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refer to the label on the immediate container and package and other printed materials that are made available with the veterinary drug and product at the time of purchase and/or where the veterinary drug and product is used, such as the outer wrapper cartons, leaflet/package insert accompanying the product, which provide the accurate and necessary detailed information for the identification and proper use of the veterinary drug and product.
Labeling materials
refer to any substance, including biological products, applied or administered to food producing, companion, aquatic, laboratory and exotic animals. Whether used for therapeutic prophylactic or diagnostic purposes or for modification of physiological functions or behavior.
Veterinary Drug and products
refers to the proprietary/trade name assigned to the veterinary drug and products by the veterinary drug and product establishment.
Brand Name
refers to the identification of veterinary drugs and products by their scientifically and internationally recognized active ingredient as determined by the Bureau of Food and Drugs of the DOH/Bureau of Animal Industry of the DA. In case of feed products containing veterinary drugs and products, generic name refers to the internationally recognized technical name of the feeds as determined by the Bureau of Animal Industry of the Department of Agriculture.
Generic Name
refers to the classification and listings of the veterinary drug and product.
Philippine National Veterinary Drug Formulary
refers to the name(s) and amount(s) of ingredients per unit quantity expressed in the metric system.
Formulation
refers to the approved clinical and non-clinical use of the veterinary drug and product in terrestrial and aquatic animals based on substantial scientific evidence of the safety and efficacy in the given dosage form.
Indication
refers to the pharmaceutical form of the preparation based on an official pharmacopoeia.
Dosage form
refers to the site and manner by which the product is to be introduced to animal.
Mode of Administration
refers to statements regarding the withdrawal period of the product before the animal is slaughtered for food and/or the occurrence of potential hazard and side effects associated with the use of the product and the limitation of its use.
Warning
refer to statements of conditions under which veterinary drug and product should not be used.
Contraindications
refers to the instructions and special procedures required in the use and handling of the veterinary drug and product to avoid undesired effects and to ensure the safety and effective use of the veterinary drugs and products.
Caution
refers to a specific substance or combination of substances that would counteract the effect of any undue reaction and overdosage.
Antidote
refers to any distinctive combination of letters and/or numbers assigned to a particular batch.
Batch Number