Study Set Content:
-Expressed in numerals and units as part of the product name for each active ingredient
STRENGTH
-(e.g. Number of tablets, ml of liquid)
TOTAL QUANTITY IN THE PACKAGE
As stated or agreed with the prescriber
INDIVIDUAL DOSAGE INSTRUCTIONS
This is applicable to both bulk dispensing or original packs
BATCH IDENTIFICATION
Expressed as “use before”. If the medicine has a limited shelf life once the package is opened, this should also be on the label
EXPIRY DATE
All excipients of medical relevance
LIST OF EXCIPIENTS
For example “Do not chew”, “Take with a meal”
ANY SPECIAL INSTRUCTIONS FOR USE
For example, “Store between 2-8 ° C, “Keep of sunlight
ANY SPECIAL STORAGE INSTRUCTIONS
For example, “ Do not drink Alcohol”, “This may make you feel sleepy
ANY SPECIAL WARNINGS OR PRECAUTIONS
To reduce medication errors
To reduce medication errors
MINIMUM LABELLING-GSD
FIP considers it necessary to define an absolute minimum of information for labels of prescribed medicines as follows:
Generic name
Strength of medicine
Individual Dosage Instructions
The route of administration should be stated if other than oral. This absolute minimum of information termed
GSD.
DESIGN AND READABILITY
o On individual patient prepacks, the design of manufacturer’s label should allow the addition of the pharmacy label without covering
mportant patient information.
should be adjacent to each other so that they can be read at a glance and should not be distributed amongst the remaining text.
Primary patient information elements
There should be a (blank) reserved for primary patient information with a clear blank space for the pharmacy label.
“patient side”
Any information that is not primary information should appear on the
other sides of the container
Pharmacy labels should be
printed or typewritten.
Print size should be a minimum
Print size should be a minimum
The printshould not fade when exposed to water or sunlight. Manufacturers’ labels should fulfil established criteria for
good readability
should not be used, especially for the indications for use and dosage instructions.
Abbreviations and unfamiliar expressions
