Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)
Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)
Terumo Corporation
Human Prescription Drug
NDC 53877-001Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1) also known as Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1) is a human prescription drug labeled by 'Terumo Corporation'. National Drug Code (NDC) number for Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1) is 53877-001. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1) drug includes Adenine - .275 g/1000mL Anhydrous Citric Acid - 2.99 g/1000mL Dextrose Monohydrate - 31.9 g/1000mL Sodium Phosphate, Monobasic, Monohydrate - 2.22 g/1000mL Trisodium Citrate Dihydrate - 26.3 g/1000mL . The currest status of Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1) drug is Active.
Drug Information:
| Drug NDC: | 53877-001 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1) |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1) |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Terumo Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ADENINE - .275 g/1000mL
ANHYDROUS CITRIC ACID - 2.99 g/1000mL
DEXTROSE MONOHYDRATE - 31.9 g/1000mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE - 2.22 g/1000mL
TRISODIUM CITRATE DIHYDRATE - 26.3 g/1000mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 18 Nov, 2009 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 13 Jan, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | BN820528 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Terumo Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000175833
N0000175835
N0000175980
N0000008556
N0000175089
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | JAC85A2161
XF417D3PSL
LX22YL083G
593YOG76RN
B22547B95K
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class MOA: | Acidifying Activity [MoA]
Calcium Chelating Activity [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Calculi Dissolution Agent [EPC]
Anti-coagulant [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Decreased Coagulation Factor Activity [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class: | Acidifying Activity [MoA]
Anti-coagulant [EPC]
Calcium Chelating Activity [MoA]
Calculi Dissolution Agent [EPC]
Decreased Coagulation Factor Activity [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 53877-001-01 | 30 BAG in 1 CASE (53877-001-01) / 35 mL in 1 BAG | 18 Nov, 2009 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Teruflex blood bag system anticoagulant citrate phosphate dextrose adenine (cpda-1) anticoagulant citrate phosphate dextrose adenine (cpda-1) anhydrous citric acid anhydrous citric acid trisodium citrate dihydrate anhydrous citric acid sodium phosphate, monobasic, monohydrate phosphate ion dextrose monohydrate anhydrous dextrose adenine adenine water
Indications and Usage:
For the collection of 250 ml of whole blood revised 2015-12 n-bb-a 3 full prescribing information * sections or subsections omitted from the full prescribing information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17]. 1. indications and usage 1.1. read these instructions carefully before use. 1.2. rx only. 1.3. intended for the collection, processing and preservation of whole blood and blood components. not intended for direct intravenous infusion. 1.4. for the collection of 250 ml ±10% whole blood: 1.4.1. from elderly, pediatric, or smaller autologous donors who may not tolerate larger blood collections. 1.4.2. for blood collections as directed by a patient's physician. 1.5. note : production of platelets and plasma is not intended with this product. image of fig. 1 sealing with tape
Warnings and Cautions:
5. warnings and precautions 5.1. rx only. 5.2. do not use unless solutions are clear and free from particulates. 5.3. always inspect the blood bag set for leaks before use. 5.4. avoid excessive heat and direct sunlight. protect from freezing. 5.5. recommended storage conditions: room temperature (15-30°c/59-86°f). 5.6. it is normal to have condensation in the blister packaging. if the amount of moisture is greater than expected, check for leaks from the fluid-filled components of the blood bag set. 5.7. use aseptic techniques. 5.8. do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose. 5.9. do not touch needle after removing the needle cover. 5.10. discard phlebotomy needle/donor tubing according to institutional standard operating procedures. 5.11. the ageless® (oxygen absorber packet, mitsubishi gas chemical) contained in this package absorbs oxygen and generates heat on removal. do n
Read more...ot open and handle it with care. 5.12. dispose of the ageless packet with the blister tray. 5.13. do not dispose the ageless packet with wastes containing volatile or flammable materials. 5.14. due to possible exposure to infectious agents in the handling of blood, take adequate precautions at all times to prevent exposure to and transmission of such agents. follow your institution's standard operating procedures.
