Steeloral "Tick Allergen" - Instructions For Use, Supporting Course

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Steeloral "Tick Allergen"

Steeloral "Tick Allergen": instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. Drug interactions
12. 12. Analogs
13. 13. Terms and conditions of storage
14. 14. Terms of dispensing from pharmacies
15. 15. Reviews
16. 16. Price in pharmacies

Latin name: Staloral "Allergen of mites"

ATX code: V01AA03

Active ingredient: household allergens (Domestic allergens)

Manufacturer: Stallerzhen S. A. (Stallergenes SA) (France)

Description and photo update: 2019-30-12

Staloral "Tick Allergen" is a drug used for allergen-specific immunotherapy (ASIT) in people with hypersensitivity to house dust mites.

Release form and composition

The drug is produced in the form of sublingual drops: a clear liquid from colorless to yellow-brown color [10 ml at a dosage of 10 or 300 TS / ml * in a glass bottle with a volume of 14 ml, closed with a rubber stopper, sealed with an aluminum cap with a blue plastic cap (10 IR / ml) and violet (300 TS / ml) colors; 1 set includes: 1 bottle of 10 IR / ml, 2 bottles of 300 IR / ml and 3 dispensers, or 2 bottles of 300 IR ml and 2 dispensers, or 5 bottles of 300 IR / ml and 5 dispensers; in a plastic box 1 set and instructions for use Staloral "Mites allergen"].

* IR / ml - Reactivity Index, biological standardization unit.

10 ml of the preparation contains:

• active substance: extract of the allergen from Dermatophagoides pteronyssinus, Dermatophagoides farinae mites in equal proportions - 10 or 300 IR / ml;
• additional components: mannitol, glycerol, sodium chloride, purified water.

Pharmacological properties

Pharmacodynamics

Steeloral "Tick Allergen" is a medical immunobiological preparation (MIBP), an allergen.

When performing ASIT, the exact mechanism of action of the allergen has not been thoroughly studied. It has been established that Staloral "Tick Allergen" leads to the appearance of specific antibodies - immunoglobulins G ₄ (IgG ₄), which perform the mission of blocking antibodies; reduces the plasma content of specific total immunoglobulins E (IgE) and the reactivity of cells involved in an allergic reaction. It has also been proven that the drug enhances the activity of interaction between type 2 T-helpers (Th2) and type 1 T-helpers (Th1), which provides a positive change in cytokine production, namely, an increase in γ-interferon and a decrease in interleukin 4 (IL- 4), regulating IgE synthesis.

Against the background of ASIT, the development of an immediate allergic reaction, including its early and late phases, also slows down.

Indications for use

Staloral "Tick Allergen" is recommended for ASIT in children from 5 years of age and adults with an allergic reaction of type 1 (IgE-mediated), manifested by rhinitis, rhinoconjunctivitis, conjunctivitis, mild or moderate form of bronchial asthma, with hypersensitivity to house dust mites (D. Pteronyssinus and / or D. farinae).

Contraindications

• uncontrolled or severe bronchial asthma (forced expiratory volume 70%);
• active forms of severe autoimmune diseases or immunodeficiencies;
• inflammatory lesions of the oral mucosa (ulceration, mycoses of the oral mucosa, erosive and ulcerative form of lichen planus of the oral mucosa);
• malignant neoplasms;
• therapy with β-blockers (including local therapy in ophthalmology);
• hypersensitivity to any of the additional components.

Steeloral "Allergen of ticks", instructions for use: method and dosage

Staloral "Mite Allergen" is instilled directly under the tongue using a dispenser and then kept in the sublingual area for 2 minutes, after which it is swallowed. The drops are administered on an empty stomach during the day. Children need to apply the allergen with the help of an adult.

The effectiveness of ASIT is enhanced in cases when it is started in the early stages of the disease. The scheme of use of the drug and its dosage are the same for patients of any age, but can be changed taking into account the individual reactivity of the patient. The doctor adjusts the dose and treatment regimen based on possible symptomatic changes and individual reaction to Staloral “Tick Allergen”. It is recommended to carry out therapy throughout the year. Treatment includes 2 stages - initial and maintenance therapy.

Initial therapy

At the initial stage of treatment (dose escalation), Staloral “Mite Allergen” is used daily at a concentration of 10 IR / ml (contents of a bottle with a blue cap), starting with 1 press on the dispenser and then gradually increasing to 5. At 1 press on the dispenser, approximately 0.2 ml of the product. In the future, the patient is transferred to a daily dose of the drug at a concentration of 300 IR / ml (bottle with a purple cap), starting with 1 pressing, and gradually increasing the number of injections to the most optimal (well tolerated). The first stage lasts 9 days. During this period, an individual maximum dose is determined - from 2 to 4 clicks daily at a dosage of 300 IR / ml, then the second stage of treatment is started.

