Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/492
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| rdf:type | |
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Sterile Water (Irrigant)
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| dailymed-instance:dosage |
The dose is dependent upon the capacity or surface area of
the structure to be irrigated and the nature of the procedure. When used as
a diluent or vehicle for drugs, the manufacturer's recommendations
should be followed. Drug Interactions Additives may be incompatible. Consult with
pharmacist, if available. When introducing additives, use aseptic technique,
mix thoroughly and do not store. Parenteral drug products
should be inspected visually for particulate matter and discoloration prior
to administration, whenever solution container permits. See PRECAUTIONS.
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| dailymed-instance:descripti... |
Sterile Water for Irrigation, USP is a sterile, distilled,
nonpyrogenic water for injection intended only for sterile irrigation, washing,
rinsing and dilution purposes. pH 5.5 (5.0 to 7.0). Sterile
Water for Irrigation, USP contains no bacteriostat, antimicrobial agent or
added buffer and is intended for use only as a single-dose or short procedure
irrigation. When smaller volumes are required the unused portion should be
discarded. Sterile Water for Irrigation, USP may be
classified as a sterile irrigant, wash, rinse, diluent and pharmaceutical
vehicle. Water for Irrigation, USP is chemically designated
HO. The flexible plastic container is fabricated
from a specially formulated polyvinylchloride. Water can permeate from inside
the container into the overwrap but not in amounts sufficient to affect the
solution significantly. The semi-rigid container is
fabricated from a specially formulated polyolefin. It is a copolymer of ethylene
and propylene. The container requires no vapor barrier to maintain the proper
drug concentration. The flexible plastic container
is fabricated from a specially formulated polyvinylchloride. Water can permeate
from inside the container into the overwrap but not in amounts sufficient
to affect the solution significantly. Solutions in contact with the plastic
container may leach out certain chemical components from the plastic in very
small amounts; however, biological testing was supportive of the safety of
the plastic container materials. Exposure to temperatures above 25��C/77��F
during transport and storage will lead to minor losses in moisture content.
Higher temperatures lead to greater losses. It is unlikely that these minor
losses will lead to clinically significant changes within the expiration period.
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| dailymed-instance:clinicalP... |
Sterile Water for Irrigation, USP exerts a mechanical cleansing
action for sterile irrigation of body cavities, tissues or wounds, indwelling
urethral catheters and surgical drainage tubes, and for washing, rinsing or
soaking surgical dressings, instruments and laboratory specimens. It also
serves as a diluent or vehicle for drugs used for irrigation or other pharmaceutical
preparations. Water is an essential constituent of
all body tissues and accounts for approximately 70% of total body weight.
Average normal adult daily requirement ranges from two to three liters (1.0
to 1.5 liters each for insensible water loss by perspiration and urine production). Water
balance is maintained by various regulatory mechanisms. Water distribution
depends primarily on the concentration of electrolytes in the body compartments
and sodium (Na) plays a major role in maintaining physiologic
equilibrium.
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| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
NOT FOR INJECTION BY USUAL PARENTERAL ROUTES.
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| dailymed-instance:supply |
Sterile Water for Irrigation, USP is supplied in single-dose
1000, 2000 and 3000 mL flexible irrigation container (List No. 7973), single-dose
250 and 500 mL semi-rigid irrigation container (List No. 6139), and single-dose
1000 and 1500 mL semi-rigid irrigation container (List No. 7139). 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 (25��C/77��F). HOSPIRA,
INC., LAKE FOREST, IL 60045 USA
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| dailymed-instance:activeMoi... | |
| dailymed-instance:precautio... |
Do not use for irrigation that may result in absorption into
the blood. Caution should be observed when solute-free
water is used for continuous irrigation or allowed to���dwell���inside body cavities because of possible absorption into the blood stream
and the production of intravascular hemolysis and circulatory overload. Aseptic
technique is essential with the use of sterile preparations for irrigation
of body cavities, wounds and urethral catheters or for wetting dressings that
come in contact with body tissues. When used as a���pour���irrigation, no part of the contents should be allowed to contact the surface
below the outer protected thread area of the semi-rigid wide mouth container.
The flexible container is designed for use with nonvented irrigation sets.
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. Do not administer
unless water is clear, seal is intact and container is undamaged. Discard
unused portion.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:: Studies with Sterile Water for Irrigation, USP have not been
performed to evaluate carcinogenic potential, mutagenic potential, or effects
on fertility.<br/>Nursing Mothers:: Caution should be exercised when Sterile Water for Irrigation,
USP is administered to a nursing woman.<br/>Pregnancy:: Teratogenic Effects. Pregnancy Category C. Animal reproduction studies
have not been conducted with Sterile Water for Irrigation, USP. It is also
not known whether Sterile Water for Irrigation, USP can cause fetal harm when
administered to a pregnant woman or can affect reproduction capacity. Sterile
Water for Irrigation, USP should be given to a pregnant woman only if clearly
needed.<br/>Pediatric Use:: Safety and effectiveness in pediatric patients
have not been established.
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| dailymed-instance:overdosag... |
In the event of overhydration or solute overload (if solutes
have been added to the irrigation), re-evaluate the patient and institute
appropriate corrective measures. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.
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| dailymed-instance:genericMe... |
Water
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| dailymed-instance:fullName |
Sterile Water (Irrigant)
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| dailymed-instance:adverseRe... |
Possible adverse effects arising from the irrigation of body
cavities, tissues, or indwelling catheters and tubes are completely avoidable
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 distention or disruption of tissues. Accidental contamination from careless
technique may transmit infection. Should any adverse
reaction occur, discontinue the irrigant, evaluate the patient, institute
appropriate therapeutic countermeasures and save the remainder of the fluid
for examination, if deemed necessary.
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| dailymed-instance:warning |
FOR IRRIGATION ONLY. This preparation
is solute-free and its entry into the circulation will cause hemolysis. Solutions
for urologic irrigation must be used with caution in patients with severe
cardiopulmonary or renal dysfunction. Irrigating fluids
used during transurethral prostatectomy have been demonstrated to enter the
systemic circulation in relatively large volumes, thus, Sterile Water for
Irrigation, USP must be regarded as a systemic drug. Absorption of large amounts
of Sterile Water for Irrigation, USP with or without additives can cause fluid
and/or solute overloading 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 administered
solutions. The risk of solute overload causing congested states with peripheral
and pulmonary edema is directly proportional to the electrolyte concentrations
of such solutions. Do not heat container over 66��C
(150��F).
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| dailymed-instance:indicatio... |
Sterile Water for Irrigation, USP is indicated for all general
irrigation, washing, rinsing and dilution purposes which permit use of sterile,
nonpyrogenic, solute-free water.
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| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Sterile Water
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