Guidance on veterinary drug labelling: Package insert

On this page

• Description
• Indications
• Directions for use
• Contraindications
• Cautions
• Warnings
• Adverse reactions
  • Information for animal owners
  • Overdose information
• Scientific information
  • Clinical pharmacology
  • Therapeutic drug monitoring
  • Microbiology
  • Target animal safety
  • Target animal efficacy
• Storage information
• Disposal information
• Presentation/package types
• Manufacturer’s name and address
• Date

In addition to the regulatory requirements for the inner and outer label, a package insert that contains information for the sections listed above is recommended. The package insert would give complete detailed information on how to use the drug safely and effectively. If there is not enough space on the inner and outer labels for complete information under a specific section (for example, Warnings), use a package insert.

The section headings of the package insert should follow the order as presented above and can be tailored as needed. They should appear in capitals and boldface. Each section should always contain complete information (for example, all warnings and adverse events, not only those that don't fit on the drug's outer label).

The following introductory information should appear at the top of the package insert:

• brand name, proper/common name
• drug identification number (DIN)
• "Veterinary Use Only" and scheduling symbols, as applicable
• therapeutic classification (for example, antibiotic, non-steroidal anti-inflammatory) and the ATCvet code, if applicable

Description

Under this heading, include the key product description information such as:

• physicochemical properties of the drug, including scoring, colour and shape
• quantitative and qualitative lists of medicinal and non-medicinal ingredients

Indications

Under this heading, list the indications by animal species. To further define the species, you should also list subspecies, age or production group and genders, as applicable (for example, grower, finisher, lactating dairy cattle).

Directions for use

Under this heading, give a detailed description of the dosage, route and method of administration, instructions (how to reconstitute or mix with feed, for example) and duration of use/treatment. Provide dosages for each indication and species.

For drugs containing medically important antimicrobials (MIAs), include the following statement at the beginning of the dosage and administration section of the package insert:

• "To reduce the development of antimicrobial resistance and maintain effectiveness, use this antibiotic prudently"

For more information and guidance, refer to the following:

• categorization of antimicrobial drugs based on importance in human medicine
• list of certain antimicrobial active pharmaceutical ingredients

Contraindications

Under this heading, list the contraindications where the drug should not be used because the risk outweighs any potential benefit. For example, NSAIDS (non-steroidal anti-inflammatory drugs) used in companion animals may have the contraindication "Do not administer to dogs with gastrointestinal ulcers, renal disease, hepatic disease or dehydration".

Cautions

Under this heading, list the known serious or other adverse effects of the drug that may pose a health risk to the animal. These are important considerations for the veterinarian or user. They are there to ensure the safe and effective use of the drug.

You may make specific reference to animal species, subspecies, age or production groups and genders. For example:

• "Safe use in puppies less than 12 weeks of age has not been established"
• "The safety of this drug has not been studied in cattle with immature reproductive tracts"

Warnings

Warning statements provide information on any potential human health risks associated with the use of veterinary drugs. These include:

• those related to food safety (for example, withdrawal period or milk withholding time, not for use in lactating dairy cattle) and that are intended to minimize any potential human health risks associated with consuming food from food-producing animals treated with the drug product
• warning statements on specified withdrawal periods/withholding times on the inner/outer label must also be included in the package insert
• those related to occupational or user health and safety hazards from handling and administering drug products or accidental direct contact with the drug, including relevant warnings for people who may be sensitive to the drug product
• those related to microbiological safety of the drug product, such as the hazard or risk of antimicrobial resistance development associated with the use of the drug product (as applicable to antimicrobial products)

The order of the warning statements should follow a logical sequence. They should consider the species, withdrawal periods and withholding times (if applicable).

For more information, refer to the Warnings section under Principal display panel.

For English/French translations of terms, including warning statements, which often appear on veterinary drug labels, consult the English-French lexicon for standard labelling statement.