Recommended scheme for the initial course (number of pressings on the dispenser - dose) for a dosage of 10 IR / ml (blue cap):

• I day: 1 - 2 IR;
• II day: 2 - 4 IR;
• III day: 3 - 6 IR;
• IV day: 4 - 8 IR;
• V day: 5 - 10 IR.

For a dosage of 300 RI / ml (purple cap):

• VI day: 1 - 60 IR;
• VII day: 2 - 120 IR;
• VIII day: 3 - 180 IR;
• IX day: 4 - 240 IR.

Supportive therapy

Supportive course of Staloral "Mite allergen", using drops of concentration 300 IR / ml in a constant optimal dose determined during the initial treatment. Recommended scheme: daily from 2 to 4 presses on the dispenser or 3 times a week for 4 presses. It is preferable to use the drug daily, since at a given frequency of administration, adherence to treatment increases when compared with taking 3 times a week. According to the results of clinical studies, the agent is well tolerated in a daily dose of 300 IR.

ASIT is recommended to be carried out for 3-5 years. If after the first year of therapy there is no improvement, it is required to reconsider the appropriateness of the performed ASIT.

In order to preserve and ensure safety, the vials with the drug are hermetically sealed with lids and sealed with caps.

When using for the first time, it is recommended to use a bottle of Staloral "Tick Allergen" as follows:

1. Tear off the colored plastic cover.
2. Pull on the metal ring to remove the entire aluminum cap.
3. Remove the rubber plug.
4. Remove the dispenser from the protective packaging. Place the bottle on a smooth surface and, holding it securely with one hand, snap the dispenser onto it by pressing the upper surface of the latter with the other hand.
5. Remove the purple protective ring.
6. Over the sink, press the dispenser 5 times strongly, because after this number of presses it provides the required dose of the drug.
7. Place the pipette tip in your mouth under the tongue and press down firmly on the pipette as many times as prescribed by your doctor to deliver the required dose. Hold the product under the tongue for 2 minutes.
8. After completing the procedure, wipe the pipette tip and put on the protective ring. A bottle equipped with a dispenser must be immediately placed in the refrigerator.

The next time you use the bottle, you need to remove the protective ring and follow points 7 and 8.

In case of prolonged skipping of taking immunotherapeutic agents, it is necessary to consult your doctor. If the interval in admission is less than 1 week, it is recommended to continue therapy without changes. When more than 1 week is missed, you should start taking it again with one press on the dispenser, using Staloral "Mite Allergen" of the same concentration as before the break, and then increase the number of clicks in accordance with the scheme of the initial stage of treatment to the optimal dose.

Side effects

During the period of therapy, both local and general side effects may develop. These phenomena can be observed at the beginning of treatment and during its further implementation of immune therapy. It is necessary to stop using Staloral "Mite Allergen" and consult a doctor in case of severe allergic reactions with the rapid onset of the following symptoms: severe itching or rash, abdominal pain, shortness of breath; disorders caused by a drop in blood pressure (BP) - dizziness, fainting.

If side effects develop, you should consult a specialist for a possible revision of therapy. Pre-treatment with antihistamines may be prescribed to reduce the severity and frequency of adverse reactions.

Side effects that may occur during ASIT:

• immune system: infrequently - hypersensitivity; rarely - reactions like serum sickness;
• blood and lymphatic system: rarely - enlarged lymph nodes;
• respiratory system, chest and mediastinal organs: often - rhinitis, throat irritation, cough, oropharyngeal blisters, pharyngeal edema; infrequently - dysphonia, dyspnea, nasopharyngitis, exacerbation of asthma;
• organ of hearing and labyrinthine disorders: often - itchy ears;
• organ of vision: often - itching in the eyes; infrequently - conjunctivitis;
• nervous system: infrequently - paresthesia; rarely headache;
• digestive tract: often - discomfort / itching in the oral cavity, paresthesia of the oral cavity, stomatitis, disruption of the salivary glands, edema of the lips, swelling of the tongue, edema of the oral mucosa, nausea, vomiting, diarrhea, abdominal pain; infrequently - pain in the mouth, esophageal spasm, gastritis;
• musculoskeletal system and connective tissue: rarely - muscle pain, joint pain;
• skin and subcutaneous fat: often - redness, itching; infrequently - urticaria; rarely - eczema;
• general disorders and disorders at the injection site: rarely - fever, asthenia.

According to the post-registration experience of use, the development of such disorders was noted: a change in taste, dry lips, dizziness, laryngeal edema, oropharyngeal edema, eosinophilic esophagitis, angioedema, anaphylactic shock.

It is required to inform the attending physician about the occurrence of any adverse reactions.