Dosage and Administration:
2. dosage and administration 2.1. to open blister package, peel cover film back 4/5 of its length. 2.2. prepare the blood bag following your institution's standard operating procedures. 2.3. make a loose knot in the donor tubing approximately 10 cm or 4 inches from the needle unless alternate methods are used to seal the tubing at the end of collection. 2.4. temporarily clamp donor tubing. 2.5. suspend the collection bag as far as possible below the donor's arm. 2.6. apply blood pressure cuff or tourniquet to donor's arm. disinfect site of phlebotomy according to institutional standard operating procedures. if blood pressure cuff is used, inflate to approximately 60 mmhg. 2.7. remove the needle cover and perform phlebotomy. 2.7.1. caution : do not touch the needle after removing the needle cover. 2.8. remove the temporary clamp on the donor tubing to permit blood flow into the collection bag. 2.9. secure donor tubing to donor's arm. 2.10. mix blood with anticoagulant in the collection
Read more...bag and continue to mix at several intervals during collection and immediately after collection. if using an automated mixer, follow manufacturer's instructions. 2.11. collect labeled volume of blood 250 ml ±10%. 2.12. when the desired amount of blood has been collected, seal the tubing or tighten the loose knot (white knot) prepared in step 2.3. temporarily clamp between the knot and needle. sever donor tubing between knot and clamp. alternate methods may be used to seal tubing. collect blood samples using careful attention to aseptic technique and following your institution's standard operating procedures. 2.12.1. caution : do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose. 2.13. reapply clamp to donor tubing; release pressure on donor's arm and remove needle. if using a needle safety device, follow manufacturer's instructions. 2.13.1. caution : discard phlebotomy needle/donor tubing according to institutional standard operating procedures. 2.14. immediately after collection, invert collection bag several times to assure blood and anticoagulant are well mixed. 2.15. strip blood from donor tubing into collection bag, mix well, and allow tubing to refill; repeat once. to prevent the blood from clotting in the tubing, work quickly as possible. make an appropriate number of segments of anticoagulated blood for testing by sealing on or near the x marks. leave segments attached to whole blood unit. 2.16. store cpda-1 whole blood (or red blood cells) between 1 â 6 ° c for up to 35 days. 2.17. for further preparation and processing of other components, use standard processing and storage techniques following approved regulations and standards. 2.17.1. note : production of platelets and plasma is not intended with this product.
Dosage Forms and Strength:
3. dosage forms and strengths 3.1. 35 ml citrate phosphate dextrose adenine (cpda-1) anticoagulant usp for collection of 250 ml whole blood. each 35 ml contains 105mg citric acid (anhydrous) usp, 921mg sodium citrate (dihydrate) usp, 77.7mg monobasic sodium phosphate (monohydrate) usp, 1.12g dextrose (monohydrate) usp and 9.63mg adenine usp.
Description:
11. description 11.1. this blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and a 250 ml (nominal capacity 300 ml) collection bag containing 35 ml citrate phosphate dextrose adenine (cpda-1) anticoagulant. 11.2. the blood bag collection set is made of pvc (polyvinyl chloride with dehp plasticizer). 11.3. the blood bag has no components made of natural rubber latex. 11.4. tubing internal diameter (id) nominal 3.0 mm. 11.5. tubing outer diameter (od) nominal 4.4 mm. 11.6. donor tubing line maximum 12 segments available.
How Supplied:
16. how supplied/storage and handling 16.1. single use only. 16.2. sterile and non-pyrogenic fluid path. sterilized by steam. opacity of the blood bag system may be observed. this is due to moisture absorption during the sterilization process. this is normal and does not affect the solution quality or safety. the opacity will diminish gradually. 16.3. a material safety data sheet (msds) is not required for this product. 16.4. recommended storage conditions: room temperature (15-30°c/59-86°f). 16.5. avoid excessive heat and direct sunlight. protect from freezing. 16.6. to open blister package, peel cover film back 4/5 of its length. 16.7. after opening the blister package, unused blood bags may be stored at room temperature for 96 hours or they may be stored for 30 days by returning cover film to original position and sealing with tape to prevent evaporation of solutions. 16.8. blood bags in the unopened blister package may be used through the last day of the month and year as ind
Read more...icated on the original manufacturer's packaging. 16.9. the ageless packet contained in this package absorbs oxygen and generates heat on removal. do not open and handle it with care. 16.10. dispose of the ageless packet with the blister tray. 16.11. do not dispose the ageless packet with wastes containing volatile or flammable materials. 16.12. the single blood bag set, code bb ï¼ scd256a , is supplied 90/case. manufactured by: terumo corporation 44-1, 2-chome, hatagaya, shibuya-ku, tokyo 151-0072, japan made in japan ï¼rï¼: registered trademark ©terumo corporation december, 2015 ageless is a registered trademark of mitsubishi gas chemical co., inc.
Package Label Principal Display Panel:
Tray/case label teruflex® blood bag system anticoagulant citrate phosphate dextrose adenine solution (cpda-1) usp for collection of 250ml of blood each unit consists of a primary bag containing 35 ml of solution with 105 mg citric acid (anhydrous) usp, 921 mg sodium citrate (dihydrate) usp, 77.7 mg monobasic sodium phosphate (monohydrate) usp, 1.12 g dextrose (monohydrate) usp, 9.63 mg adenine usp. sterile, non-pyrogenic fluid path. do not use unless anticoagulant is clear code lot no. expiry unit(s) donor needle 16g x 1 1/2Ë (1.60 x 38mm) rx only recommended storage: room temperature (15-30°c/59-86°f). avoid excessive heat. protect from freezing. after opening, unused bags may be stored at room temperature for 96 hours, or they may be stored for 30 days in the blister package after returning the cover film to original position and sealing with tape to prevent possible loss of moisture. see instructions for blood collection manufactured by : terumo corporation tokyo, japan ® : registered trademark issued 2009 -10 image of label: image of representative tray/case label cpda-1 250ml