Adverse reactions

An adverse veterinary drug reaction is any unwanted or harmful event that occurs after a veterinary drug is administered (on-label and/or extra-label). These include adverse reactions in animals or humans involved in administering a veterinary drug to an animal and those that result from a suspected lack of effect/response.

For drugs that have not been marketed previously, safety data from the pivotal efficacy study should be included. A table of clinical signs (adverse reactions) occurring in the study animals is usually presented. Serious adverse reactions may also be described in text.

For drugs that have been marketed internationally or in Canada, post-market information should be presented under this heading. Inclusion of an adverse event from spontaneous reports is based on reporting frequency and/or seriousness of the reaction. To provide a common understanding when interpreting post-market adverse drug reaction data and reporting, an explanatory paragraph should appear in this section:

"Although not all adverse reactions are reported, the following information is based on voluntary post-approval drug experience reporting. It is generally recognized that this results in significant under-reporting. The adverse events listed here reflect reporting and not necessarily causality. Adverse events are listed by body system, in decreasing order of frequency."

If there are expected adverse reactions associated with a drug class, you may include a general statement to this effect.

If serious adverse reactions are reported post-market, changes to the product labelling may be requested.

Information for animal owners

If applicable, include a general description of important information for animal owners, such as:

• a list of adverse reactions and clinical signs associated with an intolerance to the drug
• importance of periodic follow-up with a veterinarian during treatment
• advice on when to stop treatment and consult a veterinarian

Overdose information

Briefly describe the recommended medical procedure to follow in case of an accidental overdose and antidote information. Describe any clinical signs and symptoms of an overdose. You may also consider including poison control contact information.

Scientific information

In the package insert, include key scientific information (refer to the following headings). If available, provide the chemical name and structure of the drug.

Clinical pharmacology

Give a concise synopsis of the drug's mechanism(s) of action, pharmacodynamics and pharmacokinetics in the target animal species. Also include:

• a description of the absorption, distribution, metabolism and excretion of the drug
• information on drug interactions and recommendations to avoid or minimize pharmacokinetic and/or pharmacodynamic interactions (when applicable)

Therapeutic drug monitoring

Provide relevant therapeutic drug monitoring information, such as time to reach steady-state, time for blood sampling and therapeutic range.

Microbiology

Describe the laboratory studies (in vitro and in vivo) and the microbiological data (summarized under "clinical pharmacology" above) for antimicrobials. These data should include the following details (with drug susceptibility data often included in a table):

• antimicrobial susceptibility testing using Clinical and Laboratory Standards Institute (CLSI) or other internationally recognized guidelines
• reference and target pathogens studied, including the year, location and numbers of isolates tested
• minimum inhibitory concentration (MIC) data (including MIC range, MIC₅₀ and MIC₉₀ values) and a statement indicating whether the mode of action of the drug is time- or concentration-dependent
• information on drug resistance and cross-resistance

Target animal safety

Summarize the pivotal studies conducted that support target animal safety and the results.

Target animal efficacy

Summarize the pivotal studies conducted that support target animal efficacy and the results.

Storage information

Describe the storage conditions and other recommendations to help veterinarians and users maintain product quality, safety and efficacy. Avoid using terms such as "ambient conditions" or "room temperature".

Examples include:

• store between X°C and Y°C
• protect from light
• keep from freezing

Disposal information

Provide instructions on how to dispose of the product properly if there are specific instructions available. Include environmentally sound disposal methods if applicable.

Presentation/package types

Provide information on all different packaging formats and sizes that are available for the product, with the net amounts for each. For example, outline that the product comes in strengths of 15 mg, 45 mg and 60 mg per tablet, where each strength is packaged in 20- and 100-count bottles.

Also describe any product markings/imprinting.

Manufacturer’s name and address

Include the manufacturer's name and address in the package insert. If the drug is imported, include the name and address of the Canadian importer or distributor.

For more information on the requirements for contact information, refer to the information on any panel – name and address.

Date

This is the date when the package insert was revised last. To help us distinguish the different versions during our review process, sponsors should indicate any version numbers for the labelling that has been submitted.