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 reactions (IgE-mediated) suffering from rhinitis, conjunctivitis, mild to moderate forms of seasonal bronchial asthma, having hypersensitivity to house dust mites.

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

Composition

Active ingredient:

Allergen extract from Dermatophagoides pteronyssinus mites,

Dermatophagoides farinae in equal proportions of 300 IR/ml;

Associates:

Sodium chloride,

Glycerol,

Mannitol,

Purified water.

Directions for use

The effectiveness of ASIT is higher when treatment is started early in the course of the disease.

The dosage and regimen are the same for all ages, but can be changed depending on a patient’s individual reactivity.

The attending physician will adjust the dosage and the regimen according to the patient’s possible symptomatic changes and individual response to the drug.

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

1. Initial therapy starts 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 press of the pipette is about 0.1 ml of product.

Then we progress to daily dosing at 300 IU/ml (purple vial cap), starting with one squeeze and gradually increasing to the optimal (well tolerated by the patient) dosing amount. 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. Maintenance therapy with a constant dose using a 300 IU/ml bottle.

The optimal dose achieved in the first phase of initial therapy is continued in the second phase of maintenance therapy.

The recommended dosing regimen is 4 to 8 doses daily or 8 doses 3 times weekly.

• Duration of treatment

Allergen specific immunotherapy is recommended for 3-5 years. If there is no improvement after treatment, the appropriateness of ASIT should be reconsidered.

• Taking the medication:

Be sure before taking the medication that: the expiration date has not expired and the correct vial concentration is used.

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 an adult should be used with the medication.

The bottles are sealed with plastic caps and rolled aluminum caps to ensure safety and preservation of the product.

The first time you use the vial, open it as follows:

1. Remove the colored plastic cap from the vial.
2. Pull on the metal ring, pulling the aluminum cap all the way off.
3. Pull out the rubber stopper.
4. Pick the dispenser out of the plastic container. Holding the bottle firmly in one hand, with the other hand, press down firmly on the top flat surface of the pipette, snap it onto the bottle.
5. Remove the orange protective ring.
6. Press the pipette firmly 5 times over the sink. After 5 squeezes, the pipette dispenses the desired amount of product.
7. Place the tip of the pipette in your mouth under your tongue. Press down firmly on the pipette as many times as your doctor prescribes to get the desired amount of medication. Hold the liquid under your tongue for 2 minutes.
8. After use, wipe the pipette tip and put on the protective ring.

When using again, remove the protective ring and follow steps 7 and 8.

• Interruption of medication

Consult with your doctor if you skip taking the medication for a long time.

If the missed dose is less than one week, it is recommended that you continue treatment without modification.

If the missed dose is more than one week during initial or maintenance therapy, it is recommended that we repeat treatment with one press of the dosing device using the same concentration of the medication (as before the pause) and then increase the number of presses, following the Initial Dose Control regimen to the optimal tolerated dose.

Special Instructions

Assit should not be started during pregnancy.

If pregnancy occurs during the first phase of treatment, the therapy should be discontinued. If pregnancy occurs during maintenance therapy, the physician should evaluate the possible benefit of ASIT based on the patient’s general condition.

No adverse events have been reported with the use of ASIT in pregnant women.

It is not recommended to start a course of ASIT while breastfeeding.

If a woman continues to have ASIT during lactation, no adverse symptoms or reactions are expected in children.

There are no clinical data on the use of the drug during lactation.

For patients, especially children on a salt-reduced diet, be aware that the product contains sodium chloride (one press of the pipette is about 0.1 mL of the product containing 5.9 mg of sodium chloride).

Make sure the bottle is upright during travel. The bottle should be in a box with a protective ring on the dispenser. Whenever possible, the bottle should be placed in the refrigerator.

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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