Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Citrate reactions or toxicity may occur with the injection of blood products containing citrate anticoagulant.
The recipient of the blood product 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 injection of blood products containing citrate anticoagulant.
The recipient of the blood product 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 .
5 WARNINGS AND PRECAUTIONS Do not use the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A unless the solution is clear and the container is intact and undamaged.
Do not transfer the solution bag directly into the sterile field.
Do not reuse.
Discard unused or partially used solution bags.
Discard the product if the Needleless Access Valve (NAV) does not function as intended.
Like all medications, Anticoagulant Citrate Dextrose (acd-A) can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: