Labelling of medicines
Overage, tolerance, overfill
Overages and deviations from declared values. Vials, ampoules, perfusion bags, etc usually have an overage (to make it possible to obtain the stated content). There is neither regulation nor tradition for specifying this overfill, despite it being relevant in situations like reconstitution and preparing partial doses.
From a medical point of view , it is usually the size of the deviation that is important, not whether it is positive or negative. What tolerance regulatory authorities accept will depend on processes and technology available, and on the importance of accuracy in the therapeutic situation.
I do not know, but it would surprise me if overage (biased composition) of a final medicinal product is accepted. But I know several examples of overfill.
*Perfusion solutions in plastic bags. Overfill partly to compensate for water loss by diffusion. They should give the specified volume also after three year storage. Overfill also to compensate for residual volume in bag and infusion equipment.
*Overfill in ampoules and vials to ensure that it is possible to extract the declared amount by the most usual method (syringe and canulla). The overfill becomes an overdose if all the content is extracted, which is the case when a transfer needle adapter is used. The relative overfill will be greater for smaller containers. The intended overfill is never(?) indicated on the label. I only know one exception of that: Taxotere has an overfill of 14%, which is indicated in small print on the package insert. The indication in very large fonts on the container and the cartoon, gives the amount without the overfill. There are at least twentyone reported cases of exessive doses of Taxotere in US, and I know the same error has been done in two hospital pharmacies in Norway.
I strongly feel that the degree of overfill ought to be declared on the label or the package insert.
last revision 01052002