Anticoagulant Sodium Citrate
Trisodium Citrate Dihydrate
Csl Plasma Inc.
Human Prescription Drug
NDC 81839-782Anticoagulant Sodium Citrate also known as Trisodium Citrate Dihydrate is a human prescription drug labeled by 'Csl Plasma Inc.'. National Drug Code (NDC) number for Anticoagulant Sodium Citrate is 81839-782. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Anticoagulant Sodium Citrate drug includes Trisodium Citrate Dihydrate - 40 mg/mL . The currest status of Anticoagulant Sodium Citrate drug is Active.
Drug Information:
| Drug NDC: | 81839-782 |
| 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: | Anticoagulant Sodium Citrate |
| 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: | Csl Plasma Inc. |
| 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: | TRISODIUM CITRATE DIHYDRATE - 40 mg/mL
|
| 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: | 01 Jul, 2022 |
| 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: | BA125750 |
| 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: | CSL Plasma Inc.
|
| 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 |
|---|
| 81839-782-02 | 30 BAG in 1 CARTON (81839-782-02) / 250 mL in 1 BAG (81839-782-01) | 01 Jul, 2022 | 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:
Anticoagulant sodium citrate trisodium citrate dihydrate trisodium citrate dihydrate anhydrous citric acid water citric acid monohydrate
Indications and Usage:
1. indications and usage anticoagulant sodium citrate 4% w/v solution usp is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. [see dosage and administration (2) .] anticoagulant sodium citrate 4% w/v 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 anticoagulant sodium citrate 4% w/v 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. single-use container. do not reuse. discard any unused or partially used product. rx only verify that the anticoagulant sodium citrate 4% w/v 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. single-use container, do not reuse. discard any unused or partially used product. rx only ( 5 )
Dosage and Administration:
2. dosage and administration anticoagulant sodium citrate 4% w/v solution usp is added to tubing sets during apheresis procedures. ( 2 ) anticoagulant sodium citrate 4% w/v 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 anticoagulant sodium citrate 4% w/v solution usp bag to the apheresis system. ( 2.2 ) 2.1. general dosing information anticoagulant sodium citrate 4% w/v solution usp is added to tubing sets during apheresis procedures. the solution bag 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. administration ensure solution is the anticoagu
Read more...lant sodium citrate 4% w/v 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 anticoagulant sodium citrate 4% w/v 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 anticoagulant sodium citrate 4% w/v 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 anticoagulant sodium citrate 4% w/v 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 twist off 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 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 anticoagulant sodium citrate 4% w/v solution usp is a sterile solution in a pvc bag. each 100 ml contains: sodium citrate (dihydrate) 4.0 g; water for injection to 100 ml, (ph adjusted with citric acid). approximate millimoles of sodium citrate: 13.6. 250 ml sterile fluid in a pvc bag. ( 3 )
Contraindications:
4. contraindications do not infuse anticoagulant sodium citrate 4% w/v solution usp directly to the donor. do not infuse anticoagulant sodium citrate 4% w/v 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 patient 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 csl plasma inc. at 1-833-275-
Read more...0044 or fda at 1-800-fda-1088 or www.fda.gov/medwatch .
Use in Specific Population:
8. use in specific populations anticoagulant sodium citrate 4% w/v solution usp has not been adequately studied in controlled clinical trials with specific populations. anticoagulant sodium citrate 4% w/v solution usp has not been studied in controlled clinical trials with specific populations.
Description:
11. description anticoagulant sodium citrate 4% w/v 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. sterilized with steam. 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 anticoagulant sodium citrate 4% w/v solution usp contains: sodium citrate (dihydrate) 4.0 g; and water for injection to 100 ml (ph adjusted with citric acid). approximate millimoles of sodium citrate: 13.6. the pvc bag is not made with natural rubber latex. the bag 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 anticoagulant sodium citrate 4% w/v 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 anticoagulant sodium citrate 4% w/v 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 anticoagulant sodium citrate 4% w/v 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 1000782 bag: 81839-782-01 case: 81839-782-02 storage store at 20° to 25°c (68°to 77°f); excursions permitted between 15° to 30°c (59° to 86°f) [see usp controlled room temperature]. brief exposure up to 40°c (104°f) does not adversely affect the product. protect from freezing.
Package Label Principal Display Panel:
Principal display panel - 250 ml bag label anticoagulant sodium citrate 4% w/v solution, usp 250ml ndc 81839-782-01 product no. 1000782 rx only intended for use only with automated apheresis devices each 100 ml contains: sodium citrate (dihydrate), usp 4.0g (ph adjusted with citric acid, monohydrate usp) caution: not for direct intravenous infusion. the pouch is a moisture barrier. do not use unless solution is clear and no leaks detected. single use container. discard unused portion. sterile, nonpyrogenic fluid path. recommended storage: store at 20° to 25°c (68° to 77°f); excursions permitted between 15° to 30°c (59° to 86°f) [see usp controlled room temperature]. brief exposure up to 40°c (104°f) does not adversely affect the product. protect from freezing. manufactured by: csl plasma inc. 155 medical sciences dr. union, sc 29379 usa made in usa 62635v01 principal display panel - 250 ml bag label
Principal display panel - 250 ml carton label anticoagulant sodium citrate 4% w/v solution, usp 250ml ndc# 81839-782-02 30 units rx only product code: 1000782 lot # 21x000xu exp. date yyyy mmm recommended storage: store at 20° to 25°c (68° to 77°f); excursions permitted between 15° to 30°c (59° to 86°f) [see usp controlled room temperature]. brief exposure up to 40°c (104°f) does not adversely affect the product. protect from freezing. manufactured by: csl plasma inc. 155 medical sciences drive union, sc 29379 made in usa 62635v01 000000 000000 principal display panel - 250 ml bag label