===== EXTRA_INSTRUCTIO ===== === Extra-label use (ELDU) === \\ \\ **The use of a drug product (that has a DIN):** \\ \\ - in a different dosage than what is approved on the label; - with a greater or lesser frequency of administration than what is approved on the label; - for a different indication (ie., different disease or condition) that was stated on the label; - for a longer or shorter duration of treatment than what is indicated on the label; - by different routes of administration (e.g. oral versus injectable); - in a different species than what is indicated on the label (e.g. a drug approved in cattle administered to sheep); - in a different age group; in a different stage of the animal's production cycle (e.g. dried out cows versus lactating dairy cows); - in a different dosage form (e.g. a tablet may be crushed into powder and incorporated into a gel i.e., by ""Compounding""); - that has been approved for human use, to treat an animal; - in a medicated feed outside of Medicated Ingredient Brochure (MIB) listing; - in a different formulation e.g. two drugs being mixed in the same syringe i.e., by ""Compounding""; **The use of drug product ( with no DIN)** - the use of unapproved drugs (no DIN) in animals - the use of bulk pharmaceutical substances (with no DIN), also called Active Pharmaceutical Ingredients (APIs), which have been formulated by compounding or administered as is".[[https://www.canada.ca/en/health-canada/services/drugs-health-products/veterinary-drugs/extra-label-drug-use/questions-answers-health-canada-policy-extra-label-drug-use-eldu-food-producing-animals.html#q20 | Health Canada]] ---- === Extra-label use (ELDU), VERSION OF THE GLOSSARIUM === Actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labelling. This includes, but is not limited to: - use in species not listed in the labelling - use for indications (disease or other conditions) not listed in the labelling - use at dosage levels, frequencies, or routes of administration other than those stated in the labelling - deviation from the labeled withdrawal time based on these different uses.[[https://cdpq02.ca/DOMglossarium/docs/glossary_cvma_pugs_2008.pdf | CVMA (PUGS 2008)]]