CANEAL PERITONEAL DIALYSIS SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

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

Disponibil de la:

CHIEF MEDICAL SUPPLIES LTD

Codul ATC:

B05ZA

INN (nume internaţional):

HEMODIALYTICS, CONCENTRATES

Dozare:

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

Forma farmaceutică:

SOLUTION

Compoziție:

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

Calea de administrare:

HAEMODIALYSIS (INTRAPERITONEAL)

Unități în pachet:

100

Tip de prescriptie medicala:

Ethical

Zonă Terapeutică:

HEMODIALYSIS SOLUTION

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2016-03-11

Caracteristicilor produsului

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