Label: SODIUM CHLORIDE injection
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Contains inactivated NDC Code(s)
NDC Code(s): 0264-9999-10 - Packager: B. Braun Medical Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Unapproved drug for use in drug shortage
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated August 19, 2014
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IMPORTANT PRESCRIBING INFORMATION
B. Braun Medical Inc.
824 12th Avenue
Bethlehem, PA 18018
610-691-5400August 29, 2014
Subject: Temporary Importation of 0.9% Sodium Chloride w/v Intravenous Infusion in Ecoflac® Plus Containers
Dear Health Care Provider,
The purpose of this letter is to inform you of an additional foreign product that B. Braun Medical Inc. (B. Braun) will be providing in the United States (U.S.) to address the critical drug shortage of 0.9% Sodium Chloride for Injection. Due to the shortage of 0.9% Sodium Chloride Injection products in the U.S., B. Braun is coordinating with the U.S. Food and Drug Administration (FDA) to temporarily import foreign Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac® plus container into the U.S. market. The foreign product is manufactured at an FDA inspected B. Braun sterile injectable facility in Melsungen, Germany which is currently in compliance with FDA regulations.
At this time, FDA is not objecting to the importation and distribution of Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac® plus container product by B. Braun to address the critical U.S. shortage of 0.9% Sodium Chloride Injection. Importation or distribution of B. Braun’s Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac® plus container by any entity other than B. Braun and its authorized distributor(s), is not within the scope of this decision and may be subject to enforcement action by the FDA. FDA has not approved B. Braun’s Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac® plus container in the United States.
Effective immediately and during this temporary period, B. Braun will offer the following presentations of B. Braun’s Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac® plus container:
Product Name Volume Ingredients Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac® plus container 500 mL Each 500 mL contains: Sodium Chloride 4.5 g,
Water for Injections to 500 mL Electrolytes per 500 mL is Sodium 77 mmol, Chloride 77 mmol
Ecoflac plus container- Not made with natural rubber latex, PVC, or DEHP.
Indications and Usage and Dosage Administration
The foreign unapproved product, packaged in a semi-rigid Ecoflac® (polyethylene plastic) container, contains the same active ingredient in the same concentration as the 0.9% Sodium Chloride Injection products approved in the U. S., packaged in the flexible plastic EXCEL® (ethylene-propylene copolymer) bag. As such, clinical practice pertaining to indication, usage and dosage administration for Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac® plus container is the same as with the EXCEL® containers.
However, some key differences between the Ecoflac® and EXCEL® container packaging and labeling are described below in the Product Comparison Table.
It is also important to note that the Ecoflac® plus container is a semi rigid plastic bottle. However, no venting is necessary during infusion. Ecoflac® plus collapses completely when emptying.
Ecoflac® plus container and carton labeling may include barcodes that may not register accurately in the U.S. scanning systems. Institutions should manually input the product into their systems and confirm that barcode systems do not provide incorrect information when the product is scanned. Alternative procedures should be followed to assure that the correct drug product is being used and administered to individual patients.
Reporting Adverse Events
To report adverse events or quality problems with B. Braun’s Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac® plus container, please contact the B. Braun Clinical and Technical Support Department at 1-800-854-6851. Adverse events that may be related to the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either via phone, online, regular mail or fax:
- Phone: 1-800-FDA-1088
- Online: www.fda.gov/Safety/MedWatch
- Regular Mail: use postage-paid FDA form 3500 available at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms and mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
- Fax: 1-800-FDA-0178
Thank you for your commitment to B. Braun’s IV solution products.
Rick Williamson
Vice President of Pharmaceutical MarketingPRODUCT COMPARISON TABLE Item German Product – Ecoflac® Container US Product - EXCEL® Container Product Drawing Ecoflac® Plus
EXCEL®
Product Description 0.9% w/v Sodium Chloride BP 0.9% Sodium Chloride Injection USP Product Code 9999-10 L8001 Unit Bar Code No Yes (NDC and Lot/Exp) NDC # 0264-9999-10 0264-7800-10 Volume 500 mL 500 mL Case Quantity 10 units per case 24 units per case Storage Condition Do not store above 25°C Store at room temperature (25°C) Shelf Life 36 months 30 months Ingredients Each 500 mL contains:
Sodium Chloride EP 450 mg,
Water for Injection EP to 500 mL
Total Electrolytes per 500 mL:
Sodium 77 mEq, Chloride 77 mEqEach 500 mL contains:
Sodium Chloride USP 450 mg,
Water for Injection USP to 500 mL.
Total Electrolytes per 500 mL:
Sodium 77 mEq, Chloride 77 mEqContainer Type Ecoflac® Plus, Polyethylene Plastic Containers (semi rigid plastic bottle) Excel®, Primary plastic container with a clear overwrap (flexible plastic bag) Container material Low Density Polyethylene (LDPE) Copolymer of ethylene and propylene Container Description Blow/Fill/Seal (BFS) Form/Fill/Seal (FFS) PVC, DEHP, Latex No No Overwrap No Yes Closure Description Twin cap with peel tab cover Additive port with elastomeric stopper, Administration port with plastic cover Pictures of Difference in Container Port System Twin Port with peel tab cover and two interchangeable access ports with thermoplastic elastomeric septum
Separate additive and administration ports
Additive Port Material Thermoplastic elastomer Synthetic Isoprene Needle Size 18-21 gauge 18-22 gauge Additive Volume 120 mL 50 mL Spike Port Resealable Yes No Pressure Infusion No Yes, not to exceed 300mm Hg Sterilization Process Terminal Steam Sterilization
Sterility Test (Ph. Eur.)
Sterility Assurance Level of 10-6Terminal Steam Sterilization
Parametric Release
Sterility Assurance Level of 10-6
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PRINCIPAL DISPLAY PANEL
Sodium Chloride 0.9% w/v Intravenous Infusion BP
Expel all air before pressure infusion.
This 500 ml contains:
Electrolytes mmol
Sodium 77
Chloride 77
Sodium Chloride 4.5 g
Water for injectionspH 4.0 - 7.0
Solution for infusion. For intravenous use only. Use as directed by a medical practitioner. Do not use if container or closure is damaged. For single use only. Do not reconnect partially used containers.
Contents: 500 ml
Discard any unused contents. Solutions containing visible solid particles should not be administered. Keep out of the reach and sight of children. Do not store above 25 °C. In case of an adverse reaction, infusion must be stopped immediately. No other medication or substance should be added to this fluid unless the compatibility is known. Thorough and careful mixing of any additive is mandatory. For further information, see enclosed package leaflet.
LOT
EXP:B. Braun Melsungen AG
D-34209 Melsungen, Germany5/12619414/0914
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INGREDIENTS AND APPEARANCE
SODIUM CHLORIDE
sodium chloride injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0264-9999 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 450 mg in 500 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0264-9999-10 10 in 1 CASE 1 500 mL in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE 08/19/2014 Labeler - B. Braun Medical Inc. (002397347)