Veterinary Biologics Guideline 3.3
Labelling of Veterinary Biologics

Table of Contents

I. Introduction

The following provides guidance to veterinary biologics manufacturers and importers regarding the Canadian requirements for labelling veterinary biologics manufactured and/or distributed in Canada. Labelling includes any legend, word or mark attached to or accompanying any veterinary biologic.

The Canadian Food Inspection Agency (CFIA) is responsible for licensing veterinary biologics, including veterinary vaccines, colostrum, antibody products and diagnostic kits, manufactured and/or used in Canada. The licensing program operates under the authority of the Health of Animals Act and Regulations, and is administered by the Canadian Centre for Veterinary Biologics (CCVB).

II. Legal Authority

Health of Animals Regulations, Part XI

130. No person shall sell a veterinary biologic or any diluent to be used therewith if the veterinary biologic or diluent has been prepared, manufactured, preserved, packed, labelled or tested otherwise than in the manner described in the product outline.

130.1 Every veterinary biologic imported, sold, advertised or offered for sale in Canada shall be stored at a temperature between 2°C and 7°C unless otherwise stated in the product outline or the labelling.

132.(1) No person shall import, sell, advertise or offer for sale a veterinary biologic unless it is packed and labelled in accordance with these Regulations.

132.(2) All information required by section 134 to be shown on the label of a veterinary biologic

  1. shall be clearly and prominently displayed on the label; and
  2. shall be readily visible by a purchaser under the customary conditions of purchase and use.

133.(1) Subject to subsection (2), every veterinary biologic sold, advertised or offered for sale in Canada shall carry a label on or attached to every container in which the veterinary biologic is packed.

133.(2) Subsection (1) does not apply to a single dose of a killed veterinary biologic packed in a ready to use syringe if the syringe is in a sealed pouch that carries a label.

133.(3) Every veterinary biologic imported into Canada shall carry a label on or attached to every outer container and shipping container.

134.(1) Subject to this section, every label of a veterinary biologic imported, sold, advertised or offered for sale in Canada shall show

  1. the assigned name of the veterinary biologic,
  2. the name of the manufacturer of the veterinary biologic or, if there is more than one manufacturer of that veterinary biologic, the name of the first or the name of the final manufacturer,
  3. the place where the manufacturer referred to in paragraph (b) manufactures the veterinary biologic,
  4. the lot or serial number or other means of identifying the veterinary biologic,
  5. the same establishment licence number, whether Canadian or foreign, on all components of the label except that the Minister may, in writing, exempt from that requirement diluents manufactured in Canada,
  6. directions for use of the veterinary biologic or that directions for its use are contained inside the package,
  7. the expiration date of the veterinary biologic,
  8. the components of the veterinary biologic, including:
    1. viruses, bacteria, toxoids and antibodies, and
    2. antibiotics, if added during the production process as preservatives,
  9. the net quantity of the veterinary biologic in the container, expressed in metric units or in doses,
  10. the temperature range, expressed in metric units, necessary to maintain prescribed potency of the veterinary biologic,
  11. in the case of a veterinary biologic manufactured for use in food producing animals, the cautionary statement indicating the appropriate withdrawal period as stated in the product outline on the basis of which the import permit or product licence was issued, and

  12. in the case of modified live virus rabies vaccines, the cautionary statement

    "In the event of accidental human exposure to the vaccine virus, the possible hazard to health should be considered and public health officials or a physician should be consulted" or "En cas d'exposition accidentelle d'une personne au vaccin viral, il faut prendre en considération le risque sanitaire et consulter les responsables de la santé publique ou un médecin,"

and shall be marked with the words "For veterinary use only" or "Pour usage vétérinaire seulement" or alternative wording approved by the Minister.

134.(2) Where the label of a veterinary biologic is too small to show all the information required by subsection (1), any such information as the Minister may permit may be shown on the directions for use inside the package.

134.(3) The information contained on the label of a veterinary biologic imported into or sold, advertised or offered for sale in Canada shall be shown in its entirety in either or both official languages and, if both official languages are shown, may additionally be shown in whole or in part in any other language.

