SPL PATIENT PACKAGE INSERT SECTION.


Directions For Use of PIC(TM) (Plastic Irrigation Containers). Not for injection.Aseptic technique is required.Caution Before use, perform the following checks: Read the label. Ensure solution is the one ordered and is within the expiration date.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. Discard unused portion. 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. Connect the administration set through the sterile set port according to set instructions or remove screw cap and pour. Do not warm above 150F to assure minimal bottle distortion. Keep bottles upright.B. Braun Medical Inc.Irvine, CA 92614-5895 USA Made in USAY36-002-700. Caution Before use, perform the following checks: Read the label. Ensure solution is the one ordered and is within the expiration date.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. Discard unused portion. Read the label. Ensure solution is the one ordered and is within the expiration date.. 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. Discard unused portion.. 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. Connect the administration set through the sterile set port according to set instructions or remove screw cap and pour. Do not warm above 150F to assure minimal bottle distortion. Keep bottles upright.. Figure illustration. Figure illustration.

SPL UNCLASSIFIED SECTION.


Nonelectrolyte Irrigating Fluid for Urologic Irrigation Only.Not for Injection.

ADVERSE REACTIONS SECTION.


ADVERSE REACTIONS. Occasional adverse reactions may occur which include slight increases in postoperative serum glucose, inhibition of intestinal absorption of vitamin B12, fluid and electrolyte disturbances, such as acidosis, electrolyte loss, edema, dryness of the mouth, thirst and dehydration, cardiovascular/pulmonary disorders such as pulmonary congestion, hypotension, tachycardia and angina-like pains. In addition, patients unable to metabolize sorbitol rapidly enough may develop hyperosmolar states.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.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.


Carcinogenesis, Mutagenesis, Impairment of Fertility. Studies with 3.3% Sorbitol Irrigation have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

CLINICAL PHARMACOLOGY SECTION.


CLINICAL PHARMACOLOGY. In humans, sorbitol is nontoxic and rapidly metabolized. Sorbitol will either be excreted in the urine by the kidneys, or metabolized to carbon dioxide and dextrose.When sorbitol is absorbed intravascularly in amounts which depend primarily on the extent of the surgery, it produces osmotic diuresis.As 3.3% solution, sorbitol is recommended for irrigation of the urinary bladder and prostatic bed during transurethral prostatectomy. Unlike dextrose solutions, sorbitol solutions are not sticky, and if administered in the above dilution, are not hemolytic.Sorbitol is nonelectrolytic and is therefore nonconductive making it suitable for urologic irrigation during electrosurgical procedures.

CONTRAINDICATIONS SECTION.


CONTRAINDICATIONS. 3.3% Sorbitol Irrigation is not for injection. It is contraindicated in patients with anuria.

DESCRIPTION SECTION.


DESCRIPTION. Each 100 mL contains:Sorbitol (from Sorbitol Solution USP) 3.3 Water for Injection USP qspH: 5.3 (5.0-7.0)Calculated Osmolarity: 185 mOsmol/liter, hypotonicThe formula of the active ingredient is: Ingredient Molecular Formula Molecular Weight Sorbitol 182.17Sorbitol is chemically designated D-glucitol (C6H14O6).Sorbitol, an isomer of mannitol, is hexitol naturally occurring in many fruits, and is produced commercially by the reduction of glucose.3.3% Sorbitol Irrigation is prediluted, sterile, nonpyrogenic aqueous solution suitable for urologic irrigation. The solution is slightly hypotonic.The solution contains no antimicrobial or bacteriostatic agents or added buffers.The plastic container is 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.. Chemical Structure.

DOSAGE & ADMINISTRATION SECTION.


DOSAGE AND ADMINISTRATION. As required for urologic irrigation.3.3% Sorbitol 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.

STORAGE AND HANDLING SECTION.


Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25C); however, brief exposure up to 40C does not adversely affect the product.Do not warm above 150F (66C).

GENERAL PRECAUTIONS SECTION.


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 sorbitol irrigation 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 3.3% Sorbitol Irrigation may lower serum sodium concentration and aggravate pre-existing hyponatremia.Excessive loss of water and electrolytes may lead to serious imbalances. Continuous administration of 3.3% Sorbitol Irrigation may cause loss of water in excess of electrolytes and produce hypernatremia.Sustained diuresis from transurethral irrigation with 3.3% Sorbitol Irrigation 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 fresh container of appropriate size used for the start up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, separate container should be used for each patient.

GERIATRIC USE SECTION.


Geriatric Use. Clinical studies of 3.3% Sorbitol Irrigation did not include 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.

HOW SUPPLIED SECTION.


