SODIUM CITRATE BLOOD-PACK UNITS, (PL 146 PLASTIC)- anticoagulant sodium citrate solution 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:

Fenwal, Inc.

INN (International Name):

TRISODIUM CITRATE DIHYDRATE

Composition:

Anhydrous Citric Acid 2 g in 50 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

SODIUM CITRATE BLOOD-PACK UNITS, (PL 146 PLASTIC)- ANTICOAGULANT
SODIUM CITRATE SOLUTION SOLUTION
FENWAL, INC.
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ANTICOAGULANT SODIUM CITRATE SOLUTION, USP,
BLOOD-PACKTM UNIT
INSTRUCTIONS FOR BLOOD COLLECTION AND PLASMAPHERESIS USING DOUBLE
PLASMAPHERESIS BLOOD-PACKTM UNIT
1. Identify Blood-Pack unit using appropriate donor identification
system. Confirm that
the numbers on the tubing of each Blood-Pack unit container are
present and
identical.2. Attach one lead of a multiple lead blood-solution
recipient set to a container
of 0.9% Sodium Chloride Injection, USP following instructions on
recipient set carton.
3. Clamp tubing of each Blood-Pack container.
4. Remove plug from end of manifold and immediately insert needle
adapter of primed
recipient set.
5. Position primary container on the donor scale as far as possible
below donor arm.
6. Apply pressure to donor’s arm and disinfect site of venipuncture.
7. If blood pressure cuff is used, inflate to approximately 60 mmHg.
8. Remove needle cover and accomplish venipuncture per instructions
below:
a. Holding the hub and cover near the tamper-evident seal, twist cover
1/4 turn to break
seal.
b. Remove needle cover, being careful not to drag the cover across the
needle point.
c. Accomplish venipuncture.
9. Open clamp on tubing of one Blood-Pack container to permit flow of
blood.
10. Mix blood and anticoagulant at several intervals during collection
and immediately
after collection.
11. Collect specified volume of blood.
12. Release pressure as appropriate on the donor’s arm.
13. Make two seals below first number on container tubing, and sever
tubing between
seals.
14. Flush donor tubing with intravenous solution and adjust flow to
slow drip to maintain
patency of phlebotomy needle.
15. Centrifuge container to achieve plasma-red cell separation
following standard
procedures.
16. Transfer plasma to an appropriate container. Seal transfer tubing
in two places and
sever
tubing between seals.
17. Utilize more than one identification system following standard
pr