| Document Date: 2009-04-28 14:40:35
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Company SGPT/ALT / NVR / SUSPECTED ADVERSE REACTIONS / Ames / Novartis Pharmaceuticals Corporation / / Currency pence / / Facility Laboratory Tests Measure / Laboratory Parameter Serum Creatinine Creatinine / Perform laboratory / / IndustryTerm aluminum-containing antacid products / medicinal products / food / / MedicalCondition hematological disorders / cholelithiasis / Skin disorders / myelodysplastic syndrome / rash / gastrointestinal disorders / drug-induced hepatitis / duodenal ulcer / esophagitis / subcutaneous tissue disorders / Fanconi’s syndrome / Includes ‘abdominal pain / lens opacities / nausea / skin rash / anaphylaxis / thrombocytopenia / transfusional hemosiderosis / Hepatic Dysfunction / fatigue / hematologic disorders / gastrointestinal hemorrhage / glycosuria/proteinuria / gastritis / liver cirrhosis / diarrhea / Hypersensitivity / hepatitis / infections / Gastrointestinal irritation / agranulocytosis / gallstones / purpura / proteinuria / abdominal pain / chronic iron / pigmentation disorder / disease / cataracts / gastric ulcer / such hematological disorders / iron overload / Carcinogenesis / optic neuritis / chronic / sleep disorder / neutropenia / Serious hypersensitivity / vomiting / pain / Renal Insufficiency / leukocytoclastic vasculitis / anemias / hepatic failure / urticaria / angioedema / pancreatitis / high frequency hearing loss / proteinuria / monthly monitoring / sickle cell disease / hyperactivity/insomnia / irritation / Immune system disorders / early cataract / dizziness / Cell Disease / retinal disorders / rash / acute renal failure / cataract / atypical tuberculosis / / MedicalTreatment chelation therapy / blood transfusions / clinical protocols / drug therapy / / Organization DOSAGE AND ADMINISTRATION / FDA / / Person Henoch Schönlein / Take Exjade / / / Product Hydroxyurea / Exjade / simvastatin / cyclosporine / Disperse / repaglinide / phenytoin / paclitaxel / Digoxin / / Technology UDP / 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 Exjade safely and effectively. See full prescribing information for Exjade. •