Mannitol

Package Insert

PIC^™ (Plastic Irrigation Containers)

Nonelectrolyte Irrigating Fluid for Transurethral
Surgical Procedures.

For Urologic Irrigation Only.

Not for Injection.

Each 100 mL contains:
Mannitol USP 5 g
Water for Injection USP qs

pH: 5.5 (4.5–7.0)
Calculated Osmolarity: 275 mOsmol/liter

The formula of the active ingredient is:

Ingredient	Molecular Formula	Molecular Weight
Mannitol USP	Chemical Structure	182.17

5% Mannitol Irrigation is a prediluted, sterile, nonpyrogenic aqueous solution suitable for urologic irrigation. The solution is approximately isotonic.

Mannitol USP is chemically designated D-mannitol (C₆H₁₄O₆). Mannitol is a hexitol naturally occurring in fruits and vegetables and is produced commercially by the reduction of glucose.

The solution contains no antimicrobial or bacteriostatic agents or added buffers.

The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert.

The PIC^™ Container is PVC-free and DEHP-free.

In humans, mannitol is confined to the extracellular space and is only slightly metabolized. It is rapidly excreted in the urine. When mannitol is absorbed intravascularly, it produces osmotic diuresis and will be excreted by the kidneys.

Mannitol is nonelectrolytic and is, therefore, nonconductive, making it suitable for urologic irrigation during electrosurgical procedures.

5% Mannitol is a nonhemolytic irrigating solution.

5% Mannitol is indicated for use as a urologic irrigation fluid for transurethral prostatic resection and other transurethral surgical procedures.

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.

Occasional adverse reactions to intravenous mannitol infusions have been reported. These include fluid and electrolyte disturbances, such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema, dryness of the mouth, thirst and dehydration, cardiovascular/pulmonary disorders such as pulmonary congestion, hypotension, tachycardia, angina-like pain, and thrombophlebitis, and other general reactions such as blurred vision, convulsions, nausea, vomiting, rhinitis, chills, vertigo, backache, and urticaria.

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.

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 transurethral 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.

5% Mannitol Irrigation is supplied sterile and nonpyrogenic in PIC™ (Plastic Irrigation Containers). The 2000 mL containers are packaged 8 per case and the 4000 mL containers are packaged 4 per case.

Rx only

Revised: March 2009

PIC is a trademark of B. Braun Medical Inc.

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.
Figure 1

3. Connect the administration set through the sterile port according to set instructions or 
    remove screw cap and pour.
Figure 2

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

5% Mannitol Irrigation

For Urologic Irrigation

REF R6515-01
NDC 0264-2303-50
DIN 01963953

2000 mL

Lot
Exp.

Each 100 mL contains:
Mannitol USP 5 g
Water for Injection USP qs

pH: 5.5 (4.5-7.0)
Calc. Osmolarity: 275 mOsmol/liter

Not for Injection: Use only if
solution is clear and container
and seal are intact.

Sterile, nonpyrogenic.
Single dose container.

Warning: Do not warm above
150°F (66°C).

Recommended Storage:
Room temperature (25°C).
Avoid excessive heat.
Protect from freezing.
See Package Insert.

Rx only

PVC-free and DEHP-free

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

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

Y37-002-334