Staloral "Allergen pollen of birch" - instructions for use, doses, side effects, contraindications

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Dosage form: & nbspDrops are sublingual.

Composition:In 10 ml contains:
Active ingredient:
Extract of the allergen from pollen of birch 10 IR / ml *, 300 IR / ml Excipients:
sodium chloride 590 mg, glycerol 5800 mg, mannitol 200 mg, water purified to 10 ml.
* IR / ml - The Reactivity Index is the biological standardization unit.

Description:Transparent solution from colorless to dark yellow color.

Pharmacotherapeutic group:MIBP-allergen.

Pharmacodynamics:The exact mechanism of action of the allergen in the conduct of allergen-specific immunotherapy (ASIT) has not been fully studied.
ASIT results in a change in the immune response of T-lymphocytes followed by an increase in the level of specific antibodies (IgG₄ and / or IgG₁ and, in some cases, IgA) and a decrease in the level of specific IgE. A secondary and, perhaps, a later immune response is immune deviation with a change in the immune response of specific T cells.

Indications:Allergen-specific immunotherapy (ASIT) is indicated for patients with type 1 allergic reaction (IgE mediated), manifested in the form of rhinitis, conjunctivitis, rhinoconjunctivitis, mild or moderate form of seasonal bronchial asthma, which has an increased sensitivity to birch pollen.
Immunotherapy can be given to adults and children from the age of 5.

Contraindications:- Hypersensitivity to any of the excipients included in the preparation;
- Active forms of severe immunodeficiency or autoimmune diseases;
- Malignant neoplasms;
- Uncontrolled or severe bronchial asthma (volume of forced expiration less than 70%);
- Inflammatory diseases of the oral mucosa (erosive-ulcerative form of red flat lichen, ulceration of the oral mucosa, mycosis of the oral mucosa);
- Therapy with beta-blockers.

Pregnancy and lactation:Pregnancy
There are no clinical data on the use of the drug during pregnancy.
Do not start ASIT during pregnancy.
If the pregnancy occurred during the first stage of treatment, then stop the therapy. If the pregnancy has 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
There are no clinical data on the use of the drug during breastfeeding. Data on the isolation of the active substance with breast milk are not available. Nevertheless, it is not recommended to begin the course of ASIT during the period of breastfeeding. The decision to continue the course of ASIT during breastfeeding should be taken after assessing the risk-benefit ratio.

Dosing and Administration:The effectiveness of ASIT is higher in those cases when treatment is started in the early stages of the disease.
The safety and efficacy of treatment in children younger than 5 years are not established.
Doses and treatment regimen
The dosage of the drug and the treatment regimen are the same for all ages, but can be changed depending on the individual reactivity of the patient.
The attending physician adjusts the dosing and treatment schedule according to the possible symptomatic changes in the patient and the individual response to the drug. Treatment is advisable to begin no later than 2-3 months before the expected flowering season, and continue throughout the flowering period.
Treatment consists of two stages: initial therapy (increasing the dose) and maintenance therapy (taking a maintenance dose).
1.Initial therapy begins with a daily intake of the drug at a dosage of 10 IR / ml (bottle with a blue lid) with a single click on the dispenser and gradually increase the dose to 5 strokes. One click on the dispenser is about 0.2 ml of the drug.
Next, go to the daily intake of the drug at a dosage of 300 IR / ml (vial with a violet lid), starting with one click and gradually increasing the number of clicks to the optimal (well tolerated by the patient). The first stage lasts 9 days. During this period, the maximum dose is achieved, individual for each patient (from 2 to 4 times daily, at a dosage of 300 IR / ml), and then proceeds to the second stage.
Recommended scheme of the initial course ASIT:

Day	Dosage of the drug	Number of dosing	Dose, MI
1	10 IR / ml (bottle with blue cover)	1	2
2		2	4
3		3	6
4		4	8
5		5	10
6	300 IR / ml (vial with a violet cover)	1	60
7		2	120
8		3	180
9		4	240

2. Supportive therapy with a constant dose with the use of the drug at a dosage 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 2 to 4 clicks on the dispenser daily or 4 clicks 3 times a week.The daily intake of the drug is preferred, since it is associated with better adherence to treatment than administration 3 times a week.
Duration of treatment
Allergenspecific immunotherapy is recommended for 3-5 years. If the improvement did not occur during the first flowering season, the expediency of ASIT should be reviewed.
Mode of application
Before using the drug, make sure that:
- the expiration date has not expired;
- A vial of the correct dosage is used.
The drug is recommended to be taken on an empty stomach during the day.
The drug should be dripped directly under the tongue with a dispenser and kept in the sublingual area for 2 minutes, then swallowed.
Children are advised 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 protective packaging. Place the vial on a flat surface and, firmly grasping it with one hand, snap the dispenser on the vial by pressing the other hand on the top surface of the dispenser.

5) Remove the protective ring of purple.

6) 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 drug under the tongue for 2 minutes.

8) After use, wipe the tip of the dispenser and put on the protective ring. It is necessary to place the vial with the dispenser in the refrigerator immediately after use.

For subsequent use, remove the protective ring and follow steps 7 and 8.
Interruption in taking the drug
If the admission admission is less than one week, it is recommended to continue treatment without changes.
If the admission admission is more than one week, it is recommended to treat again with one click on the dispenser, using a vial of the same dosage of the drug (as before the break)and then increase the number of clicks, according to the initial phase of therapy to the optimal well-tolerated dose.

