CANEAL PERITONEAL DIALYSIS SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

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

Disponible desde:

CHIEF MEDICAL SUPPLIES LTD

Código ATC:

B05ZA

Designación común internacional (DCI):

HEMODIALYTICS, CONCENTRATES

Dosis:

448MG; 1.5G; 5.08MG; 18.3MG; 538MG

formulario farmacéutico:

SOLUTION

Composición:

SODIUM LACTATE 448MG; DEXTROSE 1.5G; MAGNESIUM CHLORIDE 5.08MG; CALCIUM CHLORIDE 18.3MG; SODIUM CHLORIDE 538MG

Vía de administración:

HAEMODIALYSIS (INTRAPERITONEAL)

Unidades en paquete:

100

tipo de receta:

Ethical

Área terapéutica:

HEMODIALYSIS SOLUTION

Resumen del producto:

Active ingredient group (AIG) number: 0500162036; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2016-03-11

Ficha técnica

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