Index of drugs

Plant pollen allergens for desensitization (specific immunotherapy). Causal treatment of 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.

Set for the basic treatment: vial A - 1000 TU / ml (therapeutic units / ml), vial B - 10,000 TU / ml plant pollen allergoids. Maintenance kit: vial B - 10,000 TU / ml plant pollen allergens. The composition of the preparation is selected individually depending on the spectrum of patient sensitization.

Standardized allergenic extracts of vegetable origin. Following subcutaneous administration, the active substances are absorbed by cells presenting antigens in the skin, dendritic cells and macrophages, and then processed and presented to B and T lymphocytes. The allergens contained in the preparation have been modified to reduce their reactivity with IgE class antibodies. In this way activation of mast cells and basophils was reduced as well as the release of inflammatory mediators responsible for triggering allergic reactions. Reactivity with T lymphocytes and immunogenicity of allergoids have been preserved. The preparation is an allergenic extract, adsorbed on aluminum hydroxide, which allows the gradual release of active substances.

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 severe disease symptoms, in particular asthmatic complaints. Particular caution is recommended during: treatment with convertase inhibitors, treatment of patients not adequately complying with medical recommendations, pregnancy (due to the possibility of anaphylactic reactions). 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 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 there is a change in the composition, the therapy should be restarted from the lowest concentration. This also applies to the case of earlier desensitization with another preparation (also oral or sublingual). Children under 5 years of age are not usually suitable candidates for immunotherapy due to higher probability of cooperation problems than in adults. 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.

Common: pruritus, rhinitis, injection site reactions (swelling, pruritus, erythema, pain). Uncommon: urticaria, inflammation or swelling of the conjunctiva, coughing, shortness of breath, sneezing, throat irritation, wheezing, pruritus, pruritus, rash, joint pain, peripheral edema, swelling, granuloma, hypertrophy or vesicles at the injection site. The following may occur: hypotension, tachycardia, weakness, anxiety, anaphylactic shock. After the onset of intolerance during injection, the administration of the allergen should be stopped immediately. In isolated cases, there may be delayed reactions at the injection site (visible symptom of immune response). Occasionally, side effects may occur a few hours after injection.

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 sensitivity of the patient is determined based on the interview and the result of the test response. The dose can 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 the lowest dose of conc. A. Further treatment should be strictly adjusted to the 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 seasonal allergens, treatment begins before the season, up to 7 weeks before the expected pollen season. Injections should be completed about 1 week before pollination begins. It should be taken into account that pollination in early flowering trees - such as hazel or alder - may occur already in January or even earlier. Initial treatment should always be started with the lowest dose of lower concentration (A) - 0.1 ml. Increased doses of the preparation (concentration A: 0.2 ml, 0.4 ml, 0.8 ml, then concentration B: 0.15 ml, 0.3 ml, 0.6 ml) should be injected at seven-day intervals, which in no case may be shortened, but may be extended to 14 days. In the case of very early pre-season therapy, significantly preceding the natural dusting period, after 14 days from reaching the individual maximum dose, another injection can be made. At the same time, you can gradually extend the gap between injections up to 4-8 weeks, finishing them one week before the expected beginning of pollination. If the initial treatment has been discontinued for more than 2 weeks (up to 4 weeks) from the last injection, for safety reasons, the treatment should be continued at the most-used half of the last dose administered. If the interruption lasted longer than 4 weeks, treatment should be initiated with the lowest dose of A concentration. The dose should be increased with caution, especially in highly sensitized patients, with the possible introduction of intermediate doses, until the individual maximum tolerance level is reached. It corresponds to the individual maximum dose, which must not be exceeded (risk of allergic adverse reactions). The maximum dose is 0.6 ml conc. B, but the individual maximum dose for a given patient may be smaller.Maintenance treatment. It is most often carried out in the Next year before the pollen season with a new packaging of concentrate. A and B. In the case of treatment also during the flowering period, 5 to 20% of the maximum achieved dose can be injected at approx. 2-week intervals, the intervals between injections can be gradually extended to 4-8 weeks. After the flowering period should be doubled dose at 2-week intervals until the individual maximum dose is again reached; then the gap between injections up to 4-8 weeks may be gradually prolonged. If the maintenance treatment is interrupted for more than 8 weeks after the last injection, for safety reasons, the therapy should be continued with at most half the last dose administered. In the event of a break lasting longer than 9 weeks, it is necessary to restart therapy with concentrations A and B.It is not necessary to reduce the first dose from the new package of the maintenance kit.
Injections must be carried out by the doctor under sterile conditions, slowly and deeply subcutaneously on the outer surface of the extensors of the arm, the width of the hand above the elbow joint, using a shortly ground 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!). After each injection, the patient must be observed for at least 30 minutes, after which the condition should be evaluated by a physician. In the case of running in a single day of parallel therapy with depot preparations, 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. A 2-3 day interval between injections is recommended to 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 duration of treatment is generally 3 years, if possible a year after the symptoms have been clearly alleviated or their resolution resolved.