Multi-dose vial: difference between revisions
Diff·revision 49 → 50·21:05, 24 Dec 2025
Difference between revision 49 and revision 50 of Multi-dose vial. 2 lines changed; the page grew by 408 bytes.
| Revision 49 — 19:57, 15 Dec 2025 LyophilLena (talk) expand §Repeated entry: coring and closure integrity 23,237 bytes ±0 | Revision 50 — 21:05, 24 Dec 2025 A1c_Alder (talk) replace primary source with the review 23,645 bytes +408 | ||
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| 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}} | 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 | 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 | ||
| 132 | == References == | 134 | == References == |
| 133 | {{reflist}} | 135 | {{reflist}} |