR;
• 3rd day, 10 IR / ml (bottle with blue cap): 3 presses - 6 doses of IR;
• 4th day, 10 IR / ml (bottle with blue cap): 4 presses - 8 doses of IR;
• 5th day, 10 IR / ml (bottle with blue cap): 5 pressings - 10 doses of IR;
• 6th day, 300 IR / ml (bottle with purple cap): 1 press - 60 doses of IR;
• 7th day, 300 IR / ml (bottle with purple cap): 2 presses - 120 doses of IR;
• 8th day, 300 IR / ml (bottle with purple cap): 3 presses - 180 doses of IR;
• Day 9, 300 IR / ml (bottle with purple cap): 4 presses - 240 doses of IR.

After the end of the 9-day period of initial therapy, they proceed to the second stage - maintenance treatment with a constant dose using drops at a dosage of 300 IR / ml.

The optimal dose achieved at the first stage of the initial course of Staloral "Birch pollen allergen" continues to be taken at the second stage of maintenance therapy.

Recommended scheme of immunization: 2-4 presses on the dispenser daily or 4 presses 3 times a week. It is preferable to take drops every day, this regimen provides better adherence to treatment than instillations 3 times a week.

The duration of the course of allergen-specific immunotherapy should be optimally from 3 to 5 years. Patients who did not improve during the first flowering season should clarify the feasibility of ASIT.

Before using the drops, you need to make sure that their expiration date has not expired and that the vial of the correct dosage is used for the stage of therapy.

Plastic caps, sealed with aluminum caps, provide a hermetic closure of the bottle for the safety and security of the drug.

Step-by-step algorithm for opening the bottle for the first time Staloral "Birch pollen allergen":

1. Tear off the colored plastic cap from the bottle.
2. Pull on the metal ring and remove the aluminum cap completely.
3. Remove the rubber plug.
4. Take the pipette out of the protective packaging. Place the bottle on a flat horizontal surface, hold it firmly with one hand, press the top surface of the dispenser with the other hand and snap the dispenser onto the bottle.
5. Remove the purple protective ring.
6. Above the sink, press the dispenser firmly five times, after which it dispenses the required amount of the drug in 1 press.
7. Place the pipette tip into the mouth under the tongue. Press the dispenser firmly for the prescribed number of times to obtain the required amount of solution. Hold the drug under the tongue for two minutes, then swallow.
8. After completing the procedure, wipe the pipette tip, put on the purple protective ring. Immediately after use, place a bottle with a dispenser on in the refrigerator.

For subsequent uses of the bottle, follow points 5, 7 and 8.

If you miss the next appointment Staloral "Birch pollen Allergen":

• a break of less than one week: therapy is continued unchanged;
• a break of more than one week: treatment begins with one press on the dispenser, using a bottle with the dosage that was used before the break. Then the number of pressing is increased according to the scheme of the initial therapy, bringing to a well-tolerated optimal dose.

Side effects

Like any drug, Staloral "Birch pollen allergen" in individual patients can cause negative side reactions, which can be both local and systemic, develop at the beginning of the course of therapy or during treatment.

Taking the drug immediately stop and seek medical advice if the following pathologies appear: rapid development of severe itching or rash, shortness of breath, abdominal pain, other signs of severe allergic reactions; dizziness, fainting, other signs due to a drop in blood pressure.

Dose tolerance varies with the well-being and physical condition of the patient.

The development of adverse reactions may require a revision of therapy. In this regard, it is recommended to prescribe antiallergic drugs in advance to reduce the frequency and severity of adverse reactions.

Possible negative side reactions, grouped by systems and organs, in accordance with the frequency of development [very often (at least 1/10); often (from 1/100 to 1/10); infrequently (from 1/1000 to 1/100); rarely (from 1/10 000 to 1/1000); very rare (less than 1/10 000)]:

• blood and lymphatic system: rarely - enlargement of the lymph glands;
• immune system: infrequently - hypersensitivity; rarely - immune reactions such as serum sickness;
• nervous system: infrequently - sensitivity disorders (paresthesia); rarely headache;
• organ of vision: often - itching in the eyes; infrequently - conjunctivitis;
• organ of hearing and labyrinthine disorders: often - itching in the ears;
• respiratory system, chest and mediastinal organs: often - irritation in the throat, blisters in the oropharynx, swelling of the pharynx, cough, rhinitis; infrequently - dyspnea, exacerbation of asthma, dysphonia, nasopharyngitis;
• gastrointestinal tract: often - swelling of the tongue, swelling of the lips, itching in the mouth, swelling / paresthesia of the oral cavity, discomfort in the mouth, disruption of the salivary glands, stomatitis, nausea, vomiting, diarrhea, abdominal pain; infrequently - gastritis, pain in the mouth, esophageal spasm;
• skin and subcutaneous tissue: often - redness, itching; infrequently - urticaria; rarely - eczema;
• musculoskeletal system and connective tissue: rarely - muscle / joint pain;
• general disorders and disorders at the site of instillation: rarely - asthenia, hyperthermia.

According to post-registration observations, the following side effects of Staloral "Birch pollen Allergen" were recorded: change in taste, dizziness, dry lips, laryngeal edema, oropharyngeal edema, angioedema, anaphylactic shock, eosinophilic esophagitis.

