Water for Injections BP – Summary of Product Characteristics

Water for Injection Description


This Water for Injections preparation is designed solely for parenteral use only after addition to pills that require dilution or must be dissolved in an aqueous vehicle prior to injection.

Sterile Water for Injections uses, USP is a sterile, nonpyrogenic preparation of Water for Injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single dose containers to dilute or dissolve drugs for injection.  For IV injection, add sufficient amount to a solute to make an approximately isotonic solution. pH 5.0 to 7.0.

DOSAGE AND ADMINISTRATION

The Water for Injections production volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.

Parenteral pills products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

INDICATIONS AND USAGE

Sterile Water for Injections definition, USP is indicated for use only as a solvent or diluent vehicle for parenterally administered drugs or solutions and as a source of water for parenteral fluid replenishment after suitable additives are introduced.

For intravenous administration, an osmolar concentration not less than two-fifths (0.4) of the normal osmolarity of the extracellular fluid (280 mOsmol/liter) is essential to avoid intravascular hemolysis.

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SIDE EFFECTS

Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.

Warnings

Intravenous administration of Sterile buy Water for Injections without a solute may result in hemolysis.

Where Water for Injection is required for preparing or diluting medications for use in newborns, only preservative-free Sterile Water for Injection should be used.