GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW) | ||||||
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18:19 Dec 8, 2011 |
English to Serbian translations [PRO] Medical - Medical: Pharmaceuticals / veterinary medical products | |||||||
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| Selected response from: Sladjana Daniels Serbia Local time: 17:03 | ||||||
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Summary of answers provided | ||||
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3 | (slučajni) mikrobiološki kontaminanti |
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1 | sporedni agensi |
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sporedni agensi Explanation: off the top of my head |
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(slučajni) mikrobiološki kontaminanti Explanation: Predlog, mislim da ne postoji ustaljeni termin. In medicine, adventitious and related words such as adventitia refer in various senses to the basic meanings associated with the Latin root advenire. Typically the general intention is to convey something like: of the nature of a later addition from without, accidental, casual. http://en.wikipedia.org/wiki/Adventitiousness Adventitious agents are microorganisms that have been unintentionally introduced into the manufacturing process of a biological product. Include bacteria, fungi, mycoplasmas, rickettsia, protozoa, parasites, TSE agents, and viruses. For a substance to be free of an adventitious agent, assays must demonstrate that a defined quantity of a vaccine is negative for that agent at a defined level of sensitivity. www.fda.gov/downloads/AdvisoryCommittees/.../UCM211995.ppt Tiomersal sprečava kontaminaciju vakcine mikroorganizmima. http://www.pharmamedica.rs/images/prelistavanje/3/phm.06.swf (Test mikrobiološke čistoće) Određivanje se izvodi pod uslovima koji izbegavaju slučajne kontaminacije proizvoda koji se ispituje. KONTAMINACIJA FARMACEUTSKIH PROIZVODA Kontaminanti su najčešće nepatogene komensalne bakterije ili gljivice iz okruženja koje mogu izazivati oportunističke infekcije kod imunokompromitovanih bolesnika. Ređe su prisutni patogeni mikroorganizmi. Izvor kontaminacije je osoblje koje radi u procesu proizvodnje i/ili distribucije leka (fiziološka flora kože ili sluzokoža ili patogeni mikroorganizmi) ili sredina (vazduh, voda, aparatura) u kojoj se ove aktivnosti odvijaju. supa.pharmacy.bg.ac.rs/assets/8431 https://docs.google.com/viewer?a=v&q=cache:WstimxKsYZMJ:supa... Posebno su definisani mikrobiološki kontaminanti, a posebno hemijski i fizički kontaminanti. http://www.cqm.rs/2008/pdf/3/21.pdf |
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