FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: molecular formula,
Slovenian: molekulsko formulo,
English: molecular weight,
Slovenian: molekulsko maso,
English: degree of impurity,
Slovenian: stopnjo nečistote,
English: qualitative and quantitative composition of impurities,
Slovenian: kakovostno in količinsko sestavo nečistot,
English: description of physical properties,
Slovenian: opisom fizikalnih lastnosti,
English: melting point,
Slovenian: točko tališča,
English: boiling point,
Slovenian: točko vrelišča,
English: vapour pressure,
Slovenian: parnim tlakom,
English: solubility in water and organic solvents expressed in g/l, with indication of temperature,
Slovenian: topnostjo v vodi ter organskih topilih izraženo v g/l, z navedbo temperature,
English: density,
Slovenian: gostoto,
English: spectra of refraction, rotation, etc;
Slovenian: refrakcijskimi spektri, rotacijo itd.
English: a detailed experimental protocol giving the reasons for any omission of certain tests listed above, a description of the methods, apparatus and materials used, details of the species, breed or strain of animals, where they were obtained, their number and the conditions under which they were housed and fed, stating inter alia whether they were free from specific pathogens (SPF);
Slovenian: podroben eksperimentalni protokol z navedbo razlogov za opustitev določenih zgoraj naštetih preskusov, opisom metod, opreme in materialov, podrobnostim o živalski vrsti, pasmi ali rodu živali, od kod izvirajo, število živali ter pogoje, pod katerimi so bivale in bile vzrejene, med drugim tudi, če bile proste specifičnih patogenov (SPF);
English: all the results obtained, whether favourable or unfavourable.
Slovenian: vsi pridobljeni podatki, bodisi ugodni ali neugodni.
English: The original data should be described in sufficient detail to allow the results to be critically evaluated independently of their interpretation by the author.
Slovenian: Originalne podatke je treba opisati dovolj podrobno, da je možno podati kritične ocene, neodvisno od avtorjeve interpretacije.
English: By way of explanation, the results may be accompanied by illustrations;
Slovenian: Rezultati so lahko opremljeni z ilustracijami;
English: a statistical analysis of the results, where such is called for by the test programme, and variance within the data;
Slovenian: statistična analiza rezultatov, kjer je to potrebno zaradi programa testiranja, ter razhajanja med podatki;
English: an objective discussion of the results obtained, leading to conclusions on the safety of the substance, on its safety margin in the test animal and the target animal and its possible side-effects, on its fields of application, on its active dose levels and any possible incompatibilities;
Slovenian: objektivna razlaga dobljenih rezultatov, ki vodi do zaključka o varnosti snovi, mejah varnosti pri poskusni živali ter ciljni živali ter možnih stranskih učinkih, področjih uporabe, nivojih aktivnih odmerkov ter kakršnih koli možnih neskladjih;
English: a detailed description and a thorough discussion of the results of the study of the safety of residues in food, and its relevance for the evaluation of potential risks presented by residues to humans.
Slovenian: podroben opis ter temeljita diskusija o rezultatih študije o varnosti zaostankov v živilih ter relevantnostjo za oceno potencialnih tveganj, ki jih predstavljajo zaostanki za ljudi.
English: This discussion shall be followed by proposals to ensure that any danger to man is eliminated by applying internationally recognized assessment criteria, for example:
Slovenian: Temu komentarju morajo slediti predlogi, ki zagotavljajo, da je vsakršno tveganje za človeka odstranjeno, kar je bilo storjeno na osnovi mednarodno priznanih meril, na primer:
English: no observed effect level in animals, proposals for a choice of safety factor and for acceptable daily intake (ADI);
Slovenian: da ni nobenih opaženih učinkov na živalih, da je predlagana izbira varnostnega faktorja ter sprejemljivega dnevnega vnosa v organizem (ADI);
English: a thorough discussion of any risks for persons preparing the medicinal product or administering it to animals, followed by proposals for appropriate measures to reduce such risks;
Slovenian: izčrpen komentar tveganj za tiste, ki pripravljajo zdravilo ali ga dajejo živali, čemur sledijo predlogi za uvedbo ustreznih ukrepov za zmanjšanje tveganj;
English: a thorough discussion of the risks which use of the veterinary medicinal product under the practical conditions proposed may represent for the environment followed by appropriate proposals to reduce such risks;
Slovenian: izčrpen komentarjem o tveganjih za okolje pri zdravilih za uporabo v veterinarski medicini, katerih uporaba pod predlaganimi praktičnimi pogoji bi lahko predstavljala tveganje ter predlog ustreznih rešitev za zmanjšanje tveganj;
English: all information necessary to acquaint the clinician as fully as possible with the utility of the proposed product.
