Product Monograph - Sterile Water for Injection, USP (Baxter)
ADVERSE REACTIONS
The administration of a suitable admixture of prescribed drugs may be associated with adverse reactions because of the solution or the technique of administration including febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
DOSAGE AND ADMINISTRATION
Following suitable admixture of prescribed drugs, the dosage is usually dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations. See directions accompanying drugs. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions where possible. Sterile Water for Injection, USP in the Pharmacy Bulk Package is intended for use in the preparation of sterile, intravenous admixtures. Additives may be incompatible with the fluid withdrawn from this container. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. When compounding admixtures, use aseptic technique. Mix thoroughly. Do not store any unused portion of Sterile Water for Injection, USP.
OVERDOSAGE Overdose may occur in patients receiving large quantities of Sterile Water for Injection. Symptoms of overdose may include central nervous system changes (weakness, muscle twitching, headaches, nausea, vomiting, convulsions), behavioural changes (confusion, apathy, disorientation, and hyponatremia). Treatment may include withholding fluids until excessive water is excreted. In cases of severe hyponatremia, hypertonic saline can be administered to increase extracellular osmotic pressure and excretion of excess water by the kidneys.
DOSAGE FORMS, COMPOSITION AND PACKAGING
How Supplied
Sterile Water for Injection, USP is supplied in a VIAFLEX plastic Pharmacy Bulk Package container as follows:
1000 mL JB0304
Directions for use of VIAFLEX Plastic Pharmacy Bulk Package Container
To Open
Tear overwrap down side at slit and remove solution container. 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 inner bag firmly, if leaks are found, discard solution as sterility may be impaired.
For Compounding only, not for direct infusion.
Preparation for Admixing
- 1. The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).
- 2. Suspend Container from eyelet support.
- 3. Remove plastic protector from outlet port at bottom of container.
- 4. Attach solution transfer set. Refer to complete directions accompanying set. Note: The closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents.
- 5. VIAFLEX containers should not be written on directly since ink migration has not been investigated. Affix accompanying label for date and time of entry.
- 6. Once container closure has been penetrated, withdrawal of contents should be completed without delay. After initial entry, maintain contents at 15° C to 25° C and dispense within 4 hours.
Storage
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at 15° C to 25° C.
Baxter Corporation Mississauga, ON L5N 0C2
Made in Canada
Baxter, VIAFLEX and PL 146 are trademarks of Baxter International Inc.
Last revised: August 15, 2014