Jun 27, 2016 13:46
7 yrs ago
1 viewer *
English term

overfill

English to Turkish Science Medical (general)
Based on the target manufacturing fill volume for XXXX IV 500 mg/50 mL vials, overfill is 1 mL.

Proposed translations

+1
5 mins
Selected

eksez doz

Formülasyondaki fazla doz miktarı.

Bkz: http://thsk.gov.tr/dosya/murat.dogan/476_ilan_.pdf

Bkz: http://www.ilacrehberi.com/v/messina-combi-12-mcg-200-mcg-in...

Bkz: http://ruhsat.orkestra.com.tr/htmldocs/ruhsat/icerik2059/ort...

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Note added at 20 mins (2016-06-27 14:07:06 GMT)
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Şu linkte açıklaması var. Overfill bir üretim hatası veya yanlışlıkla olan birşey değil. Formülasyonda kasten yapılır ve doğru dozaj için bazen gereklidir.

Bkz: https://www.aana.com/resources2/professionalpractice/Documen...

As noted in the FDA guidance, USP General Chapter <1> allows for some overfill to provide sufficient amounts for the correct dosage of the medication or biologic to be properly prepared for administration.
However, excessive volumes in single-dose/single-use vials have on occasion contributed to bloodborne illness transmission because overfill volumes were pooled to obtain additional doses. AANA supports limiting the amount of recommended overfill to the volumes prescribed in USP General Chapter <1>, as this will discourage pooling and sharing of single-dose/single-use vials.

* FDA'nın bir kılavuzunda bu konudan bahsediliyor şu linkte:

http://www.raps.org/Regulatory-Focus/News/2015/06/24/22756/F...

Liquid products must often be administered through an intermediary device, such as a syringe. Unlike a solid pharmaceutical tablet, which contains the full dose of the product in solid form, a vial of liquid product usually contains more than the recommended dose.

That occurs because it may be difficult or impossible to remove 100% of the contents from the vial. For example, a vial which contains a recommended dose of 1 mL may have 1.1 mL of liquid product to ensure that a syringe can withdraw a 1 mL dose, since some product will remain as residue on the wall of the vial

- See more at: http://www.raps.org/Regulatory-Focus/News/2015/06/24/22756/F...
Peer comment(s):

agree Salih YILDIRIM
13 hrs
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4 KudoZ points awarded for this answer. Comment: "teşekkürler, kulağa ne kadar tuhaf gelse de epey yaygın kullanıldığını gördüm."
+1
8 mins

fazlalık

bu cümle devamında bence gelebilecek karşılık bu.
fazlalık, fazla miktar, miktar fazlası gibi ifadeler önerimin alternatifleri.
Note from asker:
çok teşekkür ederim
Peer comment(s):

agree Salih YILDIRIM
13 hrs
Teşekkürler
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+1
10 mins

aşırı dolum

Burada ilaç doldurma prosesinden söz edildiğini düşünüyorum. 50 ml hacimdeki dolum için 1 ml hacmi tolerans değeri olarak belirlemişler. Yani 1 ml'ye kadar fazla dolum normal kabul edilebiliyor ama 1 ml ve fazlası aşırı dolum oluyor. Bu, sanırım üretim hatası olarak değerlendiriliyor.
Note from asker:
çok teşekkür ederim
Peer comment(s):

agree James Dirgin : tolerans miktari sounds the best [bu baglamda]
1 hr
Teşekkür ederim.
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