Rx Item-Triferic ferric pyrophosphate Dialysis Powde 24X50Ml By Rockwell Medical

Triferic is available in ampules or packets in the following package sizes:
NDC Code Package Description Amount/Total Volume in Ampule
5 mL Ampule 27.2 mg iron (III)/ 5mL as Triferic solution (5.44 mg of iron (III) per mL)
NDC 57278-314-01 5 X 5 mL Ampules per Pouch
NDC 57278-314-02 8 Pouches per Carton
NDC 57278-316-01 50 mL Ampule 272 mg iron (III)/ 50 mL as Triferic solution (5.44 mg of iron (III) per mL)
NDC 57278-316-02 4 Ampules per Pouch
NDC 57278-316-03 6 Pouches per Carton
NDC Code Package Description Amount/Packet
NDC 57278-315-01 Packet 272 mg iron (III)/ packet as Triferic powder
NDC 57278-315-02 100 Packets per Carton

16.2 Storage

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].
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 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 (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 Rockwell Medical at 1-855-333-4315 or 1-248-960-9009 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. (6)

(6)

(6)
USE IN SPECIFIC POPULATIONS

Pregnancy: Based on animal data may cause fetal harm. (8.1) (7)



Revised: 4/2018

Triferic ferric pyrophosphate
Triferic ferric pyrophosphate Dialysis Powde 24X50Ml By Rockwell Medical

Triferic ferric pyrophosphate
Triferic ferric pyrophosphate Dialysis Powde 24X50Ml By Rockwell Medica

AmericanPharmaWholesale.com
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Buy More Save More!
Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.