Staloral "Allergen ticks" (Staloral "Allergen of mites")

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspsublingual drops
Composition:

Active component:

Extract of mite allergen Dermatophagoides pteronyssinus, Dermatophagoides farinae in equal proportions 10 IR / ml *, 300 IR / ml.

Excipients:

sodium chloride, glycerol, mannitol, purified water

* IR / ml - The Reactivity Index is the biological standardization unit.

Description:

Transparent solution from colorless to yellow-brown in color.

Pharmacotherapeutic group:MIBP is an allergen
ATX: & nbsp
  • Allergens of insects
    • Pharmacodynamics:

    The exact mechanism of action of the allergen in the conduct of allergen specific immunotherapy (ASIT) is not fully understood.

    The following biological changes are proven:

    - the appearance of specific antibodies (IgG4), which play the role of "blocking antibodies";

    - reduction of specific IgE in plasma;

    - a decrease in the reactivity of cells involved in an allergic reaction;

    - increased interaction between Th2 and Th1, leading to a positive change in the production of cytokines (decrease IL-4 and increase γ-interferon), regulating production IgE.

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

    Indications:

    Allergen specific immunotherapy (ASIT) of patients with type 1 allergic reaction (IgE mediated), suffering from rhinitis, conjunctivitis, mild to moderate bronchial asthma,having increased sensitivity to house dust mites (D.pteronyssinus, D.farinae).

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

    Contraindications:

    - Hypersensitivity to one of the excipients (see list of excipients);

    - autoimmune diseases, immunocomplex diseases, immunodeficiencies;

    - malignant neoplasms;

    - uncontrolled or severe bronchial asthma (volume of forced exhalation 70%);

    - therapy with beta-blockers (including local therapy in ophthalmology);

    - severe inflammatory diseases of the oral mucosa, for example, erosive-ulcerative form of red flat lichen, mycoses.

    Pregnancy and lactation:

    Pregnancy

    Do not start ASIT during pregnancy.

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

    There were no reports of side effects when using ASIT in pregnant women.

    Breast-feeding

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

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

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

    Dosing and Administration:

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

    Dosage and treatment regimen

    The dosage of the drug and the scheme of its use are the same for all ages, but can be changed depending on thedithe patient's reactivity.

    The attending physician adjusts the dosage and treatment schedule 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 start with a daily intake of the drug concentration of 10 IR / ml (blue vial cap) with a single click on the dispenser and gradually increase the daily dosage to 10 clicks. One click on the dispenser is about 0.1 ml of the drug.

    Next, they switch to the daily intake of the drug at a concentration of 300 IR / ml (purple bottle cap), starting with a single press and gradually increasing the number of clicks to the optimal (well tolerated by the patient). The first stage can continue 9-21 day.During this period, the maximum dosage is achieved, individual for each patient (from 4 to 8 times daily, the drug concentration of 300 IR / ml), and then go to the second stage.

    Recommended scheme of the initial course ASIT:

    Bottle 10 IR / ml (blue cap)

    Bottle 300 IR / ml (purple cap)

    Day

    Number of dosing

    Day

    Number of dosing

    1

    1

    7

    1

    2

    2

    8

    2

    3

    4

    9

    4

    4

    6

    10

    6

    5

    8

    11

    8

    6

    10

    2. Supportive therapy a constant dose with the use of a vial of 300 IR / ml.

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

    Recommended reception scheme: from 4 to 8 clicks per dispenser daily or 8 clicks 3 times a week.

    Duration of treatment

    Supportive therapy is recommended for 3-5 years.

    If the improvement does not occur after the first year of treatment, the expediency of ASIT should be reviewed.

    Mode of application

    Before taking the drug, make sure that:

    - the expiration date has not expired;

    - The vial of the desired concentration is used.

    The drug is recommended in the morning before breakfast.

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

    Children it is recommended to use the drug with the help of adults.

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

    For the first time, open the bottle as follows:

    1. Tear off the colored plastic cover from the bottle.

    2. Pull the metal ring, removing the aluminum cap completely.

    3. Remove the rubber plug.

    4. Remove the dispenser from the plastic bag. Strongly taking the bottle with one hand, the other hand, strongly pressing the naked upper flat surface of the dispenser, snap it on the vial.

    5. Remove the protective ring in orange.

    6. Strongly push the dispenser 5 times over the sink. After five clicks, the dispenser dispenses the required amount of the drug.

    7. Place the tip of the dispenser in the mouth under the tongue. Strongly push the dispenser as many times as prescribed by your doctor to get the right amount of the drug. Hold the liquid under the tongue for 2 minutes.

