Sterile Water for Injection USP (Hikma Canada) Product Monograph

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.

Some additives may be incompatible. Consult with pharmacist or call the manufacturer at 1-800-656-0793 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 LDPE plastic ampoules and in single use 10 mL type I glass vials. The ampoules are available in boxes of 20 and the vials are available in boxes of 10.

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.

Directions for Use of Plastic Ampoules

The instructions below should be followed when using the plastic ampoules with Luer systems:

Hikma Canada Limited

Mississauga, Ontario

L5R 3P9

Last Revised:

JAN 21, 2025