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Anilides / Ertapenem / Pyrrolidines / Piperazines / Clostridium difficile / Omeprazole / Valproic acid / Anakinra / Flucytosine / Chemistry / Organic chemistry / Pharmacology


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Document Date: 2015-03-26 19:23:33


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Company

Pneumonia 1 / Includes Phase IIb/III Community / Hospira Laboratories Inc. / Pneumonia INVANZ / Merck Sharp & Dohme Corp. / Merck & Co. Inc. / /

Event

FDA Phase / /

Facility

Laboratory Tests ADVERSE REACTIONS / Laboratory Tests While INVANZ / /

IndustryTerm

drug products / rubber stopper / /

MedicalCondition

septicemia / septic shock / vaginitis / ventricular tachycardia / postpartum endomyometritis / cholelithiasis / Seizures / sterility / esophagitis / hemorrhoids / osteomyelitis / stomatitis / CNS disorders / gout / skin structure infections / penicillin hypersensitivity / gastrointestinal hemorrhage / bradycardia / diarrhea / anaphylactic reactions / severe infections / urinary tract infections / vulvovaginitis / end-stage renal disease / complicated urinary tract infections / intra-abdominal infections / pelvic infections / Complicated Intra-Abdominal Infections INVANZ / asthma / Abdominal pain / pneumonia / Community Acquired Pneumonia / Complicated Urinary Tract Infections Including Pyelonephritis / occasionally fatal hypersensitivity / Body Weight Daily Dose Daily Dose Recommended Infection / chills / Seizure Potential Seizures / dysphagia / Carcinogenesis / candidiasis / tachycardia / cardiac arrest / surgical site infection / diabetic foot infections / Fever / superinfection / Serious hypersensitivity / seizure / vomiting / asthenia/fatigue / pancreatitis / pyelonephritis / atrial fibrillation / Dizziness / Acute Pelvic Infections Including Postpartum Endomyometritis / surgical gynecological infections / depression / Rash / paresthesia / bronchoconstriction / hematuria / urinary retention / allergic reaction / myoclonus / chest pain / Post Surgical Gynecologic Infections / Complicated Intra-Abdominal Infections / headache / Osteomyelitis INVANZ / duodenitis / bladder dysfunction / dermatitis / focal tremors / nausea / leg pain / hemoptysis / tremor / severe hypersensitivity / vaginal pruritus / concomitant osteomyelitis / gastritis / asystole / skin infections / hypersensitivity / Community-acquired pneumonia / Complicated Urinary Tract Infections Including Pyelonephritis INVANZ / Constipation / vaginal candidiasis / concurrent bacteremia / Pruritus / infections / seizure disorders / Community Acquired Pneumonia INVANZ / Hypotension / fatal colitis / oliguria/anuria / arrhythmia / Serious anaphylactic reactions / Insomnia / epistaxis / necrosis / breakthrough seizures / hypertension / flushing / Dyspnea / skin and skin structure infections / surgical gynecologic infections / mouth ulcer / disorientation / ileus / erythema / hypesthesia / oral candidiasis / severe baseline infections / pain / heart failure / pleural effusion / bacterial infection / Post Surgical Gynecologic Infections INVANZ / mild diarrhea / acute pelvic infections / Treatment Regimen Known hypersensitivity / spasm / cough / phlebitis/thrombophlebitis / pharyngitis / septic abortion / respiratory distress / dehydration / /

MedicalTreatment

incision / colorectal surgery / emergency treatment / surgery / oral therapy / peritoneal dialysis / antibiotics / Intravenous infusion / hemodialysis / hemofiltration / /

Organization

DOSAGE AND ADMINISTRATION / FDA / INVANZ MUST BE RECONSTITUTED PRIOR TO ADMINISTRATION / administration of INVANZ / Intramuscular Administration / /

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Product

probenecid / divalproex sodium / dextrose / INVANZ / HCl injection / Piperacillin / epinephrine / lidocaine / penicillin / Sodium Chloride / valproic acid / Bacteriostatic Water for Injection / Ceftriaxone / to / /

Technology

flow control / dialysis / Pharmacokinetics / /

URL

www.fda.gov/medwatch / /

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