Staloral Mite Allergen, drops 10 ml 5 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 reaction (IgE mediated), suffering from rhinitis, conjunctivitis, mild or moderate form of seasonal bronchial asthma, and hypersensitivity to house dust mites.

Immunotherapy can be administered to adults and children from 5 years of age.

Pharmacological effect

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), regulating the production of IgE.

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

Special instructions

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.

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.

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.

Active ingredient

Mite allergens

Composition

Active ingredient:

Allergen extract from Dermatophagoides pteronyssinus mites,

Dermatophagoides farinae in equal proportions 300 IR/ml;

Excipients:

sodium chloride,

glycerol,

mannitol,

purified water.

Contraindications

Hypersensitivity to one of the excipients (see list of excipients);
Autoimmune diseases, immune complex diseases, immunodeficiencies;
Malignant neoplasms;
Uncontrolled or severe bronchial asthma (forced expiratory volume <70%); 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.

Recommendations for use

The effectiveness of ASIT is higher in cases where treatment is started in the early stages of the disease.

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.

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 for 3-5 years. If there is no improvement after treatment, the advisability of ASIT should be reconsidered.

Taking the drug:

Before taking the drug, make sure that: the expiration date has not expired and the 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:

Tear off the colored plastic cap from the bottle.
Pull the metal ring to remove the aluminum cap completely.
Remove the rubber plug.
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.
Remove the orange protective ring.
Press the dispenser firmly 5 times over the sink. After five clicks, the dispenser dispenses the required amount of the drug.
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.
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 skip 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 treat 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.

Storage conditions

Store and transport at temperatures from 2 to 8°C.

Manufacturer

Stallergen, France