Slovenian: vse potrebne informacije, ki do največje možne mere poučijo klinika o uporabnosti predlaganega proizvoda.
English: The discussion will be supplemented by suggestions as to side-effects and possible treatment for acute toxic reactions in animals to which the product is to be administered;
Slovenian: Komentar je treba dopolniti s predlogi glede stranskih učinkov ter možnega zdravljenja akutnih toksičnih reakcij pri živalih, ki se jim bo ta proizvod dajal;
English: a concluding expert report which provides a detailed critical analysis of the information referred to above in the light of the state of scientific knowledge at the time the application is submitted together with a detailed summary of all the results of the relevant safety tests and precise bibliographical references.
Slovenian: zaključno izvedensko poročilo s kritično analizo o vseh zgoraj naštetih informacijah glede na stopnjo razvoja znanosti v času, ko je bila vloga vložena, skupaj s podrobnim povzetkom vseh rezultatov relevantnih varnostnih testov ter podrobnimi bibliografskimi referencami.
English: RESIDUE TESTING
Slovenian: TESTIRANJE ZAOSTANKOV
English: Performance of tests
Slovenian: Izvajanje preskusov
English: For the purposes of this Directive, "residues" means all active substances or metabolites thereof which remain in meat or other foodstuffs produced from the animal to which the medicinal product in question has been administered.
Slovenian: V tej direktivi pomeni izraz "zaostanek" vse zdravilne učinkovine ali njihove metabolite, ki ostanejo v mesu ali drugih živilih, ki se pridobivajo iz živali, ki so jim bili dana zadevna zdravila.
English: The purpose of studying residues is to determine whether, and if so under what conditions and to what extent, residues persist in foodstuffs produced from treated animals and to ascertain the withdrawal periods to be adhered to in order to obviate any hazard to human health and/or difficulties in the industrial processing of foodstuffs.
Slovenian: Namen študije zaostankov je ugotavljanje, ali so zaostanki prisotnosti in, pod katerimi pogoji ter do kakšne količine ostajajo v živilih, pridobljenih iz zdravljenih živali in določitev karence, potrebne za odpravo tveganja za zdravje ljudi in/ali težav pri industrijskem procesiranju živil.
English: Assessment of the hazard due to residues entails establishing whether residues are present in the animals treated under recommended conditions of use and investigating the effects of those residues.
Slovenian: Ocena tveganja zaradi zaostankov pomeni ugotovitev prisotnosti zaostankov v zdravljenih živalih pod priporočenimi pogoji uporabe ter raziskava o učinkih le-teh.
English: In the case of veterinary medicinal products intended for use in food-producing animals, the residue documentation shall show:
Slovenian: Za zdravila za uporabo v veterinarski medicini, namenjenih za živali za proizvodnjo živil, mora dokumentacija o zaostankih dokazovati naslednje:
English: to what extent, and how long, do residues of the veterinary medicinal product or its metabolites persist in the tissues of the treated animal or foodstuffs obtained therefrom;
Slovenian: do kakšne količine kako dolgo zaostanki zdravila za uporabo v veterinarski medicini ali njihovi metaboliti ostajajo v tkivih zdravljene živali ali v živilih, ki se pridobivajo iz takih živali;
English: that in order to prevent any risk to the health of the consumer of foodstuffs of treated animals, or difficulties in the industrial processing of foodstuffs, it is possible to establish realistic withdrawal periods which can be observed under practical farming conditions;
Slovenian: da je možno določiti realno karenco zdravila, ki jo je možno spoštovati pod praktičnimi pogoji kmetovanja, da bi se tako preprečilo tveganje za zdravje potrošnika živil, ki izhajajo iz zdravljenih živali, ali težave pri industrijski predelavi živil;
English: that practical analytical methods suitable for routine use are available to verify compliance with the withdrawal period.
Slovenian: da so na voljo praktične analizne metode, primerne za rutinsko uporabo, ki lahko potrdijo skladnost s karenco zdravila.
English: Metabolism and residue kinetics
Slovenian: Metabolizem in kinetika zaostankov
English: Pharmacokinetics (absorption, distribution, biotransformation, excretion)
Slovenian: Farmakokinetika (absorpcija, porazdelitev, biotransformacija, izločanje)
English: The purpose of pharmacokinetic studies with respect to residues of veterinary medicinal products is to evaluate the absorption, distribution, biotransformation and excretion of the product in the target species.
