FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: If substantial exposure of the user of the medicinal product is anticipated, for example by inhalation or dermal contact, these routes should be studied.
Slovenian: Če pričakujemo, da bo uporabnik zdravila znatno izpostavljen, na primer z vdihavanjem ali preko kože, moramo te načine preučiti.
English: In order to reduce the number and suffering of the animals involved, new protocols for single dose toxicity testing are continually being developed.
Slovenian: Da bi zmanjšali število živali, vključenih v te študije ter njihovo trpljenje, je treba razvijati nove protokole za preskušanje toksičnosti enkratnega odmerka.
English: Studies carried out in accordance with these new procedures when properly validated will be accepted, as well as studies carried out in accordance with established internationally recognized guidelines.
Slovenian: Študije, ki se izpeljejo v skladu s temi novimi postopki se sprejmejo potem, ko se ustrezno validirane, prav tako pa tudi študije, izvedene v skladu z dobro uveljavljenimi mednarodno priznanimi navodili.
English: Repeated-dose toxicity
Slovenian: Toksičnost pri ponovljenih odmerkih
English: Repeated-dose toxicity tests are intended to reveal any physiological and/or pathological changes induced by repeated administration of the active substance or combination of active substances under examination, and to determine how these changes are related to dosage.
Slovenian: Preskusi toksičnosti pri ponovljenih odmerkih so namenjeni odkrivanju fizioloških in/ali patoloških sprememb, ki jih povzroča ponavljajoče dajanje zdravilne učinkovine ali kombinacije zdravilnih učinkovin, ki se preučujejo, ter določanje povezav med spremembami in odmerki.
English: In the case of substances or medicinal products intended solely for use in non food-producing animals, a repeated dose toxicity study in one species of experimental animal will normally be sufficient.
Slovenian: V primeru snovi ali zdravil, ki se uporabljajo izključno za uporabo pri živalih, ki niso namenjene za proizvodnjo živil, ponavadi zadostuje študija toksičnosti pri ponovljenih odmerkih na eni eksperimentalni živalski vrsti.
English: This study may be replaced by a study conducted in the target animal.
Slovenian: To študijo se lahko nadomesti s študijo, ki se izvede na ciljni živali.
English: The frequency and route of administration, and the duration of the study should be chosen having regard to the proposed conditions of clinical use.
Slovenian: Pogostost in način dajanja ter trajanje študije je treba izbrati glede na predlagane pogoje klinične uporabe.
English: The investigator shall give his reasons for the extent and duration of the trials and the dosages chosen.
Slovenian: Raziskovalec mora podati razloge za obseg in trajanje poskusov ter izbrane odmerke.
English: In the case of substances or medicinal products intended for use in food producing animals, the study should be conducted in at least two species, one of which should be a non-rodent.
Slovenian: V primeru snovi ali zdravil, namenjenih za uporabo pri živalih za proizvodnjo živil, je treba študijo izvesti na najmanj dveh živalskih vrstah, od katerih ena ne sme biti glodalec.
English: The investigator shall give his reasons for the choice of species, having regard to the available knowledge of the metabolism of the product in animals and man.
Slovenian: Raziskovalec mora podati svoje razloge za izbor živalskih vrst, glede na dostopno znanje o metabolizmu proizvoda pri živalih in človeku.
English: The test substance shall be administered orally.
Slovenian: Preskušano snov je treba dajati peroralno.
English: The duration of the test shall be at least 90 days.
Slovenian: Poskušanje mora trajati najmanj 90 dni.
English: The investigator shall clearly state and give his reasons for the method and frequency of administration and the length of the trials.
Slovenian: Raziskovalec mora jasno opredeliti razloge za izbor metode in pogostosti dajanja snovi ter dolžino poskusa.
English: The maximum dose should normally be selected so as to bring harmful effects to light.
Slovenian: Največji odmerek je normalno treba izbrati zato, da bi osvetlili škodljive učinke.
English: The lowest dose level should not produce any evidence of toxicity.
Slovenian: Najnižja stopnja odmerka ne sme izzvati nobenega dokaza toksičnosti.
English: Evaluation of the toxic effects shall be based on observation of behaviour, growth, haematology and physiological tests, especially those relating to the excretory organs, and also on autopsy reports and accompanying histological data.
Slovenian: Ocena toksičnih učinkov mora temeljiti na opazovanju obnašanja, rasti, hematoloških in fizioloških preskusih, posebno tistih, ki se nanašajo na organe izločanja, ter na poročilih o raztelesbi ter spremljajočih histoloških podatkih.
English: The choice and range of each group of tests depends on the species of animal used and the state of scientific knowledge at the time.
