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English to Serbian translations [PRO]
Medical - Medical: Pharmaceuticals / veterinary medical products | | English term or phrase: adventitious agents | | 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. |
| | | (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 |
| Selected response from:
  Sladjana Daniels
Serbia
Local time: 16:57
| Grading comment Hvala!
4 KudoZ points were awarded for this answer |
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30 mins confidence:  
1 day14 hrs confidence: (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
| Sladjana Daniels
Serbia
Local time: 16:57
Specializes in field
Native speaker of:  Serbian
PRO pts in category: 20
|
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