CANEAL PERITONEAL DIALYSIS SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

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

Tersedia dari:

CHIEF MEDICAL SUPPLIES LTD

Kode ATC:

B05ZA

INN (Nama Internasional):

HEMODIALYTICS, CONCENTRATES

Dosis:

448MG; 2.5G; 5.08MG; 18.3MG; 538MG

Bentuk farmasi:

SOLUTION

Komposisi:

SODIUM LACTATE 448MG; DEXTROSE 2.5G; MAGNESIUM CHLORIDE 5.08MG; CALCIUM CHLORIDE 18.3MG; SODIUM CHLORIDE 538MG

Rute administrasi :

HAEMODIALYSIS (INTRAPERITONEAL)

Unit dalam paket:

2000ML

Jenis Resep:

Ethical

Area terapi:

HEMODIALYSIS SOLUTION

Ringkasan produk:

Active ingredient group (AIG) number: 0500162032; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2018-02-08

Karakteristik produk

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