Acd A
Citric Acid Monohydrate, Dextrose Monohydrate, And Trisodium Citrate Dihydrate
Terumo Bct, Ltd.
Human Prescription Drug
NDC 14537-815Acd A also known as Citric Acid Monohydrate, Dextrose Monohydrate, And Trisodium Citrate Dihydrate is a human prescription drug labeled by 'Terumo Bct, Ltd.'. National Drug Code (NDC) number for Acd A is 14537-815. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Acd A drug includes Citric Acid Monohydrate - .8 g/100mL Dextrose Monohydrate - 2.45 g/100mL Trisodium Citrate Dihydrate - 2.2 g/100mL . The currest status of Acd A drug is Active.
Drug Information:
| Drug NDC: | 14537-815 |
| 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: | Acd A |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Acd |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | A |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Citric Acid Monohydrate, Dextrose Monohydrate, And Trisodium Citrate Dihydrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Terumo Bct, Ltd. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, 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: | CITRIC ACID MONOHYDRATE - .8 g/100mL
DEXTROSE MONOHYDRATE - 2.45 g/100mL
TRISODIUM CITRATE DIHYDRATE - 2.2 g/100mL
|
| 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: | ANDA |
| 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: | 25 Feb, 2002 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 27 Dec, 2025 |
| 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: | BA010228 |
| 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 BCT, Ltd.
|
| 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. |
| UNII: | LX22YL083G
2968PHW8QP
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: | 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 |
|---|
| 14537-815-50 | 18 BAG in 1 CARTON (14537-815-50) / 500 mL in 1 BAG | 25 Feb, 2002 | 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:
Acd a citric acid monohydrate, dextrose monohydrate, and trisodium citrate dihydrate citric acid monohydrate anhydrous citric acid dextrose monohydrate anhydrous dextrose trisodium citrate dihydrate anhydrous citric acid water acd a citric acid monohydrate, dextrose monohydrate, and trisodium citrate dihydrate citric acid monohydrate anhydrous citric acid dextrose monohydrate anhydrous dextrose trisodium citrate dihydrate anhydrous citric acid water
Indications and Usage:
1 indications and usage anticoagulant citrate dextrose solution usp (acd) solution a is an anticoagulant for blood collection for use only with apheresis devices. [see dosage and administration (2) .] anticoagulant citrate dextrose solution usp (acd) solution a is an anticoagulant for blood collection for use only with apheresis devices. ( 1 )
Warnings and Cautions:
5 warnings and precautions verify that the anticoagulant citrate dextrose solution usp (acd) solution a has been securely attached to the anticoagulant (ac) line on the system tubing set. use aseptic technique throughout all procedures to ensure donor safety and quality. do not reuse. discard unused or partially used solution bags. verify that the anticoagulant citrate dextrose solution usp (acd) solution a has been securely attached to the anticoagulant (ac) line on the system tubing set. use aseptic technique throughout all procedures to ensure donor safety and quality. ( 5 )
Dosage and Administration:
2 dosage and administration anticoagulant citrate dextrose solution usp (acd) solution a is added to tubing sets during apheresis procedures. ( 2 ) anticoagulant citrate dextrose solution usp (acd) solution a may only be used with apheresis devices. for instructions on the use of the solution see the apheresis device operator's manual. ( 2.1 ) follow the directions for connecting the anticoagulant citrate dextrose solution usp (acd) solution a bag to the apheresis system. ( 2.2 ) 2.1 general dosing information anticoagulant citrate dextrose solution usp (acd) solution a is added to tubing sets during apheresis procedures. the solution is connected to the tubing set in an apheresis collection. the recommended dose is determined by the apheresis device and metered into the tubing set by the apheresis device. it is not intended for direct intravenous infusion. for instructions on the use of the solution with the apheresis device and tubing set, see the device operator's manual. 2.2 admini
Read more...stration ensure solution is the anticoagulant citrate dextrose solution usp (acd) solution a and is within the expiration date. inspect the bag. do not use if the container is damaged, leaking or if there is any visible sign of deterioration. use only if solution is clear and free of particulate matter. protect from sharp objects. directions for connecting the anticoagulant citrate dextrose solution usp (acd) solution a bag to the apheresis device. at the prompt to connect anticoagulant to the apheresis device tubing set: remove the overwrap by pulling down at notch, and remove the anticoagulant citrate dextrose solution usp (acd) solution a bag. before use, perform the following checks [see warnings and precautions (5) .] : check for leaks by gently squeezing the bag. if leaks are found, discard the bag. ensure that the solution is the anticoagulant citrate dextrose solution usp (acd) solution a and is within the expiration date. inspect the solution in adequate light. bags showing cloudiness, haze, or particulate matter should not be used. remove the protective cap from the port on the bag. connect the bag to the apheresis device tubing set using aseptic technique and hang the solution. break the frangible connector. when you break frangible connectors, bend them in both directions to ensure that you break them completely. failure to do so may result in restricted flow. proceed according to the apheresis device operator's manual. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Dosage Forms and Strength:
3 dosage forms and strengths 500 ml or 750 ml anticoagulant citrate dextrose solution usp (acd) solution a is a sterile solution in a polyolefin bag. each 100 ml contains: (%w/v) citric acid, monohydrate 0.8 g; dextrose monohydrate 2.45 g; sodium citrate dihydrate 2.2 g; and water for injection. 500 ml or 750 ml sterile fluid in polyolefin bag. ( 3 )
Contraindications:
4 contraindications do not infuse anticoagulant citrate dextrose solution usp (acd) solution a directly to the patients. do not infuse anticoagulant citrate dextrose solution usp (acd) solution a directly to the patients. ( 4 )
Adverse Reactions:
6 adverse reactions citrate reactions or toxicity may occur with the infusion and return of blood containing citrate anticoagulant. the recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity. the signs and symptoms of citrate toxicity begin with paresthesia, a "tingling" sensation around the mouth or in the extremities, followed by severe reactions that are characterized by hypotension and possible cardiac arrhythmia. citrate toxicity may occur more frequently in patients who are hypothermic, have impaired liver or renal function, or have low calcium levels because of an underlying disease. citrate reactions or toxicity may occur with the infusion and return of blood containing citrate anticoagulant. the recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity. ( 6 ) to report suspected adverse reactions, contact terumo bct, inc. at 1-877-339-4228 or fda at 1-800-fda-1088 or www.fd
Read more...a.gov/medwatch .
