Sodium Citrate 4% w/v Anticoagulant

Generic: TRISODIUM CITRATE DIHYDRATE

Prescription DrugINTRAVENOUS

Drug Information

Brand Name
Sodium Citrate 4% w/v Anticoagulant
Generic Name
TRISODIUM CITRATE DIHYDRATE
Manufacturer
Terumo BCT, Ltd
Product Type
Prescription Drug
Route
INTRAVENOUS
Application Number
0775912f-f14a-4967-ac00-c8c1b36040bf

Indications & Usage

1 INDICATIONS AND USAGE SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION 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 )

Warnings

5 WARNINGS AND PRECAUTIONS Verify that the SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP has been securely attached to the Anticoagulant (AC) line on the system tubing set. Use aseptic technique throughout all procedures to ensure donor safety and quality. Do not reuse. Discard unused or partially used solution bags. Verify that the SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP has been securely attached to the Anticoagulant (AC) line on the system tubing set. Use aseptic technique through...

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5 WARNINGS AND PRECAUTIONS Verify that the SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP has been securely attached to the Anticoagulant (AC) line on the system tubing set. Use aseptic technique throughout all procedures to ensure donor safety and quality. Do not reuse. Discard unused or partially used solution bags. Verify that the SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP has been securely attached to the Anticoagulant (AC) line on the system tubing set. Use aseptic technique throughout all procedures to ensure donor safety and quality. ( 5 )

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 card...

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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 .

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare provider before making any decisions about your medications. Data sourced from openFDA.