NDC 0942-6322 Cpda-1

Anticoagulant Citrate Phosphate Dextrose Adenine

NDC Product Code 0942-6322

NDC 0942-6322-04

Package Description: 63 mL in 1 BAG

NDC Product Information

Cpda-1 with NDC 0942-6322 is a a human prescription drug product labeled by Fenwal, Inc.. The generic name of Cpda-1 is anticoagulant citrate phosphate dextrose adenine. The product's dosage form is solution and is administered via intravenous form.

Labeler Name: Fenwal, Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Cpda-1 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DEXTROSE MONOHYDRATE 2 g/63mL
  • TRISODIUM CITRATE DIHYDRATE 1.66 g/63mL
  • ANHYDROUS CITRIC ACID 188 mg/63mL
  • SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 140 mg/63mL
  • ADENINE 17.3 mg/63mL

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Acidifying Activity - [MoA] (Mechanism of Action)
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Anti-coagulant - [EPC] (Established Pharmacologic Class)
  • Decreased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Calcium Chelating Activity - [MoA] (Mechanism of Action)
  • Acidifying Activity - [MoA] (Mechanism of Action)
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Anti-coagulant - [EPC] (Established Pharmacologic Class)
  • Decreased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Calcium Chelating Activity - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Fenwal, Inc.
Labeler Code: 0942
FDA Application Number: BN770420 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-24-2007 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Cpda-1 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Instructions For Blood Collection Using Anticoagulant Citrate Phosphate Dextrose Adenine Solution, Usp (Cpda-1) Blood-Pack™ Units With Elongated Primary Container

