Sodium Citrate w/v Anticoagulant
Generic: TRISODIUM CITRATE DIHYDRATE
Basic Information
Manufacturer
Terumo BCT, Ltd
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
c9d0e9c8-379f-4895-b272-329efab575c4
Indications & Usage
1 INDICATIONS AND USAGE SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures.
[See Dosage and Administration (2) .] SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures.
( 1 )
[See Dosage and Administration (2) .] SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS Citrate reactions or toxicity may occur with the infusion of blood products to patients and return of blood containing citrate anticoagulant to donors.
The recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity.
The signs and symptoms of citrate toxicity begin with paresthesia, a "tingling" sensation around the mouth or in the extremities, followed by severe reactions that are characterized by hypotension and possible cardiac arrhythmia.
Citrate toxicity may occur more frequently in patients who are hypothermic, have impaired liver or renal function, or have low calcium levels because of an underlying disease.
Citrate reactions or toxicity may occur with the infusion and return of blood containing citrate anticoagulant.
The recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Terumo BCT, Inc.
at 1-877-339-4228 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
The recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity.
The signs and symptoms of citrate toxicity begin with paresthesia, a "tingling" sensation around the mouth or in the extremities, followed by severe reactions that are characterized by hypotension and possible cardiac arrhythmia.
Citrate toxicity may occur more frequently in patients who are hypothermic, have impaired liver or renal function, or have low calcium levels because of an underlying disease.
Citrate reactions or toxicity may occur with the infusion and return of blood containing citrate anticoagulant.
The recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Terumo BCT, Inc.
at 1-877-339-4228 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .