| Document Date: 2013-08-28 09:22:44
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City Cisplatin / Cyclophosphamide / Schaumburg / / Company Sagent Pharmaceuticals Inc. / Placebo Group / Alteon Inc. / / Country India / United States / / Event FDA Phase / Product Issues / / IndustryTerm injection solution / physical and chemical compatibility / aqueous solution / medicinal products / drug products / natural rubber latex / sterile solution / to alkaline solutions / chemical name / / MedicalCondition Further Postoperative Nausea / bradycardia / electrocardiographic alterations / Sudden blindness / Median nausea / pediatric cancer / further nausea / serious cardiac arrhythmias / congenital long QT syndrome / amaurosis / syncopal episode / anaphylaxis / premature ventricular contractions / bradyarrhythmias / Urticaria Eye Disorders / Drowsiness / patients No nausea / angina / Anaphylactic reactions / diarrhea / progressive ileus / cancer receiving concurrent medications / Vomiting HOW SUPPLIED/STORAGE AND HANDLING PATIENT COUNSELING INFORMATION Headache / vomiting occurring / laryngospasm / cancer / ST segment depression / shortness of breath / chills / Carcinogenesis / chemotherapy-induced nausea / stroke / fever / grand mal seizure / transient blindness / vomiting / postoperative nausea / atrial fibrillation / hypokalemia / rash / loss of consciousness / chest pain / laryngeal edema / headache / adult cancer / Liver failure / Hypersensitivity Reactions Hypersensitivity / Nausea / syncope / Transient dizziness / Torsade de Pointes / tachycardia / hypersensitivity / Constipation / profound hypotension / ventricular and supraventricular tachycardia / hypotension / congestive heart failure / bronchospasm / cardiopulmonary arrest / disease / Flushing / heart block / severe cardiac arrhythmias / emetogenic cancer / shock / cardiac arrhythmias / severe constipation / Pain / experience nausea / angioedema / Emetic episodes Failurea Nausea / Fever Cold sensation Pruritus Paresthesia / strabismus / postoperative vomiting / transient second-degree heart block / patients Mean nausea / / MedicalTreatment surgery / cisplatin chemotherapy / intravenous infusions / antibiotics / chemotherapy / laparoscopic procedures / Intravenous Infusion / abdominal surgery / / Organization Oral administration / Multiday administration / DOSAGE AND ADMINISTRATION / FDA / After administration / / Person Adult Patients / / / Position Major / / Product cisplatin / Alfentanil / Dextrose / Phenytoin / etoposide / fentanyl / ondansetron hydrochloride / Metoclopramide / dexamethasone / Sodium Chloride / cyclophosphamide / Carbamazepine / Temazepam / Rifampin / isoflurane / fluorouracil / Ondansetron / adults / Although / fertility / / ProvinceOrState Illinois / / Technology Geriatrics / Chemotherapy / Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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Ondansetron_2 mL & 20 mL Combined PI page 1&2 Sagent