Official Languages Act

26. Every federal institution that regulates persons or organizations with respect to any of their activities that relate to the health, safety or security of members of the public has the duty to ensure, through its regulation of those persons or organizations, wherever it is reasonable to do so in the circumstances, that members of the public can communicate with and obtain available services from those persons or organizations in relation to those activities in both official languages.

41.(1) The Government of Canada is committed to

  1. enhancing the vitality of the English and French linguistic minority communities in Canada and supporting and assisting their development; and
  2. fostering the full recognition and use of both English and French in Canadian society.

41.(2) Every federal institution has the duty to ensure that positive measures are taken for the implementation of the commitments under subsection (1). For greater certainty, this implementation shall be carried out while respecting the jurisdiction and powers of the provinces.

III. Labelling Requirements

III.A. Labels of Veterinary Biologics Distributed Within Canada

All applicable federal legal labelling requirements prescribed in the Health of Animals Regulations, as well as any conditions or restrictions set out in a product licence or import permit, must be complied with before a label is accepted for use in Canada.

Please note that some provincial or local regulations may apply to the labelling of veterinary biologics. It is the responsibility of the manufacturers and the importers to ensure that all applicable legal requirements are met before a veterinary biologic is distributed in Canada.

The following information must appear on a product's labelling:

  1. assigned name;
  2. manufacturer;
  3. location of manufacturer;
  4. Establishment Licence Number, if applicable;
  5. serial number – exemption for package inserts;
  6. expiry date – exemption for package inserts;
  7. directions for use, or instructions to consult a carton or package insert for full directions;
  8. all components including antigens and preservatives – exemption for containers of 50 mL or less;
  9. quantity of vaccine in the container, expressed in metric units or doses – exemption for package inserts;
  10. storage temperature expressed in metric units;
  11. withdrawal period, if applicable – exemption for containers of 50 mL or less; and
  12. recommended treatment in case of allergic reaction – exemption for containers of 50 mL or less.

III.A.1. Assigned Name

This is considered to be the true or proper name of the micro-organism(s) contained in the product and is not the trade or brand name. The assigned name should be identical to that shown on the Veterinary Biologics Product Licence or Permit to Import Veterinary Biologics. No other statement, design, device, or trade name should overshadow the assigned name, which must be given prominence by the location and by the style and/or size of lettering. The letters of the assigned name should not be smaller than the letters of the trade name. The assigned name should appear on every part of a product's labelling.

The assigned name is determined by the relevant regulatory authority in the country of manufacture.

The CCVB will approve the French assigned name for each product licensed in Canada. Consistency of terminology must be maintained for all products if there is a choice of appropriate terminology. Check the CCVB website for similar licensed products prior to suggesting a new French assigned name.

III.A.2. Establishment or Product Identification Number

The Establishment Licence Number of the manufacturer, as issued by the regulatory authority of the country where the manufacturer is located, must be on the labels, unless such a system is not used by that country. The same number must be on all labels.

It is the veterinary biologics importer's responsibility to determine whether the manufacturer's Establishment Licence Number may appear on labelling applied outside the country of manufacture.

A product code, issued by the regulatory authority of the country of manufacture, may appear on the labels. This is not mandatory for labels on products distributed in Canada.

III.A.3. Pertinent Information

Pertinent information for all veterinary biologics, except diagnostic test kits, includes the following:

  1. recommended dose;
  2. route(s) of administration;
  3. recommendations with respect to the optimum age for vaccination and repeat dose (booster) instructions;
  4. precautions;
  5. withdrawal period;
  6. antidote; and
  7. disposal recommendations.

Pertinent information for diagnostic test kits includes the following:

  1. test procedure;
  2. safety precautions;
  3. results of efficacy testing (sensitivity and specificity); and
  4. disposal recommendations.

III.A.4. Expiry Date

Such a date must be supported by satisfactory stability data, and the product must not be sold after this expiry date. The expiry date is calculated from the date of initiation of the first potency test. For multi-component products, the expiry date should be the earliest expiry date among the individual product components.

