Index of drugs

Specific immunotherapy (desensitizing treatment) of allergic IgE-derived inhalation, with symptoms of allergic rhinitis, allergic conjunctivitis, allergic asthma. The diagnosis should be based on a detailed interview confirming the occurrence of hypersensitivity reactions to plant pollen.

1 ml of suspension contains 20,000 AUM of a mixture of allergoids of pollen: grasses, trees, grasses and trees or grasses and birches.

Preparation for specific immunotherapy containing chemically modified glutaraldehyde allergenic extracts (allergoids) of vegetable origin, adsorbed on aluminum hydroxide. The mechanism of action consists in modulating the function of T lymphocytes (shifting dominance from Th2 to Th1), creating specific IgG antibodies and decreasing the reactivity of the mediators producing cells. Modified plant pollen allergens are slowly released from aluminum hydroxide. After a subcutaneous injection, the pollen allergens remain at the injection site for several days. Due to the slow release and the possibility of accumulation, the minimum interval between two consecutive injections should be 7 days.

Hypersensitivity to the components of the preparation. Reduced immunity (eg due to the use of immunosuppressive drugs). Autoimmune diseases (e.g., rheumatic disease). Severe bronchial asthma, especially at FEV₁ persistent <70% of due or bronchoconstricoid-dependent bronchial asthma. Cardiovascular failure, treatment with β-blockers or ACE inhibitors. Contraindications to the use of adrenaline (eg hyperthyroidism). Serious mental disorder, difficult contact with the patient or failure to follow the doctor's instructions. Active tuberculosis. Cancer. Children under 5 years old. Pregnancy. If the treatment was started before pregnancy, it can be continued in consultation with the treating physician.

Do not start desensitization in the pollen season. During treatment, immediate access to an appropriate resuscitation and resuscitation set for the treatment of shock should be provided. In rare cases, the injection may result in increased systemic response (wheezing, shortness of breath, Quincke's angioedema, generalized urticaria), and in extreme cases, anaphylactic shock may occur. Typical warning signs are: a feeling of burning pain, pruritus, a feeling of heat on or under the tongue, in the throat, on the hands and soles of the feet. These symptoms directly precede the onset of anaphylactic shock with gray cyanosis, hypotension, tachycardia, bronchial stenosis and loss of consciousness. Treatment consists in the use of life-saving procedures. If desensitization is carried out during the pollen season, special precautions should be taken: during the pollen season, the preparation can only be administered to patients who do not show allergy symptoms; if during treatment during the pollen season the patient is diagnosed with allergy symptoms, the Next injection should be postponed until they disappear or discontinue the treatment. The patient should be warned about the need to avoid physical exertion (sports, hard physical work) before and after each injection of the product. Do not use in children under 5 years.

There is no documented data on the use of allergens in pregnant women. The potential risk to the mother and the fetus is unknown. During pregnancy and during breastfeeding, treatment with the preparation should not be started. If such treatment has been started before pregnancy, it can be continued in consultation with the treating physician.

In patients with a high degree of sensitization, the following side effects, occurring up to 30 minutes after injection, may occur. Common: slight swelling, subcutaneous thickening and swelling (granulomas) at the injection site.Rare: Quincke angioedema, exacerbation of allergic-specific allergic reactions in the form of atopic eczema, generalized urticaria, wheezing, shortness of breath, sneezing, coughing, severe local reaction in the form of severe swelling at the injection site diameter> 12 cm, pruritus in the area eyes. Very rare: anaphylactic shock (typical symptoms preceding anaphylactic shock are: burning pain, pruritus, feeling hot on or under the tongue, in the throat, on the hands and soles of the feet). Side effects may be more frequent after using the formula according to the accelerated pattern. Side effects may occur a few hours after the injection. Treatment of complications has been described in the Summary of Product Characteristics.

Subcutaneously. Adults and children ≥ 5 years. The preparation should only be used by specialist allergologists who have experience in the treatment. The preparation can be used before the pollen season or throughout the whole year.Initial treatment begins with a dose of 0.05 ml (the first injection) and then the dose is increased gradually at weekly intervals up to a maximum dose of 0.5 ml. Initial treatment is completed when the maximum dose is reached. Further treatment depends on the choice of treatment regimen, i.e. whether it will be shortened, pre-season or all-season immunotherapy.Initial treatment according to the accelerated pattern can be performed in adult patients: 3 injections at weekly intervals (0.1 ml, 0.3 ml and 0.5 ml) until the maximum dose is reached. After this treatment, maintenance treatment can be continued. Initial treatment according to the accelerated schedule has not been studied in patients younger than 18 years and requiring a different mixture of allergoids than the blend of grass pollen allergens.Short-term immunotherapy can be completed after 6 injections at weekly intervals, within 5 weeksPre-season or all-season maintenance immunotherapy. After the initial treatment is completed, injection is recommended every 14 days. If the patient tolerates the treatment well, after the third injection in the 14-day cycle, the interval between consecutive injections can be extended to 4 weeks (+/- 2 weeks). There is no need to reduce the dose after the start of the new vial. The attending physician may determine a different dosage based on the patient's degree of tolerance. Any decision to increase the dose must be based on an evaluation of the response after the last dose administered. You can continue treatment with an increased dose if you have no side effects and your allergic reaction has not increased after the last dose.Dose adjustment after exceeding the recommended interval between injections. During initial treatment, during which intervals between injections are 1 week, if the interval between injections is extended by: 2 weeks (3 weeks from the last injection), the dose should not be increased, but the dose given in the last injection should be repeated; 3 weeks (4 weeks from the last injection), the dose should be reduced by 0.1 ml; 4 weeks (5 weeks after the last injection), the dose should be reduced by 0.3 ml; more than 4 weeks (more than 5 weeks since the last injection), the treatment should start at the lowest doses. During the maintenance treatment, during which the intervals between injections are 4 weeks, if the interval between injections is extended by: up to 3 weeks (7 weeks from the last injection), repeat the last dose administered; 4 weeks (8 weeks since the last injection), the dose should be reduced by 0.1 ml, 5-6 weeks (9-10 weeks after the last injection), the dose should be reduced by 0.2 ml or 0.3 ml; over 6 weeks (more than 10 weeks since the last injection) - the treatment should start at the lowest doses.Dose adjustment in case of increased reaction: maximum reaction at the injection site with a diameter of up to 5 cm - the treatment should be continued according to the scheme; local reaction with a diameter of 5-12 cm - repeat the dose given in the last injection, do not increase the dose; swelling> 12 cm in diameter - reduce the dose by 0.1-0.3 ml; mild to intensive, generalized reaction - reduce the dose by 0.1-0.3 ml; severe generalized reactions or anaphylactic shock - a treatment regimen should be re-designed.
The patient should be under medical supervision for at least 30 minutes after the injection. The patient should be advised to consult a doctor if any adverse reactions occur.If two different formulations are used for specific immunotherapy using the same patient on the same day each in a different hand, it is recommended to administer each preparation with an interval of 15 min between successive injections. To avoid the effect of cumulation, it is recommended to administer each preparation on a different day, with a 2-3 day interval between injections. The full and lasting effect of the treatment is obtained after 3-5 years of use.