Slovenian: Izbor ter obseg preskusov za vsako skupino je odvisen od vrste živali ter stopnje znanstvenih dognanj v tem času.
English: In the case of new combinations of known substances which have been investigated in accordance with the provisions of this Directive, the repeated-dose tests may, except where toxicity tests have demonstrated potentiation or novel toxic effects, be suitably modified by the investigator, who shall submit his reasons for such modifications.
Slovenian: V primeru novih kombinacij znanih snovi, ki so bile raziskane v skladu z določili te direktive, lahko raziskovalec preskuse pri ponovljenih odmerkih, razen če so preskusi toksičnosti izkazali potenciranje novih toksičnih učinkov, primerno prilagodi, mora pa navesti razloge za prilagoditve.
English: Tolerance in the target species
Slovenian: Toleranca pri ciljnih živalskih vrstah
English: Details should be provided of any signs of intolerance which have been observed during studies conducted in the target species in accordance with the requirements of Part 4, Chapter I, Section B. The studies concerned, the dosages at which the intolerance occurred and the species and breeds concerned should be identified.
Slovenian: Predložiti je treba podrobnosti o vsakršnih znakih netolerance, opaženih med študijami na ciljnih živalskih vrstah, ki so bile izveden v skladu, z zahtevami oddelka B dela 4 poglavja 1. Treba je navesti zadevne študije, odmerke, pri katerih se je pojavila netoleranca, živalsko vrsto ter pasmo.
English: Details of any unexpected physiological changes should also be provided.
Slovenian: Treba je navesti podatke o nepričakovanih fizioloških spremembah.
English: Reproductive toxicity including teratogenicity
Slovenian: Reproduktivna toksičnost vključno z teratogenostjo
English: Study of the effects on reproduction
Slovenian: Študije učinkov na reprodukcijo
English: The purpose of this study is to identify possible impairment of male or female reproductive function or harmful effects on progeny resulting from the administration of the medicinal products or substance under investigation.
Slovenian: Namen te študije je identificirati možno prizadetost reproduktivne funkcije pri samcih ali samicah ali škodljive učinke na potomcih, ki so posledica dajanja zdravila ali snovi, ki je v postopku raziskave.
English: In the case of substances or medicinal products intended for use in food-producing animals, the study of the effects on reproduction shall be carried out in the form of a two-generation study on at least one species, usually a rodent.
Slovenian: V primeru snovi ali zdravil, ki so namenjeni za živali za proizvodnjo živil, je treba izvesti raziskavo učinkov na reprodukcijo in sicer v obliki dvo-generacijskih študij na najmanj eni živalski vrsti, ponavadi na glodalcu.
English: The substance or product under investigation shall be administered to males and females at an appropriate time prior to mating.
Slovenian: Snov, ali proizvod, ki ga raziskujemo, je treba dajati samcem in samicam v primernem času pred parjenjem.
English: Administration should continue until the weaning of the F2 generation.
Slovenian: Dajanje zdravila je treba nadaljevati do odstavitve generacije F2.
English: At least three dose levels shall be used.
Slovenian: Treba je dati najmanj tri stopnje odmerkov.
English: The maximum dose should be selected so as to bring harmful effects to light.
Slovenian: Največji odmerek je treba izbrati tako, da se pokažejo škodljivi učinki.
English: The lowest dose level should not produce any evidence of toxicity.
Slovenian: Najnižji nivo odmerka ne sme izkazovati nobenega znaka toksičnosti.
English: Evaluation of the effects on reproduction shall be based upon fertility, pregnancy and maternal behaviour;
Slovenian: Ocena učinkov na reprodukcijo mora temeljiti na plodnosti, brejosti ter materinskem obnašanju samice;
English: the suckling, growth and development of the F1 offspring from conception to maturity;
Slovenian: sesanju, rasti ter razvoju F1 potomcev od spočetja do zrelosti;
English: the development of the F2 offspring to weaning.
Slovenian: razvoju F2 potomcev do odstavitve.
English: Study of embryotoxic/fetotoxic effects including teratogenecity
Slovenian: Študije embriotoksičnih/fetotoksičnih učinkov vključno s teratogenostjo
English: In the case of substances or medicinal products intended for use in food producing animals, studies of embryotoxic/fetotoxic effects, including teratogenicity, shall be carried out.
Slovenian: V primeru snovi ali zdravil, namenjenih za uporabo pri živalih za proizvodnjo živil, je treba izvesti študije učinkov embriotoksičnosti/fetotoksičnosti, vključno s teratogenenostjo.
English: These studies shall be carried out in at least two mammalian species, usually a rodent and the rabbit.