Slovenian: Namen farmakokinetičnih študij zaostankov zdravil za uporabo v veterinarski medicini je ocena absorpcije, porazdelitve, biotransformacije ter izločanja proizvoda v ciljnih živalih.
English: The final product, or a formulation which is bioequivalent, shall be administered to the target species at the maximum recommended dose.
Slovenian: Končni proizvod, ali formulacijo, ki je bioekvivalentna, je treba dajati ciljni živali v največjem priporočenem odmerku.
English: Having regard to the method of administration, the extent of absorption of the medicinal product shall be fully described.
Slovenian: Glede na način dajanja zdravila, mora biti obseg absorpcije zdravila podrobno opisan.
English: If it is demonstrated that systemic absorption of products for topical application is negligible, further residue studies will not be required.
Slovenian: Če se dokaže, da je sistemska absorpcija proizvodov za lokalno uporabo zanemarljiva, nadaljnje študije o zaostankih niso potrebne.
English: The distribution of the medicinal product in the target animal shall be described;
Slovenian: Opisana mora biti porazdelitev zdravila v ciljni živali;
English: the possibility of plasma protein binding, or passage into milk or eggs and of the accumulation of lipophilic compounds shall be considered.
Slovenian: upoštevati je treba možnost vezave na plazemske beljakovine, prenos v mleko ali jajca ter kopičenje lipofilnih spojin.
English: The pathways for the excretion of the product from the target animal shall be described. The major metabolites shall be identified and characterised.
Slovenian: Treba je opisati poti izločanja proizvoda iz cilje živali in identificirati ter karakterizirati glavne metabolite.
English: Depletion of residues
Slovenian: Izločanje zaostankov
English: The purposes of these studies, which measure the rate at which residues deplete in the target animal after the last administration of the medicinal product, is to permit the determination of withdrawal periods.
Slovenian: Namen tovrstnih študij, ki merijo hitrost s katero se zaostanki izločajo iz ciljne živali po zadnjem dajanju zdravila, je določitev karence.
English: At varying times after the test animal has received the final dose of the medicinal product, the quantities of residues present shall be determined by appropriate physical, chemical or biological methods;
Slovenian: Potem, ko je poskusna žival prejela zadnji odmerek zdravila, je treba v različnih obdobjih določiti količine prisotnih zaostankov z uporabo ustreznih fizikalnih, kemijskih ali bioloških metod;
English: the technical procedures and the reliability and sensitivity of the methods employed shall be specified.
Slovenian: treba je specificirati tehnološke postopke ter zanesljivost in občutljivost uporabljenih metod.
English: Routine analytical method for the detection of residues
Slovenian: Rutinska analitska metoda za odkrivanje zaostankov
English: Analytical procedures shall be proposed which can be carried out in the course of a routine examination and which have a level of sensitivity such as to enable violations of legally permitted maximum residue limits to be detected with certainty.
Slovenian: Treba je predlagati analizne postopke, ki jih je moč izvesti med rutinsko preiskavo in ki imajo tako stopnjo občutljivosti, ki omogoča zanesljivo odkrivanje prekoračitev zakonsko dovoljenih najvišjih dovoljenih količin zaostankov.
English: The analytical method proposed shall be described in detail.
Slovenian: Predlagano analitsko metodo je treba do podrobnosti opisati.
English: It shall be validated and shall be sufficiently rugged for use under normal conditions of routine monitoring for residues.
Slovenian: Metoda mora biti validirana in dovolj zanesljiva za uporabo pod normalnimi pogoji rutinskega nadzora nad zaostanki.
English: The following characteristics shall be described:
Slovenian: Treba je opisati naslednje značilnosti:
English: specificity,
Slovenian: specifičnost,
English: accuracy, including sensitivity,
Slovenian: točnost, vključno z občutljivostjo,
English: precision,
Slovenian: natančnost,
English: limit of detection,
Slovenian: mejo zaznavnosti,
English: limit of quantitation,
Slovenian: mejo merljivosti količine,
English: practicability and applicability under normal laboratory conditions,
Slovenian: praktičnost in uporabnost pod normalnimi laboratorijskimi pogoji,
English: susceptibility to interference.
Slovenian: dovzetnost za motnje.
English: The suitability of the analytical method proposed shall be evaluated in the light of the state of scientific and technical knowledge at the time the application is submitted.
Slovenian: Primernost predlaganih analitskih metod je treba oceniti glede na stopnjo znanstvenih dosežkov ter tehničnega znanja v času, ko je bila vloga vložena.
