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:

2022-10-31

Original market date: ^{See footnote 1}

1989-12-31

Lot number: ^{See footnote 2}

M3509-02

Expiry date: ^{See footnote 2}

2022-07-31

Product name:

APRALAN

Description:

APRAMYCIN SULFATE SOLUBLE POWDER

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:

00818542

Product Monograph/Veterinary Labelling:

Date: 2019-06-10 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

ELANCO CANADA LIMITED
401 1919 Minnesota Court
Mississauga
Ontario
Canada L5N 0C9

Class:

Veterinary

Species:

Swine (pigs)

Dosage form(s):

Powder For Solution

Route(s) of administration:

Oral

Number of active ingredient(s):

Schedule(s):

Prescription

American Hospital Formulary Service (AHFS): ^{See footnote 3}

Anatomical Therapeutic Chemical (ATC): ^{See footnote 4}

Not Applicable

Active ingredient group (AIG) number:^{See footnote5}

0131406002

List of active ingredient(s)
Active ingredient(s)	Strength
APRAMYCIN (APRAMYCIN SULFATE)	50 MG / JAR

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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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Date modified:: 2019-03-01