Sodium Citrate 4% W/v Anticoagulant
Trisodium Citrate Dihydrate
Terumo Bct, Ltd
Human Prescription Drug
NDC 14537-881Sodium Citrate 4% W/v Anticoagulant also known as Trisodium Citrate Dihydrate is a human prescription drug labeled by 'Terumo Bct, Ltd'. National Drug Code (NDC) number for Sodium Citrate 4% W/v Anticoagulant is 14537-881. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Sodium Citrate 4% W/v Anticoagulant drug includes Trisodium Citrate Dihydrate - 4 g/100mL . The currest status of Sodium Citrate 4% W/v Anticoagulant drug is Active.
Drug Information:
| Drug NDC: | 14537-881 |
| 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: | Sodium Citrate 4% W/v Anticoagulant |
| 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: | 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: | TRISODIUM CITRATE DIHYDRATE - 4 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: | 26 Jun, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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: | BA125608 |
| 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: | 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 |
|---|
| 14537-881-25 | 30 BAG in 1 CARTON (14537-881-25) / 250 mL in 1 BAG | 26 Jun, 2018 | 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:
Sodium citrate 4% w/v anticoagulant trisodium citrate dihydrate trisodium citrate dihydrate anhydrous citric acid water citric acid monohydrate
Indications and Usage:
1 indications and usage sodium citrate 4% w/v anticoagulant solution is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. [see dosage and administration (2) .] sodium citrate 4% w/v anticoagulant solution usp is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. ( 1 )
Warnings and Cautions:
5 warnings and precautions verify that the sodium citrate 4% w/v anticoagulant solution usp 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 sodium citrate 4% w/v anticoagulant solution usp 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 sodium citrate 4% anticoagulant solution usp is added to tubing sets during apheresis procedures. ( 2 ) sodium citrate 4% anticoagulant solution usp 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 sodium citrate 4% anticoagulant solution usp bag to the apheresis system. ( 2.2 ) 2.1 general dosing information sodium citrate 4% w/v anticoagulant solution usp is added to tubing sets during apheresis procedures. the solution is connected 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 administration ensure solution is the sodium citrate 4% w/v anticoagu
Read more...lant solution usp 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 sodium citrate 4% w/v anticoagulant solution usp bag to the apheresis device. at the prompt to connect anticoagulant to the apheresis device tubing set: remove the overwrap by pulling down at the notch, and remove the sodium citrate 4% w/v anticoagulant solution usp 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 sodium citrate 4% w/v anticoagulant solution usp and is within the expiration date. inspect the solution in good 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. 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 the solution and container permit.
Dosage Forms and Strength:
3 dosage forms and strengths 250 ml sodium citrate 4% w/v anticoagulant solution usp is a sterile solution in a pvc bag. each 100 ml contains: sodium citrate (dihydrate) 4.0 g; and 100 ml water for injection, (ph adjusted with citric acid). 250 ml sterile fluid in a pvc bag. ( 3 )
Contraindications:
4 contraindications do not infuse sodium citrate 4% w/v anticoagulant solution usp directly to the donor. do not infuse sodium citrate 4% w/v anticoagulant solution usp directly to the donor. ( 4 )
Adverse Reactions:
6 adverse reactions citrate reactions or toxicity may occur with the infusion of blood products to patients and return of blood containing citrate anticoagulant to donors. 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
Read more...-4228 or fda at 1-800-fda-1088 or www.fda.gov/medwatch .
Use in Specific Population:
8 use in specific populations sodium citrate 4% w/v anticoagulant solution usp has not been adequately studied in controlled clinical trials with specific populations. anticoagulant solution has not been studied in controlled clinical trials with specific populations.
Description:
11 description sodium citrate 4% w/v anticoagulant solution usp 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 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 sodium citrate 4% w/v anticoagulant solution usp contains: sodium citrate (dihydrate) 4.0 g; and 100ml water for injection (ph adjusted with citric acid). the pvc bag is not made with natural rubber latex. 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 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 sodium citrate 4% w/v anticoagulant solution usp 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 anticoagulant this solution has no pharmacological effect.
Mechanism of Action:
12.1 mechanism of action sodium citrate 4% w/v anticoagulant solution usp 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 anticoagulant this solution has no pharmacological effect.
How Supplied:
16 how supplied/storage and handling sodium citrate 4% w/v anticoagulant solution usp is a clear solution supplied in sterile and non-pyrogenic pvc bags. the bags are packaged 30 bags per case. size catalog number ndc number 250 ml 40881 14537-881-25 storage up to 25 °c. protect from freezing.
Package Label Principal Display Panel:
Principal display panel - 250 ml bag carton label sodium citrate 4% w/v anticoagulant solution usp catalog # 40881 30 x 250 ml units ndc 14537-881-25 for use only with automated apheresis procedures. see apheresis device operator's manual for complete instructions. read the package insert before application. sterile. non-pyrogenic. sterilized with steam. caution: do not use unless the solution is clear and the container is intact. single use container. discard any unused product. not for direct intravenous infusion. rx only. recommended storage: up to 25 °c. protect from freezing. each 100 ml contains: sodium citrate dihydrate 4.0 g water for injection to (ph adjusted with citric acid) 100 ml approximate millimoles: sodium citrate 13.8 manufactured by terumo bct, inc. 10811 w. collins ave., lakewood co 80215, usa 777962-240 terumo bct lot expiry date principal display panel - 250 ml bag carton label