Sterile Water for Injection, USP, is sterile, nonpyrogenic, distilled water in a single dose container for intravenous administration after the addition of a suitable solute. It may also be used as a dispensing container for diluent use. No antimicrobial or other substance has been added. The pH is 5.5 (5.0 to 7.0). The osmolarity is 0.
The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the
container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the
plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.
Sterile Water for Injection, USP is used for fluid replacement only after suitable additives are introduced to approximate isotonicity and to serve as a vehicle for suitable
INDICATIONS AND USAGE
Sterile Water for Injection, USP is indicated in the aseptic preparation of parenteral solutions. sterile Water for Injection, USP is sterile, nonpyrogenic, distilled water in a single dose container for intravenous administration after the addition of a suitable solute. It may also be used as a dispensing container for diluent use. No antimicrobial or other substance has been added. The pH is 5.5 (5.0 to 7.0).
Sterile Water for Injection, USP is a hemolytic agent due to its hypotonicity.
Therefore, it is contraindicated for intravenous administration without additives.
Do not use for intravenous injection unless adjusted to approximate isotonicity with a suitable solute.
Hemolysis may occur following the infusion of Sterile Water for Injection, USP.
Hemoglobin induced renal failure has been reported following hemolysis.
Do not administer unless a solution is clear and the seal is intact.
The administration of a suitable admixture of prescribed additives may be associated with reactions because of the solution or the technique of administration including the 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 additives, the dosage is usually dependent upon the age, weight and clinical condition of the patient as well as laboratory
determinations. See directions accompanying addictive drugs.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Injections in VIAFLEX plastic containers are intended for intravenous administration using sterile equipment.
- Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available.
- If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Do not store an unused portion of Sterile Water for Injection, USP.
- Mix thoroughly when additives have been introduced. Do not store solutions containing