overfill
Turkish translation: eksez doz
| 13:46 Jun 27, 2016 |
| English to Turkish translations [PRO] Science - Medical (general) | |||||||
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|  Selected response from: Tuncay Kurt Türkiye Local time: 11:53 | ||||||
Grading comment
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| Summary of answers provided | ||||
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| 5 +1 | fazlalık |
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| 3 +1 | aşırı dolum |
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| 3 +1 | eksez doz |
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Answers
8 mins confidence: 
peer agreement (net): +1
peer agreement (net): +1fazlalık Explanation: bu cümle devamında bence gelebilecek karşılık bu. fazlalık, fazla miktar, miktar fazlası gibi ifadeler önerimin alternatifleri. |
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10 mins confidence: 
peer agreement (net): +1
peer agreement (net): +1aşırı dolum Explanation: 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. |
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5 mins confidence: peer agreement (net): +1
peer agreement (net): +1eksez doz Explanation: 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... -------------------------------------------------- Note added at 20 mins (2016-06-27 14:07:06 GMT) -------------------------------------------------- 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... Reference: http://www.s2ys.com/monodoks-100-mg-14-kapsul/ Reference: http://www.acikarsiv.gazi.edu.tr/index.php?menu=2&secim=10&Y... |
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