CPDA-1- anticoagulant citrate phosphate dextrose adenine solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), Trisodium Citrate Dihydrate (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL), CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (Anhydrous Citric Acid - UNII:XF417D3PSL), Sodium Phosphate, Monobasic, Monohydrate (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR), Adenine (UNII: JAC85A2161) (Adenine - UNII:JAC85A2161)

Available from:

Fenwal, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

CPDA-1 - ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION
FENWAL, INC.
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CPDA-1 BLOOD-PACK™ UNIT
INSTRUCTIONS FOR BLOOD COLLECTION USING (CPDA-1) BLOOD-PACK™ UNIT
RX ONLY
Integral Donor Tube (IDT)
Use aseptic technique.
CAUTION: Do not use unless the solutions are clear.
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NOTE:
In order to establish fluid transfer from primary container to
secondary system, hold the cannula by its
base with one hand, and with the other hand break the cannula by
bending it 90º in one direction, then
180º in the opposite direction (Figure 6).
For further processing, use standard component processing and storage
techniques.
Identify BLOOD-PACK™ unit using appropriate donor identification
system.
Adjust donor scale to desired collection weight/volume.
Suspend primary container from donor scale as far as possible below
donor arm and clamp donor
tubing at Position 1 (see Figure 1). Use one of the clamps that come
inside the aluminum pouch.
Apply pressure to donor’s arm and disinfect site of venipuncture.
If blood pressure cuff is used, inflate to approximately 60 mm Hg.
Remove needle cover per instructions below:
a)
b)
Hold the needle hub upwards. With the other hand, grasp the base of
the needle cover
(Figure 2), twist approximately 1/4 turn to break tamper evident seal
(Figure 3).
Remove needle cover (Figure 4), be careful not to drag cover across
the needle point
(Figure 5).
Perform venipuncture, appropriately secure donor needle and/or tubing
and move clamp to
Position 2 (Figure 1).
MIX BLOOD AND ANTICOAGULANT AT SEVERAL INTERVALS DURING COLLECTION AND
IMMEDIATELY AFTER
COLLECTION.
Collect labeled volume of blood. Anticoagulant volume is sufficient
for labeled volume ± 10%.
Place clamp back to Position 1 (Figure 1).
Seal donor tubing between clamp and primary container (a hand sealer
clamp may be used).
Dispose of needle and tubing appropriately. Cut between clamp and
clip/seal; collect any needed
samples using standard techniques.
Release pressure on do