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The pH is 5. 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. The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly.
The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. When administered intravenously as a vehicle for drugs, sterile water for injection provides a source of water for parenteral fluid replenishment after sufficient solute is introduced to achieve an osmolarity of mOsmol or more per liter.
Average normal adult daily requirement ranges from two to three liters 1. Water balance is maintained by various regulatory mechanisms. 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. Intravenous administration of Sterile Water for Injection without additives may result in hemolysis. 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.
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. Tissue loading may occur at even lower rates of administration. Animal reproduction studies have not been conducted with sterile water for injection.
It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sterile water for injection with additives should be given to a pregnant woman only if clearly needed. The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations.
These complications can manifest after irrigation has ended and immediate intervention may be required. Monitor patients closely for absorption of clinically relevant amounts of fluid during and for an appropriate period after the procedure. If absorption occurs, discontinue Sterile Water for Irrigation. Avoid use of Sterile Water for Irrigation in patients with wounds where significant absorption may occur, such as procedures that require irrigation over a longer period of time or an irrigation fluid pressure that promotes absorption e.
Sterile Water for Irrigation should only be used by clinicians familiar with the treatment of possible complications. In contrast to other irrigation fluids containing electrolytes, Sterile Water for Irrigation is non-conductive.
The following adverse reactions have been identified during post approval use of Sterile Water for Irrigation. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Metabolism and Nutrition disorders : Hyponatremia, fluid overload, fluid absorption, electrolyte imbalance Nervous System Disorders : Cerebral edema General Disorders and Administration Site Conditions : Burning sensation with irrigation of eyes and skin wounds Musculoskeletal and Connective Tissue Disorders : Rhabdomyolysis myoglobinuria Renal and Urinary Disorders : Renal failure.