English: Presentation of particulars and documents
Slovenian: Predstavitev podrobnih podatkov ter dokumentacije
English: As in any scientific work, the dossier of residue tests shall include the following:
Slovenian: Kot pri vsakem znanstvenem delu, mora dosje o testiranju zaostankov vsebovati naslednje:
English: an introduction defining the subject, accompanied by any useful bibliographical references;
Slovenian: uvod, ki opredeljuje predmet, skupaj s koristnimi bibliografskimi referencami;
English: a detailed identification of the medicinal, including:
Slovenian: podrobno identifikacijo zdravila, vključno z:
English: composition,
Slovenian: sestavo,
English: purity,
Slovenian: čistoto,
English: batch identification,
Slovenian: identifikacijo serije,
English: relationship to the final product,
Slovenian: povezanostjo s končnim proizvodom,
English: specific activity and radio-purity of labelled substances,
Slovenian: specifično aktivnostjo ter radio-čistoto označenih snovi,
English: position of labelled atoms in the molecule;
Slovenian: lego označenih atomov v molekuli,
English: a detailed experimental protocol giving the reasons for any omission of certain tests listed above, a description of the methods, apparatus and materials used, details of the species, breed or strain of animals, where they were obtained, their number and the conditions under which they were housed and fed;
Slovenian: podroben eksperimentalni protokol z navedbo razlogov za opustitev določenih zgoraj navedenih preskusov, opis metod, instrumentov ter materialov, podrobnosti o živalski vrsti, pasmi ali rodu živali, njihov izvor, njihovo število ter pogoje, pod katerimi so bivale in bile vzrejene;
English: all the results obtained, whether favourable or unfavourable.
Slovenian: vse dobljene rezultate, tako ugodne kot neugodne.
English: The original data should be described in sufficient detail to allow the results to be critically evaluated independently of their interpretation by the author.
Slovenian: Originalne podatke je treba opisati dovolj podrobno, da bi se rezultate lahko kritično ocenilo, neodvisno od avtorjeve interpretacije.
English: The results may be accompanied by illustrations;
Slovenian: Rezultate lahko spremljajo tudi skice;
English: a statistical analysis of the results, where such is called for by the test programme, and variance within the data;
Slovenian: statistično analizo rezultatov, če tako zahteva preskusni program ter razhajanje med podatki;
English: an objective discussion of the results obtained, followed by proposals for maximum residue limits for the active substances contained in the product, specifying the marker residue and target tissues concerned, and proposals concerning the withdrawal periods necessary to ensure that no residues which might constitute a hazard for consumers are present in foodstuffs obtained from treated animals;
Slovenian: objektivno razlago dobljenih rezultatov, čemur sledijo predlogi za določitev najvišjih dovoljenih količin zaostankov zdravilnih učinkovin, ki jih proizvod vsebuje, določitev marker zaostanka ter zadevnih ciljnih tkiv ter predloge glede karence, potrebne, da bo zagotovljeno, da v živilih, pridobljenih iz zdravljenih živali ni nobenih zaostankov, ki bi lahko predstavljali tveganje za potrošnika;
English: a concluding expert report which provides a detailed critical analysis of the information referred to above in the light of the state of scientific knowledge at the time the application is submitted together with a detailed summary of the results of the residue tests and precise bibliographical references.
Slovenian: sklepno izvedensko poročilo s podrobno kritično analizo zgoraj naštetih informacij glede na stanje znanstvenega napredka v času, ko je bila vložena vloga skupaj s podrobnim povzetkom rezultatov o testiranju zaostankov ter podrobne bibliografske reference.
English: PART 4
Slovenian: DEL 4
English: Pre-clinical and clinical testing
Slovenian: Predklinična in klinična preskušanja
English: The particulars and documents which shall accompany applications for marketing authorizations pursuant to Articles 12(3)(j) and 13(1) shall be submitted in accordance with the provisions of this Part.
Slovenian: Podrobne podatke ter dokumentacijo, ki morajo spremljati vlogo za pridobitev dovoljenja za promet z zdravilom v skladu z členi 12(3)(j) ter 13(l), je treba predložiti v skladu z določili tega dela.
English: Pre-clinical requirements
Slovenian: Predklinične zahteve
English: Pre-clinical studies are required to establish the pharmacological activity and the tolerance of the product.
Slovenian: Predklinične študije so potrebne za ugotovitev farmakološke aktivnosti ter tolerance proizvoda.
English: PHARMACOLOGY
Slovenian: FARMAKOLOGIJA
English: Pharmacodynamics
Slovenian: A.1 Farmakodinamika
English: The study of pharmacodynamics shall follow two distinct lines of approach:
Slovenian: Študija farmakodinamike mora slediti dvema ločenima pristopoma:
English: First, the mechanism of action and the pharmacological effects on which the recommended application in practice is based shall be adequately described.
