Glossary entry (derived from question below)
English term or phrase:
adventitious agents
Serbian translation:
(slučajni) mikrobiološki kontaminanti
Added to glossary by
Marina Nedeljković
Dec 8, 2011 18:19
12 yrs ago
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English term
Serbia
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adventitious agents
English to Serbian
Medical
Medical: Pharmaceuticals
veterinary medical products
The submission of data on each individual active substance, in conjunction with the required user safety studies, residues depletion studies and clinical studies on the fixed combination product, may be considered a suitable justification for omitting data on the combination product, based on animal welfare grounds and unnecessary testing on animals, unless there is suspected interaction leading to added toxicity. Where applicable, information regarding the manufacturing sites and the safety evaluation of adventitious agents shall be provided.
Proposed translations
(Serbian)
| 3 | (slučajni) mikrobiološki kontaminanti |
Sladjana Daniels
|
| 1 | sporedni agensi |
holland22
|
Proposed translations
1 day 14 hrs
Sladjana Daniels
Serbia
Serbia
Native in Serbian
Specializes in field
Serbia
Perfect blend of medicine and languages
Native in: Serbian
Works in: English to Serbian, Serbian to English
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Selected
(slučajni) mikrobiološki kontaminanti
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
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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