If the expiry date is indicated using only year/month, it is understood that the expiry date corresponds to the last day of this month. The expiry date is calculated from the date of the start of the first potency test, and therefore the month that is indicated must fall within the total expiry time, stipulated in the outline of production (OP). For example, if potency testing started June 14, 2004, for a product with an expiry dating of 12 months, the expiry date would be written 2005/05.

The preferred format for expiry date is as follows: yyyy/mm/dd (year/month/day).

III.A.5. Label Claims

All claims written on the labels must be supported by data that have been approved by the CCVB. The recommendations for product use must be consistent with the recommendations stipulated in Section VI of the OP, unless otherwise approved by the CCVB.

III.A.6. Logos and Slogans

Company logos and other artwork may appear on labels, provided they are discreet and do not overshadow required information. Slogans and taglines should not ordinarily appear on container and carton labels, except for large containers and cartons where there is sufficient space to include this information without displacing the other text.

Slogans and company taglines may appear on the package insert, provided claims by the slogan or tagline are consistent with data filed with the CCVB. All claims are subject to approval by the CCVB.

III.A.7. Language Requirements

In accordance with applicable Canadian federal legislation and policies, veterinary biologics intended for sale in Canada should bear English-French bilingual labels as reviewed and approved by the CCVB. Wherever feasible, all label information (including all containers, cartons and package inserts) should appear in both Canadian official languages. The label's text must be clearly legible in conditions of normal use. Where there is insufficient space on the container or carton label to provide fully bilingual text, the required product information listed at III.A may be provided in a separate bilingual package insert or carton that accompanies the product.

Veterinary biologics that have English-only labels should be accompanied by an English-French bilingual package insert developed by the manufacturer or designated Canadian importer. This insert should accompany all products distributed in Canada. A case-by-case evaluation will be completed by the CCVB to determine whether this labelling is acceptable for use on an interim basis for new products until fully bilingual labels are available for the product, or for use on an ongoing basis for "minor use" products. Please see Veterinary Biologics Memorandum 2011-03: Information Requirements for Addition of Package Inserts at Canadian Veterinary Biologics Importer Facilities for more information regarding the preparation of this type of package insert.

Use of text in languages other than English or French on carton labels, container labels or package inserts is prohibited, unless the relevant container label, carton label, or package insert is already fully English-French bilingual, as described above. Importers submitting multi-lingual labelling items for review and approval will be required to include a note from the translator to attest that the foreign language text is an equivalent translation of the English or French text.

III.A.8. Preservatives

These include all substances added to prevent spoilage of the final product. Preservatives added at the cell culture stage should also be listed on the label. For diagnostic test kits, all preservatives included in the components that are necessary to perform the test should be listed in the labelling.

III.A.9. Manufacturer Identification

The name of the company responsible for the manufacture of the product should be clearly indicated on the labels. If more than one company is responsible for this process, the company responsible for the first or last stage should be identified.

III.A.10. Shipping Containers

Approval of outer shipping container labels by the CCVB is not mandatory. However, shipping containers should include the following information:

  1. product assigned name;
  2. volume and number of containers;
  3. serial number(s);
  4. expiry date(s);
  5. name and address of manufacturer; and
  6. other information as necessary:
    • trade name(s),
    • Global Trade Item Number(s) (GTIN),
    • above information in the language of the country importing the product, provided the information is also available in English and French,
    • storage temperature (wording such as "store below 7°C – do not freeze" would be considered acceptable, where appropriate), and
    • World Customs Organization (WCO) Harmonized Commodity Description and Coding System (HS) Codes.

III.B. Labels of Veterinary Biologics Manufactured in Canada for Export Only

It is the manufacturer's responsibility to provide the CCVB with the data supporting all claims made on the labels, and certification that text in a language other than English and/or French is equivalent to the text approved by the CCVB. If the government of the importing country regulates veterinary biologics, a document in English or French attesting its approval of the label claims must be submitted to the CCVB.

IV. Submission Procedure

It is the manufacturer's responsibility to proofread labels before their submission to the CCVB.

