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Calcium channel blockers / Dihydropyridines / Organochlorides / Nicardipine / Nitrobenzenes / Lorazepam / Methadone / Clevidipine / Chemistry / Organic chemistry / Amines


Microsoft Word - CTCI[removed]W Cardene 0.1 mg_mL_Changes Accepted Draft 4_08182014
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Document Date: 2014-09-11 15:59:28


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City

Cary / /

Company

Baxter International Inc. / Cornerstone Therapeutics Inc. / EKR Therapeutics Inc. / Baxter Healthcare Corporation / /

Country

New Zealand / United States / /

Event

FDA Phase / Product Issues / /

IndustryTerm

infusion site / iso-osmotic solution / chemical name / discard solution / treatment of hypertension / chemical / /

MedicalCondition

local irritation / headache / acidosis / peripheral venous irritation / left ventricular dysfunction / sterility / progressive atrioventricular conduction block / nausea/vomiting / nausea / hypophosphatemia / peripheral edema Nervous / Chronic elevation / chronic therapy / ear disorder / acute cerebral infarction / systemic hypotension / conjunctivitis / postpartum hemorrhage / initial tachycardia / pulmonary / angina pectoris / drowsiness / atrioventricular block / preterm labor / pulmonary edema / bradycardia / tachycardia / angina / air embolism / liver disease / profound hypotension / hypotension / asthma / sporadic focal hepatic necrosis / cerebral anoxia / hypertension / bronchospasm / ST segment depression / disease / flushing / Advanced Aortic Stenosis Cardene I.V / dyspnea / significant left ventricular dysfunction / Carcinogenesis / symptomatic hypotension / venous thrombosis / chronic / pre-eclampsia / unacceptable hypotension / phlebitis / fever / dystocia / myocardial infarction / concomitant disease / heart failure / urinary frequency Sinus node dysfunction / coronary artery disease / advanced aortic stenosis / Cardiovascular Digestive Nausea/vomiting / marked hypotension / follicular adenoma/carcinoma / dizziness / reflex tachycardia / preeclampsia / Whole Headache / /

MedicalTreatment

intravenous infusion / oral therapy / abdominal surgery / relaxation / drug therapy / tocolysis / /

Organization

AND ADMINISTRATION / Cardene I.V. Premixed Injection administration / Cyclosporine Concomitant administration / Administration of Cardene I.V. / International Union of Pure and Applied Chemistry / DOSAGE AND ADMINISTRATION / FDA / DOSAGE AND ADMINISTRATION For Intravenous Use / /

/

Product

I.V. Premixed Injection / sodium chloride / GALAXY / nicardipine hydrochloride / cyclosporine / dextrose / Cimetidine / naproxen / Beta / Premixed Injection / acetic acid / dipyridamole / sorbitol / Cardene / furosemide / premixed / I / /

ProvinceOrState

Illinois / North Carolina / /

PublishedMedium

Pure and Applied Chemistry / /

Technology

AV / Pharmacokinetics / Pharmacodynamics / /

URL

www.fda.gov/medwatch / /

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