  • Rx onlyContains Sample Diversion System for the collection of unanticoagulated whole blood samples for laboratory testing and the DONORCARE™ Needle Guard. The elongated primary container may be used to collect and store 450 mL of blood for 35 (CPDA-1) days. It may also be used to prepare and store frozen red cells using the high glycerol (40% W/V) technique.Use aseptic technique.Notes: •If Sample Diversion System is not used, donor samples may be collected using an alternate method following standard procedures. •Nominal tubing dimensions of product are 0.118" inner diameter x 0.025" wall thickness.Precautions: •Upon removal of BLOOD-PACK™ unit from the clear plastic overwrap, visually inspect the unit. •Do not use the product if the in-line cannula is broken and/or anticoagulant is present in the sample pouch or in the tubing from the in-line cannula to the sample pouch and donor needle (see Figure 1). Note that condensation in the empty tubing of the BLOOD-PACK unit is expected as a result of the sterilization process. •Do not use unless the solutions are clear. •Since plastics become brittle at freezer temperatures, use caution during handling to prevent container breakage. •The elongated primary container should not be used for the storage of red cells at liquid nitrogen temperatures.1.Identify BLOOD-PACK unit using appropriate donor identification system.2.Adjust donor scale to desired collection weight.3.Position primary container on the donor scale as far as possible below donor arm.4.Clamp donor tubing between the needle and Y-junction with hemostat. (This step can be performed prior to step 1 or 2.)5.Visually inspect the tubing from the in-line cannula to the sample pouch and donor needle, as well as the sample pouch to reconfirm that there is no anticoagulant present.Note: Ensure that the sample pouch remains below the donor’s 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 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.9.Perform venipuncture, appropriately secure donor needle and/or tubing and release hemostat.10.When good blood flow is established, slide the DONORCARE™ needle guard over the needle hub into the engaged position. Leave the front third of the needle hub exposed for access. Stabilize the front of the needle guard to arm with tape. (see Figure 2) Note: In difficult collection conditions (e.g. slow blood flow), leave the needle guard disengaged behind the hub during collection.Engage the needle guard at the end of blood collection.11.Allow the sample pouch to fill with blood according to center procedure. Monitor blood flow into sample pouch.Notes: •The sample pouch contains an average fill volume of approximately 53 mL with a maximum fill volume of approximately 60 mL when filled to capacity. •If less blood sample volume is required, the flow to the sample pouch may be stopped prior to completely filling the pouch. For example, in order to target a fill volume of approximately 40 mL, fill to the level indicated by the arrows in Figure 1. Ensure the pouch is hanging vertically. •The tube leading from the Y-junction to the sample pouch contains an additional volume of approximately 2 mL.Precautions: •Do not elevate or squeeze the sample pouch as this could cause blood to backflow from the sample pouch into the collection system. •Once the sample pouch is filled to desired volume, complete steps 12 - 20 within approximately 4 minutes to avoid possible clot formation in the tubing and/or sample pouch.12.Close the blue clamp on tubing between the Y-junction and the sample pouch.13.Break the in-line cannula below the Y-junction in the donor tubing to the primary container allowing blood collection to proceed. To completely break the in-line cannula, grasp with both hands. Snap it at a 90° angle in one direction, and then bend it at a 90° angle in the opposite direction. Ensure the in-line cannula is completely broken and that the blood flows freely to the primary container.Precaution: Failure to break the in-line cannula completely may result in restricted blood flow.14.Mix blood and anticoagulant in primary container at several intervals during collection and immediately after collection.15.Following blood center procedures, hermetically seal the tubing between the sampling site and the Y-junction to maintain sterility of the blood collection system prior to removing blood samples.Warning: •Do not proceed with the remaining steps until the tubing leading to the sample pouch is hermetically sealed between the sampling site and the Y-junction. To maintain the whole blood collection container as a closed system, the tubing between the sample pouch and Y-junction must be hermetically sealed prior to inserting the access device into the sampling site. Failure to do so may lead to contamination of the whole blood collection.16.Insert the access device by pushing firmly into the sampling site until the membrane seal is penetrated.Note: If the access device is assembled such that the outer barrel is screwed onto the Luer, make sure to rotate clockwise upon insertion to avoid barrel detaching from Luer.17.Open the cap on the access device (if applicable). Hold access device so that the sample pouch hangs down.18.Directly align the vacuum sample tube with the internal needle in the access device. Insert vacuum sample tube into device.19.Allow vacuum sample tube to fill with blood then remove from the access device.20.Repeat steps 18 and 19 until the desired number of vacuum sample tubes have been filled.Notes: •If the access device needs to be replaced, use a hemostat to clamp the tubing between the sampling site and the sample pouch. Then, grasp base of sampling site with one hand and pull the access device out with the other hand. Firmly insert the new access device. Remove hemostat and continue sampling. •If the access device is assembled such that the outer barrel is screwed onto the Luer, make sure to rotate clockwise upon removal to avoid barrel detaching from Luer. •The access device can only be replaced one time.Precaution: When replacing access device, be careful to avoid contact with any blood droplets on the Luer or sampling site. Discard used access device appropriately.21.Collect only 450 ± 45 mL of blood into the elongated primary container.Precaution: The primary container of this blood collection system is larger than conventional primary containers and will not appear as full as smaller containers when 450 mL of blood has been collected. The amount of blood collected should be determined by weight for collection of 450 mL of blood.Precaution: Once the desired blood volume is collected, complete steps 22-25 within approximately 4 minutes to avoid possible clot formation in the tubing.22.Release pressure on the donor’s arm. If appropriate, apply hemostat to donor tubing between the needle and the Y-junction.23.Hermetically seal donor tubing near in-line cannula on side leading to the primary container.24.Withdrawal of Needle (see Figure 3)Precaution: The needle guard must be held stationary while the needle is withdrawn into it.a)Place folded sterile gauze over puncture site and hold in place with finger tip without exerting pressure.b)Hold sides of needle guard near the front, between the index finger and thumb. Pull the tubing smoothly until the needle is locked into the needle guard.c)Confirm the needle lock by: •Listen for the 2nd “click” as the needle is drawn into the needle guard. •Ensure the tubing cannot be pulled through the needle guard.25.Strip blood from donor tubing into primary container, mix and allow the tubing to refill; repeat once.26.Seal at X marks on donor tubing to provide numbered aliquots of anticoagulated blood for typing or crossmatching.Note: Step 27 may be performed prior to step 25 or 26 if desired.27.Remove and discard the Sample Diversion System and needle guard into an appropriate biohazardous waste container following established procedures.28.For component preparation, prior to centrifugation, the excess material at bottom of the elongated primary container should be rolled over as follows: •To perform bottom rolling, invert primary container (Figure 4A). •With ports down, roll over excess container material (Figure 4B) and secure with tape (Figure 4C). •Place the rolled primary container in an upright position (ports up) on top of secondary containers in centrifuge cup (Figure 4D). 