B Braun Q8001 - ExcelPlus Sodium Chloride Injections, 0.9%, 500 ml, 24/Cs
B Braun Q8001 0.9% Sodium Chloride Injection USP in EXCEL Plus IV Solution Container
Increasing Capacity and Reducing Risk. Not made with DEHP, PVC, or natural rubber latex to support you, your patients, and environmental safety.
Each 100 mL of 0.9% Sodium Chloride Injection USP contains:
- Sodium Chloride USP 0.9 g; Water for Injection USP qs
- pH: 5.6 (4.57.0) Calculated Osmolarity: 308 mOsmol/liter
- pH adjusted with Hydrochloric Acid NF
- Concentration of Electrolytes (mEq/liter): Sodium 154 Chloride 154
The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.
Indications and Usage
These intravenous solutions are indicated for use in adults and pediatric patients as sources of electrolytes and water for hydration.
0.9% Sodium Chloride Injection USP is indicated for extracellular fluid replacement, treatment of metabolic alkalosis in the presence of fluid loss and mild sodium depletion.
0.9% Sodium Chloride Injection USP is also indicated for use as a priming solution in hemodialysis procedures and may be used to initiate and terminate blood transfusions without hemolyzing red blood cells.
Sodium Chloride Injections USP are also indicated as pharmaceutic aids and diluents for the infusion of compatible drug additives.
How are B. Braun IV containers different from those that contain PVC?
B. Braun IV containers are biologically inert and are not made with natural rubber latex, PVC or the plasticizer DEHP. When certain medications come in contact with PVC, there is potential for sorption of the drug and therefore the release of DEHP into the fluid and/or absorption of the active ingredient with subsequent sub-therapeutic dosing. Using B. Braun IV containers minimizes patient exposure to the toxic DEHP plasticizer compared to using PVC containers containing DEHP.
How long and at what temperature can EXCEL Plus IV containers be placed in a warming cabinet?
B. Braun conducted container integrity, as well as chemical and biological stability testing, on the following products to support warming up to 40 dgree clesius for a period of up to 28 days until expiration, whichever is sooner. Products should not be returned to stock after warming.
What are the volume specifications for solutions in the EXCEL Plus IV container?
The fill volumes for EXCEL Plus IV containers account for water vapor transmission loss over the shelf life of the products and volume remaining in the container after drainage. The United States Pharmacopeia (USP) requires containers of injections to have "a volume in slight excess of the labeled 'size' or the volume that is to be withdrawn," referred to as excess volume. For labeled volumes of 50 mL or more, USP recommends excess volume of 2% (3% for viscous solutions), which is considered sufficient to permit withdrawal and administration of the labeled volume.
