Mannitol Irrigation

5% Mannitol is not for injection. It is contraindicated in patients with anuria.

FOR UROLOGIC IRRIGATION ONLY. NOT FOR INJECTION.

Solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary or renal dysfunction.

Since irrigating fluids used during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large volumes, any irrigation solution must be regarded as a systemic drug.

Absorption of large amounts of fluids containing mannitol and the resultant osmotic diuresis may significantly affect cardiopulmonary and renal dynamics.

Do not warm above 150°F (66°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 preservative.

General

Use aseptic technique when preparing and administering sterile irrigation solutions.

Use only if solution is clear and container and seal are intact.

Cardiovascular status, especially in patients with cardiac disease, should be carefully determined before and during transurethral resection of the prostate when using 5% Mannitol as an irrigant. The fluid absorbed into the systemic circulation via severed prostatic veins may produce significant extracellular fluid expansion and lead to fulminating congestive heart failure.

Shift of sodium-free intracellular fluid into the extracellular compartment following systemic absorption of 5% Mannitol may lower serum sodium concentration and aggravate pre-existing hyponatremia.

Excessive loss of water and electrolytes may lead to serious imbalances. Continuous administration of 5% Mannitol may cause loss of water in excess of electrolytes and produce hypernatremia.

Sustained diuresis from transurethral irrigation with 5% Mannitol may obscure and intensify inadequate hydration or hypovolemia.

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with 5% Mannitol Irrigation have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with 5% Mannitol Irrigation. It is also not known whether 5% Mannitol Irrigation can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 5% Mannitol Irrigation should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Caution should be exercised when 5% Mannitol Irrigation is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of 5% Mannitol Irrigation did not include a sufficient number of patients age 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, 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. See WARNINGS.

In the event of dehydration or fluid or solute overload, discontinue the irrigant, evaluate the patient and institute appropriate corrective treatment. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.

As required for urologic irrigation.

5% Mannitol Irrigation should be administered only by the appropriate transurethraI urologic instrumentation.

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

Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.

Not for injection.

Aseptic technique is required.

1. Caution – Before use, perform the following checks:
             (a) Read the label. Ensure solution is the one ordered and is within the expiration date.

             (b) Invert container and inspect the solution in good light for cloudiness, haze, or particulate 
                  matter; check the container for leakage or damage. Any container which is suspect
                  should not be used.

Use only if solution is clear and container and seal are intact.

Single dose container.

2. Outer Closure Removal – Grasp the container with one hand and turn the breakaway ring 
    counterclockwise with the other hand until slight resistance is felt. Then, twisting the 
    container in the opposite direction, turn the breakaway ring sharply until the entire outer
    cap is loose and can be lifted off.

3. Connect the administration set through the sterile port according to set instructions or 
    remove screw cap and pour.

4. Do not warm above 150°F to assure minimal bottle distortion. Keep bottles upright.

B. Braun Medical Inc.
Irvine, CA 92614-5895 USA
Made in USA

In Canada, distributed by:
B. Braun Medical Inc.
Scarborough, Ontario M1H 2W4

Y36-002-697