CANEAL PERITONEAL DIALYSIS SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

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

Available from:

CHIEF MEDICAL SUPPLIES LTD

ATC code:

B05ZA

INN (International Name):

HEMODIALYTICS, CONCENTRATES

Dosage:

392MG; 1.5G; 15.2MG; 25.7MG; 567MG

Pharmaceutical form:

SOLUTION

Composition:

SODIUM LACTATE 392MG; DEXTROSE 1.5G; MAGNESIUM CHLORIDE 15.2MG; CALCIUM CHLORIDE 25.7MG; SODIUM CHLORIDE 567MG

Administration route:

HAEMODIALYSIS (INTRAPERITONEAL)

Units in package:

100

Prescription type:

Ethical

Therapeutic area:

HEMODIALYSIS SOLUTION

Product summary:

Active ingredient group (AIG) number: 0500162031; AHFS:

Authorization status:

APPROVED

Authorization date:

2016-03-11

Summary of Product characteristics

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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
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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