| Document Date: 2009-03-31 14:56:00
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Company Ames / / Country Australia / / Event Product Issues / FDA Phase / / IndustryTerm treatment of the anaphylactoid symptoms / sterile solution / / MedicalCondition acetaminophen poisoning / bronchospasm / flushing / Acute flushing / shortness of breath / mouse lymphoma cell / Carcinogenesis / severe hepatic injury / cirrhosis / erythema / seizure / hepatic injury / hyponatremia / secondary biliary cirrhosis / urticaria / acute hypersensitivity / transient erythema / hypersensitivity / liver injury / pruritus / rash / wheezing / hypotension / asthma / cellular necrosis / / Organization DOSAGE AND ADMINISTRATION / / / Product acetaminophen / acetylcysteine / Acetadote / epinephrine / dextrose / disodium edetate / Sterile Water for Injection / S-004 / fertility / / Technology PHARMACOKINETICS / /
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NDA[removed]S-004 Page 3