Pharmaceutical Labeling Flashcards
This includes the label on the immediate container, and the other printed materials that are made available with the product at the time of purchase and/or where the 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 used of the product
Labeling materials
Refers to pharmaceutical products which mean any pharmaceutical or biological product intended for used in the diagnosis, cure mitigation, treatment or prevention of disease in human, or to affect the structure or any function of the human body.
Product
refers to the proprietary/trade name assign to the product by the drug establishment.
Brand name
refers to the identification of drugs and medicines by their scientifically and internationally recognized active ingredients determined by the Bureau of Food and Drugs of the DOH.
Generic Name
refers to the classification of the product based on its therapeutic action as specified in the product registration.
Pharmacologic Category
refers to the name (s) and amount (s) of active medicinal ingredients per dosage unit expressed in the metric system.
Formulation
refers to the approved clinical use of the product based on substantial and scientifically supported evidence of the safety and efficacy of the drug in the given dosage form.
Indication
means the pharmaceutical form of the preparation based on official pharmacopoeia.
Dosage Form
refers to the site and manner the product is to be introduced in to or applied on the body.
Mode of Administration
refers to statements regarding the occurrence of potential hazards and side effects associated with the use of the product and the limitation of its use.
Warnings
refers to statements regarding the conditions wherein the use of the product may cause harm to the patient.
Contraindications
refers to the instruction and special care required in the used of the product to avoid undesired effects and to ensure the safe and effective use of the drug.
Precautions
for products other than biological products means the date (month and year) during which processing of the bulk product, from which the goods are to be filled, is completed.
Date of Manufacturer
refers to any distinctive combination of letters and/or numbers, assigned to a particular batch herein defined as any product produced during a given cycle of manufacture. The batch number permits the production history of the batch including all stages of manufacture and control, to be traced and reviewed.
Batch Number
refers to any distinctive combinations of letters and/or numbers assigned to a particular lot, herein defined as a portion of a batch.
Lot Number
