Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3299
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Kinlytic (Injection, Powder, Lyophilized, For Solution)
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Kinlytic���IS INTENDED FOR INTRAVENOUS INFUSION ONLY. Kinlytic���treatment should be instituted soon after onset of pulmonary embolism. Delay in instituting therapy may decrease the potential for optimal efficacy .<br/>Dosing:<br/>Preparation: The following Dose Preparation-Pulmonary Embolism chart may be used as an aid in the preparation of Kinlytic���for administration. For administration directions, see next section.<br/>Administration:<br/>Anticoagulation After Terminating Kinlytic���Treatment: After infusing Kinlytic���, anticoagulation treatment is recommended to prevent recurrent thrombosis. Do not begin anticoagulation until the aPTT has decreased to less than twice the normal control value. If heparin is used, do not administer a loading dose of heparin. Treatment should be followed by oral anticoagulants.
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Kinlytic(urokinase for injection) is a thrombolytic agent obtained from human neonatal kidney cells grown in tissue culture. The principal active ingredient of Kinlytic���is the low molecular weight form of urokinase, and consists of an A chain of 2,000 daltons linked by a sulfhydryl bond to a B chain of 30,400 daltons. Kinlytic���is supplied as a sterile lyophilized white powder containing 250,000 international units urokinase per vial, mannitol (25 mg/vial), Albumin (Human) (250 mg/vial), and sodium chloride (50 mg/vial). Following reconstitution with 5 mL of Sterile Water for Injection, USP, Kinlytic���is a clear, slightly straw-colored solution; each mL contains 50,000 international units of urokinase activity, 0.5% mannitol, 5% Albumin (Human), and 1% sodium chloride (pH range 6.0 to 7.5). Thin translucent filaments may occasionally occur in reconstituted Kinlytic���vials . Kinlytic���is for intravenous infusion only. Kinlytic���is produced from human neonatal kidney cells . No fetal tissue is used in the production of Kinlytic���. Kidney donations are obtained exclusively in the United States from neonates (birth to 28 days) for whom death has not been attributed to infectious causes and that have exhibited no evidence of an infectious disease based in part, on an examination of the maternal and neonatal donor medical records. The maternal and neonatal donor screening process also identifies specific risk factors for known infectious diseases and includes testing of sera for HBV, HCV, HIV-1, HIV-2, HTLV-I, HTLV-II, CMV, and EBV. Donors with sera testing positive or associated with other risk factors are excluded. During the manufacturing process, cells are tested at multiple stages for the presence of viruses using in vitro and in vivo tests that are capable of detecting a wide range of viruses. Cells are also screened for HPV using a DNA detection-based test and for reovirus using a polymerase chain reaction-based test. The manufacturing process used for this product has been validated in laboratory studies to inactivate and/or remove a diverse panel of spiked model enveloped and non-enveloped viruses, and includes purification steps and a heat treatment step (10 hours at 60��C in 2% sodium chloride). A single vial of Kinlytic���contains urokinase produced using cells derived from one or two donors.
