33.有關單一劑量(single-dose)包裝注射劑與多劑量(multiple-dose)包裝注射劑之要求,下列敘述何者正確?
(A)單一劑量包裝注射劑內須含有防腐劑
(B)單一劑量包裝注射劑於容器開啟後,即使有足夠化學安定性,也須於24小時內使用
(C)多劑量包裝注射劑內因含有防腐劑,於首次抽取藥品後若還有剩餘量,可繼續使用至原包裝所標示之有效日 期
(D)多劑量包裝注射劑於首次使用時,須於容器上標示首次使用日期或開封後之使用期限
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統計: A(20), B(640), C(91), D(4548), E(0) #2039070
統計: A(20), B(640), C(91), D(4548), E(0) #2039070
詳解 (共 5 筆)
#5559888
單一劑量容器(非安剖瓶)在比ISO class5差的環境調製 Opened orn needle-punctured single-dose containers, such as bags, bottles, syringes, andn vials of sterile products and CSPs shall be used within 1 hour if opened inn worse than ISO Class 5 air quality. | 1小時 |
單一劑量容器(非安剖瓶)在ISO class5的環境調製 Single-dosen vials exposed to ISO Class 5 (see Table 1) or cleaner air may be used up to 6n hours after initial needle puncture. | 6小時 |
單一劑量容器(安剖瓶) Opened single-dose ampuls shall not be stored for any timen period. | 馬上用 |
多劑量容器(通常會添加防腐劑) The beyond-use date for an opened or entered (e.g., needle-punctured) multiple-dose containers with antimicrobial preservatives is 28 days | 28天 |
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