Def Of Terms: Labellin Materials Flashcards
Pharmaceutical or biological product intended for use in the diagnosis, cure and treatment
Product
Includes the label on the immediate container, and the other printed materials that are made available w the product
Labelling materials
Brand name
Propriety or trade name assigned to the product
Identification of drugs or medicine by their scientifically and internationally recognized active ingredient
Generic name
Classification of the prod based on its therapeutic action
Pharmacologic category
Names and amount of active ingredient per dosage unit
Formulation
Approved clinical use of the prod
Indication
Pharmaceutical form of the preparation
Dosage form
Site and manner the product is to be applied
Mode of administration
Statements regarding the occurrence and potential hazards
Warnings
Conditions wherein the product may cause harm to the patient
Contraindications
Instructions and special care required in the use of the prod
Precautions
Date w/c the processing of the bulk product is completed
Date of manufacturer
Distinctive letters / nos assigned to a specific lot
Lot number
Distinctive combination of nos and letters to a particular batch
Batch number
Date after wc the product is no longer effective
Expiry date
Total amount/quantity/no of dosage form in a certain container
Net amount
Prevailing specified range of temp, etc
Storage conditions
Part of the label that is displayed, presented or examined for retail sale
Principal display panel
Are where the principal panel is located
Area of principal panel display
First pack containing the individually wrapped products, strip or blister packs
Primary pack