The appearance of any of the above side effects or the development of other negative actions not indicated in the instructions must be reported to the attending physician.

Overdose

Exceeding the prescribed dose of Staloral "Birch pollen allergen" increases the risk of negative side effects and aggravates their severity.

Symptomatic treatment may be required.

special instructions

Patients should inform the doctor about any concomitant diseases or in case of worsening of the existing allergic reactions.

Before starting ASIT, if necessary, carry out appropriate therapy in order to stabilize allergy symptoms. If there are clinical symptoms of a severe allergic disease at the time of initial therapy, the course should be postponed.

Relief of allergic symptoms is ensured by the use of glucocorticosteroids, antihistamines and β ₂ -adrenomimetics.

ASIT is prescribed with caution along with tricyclic antidepressants and monoamine oxidase inhibitors (MAO).

In case of mycoses, aphthiasis, damage to the oral mucosa, loss of teeth or surgical operations in the oral cavity, including when removing teeth, as well as the presence of other inflammatory processes in the oral cavity, instillation of drops is interrupted until the patient is completely cured. Episodes of eosinophilic esophagitis have been reported due to sublingual immunotherapy. In case of severe or persistent symptoms from the anterior part of the digestive system, including difficulty in swallowing or pain in the chest, the use of Staloral "Birch Pollen Allergen" is discontinued and consult a doctor, after which therapy can be resumed with his permission.

Patients on a diet with reduced salt intake, especially children, should take into account that the sodium chloride content in one bottle with the drug (10 ml drops) is 590 mg.

When moving the bottle, for example, while traveling, it is important to ensure that it is in its original packaging with a purple protective ring on the dispenser, strictly in an upright position.

Influence on the ability to drive vehicles and complex mechanisms

Steeloral "Birch pollen allergen" does not affect the psychomotor functions of a person.

Application during pregnancy and lactation

Studies of the effect of Staloral "Birch pollen allergen" on the course of pregnancy and fetal development have not been conducted.

It is not recommended to start ASIT during pregnancy.

Women who become pregnant during the 1st stage of immunotherapy should stop taking the drug. If conception occurred during maintenance therapy, the doctor is obliged to assess the potential benefits of ASIT, taking into account the general condition of the patient.

There were no data on the development of adverse reactions when using ASIT for the treatment of pregnant women.

No studies have been conducted on the effect of the drug on mother and child during breastfeeding. There is no reliable data on the release of an allergen from birch pollen in breast milk. However, it is not recommended to start a course of ASIT during lactation. The doctor decides to continue the ASIT course while breastfeeding based on an assessment of the ratio of the benefits of therapy and the risk of developing adverse reactions in the child.

Pediatric use

In pediatric practice, Staloral "Birch Pollen Allergen" is not prescribed for the treatment of children under 5 years of age, since the safety and effectiveness of its use in this group of patients have not been established.

Drug interactions

Staloral "Birch pollen allergen" can be used simultaneously with antihistamines, nasal corticosteroids, and other drugs for symptomatic therapy of hypersensitivity reactions.

Caution is required in the appointment and conduct of specific immunotherapy in patients who are taking MAO inhibitors and tricyclic antidepressants, since epinephrine, used to arrest possible allergic responses, can lead to adverse reactions that are life-threatening.

Without a break in treatment, vaccination is allowed only after consulting a specialist.

Analogs

Allergodil, Diazolin, Ketotifen, Zyrtec, Calcium chloride 10%, Claritin, Kromohexal, etc. are analogs of Staloral "Birch pollen Allergen".

Terms and conditions of storage

Store at 2 to 8 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Staloral "Birch pollen allergen"

In the majority of reviews about Staloral "Birch pollen allergen", patients claim that this drug for allergen-specific immunotherapy is a chance to cure allergic pollinosis and not use more hormonal drugs to suppress their symptoms. The advantages include a convenient dosage form, thanks to which MIBP can be used at home, the absence of side effects, and the lack of taste in the drops, which makes them easier to use, especially for children.

Patients warn that in order to completely get rid of allergies, you need to be patient, in some cases the effect was visible only in the second year of therapy. But, despite the long-term treatment, the high exchange rate and the frequent unavailability of drops on sale, the complex intake regimen and the need to follow the diet, the harsh storage conditions of the solution, not entirely correct instructions regarding the application regimen and the lack of a clear algorithm of actions for different body reactions insufficient knowledge of Steeloral "Birch pollen allergen", for many it is the only chance to heal, thereby significantly improving the quality of their life. Disadvantages also include a poor pipette, recommending using a pipette instead.

In isolated cases, patients indicate a complete lack of effect, and some even complain of a worsening of their condition.

Price for Staloral "Birch pollen allergen" in pharmacies

Estimated price of Birch Pollen Allergen Steeloral, sublingual drops, per set is:

• 1 bottle at a dosage of 10 IR / ml + 2 bottles at a dosage of 300 IR / ml + 3 dispensers: 1 bottle - 1967 rubles, packaging - 5900 rubles;
• 2 bottles at a dosage of 300 IR ml + 2 dispensers: 1 bottle - 2570–2680 rubles, packaging - 5140–5360 rubles;
• 5 bottles at a dosage of 300 IR / ml + 5 dispensers: 1 bottle - 2090 rubles, packaging - 10 450 rubles.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!