trisodium citrate dihydrate

FDA Drug Profile — ANTICOAGULANT SODIUM CITRATE

Drug Details

Generic Name
trisodium citrate dihydrate
Brand Names
ANTICOAGULANT SODIUM CITRATE
Application Number
BN980123
Sponsor
Baxter Healthcare Corporation
NDC Codes
1
Dosage Forms
SOLUTION
Routes
EXTRACORPOREAL
Active Ingredients
TRISODIUM CITRATE DIHYDRATE

Indications and Usage

1. INDICATIONS AND USAGE 1.1. Read these instructions carefully before use. 1.2. Rx ONLY. 1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion. 1.4. For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood. 1.5. Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 1.6. For further processing, use standard component processing techniques.

Warnings

5. WARNINGS AND PRECAUTIONS 5.1. Rx ONLY. 5.2. Do not use unless solutions are clear and free from particulates. 5.3. Always inspect the blood bag set for leaks before use. 5.4. Avoid excessive heat and direct sunlight. Protect from freezing. 5.5. Recommended storage conditions: Room Temperature (15-30°C/59-86°F). 5.6. It is normal to have condensation in the blister packaging. If the amount of moisture is greater than expected, check for leaks from the fluid-filled components of the blood bag set. 5.7. Use aseptic techniques. 5.8. Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose. 5.9. Do not touch needle after removing the needle cover. 5.10. Assure that the White Clamp below the pouch is closed prior to initiating phlebotomy. 5.11. Do not collect donor test samples until the tubing between the "Y" and the diversion pouch is permanently sealed. 5.12. Discard the Diversion Blood Sampling Arm and phlebotomy needle/donor tubing according to institutional standard operating procedures. 5.13. The AGELESS oxygen absorber packet, (Mitsubishi Gas Chemical) contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care. 5.14. Dispose of the AGELESS packet with the blister tray. 5.15. Do not dispose the AGELESS packet with wastes containing volatile or flammable materials. 5.16. Due to possible exposure to infectious agents in the handling of blood, take adequate precautions at all times to prevent exposure to and transmission of such agents. Follow your institution's standard operating procedures.