Sterile non-pyrogenic ,single dose container Sodium chloride
intraveous infusion USP 0.9% w/v 500ml
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
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
factory capacity:160,000 bottles /day
Storage:Store in a cool & dark place below 30 °C,protect from light.Do
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)
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
- 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
- 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
|Product Name||Sodium Chloride Injection||Manuf. Date||Sept.2016|
|Batch No.||160914||Report Date||Oct.2016|
|Specification||0.9% 500ml||Expiry Date||Sept.2016|
|Quantity||20000 cartons||Packing||25 bottles/carton|
|Characteristic||A colorless clear liquid||A colorless clarity liquid|
|Identification||It responds to the tests for Sodium and for Chloride||Complies|
|pH||4.5 ~ 7.0||5.4|
|Sterility||Should be sterile||Sterile|
|Volume||Not less than the labeled volume||Complies|
|Visible Particles||Should be absent||Absence|
|Particulate matters||≥10μm: ≤ 25 / ml||3 / ml|
|≥25μm: ≤ 3 /ml||1 / ml|
|Assay||95.0% ~ 105.0% of the labeled amount of NaCl.||100.4%|
|Conclusion||Complies with USP 35|
|QC: Cui Jian||QP: Liu Yuzhen|