29.When processing a multiple BLOOD-PACK unit, centrifuge primary and secondary containers to prepare CPDA-1 Red Blood Cells.30.Gently remove the (bottom-rolled) elongated primary container from centrifuge cup. Using care to ensure that bottom fold area is supported, place the container in the plasma extractor.31.Express plasma into empty TRANSFER PACK™ container by releasing pressure plate and opening closure in tubing of primary container. All visible (platelet rich) plasma should be removed if cells are to be frozen subsequently.32.When desired amount of plasma has been removed, clamp tubing between Y and plasma container, remove tape, and unfold unit.33.Seal transfer tubing in three places between the Y-connectors. Cut middle seal being careful to avoid fluid splatter.34.For further processing with multiple BLOOD-PACK units, use standard component processing and storage techniques.For Liquid Red Cell Storage:35.Store suspended CPDA-1 Whole Blood/Red Blood Cells between 1 and 6°C and infuse within 35 days of collection.For Frozen Red Cell Storage:Precaution: Freeze within 6 days of collection. Use aseptic technique during red cell glycerolization.36.If remaining Red Blood Cells are intended for frozen storage in the elongated primary container, the hematocrit should be between 75 and 80% and one empty container should be left attached to the primary for glycerol removal.37.Supplies RequiredA)GLYCEROLYTE™ 57 Solution, 500 mL (Code 4A7833)B)Plasma Transfer Set (Code 4C2243)C)Sterile Filtered Airway NeedleD)Labels for elongated primary freezing pack and cardboard storage containerE)1 heat-sealable 8" x 12" plastic bag (available from 3M Company, St. Paul, Minnesota)F)Corrugated 7" x 5" x 1-1/2" cardboard protective container (available from NABI Company, Woburn, Massachusetts)G)70% isopropyl alcohol swabsH)Waterproof tape (available from 3M Company, St. Paul, Minnesota)I)Hand sealer clips (Code 4R4418)J)AgitatorK)Plasma Extractor (Code 4R4414)38.Allow glycerol solution and red cells to warm to 22-30°C prior to adding solution to red cells. Process cells within 4 hours after removal from refrigeration.39.Remove all but one numbered tubing segment. Heat seal the remaining segment as close to the container as possible. Leave the segment attached to the container.40.Weigh the unit of red cell concentrate and subtract the tare weight (approx. 72 grams for the elongated primary container and integrally attached TRANSFER PACK container). The net weight of the red cells should not exceed 330 grams.41.Place the red cell concentrate on a platform agitator.42.Remove the metal tab from the top of the glycerol solution bottle, disinfect the stopper with 70% isopropyl alcohol and aseptically insert one of the plasma transfer set couplers into the bottle outlet port. Close roller clamp on plasma transfer set.43.Insert the filtered airway needle into the bottle vent port.44.Invert the bottle and suspend it 18 inches above the level of the primary bag on the agitator.45.Aseptically insert the remaining transfer set coupler of the transfer set into the delivery tube assembly on the tubing leading from the elongated primary container.46.Glycerol solution should be added to cells based on cell volume and in three steps. Refer to Table 1.Table 1         Method of Addition of GLYCEROLYTE 57 Solution to Red Cell ConcentratesGross Weightof Unit (g)*Net Weightof Unit (g)*Initial Additionof Glycerol (mL)Second Additionof Glycerol (mL)Third Additionof Glycerol (mL)Total GlycerolAdded (mL)218-272150-2005050250350273-312201-2405050350450313-402241-3305050400500*Tare weight of the empty elongated primary container and integrally attached TRANSFER PACK container is approximately 72 grams.47.Adjust platform agitator to 180 oscillations/minute. Occlude tubing between elongated primary collection container and empty TRANSFER PACK container by folding tubing and placing a hand sealer clip over fold (do not crimp) to prevent flow of solution into TRANSFER PACK container.48.Add 50 mL of glycerol solution to the red cells while the cells are being agitated.49.Turn off agitator and allow equilibration for 5 minutes.50.Restart agitator; add 50 mL of glycerol solution to cells.51.Turn off agitator and allow equilibration for 2 minutes.52.Remove red cells from agitator.53.Refer to Table 1 to determine remaining volume of glycerol solution to be added to red cells. Use continuous, vigorous manual agitation during solution addition.54.Seal tubing proximal to the delivery tube assembly. Ensure that the TRANSFER PACK container remains integrally attached to the primary collection bag. Discard the glycerol bottle, connector tubing, and delivery tube assembly.55.Centrifuge the glycerolized red cells at 1250 x g for 10 minutes.56.Suspend primary container in plasma extractor, remove hand sealer clip, and express all visible supernatant glycerol from the red cell container into the TRANSFER PACK container.57.Seal the tubing 2 inches from the red cell container, separate tubing and discard the TRANSFER PACK container containing the supernatant glycerol solution.58.Appropriately label product (Figure 5A).59.Fold over the top portion of the primary bag approximately 2 inches (Figure 5B), place the unit into the 8" x 12" plastic overwrap (Figure 5C) and seal across the top using an impulse sealer so that there is as little trapped air as possible. Make sure that the ports and tubing segments are folded beneath the unit so that they are protected from breakage when frozen.60.Place the glycerolized red cells and overwrap into the cardboard box (Figure 5D). Close the box and seal the flaps with tape. Label the box, and place in the bottom of a -80°C freezer. To facilitate freezing, do not stack units. After 24 hours, the frozen units can be stacked and/or stored in other -80°C freezers.61.After storage, thaw and deglycerolize red cells according to standard institutional procedure.62.Infuse deglycerolized cells within 24 hours after processing.ReferencesFreezing in the Primary Polyvinylchloride Plastic Collection Bag: A new system for freezing nonrejuvenated and rejuvenated Red Blood Cells. C.R. Valeri, D.A. Valeri, J. Anastasi, J.J. Vecchione, R.C. Dennis, and C.P. Emerson. Transfusion 1981; 21:138-149.ManufacturerFENWAL, BLOOD-PACK, GLYCEROLYTE, and TRANSFER PACK are trademarks of Fenwal, Inc.DONORCARE is a trademark of ITL Corporation.© 2010 Fenwal, Inc. All rights reserved.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, MDFenwal, Inc.Lake Zurich, IL 60047 USAMade in USA1-800-933-692507-19-04-834 REV: A05/2010

