Ampoules are labeled by direct printing on the glass. For small-scale dispensing, a paper label is used and it should contain information such as the following:
- Strength expressed in terms of the amount of active ingredient in a suitable dose volume
- Name and concentration of any added substance
- Warning that a single-dose preparation should be discarded after use
- Special directions for preparation of a particular product, for example, powders for reconstitution prior to use and concentrated solutions for dilutions prior to use
- Expiry date
- Storage conditions
Preparations intended to be used as dialysis, hemofiltration or irrigation solutions should meet the standards for injections except that the label should bear a warning that the solution is not intended for intravenous infusion. Any injection containing particulate matter should be discarded. Injections prepared from chemically pure medicinal agents and stable at room temperature need not be stored under special conditions. However, all biologic products such as insulin injection, vaccines, toxoids, toxins and related products should be stored in a refrigerator.
Leave a Reply