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NDC 14537-0883-03 Sodium Citrate w/v Anticoagulant 4 g/100mL Details
Sodium Citrate w/v Anticoagulant 4 g/100mL
Sodium Citrate w/v Anticoagulant is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Terumo BCT, Ltd. The primary component is TRISODIUM CITRATE DIHYDRATE.
Product Information
| NDC | 14537-0883 |
|---|---|
| Product ID | 14537-883_4719aad5-3448-413e-ba12-7026b3330731 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Sodium Citrate w/v Anticoagulant |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | TRISODIUM CITRATE DIHYDRATE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 4 |
| Active Ingredient Units | g/100mL |
| Substance Name | TRISODIUM CITRATE DIHYDRATE |
| Labeler Name | Terumo BCT, Ltd |
| Pharmaceutical Class | Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | BA125608 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 14537-0883-03 (14537088303)
| NDC Package Code | 14537-883-03 |
|---|---|
| Billing NDC | 14537088303 |
| Package | 30 BAG in 1 CARTON (14537-883-03) / 250 mL in 1 BAG (14537-883-00) |
| Marketing Start Date | 2018-06-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c9d0e9c8-379f-4895-b272-329efab575c4 Details
HIGHLIGHTS OF PRESCRIBING INFORMATION
SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP
Sterile Fluid
Polyolefin Bag
Initial U.S. Approval: 1978
INDICATIONS AND USAGE
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)
DOSAGE AND ADMINISTRATION
- SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is added to tubing sets during apheresis procedures. (2)
- SODIUM CITRATE 4% W/V 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% W/V ANTICOAGULANT SOLUTION USP bag to the apheresis system. (2.2)
DOSAGE FORMS AND STRENGTHS
- 250 mL sterile fluid in a polyolefin bag. (3)
CONTRAINDICATIONS
- DO NOT INFUSE SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP DIRECTLY TO THE DONOR. (4)
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.
- Single-use container, do not reuse. Discard any unused or partially used product.
- Rx only (5)
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. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Terumo BCT, Inc. at 1-877-339-4228 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP has not been studied in controlled clinical trials with specific populations. (7)
Revised: 12/2019
Table Of Contents
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
2.2 Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
6 ADVERSE REACTIONS
8 USE IN SPECIFIC POPULATIONS
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
16 HOW SUPPLIED/STORAGE AND HANDLING
- *
- Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
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. [See Dosage and Administration (2).]
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
SODIUM CITRATE 4% W/V ANTICOAGULANT 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 SODIUM CITRATE 4% W/V ANTICOAGULANT 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.
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
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.
- Single-use container. Do not reuse. Discard any unused or partially used product.
- Rx only.
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.
8 USE IN SPECIFIC POPULATIONS
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. Sterilized with steam.
The formulas of the active ingredients are provided in Table 1.
| Ingredients | Molecular Formula | Molecular Weight |
|---|---|---|
| Sodium Citrate Dihydrate | C6H9Na3O9 | 294.10 |
| Water for Injection | H2O | 18.00 |
Each 100 mL of SODIUM CITRATE 4% W/V ANTICOAGULANT 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: 13.8.
The polyolefin 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.
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.
16 HOW SUPPLIED/STORAGE AND HANDLING
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 250 mL Bag Carton Label
Sodium Citrate 4% w/v Anticoagulant Solution USP
Catalog # 40883
Polyolefin Bag
30 x 250 mL units
NDC 14537-883-03
Indications for use: For use only for the anticoagulation of whole blood
as part of automated apheresis procedures. See apheresis device
operator's manual for complete instructions. Read the package insert
before application. The solution is sterile and non-pyrogenic, and it
contains no bacteriostatic or antimicrobial agents. Sterilized with Steam.
Caution: Use only if solution is clear. Do not use if the container is
damaged. 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
TERUMOBCT
0000000783
Lot
Expiry Date
INGREDIENTS AND APPEARANCE
| SODIUM CITRATE W/V ANTICOAGULANT
trisodium citrate dihydrate injection, solution |
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| Labeler - Terumo BCT, Ltd (233649834) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Terumo BCT, Ltd | 233649834 | MANUFACTURE(14537-883) , ANALYSIS(14537-883) , STERILIZE(14537-883) , LABEL(14537-883) | |