CPDA-1- anticoagulant citrate phosphate dextrose adenine solution

CPDA-1 by

Drug Labeling and Warnings

CPDA-1 by is a Prescription medication manufactured, distributed, or labeled by Fenwal, Inc., Fenwal International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Anticoagulant Citrate Phosphate Dextrose Adenine Solution (CPDA-1) BLOOD-PACK™ Unit

Rx only

Integral Donor Tube (IDT).

Use aseptic technique.

Caution: Do not use unless anticoagulant is clear.

1. Identify BLOOD-PACK™ unit using appropriate donor identification system.

2. Adjust donor scale to desired collection/weight/volume.

3. Position primary container on the donor scale as far as possible below donor arm and clamp donor tubing with hemostat.

4. Apply pressure to donor’s arm and disinfect site of venipuncture.

5. If blood pressure cuff is used, inflate to approximately 60 mm Hg.

6. Remove needle cover 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.

7. Perform venipuncture, appropriately secure donor needle and/or tubing and release hemostat.

8. Mix blood and anticoagulant at several intervals during collection and immediately after collection.

9. 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%.

10. Apply hemostat to donor tubing.

11. As appropriate, release pressure on the donor’s arm, collect donor samples following established procedures and withdraw donor needle.
Precaution: Use care to avoid accidental needle sticks. A Needle Protector System may be used to reduce the risk of needle stick injury.

12. Strip blood from donor tubing into container, mix and allow the tubing to refill; repeat once. Seal at X marks on donor tubing to provide numbered aliquots of anticoagulated blood for typing or crossmatching.

13. Discard needle into an appropriate biohazardous waste container following established procedures.

14. Store suspended CPDA-1 whole blood/red blood cells between 1 and 6ºC.

15. Infuse CPDA-1 whole blood/red blood cells within 35 days of collection.

For further processing with multiple BLOOD-PACK units, use standard component processing techniques.

Definition of Symbols:

Manufacturer

Dispose of container appropriately.

Single use only.

Do not use if there is any visible sign of deterioration.

Do not vent.

Sterilized by steam. Sterile fluid path.

Non-pyrogenic fluid path.

Store at Controlled Room Temperature.
USP Definition of “Controlled Room Temperature” United States Pharmacopeia, General Notices.
United States Pharmacopeial Convention, Inc.
12601 Twinbrook Parkway, Rockville, MD

Manufactured by:
Fenwal, Inc.
Lake Zurich, IL 60047 USA

Made in USA

Fenwal International, Inc.
Road 357, Km. 0.8
Maricao, PR 00606

Imported and distributed in India by:
Fenwal India Pvt Ltd
Upper Ground Floor, Tower B
DLF Building No. 10, DLF Cyber City
DLF Phase-II, Gurgaon 122 002,
Haryana, India
Import License No.: FF-504-14890

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

07-19-04-284 REV: A
01/2010

© 2010 Fenwal, Inc. All rights reserved.

PACKAGE/LABEL DISPLAY PANEL

REF R4R7634

6 Units

Fenwal™

Triple BLOOD-PACK™ UnitAnticoagulant Citrate PhosphateDextrose Adenine Solution (CPDA-1)

PL 146 Plastic

Rx only

Triple BLOOD-PACK™ unit consisting of a primary pack containing 49 mL of CPDA-1 anticoagulant solution and two transfer packs without solution for collection of 350 mL of blood, 16 gauge needle.

See instructions for use. Sterile, non-pyrogenic fluid path. Steam sterilized. Single use only. Do not vent. Do not use if there is any visible evidence of deterioration. Dispose of container appropriately. Store at Controlled Room Temperature (refer to direction insert).

Unused packs in open foil pouch may be kept to 60 days by folding and securing open end of foil pouch, to prevent possible loss of moisture.

Direct handling of product surfaces prior to extended storage in the foil pack may result in mold growth.

Each 49 mL CPDA-1 solution contains 1.56 g Dextrose (monohydrate), USP, 1.29 g Sodium Citrate (dihydrate), USP, 160 mg Citric Acid (monohydrate), USP, 109 mg Monobasic Sodium Phosphate (monohydrate), USP, 13.5 mg Adenine, USP, Water for Injection USP to 49 mL.

Manufactured by:
Fenwal International, Inc.
oad 357, Km. 0.8
aricao, PR 00606

Made In USA

Imported and distributed in Indonesia by:
PT.Medquest Jaya Global
Menara Salemba 6th Floor
Jl.Salemba Raya Kav 5-5A
Jakarta-Indonesia 10440
Reg. No.: See Instructions for use.

Imported and distributed in India by:
Fenwal India Pvt Ltd
Upper Ground Floor, Tower B
DLF Building No. 10, DLF Cyber City
DLF Phase-II, Gurgaon 122 002,
Haryana, India
Import License No.: FF-504-14890
MRP: Rs. 239 (inclusive of all taxes)

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

PL 146 is a trademark of Baxter International, Inc.

07-28-04-287 REV: A

INGREDIENTS AND APPEARANCE

CPDA-1 
anticoagulant citrate phosphate dextrose adenine solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0942-6329
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	Dextrose Monohydrate	1.56 g  in 49 mL
Trisodium Citrate Dihydrate (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL)	Anhydrous Citric Acid	1.29 g  in 49 mL
Anhydrous Citric Acid (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL)	Anhydrous Citric Acid	147 mg  in 49 mL
Sodium Phosphate, Monobasic, Monohydrate (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR)	Sodium Phosphate, Monobasic, Monohydrate	109 mg  in 49 mL
Adenine (UNII: JAC85A2161) (Adenine - UNII:JAC85A2161)	Adenine	13.5 mg  in 49 mL

Inactive Ingredients
Ingredient Name	Strength
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0942-6329-03	49 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	BN770420	05/25/2010

Labeler - Fenwal, Inc. (794519020)

Establishment
Name	Address	ID/FEI	Business Operations
Fenwal International, Inc.		091164590	MANUFACTURE(0942-6329)