Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3628
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
Glycine (Irrigant)
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| dailymed-instance:dosage |
The volume of
solution needed will vary with the nature and duration of the urologic
procedure. If desired, warm in
overwrap to near body temperature in a water bath or oven heated to not
more than 45��C. Parenteral drug
products should be inspected visually for particulate matter and
discoloration prior to administration whenever solution and container
permit.
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| dailymed-instance:descripti... |
1.5% Glycine
Irrigation, USP is a sterile, nonpyrogenic, nonhemolytic,
nonelectrolytic or very weakly ionized solution in single dose UROMATIC
containers for use as a urologic irrigating solution. Each liter
contains 15 g Glycine, USP (NHCHCOOH) in water
for injection. pH 6.0 (4.5 to 6.5). Osmolarity 200 mOsmol/L (calc.).
Normal physiologic osmolarity range is approximately 280 to 310
mOsmol/L. No antimicrobial agent has been added. The UROMATIC
plastic container is fabricated from a specially formulated polyvinyl
chloride (PL 146 plastic). 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
can leach out certain of its chemical components in very small amounts
within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up
to 5 parts per million; however, the safety of the plastic has been
confirmed in tests in animals according to USP biological tests for
plastic containers as well as by tissue culture toxicity
studies.
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| dailymed-instance:clinicalP... |
1.5% Glycine
Irrigation, USP is useful as an irrigating solution for the urinary
bladder because this solution is nonhemolytic, nonelectrolytic or very
weakly ionized, and provides a high degree of visibility for urologic
procedures requiring endoscopy. During transurethral surgical
procedures, the solution acts as a lavage for removing blood and tissue
fragments. It also maintains the patency of an indwelling catheter in
the immediate postoperative period. Glycine which
enters the systemic circulation is converted to serine and glyoxylic
acid.
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| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
Anuria.
|
| dailymed-instance:supply |
1.5% Glycine
Irrigation, USP in UROMATIC plastic containers is available as follows: 2B7317 3000mL NDC 0338-0289-47 2B7319 5000mL NDC
0338-0289-49 Color variation in
this product is normal and does not alter efficacy or visualization
during TUR procedures. Exposure of
pharmaceutical products to heat should be minimized. Avoid excessive
heat. It is recommended the product be stored at room temperature
(25��C); brief exposure up to 40��C does not adversely affect the
product.<br/>Directions for Use: 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 bag
firmly. If leaks are found, discard solution as sterility may be
impaired. Use Aseptic
Technique. Baxter Healthcare
Corporation Deerfield,
IL 60015 USA Printed in
USA 07-19-45-846 Rev.
January 2005 Baxter,
UROMATIC, and PL 146 are trademarks of Baxter
International Inc.
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| dailymed-instance:genericDr... | |
| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:possibleD... |
diseasome-diseases:1080,
diseasome-diseases:1090,
diseasome-diseases:1364,
diseasome-diseases:1447,
diseasome-diseases:1836,
diseasome-diseases:217,
diseasome-diseases:2488,
diseasome-diseases:2491,
diseasome-diseases:2492,
diseasome-diseases:2493,
diseasome-diseases:2567,
diseasome-diseases:2655,
diseasome-diseases:2666,
diseasome-diseases:2667,
diseasome-diseases:2683,
diseasome-diseases:3941,
diseasome-diseases:3974,
diseasome-diseases:3975,
diseasome-diseases:460,
diseasome-diseases:462,
diseasome-diseases:48,
diseasome-diseases:499,
diseasome-diseases:538,
diseasome-diseases:540,
diseasome-diseases:554,
diseasome-diseases:85
|
| dailymed-instance:overdosag... |
In the event of
overhydration or solute overload, re-evaluate the patient and institute
appropriate corrective measures. See WARNINGS, PRECAUTIONS and ADVERSE
REACTIONS.
|
| dailymed-instance:genericMe... |
Glycine
|
| dailymed-instance:fullName |
Glycine (Irrigant)
|
| dailymed-instance:adverseRe... |
Adverse reactions
may result from intravascular absorption of glycine. Large intravenous
doses of glycine are known to cause salivation, nausea and lightheadedness. Other consequences of absorption of urologic irrigating
solutions include fluid and electrolyte disturbances such as acidosis,
electrolyte loss, marked diuresis, urinary retention, edema, dryness of
mouth, thirst, dehydration, coma from hyponatremia, secondary
hyponatremia due to fluid overload, and hyperammonemia with resultant
coma and/or encephalopathy; cardiovascular disorders such as
hypotension, tachycardia, angina-like pains; pulmonary disorders such as
pulmonary congestion; and other general reactions such as blurred
vision, convulsions, nausea, vomiting, rhinitis, chills, vertigo,
backache, transient blindness and urticaria. Allergic reactions from
glycine are unknown or exceedingly rare. Should adverse
reactions occur, discontinue the irrigation and re-evaluate the clinical
status of the patient.<br/>Post-Marketing
Experience: Following
off-label use of 1.5% Glycine Irrigation, USP for hysteroscopic
procedures in women, life-threatening adverse events related to
fluid overload have been reported.
|
| dailymed-instance:warning |
Not for injection. 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 1.5% Glycine
Irrigation, USP must be regarded as a systemic drug. Absorption of large
amounts of fluids containing glycine may significantly alter
cardiopulmonary and renal dynamics. Careful
cardiovascular monitoring should be maintained due to the possibility of
fluid overload. Should fluid overload occur, intensive fluid and
electrolyte management is necessary. Monitoring of fluid and electrolyte
levels beyond the acute phase may be considered due to the possibility
of delayed fluid absorption. (See ADVERSE REACTIONS,
Post-Marketing Experience). The contents of an
opened container should be used promptly to minimize the possibility of
bacterial growth or pyrogen formation. Discard the unused portion of
irrigating solution since no antimicrobial agent has been
added.
|
| dailymed-instance:indicatio... |
1.5% Glycine
Irrigation, USP is indicated for use as a urologic irrigating fluid with
endoscopic instruments during transurethral procedures requiring
distension, irrigation, and lavage of the urinary bladder. It may be
used for lavage of an indwelling catheter to maintain
patency.
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| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Glycine
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