Index of drugs

Diagnostics (skin tests) and specific immunotherapy (desensitizing treatment) of allergic IgE-dependent diseases of hymenoptera (bee or wasp). The indication should be based on a detailed interview that confirms the occurrence of hypersensitivity reactions to the patient's insect venom.

One vial contains 120 μg of lyophilized insect venom (wasp or bee).

Preparation for the diagnosis and immunotherapy of specific (desensitization) IgE-dependent allergy to Hymenoptera poison (wasps or bees). The mechanism of action includes: modulation of T cell functions (shift of domination from Th2 to Th1), formation of IgG antibodies, reduction of reactivity of the cells that trigger mediators.

Hypersensitivity to any of the excipients. Reduced immunity (eg due to the use of immunosuppressive drugs). Autoimmune diseases (e.g., rheumatic disease). Severe bronchial asthma, especially at FEV₁ persistently at the level of <70% of the due value or glucocorticosteroid-dependent bronchial asthma. Cardiovascular failure, treatment with β-blockers or ACE inhibitors. Contraindications to the use of adrenaline (eg hyperthyroidism). Active tuberculosis. Cancer. Serious mental disorder, difficult contact with the patient or failure to follow the doctor's instructions. Pregnancy; if the treatment was started before pregnancy, it can be continued on the recommendation and in consultation with the treating physician.

During treatment, a direct reanitary-resuscitation kit should be available for the treatment of shock. The patient should be informed about the need to avoid physical exercise (sport, hard physical work) before and after each injection of the drug. acute and chronic eczema (eczema), eg atopic dermatitis at the test site, secondary inflammation or secondary degenerative dermatitis (eg ichthyosis, scleroderma), generalized or induced urticaria (dermographism) affect the skin's reactivity and can largely change results of skin tests. Before using the drug in children aged <5 years, a risk-benefit ratio should be considered. Data on clinical efficacy in children aged ≥5 years are limited, while safety data do not indicate a higher risk than in adults.

Specific immunotherapy should not be initiated during pregnancy and breast-feeding. However, if the treatment was started before pregnancy, it can be continued on the recommendation and in consultation with the treating physician.

They are rare. There have been reports of generalized reactions (runny nose, shortness of breath, angioneurotic edema) and intensified local reactions of cli (erythema, edema, transient sclerosis of the subcutaneous tissue). Mild local reactions at the injection site are common (in more than 10% of patients). For patients with a high degree of sensitivity, the following hypersensitivity reactions described below may occur within 30 minutes after the injection. Rare: severe systemic reactions - wheezing, shortness of breath, Quincke's angioedema, generalized urticaria; exacerbation of patient-specific allergic reactions in the form of a mild systemic reaction (burning around the eyes, runny nose, cough) or in the form of atopic eczema; severe local reaction in the form of a strong swelling at the injection site, with a diameter exceeding 12 cm. Very rare: Anaphylactic shock (typical alarm symptoms include burning pain, pruritus, a feeling of heat on or under the tongue, in the throat, and especially on the palms of the hands and soles of the feet).

