Sodium chloride .9 g/100mL Injection, Solution — NDC 65219-504-20 (Billing 65219-0504-20)

WARNINGS FOR IRRIGATION ONLY. NOT FOR INJECTION. Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs.

Absorption of large amounts can cause fluid and/or solute overload 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 the administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.

Do not warm container above 140°F (60°C). 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 preservatives.

ADVERSE REACTIONS Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes can be minimized when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues.

Accidental contamination from careless technique may transmit infection. If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary. 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.

Drug Interactions Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic technique. Mix thoroughly. Do not store.

PRECAUTIONS General Use aseptic technique when preparing and administering sterile irrigation solutions. Use only if solution is clear and container and seal are intact. Do not use for irrigation that may result in absorption of large amounts of fluid into the blood.

Caution should be observed when the solution is used for continuous irrigation or allowed to “ dwell ” inside body cavities because of possible absorption into the blood stream and the production of circulatory overload. When used for irrigation via appropriate irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start up of each cycle or repeat procedure.

For repeated irrigations of urethral catheters, a separate container should be used for each patient. Laboratory Tests Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance after prolonged irrigation, when fluid absorption is suspected, or whenever the condition of the patient warrants such evaluation. Drug Interactions Some additives may be incompatible.

Consult with pharmacist. When introducing additives, use aseptic technique. Mix thoroughly.

Do not store. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with 0.9% Sodium Chloride Irrigation have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility. Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Irrigation.

It is also not known whether 0.9% Sodium Chloride Irrigation can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.9% Sodium Chloride Irrigation should be given to a pregnant woman only if clearly needed. Labor and Delivery Safety and effectiveness of 0.9% Sodium Chloride Irrigation during labor and delivery have not been established.

Caution should be exercised, and the fluid balance, glucose and electrolyte concentrations, and acid-base balance, of both mother and fetus should be evaluated periodically or whenever warranted by the condition of the patient or fetus. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 0.9% Sodium Chloride Irrigation is administered to a nursing woman.

Pediatric Use The safety and effectiveness of 0.9% Sodium Chloride Irrigation in pediatric patients have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use. Geriatric Use Clinical studies of 0.9% Sodium Chloride Irrigation did not include a sufficient number of patients age 65 years and over to determine whether they respond differently from younger subjects.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Frequent laboratory determinations and clinical evaluations are recommended to monitor changes in blood glucose, electrolyte concentrations, and renal function.