Product information

From Health Canada

The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.

Current status:

Marketed

Current status date:

2013-02-06

Original market date: See footnote 1

2013-02-06

Product name:

PHYSIONEAL 40 GLUCOSE 3.86% W/V 38.6 MG/ML CLEAR-FLEX

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

DIN:

02368749

Product Monograph/Veterinary Labelling:

Date: 2016-08-23 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

BAXTER CORPORATION
7125 Mississauga Road
Mississauga
Ontario
Canada L5N 0C2

Class:

Human

Dosage form(s):

Solution

Route(s) of administration:

Haemodialysis (Intraperitoneal)

Number of active ingredient(s):

6

Schedule(s):

Ethical

 

American Hospital Formulary Service (AHFS): See footnote 3

40:34.00* See footnote6 

Anatomical Therapeutic Chemical (ATC): See footnote 4

B05ZA HEMODIALYTICS, CONCENTRATES

Active ingredient group (AIG) number:See footnote5

0649302008

List of active ingredient(s)
Active ingredient(s) Strength
CALCIUM CHLORIDE 0.245 G / L
DEXTROSE 51.5 G / L
MAGNESIUM CHLORIDE 0.068 G / L
SODIUM BICARBONATE 9.29 G / L
SODIUM CHLORIDE 19.95 G / L
SODIUM LACTATE 6.73 G / L
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