Side effects:Possible adverse reactions are grouped according to systems and organs and frequency of occurrence: very often (≥1 / 10), often (≥1 / 100 to <1/10), infrequently (≥1 / 1000 to <1/100), rarely ( ≥1 / 10000 to <1/1000), very rarely (<1/10000).
Like any STALORAL drug, "Allergen Birch Pollen" can cause side reactions in some patients.
During treatment, both local and general adverse reactions may occur. These reactions can occur at the beginning of therapy and later in the treatment process.
Immediately stop taking the drug and consult a doctor if the following symptoms occur: severe allergic reactions with the rapid development of symptoms such as severe itching or rash, shortness of breath, abdominal pain, symptoms associated with a drop in blood pressure (dizziness, fainting).
The tolerability of the dose may vary depending on the patient's condition.
In case of adverse reactions, it is necessary to consult a doctor to review the therapy.It is possible to carry out preliminary treatment with antiallergic drugs, which reduce the frequency and severity of adverse reactions. From the side of the blood and lymphatic system: rarely - enlarged lymph nodes. From the immune system: infrequently - hypersensitivity; rarely - reactions by type of serum sickness.
From the nervous system: infrequently paresthesia; rarely - a headache.
From the side of the organ of vision: often - itching in the eyes; infrequently - conjunctivitis.
From the side of the hearing organ and labyrinthine disorders: often - itching of the ears.
From the respiratory system, chest and mediastinum: often-irritation in the throat, swelling of the pharynx, blisters in the oropharynx, rhinitis, cough; infrequent - exacerbation of asthma, dyspnoea, dysphonia, nasopharyngitis.
From the gastrointestinal tract: often - swelling of the lips, swelling of the tongue, itching in the oral cavity, edema of the oral cavity, paresthesia of the mouth, discomfort in the mouth, stomatitis, dysfunction of the salivary glands, nausea, vomiting, abdominal pain, diarrhea; infrequently - pain in the oral cavity, gastritis, spasm of the esophagus.
From the skin and subcutaneous tissue: often - itching, redness; infrequently, urticaria; rarely - eczema.
From the osteomuscular system and connective tissue: rarely - pain in the joints, pain in the muscles.
General disorders and disorders at the site of administration: rarely - asthenia, fever.
Post-event application experience: dry lips, changes in taste, edema of the oropharynx, laryngeal edema, angioedema, dizziness, anaphylactic shock, eosinophilic esophagitis.
If you experience any of the side effects listed in the manual or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:If the prescribed dose is exceeded, the risk of side effects and their severity increases, which requires symptomatic treatment.

Interaction:Possible simultaneous use with drugs for symptomatic treatment of allergies (antihistamines and / or nasal corticosteroids).
Caution should be exercised in prescribing and carrying out specific immunotherapy for patients taking tricyclic antidepressants and monoamine oxidase (MAO) inhibitors, since the use of epinephrine to stop possible allergic reactions in such patients can lead to life-threatening adverse reactions.
Vaccination can be carried out without interruption in treatment only after consulting a doctor.

Special instructions:Patients should inform the doctor of any concomitant diseases or worsening of the current allergic disease.
If necessary, before the start of the AS, IT should stabilize the allergy symptoms with appropriate therapy. Treatment should be postponed in the presence of severe clinical symptoms of an allergic disease at the time of initial therapy with the drug.
When allergic symptoms occur, it is necessary to use drugs such as glucocorticosteroids, antihistamines and β2-adrenomimetics.
ASIT should be administered with caution to patients taking tricyclic antidepressants, MAO inhibitors.
In inflammatory processes in the oral cavity (mycoses, aphthae, damage to the oral mucosa, loss of teeth or surgical operations in the oral cavity, including the removal of teeth), discontinue therapy with the drug until complete cure. It was reported about the occurrence of eosinophilic esophagitis associated with sublingual immunotherapy.If in the treatment with STALORAL "Allergen birch pollen" there are severe or persistent symptoms from the upper part of the digestive system, including a violation of swallowing or chest pain, therapy with STALORAL "Allergen birch pollen" should be discontinued and consult a doctor. Treatment can be resumed only after a doctor's consultation.
1 bottle with the drug contains 590 mg of sodium chloride (in 10 ml of the drug). This should be taken into account for patients on a diet with reduced salt intake, especially in children.
During travel, make sure that the bottle is in an upright position. The bottle should be in the box with a protective ring on the dispenser.

Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive vehicles and mechanisms.

Form release / dosage:Drops sublingual 10 IR / ml, 300 IR / ml.

Packaging:For 10 ml of the allergen containing 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 caps of blue (10 IR / ml) and purple (300 IR / ml).
The kit consists of: 1 bottle with allergen 10 IR / ml, 2 bottles with allergen 300 IR / ml and three dispensers or 2 bottles with allergen 300 IR ml and two dispensers or 5 bottles with allergen 300 IR / ml and five dispensers in a plastic box with Instructions for use.

Storage conditions:Store at a temperature of 2 to 8 ° C.
Keep out of the reach of children.

Shelf life:36 months.
Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-008339/10

Date of registration:18.08.2010 / 04.10.2016

Expiration Date:Unlimited

The owner of the registration certificate:Stallergen, AOStallergen, AO France

Manufacturer: & nbsp

STALLERGENES, S.A. France

Representation: & nbspStallergen Vostok, OOOStallergen Vostok, OOO

Information update date: & nbsp2016-12-20