Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2995
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| rdfs:label |
DIANEAL PD-2 with Dextrose (Injection, Solution)
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| dailymed-instance:dosage |
Dianeal
PD-2 solutions are intended for intraperitoneal administration only. It is recommended
that adult patients being placed on continuous ambulatory peritoneal
dialysis should be appropriately trained in a program which is under the
supervision of a physician. Training materials are available from Baxter
Healthcare Corporation, Deerfield, IL, 60015 USA to facilitate this
training. Parenteral drug
products should be inspected visually for particulate matter and
discoloration prior to administration whenever solution and container
permit. The frequency of
treatment, formulation, exchange volume, duration of dwell, and length
of dialysis should be selected by the physician responsible for and
supervising the treatment of the individual patient. To avoid the risk
of severe dehydration and hypovolemia and to minimize the loss of
protein, it is advisable to select the peritoneal dialysis solution with
the lowest level of osmolarity consistent with the fluid removal
requirements for that exchange. Heating the
dialysis solution to 37��C (98.6��F) may decrease discomfort. Additives may be
incompatible. Do not store solution containing additives. Two liters of
dialysis solution are instilled into the peritoneal cavity of adults and
the peritoneal access device is then clamped. The solution remains in
the cavity for dwell times of 4 to 8 hours during the day and 8 to 12
hours overnight. At the conclusion of each dwell period, the access
device is opened, the solution drained and fresh solution instilled. The
procedure is repeated 3 to 5 times per day, 6 to 7 days per week.
Solution exchange frequency should be individualized for adequate
biochemical and fluid volume control. The majority of exchanges will
utilize 1.5% or 2.5% dextrose containing peritoneal dialysis solutions,
with 4.25% dextrose containing solutions being used when extra fluid
removal is required. Patient weight is used as the indicator of the need
for fluid removal.
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| dailymed-instance:descripti... |
Dianeal
PD-2 peritoneal dialysis solutions are sterile, nonpyrogenic solutions
in UltraBag���containers for intraperitoneal administration only. They
contain no bacteriostatic or antimicrobial agents. UltraBag���containers are designed with an integrated���Y���set and drain container
for infusion and drainage of Dianeal PD-2 when disconnection
of the���Y���set from the transfer set during dwell is desired. Composition,
calculated osmolarity, pH, and ionic concentrations are shown in the
following table. The plastic
container tubing set is fabricated from 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. It 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 solution container into the overpouch 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.
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| dailymed-instance:clinicalP... |
Peritoneal dialysis
is a procedure for removing toxic substances and metabolites normally
excreted by the kidneys, and for aiding in the regulation of fluid and
electrolyte balance. The procedure is
accomplished by instilling peritoneal dialysis fluid through a conduit
into the peritoneal cavity. Toxic substances and metabolites, present in
high concentration in the blood, cross the peritoneal membrane into the
dialyzing fluid. Dextrose in the dialyzing fluid is used to produce a
solution hyperosmolar to the plasma, creating an osmotic gradient which
facilitates fluid removal from the patient's plasma into the peritoneal
cavity. After a period of time, (dwell time), the fluid is drained by
gravity from the cavity. The solution does
not contain potassium. In situations in which there is a normal serum
potassium level or hypokalemia, the addition of potassium chloride (up to a concentration of 4 mEq/L) may be indicated to prevent severe
hypokalemia. Addition of potassium chloride should be made after careful
evaluation of serum and total body potassium and only under the
direction of a physician. Clinical studies
have demonstrated the use of this solution resulted in significant
increases in serum CO2 and decreases in serum magnesium levels. The
decrease in magnesium levels did not cause clinically significant
hypomagnesemia.
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| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
None
known.
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| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:precautio... |
General: Do not
administer unless solution is clear. Aseptic
technique must be used throughout the procedure and at its
termination in order to reduce the possibility of infection. Significant losses of protein, amino acids and water soluble vitamins may
occur during peritoneal dialysis. Replacement therapy should be
provided as necessary. When
prescribing the solution to be used for an individual patient,
consideration should be given to the potential interaction
between the dialysis treatment and therapy directed at other
existing illnesses. For example, rapid potassium removal may
create arrhythmias in cardiac patients using digitalis or
similar drugs; digitalis toxicity may be masked by elevated
potassium or magnesium, or by hypocalcemia. Correction of
electrolytes by dialysis may precipitate signs and symptoms of
digitalis excess. Conversely, toxicity may occur at suboptimal
dosages of digitalis if potassium is low or calcium high.
