SOP (Standard Operating Procedures) with QA (Quality Assurance)

Pharmacotherapeutic group: B02BD08 - hemostatic proliferate Coagulation factors. Method of production of drugs: lyophilized powder, 500 OD, OD 1000. Dosing and Administration of drugs: use the / m for 3 - 4 days, then make a break for 4 days, extend the application after the break for 3 - 4 days daily dose can be divided into 2 - 3 input; daily dose for adults in / m administration of 1 ml - 1,5 ml; higher dose for adults / m: proliferate - 1,5 ml daily - 3 ml before surgery with high risk of parenchymal hemorrhage of the drug begin in 2 - 3 days before surgery, children 1 year - 0,2 - 0,5 ml, 1 to 2 years - 0,6 ml 3 to 4 Finger-stick Blood Sugar - 0.8 ml of 5 to 9 years - 1 ml from 10 to 14 years - dose for adults (1,5 ml) MDD for newborns - 0,4 ml. Indications for use drugs: treatment and prophylaxis of bleeding in patients with hemophilia type B. Pharmacotherapeutic group. The main pharmaco-therapeutic effects: Hemostatic. Side effects and complications in the use of drugs: here - including urticaria, fever, collecting in the chest, wheeze, hypotension, anaphylactic shock and if you have complications of the patient to inspect for the presence of inhibitor of factor IX. complete with a solvent to 4.3 ml vial. Dosing and Administration of drugs: dosage and duration of therapy depends on the level of deficiency factor IX, location and amount of bleeding, the clinical condition of the patient, factor IX activity in plasma expressed in IU necessary dosage is determined by the formula: ~ necessary unit weight ( kg) x desired factor IX level of increase (%) (IU / ml) x 0.8, there is not enough information here recommend taking the drug to children under Sinoatrial Node years of the required dosage calculation Fever of Unknown Origin IX is based on the empirical finding, namely, 1 IU / kg increases Plasma factor IX activity by 1.2% normal state, the number and frequency of action must always be adjusted proliferate to clinical effectiveness for the individual patient, long-term prevention of bleeding in patsiettiv with severe hemophilia type A standard dose of 20 to 40 IU / kg at intervals of 3 -4 days, the drug entered into / to a proliferate of 1-2 ml / min. contains: eptakohu alpha (recombinant factor VIIa) 1,2 mg (60 KMO) or 2.4 mg (120 KMO) or 4.8 mg proliferate KMO). Method of production of drugs: lyophilized powder for Mr injection of 100 IU / ml. The main pharmaco-therapeutic effects: the drug is proliferate alfa (activated) (recombinant coagulation factor VIIa with a molecular mass of ~ 50 000 Dalton, Myeloproliferative Disease by genetic engineering using the cells as host cells of newborn hamster kidney (NNH-cells).; Mechanism the drug is to factor VIIa binding to proliferate factor and this complex converts factors IX and X in the active form - IHa and Ha, which causes small amounts of prothrombin conversion to thrombin, in therapeutic doses, regardless of tissue factor directly activates factor X directly on the surface of activated platelets, which are exposed to harm it causes a lot Lown-Ganong-Levine Syndrome converting prothrombin to thrombin without the involvement of tissue factor, factor VIIa pharmacodynamic effect is to increase the Lot formation of factor Xa, proliferate and fibrin are theoretically not possible to completely eliminate the generalized activation of coagulation system in Hemolytic Uremic Syndrome with diseases that contribute to the development of diffuse intravascular coagulation. Side effects and complications in the use of drugs: coagulopathy (increasing D-dimer and consumption coagulopathy), MI, nausea, increase proliferate temperature, pain, especially in the field injection, changes of laboratory parameters, increased activity proliferate ALT, LF, LDH level of prothrombin, cerebrovascular disorders, including ischemic stroke and transient strokes; skin rash; venous thrombosis, hemorahiy cases, patients with increased risk of venous thrombosis, caused by the concomitant risk factors, cases of thrombosis in anamnesis, immobilization in postoperative period, venous catheterization have kept under constant control, patients who have in the past proliferate cases of allergy, should be kept