Staloral Mite Allergen, drops 10 ml 2 pcs

The exact mechanism of allergen action 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 bronchial asthma, having hypersensitivity to house dust mites (D.pteronyssinus, D.farinae).

Active ingredient

Mite allergens

Composition

Active ingredient:

Allergen extract from mites Dermatophagoides pteronyssinus, Dermatophagoides farinae in equal proportions of 10 IR/ml*, 300 IR/ml

Associates:

Sodium chloride,

Glycerol,

Mannitol,

p> 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 early in the course 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 possible symptomatic changes in the patient and individual reactions to the drug.
The treatment consists of two stages: initial and maintenance therapy.

1. Initial therapy begins with a daily dose of 10 IU/ml (blue bottle cap) with one press of the pipette and gradually increases the daily dose 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, individual for each patient (4 to 8 pressings daily of the 300 IU/ml concentration) is reached, after which the second stage begins.

2. Maintenance therapy with a constant dose using a vial of the concentration of 300 IR/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 per week.

Duration of treatment
Maintenance therapy is recommended for 3-5 years.
If there is no improvement after the first year of treatment, the advisability of ASIT should be reconsidered.

Interruption of the drug
If the drug is missed for a long time, consult with the treating physician.
If the missed dose is less than one week, it is recommended to continue treatment unchanged.
If the missed dose is more than one week during initial or maintenance therapy, it is recommended to start treatment again with one press of the dosing device using the same concentration of the drug (as before the break) and then increase the number of presses, according to the scheme of the initial stage of therapy up 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.

.

Special Instructions

If necessary, allergy symptoms should be stabilized with appropriate therapy before starting ASIT.
Patients undergoing ASIT should always carry medications to relieve allergy symptoms, such as corticosteroids, sympathomimetics and antihistamines.

When severe itching of the palms, hands, soles of the feet, hives, swelling of the lips, larynx, accompanied by difficulty in swallowing, breathing, changes in voice should be consulted immediately. In these cases, the doctor may recommend taking epinephrine. Patients taking tricyclic antidepressants, monoamine oxidase inhibitors have an increased risk of side effects of epinephrine up to fatal outcome. This fact should be taken into consideration when prescribing ASIT.

In case of inflammatory processes in the oral cavity (mycosis, aphthae, gum damage, tooth extraction/loss or surgery) the therapy should be stopped until the inflammations are completely cured (at least for 7 days).

In the course of ASIT, vaccination is possible after consultation with the doctor.

For patients, especially children on a diet with reduced salt intake, note that the drug contains sodium chloride (one press of the pipette 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. At the first opportunity, the bottle should be placed in the refrigerator.

.

Contraindications

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

.

Side effects

Local reactions:

• oral: oral itching, swelling, feeling of discomfort in the mouth and throat, disruption 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:

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

Rare side effects not related to 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.

.