Azotemic diabetics require careful monitoring of insulin
requirements during and following dialysis with dextrose
containing solutions.<br/>Laboratory Tests: Serum electrolytes, magnesium, bicarbonate levels and fluid balance
should be periodically monitored.<br/>Carcinogenesis and
Mutagenesis and Impairment of Fertility: Long term
animal studies with Dianeal PD-2 peritoneal dialysis
solution have not been performed to evaluate the carcinogenic
potential, mutagenic potential or effect on
fertility.<br/>Pregnancy:<br/>Teratogenic
Effects:<br/>Nursing Mothers: Caution
should be exercised when Dianeal PD-2 peritoneal
dialysis solution is administered to a nursing
woman.<br/>Pediatric Use: Safety and
effectiveness in children have not been established.
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| dailymed-instance:genericMe... |
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
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| dailymed-instance:fullName |
DIANEAL PD-2 with Dextrose (Injection, Solution)
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| dailymed-instance:adverseRe... |
Adverse reactions
to peritoneal dialysis include mechanical and solution related problems
as well as the results of contamination of equipment or improper
technique in catheter placement. Abdominal pain, bleeding, peritonitis,
subcutaneous infection around the peritoneal catheter, catheter site
infection, catheter blockage, difficulty in fluid removal, and ileus are
among the complications of the procedure. Solution related adverse
reactions may include peritonitis, electrolyte and fluid imbalances,
hypovolemia, hypervolemia, hypotension, hypertension, disequilibrium
syndrome, allergic symptoms, and muscle cramping.
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| dailymed-instance:warning |
Not for Intravenous Injection. Use aseptic
technique. Contamination of Luer lock connector may result in
peritonitis. An improper
clamping sequence may result in infusion of air into the peritoneum. Peritoneal dialysis
should be done with great care, if at all, in patients with a number of
conditions, including disruption of the peritoneal membrane or diaphragm
by surgery or trauma, extensive adhesions, bowel distention, undiagnosed
abdominal disease, abdominal wall infection, hernias or burns, fecal
fistula or colostomy, tense ascites, obesity, large polycystic kidneys,
recent aortic graft replacement, lactic acidosis, and severe pulmonary
disease. When assessing peritoneal dialysis asthe mode of therapy in
such extreme situations, the benefits to the patient must be weighed
against the possible complications. An accurate fluid
balance record must be kept and the weight of the patient carefully
monitored to avoid over or under hydration with severe consequences,
including congestive heart failure, volume depletion, and shock. Excessive use of
Dianeal PD-2 peritoneal dialysis solution with 4.25% dextrose during a peritoneal dialysis treatment can result in
significant removal of water from the patient. Stable patients
undergoing maintenance peritoneal dialysis should have routine periodic
evaluation of blood chemistries and hematologic factors, as well as
other indicators of patient status. If the resealable
rubber plug on the medication port is missing or partially removed, do
not use product. After removing
overpouch, check for minute leaks by squeezing container firmly. If
leaks are found, discard the solution because the sterility may be
impaired. After the pull ring
has been removed from the outlet, check for broken connector frangible
seal as evidenced by continuous fluid flow from port. A few drops of
solution within the connector or protector cap may be present. If a
continuous stream or droplets of fluid are noted, discard solution
because sterility may be impaired. During solution
drainage, fibrin strands may be observed in the solution and may become
attached to the connector frangible closure. In occasional instances,
partial or complete obstruction of draining may occur. Manipulation of
the connector frangible closure in the tubing may free the fibrin
obstruction.
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| dailymed-instance:indicatio... |
Dianeal
PD-2 peritoneal dialysis solutions in UltraBag���containers are indicated
for use in chronic renal failure patients being maintained on continuous
ambulatory peritoneal dialysis when nondialytic medical therapy is
judged to be inadequate.
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| dailymed-instance:name |
DIANEAL PD-2 with Dextrose
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