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NDA[removed]S-047 Page 3 Desferal® deferoxamine mesylate for injection USP Vials
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Document Date: 2010-09-09 19:11:22


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City

Hanover / /

Company

Novartis Pharma Stein AG / Novartis Pharmaceuticals Corporation / /

Country

Switzerland / /

IndustryTerm

chemical reactions / yellowish solution / /

MedicalCondition

anaphylactic reaction / aphasia / acidosis / headache / CNS depression / seizures / cardiac failure / eye disorders / transfusion-dependent anemias / hyperparathyroidism / coma / ALL PATIENTS NOT IN SHOCK / nausea / Muscle spasms / neurological dysfunction / thrombocytopenia / severe chronic iron / hepatic dysfunction / sensorineural hearing loss / cardiac dysfunction / PRECAUTIONS General Flushing / deafness / scotoma / disorder / High-frequency sensorineural hearing loss / mucormycosis / Tachycardia / diarrhea / Very rare generalized rash / generalized infections / thalassemia / aluminum-related dialysis encephalopathy / hearing loss / pruritus / Infections / night blindness / hypotension / asthma / bradycardia and acute renal failure / hepatic fibrosis / chronic anemias / chronic iron / abdominal pain / tachycardia and gastrointestinal disturbances / cataracts / arthralgia / Adult respiratory distress syndrome / dyspnea / Acute respiratory distress syndrome / shock / Carcinogenesis / optic neuritis / aluminum-related encephalopathy and receiving dialysis / erythema / fever / severe renal disease / deferoxamine-associated renal dysfunction / corneal opacities / Yersinia pseudotuberculosis infections / pain / vomiting / systemic allergic reactions / concomitant disease / primary hemochromatosis / urticaria / angioedema / irritation / infection / dizziness / renal failure / CONTRAINDICATIONS Known hypersensitivity / anuria / dialysis dementia / renal tubular disorders / paresthesias / acute renal failure / color blindness / tinnitus / disorders / /

MedicalTreatment

chelation therapy / intravenous infusion / drug therapy / dialysis / /

Organization

Symptoms Inadvertent administration / Signs and Symptoms Inadvertent administration / /

Person

ANN T FARRELL / /

Position

PRECAUTIONS General / /

Product

sodium chloride / Desferal / deferoxamine mesylate / STERILE WATER FOR INJECTION / Prochlorperazine / /

ProvinceOrState

New Jersey / /

Technology

DNA synthesis / dialysis / /

SocialTag