Slovenian: Prvič, ustrezno mora biti opisan mehanizem delovanja ter farmakološki učinki, na katerih temelji priporočena praktična uporaba.
English: The results shall be expressed in quantitative terms (using, for example, dose-effect curves, time-effect curves, etc.) and, wherever possible, in comparison with a substance the activity of which is well known.
Slovenian: Rezultati morajo biti izraženi kvantitativno (na primer krivulje učinek-odmerek, krivulje čas-učinek itd.) ter, kjer je to mogoče, v primerjavi s snovjo, katere aktivnost je dobro znana.
English: Where a higher efficacy is being claimed for an active substance, the difference shall be demonstrated and shown to be statistically significant.
Slovenian: Tam, kjer se za zdravilno učinkovino zagotavlja višja učinkovitost, je treba prikazati razliko in dokazati statistično značilnost.
English: Secondly, the investigator shall give an overall pharmacological assessment of the active substance, with special reference to the possibility of side-effects.
Slovenian: Drugič, preiskovalec mora podati celovito farmakološko oceno o zdravilni učinkovini, s posebnim poudarkom na možnosti stranskih učinkov.
English: In general, the main functions shall be investigated.
Slovenian: Na splošno je treba preučiti glavne funkcije.
English: The investigator shall identify the effect of the route of administration, formulation, etc, on the pharmacological activity of the active substance.
Slovenian: Preiskovalec mora identificirati učinke načina jemanja zdravila, formulacijo, itd. na farmakološko aktivnost zdravilne učinkovine.
English: The investigations shall be intensified where the recommended dose approaches that liable to produce adverse reactions.
Slovenian: Preiskave je treba okrepiti tam, kjer se priporočeni odmerek približuje tistemu, ki bi lahko povzročil škodljive učinke.
English: The experimental techniques, unless they are standard procedures, shall be described in such detail as to allow them to be reproduced, and the investigator shall establish their validity.
Slovenian: Eksperimentalne tehnike, razen če gre za standardne postopke, je treba opisati tako natančno, da jih je možno ponoviti. Zato mora preiskovalec določiti njihovo veljavnost.
English: The experimental results shall be set out clearly and, for certain types of tests, their statistical significance quoted.
Slovenian: Eksperimentalne rezultate je treba jasno predstaviti ter za določene vrste preskusov navesti statistično značilnost.
English: Unless good reasons are given to the contrary, any quantitative modification of responses resulting from repeated administration of the substance shall also be investigated.
Slovenian: Razen če so podani tehtni nasprotni razlogi, je treba preučiti kvantitativne spremembe odzivov, ki so posledica ponavljajočega dajanja zdravila.
English: Medicinal combinations may be prompted either on pharmacological grounds or by clinical indications.
Slovenian: Farmacevtske kombinacije lahko razvijejo delovanje bodisi na farmakoloških temeljih ali s kliničnimi indikacijami.
English: In the first case, the pharmacodynamic and/or pharmacokinetic studies shall demonstrate those interactions which might make the combination itself of value in clinical use.
Slovenian: V prvem primeru morajo farmakodinamične in/ali farmakokinetične študije izkazovati tiste interakcije, ki bi lahko naredile samo kombinacijo vredno za klinično uporabo.
English: In the second case, where scientific justification for the medicinal combination is sought through clinical experimentation, the investigation shall determine whether the effects expected from the combination can be demonstrated in animals and, at least, the importance of any adverse reactions shall be checked.
Slovenian: V drugem primeru, kjer se išče znanstvena razlaga za farmacevtske kombinacije s kliničnimi eksperimenti, mora raziskava določiti, ali bodo pričakovani učinki kombinacije lahko prikazani na živalih in je vsaj treba preveriti pomembnost škodljivih učinkov.
English: If a combination includes a novel active substance, the latter shall have been previously studied in depth.
Slovenian: Če kombinacija vključuje novo zdravilno učinkovino, je treba le-to predhodno dodobra preučiti.
English: Pharmacokinetics
Slovenian: A.2 Farmakokinetika
English: Basic pharmacokinetic information concerning a new active substance is generally useful in the clinical context.
Slovenian: Osnovne farmakokinetične informacije, ki zadevajo novo zdravilno učinkovino so v kliničnem pogledu običajno koristne.
English: Pharmacokinetic objectives can be divided into two main areas:
Slovenian: Farmakokinetične cilje lahko delimo na dve glavni področji: