Multi-dose vial: difference between revisions
Diff·revision 21 → 22·16:22, 17 Dec 2025
Difference between revision 21 and revision 22 of Multi-dose vial. 7 lines changed; the page grew by 1,029 bytes.
| Revision 21 — 23:15, 26 Nov 2025 GastroparesisGwen (talk) expand §Repeated entry: coring and closure integrity 22,676 bytes +68 | Revision 22 — 16:22, 17 Dec 2025 DeadSpaceDot (talk) add the cross-link to the calculator page 23,705 bytes +1,029 | ||
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| 125 | {{seealso|Beyond-use date|Bacteriostatic water|Sterility testing}} | 125 | {{seealso|Beyond-use date|Bacteriostatic water|Sterility testing}} |
| 126 | 126 | ||
| + | 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}} | |
| + | 131 | ||
| + | 132 | The date of first puncture is a record created by the user rather than by the manufacturer, and the entire dating framework depends on it. Guidance therefore treats annotation of the container at first entry as the mechanism by which the rule is enforceable, since a vial with no such annotation cannot be shown to be within its period and is to be discarded on that ground alone.{{r|usp797,cdc_injection}} | |
| + | 133 | ||
| 127 | == References == | 134 | == References == |
| 128 | {{reflist}} | 135 | {{reflist}} |