DIANEAL PD4 CAPD SOLUTION WITH 4.25% DEXTROSE AND 2.5MEQ/L CALCIUM

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

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

Tilgængelig fra:

BAXTER CORPORATION

ATC-kode:

B05ZA

INN (International Name):

HEMODIALYTICS, CONCENTRATES

Dosering:

4.25G; 538MG; 448MG; 18.3MG; 5.08MG

Lægemiddelform:

SOLUTION

Sammensætning:

DEXTROSE 4.25G; SODIUM CHLORIDE 538MG; SODIUM LACTATE 448MG; CALCIUM CHLORIDE 18.3MG; MAGNESIUM CHLORIDE 5.08MG

Indgivelsesvej:

HAEMODIALYSIS (INTRAPERITONEAL)

Enheder i pakken:

1500/2000/2500/3000/5000 ML

Recept type:

Ethical

Terapeutisk område:

HEMODIALYSIS SOLUTION

Produkt oversigt:

Active ingredient group (AIG) number: 0500162030; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2002-06-28

Produktets egenskaber

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PRESCRIBING INFORMATION
DIANEAL PD4
DIANEAL PD101
IN VIAFLEX PLASTIC CONTAINER
Peritoneal Dialysis Solution
Baxter Corporation
Mississauga, Ontario L5N 0C2
Canada
Date of Revision:
June 14, 2023
Submission Control No: 271738
BAXTER and VIAFLEX are Trademarks of Baxter International Inc.
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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 exception o