IV.A. Fees

All label submissions must be accompanied by a cover letter outlining the requested changes, a Form CFIA/ACIA 4720 – Application for Services, and the corresponding fee.

Fees for label reviews conducted as part of a new product submission are included with the fees for the new product submission.

Fees are only waived for approval of corrections to label errors identified by CCVB. A new fee is required if any changes are made to the labels other than those corrections requested by CCVB.

A single fee is required when all the modified labels of all the affected products are submitted together and the same change (e.g. modification of a toll-free telephone number) is made to all of the labels. An individual cover letter, clearly stating that no other changes have been made to the labels, is required for each product file. Any change to the content of the text present on the labels, other than the requested change, requires a full review of the labels, and a revision fee for each product will then apply to the label review.

IV.B. Diluent Labels

Up-to-date labels for diluents distributed with vaccines should be submitted at the same time as the vaccine labels.

If a particular diluent is distributed with more than one product, the diluent labels may be submitted together in one package, with one fee, as long as the covering letter identifies all of the vaccines with which the diluent is normally distributed. The minimum number of copies of diluent labels that should be submitted is 2X + 1 where X is the number of products distributed with that diluent.

IV.C. Requirements – Final Labels

  1. A separate cover letter for each product should accompany the labels.
  2. Submitted labels must be originals or legible printer-ready colour copies. Whenever possible, printer-ready copies should accurately depict the size of the final labels.
  3. A minimum of two copies of each label must be submitted. One copy is kept on file at the CCVB. One original copy should be kept by the manufacturer and one by each designated importer, if applicable. There is no maximum number of copies that can be submitted.
  4. All the different label formats (vial labels, cartons, inserts, etc.) and dose sizes should be submitted together for approval.
  5. Each label should be mounted on an 8½" by 11" sheet of paper.
  6. Each mounting sheet should include the following information:
    1. the identification of the manufacturer (including the Establishment Licence Number, if applicable);
    2. the product assigned name;
    3. the CCVB file number;
    4. the product code issued by the country of manufacture (if applicable);
    5. the type of label (container, carton, leaflet), including dose size; and
    6. the date of preparation and/or the version number of that label.
  7. A 5-cm space minimum is required on one side of each label for the approval stamp.
  8. The labels must be mounted in such a way that all of the text on the label can be read without removing the label from the mounting sheet.
  9. Labels of co-packaged vials can be mounted on the same sheet of paper, provided that a 5-cm margin is left on one side of each label.
  10. If the layout and text of the labelling is identical for different product dose sizes, only the labelling of the smallest dose size requires submission for approval.
  11. Over-stickers must also be submitted to the CCVB for approval.
  12. The location of the serial and/or expiry date should be indicated on the labels by an asterisk and a corresponding description if they are not otherwise indicated.

IV.D. Requirements – Drafts

Draft label text may be submitted to the CCVB for review prior to the presentation of final labels. The label review fee should accompany the draft text, and this fee will also cover the review of the corresponding final labels.

If the draft label text is part of a new product submission, no fee is required to accompany the text as it is already included with the fees for the review of the new product submission.

IV.E. Labels on Containers of 50 mL or Less

Since space on the labels of containers of 50 mL or less is restricted, only the following information is required:

  1. product assigned name;
  2. volume of the contents and/or the number of doses;
  3. manufacturer's name and location;
  4. establishment number (if applicable);
  5. serial or lot number;
  6. expiry date; and
  7. instructions to consult the package insert or the carton for complete directions.

Other information may be added to the vial label, but not at the expense of clarity and legibility. The labelling must be easily read under the customary conditions of purchase and use.

Directions for use and precautions must appear on multi-vial cartons or package inserts when the individual vials are too small to legibly carry all necessary information.

A diagnostic kit's trade name can be used without the complete assigned name on the vial labels of reagents with very small volumes (10 mL or less).

