Sodium Citrate Blood-Pack Units, (PL 146 Plastic)

SODIUM CITRATE BLOOD-PACK UNITS, (PL 146 PLASTIC)- trisodium citrate dihydrate solution
Fenwal, Inc.

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 procedures. Before infusing

red cells, confirm the identity of the intended recipient as the original donor by

comparing remaining segment numbers on severed tubing with segment number on

Blood-Pack unit. Do not rely on segment numbers alone.

18. Attach Blood-Pack unit to unused lead of recipient set. Close clamp under intravenous

solution container and open clamp on the Blood-Pack unit. Infuse red cells.

19. When red cells have been infused, flush tubing with intravenous solution.

20. Close lower clamp on recipient set.

21. If blood pressure cuff is used, inflate to approximately 60 mmHg.

22. Repeat steps 9-19 for second unit of blood.

23. Clamp tubing; remove needle from donor’s arm; bandage venipuncture site.

24. Discard bags, tubing and needle according to current guidelines for handling biohazardous

PACKAGE/LABEL DISPLAY PANEL

Fenwal™

Anticoagulant Sodium Citrate Solution, USP, BLOOD-PACK™ Unit

Double For Collection and Processing of Two 500 mL Units of Blood 16 ga. Needle

Rx only

Each unit consists of two PL 146 Plastic containers, each with 50 mL of Anticoagulant Sodium Citrate Solution, USP containing 2 g Sodium Citrate (dihydrate) USP.

Not intended for storage or homologous transfusion of red cells.

These units should be used for plasmapheresis only.

Sterile , non-pyrogenic fluid path
See instructions for use.

Store at Controlled Room Temperature (refer to direction insert).

Open pouch by tearing across at notch.
Direct handling of product surfaces prior to extended storage in the foil pouch, may result in mold growth.
Unused units in open foil pouch may be kept up to 60 days by folding and securing open end of foil pouch to prevent possible loss of moisture, provided:l) Units are not removed from foil pouch, orll) Unused units removed from foil pouch are returned to the foil pouch within 12 hours. Units may be removed from the pouch and returned only once.

FENWAL and BLOOD-PACK are trademarks of Fenwal, Inc.

logo Fenwal, Inc.
Lake Zurich, IL 60047 USA
Made in USA

07-28-05-516 REV: A

Y:\Drug Listings and Establishment Registration (SPL)\Drug Listings\NDA 77-923 Sodium Citrate in PL 146\4R3202MC -- NDC 0942-9502-06\4R3202MC -- NDC 0942-9502-06 -- Version 4 -- Drug Listings -- December 2011\72805516 pouch.jpg
(click image for full-size original)
SODIUM CITRATE BLOOD-PACK UNITS, (PL 146 PLASTIC)
anticoagulant sodium citrate solution solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0942-9502
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRISODIUM CITRATE DIHYDRATE (Anhydrous Citric Acid) Anhydrous Citric Acid 2 g in 50 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0942-9502-06 50 mL in 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA BN770923 03/01/2007 01/31/2022
Labeler — Fenwal, Inc. (794519020)
Establishment
Name Address ID/FEI Operations
Fenwal International, Inc. 091164590 MANUFACTURE

Revised: 11/2021 Fenwal, Inc.

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