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BasiliximabCharacteristicsHimernye mashino / human monoclonal antibodies obtained through recombinant ДНК-технологии.Раство рим in the water, molecular weight about 144,000 D.Of drugsThe drugs-immunodepressivne. Axura interleikina-2 receptors. Associated with alfa-subjedinica interleykin-2 IL1 complex and prevents interaction with him interleikina-2. Warn интерлейкин-2-опосред��ванную lymphocyte activation and violates the immune response system to the antigens. Full receptor blockade interleikina-2 maintained until baziliximaba concentration in the serum exceed 0.2 µ g / ml and lasts for 36 days 14. There is a release or Cytokines миелосупрессии.Длите��ьных Research on carcinogenicity has been done. In clinical trials increased limfoproliferativeh disease in patients with a short baziliximaba were observed. However, it can not be excluded increased risk of malignant diseases in the application immunosupressivna therapy. Adequate and well-controlled studies on the impact on fertility has been done. The Ames test and the test V79 at the chromosomal aberrations is not mutagenic. Passes through Platzentu.posle in / in a dose of 20 mg S_max 7.1-5.1 mg / l, the values C_max and AUC increased in proportion to the increase in a single dose (60 mg). Mature volume distribution (with the equilibrium concentration) - 8.6 4.1 litres T_1/2 - 7.2 3.2 days klirens-41 19 ml / h. The children of the 5.2-2.8 litres, T_1/2-11.5 6.3 days klirens-20 4 ml / hour, the young volume distribution 10.1 7.6 litres T_1/2 - 7.2 3.6 days.IndicationsPrevention of acute transplant rejection (in a combination immunodepressivna therapy ziklosporinom and glukokortikoidami) in patients with perezajenna slides.Pregnancy and lactationContraindicated in pregnancy and breast-feeding (studies in pregnant and lactating women should be held).ContraindicationsHypersensitivity, pregnancy, breast-feeding.Side-EffectsFrom the nervous system and sensory organs : tremor, headache, dizziness, insomnia, less often, the view ajitation, anxiety, depression, gipestesia, neuropathy, Paresthesia.so the circulatory system and blood (blood, gemostaz : hypertension (asymptomatic), anemia and peripheral edema, less often gipotenzia (dizziness), Gematoma.so the respiratory system : cough, shortness of breath, swelling Legkih.so part of the intestine : abdominalnaya pain, constipation, pharyngitis, candidiasis of the oral cavity and pharynx, vomiting, nausea, neuralgia, diarrhoea, less often jeludern-kisherne bleeding (usually asymptomatic), giperplazia Desen.so the urogenital system : dizuria, infections urinary tract, less often delay Mochi.prochie : allergies giperkaliemia, fatigue, skin, pain in the back less often, the pain in the chest, mialgia, artralgia, gipertrihoz.Specific guidanceCooked solutions to be used within four hours Complete solutions can be stored in the refrigerator (with a temperature of 4 degrees ^) is not more than 24 hoursPatient interactionIn clinical studies with a joint appointment with other immunodepressantami (antilimfocitarnyi and OKT3 OKT3, azathioprine, corticosteroids, ciclosporin, etc.) of the interaction not registered.PrecautionsBasiliximab may apply only to physicians with experience immunosupressivna therapy after organ transplantation. Be wary appoint sick Infectious Diseases (possibly growing), malignant tumors, including in the thymus (immunosuppression increases the likelihood of tumor заболеваний).Стоматол огические intervention should be completed before the start of therapy, with the caution that at the time of treatment (possibly an increase in the frequency of microbial infections, slow healing processes). During and for a short time after infusions baziliximaba be monitoring the heart and lungs (for a possible preotwreatmenia anaphylactoidna reaction). In applying baziliximaba increased risk of wound infection. Women of childbearing age need to use an effective method of contraception prior to the therapy, as well as during the two months after the meeting. It should be borne in mind that in patients receiving immunosuppressants increase the risk of systemic infections, limfoproliferativeh and malignant diseases.Dosing and AdministrationIn / in struino or drip (product previously bred in 5 mL of water for injection, and then drove to the 50 ml 0.9% solution of sodium chloride or 5% glucose solution) for a period of 20-30 minutes, adults and children weighing more than 40 kg, in the dose of 20 mg for 2 hours before transplantation, and through four days after the operation (in the case of exclusion perezajennogo the second dose being). For children weighing less than 40 kg total dose of 20 mg (2 of 10 mg).See also |
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