2.1. Text Orientation
Print the pharmaceutical product name longitudinally, along the length of the ampoule. A good rule of thumb is: if the visible width of the label is less than the height of the label then the name should be printed longitudinally.
• The information listed below is the minimum and must be present on containers more than 10 ml (the small container exceptions apply to containers of 10 ml or less):
1. Pharmaceutical product name (brand name and nonproprietary name)
2. Expression of strength
3. Route of administration
4. Warnings, where important
5. Expiry date
6. Batch number
7. Marketing authorization holder
Figure 34
2.2. Labeling Methods
- Use paper labeling where possible, and ensure that the label does not wrap completely around the ampoule to allow for inspection of contents.
If ceramic or clear plastic labeling must be used, highlight key information by inverting the text color.
Keep information to a minimum and reduce overlapping with text from the reverse side as much as possible.
Labels should not come off in use and should be printed with ink that does not run when sprayed with alcohol to disinfect the ampoule surface in the pharmacy or during clinical procedures. Figure 35
- We recommend the addition of a peel-off label on ampoules or vials, which can be transferred to a syringe in practice, will help practitioners avoid selection errors. All syringes containing pharmaceutical products should be labeled if they leave the operator’s hands. Figure 36
2.3. Plastic Ampoules
• Use a clear font size.
• Information should be printed on paper label, if possible or direct on the ampoule with good contrast color.
• Use color to help to differentiate between products of the same company.
• Eliminate or reduce emphasis on the name of the container type such as ‘Plas-Amp’.
• Expiry dates and batch numbers should be easy-to-read and printed on the main body of the container, not on rip-off tabs.
• Where concentrations are shown, they should be expressed as total quantity in total volume (e.g., 20 mg per10 ml) as well as the per unit volume (e.g., 2 mg/ mL).
• Highlight the route of administration to avoid wrong route errors between products packed in plastic containers.