is it any problem to use only sterile water
Answers
Sterile Water for Irrigation is not potable water and is not intended for oral administration. Sterile Water for Irrigation that has been warmed must not be returned to storage
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Answer:Indications & Dosage
INDICATIONS
Sterile Water for Irrigation is indicated for use as an irrigant.
DOSAGE AND ADMINISTRATION
Important Administration Instructions
For irrigation only. Not for intravenous injection.
Sterile Water for Irrigation is hypotonic with an osmolarity of zero mOsmol/L. It is intended for use as an irrigation fluid and not for intravenous administration or administration by other, parenteral routes (e.g., subcutaneous or intramuscular) [see WARNINGS AND PRECAUTIONS].
Sterile Water for Irrigation is not potable water and is not intended for oral administration.
Sterile Water for Irrigation that has been warmed must not be returned to storage.
Recommended Dosage
The volume and/or rate of irrigation depend on the type of the procedure and the capacity or the surface area of the structure to be irrigated.
Preparation And Administration Instructions
For single-dose only. Sterile Water for Irrigation is available in a flexible plastic container and a plastic pour bottle. Use the contents of the opened container immediately to minimize the potential for bacterial growth and pyrogen formation. Discard the unused contents of opened containers, as Sterile Water for Irrigation contains no antimicrobial preservative.
Adding Medications To Either The Flexible Plastic Container Or The Plastic Pour Bottle
Use aseptic technique when making additions to Sterile Water for Irrigation.
Additives may be incompatible with Sterile Water for Irrigation.
The compatibility of additives with Sterile Water for Irrigation must be assessed. Before introducing additives, check for a possible color change and/or the appearance of precipitates, insoluble complexes, or crystals.
Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of Sterile Water for Irrigation is appropriate.
Additives known or determined to be incompatible should not be used.
Mix thoroughly after additives have been introduced.
Use immediately.
Administration Instructions For Irrigation By Gravity Using The Flexible Plastic Container
Use aseptic technique.
Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing the container firmly. If leaks are found, discard solution as sterility may be impaired.
Suspend container using hanger hole.
Remove plastic protector from outlet port at bottom of container.
Attach irrigation set. Refer to complete directions accompanying set.
Warming
If desired, warm the flexible plastic container in overwrap to near body temperature in a water bath or fluid warmer heated to not more than 45°C.
Microwave heating of irrigation fluids is not recommended.
Administration Using The Plastic Pour Bottle
Inspect Sterile Water for Irrigation visually for particulate matter and discoloration prior to use. Discard if the fluid is not clear or the seal is broken.
Use Aseptic Technique
Remove the plastic shrink band by tearing along the perforation line and unscrew the bottle cap.
Prevent contact of the fluid with the external surface of the container (including the thread for the bottle cap of the plastic pour bottle).
Warming
If desired, warm the plastic pour bottle in a fluid warmer to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming.
Microwave heating of irrigation fluids is not recommended.
HOW SUPPLIED
Dosage Forms And Strengths
Irrigation
250, 500, 1000, and 1500 mL sterile water for irrigation in a single-dose plastic pour bottle
1000, 2000 and 3000 mL sterile water for irrigation in a single-dose flexible plastic container
Storage And Handling
Sterile Water for Irrigation is supplied in single-dose plastic pour bottles and flexible plastic containers as follows:
Container Product Codes Fill Volume (mL) NDC
Plastic Pour Bottle 2F7112 250 0338-0004-02
2F7113 500 0338-0004-03
2F7114 1000 0338-0004-04
2F7115 1500 0338-0004-05
Flexible Plastic Container 2B7114 1000 0338-0003-44
2B7116 2000 0338-0003-46
2B7117 3000 0338-0003-47
Storage
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Store at room temperature (25°C): brief exposure up to 40°C does not adversely affect the product.
Baxter Healthcare Corporation Deerfield, IL 60015 USA. Revised: Oct 2017
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