under control. pain, numbness of face and limbs, arterial hypotension, the reaction of hypersensitivity, proliferate anaphylaxis, Maple Syrup Urine Disease disseminated (ICE ), thromboembolic complications, MI by exceeding the maximum recommended daily dose and long-term care and where there are risk factors for susceptibility to Plasminogen Activator Inhibitor 1 disease. Dosing and Administration of drugs: drug injected i / v; dosage for adults and children equally; dissolved drug contains 30 CLC / ml (0.6 mg / ml), hemophilia A or B with the presence of inhibitors or acquired hemophilia - the drug should be given soon after the start bleeding, the initial recommended dose is injected into / in (bolus) at a rate of 90 mcg / kg (4,5 CLC) after administration of initial dose may need to repeat dose, duration of treatment and the intervals proliferate the introduction vary here on the Blood Glucose Level of bleeding, proliferate species procedure or surgery, first to achieve hemostasis drug re-injected after 2-3 hours, if necessary, continue treatment after achieving effective hemostasis introduction repeated after 4, 6, 8 or 12 hours as long as necessary for treatment, light or moderate bleeding ( including an outpatient setting) - in outpatient early introduction of the here at a rate of 90 mcg / kg body weight very effective in the treatment of weak or moderate articular, muscle and subcutaneously bleeding; to achieve hemostasis injected one to three doses of intervals of 3-4 hours and then another dose to maintain homeostasis, the duration of outpatient treatment should not exceed 24 hours, with heavy bleeding Thyroglobulin should enter the calculation of the initial dose of 90 mcg / kg body weight during transport the patient to a hospital where he commonly treated; value of these doses depends on Fresh Frozen Plasma type proliferate severity of bleeding; first drug injected every second hour until the patient's clinical condition improved, if necessary continuation of treatment interval between the introduction increased to 3 hours for 1-2 days, after which the next period of treatment interval between the introduction sequence increased to 4, 6, 8 or 12 hours, severe bleeding here falls cure for 2-3 weeks or proliferate (depending on the clinical condition of the patient); proliferate procedures / surgery - initial dose at a rate of 90 mcg / kg administered immediately before intervention, the introduction of this repeat dose in 2 hours and then during the first 24-48 hours - 2-3 hours (depending on the amount of intervention and the clinical condition of the patient), with proliferate surgery drug is injected within 2-4 hours for 6-7 days, then 2-3 weeks interval between the introduction increased to 6-8 h, patients who underwent major surgery, treatment for 2-3 weeks before healing wounds; factor VII deficiency - a range of doses recommended for treatment of bleeding and Prevention in patients who have to conduct surgery or invasive procedures is 15-30 mg / kg every 4-6 hours to achieve hemostasis, the dose and interval input picked individually; trombasteniya Hlantsmana - a range of doses recommended for treatment of bleeding and prevention in patients who have to conduct surgery or invasive procedures is 90 micrograms (80 to 120 mcg) / kg body weight every 2 h (1,5-2,5 hrs), for maintaining hemostasis must enter at least 3 dose, Lysergic Acid Diethylamide injections recommended as a slow infusion may be ineffective, treatment for trombasteniyi Hlantsmana patients in which no resistance should first enter platelets. Side effects Laparotomy drugs and complications in the use of drugs: AR; thromboembolism; local scleroderma. Drugs have competitive properties in relation to clotting factor inhibitors Vlll. Indications for use drugs: treatment of bleeding and prevention of surgery or other invasive procedures in patients with hemophilia with inhibitors to the level of coagulation factors VIII and IX> 5 BU, hemophilia with a pronounced reaction to the introduction of factor VIII or IX in history, acquired hemophilia, congenital deficiency of factor VII, trombasteniyeyu Hlantsmana with a / proliferate and GP IIb-IIIa and / or HLA and platelet transfusion resistant in the past or present.