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Last Time Saved: [removed]:46 AM Document Name: QEN-2317v2.qxp PMS Black Approved for FDA Submission
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Document Date: 2010-02-25 09:04:32


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File Size: 70,20 KB

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City

Lake Forest / /

Company

USA Hospira Inc. / /

Event

FDA Phase / Product Issues / /

IndustryTerm

drug solution / injection site / anesthetic solution / nerve / cardiovascular systems / sterile isotonic solutions / cardiovascular and central nervous systems / local anesthetic drug products / Local anesthetic solutions / administration site / local anesthetic solution / /

MedicalCondition

loss of consciousness / severe persistent hypertension / severe hepatic disease / tremors / allergies / fetal acidosis / laryngeal edema / Serious dose-related cardiac arrhythmias / acidosis / headache / urinary retention / unconsciousness / severe / persistent hypertension / coma / nausea / severe hypotension / fecal and urinary incontinence / hepatic and renal disease / secondary cardiac arrest / circulatory depression / syncope / numbness / fetal bradycardia / Ischemic injury / drowsiness / OF ACIDOSIS / atrioventricular block / cerebrovascular accidents / septic meningitis / asystole / erythema / angioneurotic edema / bradycardia / renal disease / tachycardia / hypersensitivity / restlessness / maternal hypotension / cardiac arrest / liver disease / paresis / pruritus / meningismus / related depression / sepsis / CARDIAC ARREST AND / hypotension / hypertensive vascular disease / paralysis / unexplained neonatal depression / bradycardia / ventricular arrhythmias / usually manifest seizures / necrosis / hypertension / respiratory paralysis / convulsions / backache / heart block / chills / shock / Carcinogenesis / metabolic acidosis / cardiac arrhythmias / mean seizure / severe prolonged hypertension / apnea / systemic diseases / pain / vomiting / postictal depression / toxemia / urticaria / metallic taste / ventricular fibrillation / respiratory depression / irritation / local anesthetic induced convulsions / cranial nerve palsies / dizziness / inflammation / depression / myocardial depression / joint pain / paresthesia / methemoglobinemia / tinnitus / lightheadedness / /

MedicalTreatment

surgery / oxygen therapy / catheter / relaxation / pain management / /

Organization

Concurrent administration / See DOSAGE AND ADMINISTRATION / DOSAGE AND ADMINISTRATION / FDA / WARNINGS / /

Position

physician / General / PRECAUTIONS General / /

Product

Potassium chloride / Sodium chloride / dantrolene sodium / Mepivacaine Hydrochloride / diazepam / Calcium chloride / epinephrine / Carbocaine / available / cardiovascular function / /

ProvinceOrState

Illinois / /

Technology

AV / Pharmacokinetics / /

SocialTag