Staloral Mite Allergen maintenance course 10ml vial, 5pcs

Composition

Active Ingredient:

Allergen extract from mites Dermatophagoides pteronyssinus,

Dermatophagoides farinae in equal proportions 300 IR / ml;

Auxiliary substances:

sodium chloride,

glycerol,

mannitol,

purified water.

Pharmacological action

The exact mechanism of action of the allergen during allergen-specific immunotherapy (ASIT) is not fully understood. The following biological changes are proven: :

• the appearance of specific antibodies (IgG4) that play the role of “blocking antibodies”;
• a decrease in the level of specific IgE in plasma;
• a decrease in the reactivity of cells involved in an allergic reaction;
• an increase in the activity of the interaction between Th2 and Th1, leading to a positive change in the production of cytokines (a decrease in IL-4 and an increase in -interferon) that regulate IgE production.

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

Indications

Allergen-specific immunotherapy (ASIT) for patients with type 1 allergic reaction (IgE-mediated), rhinitis, conjunctivitis, mild or moderate seasonal bronchial asthma, and hypersensitivity to house dust mites.

Immunotherapy can be performed for adults and children from the age of 5 years.

Recommendations for use

The effectiveness of ASIT is higher in cases where treatment is initiated 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 a single tap on the dispenser and gradually increases the daily dosage to 10 taps. One tap on the dispenser is about 0.1 ml of the drug.

Then proceed to the daily intake of the drug at a concentration of 300 IR/ml (purple bottle cap), starting with a single tap and gradually increasing the number of taps to the optimal one (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 taps daily of the drug at 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 300 IR/ml.

The optimal dose achieved at the first stage of initial therapy is continued to be taken at the second stage of maintenance therapy.

Recommended dosage regimen: 4 to 8 taps on the dispenser daily or 8 taps 3 times a week.

• Duration of treatment

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

• Taking the drug:

Before taking the drug, make sure that:  the expiration date has not expired and a bottle of the desired concentration is used.

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.

To ensure the safety and security of the drug, the vials are hermetically sealed with plastic lids and rolled with aluminum caps.

When using it for the first time, open the bottle as follows:  

For subsequent use, remove the protective ring and follow steps 7 and 8.

• Break in taking the drug

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

If you missed taking the drug for less than one week, it is recommended to continue treatment without changes.

If the drug is missed for more than one week at the initial stage or during maintenance therapy, it is recommended to start treatment again with a single tap on the dispenser, using the same concentration of the drug (as before the break), and then increase the number of taps, according to the scheme of the initial stage of therapy, to the optimal well-tolerated dose.

Contraindications

• Hypersensitivity to one of the excipients (see the list of excipients);
• Autoimmune diseases, immunocomplex diseases, and immunodeficiency disorders; 
• Malignant neoplasms;
• Uncontrolled or severe bronchial asthma (forced expiratory volume < 70%);
• Beta-blocker therapy (including topical therapy in ophthalmology);
• Severe inflammatory diseases of the oral mucosa, for example, erosive and ulcerative form of lichen planus, mycoses.

Special instructions

Do not start ASIT during pregnancy.

If pregnancy occurs at the first stage of treatment, then therapy should be discontinued. If pregnancy occurs during maintenance therapy, the doctor should evaluate the possible benefits of ASIT based on the general condition of the patient.

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

It is not recommended to start the ASIT course during breastfeeding.

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

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

For patients, especially children, who are on a diet with reduced salt intake, it should be taken into account that the drug contains sodium chloride (one tap on the dispenser makes about 0.1 ml of the drug with a content of 5.9 mg of sodium chloride).

When traveling, make sure that the bottle is in an upright position. The bottle should be placed in a box with a protective ring on the dispenser. The bottle should be placed in the refrigerator as soon as possible.

Product form

5 vials of 10 ml allergen containing 300 IR / ml in glass vials closed with rubber stoppers complete with dispensers in a plastic box with Instructions for use.

Storage conditions

Store and transport at a temperature of 2 to 8°C. Keep out of reach of children.

Active ingredient

Tick allergens

Conditions of release from pharmacies

By prescription

Dosage form

oral drops