Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Sterile Water for Injection, USP is supplied in a single dose flexible plastic container as follows: Product No. NDC No. Bag Size Bags Per Carton 917876 63323-178-76 1,000 mL Bag 10 Bags The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.; PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Sterile Water 1,000 mL Bag Label free flex ® 1,000 mL Sterile Water for Injection, USP Do not give intravenously. For drug diluent use only. For intravenous use. Rx only red
- HOW SUPPLIED: Sterile Water for Injection, USP is supplied in a single dose flexible plastic container as follows: Product No. NDC No. Bag Size Bags Per Carton 917876 63323-178-76 1,000 mL Bag 10 Bags The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Sterile Water 1,000 mL Bag Label free flex ® 1,000 mL Sterile Water for Injection, USP Do not give intravenously. For drug diluent use only. For intravenous use. Rx only red
Overview
Sterile Water for Injection, USP is a sterile, nonpyrogenic, solute-free preparation of distilled water for injection. It is for use only as a sterile solvent or diluent vehicle for drugs or solutions suitable for parenteral administration. The pH is 5.5 (5.0 to 7.0). Sterile Water for Injection contains no bacteriostat, antimicrobial agent or added buffer and is intended only for single dose injection after admixture with an appropriate solute or solution. When smaller amounts are required, the unused portion should be discarded. Sterile Water for Injection is a pharmaceutic aid (vehicle) and parenteral fluid replenisher after addition of an appropriate solute. Water for Injection, USP is chemically designated H 2 O. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.
Indications & Usage
: Sterile Water for Injection 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.
Dosage & Administration
: Following suitable admixture of prescribed additive, the dose is usually dependent upon the age, weight and clinical condition of the patient. Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (See PRECAUTIONS ).
Warnings & Precautions
WARNINGS: FOR DRUG DILUENT USE ONLY. Intravenous administration of Sterile Water for Injection without additives may result in hemolysis. The intravenous administration of sterile water for injection with additives can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Contraindications
: Do not administer without the addition of a solute.
Adverse Reactions
Reactions which may occur because of 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. 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.
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