Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/513
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
Sterile Water (Injection, Solution)
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| dailymed-instance:dosage |
Following suitable
admixture of prescribed drugs, the dosage is usually dependent upon the
age, weight and clinical condition of the patient as well as laboratory
determinations. See directions accompanying drugs. Parenteral drug
products should be inspected visually for particulate matter and
discoloration prior to administration whenever solution and container
permit. Use of a final filter is recommended during administration of
all parenteral solutions where possible. Sterile Water for
Injection, USP in the Pharmacy Bulk Package is intended for use in the
preparation of sterile, intravenous admixtures. Additives may be
incompatible with the fluid withdrawn from this container. Complete
information is not available. Those additives known to be incompatible
should not be used. Consult with pharmacist, if available. When
compounding admixtures, use aseptic technique. Mix thoroughly. Do not
store any unused portion of Sterile Water for Injection,
USP.<br/>Directions for use
of Viaflex Plastic Pharmacy Bulk Package Container:<br/>To Open: Tear overwrap down side at slit and remove solution
container. Some opacity of the plastic due to moisture absorption during the sterilization process may be
observed. This is normal and does not affect the
solution quality or safety. The opacity will diminish
gradually. Check for minute leaks by squeezing inner bag
firmly, if leaks are found, discard solution as
sterility may be impaired. For
compounding only, not for direct infusion.<br/>Preparation
for Admixing: 1.
The Pharmacy Bulk Package is to be used only in a
suitable work area such as a laminar flow hood (or an
equivalent clean air compounding area). 2.
Suspend container from eyelet support. 3.
Remove plastic protector from outlet port at bottom of
container. 4.
Attach solution transfer set. Refer to complete
directions accompanying set. Note: The closure shall be penetrated only one time
with a suitable sterile transfer device or dispensing
set which allows measured dispensing of the contents. 5.
Viaflex containers should not be written
on directly since ink migration has not been
investigated. Affix accompanying label for date and time
of entry. 6.
Once container closure has been penetrated, withdrawal
of contents should be completed without delay. After
initial entry, maintain contents at room temperature
(25��C/77��F) and dispense within 4 hours.
|
| dailymed-instance:descripti... |
Sterile Water for Injection, USP is sterile, nonpyrogenic, distilled water in a Pharmacy
Bulk Package. A Pharmacy Bulk Package is a container of a sterile
preparation for parenteral use that contains many single doses. The
contents are intended for use in a pharmacy admixture program and are
restricted to the preparation of admixtures for intravenous infusion. No
antimicrobial or other substance has been added. pH 5.5 (5.0 to 7.0).
Osmolarity O mOsmol/L (calc.). The
Viaflex plastic container is fabricated from a specially
formulated polyvinyl chloride (PL 146 Plastic). 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. lt is unlikely that these minor losses will lead to clinically
significant changes within the expiration period. The amount of water
that can permeate from inside the container into the overwrap is
insufficient 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.
|
| dailymed-instance:clinicalP... |
Sterile Water for
Injection, USP is used for fluid replacement only after suitable
admixing to approximate isotonicity.
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| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
Sterile Water for
Injection, USP is a hemolytic agent due to its hypotonicity. Therefore,
it is contraindicated for intravenous administration without
admixing.
|
| dailymed-instance:supply |
Sterile Water for
Injection, USP is supplied in a Viaflex' plastic Pharmacy Bulk Package
container as follows: Exposure of
pharmaceutical products to heat should be minimized. Avoid excessive
heat. It is recommended the product be stored at room temperature
(25��C/77��F). Baxter Healthcare Corporation Clintec Nutrition
Division 07-19-12-915 Rev. October 2000 Distributed in
Canada by Baxter Corporation Toronto, Ontario,
Canada Deerfield, IL 60015 USA
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| dailymed-instance:activeMoi... | |
| dailymed-instance:precautio... |
Do not use unless
solution is clear and seal is intact. Drug product
contains no more than 25��g/L of aluminum<br/>Pediatric Use: Safety and
effectiveness have been established in pediatric patients.
However, in neonates or very small infants the volume of fluid
may affect fluid and electrolyte balance.
|
| dailymed-instance:genericMe... |
Water
|
| dailymed-instance:fullName |
Sterile Water (Injection, Solution)
|
| dailymed-instance:adverseRe... |
The administration
of a suitable admixture of prescribed drugs may be associated with
adverse reactions because of the solution or the technique of
administration including febrile response, infection at the site of
injection, venous thrombosis or phlebitis extending from the site of
injection, extravasation and hypervolemia. If an adverse reaction does
occur, discontinue the infusion, evaluate the patient, institute
appropriate therapeutic countermeasures and save the remainder of the
fluid for examination if deemed necessary.
|
| dailymed-instance:warning |
This solution is for compounding only, not for
direct infusion. WARNING: This
product contains aluminum that may be toxic. Aluminum may reach toxic
levels with prolonged parenteral administration if kidney function is
impaired. Premature neonates are particularly at risk because their
kidneys are immature, and they require large amounts of calcium and
phosphate solutions, which contain aluminum. Research indicates
that patients with impaired kidney function, including premature
neonates, who receive parenteral levels of aluminum at greater than 4 to
5��g/kg/day accumulate aluminum at levels associated with central
nervous system and bone toxicity. Tissue loading may occur at even lower
rates of administration.
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| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Sterile Water
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