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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:

1998-09-25

Original market date: See footnote 1

1998-09-25

Product name:

NUTRINEAL PD4

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:

02230810

Product Monograph/Veterinary Labelling:

Date: 2012-07-30 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

BAXTER CORPORATION
7125 Mississauga Road
Mississauga
Ontario
Canada  L5N 0C2

Class: 

Human

Dosage form(s):

Liquid

Route(s) of administration:

Dialysis

Number of active ingredient(s):

19

Schedule(s):

Ethical  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

40:34.00* See footnote 6   HEMODIALYSIS SOLUTION

Anatomical Therapeutic Chemical (ATC): See footnote 4

B05ZA  HEMODIALYTICS, CONCENTRATES

Active ingredient group (AIG) number:See footnote 5

1931508001

List of active ingredient(s)
Active ingredient(s) Strength
ALANINE 95.1 MG / 100 ML
ARGININE 107.1 MG / 100 ML
CALCIUM CHLORIDE 18.4 MG / 100 ML
DL-METHIONINE 85 MG / 100 ML
GLYCINE 51 MG / 100 ML
HISTIDINE 71.4 MG / 100 ML
ISOLEUCINE 85 MG / 100 ML
LEUCINE 102 MG / 100 ML
LYSINE (LYSINE MONOHYDROCHLORIDE) 95.5 MG / 100 ML
MAGNESIUM CHLORIDE 5.1 MG / 100 ML
PHENYLALANINE 57 MG / 100 ML
PROLINE 59.5 MG / 100 ML
SERINE 51 MG / 100 ML
SODIUM CHLORIDE 538 MG / 100 ML
SODIUM LACTATE 448 MG / 100 ML
THREONINE 64.6 MG / 100 ML
TRYPTOPHAN 27 MG / 100 ML
TYROSINE 30 MG / 100 ML
VALINE 139.3 MG / 100 ML

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