Country: Canada
Language: English
Source: Health Canada
SODIUM LACTATE; DEXTROSE; MAGNESIUM CHLORIDE; CALCIUM CHLORIDE; SODIUM CHLORIDE
CHIEF MEDICAL SUPPLIES LTD
B05ZA
HEMODIALYTICS, CONCENTRATES
392MG; 2500MG; 15.2MG; 25.7MG; 567MG
SOLUTION
SODIUM LACTATE 392MG; DEXTROSE 2500MG; MAGNESIUM CHLORIDE 15.2MG; CALCIUM CHLORIDE 25.7MG; SODIUM CHLORIDE 567MG
HAEMODIALYSIS (INTRAPERITONEAL)
2L
Ethical
HEMODIALYSIS SOLUTION
Active ingredient group (AIG) number: 0500162002; AHFS:
APPROVED
2018-03-07
Page 1 of 12 PRESCRIBING INFORMATION CANEAL™ PERITONEAL DIALYSIS SOLUTION (DEXTROSE 1.5% - CALCIUM 3.5 MEQ/L) CANEAL™ PERITONEAL DIALYSIS SOLUTION (DEXTROSE 2.5% - CALCIUM 3.5 MEQ/L) AND CANEAL™ PERITONEAL DIALYSIS SOLUTION (DEXTROSE 4.25% - CALCIUM 3.5 MEQ/L) Peritoneal Dialysis Solution Chief Medical Supplies Ltd. Calgary, AB T2E 6J7 Canada 1 866 620-6034 Date of Revision: March 5, 2018 Submission Control No: 197601 Page 2 of 12 CHIEF MEDICAL SUPPLIES LTD. CANEAL™ PERITONEAL DIALYSIS SOLUTION (DEXTROSE 1.5% - CALCIUM 3.5 MEQ/L), CANEAL™ PERITONEAL DIALYSIS SOLUTION (DEXTROSE 2.5% - CALCIUM 3.5 MEQ/L), AND CANEAL™ PERITONEAL DIALYSIS SOLUTION (DEXTROSE 4.25% - CALCIUM 3.5 MEQ/L) FOR INTERMITTENT PERITONEAL DIALYSIS (IPD), CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD), OR AUTOMATED PERITONEAL DIALYSIS (APD) FOR INTRAPERITONEAL ADMINISTRATION ONLY SUMMARY PRODUCT INFORMATION: ROUTE OF ADMINISTRATION DOSAGE FORM / STRENGTH ALL NONMEDICINAL INGREDIENTS intraperitoneal Peritoneal Dialysis Solution- (Dextrose 1.5%-Calcium 3.5 mEq/L), (Dextrose 2.5%- Calcium 3.5 mEq/L), & (Dextrose 4.25%-Calcium 3.5 mEq/L) NaOH (pH adjustment) HCl (pH adjustment) Water for Injection DESCRIPTION CANEAL™ Peritoneal Dialysis Solution is a sterile, nonpyrogenic solution for intraperitoneal administration only. CANEAL™ Peritoneal Dialysis Solution 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 CANEAL™ 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. Solutio Read the complete document