DIANEAL PD 101 CAPD SOLUTION W 2.5% DEXTROSE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MAGNESIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE

Available from:

BAXTER CORPORATION

ATC code:

B05ZA

INN (International Name):

HEMODIALYTICS, CONCENTRATES

Dosage:

15.2MG; 2.5G; 567MG; 392MG; 23.9MG

Pharmaceutical form:

SOLUTION

Composition:

MAGNESIUM CHLORIDE 15.2MG; DEXTROSE 2.5G; SODIUM CHLORIDE 567MG; SODIUM LACTATE 392MG; CALCIUM CHLORIDE 23.9MG

Administration route:

HAEMODIALYSIS (INTRAPERITONEAL)

Units in package:

300/750ML/1/2/2.5/3/5L

Prescription type:

Ethical

Therapeutic area:

HEMODIALYSIS SOLUTION

Product summary:

Active ingredient group (AIG) number: 0500162043; AHFS:

Authorization status:

MARKETED

Authorization date:

1989-12-31

Summary of Product characteristics

Page 1 of 18
PRESCRIBING INFORMATION
DIANEAL PD4
DIANEAL PD101
IN VIAFLEX PLASTIC CONTAINER
Peritoneal Dialysis Solution
Baxter Corporation
Mississauga, Ontario L5N 0C2
Canada
Date of Revision:
February 2, 2015
Submission Control No: 180887
BAXTER and VIAFLEX are Trademarks of Baxter International Inc.
Page 2 of 18
BAXTER
DIANEAL PERITONEAL DIALYSIS SOLUTION
FOR INTERMITTENT PERITONEAL DIALYSIS (IPD), CONTINUOUS AMBULATORY
PERITONEAL DIALYSIS
(CAPD), OR AUTOMATED PERITONEAL DIALYSIS (APD)
FOR INTRAPERITONEAL ADMINISTRATION ONLY
DESCRIPTION
DIANEAL is a sterile, nonpyrogenic solution for intraperitoneal
administration only.
DIANEAL contains no bacteriostatic or antimicrobial agents or added
buffers.
Composition, approximate osmolarity, approximate pH, and approximate
ionic concentrations
are shown in Table 1.
The osmolarities shown in Table 1 are calculated values. As an
example, measured osmolarity
by freezing point depression determination of DIANEAL with 1.5%
dextrose is approximately
347 mOsmol/L, compared with measured values in normal human serum of
275 - 290
mOsmol/L.
The plastic container is fabricated from a specially formulated
polyvinyl chloride (PL146
Plastic). Water can permeate from inside the container into the
overpouch in amounts
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.
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. With the exceptio