Product Monograph - Sterile Water for Injection USP (Omega Laboratories)
ADVERSE REACTIONS
Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.
The physician should also be alert to the possibility of adverse reactions to drug additives. Prescribing information for drug additives to be administered in this manner should be consulted.
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.
OVERDOSAGE
Overdosage (hypotonic expansion) is a function of an increase in fluid intake over fluid output, and occurs when the increase in the volume of body fluids is due to water alone. Overdosage may occur in patients who receive large quantities of electrolyte-free water to replace abnormal excessive fluid losses, in patients whose renal tolerance to water loads is exceeded, or in patients who retain water postoperatively in response to stress.
Manifestations of water intoxication are behavioral changes (confusion, apathy, disorientation and attendant hyponatremia), central nervous system disturbances (weakness, muscle twitching, headaches, nausea, vomiting, convulsions) and weight gain.
Treatment consists of withholding fluids until excessive water is excreted. In severe hyponatremia it may be necessary to cautiously administer hypertonic saline to increase extracellular osmotic pressure and excretion of excess water by the kidneys.
DOSAGE AND ADMINISTRATION
This solution is for intramuscular, intravenous or subcutaneous use. Do not inject until made isotonic by addition of appropriate solute.
The dosage and administration of Sterile Water for Injection USP is dependent upon the recommended dosage and administration of the solute used. Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.
Some additives may be incompatible. Consult with pharmacist or call the manufacturer at 1-800-363-0584 for any questions or concerns. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
DOSAGE FORMS, COMPOSITION, AND PACKAGING
Sterile Water for Injection USP is supplied sterile and nonpyrogenic in single use 10 mL and 50 mL clear USP Type-I glass vials. The stoppers are made of grey chlorobutyl rubber and are latex-free. The vials are available in boxes of 10.
For management of a suspected drug overdose, contact your regional poison control centre.
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at 15 – 30°C.
Omega Laboratories Limited
Montreal, Quebec
H3M 3E4
Date of Revision:
June 05, 2020