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The raw material for the recalled heparin batches was processed in China from pig's intestines by the American pharmaceutical firm Scientific Protein Laboratories. [1] [2] [3] The U.S. Food and Drug Administration was quoted as stating that at least 81 deaths were believed to be linked to a raw heparin ingredient imported from the People's Republic of China, and that they had also received 785 ...
Activated clotting time (ACT), also known as activated coagulation time, is a test of coagulation. [1] [2]The ACT test can be used to monitor anticoagulation effects, such as from high-dose heparin before, during, and shortly after procedures that require intense anticoagulant administration, such as cardiac bypass, interventional cardiology, thrombolysis, extra-corporeal membrane oxygenation ...
The Pharmacopoeia of the People's Republic of China (PPRC) or the Chinese Pharmacopoeia (ChP), compiled by the Pharmacopoeia Commission of the Ministry of Health of the People's Republic of China, is an official compendium of drugs, covering Traditional Chinese and western medicines, which includes information on the standards of purity, description, test, dosage, precaution, storage, and the ...
The KCT test/control ratio of greater than or equal to 1.2 indicates that a defect is present. [4] If the test/control ratio is between 1.1 and 1.2, the test is equivocal. [4] A good way of expressing the result using mixes is to calculate the Rosner index. [10]
Heparin, also known as unfractionated heparin (UFH), is a medication and naturally occurring glycosaminoglycan. [3] [4] Heparin is a blood anticoagulant that increases the activity of antithrombin. [5] It is used in the treatment of heart attacks and unstable angina. [3] It can be given intravenously or by injection under the skin. [3]
The partial thromboplastin time (PTT), also known as the activated partial thromboplastin time (aPTT or APTT), is a blood test that characterizes coagulation of the blood.A historical name for this measure is the Kaolin-cephalin clotting time (KCCT), [1] reflecting kaolin and cephalin as materials historically used in the test.
The accumulation ratio of a specific drug in humans is determined by clinical studies. According to a 2013 analysis, such studies are typically done with 10 to 20 subjects who are given one single dose followed by a washout phase of seven days ( median ), and then seven to 14 repeated doses to reach steady state conditions.
Batroxobin has a similar action to thrombin but unlike thrombin it is not inhibited by heparin, so reptilase time and thrombin time can be used concurrently to distinguish anticoagulant effect from hypofibrinogenemia or dysfibrinogenemia. [1] [5] Normal values for thrombin time may be 12 to 14 seconds, [6] but the test has significant reagent ...