NDC 14537-815 Acd A

Citric Acid Monohydrate, Dextrose Monohydrate, And Trisodium Citrate Dihydrate

NDC Product Code 14537-815

NDC 14537-815-50

Package Description: 18 BAG in 1 CARTON > 500 mL in 1 BAG

NDC Product Information

Acd A with NDC 14537-815 is a a human prescription drug product labeled by Terumo Bct, Ltd.. The generic name of Acd A is citric acid monohydrate, dextrose monohydrate, and trisodium citrate dihydrate. The product's dosage form is injection, solution and is administered via intravenous form.

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

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.

Acd A 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.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • WATER (UNII: 059QF0KO0R)

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: Terumo Bct, Ltd.
Labeler Code: 14537
FDA Application Number: BA010228 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: ANDA - A product marketed under an approved Abbreviated 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: 02-25-2002 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: 12-31-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Acd A 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

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).]

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 Administration

  • 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.

Other

  • 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.

Issued: (August 2017)Manufactured byTerumo BCT, Inc.Lakewood, CO 80215

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.

4 Contraindications

DO NOT INFUSE ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A DIRECTLY TO THE PATIENTS.

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.

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.

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.

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 IngredientsIngredientsMolecular Formula Molecular Weight(%w/v) Citric Acid, MonohydrateC6H8O7192.12Dextrose MonohydrateC6H12O6 ∙ H2O198.17Sodium Citrate DihydrateC6H9Na3O9294.10Water for InjectionH2O18.00Each 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.

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 anticoagulatesDextrose for isotonicityThis solution has no pharmacological effect.

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.SIZECATALOG NUMBERNDC NUMBER500 mL4081514537-815-50750 mL4081714537-817-75

Storage And Handling

STORAGEStore up to 25 °C [See USP Controlled Room Temperature].Avoid excessive heat. Protect from freezing.

* Please review the disclaimer below.