HOW SUPPLIED. 3.3% Sorbitol Irrigation is supplied sterile and nonpyrogenic in PIC(TM) (Plastic Irrigation Containers). The 2000 mL containers are packaged per case and the 4000 mL containers are packaged per case. NDC Cat. No. Size 3.3% Sorbitol Irrigation 0264-2301-50 R6015-01 2000 mL 0264-2301-70 R6017 4000 mL. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25C); however, brief exposure up to 40C does not adversely affect the product.Do not warm above 150F (66C).

INDICATIONS & USAGE SECTION.


INDICATIONS AND USAGE. 3.3% Sorbitol Irrigation is indicated for use as urologic irrigation fluid.

NURSING MOTHERS SECTION.


Nursing Mothers. Caution should be exercised when 3.3% Sorbitol Irrigation is administered to nursing woman.

OVERDOSAGE SECTION.


OVERDOSAGE. 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL 2000 mL Label. 3.3% Sorbitol IrrigationFor Urologic Irrigation OnlyREF R6015-01NDC 0264-2301-502000 mLLotExp.Each 100 mL contains: Sorbitol(from Sorbitol Solution USP) 3.3 gWater for Injection USP qspH: 5.3 (5.0-7.0)Calc. Osmolarity: 185 mOsmol/liter,hypotonicNot for Injection. Use only if solution isclear and container and seal are intact.Sterile, nonpyrogenic.Single dose container.Warning: Do not warm above150F (66C).Recommended Storage:Room temperature (25C).Avoid excessive heat.Protect from freezing.See Package Insert.Rx onlyPVC-free and DEHP-freeBBRAUNB. Braun Medical Inc.Irvine, CA 92614-5895 USAMade in USAY37-002-323. Principal Display Panel 2000 mL Label.

PEDIATRIC USE SECTION.


Pediatric Use. Safety and effectiveness in pediatric patients have not been established.

PRECAUTIONS SECTION.


PRECAUTIONS. 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 sorbitol irrigation 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 3.3% Sorbitol Irrigation may lower serum sodium concentration and aggravate pre-existing hyponatremia.Excessive loss of water and electrolytes may lead to serious imbalances. Continuous administration of 3.3% Sorbitol Irrigation may cause loss of water in excess of electrolytes and produce hypernatremia.Sustained diuresis from transurethral irrigation with 3.3% Sorbitol Irrigation 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 fresh container of appropriate size used for the start up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, separate container should be used for each patient.. Carcinogenesis, Mutagenesis, Impairment of Fertility. Studies with 3.3% Sorbitol Irrigation have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.. Pregnancy. Teratogenic Effects. Pregnancy Category C. Animal reproduction studies have not been conducted with 3.3% Sorbitol Irrigation. It is also not known whether 3.3% Sorbitol Irrigation can cause fetal harm when administered to pregnant woman or can affect reproduction capacity.3.3% Sorbitol Irrigation should be given to pregnant woman only if clearly needed.. Nursing Mothers. Caution should be exercised when 3.3% Sorbitol Irrigation is administered to nursing woman.. Pediatric Use. Safety and effectiveness in pediatric patients have not been established.. Geriatric Use. Clinical studies of 3.3% Sorbitol Irrigation did not include 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.

PREGNULLNCY SECTION.


Pregnancy. Teratogenic Effects. Pregnancy Category C. Animal reproduction studies have not been conducted with 3.3% Sorbitol Irrigation. It is also not known whether 3.3% Sorbitol Irrigation can cause fetal harm when administered to pregnant woman or can affect reproduction capacity.3.3% Sorbitol Irrigation should be given to pregnant woman only if clearly needed.

TERATOGENIC EFFECTS SECTION.


Teratogenic Effects. Pregnancy Category C. Animal reproduction studies have not been conducted with 3.3% Sorbitol Irrigation. It is also not known whether 3.3% Sorbitol Irrigation can cause fetal harm when administered to pregnant woman or can affect reproduction capacity.3.3% Sorbitol Irrigation should be given to pregnant woman only if clearly needed.

WARNINGS SECTION.


WARNINGS. 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 systemic drug.Absorption of large amounts of fluids containing sorbitol and the resultant osmotic diuresis may significantly affect cardiopulmonary and renal dynamics.Hyperglycemia from metabolism of sorbitol may occur in patients with diabetes mellitus.Hyperlactatemia from metabolism of sorbitol may potentially produce significant lactic acidemia in metabolically compromised patients.3.3% Sorbitol Irrigation must be used with caution in patients unable to metabolize sorbitol rapidly enough to avoid the development of hyperosmolar states.Do not warm above 150F (66C).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.