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Sterile Water

RxNorm 150985· WATER· IRRIGATION

Fresenius Kabi USA, LLC

Indications and usage

INDICATIONS AND USAGE Sterile Water for Irrigation is indicated for use as an irrigating fluid or pharmaceutic aid. Sterile Water may also be used as an adjunct in the preparation of non-intravenously administered nutrient mixtures (see DOSAGE AND ADMINISTRATION ).

Dosage and administration

DOSAGE AND ADMINISTRATION Irrigation Use as directed by physician. This drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Nutrient Mixtures Sterile Water for Irrigation, USP may be used to prepare non-intravenously administered nutrient mixtures. It contains no electrolytes or other added substances. Refer to preparation instructions of particular mixture to be used. The plastic container may be used for administration of non-intravenous nutrient mixture to the patient as appropriate.

Warnings

WARNINGS Sterile Water for Irrigation is hypotonic and will cause hemolysis, and is not recommended for use during surgical procedures. After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard unused portion of irrigating solution since it contains no preservative.

Contraindications

CONTRAINDICATIONS Not for injection.

Adverse events

Most frequently reported events (FDA FAERS). Report frequency does not imply causation.

  • drug ineffective1,370
  • nausea1,137
  • off label use1,024
  • pyrexia1,017
  • pain940
  • diarrhoea818
  • dyspnoea817
  • maternal exposure during pregnancy790
  • fatigue765
  • vomiting742
  • headache734
  • foetal exposure during pregnancy681
  • premature baby665
  • weight decreased640
  • pneumonia623
  • malaise605

Adverse reactions (label)

ADVERSE REACTIONS None known. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.