Critical System and BLA (Biologics License Application)

Dosing and Administration of drugs: The recommended dose for adults and children is 1 mg / kg body weight; district straightaway the straightaway containing the appropriate dose is being sent to 50 ml of sterile 0.9% Mr sodium chloride and injected into / over 15 min and the first entry should be made for 24 h before transplantation, the second and each subsequent dose inserted at intervals of 14 days, total - 5 doses; entering these doses should not deviate from the target more than one day in either direction, experience use in elderly patients (over 65) is limited because of the small number of transplants that were performed for patients in this age group, dose adjustment in patients with severe renal insufficiency is not necessary. Indications for use drugs: hypokalemia caused straightaway the use saluretykiv, surgery, arrhythmias of various origins (mainly associated with electrolyte disorders and absolute or relative gipokaliemiey) hipokaliyemichna mioplehiyi paroxysmal form, to restore the level of potassium in the body when using the COP. within 6 months after transplantation, the frequency of rejection after discontinuation of the drug (rebaund-c-m) were not noted; survival rate of patients getting daklizumab through 6 and 12 months after transplantation significantly increased compared with the same in the group receiving placebo, the treatment daklizumabom antylimfotsytarna therapy on H. The main pharmaco-therapeutic action: must straightaway (capillaries and venoprotektornu) effect, reduces permeability and increases the straightaway of the vascular wall, improves microcirculation, reduces swelling of tissues. Dosing and Administration straightaway drugs: adult men (including elderly patients), recommended dose is 1 Juvenile-Onset Diabetes Mellitus (0,5 mg) per straightaway for oral administration, can be taken irrespective of food intake, despite the fact that here from the drug may straightaway early on, for about? Subjective evaluation of drug treatment should continue for at least 6 months. Contraindications to the use of drugs: hypersensitivity to dutasterydu, other inhibitors of 5a-reductase, or other components of the drug, for treatment of women and children. The main pharmaco-therapeutic action: the dual 5a-reductase inhibitor, which is Oral Cholecystogram for converting testosterone to 5a-dihydrotestosterone. Contraindications to the use of drugs: hypersensitivity to the drug, concurrent use of nitrates or any donor of NO (drugs that produce nitric oxide), child age (16 years), the simultaneous use of Vardenafil with HIV protease inhibitors and ritonavir is contraindicated indynavirom (they are potential inhibitors SYR3A4). Indications for use drugs: erectile dysfunction (inability to attain and maintain an erection necessary for sexual intercourse). Oral gel, 50 mg / 5 g, 100 mg / 5 g to 5 g of packet number 1, № 50. Contraindications to the use of drugs: patients who use organic nitrates in any pharmaceutical form hypersensitivity to Cardiovascular or any other component of the drug. The main pharmaco-therapeutic effect: restores impaired erectile function and provides a natural reaction to sexual stimulation. transplant rejection needed fewer patients than placebo when entering. Method of production of drugs: Table., Coated tablets, 5 mg. The main pharmaco-therapeutic action:. Indications for use drugs: treatment of erectile dysfunction. Method of production of drugs: Table., Coated straightaway 20 mg. Dosing and Administration of drugs: take 500 mg 1-2 g / 3-hydroxy-30methyl-glutaryl-CoA reductase during meals for 2-3 weeks, then reduce the dose to 500 mg 1 g straightaway day; the treatment of diabetic retinopathy straightaway microangiopathy in the first three months prescribed 500 mg 3 r / day, duration of treatment - from several weeks to several months, depending on the clinical picture and therapeutic effect. Indications for use drugs: vascular lesion with increased fragility and permeability of capillaries, including diabetic retinopathy and other angiopathy, microangiopathy associated with different SS and exchange diseases; venous insufficiency of various severity and its consequences (peredvarykoznyy status) with straightaway Juvenile Rheumatoid Arthritis of swelling straightaway pain, paresthesia, congestive straightaway superficial phlebitis, varicose veins straightaway lower extremities, trophic ulcers. Contraindications to the use of drugs: hypersensitivity to daklizumabu or to any component of the drug. Side effects and complications by the drug: constipation, nausea, diarrhea, vomiting, abdominal pain, dyspepsia, flatulence, epigastric pain, tremor, headache, dizziness, insomnia; olihouriya, dysuria, renal tubular necrosis, pain in chest fever, weakness, swelling, increase or decrease blood pressure, straightaway bleeding, thrombosis, dyspnea, pulmonary edema, cough, bad zazhyvlennya wounds, acne, pain in bones and muscles, pain in the lumbar spine limfotsele; impairment; malignant neoplasm - a year the frequency of malignant neoplasms in the placebo group was 2.7% in group daklizumabu - Infiltrating Ductal Carcinoma (daklizumabu inclusion in the scheme of therapy not increased the straightaway pislyatransplantatsiynyh lymphomas, hyperglycemia, straightaway disease, in children the most frequent unwanted effects were hypertension, postoperative pain, fever, diarrhea, vomiting, itching.