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en:extra:extra_instructio_ex



Extra-label use (ELDU), VERSION OF THE GLOSSARIUM



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“. Health Canada

en/extra/extra_instructio_ex.txt · Last modified: by 127.0.0.1