Slovenian: Te študije je treba izvesti najmanj na dveh vrstah sesalcev, ponavadi na glodalcu in na kuncu.
English: The details of the test (number of animals, doses, time at which administered and criteria for the evaluation of results) shall depend on the state of scientific knowledge at the time the application is lodged and the level of statistical significance which the results should attain.
Slovenian: Podrobnosti testa (število živali, odmerki, čas dajanja zdravila ter merila za oceno rezultatov) so odvisni od stanja znanstvenega napredka v času vlaganja vloge ter od ravni statistične značilnosti, ki jih morajo rezultati dosegati.
English: The rodent study may be combined with the study of effects on reproductive function.
Slovenian: Študije na glodalcu se lahko kombinirajo s študijo o učinkih na reproduktivno funkcijo.
English: In the case of substances or medicinal products which are not intended for use in food producing animals, a study of embryotoxic/fetotoxic effects, including teratogenicity, shall be required in at least one species, which may be the target species, if the product is intended for use in animals which might be used for breeding.
Slovenian: V primeru snovi ali zdravil, ki niso namenjeni uporabi za živali za proizvodnjo živil, se zahteva študija embriotoksičnih/fetotoksičnih učinkov, vključno s teratogenenostjo na vsaj eni živalski vrsti, ki je lahko ciljna živalska vrsta, če je proizvod namenjen uporabi za živali, ki se bo morda uporabljala za vzrejo.
English: Mutagenicity tests are intended to assess the potential of substances to cause transmissible changes in the genetic material of cells.
Slovenian: Preskusi mutagenosti so namenjeni oceni potenciala snovi, ki v genetskih materialih celic povzročajo prenosljive spremembe.
English: Any new substance intended for use in veterinary medicinal products must be assessed for mutagenic properties.
Slovenian: Vsako novo snov, ki je namenjena uporabi v zdravilu je treba oceniti z vidika mutagenih lastnosti.
English: The number and types of tests and the criteria for the evaluation of the results shall depend on the state of scientific knowledge when the application is submitted.
Slovenian: Število in vrste preskusov ter merila za oceno rezultatov morajo biti odvisni od stanja znanstvenih dosežkov v času, ko je vloga vložena.
English: Long term animal carcinogenicity studies will usually be required for substances to which human beings will be exposed
Slovenian: Študije o dolgoročni karcinogenosti pri živalih se ponavadi zahtevajo za tiste snovi, ki jim bodo izpostavljeni ljudje, t.j. tiste
English: which have a close chemical analogy with known carcinogens,
Slovenian: ki so kemijsko analogno blizu znanim karcinogenim snovem,
English: which during mutagenicity testing produced results indicating a possibility of carcinogenic effects,
Slovenian: ki med preskusom mutagenosti dajejo rezultate, ki nakazujejo na možnost karcinogenih učinkov,
English: which have given rise to suspect signs during toxicity testing.
Slovenian: pri katerih je povečano število sumljivih znakov med poskusom toksičnosti.
English: The state of scientific knowledge at the time the application is submitted shall be taken into account when designing carcinogenicity studies and evaluating their results.
Slovenian: Pri načrtovanju študije karcinogenosti in pri ovrednotenju rezultatov je treba upoštevati stanje znanstvenega napredka v času, ko je bila vloga vložena.
English: Exceptions
Slovenian: Izjeme
English: Where a medicinal product is intended for topical use, systemic absorption shall be investigated in the target species of animal.
Slovenian: V primeru, da je proizvod namenjen za lokalno uporabo, je treba preučiti sistemsko absorpcijo pri ciljni živalski vrsti.
English: If it is proved that systemic absorption is negligible, the repeated dose toxicity tests, the tests for reproductive toxicity and the carcinogenicity tests may be omitted, unless:
Slovenian: Če je dokazano, da je sistemska absorpcija zanemarljiva, lahko izpustimo preskus toksičnosti pri ponovljenih odmerkih, preskus o reproduktivni toksičnosti ter preskus karcinogenosti, razen če:
English: under the conditions of use laid down, oral ingestion of the medicinal product by the animal is to be expected, or
Slovenian: se pod pogoji predpisane uporabe pri živali lahko pričakuje, da žival zdravilo zaužije skozi usta, ali
English: the medicinal particular may enter foodstuffs obtained from the treated animal (intramammary preparations).
Slovenian: bi lahko farmacevtska snov prišla v živilo, pridobljeno iz zdravljene živali (intramamarni pripravki)
English: Other requirements
Slovenian: Ostale zahteve
English: Immunotoxicity
Slovenian: Imunotoksičnost
English: Where the effects observed during repeated dose studies in animals include specific changes in lymphoid organ weights and/or histology and changes in the cellularity of lymphoid tissues, bone marrow or peripheral leukocytes, the investigator shall consider the need for additional studies of the effects of the product on the immune system.
