ACD A- citric acid monohydrate, dextrose monohydrate, and trisodium citrate dihydrate injection, solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Citric Acid Monohydrate (UNII: 2968PHW8QP) (Anhydrous Citric Acid - UNII:XF417D3PSL), Dextrose Monohydrate (UNII: LX22YL083G) (Anhydrous Dextrose - UNII:5SL0G7R0OK), Trisodium Citrate Dihydrate (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL)

Commercializzato da:

Terumo BCT, Ltd.

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is an anticoagulant for blood collection for use only with apheresis devices. [See Dosage and Administration (2).] DO NOT INFUSE ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A DIRECTLY TO THE PATIENTS. ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A has not been adequately studied in controlled clinical trials with specific populations.

Dettagli prodotto:

ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is a clear solution supplied in sterile and non-pyrogenic polyolefin bags. The 750 mL bags are packaged 12 bags per case. The 500 mL bags are packaged 18 bags per case. STORAGE Store up to 25 °C [See USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

ACD A- CITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND 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
ANTICOAGULANT CITRATE DEXTROSE
SOLUTION USP (ACD) SOLUTION A SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A.
ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A
STERILE FLUID
POLYOLEFIN BAG
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is an
anticoagulant for blood collection
for use only with apheresis devices. (1)
DOSAGE AND ADMINISTRATION
ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is added
to tubing sets during
apheresis procedures. (2)
ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A 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 ANTICOAGULANT CITRATE
DEXTROSE SOLUTION USP (ACD)
SOLUTION A bag to the apheresis system. (2.2)
DOSAGE FORMS AND STRENGTHS
500 mL or 750 mL sterile fluid in polyolefin bag. (3)
CONTRAINDICATIONS
DO NOT INFUSE ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD)
SOLUTION A DIRECTLY TO
THE PATIENTS. (4)
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. (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 I