IV.F. Addition or Substitution in Canada of a Package Insert for an Imported Veterinary Biologic

Approval from the CCVB to add or substitute a package insert to an imported product in Canada may be granted, provided that the following is true:

  1. The applicant is an approved designated Canadian importer of veterinary biologics.
  2. The veterinary biologic is licensed for use in Canada, or authorized by the CCVB for restricted use.
  3. The importer's facilities where the package inserts are added or substituted are inspected regularly by a member of the CFIA-Veterinary Biologics Operations or the CCVB.
  4. A Special Outline describing the process has been reviewed and approved by the CCVB.
  5. The package insert is stamp-approved by the CCVB.
  6. The Special Outline is kept up to date.

More details on obtaining approval from the CCVB to add or substitute package inserts for imported licensed veterinary biologics can be found in Veterinary Biologics Memorandum 2011-03: Information Requirements for Addition of Package Inserts at Canadian Veterinary Biologics Importer Facilities.

IV.G. Temporary Use of Labels Approved by a Foreign Regulatory Authority Only

In cases where there is a shortage of CCVB-approved labels for a licensed product distributed in Canada, labels that have been approved for use by a foreign regulatory authority may be submitted to the CCVB for temporary use in Canada.

One photocopy of each label, clearly showing the foreign regulatory authority's disposition, along with the required number of mounted labels prepared as described in Section IV.B. above should be submitted to the CCVB along with the appropriate label review fee. The labels can be approved for use in Canada for up to one year.

Product labels on which a language other than English or French appears cannot be approved for temporary use in Canada unless both English and French already appear on all of the product labels.

V. Label Error Identification by CCVB

V.A. Major Errors

The following are considered major errors and will result in rejection of the submitted label(s):

  • Label claims not supported by data approved by the CCVB. This also applies to foreign language labels on products destined for international markets.
  • Non-equivalence of text translation.
  • Illegible text, or very small text that requires a magnifying glass to read.
  • Terminology, typographical, or spelling mistakes that may interfere with the prescribed use of the product.

V.B. Minor Errors

The following are considered minor errors, and may result in temporary approval of the labels until corrected labels can be submitted:

  • Spelling or typographical errors that do not interfere with the prescribed use of the product.
  • Discovery of major errors inadvertently approved previously by the CCVB.

Corrected labels must be submitted for final approval within a limited time frame, to a maximum of one year. The length of the approval period will be determined by the CCVB reviewer.

Photocopies of the labels with the required corrections are returned to the manufacturer. The final corrected labels should be submitted for review and approval before the end of the interim label approval period or the next printing of the labels, whichever comes first.

The fee submitted with the original labels remains valid for the review and approval of corrected labels. This fee does not cover subsequent changes initiated by the manufacturer.

VI. Exportation of Canadian-Manufactured Products

Labels of all products that are manufactured in Canada and destined for exportation only must be presented to the CCVB for approval.

The following information must be submitted to the CCVB by the Canadian manufacturer:

  • Proof of acceptance of the product, and labelling, by the regulatory authorities in the importing country, provided that the product is regulated by the importing country.

VI.A. Submission Procedure

Follow the procedure as described in section IV above.

VI.B. Additional Submission Requirements for Labels in a Language Other Than English or French

The following information must be submitted in addition to the information requirements already described above in Section IV:

  1. Equivalent text in either English or French of all text that appears on labels, cartons, and package inserts in a language other than English or French.
  2. The following text included on the bottom of label copy, in a text box:
    1. The undersigned certifies that this is an equivalent and accurate translation of the [insert label text language] text
    2. Translator information: name, title, signature, date
  3. The following information, on company letterhead, about the translator:
    1. Name;
    2. Affiliation (name of employer, address, telephone and facsimile numbers, email address);
    3. Language competence of the translator, including the list of languages qualified to translate (specify level of reading, writing, and speaking fluency for each language) and mother tongue; and
    4. Qualifications: training/courses taken, including those supporting the knowledge of the relevant terminology.

Please note that the CCVB may also contact a third party to verify the equivalency of the provided translation.

VII. Minor Changes

Manufacturers can make minor changes to labels and implement them without pre-approval from the CCVB, provided that the copies of the modified labels are submitted to the CCVB for approval within two months of the change.

