Država: Kanada
Jezik: engleski
Izvor: Health Canada
DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE
BAXTER CORPORATION
B05ZA
HEMODIALYTICS, CONCENTRATES
4.25G; 538MG; 448MG; 18.3MG; 5.08MG
SOLUTION
DEXTROSE 4.25G; SODIUM CHLORIDE 538MG; SODIUM LACTATE 448MG; CALCIUM CHLORIDE 18.3MG; MAGNESIUM CHLORIDE 5.08MG
HAEMODIALYSIS (INTRAPERITONEAL)
1500/2000/2500/3000/5000 ML
Ethical
HEMODIALYSIS SOLUTION
Active ingredient group (AIG) number: 0500162030; AHFS:
APPROVED
2002-06-28
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: June 14, 2023 Submission Control No: 271738 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 exception o Pročitajte cijeli dokument