Index of drugs

Desensitization (specific immunotherapy) in allergic (IgE-dependent) diseases, such as: allergic rhinitis (rhinitis), allergic conjunctivitis, allergic bronchial asthma, etc., caused by allergens that can not be eliminated from the patient's environment.

Allergic extracts of plant origin, of animal origin (cat and dog fur), house dust mites and mold fungiAlternaria. The names of individual allergens and their percentage are given on the packaging. Standardization is carried out in TU (therapeutic units) or PNU (protein nitrogen units). Plant allergenic extracts (pollen): conc. 3 contains 5000TU / ml or 2500PNU / ml. Animal allergenic extracts (cat's fur, dog's fur): conc. 1 contains 25PNU / ml; conc. 2 contains 250PNU / ml; conc. 3 contains 2500PNU / ml. Allergenic extracts of mold fungiAlternaria: conc. 1 contains 5PNU / ml; conc. 2 contains 50PNU / ml; conc. 3 contains 500PNU / ml. Allergenic dust mite extracts: conc. 1 contains 50TU / ml or 50PNU / ml; conc. 2 contains 500TU / ml or 500PNU / ml; conc. 3 contains 5000TU / ml or 5000PNU / ml. The concentration of the allergen preparation is a dilution of the concentration of 3 in a ratio of 1:10, the concentration of 1 is a dilution of the concentration of 2 in the ratio 1:10.

Allergenic extracts. Specific immunotherapy involves injecting increasing doses of allergen preparations to relieve allergic symptoms. After subcutaneous administration, active substances are absorbed by cells presenting antigens in the skin, dendritic cells and macrophages, and then processed and presented to B and T type lymphocytes. The preparation is an allergenic extract, adsorbed on aluminum hydroxide to allow depot action and a sustained release of the allergen.

Hypersensitivity to any of the excipients. Inadequately controlled or slightly severe to severe asthma (GINA III / IV) - despite adequate FEV therapy₁<70% of the value due. Irreversible changes in the organ in which the allergic reaction occurs (eg emphysema, bronchiectasis). Inflammatory / fever-related diseases, severe acute or chronic diseases (including neoplastic diseases). Clinically important heart failure / cardiovascular disease - increased cardiovascular disease risk of side effects after adrenaline. Treatment with β-blockers (local or generalized). Multiple sclerosis. Diseases of the immune system (e.g., autoimmune diseases, immune complex diseases, immunological defects). Active pulmonary tuberculosis. Severe psychiatric disorders.

Before administering the injection, the patient must not have any acute symptoms (eg: allergic symptoms, cold), especially asthmatic symptoms. Special caution is recommended during: treatment with convertase inhibitors, treatment of patients who are not sufficiently prescribed, and pregnancy (due to the possibility of allergic shock reactions) - for safety reasons, specific immunotherapy should not be started during pregnancy. Due to the fact that adrenaline is recommended for the treatment of allergic adverse reactions, it is necessary to take into account contraindications to the use of adrenaline. On the day of injection you should avoid physical exercise (as well as alcohol, sauna, hot shower, etc.). If you need to be given antiviral or antimicrobial vaccines, a weekly interval should be maintained between the last injection of the allergen extract and the vaccination date. Desensitization is continued 2 weeks after vaccination with half of the last dose administered, then the dose is increased according to the dosing schedule every 7 to 14 days. If the composition (allergen) changes, the therapy should be restarted from the lowest concentration. This also applies to the case of prior specific immunotherapy with another preparation (also oral or sublingual). Immunotherapy is not recommended for children under 5 years of age.In children over 5 years, clinical efficacy data are limited and insufficient to confirm it, while safety data do not indicate a higher risk than in adults.

There is not enough experience with the use of the preparation during pregnancy and breastfeeding. Therefore, desensitization during pregnancy is not recommended. Although there is probably no risk for breast-fed infants, the risks and benefits should be assessed individually during lactation.

Local and generalized allergic reactions of varying severity, anaphylactic shock, fatigue, skin changes (granuloma, atopic dermatitis).

