SODIUM CITRATE W/V ANTICOAGULANT- trisodium citrate dihydrate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)

Available from:

Terumo BCT, Ltd

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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).] DO NOT INFUSE SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP DIRECTLY TO THE DONOR. SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP has not been adequately studied in controlled clinical trials with specific populations.

Product summary:

SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is a clear solution supplied in sterile and non-pyrogenic polyolefin bags. The bags are packaged 30 bags per case. STORAGE Up to 25 °C. Protect from freezing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SODIUM CITRATE W/V ANTICOAGULANT- TRISODIUM CITRATE DIHYDRATE
INJECTION, SOLUTION
TERUMO BCT, LTD
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SODIUM CITRATE 4% W/V
ANTICOAGULANT SOLUTION USP SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR SODIUM
CITRATE 4% W/V ANTICOAGULANT SOLUTION USP.
SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP
STERILE FLUID
POLYOLEFIN BAG
INITIAL U.S. APPROVAL: 1978
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. (1)
DOSAGE AND ADMINISTRATION
SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is added to tubing
sets during apheresis
procedures. (2)
SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP may only be used with
apheresis devices. For
instructions on the use of the solution see the apheresis device
operator's manual. (2.1)
Follow the directions for connecting the SODIUM CITRATE 4% W/V
ANTICOAGULANT SOLUTION USP bag to the
apheresis system. (2.2)
DOSAGE FORMS AND STRENGTHS
250 mL sterile fluid in a polyolefin bag. (3)
CONTRAINDICATIONS
DO NOT INFUSE SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP
DIRECTLY TO THE DONOR.
(4)
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.
Single-use container, do not reuse. Discard any unused or partially
used product.
Rx only (5)
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. (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_.
USE IN SPECIFIC POPULATIONS
SO