| Document Date: 2015-03-06 08:55:27
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City Reference / / Company Sandoz Inc. / / Event FDA Phase / / IndustryTerm transient positive bone-imaging changes / natural rubber latex / bone-imaging results / leukapheresis product / filgrastim products / administration site / patients receiving filgrastim products / infusion solution / healthcare professional / pegfilgrastim products / treatment of patients with acute myeloid leukemia / / MedicalCondition Cancer Undergoing Autologous PBPC / cancer undergoing bone marrow transplantation / Hodgkin's disease / lymphoma / Chest pain / headache / e.g.‚fever / Myelodysplastic syndrome / Severe Chronic Neutropenia Chronic / serious allergic reactions / cancer receiving myelosuppressive chemotherapy / bronchitis / urinary tract infection / Respiratory Distress Syndrome / muscle spasms / Nausea / Thrombocytopenia / anaphylaxis / alopecia / small cell lung cancer / Hemoptysis / Leukocytosis / Severe Chronic Neutropenia ZARXIO / febrile neutropenia / Fatigue / excessive leukocytosis / Capillary Leak Syndrome / total infection / hypoesthesia / cancer undergoing mobilization / suspected chronic neutropenia / diarrhea / hypersensitivity / Severe Chronic Neutropenia / Splenic Rupture Splenic rupture / constipation / cancer receiving ZARXIO / infections / Back pain / hypoalbuminemia / sepsis / upper respiratory tract infection / shoulder pain / hypotension / Thrombocytopenia Thrombocytopenia / acute febrile neutrophilic dermatosis / tumor / insomnia / Sickle Cell Disorders / epistaxis / General disorders / congenital neutropenia / Severe Chronic Neutropenia Prior to starting ZARXIO / pulmonary infiltrates / hypertension / Cancer / Fatal splenic rupture / Capillary Leak Syndrome Capillary leak syndrome / disease / Arthralgia / lymphoblastic lymphoma receiving high-dose chemotherapy / latex allergies / dyspnea / chronic treatment / Acute respiratory distress syndrome / thoracic and mediastinal disorders Cough / Cutaneous Vasculitis Cutaneous vasculitis / Carcinogenesis / myeloid leukemia / neutropenia / Cutaneous Vasculitis / Term Bone pain General disorders / Cancer Undergoing Bone Marrow Transplantation ZARXIO / Cancer Following BMT / erythema / chronic administration / fever / acute lymphoblastic leukemia / pain / vomiting / Cancer Receiving Myelosuppressive Chemotherapy ZARXIO / myelodysplasia / allergic reactions / osteoporosis / sickle cell disease / Sweet’s syndrome / infection / sickle cell trait / chronic myeloid leukemia / Dizziness / splenic rupture / cough / acute myelogenous leukemia / rash / acute myeloid leukemia / anemia / severe neutropenia / respiratory distress / idiopathic neutropenia / cyclic neutropenia / / MedicalTreatment radiation therapy / leukapheresis / chemotherapy / intravenous infusion / concurrent radiation therapy / apheresis / leukaphereses / total body irradiation / / Organization G-CSF administration / ZARXIO administration / DOSAGE AND ADMINISTRATION / FDA / Direct administration / / Person Injection / / / Position guard / BD UltraSafe PassiveTM Needle Guard / General / Term Bone pain General / / Product methylprednisolone / cytarabine / cyclophosphamide / Dextrose / ifosfamide / Subcutaneous Injection / BD UltraSafe PassiveTM Needle Guard Injection / etoposide / mitoxantrone / ZARXIO / / ProvinceOrState ARDS / / SportsEvent NHL / / Technology Radiation / antibodies / transplantation / Pharmacokinetics / chemotherapy / Pharmacodynamics / binding antibodies / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZARXIO safely and effectively. See full prescribing information for ZARXIO. ZARXIO™ (filgrastim-sndz) injection, f