Drugs for immunotherapy should be prescribed and used only by specialist allergologists who have experience in the treatment of allergies.Skin tests. The diagnosis should start with the point test. A venom solution of 1 μg / ml is usually used for the pre-test. If a solution with this concentration of venom causes a strong or pronounced positive reaction, skin tests may be continued.Spot test - diluted venom solutions are used until the lowest concentration of the solution that causes the local reaction (blush with erythema around 5/10 mm in diameter) is determined. Intradermal test - depending on the result of the pre-puncture test, the intradermal test can be started with the use of a 0.0001 μg / ml venom solution or a more diluted solution. If the reaction is negative, solutions with a higher concentration should be used until a positive reaction occurs. If the 1 μg / ml solution does not cause an allergic reaction, the result should be considered negative. The occurrence of blistering and erythema after using a solution with a concentration> 1 μg / ml does not indicate allergy to the insect. If a negative result is obtained in the test point, an intradermal test is always recommended. In this case, the intradermal test starts with a solution of 0.001 μg / ml. The intradermal test is performed by slowly injecting a 0.02-0.05 ml tubing with a tuberculin syringe into the upper layer of skin on the forearm of the patient. The result is read after 15 minutes. During both skin tests you should always carry out the following tests: negative - with an albumin solution (solvent), positive - with a histamine solution (1% histamine in point tests and 0.01% histamine in intradermal tests). Do not start testing immediately after the sting; tests can be started 2-4 weeks after the sting.Immunotherapy. In immunotherapy, the first doses of venom are 10-100 times lower than the dose of venom that causes a positive skin test. Dosage should always be tailored to the individual sensitivity of the patient.Immunotherapy accelerated (in a hospital setting). Treatment starts with a dose of 0.1 ml poison solution at 0.0001 μg / ml (0.00001 μg / ml). From day 1 to 5 the patient receives 4 injections with increasing doses of venom every 2 hours; the final dose is 1 ml of 100 μg / ml poison solution (100 μg / injection) and is achieved on day 5 of treatment. In exceptional cases, the tolerance threshold is reached by using lower doses, then this dose should be considered as the final one and maintenance treatment can be started. Maintenance treatment at the final dose is then performed on an outpatient basis. The first injection is carried out after 7 days, the second and third injection after 14 and 21 days respectively, and subsequent injections are performed every 28 days.Conventional immunotherapy (in the infirmary). It consists of one injection every 7 days, gradually increasing the dose of venom. The doctor decides about the initial dose selection based on the patient's level of sensitization, determined on the basis of the interview and the results of skin tests. In patients with high sensitivity, immunotherapy starts with a dose of 0.1 ml poison solution at 0.0001 μg / ml (0.00001 μg / injection), and if necessary, the dose can be further reduced. At dosing intervals of seven days, doses of 0.1 ml of the solution are administered, containing increasing concentrations of venom up to a concentration of 1 μg / ml. Thereafter, gradually increasing doses are given at weekly intervals: 0.05 ml; 0.1 ml; 0.2 ml; 0.4 ml solution from a vial containing 1 μg / ml venom. This procedure is continued until a concentration of 100 μg / ml is reached. Injections of poison solution at a concentration of 100 μg / ml start with a volume of 0.05 ml. Then, increasing doses are given at weekly intervals until the maximum dose of 1.0 ml of the 100 μg / ml solution is reached. Further treatment (maintenance treatment) is continued using the maximum dose (or lower, individually determined for the patient as the maximum dose). This treatment consists of injecting at gradually increasing intervals, the first injection after 7 days, the second and third respectively after 14 and 21 days, and the Next injections every 28 days.Dose modification, due to the impossibility of maintaining the recommended interval between successive injections. If, during the initial treatment with the conventional method, the recommended interval between consecutive injections was exceeded by 2-3 weeks (ie 3 to 4 weeks since the last injection), treatment should be resumed with half of the last tolerated dose. If during the maintenance treatment, during which once monthly injections are used, the interval was longer than one month, the dose should be reduced to 1/10 of the last tolerated maximum dose.Continuing treatment, the maximum dose should be increased by increasing the venom dose solution every week, as described above.Dose selection for severe reactions after injection. Maximum diameter of the edema: <5 cm (children), <8 cm (adults) - continue the therapy according to the scheme; 5-7 cm (children), 8-12 cm (adults) - repeat the last dose; 7-12 cm (children), 12-20 cm (adults) - reduce the dose to the dose given earlier than the last one; 12-17 cm (children),> 20 cm (adults) - reduce the dose to the dose given 2 periods earlier than the last; > 17 cm (children) - reduce the dose to the appropriate dose given 3 periods earlier than the last. In case of mild generalized reactions, half of the last dose should be used and treatment should be continued. If severe generalized reactions occur, the last dose should be reduced tenfold and therapy should be continued. In order to ensure a full and lasting effect of therapy, treatment should be continued for a period of 3-5 consecutive years. The injections should be performed subcutaneously on the side of the rectifier muscle in the upper part of the arm, with the arm slightly bent at the elbow. Do not inject intravenously. Do not exceed the maximum dose of 1 ml of the stock solution (concentration of poison solution 100 μg / ml). After the injection, the patient should remain under the doctor's supervision for at least 30 minutes.