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Piperazines / Valproic acid / Levofloxacin / Doripenem / Ketorolac / Omeprazole / Ofloxacin / Clostridium difficile / Norfloxacin / Chemistry / Organic chemistry / Pharmacology


———————WARNINGS AND PRECAUTIONS——————— Serious hypersensitivity (anaphylactic) reactions have been reported with carbapenems and other beta-lactams (5.1) • It has been shown that co-adminis
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Document Date: 2009-04-23 07:20:15


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Company

Constituted Solutions / Ortho-McNeil Pharmaceutical Inc. / /

Currency

pence / /

Event

FDA Phase / Product Issues / /

IndustryTerm

colorless solutions / infusion solution / drug products / /

MedicalCondition

Pseudomonas / allergic reaction / Complicated Intra-Abdominal Infections / headache / Klebsiella Pseudomonas / seizures / Clinical Trials Complicated Urinary Tract Infections / Lymphatic System Disorders Anemia / dermatitis / Serious acute hypersensitivity / nausea / Anaphylaxis / erythema multiforme / hypersensitivity / diarrhea / anaphylactic reactions / urinary tract infections / Complicated Urinary Tract Infections / concurrent bacteremia / intra-abdominal infections / infections / Pneumonitis / Rash Complicated Intra-Abdominal Infections / seizure disorders / skin and subcutaneous disorders pruritus / fatal colitis / C. difficile colitis / breakthrough seizures / occasionally fatal hypersensitivity / Carcinogenesis / phlebitis / vulvomycotic infection / erythema / Complicated Intra-Abdominal Infections DORIBAX / azotemia / Serious hypersensitivity / Seizure / Pyelonephritis DORIBAX / urticaria / bacterial infection / mild diarrhea / pyelonephritis / infection / Phlebitis Gastro-intestinal / rash / /

MedicalTreatment

antibiotics / emergency treatment / intravenous infusion / oral therapy / hemodialysis / /

Organization

AND ADMINISTRATION / DOSAGE AND ADMINISTRATION / FDA / /

Person

Stevens Johnson / /

/

Product

Probenecid / penicillin / sodium chloride / dextrose / THE CONSTITUTED SUSPENSION IS NOT FOR DIRECT INJECTION / sterile water for injection / DORIBAX / Levofloxacin / valproic acid / epinephrine / doripenem / Comparative DORIBAX™ / intravenous study drug / DORIBAX™ IV / DORIBAX™ / for / renal function / /

Technology

Pharmacokinetics / Pharmacodynamics / /

URL

www.fda.gov/medwatch / /

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