DESCRIPTION

Sterile Water for Irrigation, USP is a sterile, distilled, nonpyrogenic water for injection intended only for sterile irrigation, washing, rinsing and also dilution objectives. pH 5.5 (5.0 to 7.0).

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Sterile Water for Irrigation, USP includes no bacteriostat, antimicrobial agent or added buffer and also is intfinished for usage only as a single-dose or short procedure irrigation. When smaller volumes are forced the unoffered percent should be discarded.

Sterile Water for Irrigation, USP may be classified as a sterile irrigant, wash, rinse, diluent and also pharmaceutical car.

Water for Irrigation, USP is chemically designated H2O.

The versatile plastic container is fabricated from a specially formulated polyvinylchloride. Water deserve to pass through from inside the container into the overwrap yet not in amounts adequate to affect the solution substantially.

The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and also propylene. The container needs no vapor obstacle to keep the correct drug concentration.

The versatile plastic container is fabricated from a specially formulated polyvinylchloride. Water have the right to permeate from inside the container right into the overwrap yet not in amounts adequate to impact the solution significantly. Solutions in call via the plastic container may leach out specific chemical components from the plastic in incredibly tiny amounts; but, biological testing was supportive of the security of the plastic container products. Expocertain to temperatures over 25°C/77°F in the time of move and storage will cause minor losses in moisture content. Higher temperatures lead to higher losses. It is unmost likely that these minor losses will certainly lead to clinically significant alters within the expiration duration.


CLINICAL PHARMACOLOGY

Sterile Water for Irrigation, USP exerts a mechanical cleansing action for sterile watering of body cavities, tissues or wounds, indwelling urethral catheters and also surgical drainage tubes, and also for washing, rinsing or soaking surgical dressings, tools and also laboratory specimens. It additionally serves as a diluent or vehicle for drugs provided for irrigation or various other pharmaceutical preparations.

Water is a critical constituent of all body tworries and accounts for around 70% of full body weight. Typical normal adult everyday necessity varieties from two to three liters (1.0 to 1.5 liters each for inwise water loss by perspiration and urine production).

Water balance is kept by various regulatory mechanisms. Water circulation counts mainly on the concentration of electrolytes in the body compartments and also sodium (Na+) plays a major duty in preserving physiologic equilibrium.


INDICATIONS AND USAGE

Sterile Water for Irrigation, USP is shown for all basic irrigation, washing, rinsing and dilution functions which permit use of sterile, nonpyrogenic, solute-complimentary water.


CONTRAINDICATIONS

NOT FOR INJECTION BY USUAL PARENTERAL ROUTES.


WARNINGS

FOR IRRIGATION ONLY.

This preparation is solute-free and its entry into the circulation will certainly cause hemolysis.

Solutions for urologic watering need to be supplied with caution in patients through significant cardiopulmonary or renal dysfeature.

Irrigating fluids offered during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large quantities, hence, Sterile Water for Irrigation, USP need to be pertained to as a systemic drug. Absorption of large quantities of Sterile Water for Irrigation, USP through or without additives can cause fluid and/or solute overloading bring about dilution of serum electrolyte concentrations, overhydration, congested claims or pulmonary edema. The hazard of dilutional says is inversely proportional to the electrolyte concentrations of administered solutions. The danger of solute overpack leading to congested claims through peripheral and pulmonary edema is straight proportional to the electrolyte concentrations of such remedies.

Do not heat container over 66°C (150°F).


PRECAUTIONS

Do not use for irrigation that might cause absorption into the blood.

Caution need to be observed once solute-complimentary water is supplied for continuous irrigation or enabled to "dwell" inside body cavities because of possible absorption into the blood stream and also the manufacturing of intravascular hemolysis and circulatory overload.

Aseptic approach is crucial with the usage of sterile preparations for irrigation of body cavities, wounds and urethral catheters or for wetting dressings that come in call through body tconcerns.

When used as a "pour" irrigation, no part of the contents should be permitted to contact the surface below the external protected threview area of the semi-rigid wide mouth container. The flexible container is designed for usage through nonvented irrigation sets. When provided for watering through correct irrigation devices, the administration set should be attached promptly. Unprovided parts have to be discarded and also a fresh container of correct dimension provided for the begin up of each cycle or repeat procedure. For repetitive irrigations of urethral catheters, a separate container should be provided for each patient.

Do not provide unmuch less water is clear, seal is intact and also container is undamaged. Discard unoffered percent.


Carcinogenesis, Mutagenesis, Impairment of Fertility:

Studies with Sterile Water for Irrigation, USP have actually not been performed to evaluate carcinogenic potential, mutagenic potential, or impacts on fertility.


Nursing Mothers:

Caution should be exercised when Sterile Water for Irrigation, USP is administered to a nursing womale.


Pregnancy: Teratogenic Effects.

Pregnancy Category C. Animal reproduction research studies have actually not been conducted via Sterile Water for Irrigation, USP. It is likewise not known whether Sterile Water for Irrigation, USP can reason fetal damage as soon as administered to a pregnant woguy or can impact remanufacturing capacity. Sterile Water for Irrigation, USP must be given to a pregnant woman only if plainly necessary.


Pediatric Use:

Safety and efficiency in pediatric patients have not been established.


ADVERSE REACTIONS

Possible adverse impacts emerging from the watering of body cavities, tconcerns, or indwelling catheters and also tubes are entirely avoidable as soon as proper steps are complied with. Displaced catheters or drainage tubes have the right to lead to watering or infiltration of unintended structures or cavities. Excessive volume or push during irrigation of closed cavities might cause undue distention or disruption of tconcerns. Accidental contamicountry from caremuch less approach might transmit infection.

Should any kind of adverse reaction happen, discontinue the irrigant, evaluate the patient, institute correct therapeutic countermeasures and conserve the remainder of the liquid for examination, if understood important.


OVERDOSAGE

In the occasion of overhydration or solute overload (if solutes have actually been included to the irrigation), re-evaluate the patient and also institute correct corrective measures. (See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.)


DOSAGE AND ADMINISTRATION

The dose is dependent upon the capacity or surconfront location of the structure to be irrigated and also the nature of the procedure. When offered as a diluent or vehicle for drugs, the manufacturer"s references must be adhered to.

Drug Interactions

Additives might be incompatible. Consult with pharmacist, if obtainable. When introducing additives, use aseptic approach, mix thoabout and execute not save.

Parenteral drug products must be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. (See PRECAUTIONS.)


HOW SUPPLIED
NDC No.

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ProductContainer Size (mL)Container Type
0409-6139-22Sterile Water for Irrigation USP250Semi-Rigid Irrigation
0409-6139-03Sterile Water for Irrigation USP500Semi-Rigid Irrigation
0409-7139-09Sterile Water for Irrigation USP1000Semi-Rigid Irrigation
0409-7139-36Sterile Water for Irrigation USP1500Semi-Rigid Irrigation
0409-7973-05Sterile Water for Irrigation USP1000Flexible Irrigation
0409-7973-07Sterile Water for Irrigation USP2000Flexible Irrigation
0409-7973-08Sterile Water for Irrigation USP3000Flexible Irrigation

Store at 20 to 25°C (68 to 77°F). Protect from freezing.

Revised: June, 2010

Printed in USA EN-2516

Hospira, Inc., Lake Foremainder, IL 60045 USA


IM-1467
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RL-3331

 

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RL-3337

 

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Revised: 6/2020