Overdose

In the case of administration of doses of Staloral "Tick Allergen" exceeding the recommended ones, the risk of adverse reactions and an increase in their severity is aggravated. Which may require the appointment of symptomatic treatment.

special instructions

It is necessary to inform the doctor about the development of any concomitant diseases or about the aggravation of the course of the allergy.

If necessary, before starting ASIT, it is necessary to achieve stability of allergy symptoms through appropriate treatment. Specific immunotherapy should be postponed if, by the time of its initial stage, severe clinical symptoms of an allergic disease are recorded.

In case of manifestations of allergy, it is necessary to use antihistamines, glucocorticosteroids and β ₂ -adrenomimetics.

Against the background of inflammatory processes in the oral cavity, including aphthae, damage to the oral mucosa, mycoses, loss / extraction of teeth or surgical interventions in the oral cavity, it is recommended to interrupt the use of Staloral "Mite Allergen" until complete recovery.

There are reports of cases of the development of eosinophilic esophagitis caused by sublingual immunotherapy, therefore, if during the period of use of the drug there are severe / persistent symptoms from the upper digestive system, including chest pain or swallowing problems, therapy should be suspended and consult a doctor … It is possible to resume taking Staloral "Tick Allergen" only after consulting a specialist.

10 ml of the product (1 bottle) contains 590 mg of sodium chloride, which should be taken into account by patients on a diet with low salt intake, especially children.

During travel (movement), the bottle must be in an upright position.

Influence on the ability to drive vehicles and complex mechanisms

Steeloral "Mite allergen" does not affect the ability to drive vehicles and control complex equipment.

Application during pregnancy and lactation

You should not start ASIT during pregnancy and lactation.

In the case when pregnancy occurs during the initial stage of treatment, therapy should be discontinued. If pregnancy was established in the course of the maintenance course Staloral "Tick Allergen", the doctor, based on the general condition of the patient, needs to evaluate the possible benefits of further implementation of ASIT.

There are no reports of adverse reactions that have occurred in pregnant women during the period of drug treatment.

If during lactation a woman continues ASIT, the development of any adverse manifestations in the child is not expected. There are no clinical data on the use of Staloral "Tick Allergen" during breastfeeding.

Pediatric use

For children under 5 years of age, therapy with Staloral "Tick Allergen" is contraindicated, since there is no data confirming the effectiveness and safety of its implementation in patients of this age category.

Drug interactions

• drugs for the symptomatic treatment of allergies (nasal corticosteroids and / or antihistamines): their simultaneous use with the drug is allowed;
• vaccines: vaccination is possible without a break in ASIT only after consulting a doctor;
• monoamine oxidase (MAO) inhibitors, tricyclic antidepressants: the threat of life-threatening adverse reactions is exacerbated if epinephrine is used during ASIT to relieve possible allergic reactions.

Analogs

Analogs of Staloral “Mite Allergen” are Acarizax, Dermatophagoides pteronyssinus mite allergen for diagnosis and treatment, Dermatophagoides pteronyssinus mite and house dust mite mix for diagnostics and treatment, Dermatophagoides farinae mite allergen for diagnosis and treatment, Dermatophagoides farinae mite allergen for diagnosis and treatment, Mite-allergen farinae and house dust for diagnosis and treatment.

Terms and conditions of storage

Keep out of the reach of children. Store and transport at 2–8 ° С.

The shelf life is 36 months.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Staloral "Tick Allergen"

The few reviews about Staloral "Tick Allergen" are mostly positive. They note that the manifestations of allergies begin to diminish 3-5 months after the start of admission, and after 2-3 years of ASIT, many people practically do not experience hypersensitivity reactions. According to patients, the drug effectively treats allergies, and not only temporarily relieves its symptoms. Thanks to specific immunotherapy, people with allergies do not need to use antihistamines and hormonal agents, they have an allergic cough, the threat of bronchitis and bronchial asthma is eliminated. Steeloral "Mite Allergen" is easy to use, it does not need to be injected.

However, some patients conducting ASIT doubt that after the completion of long-term treatment, allergies will no longer arise, since doctors do not give any guarantees. The disadvantages of the remedy include a rather long course of treatment, the high cost of Staloral "Tick Allergen" and the development of side effects.

Price for Staloral "Mite allergen" in pharmacies

The price of Staloral "Mite Allergen", sublingual drops, 10 ml per bottle, can be: maintenance course, for 2 bottles of 300 IR / ml - 3820 rubles, for 5 bottles of 300 IR / ml - 7250 rubles; initial course, a set including sublingual drops 10 IR / ml - 1 bottle 10 ml, sublingual drops 300 IR / ml - 2 bottles of 10 ml each, dispensers - 3 pcs. - from 5246 to 6500 rubles.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!