| Document Date: 2009-09-22 15:20:43
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City SHIRLEY / / Company Vifor (International) Inc. / / Country Switzerland / / Event Patent Issuance / Product Issues / / Facility Laboratory Test Interactions / / IndustryTerm dextran product / injection site / chemical characteristics / nutrition solutions / resuscitation equipment / near intravenous injection site / drug products / dextran products / / MedicalCondition Chest pain / headache / seizures / iron deficiency anemia / unconsciousness / documented iron deficiency / arthritis / local phlebitis / chronic renal failure / rheumatoid arthritis / drug allergies / cellulitis / nausea / Anaphylaxis / significant allergies / syncope / numbness / drug allergy / fatal anaphylactic reactions / lymphadenopathy / bradycardia / acute hypersensitivity / tachycardia / Anaphylactic reactions / Hypersensitivity / diarrhea / quiescent rheumatoid arthritis / cardiac arrest / sterile abscess / end-stage renal disease / high fever / pruritus / hemosiderosis / iron deficiency anemias / hemophilia / wheezing / familial telangiectasia / hypotension / asthma / hemoglobinopathies / purpura / paresthesia / febrile episodes / tumor / Abdominal pain / chronic renal dialysis / iron deficiency / literature describing tumors / hypertension / bronchospasm / flushing / arthralgia / backache / hemorrhagic diatheses / dyspnea / chills / Hematuria / shock / Carcinogenesis / cardiovascular disease / disorientation / fever / exogenous hemosiderosis / sarcoma / Hodgkins disease / vomiting / I. Iron Deficiency Anemia / anemias / Urticaria / chest tightness / anaphylactoid shock / dizziness / inflammation / rash / joint pain / anemia / refractory anemias / infectious kidney disease / / MedicalTreatment parenteral nutrition / intravenous infusion / resuscitation / hemodialysis / renal dialysis / dialysis / / Organization Dexferrum administration / DOSAGE AND ADMINISTRATION / / Position General / target Hb / / Product DEXFERRUM / Sodium chloride / Epinephrine / IRON DEXTRAN / state / subjects / / ProgrammingLanguage ML / / ProvinceOrState New York / / Technology dialysis / /
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NDA[removed]S-022 Page 3 DEXFERRUM® (IRON DEXTRAN INJECTION, USP) Rx Only