TRIFERIC- ferric pyrophosphate solution TRIFERIC- ferric pyrophosphate citrate powder

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

FERRIC PYROPHOSPHATE CITRATE (UNII: UBY79OCO9G) (FERRIC CATION - UNII:91O4LML611)

Mevcut itibaren:

Rockwell Medical, Inc

INN (International Adı):

FERRIC PYROPHOSPHATE CITRATE

Kompozisyon:

FERRIC CATION 5.44 mg in 1 mL

Uygulama yolu:

PARENTERAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 with Triferic use in pregnant women to inform a drug-associated risk. No teratogenicity was observed in animal reproduction studies with administration of ferric pyrophosphate citrate to pregnant rats and rabbits during organogenesis at doses 96 and 128 times, respectively, the maximum recommended human dose (MRHD) of 27.2 mg per dialysis [see Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively. Data Animal Data In a fertility and early embryonic development study in female rats, the maternally toxic ferric py

Ürün özeti:

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].

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

TRIFERIC- FERRIC PYROPHOSPHATE SOLUTION
TRIFERIC- FERRIC PYROPHOSPHATE CITRATE POWDER
ROCKWELL MEDICAL, INC
REFERENCE LABEL SET ID: 2ACF4711-D225-1271-E054-00144FF88E88
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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. ( 1.1)
Triferic has not been studied in patients receiving home hemodialysis.
( 1.1)
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 50 mL ampule of Triferic solution 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)
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 50 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 in c