Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1337
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DIANEAL PD-1 with Dextrose (Injection, Solution)
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DIANEAL PD-1
solutions are intended for intraperitoneal administration only. Parenteral drug
products should be inspected visually for particulate matter and
discoloration prior to administration whenever solution and container
permit. The mode of therapy
(Intermittent Peritoneal Dialysis [IPD], Continuous Ambulatory
Peritoneal Dialysis [CAPD], or Continuous Cyclic Peritoneal Dialysis
[CCPD]), 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. Peritoneal dialysis
solutions may be warmed in the overpouch to 37��C (98.6��F) to enhance
patient comfort. However, only dry heat (for example, heating pad)
should be used. (See Directions for Use) The addition of
heparin to the dialysis solution may be indicated to aid in prevention
of catheter blockage in patients with peritonitis, or when the solution
drainage contains fibrinous or proteinaceous material (Ribot et al.
1966). 1000 to 2000 USP units of heparin per liter of solution has been
recommended for adults (Furman et al. 1978). For children, 50 units of
heparin per 100 mL of dialysis fluid has been recommended (Irwin et al.
1981). Additives may be
incompatible. Complete information is not available. Those additives
known to be incompatible should not be used. Consult with pharmacist, if
available. If, in the informed judgement of the physician, it is deemed
advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing
additives.<br/>Intermittent
Peritoneal Dialysis (IPD): For
dialysis of acute renal failure patients and maintenance
dialysis of chronic renal failure patients The cycle
of instillation, dwell and removal of dialysis fluid is repeated
sequentially over a period of hours (8 to 36 hours) as many
times per week as indicated by the condition of the patient. For
chronic renal failure patients, maintenance dialysis is often
accomplished by periodic dialysis (3 to 5 times weekly) for
shorter time periods (8 to 14 hours per session) (Mattocks and
El-Bassiouni 1971).<br/>Continuous Ambulatory Peritoneal Dialysis (CAPD) and Continuous Cyclic
Peritoneal Dialysis (CCPD): For
maintenance dialysis of chronic renal failure patients In CAPD,
1.5 to 3.0 liters of dialysis solution (depending upon patient
size) are instilled into the peritoneal cavity of adults and the
peritoneal access device is then clamped (Kim et al. 1984;
Twardowski and Janicka 1981; Twardowski and Burrows 1984). For
children, 30 to 50 mL/kg body weight with a maximum of 2 liters
has been recommended (Potter et al. 1981; Irwin et al. 1981).
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 volumes and frequency of exchange should be
individualized for adequate biochemical and fluid volume control
(Moncrief et al. 1982; Twardowski et al. 1983). The majority of
exchanges will utilize 1.5% or 2.5% dextrose containing
peritoneal dialysis solutions, with 3.5% or 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 (Popovich et al. 1978). In CCPD,
the patient receives 3 or 4 dialysis exchanges during the night
which range from 2-1/2 to 3 hours dwell duration. Typically 1.5
to 2.0 liters of dialysis solution (depending upon patient size)
are delivered each cycle by an automatic peritoneal dialysis
cycler machine. After the last outflow during the night, an
additional exchange is infused by the cycler machine into the
peritoneum. The equipment is then disconnected from the patient,
and the dialysate remains in the peritoneum for 14 to 15 hours
during the day until the next nocturnal cycle (Diaz-Buxo et al.
1981). Combinations of 1.5% or 2.5% dextrose containing
peritoneal dialysis solutions are usually used for the nighttime
exchanges while 3.5% or 4.25% dextrose is used when extra fluid
removal is required such as during thedaytime exchange. Patient
weight is used as the indicator of the need for fluid removal
(Popovich et al. 1978) so therapy should be individualized
according to the patient's need for ultrafiltration. It is
recommended that adult patients being placed on chronic peritoneal dialysis or, in the case of pediatric patients, the
selected caretaker, (as well as the patient, when suitable),
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.
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DIANEAL PD-1
peritoneal dialysis solutions in AMBU-FLEX III containers with a flanged
port are sterile, nonpyrogenic solutions for intraperitoneal
administration only. They contain no bacteriostatic or antimicrobial
agents or added buffers. Composition,
calculated osmolarity, pH and ionic concentrations are shown in Table 1. Potassium is
omitted from DIANEAL solutions because dialysis may be performed to
correct hyperkalemia. 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.
Frequent monitoring of serum electrolytes is indicated. The osmolarities
shown in Table 1 are calculated values. As an example, measured
osmolarity by freezing point depression determination of DIANEAL PD-1
peritoneal dialysis solution with 1.5% dextrose is approximately 334
mOsmol/L, compared with measured values in normal human serum of 280
mOsmol/L. The 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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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. With the exception of lactate, present as a
bicarbonate precursor, electrolyte concentrations in the fluid have been
formulated to attempt to normalize plasma electrolyte concentrations
resulting from osmosis and diffusion across the peritoneal membrane
(between the plasma of the patient and the dialysis fluid). Toxic
substances and metabolites, present in high concentrations 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 fromthe
cavity.
