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언어: 영어
출처: NLM (National Library of Medicine)
FERRIC PYROPHOSPHATE CITRATE (UNII: UBY79OCO9G) (FERRIC CATION - UNII:91O4LML611)
Rockwell Medical, Inc
HEMODIALYSIS
PRESCRIPTION DRUG
Triferic is an iron replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD). Triferic is not intended for use in patients receiving peritoneal dialysis. Triferic has not been studied in patients receiving home hemodialysis. None Risk Summary There are no data on Triferic use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In pregnant rats and rabbits, ferric pyrophosphate citrate caused adverse developmental outcomes at maternally toxic dose levels that were higher than the maximum theoretical amount of iron transferred to patients from Triferic. Use Triferic during pregnancy only if the potential benefit justifies the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background of birth defect, loss, or other adverse outcomes. In the US. general populati
Triferic is available in ampules or packets in the following package sizes: Store ampules protected from light in the aluminum pouch at controlled room temperature (20° to 25°C [68° to 77°F]); excursions permitted to 15°to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Store packets at controlled room temperature (20° to 25°C [68° to 77°F]); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
New Drug Application
TRIFERIC- FERRIC PYROPHOSPHATE SOLUTION TRIFERIC- FERRIC PYROPHOSPHATE CITRATE POWDER ROCKWELL MEDICAL, INC REFERENCE LABEL SET ID: BEF06C1F-EDA6-4CFA-A578-379F23964599 ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TRIFERIC SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRIFERIC. TRIFERIC (FERRIC PYROPHOSPHATE CITRATE) SOLUTION, FOR HEMODIALYSIS USE TRIFERIC (FERRIC PYROPHOSPHATE CITRATE) FOR SOLUTION, FOR HEMODIALYSIS USE INITIAL U.S. APPROVAL: 2015 INDICATIONS AND USAGE TRIFERIC is an iron replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD). ( 1) Limitation of Use Triferic is not intended for use in patients receiving peritoneal dialysis. ( 1) Triferic has not been studied in patients receiving home hemodialysis. ( 1) DOSAGE AND ADMINISTRATION Add one 5 mL ampule of Triferic solution to each 2.5 gallons of bicarbonate concentrate to achieve a concentration of iron (III) in the final hemodialysate of 2 micromolar (110 mcg/L). ( 2.1) Add one packet of Triferic powder to each 25 gallons of bicarbonate concentrate to achieve a concentration of iron (III) in the final hemodialysate of 2 micromolar (110 mcg/L). ( 2.1) DOSAGE FORMS AND STRENGTHS 27.2 mg of iron (III) per 5 mL ampule as Triferic solution (5.44 mg of iron (III) per mL). ( 3) 272 mg of iron (III) per packet as Triferic powder. ( 3) CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after hemodialysis and until clinically stable. ( 5.1) ADVERSE REACTIONS The most common adverse reactions (incidence >3%) are headache, peripheral edema, asthenia, AV fistula thrombosis, urinary tract infection, AV fistula site hemorrhage, pyrexia, fatigue, procedural hypotension, muscle spasms, pain in extremity, back pain, and dyspnea. (6) (6) (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ROC 전체 문서 읽기