Sterile non-pyrogenic ,single dose container Sodium chloride intraveous infusion USP 0.9% w/v 500ml
Composition:
Each 100ml contains:
Sodium Chloride USP 0.9% W/V
Water for injection USP qs
mMoles/L:Na & CI 150
Additives may be in compatible.
Discard any unused portion.
Must not be used in series connections.
Hold the bottle in vertical position & insert I.V. set.
Dosage:As directed by the physician.
To be used with pyrogen free I.V.administration set using aseptic technique.
Prescription only medicine.
Keep out of reach of children.
Products complies USP 35 standard.
Batch No.:per customer request
Mfg date: per customer request
Exp Date: per customer request
Packing:packed in plastic bottle,25 bottles/carton,carton size:39.5*38.5*23.5cm
factory capacity:160,000 bottles /day
Storage:Store in a cool & dark place below 30 °C,protect from light.Do not freeze.
Caution:Not to be used if container is found leaking or solution is hazy or contains visible solid particles.
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:
Table 1: Key Differences in 0.9% Sodium Chloride Products
Table 2: Comparison of Container Labels
Table 3: Comparison of Carton Labels
It is also important to note the following:
The injection/medication ports are similar across the VIAFLEX (PVC), AVIVA (non-PVC), and VIAFLO (non-PVC) containers. The VIAFLO (non-PVC) administration port system is fully compatible with IV set spike heads that meet the International Organization of Standardization (ISO) standards and with Baxter IV sets marketed in the United States.
Prior to use, it is important to check for leaks by squeezing the inner bag firmly. If leaks are found, discard solution as sterility may be impaired. Additionally, check to see that solution is clear and free of foreign matter. Discard the solution if solution is not clear.
VIAFLO (non-PVC) imported container and carton labeling includes barcodes; however, the barcodes 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.
Please review container labels carefully to avoid potential volume selection errors. For example, the US-approved Viaflex 1 L product and the imported 500 mL Viaflo product are of similar bag size and shape.
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