Dianeal Low Calcium Peritoneal Dialysis Solution Prescribing Information

Dianeal Low Calcium Peritoneal Dialysis Solution Description

Dianeal® Low Calcium 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® Low Calcium 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.

Related/similar drugs

Lactated Ringers Injection, Normosol-R

Dianeal Low Calcium Peritoneal Dialysis Solution - Clinical Pharmacology

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.

Indications and Usage for Dianeal Low Calcium Peritoneal Dialysis Solution

Dianeal® Low Calcium 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.

Contraindications

None known.

Warnings

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 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® Low Calcium 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.

Precautions

Adverse Reactions/Side Effects

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.

Dianeal Low Calcium Peritoneal Dialysis Solution Dosage and Administration

Dianeal® Low Calcium 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 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.

Approximately 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.

DIRECTIONS FOR USE

Use aseptic technique.

For complete system preparation, see directions accompanying ancillary equipment.

How is Dianeal Low Calcium Peritoneal Dialysis Solution supplied

Dianeal® Low Calcium peritoneal dialysis solutions in UltraBag™ containers are available in nominal size flexible containers as shown in the table in the DESCRIPTION section.

All Dianeal® Low Calcium peritoneal dialysis solutions have overfills which are declared on container labeling.

Freezing of solutions may occur at temperatures below 0°C (32°F). Allow to thaw naturally in ambient conditions and thoroughly mix contents by shaking.

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
Deerfield, IL 60015 USA

Printed in USA

©Copyright 1992, Baxter Healthcare Corporation. All rights reserved.

07-19-26-995
2002/02

*BAR CODE POSITION ONLY
071926995

PRINCIPAL DISPLAY PANEL

5B9766
NDC 0941-0424-52

2000 mL
(APPROX 80 mL EXCESS)

Baxter Logo

Dianeal
Low Calcium (2.5 mEq/L)
Peritoneal Dialysis Solution
with 1.5% Dextrose

EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM
LACTATE 18.3 mg CALCIUM CHLORIDE USP 5.08 mg
MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM - 0.5
CHLORIDE - 95 LACTATE - 40
OSMOLARITY - 344 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

READ PACKAGE INSERT FOR FULL INFORMATION

FOR INTRAPERITONEAL ADMINISTRATION ONLY

DOSAGE AS DIRECTED BY A PHYSICIAN

CAUTIONS SQUEEZE AND INSPECT INNER BAG
WHICH MAINTAINS PRODUCT STERILITY DISCARD
IF LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25° C/77°F) UNTIL READY TO
USE
AVOID EXCESSIVE HEAT SEE INSERT

UltraBag CONTAINER PL 146 PLASTIC

BAXTER DIANEAL ULTRABAG AND PL 146 ARE

TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

US PAT NOS 4340049 4346703

4439188 4573980

Low Calcium 1.5% Dextrose

5B9766

6-2000ML IN 2000ML
ULTRABAGTM CONT

1.5%

DIANEAL® LOW CALCIUM 1.5% DEX
PERITONEAL DIALYSIS SOLUTION

EXP
XXXXX

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

LOT
XXXXX

PRIMARY BAR CODE

(01) 50309410424525