Package/Label Display Panel

  • Code 4R12503 UnitsFenwal™Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) BLOOD-PACK™ Unit with Elongated Primary ContainerQuadruple Sample Diversion System, DONORCARE™ Needle Guard, 16 ga. Ultra Thin Wall NeedleFor Collection of 450 mL Blood and Optional Freezing of Red Blood Cells in the Primary ContainerRx onlyEach unit consists of an elongated PL 146 Plastic primary container with delivery tube assembly and with 63 mL of CPDA-1 solution containing 2 g Dextrose (monohydrate) USP, 1.66 g Sodium Citrate (dihydrate) USP, 188 mg Citric Acid (anhydrous) USP, 140 mg Monobasic Sodium Phosphate (monohydrate) USP and 17.3 mg Adenine USP, pH may have been adjusted with sodium hydroxide; three empty 400 mL PL 1240 Plastic TRANSFER-PACK™ containers.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:I)Units are not removed from foil pouch, orII)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. •Units removed from the foil pouch (that are not returned to the pouch within 12 hours) must be used within 4 days (96 hours). Units out of the foil pouch for longer than 96 hours must be discarded.FENWAL, TRANSFER-PACK and BLOOD-PACK are trademarks of Fenwal, Inc.DONORCARE is a trademark of ITL Corporation.Fenwal, Inc.Lake Zurich, IL 60047 USAMade in USA07-28-05-460 REV: A

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