The dose must be individually selected; the recommended dosage regimens contained in the Summary of Product Characteristics are only indicative. Dosage must be adapted to the individual course of therapy. The degree of sensitization of the patient is determined based on the medical history and the result of the test response. Remember to regularly increase the dose. The dose may only be increased if the last dose is well tolerated. Otherwise, the last dose used should be maintained or reduced. The following scheme may be used as a model of conduct: increased local reaction - repeat the last well-tolerated dose; mild generalized response - go back in the dosing schedule by 2-3 doses; severe generalized reaction - re-start therapy with concentration 1. Further treatment should be strictly adjusted to the course and severity of allergic adverse reactions. In further therapy, intermediate doses may be included in the injection schedule, with the recommended intervals between injections.Initial treatment. In the case of all-season allergens, treatment begins in the period with the lowest possible severity of symptoms. Initial treatment always starts with the lowest dose of the lowest concentration (concentration 1). In children and highly sensitized patients, specific immunotherapy is carried out according to the "highly sensitive" dose regimen. Increasing doses of the preparation are injected at 7-day intervals, which in no case may be shortened, but may be extended to 14 days. used only in exceptional cases, because it may be accompanied by a higher incidence of localized and generalized reactions of greater severity.If initial treatment is discontinued later than 2 (to 4) weeks after the last injection, when taking the therapy, for safety reasons should be given at most half of the last given In the event of interruptions lasting longer than 4 weeks, the lowest dose of the lowest concentration (concentration 1) should be restarted. The dose escalation must be performed with caution, especially in children and highly sensitized patients, possibly with intermediate steps, up to indy The maximum dose in one injection is 1 ml of concentration 3, but the individual maximum dose for a given patient may be lower. After reaching the individual maximum dose, the gap between injections up to 4 weeks and then up to 6 weeks can be gradually increased.Maintenance treatment. In the case of seasonal allergens, during the flowering period, 5 to 20% of the maximum dose achieved can be injected at approximately 2 weeks intervals, the intervals between injections can be gradually extended to 4 weeks. After completion of flowering, the dose should be doubled at 2-week intervals, until the individual maximum dose is again reached; then, the gap between injections up to 4-6 weeks may be lengthened gradually. For all-season allergens (eg mites) the individual dose achieved is administered (after gradual extension of the intervals between injections) at 4-6 weeks intervals for a year after a significant relief of symptoms. When continuing treatment with a new pack, the first dose should be at most 20% (50% for mites) of the last dose administered. You can then increase the dose again (with a 7-14 day interval) to your individual maximum dose by introducing an intermediate dose with good tolerability.If the anticipated moment of injection is exceeded by no more than 2 weeks during maintenance therapy, therapy should be continued at most half the last dose administered for safety reasons. If the scheduled injection time is exceeded by more than 2 weeks, restarting the therapy is possible with at most 5% of the last dose administered. In the event of a break lasting over a year, the treatment should start at the lowest concentration.
Injections must be carried out by the doctor in sterile conditions, slowly and deeply subcutaneously on the outer surface of the arm, with the palm of the hand over the elbow, using a shortly grounded injection needle. Deep subcutaneous injection can be facilitated by the formation of a skinfold. After applying the preparation, the injection site should be squeezed for about 5 minutes. Vascular access should be strictly avoided (aspire!). Always have an anti-shock kit ready. After each injection, the patient must be observed for at least 30 minutes, after which the condition should be evaluated by a physician. Doses of 0.5-1 ml can be divided and administered in both arms. In the case of parallel treatment with two depot preparations on one day, a distance of at least 30 minutes between injections should be maintained. The second injection can only be performed after finding that the first injection has not caused an adverse reaction. It is recommended to maintain a 2-3 day interval between injections to more effectively avoid the effect of cumulation. The interval between injections of the same extract should not last less than 7 days. In addition, it is recommended to administer each allergenic extract in a separate arm. The result of treatment depends on from reaching the individual maximum dose, which can not be exceeded. The total duration of treatment is generally 3 years, if possible a year after the symptoms are clearly alleviated or they disappear.