| Document Date: 2014-11-24 11:14:51
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City Schaumburg / / Company CSC / Sagent Pharmaceuticals Inc. / Ames / / Country Switzerland / / Currency pence / / Event Product Issues / FDA Phase / / Facility Laboratory Parameter Zoledronic Acid Pamidronate Placebo Injection / Laboratory Abnormalities / Storage Conditions Store / Laboratory Parameter Serum Creatinine1 Hypocalcemia2 Hypophosphatemia3 Hypomagnesemia4 / The terminal / / IndustryTerm food / intravenous solution / divalent cation-containing infusion solutions / drug products / divalent cation-containing solutions / infusion site / rubber / ready-to-use solution / / MedicalCondition polyuria / severe hypocalcemia / Limb Neoplasms Malignant Neoplasm Aggravated Nervous Headache Dizziness / ovarian cancer / scleritis / multiple myeloma / Hypocalcemia / seizures / arthritis / sterility / hyperparathyroidism / Jaw Cancer / osteomyelitis / bladder cancer / small cell lung cancer / Lymphatic Anemia Neutropenia Thrombocytopenia Gastrointestinal Nausea Vomiting Constipation Diarrhea Abdominal Pain Dyspepsia Stomatitis Sore Throat General Disorders / renal cancer / genitourinary cancer / bradycardia / asymptomatic hypercalcemia / iritis / diarrhea / osteogenesis imperfecta / bone resorption / muscle cramps / Prostate cancer / illness / breast cancer / Asthma / tumor / abdominal pain / cancer / tumors / arthralgia / neoplasm / NSCLC / pancytopenia / nonspecific infection / mg Ocular Adverse Reactions Ocular inflammation / chills / dysphagia / Carcinogenesis / hyperesthesia / tetany / chronic / muscle pain / Bone Metastases / fever / bone metastasis / vomiting / dystocia / cleft palate / dizziness / renal failure / hypokalemia / metastases / rash / paresthesia / bronchoconstriction / interstitial lung disease / uveitis / local infection / Osteonecrosis / allergic reaction / influenza-like illness / lymphoma / chest pain / headache / colorectal cancer / cardiac failure / metastasis / hypercalcemia therapy / solid tumors / nausea / thrombocytopenia / tremor / syncope / conjunctivitis / arthralgias / numbness / fatigue / documented bone metastases / mL single-use bag Hypocalcemia Hypocalcemia / controlled multicenter bone metastases / granulocytopenia / head and neck cancer / renal cell carcinoma / nontumor-related hypercalcemia / constipation / episcleritis / pruritus / periodontal disease / back pain / hypoalbuminemia / hepatic insufficiency / hypotension / cancers / proteinuria / bronchospasms / hyperkalemia / insomnia / adenomas / hypertension / dyspnea / hematuria / hypophosphatemia / Cardiac arrhythmias / Respiratory Dyspnea Cough Skin Alopecia Dermatitis / solid tumor / vertigo / mucositis / bone disease / Pain / renal insufficiency / hypernatremia / anaphylactic reaction/ shock / urticaria / angioedema / rigors / hypercalcemia / Malignancy Hypersensitivity / cough / inflammation / anaphylactic reaction/shock / anemia / dehydration / / MedicalTreatment dialysis / antineoplastic therapy / retreatment / chemotherapy / intravenous infusion / hormonal therapy / dental surgery / / Organization DOSAGE AND ADMINISTRATION / FDA / Renal Toxicity Administration of Zoledronic Acid Injection / Zoledronic Acid Injection administration / / / Position General / treating physician / Lymphatic Anemia Neutropenia Thrombocytopenia Gastrointestinal Nausea Vomiting Constipation Diarrhea Abdominal Pain Dyspepsia Stomatitis Sore Throat General / / Product Renal Impairment Zoledronic Acid Injection / Laboratory Parameter Zoledronic Acid Pamidronate Placebo Injection / Same Drug Class Zoledronic Acid Injection / Solution Zoledronic Acid Injection / Zoledronic Acid Injection / magnesium sulfate / prednisone / dexamethasone / sodium chloride / Vitamin D / FULL PRESCRIBING INFORMATION Zoledronic Acid Injection / Solid Tumors Zoledronic Acid Injection / mannitol / CL / Body System Zoledronic Acid Pamidronate Placebo Injection / Pregnancy Zoledronic Acid Injection / Reclast / Confusion Agitation Respiratory Dyspnea Coughing Urogenital Urinary Tract Infection Zoledronic Acid Injection / Zoledronic Acid Zoledronic Acid Population Patients Injection / Zoledronic / Zoledronic acid / renal / solid / renal function / / ProvinceOrState Illinois / / Technology apoptosis / Geriatrics / chemotherapy / dialysis / Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Zoledronic Acid Injection safely and effectively. See full prescribing information for Zoledronic Acid Injection. h