adventitious agents

Serbian translation: (slučajni) mikrobiološki kontaminanti

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:adventitious agents
Serbian translation:(slučajni) mikrobiološki kontaminanti
Entered by: Marina Nedeljković

18:19 Dec 8, 2011
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.
Marina Nedeljković
Serbia
Local time: 17:03
(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: 17:03
Grading comment
Hvala!
4 KudoZ points were awarded for this answer



Summary of answers provided
3(slučajni) mikrobiološki kontaminanti
Sladjana Daniels
1sporedni agensi
holland22


  

Answers


30 mins   confidence: Answerer confidence 1/5Answerer confidence 1/5
sporedni agensi


Explanation:
off the top of my head

holland22
Local time: 17:03
Native speaker of: Native in SerbianSerbian
Login to enter a peer comment (or grade)

1 day 14 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
(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: 17:03
Specializes in field
Native speaker of: Serbian
PRO pts in category: 36
Grading comment
Hvala!
Login to enter a peer comment (or grade)



Login or register (free and only takes a few minutes) to participate in this question.

You will also have access to many other tools and opportunities designed for those who have language-related jobs (or are passionate about them). Participation is free and the site has a strict confidentiality policy.

KudoZ™ translation help

The KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.


See also:
Term search
  • All of ProZ.com
  • Term search
  • Jobs
  • Forums
  • Multiple search