SODIUM CHLORIDE- sodium chloride injection, solution
Baxter Healthcare Corporation
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.
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March 2014
Subject: Temporary Importation of 0.9% Sodium Chloride Injection in VIAFLO (non-PVC) Containers
Dear Healthcare Professional,
Due to current critical shortage of 0.9% Sodium Chloride Injection in the U.S. market, Baxter Healthcare Corporation (Baxter) is coordinating with the Food and Drug Administration (FDA) to increase the availability of the drug. Baxter has initiated temporary importation of a foreign Sodium Chloride 0.9% Injection Solution for Intravenous Infusion in VIAFLO non-polyvinyl chloride (non-PVC) containers manufactured at Baxter’s Bieffe Medital, Sabinanigo, Spain facility and marketed within the European Union.
At this time, FDA is not objecting to the importation and distribution of Baxter’s Sodium Chloride 0.9% Injection Solution for Intravenous Infusion to address the critical shortage of Sodium Chloride 0.9% Injection. Importation or distribution of Baxter’s Sodium Chloride 0.9% Injection Solution for Intravenous Infusion by any entity other than Baxter is not within the scope of this decision and may be subject to enforcement action by the FDA. FDA has not approved this product in the United States.
Effective immediately, Baxter will offer the Sodium Chloride 0.9% Intravenous Infusion in VIAFLO (non-PVC) containers in the following volumes and quantities:
Product |
VIAFLO (non-PVC) Container |
Sodium Chloride 0.9% Intravenous Infusion, 250 mL |
30 bags per carton |
Sodium Chloride 0.9% Intravenous Infusion, 500 mL |
20 bags per carton |
Sodium Chloride 0.9% Intravenous Infusion, 1000 mL (1L) |
10 bags per carton |
Indications and Usage and Dosage Administration
Baxter’s Sodium Chloride 0.9% Intravenous Infusion in the VIAFLO (non-PVC) containers is the same formulation and concentration of active ingredient (sodium chloride) as the 0.9% Sodium Chloride Injection products currently approved by the U.S. FDA in the VIAFLEX (PVC) and AVIVA (non-PVC) containers. As such, clinical practice pertaining to indication, usage and dosage administration for Sodium Chloride 0.9% Intravenous Infusion in VIAFLO (non-PVC) containers is the same as with VIAFLEX (PVC) and AVIVA (non-PVC) containers.
However, before prescribing, healthcare providers should be aware of some key differences between the VIAFLEX (PVC), AVIVA (non-PVC) and VIAFLO (non-PVC) container packaging and labeling. Healthcare providers should refer to the product package inserts before use. Key differences are highlighted in the attached Product Comparison Tables as follows:
It is also important to note the following:
If you have any questions about the information contained in this letter or the use of 0.9% Sodium Chloride Injection in the VIAFLO (non-PVC) container, please contact Baxter’s Medical Information Service at 1-800-933-0303. To place an order, please contact Baxter's Center for Service by calling 1-888-229-0001.
To report product quality issues please contact Baxter Product Surveillance at 1-800-437-5176. To report adverse events associated with 0.9% Sodium Chloride Injection, please call Baxter at 1-866-888-2472, or fax: 1-800-759-1801. 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, by regular mail or by fax.
Sincerely,
Thomas J. Progar
Marketing Strategy and Operations
Medication Delivery US Region
Baxter Healthcare Corporation
Baxter, Aviva, Viaflex and Viaflo are trademarks of Baxter International Inc
Baxter Logo
Viaflo Logo
FE1322
250 ml
Sodium Chloride 0.9% w/v
Intravenous Infusion BP
Isotonic
pH 5.5 (approx) Osmolarity 308 mOsm/l (approx)
Formula per 250 ml mmol per 250 ml (approx)
Sodium Chloride 2.25 g Sodium 38.5
Water for Injections Chloride 38.5
IV administration
Read package leaflet before use
Keep out of the reach and sight of children
Do not remove from overwrap until ready for use
Do not use unless solution is clear without visible
particles, and container undamaged
Do not reconnect partially used bags
Baxter Healthcare Ltd
Thetford Norfolk IP24 3SE
United Kingdom
PL00116/0334
PA167/8/15
MA161/00403
PDM
07
Bar Code
5413760277691
LOT
EXP
LN-35-01-667 1
FE1322
30 x 250 ml
(= 9.5 kg)
Sodium Chloride 0.9% w/v
Intravenous Infusion BP
Formula per 250 ml
Sodium Chloride 2.25 g
Water for Injections
Osmolarity 308 mOsm/l (approx)
mmol per 250 ml (approx)
Sodium 38.5
Chloride 38.5
pH: 5.5 (approx)
IV administration.
Read package leaflet before use.
Keep out of the reach and sight of children.
Do not reconnect partially used bags.
PL00116/0334
PA167/8/15
MA161/00403
Baxter Healthcare Ltd.,
Capton Way, Thetford, Norfolk,
IP24 3SE, United Kingdom.
Viaflo Logo
P111E547
XX-0001
LOT: XXXXXXXX
EXP: XXXXXXXX
Bar Code
(01)55413760277696(17)XXXX00(10)XXXXXXXX
FE1322
30 X 250 ML
(= 9.5 kg)
Sodium
Chloride 0.9% w/v
Intravenous Infusion BP
Viaflo Logo
LOT:
XXXXXXXX
EXP:
XXXXXXXX
SODIUM CHLORIDE
sodium chloride injection, solution |
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Labeler - Baxter Healthcare Corporation (005083209) |
Registrant - Baxter Healthcare Corporation (005083209) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Bieffe Medital SA | 464755693 | ANALYSIS(0338-9542) , MANUFACTURE(0338-9542) , LABEL(0338-9542) , PACK(0338-9542) , STERILIZE(0338-9542) |