Slovenian: Če učinki, ki smo jih opazili med študijami ponovljenih odmerkov pri živalih kažejo na specifične spremembe v teži pri limfnih organih in/ali histološke spremembe v celičnosti limfnih tkiv, kostnega mozga ali periferih levkocitih, mora raziskovalec razmisliti o potrebi po dodatnih študijah učinkov proizvoda na imunski sistem.
English: The state of scientific knowledge at the time the application is submitted shall be taken into account when designing such studies and evaluating their results.
Slovenian: Pri načrtovanju takih študij ter oceni rezultatov je treba upoštevati stanje znanstvenega napredka v času, ko je bila vloga vložena.
English: Microbiological properties of residues
Slovenian: Mikrobiološke lastnosti zaostankov
English: Potential effects on the human gut flora
Slovenian: Potencialni učinki na črevesno floro človeka
English: The microbiological risk presented by residues of anti-microbial compounds for the human intestinal flora shall be investigated in accordance with the state of scientific knowledge at the time the application is submitted.
Slovenian: Mikrobiološko tveganje, ki ga za črevesno floro človeka predstavljajo zaostanki protimikrobnih spojin, je treba raziskati v skladu z nivojem znanstvenega napredka v tistem času, ko je bila vloga vložena.
English: Potential effects on the microorganisms used for industrial food processing
Slovenian: Potencialni učinki na mikroorganizme, ki se uporabljajo v industrijski predelavi hrane
English: In certain cases, it may be necessary to carry out tests to determine whether residues cause difficulties affecting technological processes in industrial foodstuff processing.
Slovenian: V nekaterih primerih je morda treba izvesti preskuse ali zaostanki povzročajo težave, ki imajo vpliv na tehnološke procese v industrijski predelavi živil.
English: Observations in humans
Slovenian: Opažanja pri ljudeh
English: Information shall be provided showing whether the constituents of the veterinary medicinal product are used as medicinal products in human therapy;
Slovenian: Treba je predložiti informacije o tem, ali se sestavine zdravila za uporabo v veterinarski medicini uporabljajo kot zdravila v terapiji ljudi;
English: if this is so, a report should be made on all the effects observed (including adverse reactions) in humans and on their cause, to the extent that they may be important for the assessment of the veterinary medicinal product, where appropriate in the light of trial results of bibliographical documents;
Slovenian: če je temu tako, je treba napisati poročilo o vseh opaženih učinkih (vključno s škodljivimi učinki) pri ljudeh ter o vzrokih učinkov do take mere, ki je lahko pomembna za oceno zdravila za uporabo v veterinarski medicini, kjer je to ustrezno, v luči rezultatov testiranj iz bibliografskih podatkov.
English: where constituents of the veterinary medicinal products are themselves not used or are no longer used as medicinal products in human therapy, the reasons should be stated.
Slovenian: Kjer se sestavine zdravila za uporabo v veterinarski medicini same kot take ne uporabljajo, ali niso več v uporabi kot zdravila v terapiji ljudi, je treba navesti razloge.
English: Ecotoxicity
Slovenian: Ekotoksičnost
English: The purpose of the study of the ecotoxicity of a veterinary medicinal product is to assess the potential harmful effects which the use of the product may cause to the environment and to identify any precautionary measures which may be necessary to reduce such risks.
Slovenian: Namen študije ekotoksičnosti zdravila za uporabo v veterinarski medicini je oceniti potencialne škodljive učinke, ki jih lahko povzroči uporaba proizvoda na okolju ter identificirati previdnostne ukrepe, potrebne za zmanjšanje takega tveganja.
English: An assessment of ecotoxicity shall be compulsory for any application for marketing authorization for a veterinary medicinal product other than applications submitted in accordance with Articles 12(3)(j) and 13(1).
Slovenian: Ocena ekotoksičnosti mora biti obvezna za vsako vlogo za dovoljenje za promet z zdravilom za zdravila za uporabo v veterinarski medicini, razen za vloge, vložene v skladu s členi 12(3)(j) ter 13(1).
English: This assessment shall normally be conducted in two phases.
Slovenian: To oceno je treba izpeljati v dveh fazah.
