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City PANHEMATIN / / Company RDAT I RARE DISEASES INC. / U.S.A. U. / USA LLC / MANUFACTURE(5529 2-70 1) RECORDATI RARE DISEASES INC. / Fresenius Kabi USA LLC / Item Co / RECORDATI RARE DISEASES GROUP / RECORDATI RARE DISEASES INC. / / Country Lebanon / / Event FDA Phase / / IndustryTerm mammalian systems / bacteria systems / rapid chemical decompos ition / natural rubber latex / healthcare / chemical reaction product / sodium carbonate solution / chemical agent / chemical and physical stability / uch products / / MedicalCondition unknown infectious agents / certain current virus infections / hereditary coproporphyria / Hepatic Porphyria / olution RECORDATI RARE DISEASES / acute intermittent porphyria / thrombocytopenia / porphyrias / disorder / porphyria cutanea tarda / infectious agent / hypersensitivity / infections / progressive neurologic signs / porphyria / infectious agents / hepatic porphyrias / Creutzfeldt-Jakob disease / hypertension / acute porphyria / Oliguria / tachycardia / abnormal mental status / phlebitis / ADVERSE REACTIONS Clinical Trials Experience Phlebitis / pain / Acute Hepatic Porphyria / concomitant disease / acute porphyrias / allergic reactions / RECORDATI RARE DISEASES / I RARE DISEASES / / MedicalTreatment intravenous infusion / alternate therapy / catheter / drug therapy / / OperatingSystem Dos / / Organization Transitory Renal Failure Following Rapid Administration of a Relatively Large Amount of Hematin / DOSAGE AND ADMINISTRATION / FDA / / Person Marke ting End / Ann Intern Med / / / Position physician / PRECAUTIONS General / / Product Exp / Vial Hemin For Injection / mannitol / Sterile Water for Injection / Hemin For Injection / sorbitol / Rx / Contains One Vial Hemin For Injection / BLA10 / / ProvinceOrState New Jersey / North Carolina / / TVShow Spring / / Technology pharmacokinetics / / URL www.fda.gov/medwatch / / SocialTag 
Panhematin® Hemin For Injection Rx only For intravenous infusion only.