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Urokinase is an enzyme (protein) produced by the kidney, and found in the urine. There are two forms of urokinase which differ in molecular weight but have similar clinical effects. Kinlytic���is the low molecular weight form. Kinlytic���acts on the endogenous fibrinolytic system. It converts plasminogen to the enzyme plasmin. Plasmin degrades fibrin clots as well as fibrinogen and some other plasma proteins. Information about the pharmacokinetic properties in man is limited. Urokinase administered by intravenous infusion is rapidly cleared by the liver with an elimination half-life for biologic activity of 12.6��6.2 minutes and a distribution volume of 11.5 L. Small fractions of the administered dose are excreted in bile and urine. Although the pharmacokinetics of exogenously administered urokinase have not been characterized in patients with hepatic impairment, endogenous urokinase-type plasminogen activator plasma levels are elevated 2- to 4-fold in patients with moderate to severe cirrhosis.Thus, reduced urokinase clearance in patients with hepatic impairment might be expected. Intravenous infusion of Kinlytic���in doses recommended for lysis of pulmonary embolism is followed by increased fibrinolytic activity in the circulation. This effect disappears within a few hours after discontinuation, but a decrease in plasma levels of fibrinogen and plasminogen and an increase in the amount of circulating fibrin and fibrinogen degradation products may persist for 12-24 hours.There is a lack of correlation between embolus resolution and changes in coagulation and fibrinolytic assay results. Treatment with urokinase demonstrated more improvement on pulmonary angiography, lung perfusion scanning, and hemodynamic measurements within 24 hours than did treatment with heparin. Lung perfusion scanning showed no significant treatment-associated difference by day 7. Information based on patients treated with fibrinolytics for pulmonary embolus suggests that improvement in angiographic and lung perfusion scans is lessened when treatment is instituted more than several days (e.g., 4 to 6 days) after onset.
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Kinlytic���is supplied as a sterile lyophilized preparation (NDC 24430-1003-1). Each vial contains 250,000 international units urokinase activity, 25 mg mannitol, 250 mg Albumin (Human), and 50 mg sodium chloride. Refrigerate Kinlytic���powder at 2��to 8��C (36��to 46��F) (See USP).
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UROKINASE
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Kinlytic (Injection, Powder, Lyophilized, For Solution)
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The most serious adverse reactions reported with Kinlytic���administration include fatal hemorrhage and anaphylaxis .<br/>Bleeding: Bleeding is the most frequent adverse reaction associated with Kinlytic���and can be fatal . In controlled clinical studies using a 12-hour infusion of urokinase for the treatment of pulmonary embolism (UPET and USPET),bleeding resulting in at least a 5% decrease in hematocrit was reported in 52 of 141 urokinase-treated patients. Significant bleeding events requiring transfusion of greater than 2 units of blood were observed during the 14-day study period in 3 of 141 urokinase-treated patients in these studies. Multiple bleeding events may have occurred in an individual patient. Most bleeding occurred at sites of external incisions and vascular puncture, with lesser frequency in gastrointestinal, genitourinary, intracranial, retroperitoneal, and intramuscular sites.<br/>Sources of Information on Adverse Reactions: There are limited well-controlled clinical studies performed using urokinase. The adverse reactions described in the following sections reflect both the clinical use of Kinlytic���in the general population and limited controlled study data. Because post-marketing reports of adverse reactions are voluntary and the population is of uncertain size, it is not always possible to reliably estimate the frequency of the reaction or establish a causal relationship to drug exposure.<br/>Allergic Reactions: Rare cases of fatal anaphylaxis have been reported . In controlled clinical trials, allergic reaction was reported in 1 of 141 patients (<1%). The following allergic-type reactions have been observed in clinical trials and/or post-marketing experience: bronchospasm, orolingual edema, urticaria, skin rash, and pruritus . Infusion reaction symptoms include hypoxia, cyanosis, dyspnea, tachycardia, hypotension, hypertension, acidosis, fever and/or chills/rigors, back pain, vomiting, and nausea .<br/>Other Adverse Reactions: Other adverse events occurring in patients receiving Kinlytic���therapy in clinical studies, regardless of causality, include myocardial infarction, recurrent pulmonary embolism, hemiplegia, stroke, decreased hematocrit, substernal pain, thrombocytopenia, and diaphoresis. Additional adverse reactions reported from post-marketing experience include cardiac arrest, vascular embolization (cerebral and distal) including cholesterol emboli , cerebral vascular accident, pulmonary edema, reperfusion ventricular arrhythmias and chest pain. A cause and effect relationship has not been established.<br/>Immunogenicity: The immunogenicity of Kinlytic���has not been studied.
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Kinlytic���is indicated in adults: The diagnosis should be confirmed by objective means, such as pulmonary angiography or non-invasive procedures such as lung scanning.
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Kinlytic
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