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ispitivanje neškodljivosti
safety tests
Last Update: 2017-04-06
Usage Frequency: 1
Quality:
dokumentacija o neŠkodljivosti
safety documentation
Last Update: 2017-04-06
Usage Frequency: 1
Quality:
neklinički podaci o neškodljivosti
preclinical safety data
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
periodička izvječća o neškodljivosti lijeka
periodic safety update reports
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
dokumentacija o neškodljivosti uključuje procjenu:
the safety documentation shall include an assessment of:
Last Update: 2017-04-06
Usage Frequency: 1
Quality:
zahtjevi u pogledu podataka o neŠkodljivosti
data set requirements for safety
Last Update: 2017-04-06
Usage Frequency: 1
Quality:
periodička izvješća o neškodljivosti (psur-evi)
periodic safety update reports (psurs)
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
ispitivanja neškodljivosti na reprodukciju mužjaka nisu provedena.
no safety study on the reproductive performance has been conducted in male rabbits (bucks).
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
ispitivanja neškodljivosti su pokazala da je soj siguran za pure.
safety trials have shown that the strain is safe for turkeys.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
ne postoje dostupni podaci o neškodljivosti u slučaju predoziranja.
no data are available on the safety of an overdose.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
podaci o neškodljivosti primjene na životinjama u laktaciji nisu dostupni.
no data is available on safety in lactating animals.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
itrakonazol ima općenito mali terapijski raspon neškodljivosti primjene u ptica.
itraconazole generally has a narrow margin of safety in birds.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
nema dostupnih informacija o neškodljivosti primjene ovog cjepiva u rasplodnih nerasta.
no information is available on the safety of this vaccine in breeding boars.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
nije nužno osigurati studije o neškodljivosti i djelotvornosti svake djelatne tvari.
it shall not be necessary to provide studies on the safety and efficacy of each active substance.
Last Update: 2017-04-06
Usage Frequency: 1
Quality:
ispitivanja neškodljivosti i povrata virulencije su pokazala da soj nije škodljiv za purane.
safety and reversion to virulence trials have shown that the strain is safe for turkeys.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
ne postoje dostupni podaci o neškodljivosti koji bi pokazali utjecaj cijepljenja na laktaciju.
no safety data are available to demonstrate the impact of vaccination on lactation.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
ne postoje dostupni podaci o neškodljivosti i djelotvornosti istodobne primjene ovog proizvoda s cjepivima.
no information is available on the safety and efficacy of the concurrent use of this product with vaccines.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
godišnja izvješća će se podnositi uz periodičko izvješće o neškodljivosti lijeka (psur).
annual reports will be submitted with the psur.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
na temelju općih ispitivanja neškodljivosti, neklinički podaci ne ukazuju na poseban rizik za ljude.
non-clinical data reveal no special hazard for humans based on general safety studies.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
ako je to primjenjivo, dostavljaju se podaci u pogledu mjesta proizvodnje i procjene neškodljivosti stranih tvari.
where applicable, information regarding the manufacturing sites and the safety evaluation of extraneous agents shall be provided.
Last Update: 2017-04-06
Usage Frequency: 1
Quality: