Multi-dose vial: difference between revisions
Diff·revision 47 → 48·22:34, 3 Dec 2025
Difference between revision 47 and revision 48 of Multi-dose vial. 7 lines changed; the page grew by 689 bytes.
| Revision 47 — 20:54, 25 Nov 2025 NPOV_Nadia (talk) rm unsourced claim per PP:V 22,548 bytes ±0 | Revision 48 — 22:34, 3 Dec 2025 UACR_Ulric (talk) move unsourced paragraph to talk 23,237 bytes +689 | ||
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| 123 | Community practice, as collated on this wiki, generally assigns a period of about 28 days to a vial reconstituted with bacteriostatic water and a much shorter period to one reconstituted with unpreserved diluent, and stores both refrigerated. That practice is consistent with the compendial framework in shape, but it rests on an analogy rather than on data for any specific preparation, and no sterility or preservative-effectiveness testing of such preparations has been published. The reports are self-selected and record no adverse outcome, which is a weak endpoint given that the outcome of concern is uncommon.{{r|ppmdv}} | 123 | Community practice, as collated on this wiki, generally assigns a period of about 28 days to a vial reconstituted with bacteriostatic water and a much shorter period to one reconstituted with unpreserved diluent, and stores both refrigerated. That practice is consistent with the compendial framework in shape, but it rests on an analogy rather than on data for any specific preparation, and no sterility or preservative-effectiveness testing of such preparations has been published. The reports are self-selected and record no adverse outcome, which is a weak endpoint given that the outcome of concern is uncommon.{{r|ppmdv}} |
| 124 | 124 | ||
| + | 125 | {{seealso|Beyond-use date|Bacteriostatic water|Sterility testing}} | |
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| + | 127 | == Labelling and records == | |
| + | 128 | A multiple-dose container's label carries information that a single-dose container's does not, and its absence changes the container's status. | |
| + | 129 | ||
| + | 130 | The preservative and its concentration must be declared, because the presence of a preservative is a use-relevant property and because some preservatives are contraindicated in particular populations — benzyl alcohol in neonates being the standard example. The label also carries the statement identifying the container as multiple-dose, and where the manufacturer specifies an in-use period shorter than 28 days, that period.{{r|usp659,usp797}} | |
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| 125 | == References == | 132 | == References == |
| 126 | {{reflist}} | 133 | {{reflist}} |