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None
known.
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DIANEAL PD-1
peritoneal dialysis solutions in AMBU-FLEX III containers are available
in nominal size flexible containers with fill volumes and dextrose
concentrations as indicated in Table 1. All DIANEAL PD-1
peritoneal dialysis solutions have overfills which are declared on
container labeling. 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): brief exposure up to 40��C (104��F) does not adversely affect
the product.<br/>Directions for Use: Use aseptic
technique. For
complete system preparation, see directions accompanying
ancillary equipment. Peritoneal
dialysis solutions may be warmed in the overpouch to 37��C
(98.6��F) to enhance patient comfort. However, only dry heat (for
example, heating pad) should be used. Solutions should not be
heated in water due to an increased risk of infection. Microwave
ovens should not be used to heat solutions because there is a
potential for damage to the solution container. Moreover,
microwave oven heating may potentially cause overheating and/or
non-uniform heating of the solution thatmay result in patient
injury or discomfort.<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. If supplemental
medication is desired, follow directions below before preparing
for administration. Check for minute leaks by squeezing
container firmly.<br/>To Add Medication: Additives may be incompatible. If the
resealable rubber plug on the medication port is missing or
partially removed, do not use product if medication is to be
added.<br/>Preparation for
Administration: Discard
unused portion.
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Aseptic technique
must be used throughout the procedure and at its termination in order to
reduce the possibility of infection. If peritonitis occurs, the choice
and dosage of antibiotics should be based upon the results of
identification and sensitivity studies of the isolated organism(s) when
possible. Prior to identification of the involved organism(s),
broad-spectrum antibiotics may be indicated. Peritoneal dialysis
solutions may be warmed in the overpouch to 37��C (98.6��F) to enhance
patient comfort. However, only dry heat (for example, heating pad)
should be used. Solutions should not be heated in water due to an
increased risk of infection. Microwave ovens should not be used to heat
solutions because there is a potential for damage to the solution
container. Moreover, microwave oven heating may potentially cause
overheating and/or non-uniform heating of the solution that may result
in patient injury or discomfort. Significant losses
of protein, amino acids and water soluble vitamins may occur during
peritoneal dialysis. Replacement therapy
should be provided as necessary.<br/>Pregnancy:<br/>Teratogenic
Effects:
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Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
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DIANEAL PD-1 with Dextrose (Injection, Solution)
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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 a chronic peritoneal catheter, catheter
blockage, difficulty in fluid removal, and ileus are among the
complications of the procedure. Solution related adverse reactions may include electrolyte and fluid imbalances, hypovolemia, hypervolemia,
hypertension, hypotension, disequilibrium syndrome and muscle
cramping.
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Peritoneal dialysis
should be done with great care, if at all, in patients with a number of
abdominal 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, and large
polycystic kidneys (Vaamonde and Perez 1977).Other conditions include
recent aortic graft replacement and severe pulmonary disease. When
assessing peritoneal dialysis as the 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-1 peritoneal dialysis solution with 3.5% or 4.25% dextrose
during a peritoneal dialysis treatment can result in significant removal
of water from the patient. In acute renal
failure patients, plasma electrolyte concentrations should be monitored
periodically during the procedure. 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. Not for use in the
treatment of lactic acidosis. Potassium is
omitted from DIANEAL PD-1 solutions because dialysis may be performed to
correct hyperkalemia. Addition of potassium
chloride should be made after careful evaluation of serum and total
body potassium and only under the direction of a
physician. The use of 5 liters
of dialysis solution is not indicated in a single exchange. Refer to
manufacturer's directions accompanying drugs to obtain full information
on additives. If the resealable
rubber plug on the medication port is missing or partially removed, do not use product if medication is to be added. After removing
overwrap, check for minute leaks by squeezing container firmly. If leaks
are found, discard the solution because the sterility may be impaired. Freezing of
solution may occur at temperatures below 0��C (32��F). Do not flex or
manipulate container when frozen. Allow container to thaw naturally in
ambient conditions and thoroughly mix contents by shaking.
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Peritoneal
dialysis is indicated for patients in acute or chronic renal failure
when nondialytic medical therapy is judged to be inadequate (Vaamonde
and Perez 1977). It may also be indicated in the treatment of certain
fluid and electrolyte disturbances, and for patients intoxicated with
certain poisons and drugs (Knepshield et al. 1977). However, for many
substances other methods of detoxification have been reported to be more
effective than peritoneal dialysis (Vaamonde and Perez 1977; Chang
1977).
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DIANEAL PD-1 with Dextrose
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