Staloral Allergen of birch pollen initial course, drops 10 ir/ml 1 pc.+300 ir/ml 2 pcs.

Tree pollen allergens

IMMUNOBIOLOGICAL PROPERTIES
The exact mechanism of action of the allergen during allergen specific immunotherapy (ASIT) is not fully understood. The following biological changes have been proven:

• appearance of specific antibodies (IgG4) playing the role of “blocking antibodies”;
• reduction of specific IgE levels in plasma;
• reduction of reactivity of cells involved in the allergic reaction;
• increased interaction between Th2 and Th1, leading to positive changes in cytokine production (decreased IL-4 and increased g-interferon) that regulate IgE production.

The administration of ASIT also inhibits the development of both the early and late phase of the immediate allergic reaction.

Indications

Allergen-specific immunotherapy (ASIT) for patients with type 1 allergic reactions (IgE-mediated), suffering from rhinitis, conjunctivitis, mild or moderate form of bronchial asthma of seasonal character, having hypersensitivity to birch pollen.

The immunotherapy can be carried out on adults and children from the age of 5 years.

Composition

Active ingredient:

Birch pollen allergen extract 10 IR/ml*, 300 IR/ml

Associates:

Sodium chloride,

Glycerol,

Mannitol,

purified water

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

How to take, the dosage

The effectiveness of ASIT is higher when treatment is started at an early stage of the disease.

Dosage and treatment regimen
The drug dosage and 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 the scheme of treatment according to the possible symptomatic changes in the patient and the individual response to the drug.

The treatment should be started at least 2-3 months prior to the expected flowering season and continued throughout the flowering season.

The treatment consists of two phases: initial and maintenance therapy.

1. Initial therapy begins with a daily dosing concentration of 10 IU/ml (blue bottle cap) with one press of the pipette and gradually increases the daily dosage to 10 presses. One pressure on the pipette is about 0.1 ml of the drug.
Then proceed to daily dosing of the 300 IU/ml concentration (purple vial cap), starting with a single press and gradually increasing the number of presses to the optimal (well tolerated by the patient). The first stage may last 9 to 21 days. During this period the maximum dosage is reached which is individual for each patient (4 to 8 pressings daily of 300 IU/ml concentration), after which the second stage begins.

2. 2. Maintenance therapy with a constant dose using a 300 I.R. concentration vial/ml.
The optimal dose achieved in the first phase of initial therapy is continued in the second phase of maintenance therapy.
Recommended dosing regimen: 4 to 8 doses daily or 8 doses 3 times a week.

Duration of treatment
Allergen-specific immunotherapy is recommended by the above mentioned two-stage courses (2-3 months before the supposed blooming season to the end of the season) for 3-5 years.
If after the treatment no improvement is seen during the first blooming season, the advisability of ASIT should be reconsidered.

How to use
Before taking the drug, make sure that:

• has not expired;
• use the correct concentration bottle.

The drug is recommended to be taken 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.

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

Prescribing interruption of the drug

In case of prolonged missing of taking the drug it is necessary to consult the attending physician.

If the missed dose is less than one week, it is recommended to continue treatment without change.

If the missed dose is more than one week at baseline or maintenance therapy, it is recommended that therapy be repeated with one press of the dosing device using the same concentration of the medication (as before the pause) and then increasing the number of presses, following the Initial Dose Control regimen to the optimal well tolerated dose.

Interaction

Do not use simultaneously with the intake of beta-adrenoblockers.

Possible simultaneous use with symptomatic antiallergic drugs (H1 antihistamines, beta-2-mimetics, corticoids, mast cell degranulation inhibitors) for better tolerance of ASIT.

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Contraindications

• High sensitivity to one of the excipients (see list of excipients.
• Autoimmune diseases, immunocomplex diseases, immunodeficiencies;
• Malignant neoplasms;
• Uncontrolled or severe bronchial asthma (forced expiratory volume < 70%);
• Therapy with beta-adrenoblockers (including topical therapy in ophthalmology);
• Severe inflammatory diseases of the oral mucosa, such as erosive and ulcerative forms of red lichen planus, mycoses.

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Side effects

The administration of ASIT may cause both local and general adverse reactions.
Dosage and treatment regimen may be revised by the treating physician in case of an individual reaction or changes in the patient’s general condition.
Local reactions:

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

In general, these symptoms go away quickly, and there is no need to change the dosage and treatment regimen. If symptoms occur frequently, continuation of therapy should be reconsidered.
General reactions are rare:

• rinitis, conjunctivitis, asthma, urticaria require symptomatic treatment with H1 antagonists, beta-2-mimetics, or corticosteroids (oral). The physician should reconsider the dosage and regimen or the possibility of continuing ASIT.
• In extremely rare cases, generalized urticaria, angioedema, laryngeal edema, severe asthma, and anaphylactic shock may occur, requiring cancellation of ASIT.

Rare side effects other than Ig-E mediator reactions:

• asthenia, headache;
• acute preclinical atopic eczema;

All side effects should be reported to the treating physician.

Overdose

If the prescribed dose is exceeded, there is an increased risk of side effects, which requires symptomatic treatment.

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