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 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.
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 .
5 WARNINGS AND PRECAUTIONS Verify that the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A 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 ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A has been securely attached to the Anticoagulant (AC) line on the system tubing set.
Like all medications, 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: