Staloral Allergen of mites, initial course of drops 10 ml 3 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;
• decrease in the reactivity of the cells involved in the allergic reaction;
• increased interaction between Th2 and Th1, leading to a positive change in cytokine production (decreased IL-4 and increased ?-interferon) which regulate the production of IgE.

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) of patients with type 1 allergic reactions (IgE-mediated), suffering from rhinitis, conjunctivitis, mild or moderate form of bronchial asthma, having hypersensitivity to house dust mites (D.pteronyssinus, D.farinae).

The immunotherapy can be given to adults and children from the age of 5 years.

Composition

Active ingredient:

Dermatophagoides pteronyssinus mite allergen extract,

Dermatophagoides farinae in equal proportions of 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 possible symptomatic changes in the patient and individual reactivity to the drug.
The treatment consists of two phases: 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 the daily dosing of the 300 IU/ml concentration (purple bottle 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
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.

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

The drug is recommended to be taken in the morning before breakfast.

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

In children, it is recommended that the drug be taken with the help of an adult.

The bottles are sealed with plastic caps and sealed with aluminum caps for safety and preservation of the drug.

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

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 restarted with one press of the dosing device using the same concentration of the medication (as before the pause) and then increased in number of pressings, according to the Initial Treatment 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.

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 damages, tooth extraction/loss or surgery) the therapy should be stopped until the inflammations are completely cured (at least for 7 days).

During 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

Side effects

The administration of ASIT may cause both local and general adverse reactions.
The 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:

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:

Rare side effects not related to IgE mediator reactions:

Overdose

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