To streamline the review and approval procedure, manufacturers are encouraged to submit revised labels for all of their products together.

The following are considered minor label changes:

  1. commercial logo of the company
  2. background picture
  3. colour scheme
  4. minor change to the shape of the labels (including new peel-off format)
  5. introduction or removal of patent number or registration logo/number (e.g. ®, ©, ™)
  6. modification to the layout of the already approved text
  7. addition of, or change to, a toll-free telephone number
    1. Companies should ensure that toll-free telephone numbers displayed on the labels of products distributed in Canada are accessible to Canadian consumers.

VIII. Standardized Terminology

VIII.A. Recommended Statements

  1. Vaccination: Applies to the administration of a veterinary biologic to an animal regardless of the route of administration. Terms to avoid: immunisation, inoculation.
  2. Withdrawal period: "Do not vaccinate within [X] days before/prior to slaughter."
  3. "For veterinary use only," "For use in animals only," or "For use in dogs, cats, swine, cattle, horses, chicken, turkey, salmon, etc." (or similar statement), if the animal species is stipulated.
  4. "Do not vaccinate pregnant females."

VIII.B. Recommended Translations of Product Claims

English
for the prevention of
as an aid in the prevention of
for the control of
as an aid in the control of
to reduce
as an aid in the reduction of

French
pour prévenir
pour aider à prévenir
pour contrôler
pour aider à contrôler
pour réduire
pour aider à réduire

VIII.C. Frequently Observed Terminology Errors

The following includes some of the most common terminology errors:

  1. Using the disease name to indicate the causal organism (e.g. "clinical signs caused by infectious bovine rhinotracheitis" instead of "clinical signs of infectious bovine rhinotracheitis").
  2. Incorrectly writing an antigen's Latin name.
  3. Capitalizing the letters of a disease name that does not contain a proper noun (e.g. "Canine Hepatitis").

