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Sodium Chloride 0.9% w/v Intravenous Infusion | Sodium Chloride [B. Braun Medical Inc.] | BioPortfolio

13:46 EST 27th January 2019 | BioPortfolio

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B. Braun Medical Inc. 824 12th AvenueBethlehem, PA 18018610-691-5400

October 20, 2017

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, no other entity except B. Braun is authorized by the FDA to import or directly/indirectly distribute Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac plus container in the U.S. 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:

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 online, or regular mail or by fax:

Thank you for your commitment to B. Braun’s IV solution products.

Tom Sutton

Vice President of Marketing

 Product Name    Volume   Ingredients
Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac plus container   1,000 mL Each 1,000 mL contains: Sodium Chloride 9.0 g,
Water for Injections to 1,000 mL Electrolytes per 1,000 mL is Sodium 154 mmol, Chloride 154  mmol
 PRODUCT 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  9999-00 L8000
 Unit Bar Code  No  Yes (NDC and Lot/Exp)
 NDC # 0264-9999-00 0264-7800-00
 Volume 1,000 mL 1,000 mL
 Case Quantity  10 units per case 12 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 1,000 mL contains:
Sodium Chloride EP 900 mg, Water for
Injection EP to 1,000 mL
Total Electrolytes per 1,000 mL :
Sodium 154 mEq, Chloride 154 mEq
Each 1,000 mL contains:
Sodium Chloride USP 900 mg, Water for
Injection USP to 1,000 mL.
Total Electrolytes per 1,000 mL:
Sodium 154 mEq, Chloride 154 mEq
 Container 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 170 mL 200 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 10-6
 Terminal Steam Sterilization
Parametric Release
Sterility Assurance Level of 10-6

Sodium Chloride 0.9% w/v Intravenous Infusion BP

Expel all air before pressure infusion.

This 1000 ml contains: Electrolytes                            mmol Sodium                                      154Chloride                                    154Sodium Chloride                       9.0 gWater for injectionspH                                            4.5 - 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: 1000 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.

LOTEXP:

 

B. Braun Melsungen AG D-34209 MelsungenGermany

5/12625007/1117

Manufacturer

B. Braun Medical Inc.

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