Use in Specific Population:
8 use in specific populations anticoagulant citrate dextrose solution usp (acd) solution a has not been adequately studied in controlled clinical trials with specific populations. anticoagulant citrate dextrose solution usp (acd) solution a has not been studied in controlled clinical trials with specific populations.
Description:
11 description anticoagulant citrate dextrose solution usp (acd) solution a is designed to be metered by an apheresis device in apheresis procedures, to prevent platelet activation and coagulation as blood moves throughout the extracorporeal unit (tubing set) in an apheresis procedure. the solution is sterile and non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents. the formulas of the active ingredients are provided in table 1. table 1: active ingredients ingredients molecular formula molecular weight (%w/v) citric acid, monohydrate c 6 h 8 o 7 192.12 dextrose monohydrate c 6 h 12 o 6 â h 2 o 198.17 sodium citrate dihydrate c 6 h 9 na 3 o 9 294.10 water for injection h 2 o 18.00 each 100 ml of anticoagulant citrate dextrose solution usp (acd) solution a contains: (%w/v) citric acid, monohydrate 0.8 g; dextrose monohydrate 2.45 g; sodium citrate dihydrate 2.2 g; and water for injection. the polyolefin bag is not made with natural rubber latex or pvc. the bag is made from a multilayered film. it contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. the solution contact layer is an elasticized polyolefin. the bag is nontoxic and biologically inert. the bag-solution unit is a closed system and is not dependent upon entry of external air during administration. the bag is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.
Clinical Pharmacology:
12 clinical pharmacology 12.1 mechanism of action anticoagulant citrate dextrose solution usp (acd) solution a acts as an extracorporeal anticoagulant by binding the free calcium in the blood. calcium is a necessary co-factor to several steps in the clotting cascade. the following ingredients are key components of the solution: citric acid for ph regulation sodium citrate anticoagulates dextrose for isotonicity this solution has no pharmacological effect.
Mechanism of Action:
12.1 mechanism of action anticoagulant citrate dextrose solution usp (acd) solution a acts as an extracorporeal anticoagulant by binding the free calcium in the blood. calcium is a necessary co-factor to several steps in the clotting cascade. the following ingredients are key components of the solution: citric acid for ph regulation sodium citrate anticoagulates dextrose for isotonicity this solution has no pharmacological effect.
How Supplied:
16 how supplied/storage and handling anticoagulant citrate dextrose solution usp (acd) solution a is a clear solution supplied in sterile and non-pyrogenic polyolefin bags. the 750 ml bags are packaged 12 bags per case. the 500 ml bags are packaged 18 bags per case. size catalog number ndc number 500 ml 40815 14537-815-50 750 ml 40817 14537-817-75 storage store up to 25 °c [see usp controlled room temperature]. avoid excessive heat. protect from freezing.
Package Label Principal Display Panel:
Principal display panel - 750 ml bag label anticoagulant citrate dextrose solution usp (acd) solution a catalog # 40817 polyolefin bag 750 ml ndc 14537-817-75 sterile. non-pyrogenic. sterilized with steam. do not use unless the solution is clear and the container is intact. rx only. single use container. read the package insert before application. for use only with apheresis devices. see apheresis device operator's manual for complete instructions. caution: not for direct intravenous infusion. recommended storage: store up to 25 °c. (see usp controlled room temperature). avoid excessive heat. protect from freezing. each 100 ml contains: dextrose monohydrate usp 2.45 g sodium citrate dihydrate usp 2.20 g citric acid monohydrate usp 0.80 g in water for injection usp manufactured by terumo bct, inc. 10811 w. collins ave., lakewood co 80215, usa 777967-057 terumo bct lot expiry date principal display panel - 750 ml bag label
Principal display panel - 500 ml bag label anticoagulant citrate dextrose solution usp (acd) solution a catalog # 40815 polyolefin bag 500 ml ndc 14537-815-50 sterile. non-pyrogenic. sterilized with steam. do not use unless the solution is clear and the container is intact. rx only. single use container. read the package insert before application. for use only with apheresis devices. see apheresis device operator's manual for complete instructions. caution: not for direct intravenous infusion. recommended storage: store up to 25 °c. (see usp controlled room temperature). avoid excessive heat. protect from freezing. each 100 ml contains: dextrose monohydrate usp 2.45 g sodium citrate dihydrate usp 2.20 g citric acid monohydrate usp 0.80 g in water for injection usp manufactured by terumo bct, inc. 10811 w. collins ave., lakewood co 80215, usa 777967-540 terumo bct lot expiry date principal display panel - 500 ml bag label