    8. After use, wipe the tip of the dispenser and put on the protective ring.

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

    Interruption in taking the drug

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

    If the admission admission is less than one week, it is recommended to continue treatment of the disasters.

    If the admission admission is more than one week at the initial stage or with maintenance therapy, it is recommended to treat again with a single click on the dispenser, using the same concentration of the drug (as before the break), and then increase the number of strokes according to the initial phase of therapy up to the optimum tolerated dose.

    Side effects:

    Conducting ASIT can cause side reactions, both local and general.

    Dosage and treatment regimen can be reviewed by the attending physician in case of an individual reaction or changes in the general condition of the patient.

    Local Reactions:

    - oral: itching in the mouth, swelling, a feeling of discomfort in the mouth and throat, disruption of the salivary glands (increased salivation or dry mouth);

    - gastroenterological reactions: abdominal pain, nausea, diarrhea.

    Usually these symptoms quickly pass, and there is no need to change the dosage and treatment regimen.In case of frequent occurrence of symptoms, the possibility of continuing therapy should be reviewed.

    General reactions are rare:

    - rhinitis, conjunctivitis, asthma, urticaria require symptomatic treatment H1- antagonists, beta-2-mimetics or corticosteroids (orally). The physician should review the dosage and treatment regimen or the possibility of continuing ASIT.

    - In extremely rare cases, generalized urticaria, angioedema, laryngeal edema, severe asthma, anaphylactic shock are possible, which requires the cancellation of ASIT.

    Rare side effects not related to Ig-E mediated reactions:

    - asthenia, headache;

    - exacerbation of preclinical atopic eczema;

    - delayed reactions of the type of serum sickness with arthralgia, myalgia, urticaria, nausea, adenopathy, fever, which requires the cancellation of ASIT.

    All side effects should be reported to the doctor in charge.

    Overdose:

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

    Interaction:

    Do not use simultaneously with the use of beta-blockers.

    Possible simultaneous reception with symptomatic antiallergic drugs (H1-antigistamines, beta-2-mimetics, corticoids, inhibitors of degranulation of mast cells) for better tolerability of ASIT.

    Special instructions:

    If necessary, before the beginning of ASIT should stabilize the symptoms of allergy appropriate therapy.

    Patients undergoing an ASTI course should always have a medication to relieve allergy symptoms, such as corticosteroids, sympathomimetic and antihistamines.

    Immediately consult a doctor if there is severe itching of the palms, hands, soles of the legs, urticaria, edema of the lips, larynx, accompanied by difficulty swallowing, breathing, change of voice. In these cases, the doctor can recommend the use of epinephrine.

    In patients taking tricyclic antidepressants, monoamine oxidase inhibitors, the risk of epinephrine side effects up to a lethal outcome increases. This circumstance should be taken into account in the appointment of ASIT.

    In inflammatory processes in the oral cavity (fungi, aphthae, gum damage, removal / loss of teeth or surgical intervention), discontinue therapy until the inflammation is completely cured (at least for 7 days).

    During the course of the ASTI course, vaccination can be carried out after consultation with a doctor.

    For patients, especially children on a diet with reduced salt intake, it should be noted that the drug contains sodium chloride (one depression on the dispenser is about 0.1 ml of the drug with 5.9 mg of sodium chloride).

    During travel, make sure that the bottle is in an upright position. The bottle should be in the box with the protective ring on the dispenser. At the first opportunity, the bottle should be placed in the refrigerator.

    Form release / dosage:Drops are sublingual, 10 RI / ml and 300 IR / ml.
    Packaging:

    For 10 ml of the allergen with a content of 10 IR / ml and 300 IR / ml in glass bottles with a capacity of 14 ml, closed with rubber stoppers, sealed with aluminum caps with plastic blue color covers (10 RI / ml) and violet (300 RI / ml).

    The kit consists of: 1 bottle with Allergen 10 IR / ml, 2 vials with allergen 300 IR / ml and three dispensers or 2 vials with allergen 300 IR / ml and two dispensers or 5 bottles with the allergen 300 IR / ml and five 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 the reach of children.

    Shelf life:

    36 months.

    Do not use at expiration date

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-008340/10
    Date of registration:18.08.2010 / 05.11.2015
    The owner of the registration certificate:Stallergen, AOStallergen, AO France
    Manufacturer: & nbsp
    Representation: & nbspStallergen Vostok, OOOStallergen Vostok, OOO
    Information update date: & nbsp23.03.2016
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