Product information

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:

Cancelled Post Market

Current status date:

2021-11-02

Original market date: ^{See footnote 1}

1998-09-25

Lot number: ^{See footnote 2}

W9B07T1

Expiry date: ^{See footnote 2}

2020-08-31

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:

Haemodialysis

Number of active ingredient(s):

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}

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

New search

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Footnotes

Footnote 1

The earliest marketed date recorded in the Drug Product Database.

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Footnote 2

When a manufacturer decides to discontinue the sale of their drug, the date of discontinuation is the date of the last sale by the manufacturer. The DIN will be cancelled further to the receipt of a sale discontinuation notification from the manufacturer. The status of the DIN will be updated to “Cancelled (Post-Market)” in the online Drug Product Database. For DINs cancelled on or after March 14, 2017, the latest expiry date and lot number of the product distributed in Canada will be posted on the online Drug Product Database. Other parties in the health product distribution chain such as wholesalers, retailers, pharmacists and medical practitioners may still sell or distribute that drug after DIN cancellation if the expiry date of the drug lot has not passed. This may be acceptable so long as the DIN cancellation is not due to health and/or safety reasons.

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Footnote 3

The American Hospital Formulary Service permits an easy review of information on a group of drugs with similar activities and uses and allows the reader to determine quickly the similarities and differences among drugs within a group. AHFS® Pharmacologic/Therapeutic Classification© used with permission. © 2022, the American Society of Health-System Pharmacists, Inc. (ASHP). The Data is a part of the AHFS Drug Information®; ASHP is not responsible for the accuracy of transpositions from the original context.

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Footnote 4

The purpose of the World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) classification system is to be used as a tool for drug utilization research in order to improve quality of drug use. Drugs are divided into different groups according to the organ or system on which they act and their chemical, pharmacological and therapeutical properties.

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Footnote 5

The AIG number is a 10 digit number that identifies products that have the same active ingredient(s) and ingredient strength(s). The AIG is comprised of three portions:

the first portion (2 digits) identifies the number of active ingredients,
the second portion (5 digits) identifies the unique groups of active ingredients(s),
the last portion (3 digits) identifies the active ingredient group strength. The strength group has a tolerance of ‑2% to +10%.

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Footnote 6

The asterisk indicates that an AHFS code was created by Health Canada and is not found in the AHFS book.

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Date modified:: 2019-03-01