IX. Glossary - Recommended English and French Terms

English French
Act Loi
adjuvant; oil-based adjuvant adjuvant; adjuvant huileux / à base d'huile
adjuvanted adjuvanté; adjuvé
administer administrer
adverse event / reaction évènement / réaction indésirable
advertisement publicité / annonce publicitaire
albumin (egg white) albumen (blanc d'oeuf)
ampule / ampoule (liquid nitrogen) ampoule (azote liquide)
anaphylaxis
  - anaphylactic reaction
  - anaphylactic shock		 anaphylaxie
  - réaction anaphylactique
  - choc anaphylactique
animals under X weeks of age
  - X-week / month-old animals		 animaux âgés de moins de X semaines
  - animaux âgés de X semaines / mois
antibody anticorps
antibody test kit trousse de détection / dépistage d'anticorps
anticoagulated blood sang traité à l'anticoagulant / anticoagulé
antigen antigène
antigen test kit trousse de détection / dépistage d'antigènes / des antigènes
antitoxin antitoxine
assigned name nom attribué
autogenous
  - a. bacterin
  - a. vaccine		 autogène
  - bactérine a.
  - vaccin a.
bacteria; bacterium bactéries; bactérie
bacterial bactérien
bacterin bactérine
biohazardous waste matières biologiques dangereuses
biotechnology biotechnologie
bluetongue fièvre catarrhale du mouton
breeder flock (poultry) troupeau reproducteur (volaille)
breeding accouplement, saillie
bring to room temperature amener à la température ambiante
brucellosis brucellose
buffer (diagnostic kit) tampon (trousse diagnostique)
Canadian Food Inspection Agency (CFIA) Agence canadienne d'inspection des aliments (ACIA)
Canadian Veterinary Biologics
Establishment License Number
(Can. Vet. Biol. Estab. Lic. No.)		 Numéro de permis canadien
d'établissement de produits biologiques vétérinaires
(No / no de perm. can. établ. prod. biol. vét.)
cattle bovins
cautionary statement mise en garde
cell line lignée cellulaire
challenge provocation
chicken; chicks; pullets; laying hens poulet; poussins; poulettes; poules pondeuses
chimera chimère
coated microtiter plates microplaques sensibilisées
coccidia; coccidium coccidies; coccidie
confidence limit (CL) limite de confiance (LC)
contraindication contre-indication
competitive enzyme-linked immunosorbent assay (cELISA) épreuve immuno-enzymatique de compétition (cELISA)
components composants; composantes
cut-off (diagnostic kit) seuil de détection (trousse de diagnostic)
degree-days (fish) degrés-jours (poissons)
device (diagnostic kit) dispositif (trousse de diagnostic)
diagnostic kit trousse diagnostique / trousse de diagnostic
disclaimer déni de responsabilité
disease maladie
dispense (reagents) distribuer (réactifs)
disposal; to dispose / discard élimination; éliminer
dissolved dissous
Dispose according to local regulations. Éliminer conformément aux règlements locaux en vigueur.
Do not vaccinate pregnant animals. Ne pas vacciner les femelles gestantes / gravides.
Do not vaccinate pregnant cows or calves nursing from pregnant cows. Ne pas vacciner les vaches gestantes / gravides ou les veaux allaités par des vaches gestantes / gravides.
Do not vaccinate pregnant sows or piglets nursing from pregnant sows. Ne pas vacciner les truies gestantes / gravides ou les porcelets allaités par des truies gestantes / gravides.
Do not vaccinate within 21/40/60 days prior to / before slaughter. Ne pas vacciner dans les 21/40/60 jours précédant l'abattage.
dosage of oral administration (rate) dosage d'administration orale (taux)
dot; spot (diagnostic kit) pastille (trousse de diagnostic)
drinking water eau potable
droplet spray nuage de gouttelettes
egg antibody anticorps dans les oeufs
egg inoculation machine vaccinateur d'oeufs
egg powder poudre d'oeufs
egg white (albumin) blanc d'oeufs (albumen)
embryonated eggs oeufs embryonnés
emulsion émulsion
enterotoxigenic entérotoxigène
enzyme-linked immunosorbent assay (ELISA) épreuve immuno-enzymatique (ELISA)
excretion excrétion
expiry date; Exp.; EXP. date de péremption; Pér.; EXP.
fetus foetus
fetal foetal
field trial; field test essai sur le terrain
fingerling (fish) alevin (poisson)
flock troupeau
flock / herd of origin troupeau de provenance
food animal animal destiné à l'alimentation
food-producing animal animal producteur de denrées alimentaires
For investigational use. Pour usage en recherche.
For emergency use. Pour usage en cas d'urgence.
formalin-inactivated cultures cultures inactivées au formol
For use in animal only. Destiné aux animaux seulement.
For veterinary use only. Pour usage vétérinaire seulement.
fry (fish) alevin (poisson)
fungi; fungus champignons; champignon
gilt cochette
heifer génisse
herd troupeau
high incidence state état à forte incidence
hindquarter arrière-train
homogenizer homogénéisateur
hyperimmunized hyperimmunisé
In case of accidental human injection, seek immediate medical attention. En cas d'injection accidentelle chez l'humain, consulter immédiatement un médecin.
Incubate at room temperature Incuber à la température ambiante.
incubator étuve
injection site point / site d'injection