English: In the first phase, the investigator shall assess the potential extent of exposure to the environment of the product, its active substances or relevant metabolites, taking into account:
Slovenian: V prvi fazi mora preiskovalec oceniti potencialni obseg izpostavljenosti okolja proizvodu, njegovi zdravilni učinkovini ali ustreznim metabolitom, ob upoštevanju:
English: the target species, and the proposed pattern of use (for example, mass-medication or individual animal medication),
Slovenian: ciljne živalske vrste ter predlaganega načina uporabe (na primer masovno zdravljenje ali individualno zdravljenje živali),
English: the method of administration, in particular the likely extent to which the product will enter directly into environmental systems,
Slovenian: načina dajanja zdravila, še posebno možnost, da bi proizvod direktno prišel v okoljske sisteme,
English: the possible excretion of the product, its active substances or relevant metabolites into the environment by treated animals;
Slovenian: možnosti izločanja proizvoda, njegovih zdravilnih učinkovin ali relevantnih metabolitov v okolje prek zdravljenih živali;
English: persistence in such excretia,
Slovenian: obstojnost takih izločkov,
English: the disposal of unused or waste product.
Slovenian: odlaganja neporabljenih ali odpadnih proizvodov.
English: In a second phase, having regard to the extent of exposure of the product to the environment, and the available information about the physical/chemical, pharmacological and/or toxicological properties of the compound which has been obtained during the conduct of the other tests and trials required by this Directive, the investigator shall then consider whether further specific investigation of the effects of the product on particular eco-systems is necessary.
Slovenian: V drugi fazi, ob upoštevanju stopnje izpostavljenosti okolja proizvodu, ter ob razpoložljivih informacijah o fizikalno-kemijskih, farmakoloških in/ali toksikoloških lastnostih spojine, ki smo jo dobili med izvajanjem drugih preskusov ter testov, ki jih zahteva ta direktiva, mora raziskovalec premisliti, ali bi bila potrebna nadaljnja preiskava učinkov proizvoda na eko-sisteme.
English: As appropriate, further investigation may be required of:
Slovenian: Po potrebi so možne še nadaljnje preiskave o:
English: fate and behaviour in soil,
Slovenian: vplivu in obnašanju v zemlji,
English: fate and behaviour in water and air,
Slovenian: vplivu in obnašanju v vodi in zraku,
English: effects on aquatic organisms,
Slovenian: učinkih na vodne organizme,
English: effects on other non-target organisms.
Slovenian: učinkih na druge ne-ciljne organizme.
English: These further investigations shall be carried out in accordance with the test protocols laid down in Annex V of Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(6), or where an end point is not adequately covered by these protocols, in accordance with other internationally recognized protocols on the veterinary medicinal product and/or the active substance(s) and/or the excreted metabolites as appropriate.
Slovenian: Te nadaljnje preiskave morajo biti izvedene v skladu s protokoli testa, kakor je določeno v Prilogi V k Direktivi Sveta 67/548/EGS z dne 27. junija 1967 o približevanju zakonov in drugih predpisov v zvezi z razvrščanjem, pakiranjem in označevanjem nevarnih snovi [6], ali če končna točka ni točno določena s protokoli, v skladu z drugimi mednarodno priznanimi protokoli o zdravilih za uporabo v veterinarski medicini in/ali zdravilnih učinkovinah in/ali izločenih metabolitih, če to ustreza.
English: The number and types of tests and the criteria for their evaluation shall depend upon the state of scientific knowledge at the time the application is submitted.
Slovenian: Število in tipi preskusov ter merila za ocenjevanje so odvisni od nivoja znanstvenega napredka v času vlaganja vloge.
English: Chapter II
Slovenian: Poglavje II
English: Presentation of particulars and documents
Slovenian: Predstavitev podrobnih podatkov in dokumentacije
English: As in any scientific work, the dossier of safety tests shall include the following:
Slovenian: Kot v znanstvenih delih na splošno, mora dosje preskusov o varnosti vsebovati naslednje:
English: an introduction defining the subject, accompanied by any useful bibliographical references;
Slovenian: uvod z opredelitvijo vsebine in navedbo vseh koristnih bibliografskih referenc;
English: the detailed identification of the substance under review, including:
Slovenian: podrobno identifikacijo preiskovane snovi, vključno z:
English: international non-proprietary name (INN),
Slovenian: mednarodnim nelastniškim imenom (INN),
English: International Union of Pure and Applied Chemistry Name (IUPAC),
Slovenian: oznako IUPAC,
English: Chemical Abstract Service (CAS) number,
Slovenian: številko iz Chemical Abstract Service (številko CAS),
English: therapeutical and pharmacological classification,
Slovenian: terapevtsko in farmakološko klasifikacijo,
English: synonyms and abbreviations,
Slovenian: sopomenkami in kraticami,
English: structural formula,
Slovenian: strukturno formulo,