ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) BLOOD-PACK UNITS IN PL 146 PLASTIC (anticoagulant citrate phosphate dextrose- cpd

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL), DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL), SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR)

Available from:

Fenwal, Inc.

INN (International Name):

TRISODIUM CITRATE DIHYDRATE

Composition:

Anhydrous Citric Acid 1.66 g in 63 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) BLOOD-PACK UNITS
IN PL 146 PLASTIC - ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD)
SOLUTION
FENWAL, INC.
----------
ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION, USP (CPD) BLOOD-
PACK™ UNIT
4R0012MC, 4R0837MC, 4R0112MC
FENWAL BLOOD-PACK UNITS
RX ONLY
WITH INTEGRAL DONOR TUBE USING ACD OR CPD AND FENWAL HIGHFLO NEEDLE
INSTRUCTIONS FOR USE
COLLECTION PROCEDURE:
USE ASEPTIC TECHNIQUE.
PRECAUTION: DO NOT USE UNLESS SOLUTION IS CLEAR.
1. Identify Blood-Pack unit using appropriate donor identification
system. Confirm that all
numbered tubing of each Blood-Pack unit contains its own identical
segment numbers.
2. Adjust donor scale to desired collection weight.
3. Position primary container from donor scale as far as possible
below donor arm and
clamp donor tubing.
4. Following blood center procedures, apply pressure to donor's arm
and disinfect site
of venipuncture.
5. Remove HighFlo needle cover per instructions below:
a) Holding the hub and cover near the tamper-evident seal, twist cover
and hub in
opposite directions to break seal.
b) Remove needle cover, being careful not to drag the cover across the
needle point.
Following blood center procedures, perform venipuncture, appropriately
secure donor
needle and/or tubing and release clamp.
6. MIX BLOOD AND ANTICOAGULANT AT SEVERAL INTERVALS DURING COLLECTION
AND
IMMEDIATELY AFTER COLLECTION.
7. Collect the appropriate volume based on Blood-Pack unit used.
NOTE: The volume of anticoagulant is sufficient for the blood
collection indicated on
Blood-Pack unit ± 10%.
8. Apply clamp to donor tube.
9. As appropriate, release pressure on the donor's arm, collect donor
samples following
established procedures and withdraw donor needle.
10. WITHDRAWAL OF NEEDLE INTO NEEDLE GUARD.
PRECAUTION: THE NEEDLE GUARD MUST BE HELD STATIONARY WHILE THE NEEDLE
IS
WITHDRAWN INTO IT.
a) Hold sides of needle guard near the front, between the index finger
and thumb.
Pull the hub back smoothly until the needle is completely enclosed and
secu