insert; leaflet notice; dépliant
inspector inspecteur
isolates isolats
keep / store out of direct sunlight entreposer / garder à l'abri de la lumière directe du soleil / protéger du soleil
killed virus virus tué
kit (diagnostic) trousse (de diagnostic)
label étiquette
laboratory test épreuve en laboratoire
leaflet; insert dépliant; notice
licence / license (U.S.) permis
licensing homologation
licensed homologué
licensed establishment établissement agréé
liquid nitrogen tank réservoir d'azote liquide
livestock animaux de ferme / bétail
local swelling enflure / inflammation localisée
lot lot
manufacture manufacture
manufactured for; manufactured by fabriqué pour; fabriqué par
manufacturer; man. fabricant; fabr.
master seed; master seed virus (MSV) souche mère; virus de la souche mère (VSM)
master cell cellules de souche mère
medicators distributeurs de médicaments
micro-organism micro-organisme
microtiter plates; microplates microplaques
midline (fish) ligne médiane / du centre (poissons)
minister ministre
mix well bien mélanger
modified live virus virus vivant atténué
mouth gueule (carnivore); bouche (herbivore)
multichannel pipet / pipette pipette à canaux multiples
nares; nostrils narines (chien, chat, oiseau); naseaux (grands animaux)
needle aiguille
Not for human consumption. Non destiné à l'alimentation humaine.
oocyst (coccidia) oocyste; ookyste (coccidies)
outline of production / production outline protocole de production / données générales sur le produit
package emballage
parr (fish) tacon (poisson)
patent pending brevet en instance
permit permis
Permit to import veterinary biologics Permis d'importation de produits biologiques vétérinaires
Permit to release veterinary biologics Permis de dissémination de produits biologiques vétérinaires
peroxidase peroxydase
phosphate buffer saline solution saline dans un tampon phosphate
pipet; pipette pipette
pipet / pipette tip embout de pipette
pouch; sachet pochette; sachet
poult (turkey) dindonneau (dindon)
precaution mise en garde
pregnancy gestation
pregnant animals (cows; sows; mares; bitches; queens) animaux (vaches; truies; juments; chiennes; chattes) gestantes / gravides
preservative agent de conservation, conservateur
product code code de produit
product licence permis de fabrication
production outline / outline of production données générales sur le produit / protocole de production
progeny descendance
quarantine quarantaine
rate (dosage of oral administration) taux (dosage d'administration orale)
ratio (interpretation of ELISA) ratio (interprétation de l'ELISA)
reagents réactifs
records; keep a record registre; Tenir un registre
registration enregistrement
registered enregistré
regulations règlement
rehydrate réhydrater
room temperature température ambiante
salmonids salmonidés
sample échantillon
screening test test de dépistage
serial série
serial number; ser. no.; ser.; SER. numéro de série; No de sér.; sér.; SER.
serial release mise en circulation d'une série
shake well bien agiter / secouer
smolts (fish) saumoneaux (poisson)
specific pathogen-free exempt d'organismes pathogènes spécifiques
spot; dot (diagnostic kit) pastille (trousse de diagnostic)
spray administration; sprayer administration par vaporisation / nébulisation;
vaporisateur / nébuliseur
spray-dried whole egg powder poudre d'oeuf entier séchée par pulvérisation
standard deviation écart type
store at room temperature entreposer à la température ambiante
store below conserver / entreposer en-dessous de
stored entreposé
strip (microplate) barrette (microplaque)
strip (electrophoresis) languette (électrophorèse)
subunit vaccine vaccin sous-unitaire
susceptible animals animaux susceptibles
suspected adverse event / reaction événement indésirable soupçonné / réaction indésirable soupçonnée
swab écouvillon
syringe seringue
test (laboratory); field test test, analyse (laboratoire); essai au champ / sur le terrain
titration titrage
toxigenic toxigène
toxoid anatoxine
trade name nom commercial
turkey; poults dinde; dindonneaux
US Veterinary License No. No / no de permis vétérinaire américain / des É.-U.
US Veterinary Biologics Establishment License No. No / no de permis d'établissement de produits biologiques vétérinaires des É.-U.
US Vet. Biol. Est. Lic. No. No / no de permis d'établ. de prod. biol. vét. amér. / des É.-U.
using aseptic technique de façon aseptique
veterinarian
  - accredited v.
  - licensed v.		 vétérinaire
  - v. accrédité(e)
  - v. licencié(e)
Veterinary License (Vet. Lic.) Permis vétérinaire (Perm. vét.)
Veterinary Biologics Product Licence Permis de fabrication de produits biologiques vétérinaires
veterinary biologic produit biologique vétérinaire
veterinary inspector vétérinaire-inspecteur
vial fiole / flacon
virus virus
well (microplate) puits; cupule (microplaque)
whole blood sang total / complet / entier
wing web (chicken) membrane alaire / voile de l'aile (poulet)
winter ulcers (fish) ulcères hivernaux (poisson)
withholding / withdrawal period période de retrait