FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: The toxicology and pharmacokinetics of an excipient used for the first time in the pharmaceutical field shall be investigated.
Slovenian: Razišče se toksikologija in farmakokinetika pomožne snovi, ki se prvikrat uporablja na farmacevtskem področju.
English: Where there is a possibility of significant degradation during storage of the medicinal product, the toxicology of degradation products must be considered.
Slovenian: Kadar obstaja možnost znatne razgradnje med shranjevanjem zdravila, je treba upoštevati toksikologijo razgradnih produktov.
English: PERFORMANCE OF TESTS
Slovenian: IZVAJANJE PRESKUSOV
English: Single dose toxicity
Slovenian: Toksičnost pri enkratnem odmerku
English: An acute test is a qualitative and quantitative study of the toxic reactions which may result from a single administration of the active substance or substances contained in the medicinal product, in the proportions and physico-chemical state in which they are present in the actual product.
Slovenian: Preskus akutne toksičnosti je kakovostna in količinska študija toksičnih reakcij, ki so lahko posledica enkratnega dajanja zdravilne učinkovine ali snovi, ki jih vsebuje zdravilo, v razmerjih in v fizikalno-kemijskem stanju, v katerem so dejansko prisotne v izdelku.
English: The acute toxicity test must be carried out in two or more mammalian species of known strain unless a single species can be justified.
Slovenian: Preskus akutne toksičnosti je treba izvesti na dveh ali več znanih vrstah sesalcev, razen če se lahko utemelji preskus na eni sami vrsti.
English: At least two different routes of administration shall normally be used, one being identical with or similar to that proposed for use in human beings and the other ensuring systemic exposure to the substance.
Slovenian: Običajno se uporabljata najmanj dve različni poti uporabe zdravila, ena, ki je enaka ali podobna predlagani za uporabo pri ljudeh, ter druga, ki zagotavlja sistemsko izpostavljenost snovi.
English: This study will cover the signs observed, including local reactions.
Slovenian: Študija zajema opažene znake, vključno z lokalnimi reakcijami.
English: The period during which the test animals are observed shall be fixed by the investigator as being adequate to reveal tissue or organ damage or recovery, usually for a period of 14 days but not less than 7 days, but without exposing the animals to prolonged suffering.
Slovenian: Obdobje opazovanja poskusnih živali določi preiskovalec in traja primerno dolgo, da se odkrijejo poškodbe tkiva ali organa ali njihova obnovitev, ponavadi je to čas 14 dni, vendar ne manj kot 7 dni, toda brez izpostavljanja živali dolgotrajnemu trpljenju.
English: Animals dying during the observation period should be subject to autopsy as also should all animals surviving to the end of the observation period.
Slovenian: Živali, ki v času opazovanja poginejo, je treba obducirati, kot tudi vse preživele ob zaključku opazovanja.
English: Histopathological examinations should be considered on any organ showing macroscopic changes at autopsy.
Slovenian: Upoštevati je treba histopatološke preiskave vseh organov, ki pri obdukciji kažejo makroskopske spremembe.
English: The maximum amount of information should be obtained from the animals used in the study.
Slovenian: Iz študij na živalih, uporabljenih v študiji, je treba pridobiti kar največ informacij.
English: The single dose toxicity tests should be conducted in such a way that signs of acute toxicity are revealed and the mode of death assessed as far as reasonably possible.
Slovenian: Preskuse toksičnosti pri enkratnem odmerku je treba izvajati tako, da se razkrijejo znaki akutne toksičnosti in da se način smrti oceni, kolikor je smiselno mogoče.
English: In suitable species, a quantitative evaluation of the approximate lethal dose and information on the dose effect relationship should be obtained, but a high level of precision is not required.
Slovenian: Pri primernih vrstah je treba pridobiti količinsko ovrednotenje približnega smrtnega odmerka ter informacijo o odnosu med odmerkom in učinkom, vendar se ne zahteva visoka raven natančnosti.
English: These studies may give some indication of the likely effects of acute overdosage in man and may be useful for the design of toxicity studies requiring repeated dosing on the suitable animal species.
Slovenian: Te študije lahko pokažejo morebitne učinke akutnega prevelikega odmerka pri človeku in so lahko koristne za načrtovanje študij toksičnosti, ki zahtevajo večkratno odmerjanje na primerni živalski vrsti.
English: In the case of active substances in combination, the study must be carried out in such a way as to check whether or not there is enhancement of toxicity or if novel toxic effects occur.
Slovenian: V primeru kombinacije zdravilnih učinkovin, je treba študijo izvajati tako, da se preveri, ali gre za povečevanje toksičnosti ali za nove toksične učinke.
English: Repeated dose toxicity (sub-acute or chronic toxicity)
Slovenian: Toksičnost pri večkratnih odmerkih (sub-akutna ali kronična toksičnost)
English: Repeated dose toxicity tests are intended to reveal any physiological and/or anatomo-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: Namen preskusov toksičnosti pri večkratnih odmerkih je odkrivanje vsakih fizioloških in/ali anatomsko-patoloških sprememb, ki jih povzroča večkratno dajanje zdravilne učinkovine ali kombinacija zdravilnih učinkovin, ki jih preučujemo, ter določitev povezave med spremembami in odmerjanjem.
English: Generally, it is desirable that two tests be performed:
Slovenian: Na splošno je zaželeno, da se izvedeta dva preskusa:
English: one short-term, lasting two to four weeks, the other long-term.
Slovenian: en kratkotrajen preskus, ki traja dva do štiri tedne, in drugi, ki je dolgotrajen.
English: The duration of the latter shall depend on the conditions of clinical use.
Slovenian: Trajanje dolgotrajnega preskusa je odvisno od pogojev klinične uporabe.
English: Its purpose shall be to determine by experiment the non-toxic dose range of the product and normally it shall last three to six months.
Slovenian: Cilj tega preskusa je s poskusom določiti območje odmerka zdravila, v katerem ni toksično, kar običajno traja od tri do šest mesecev.
English: In respect of medicinal products to be administered once only to humans, a single test lasting two to four weeks shall be performed.
Slovenian: Kar zadeva zdravila, ki se ljudem dajo samo enkrat, se izvede en preskus, ki traja od dva do štiri tedne.
English: If however, having regard to the proposed duration of use in human beings, the investigator sees fit to carry out experiments of greater or lesser duration than indicated above, he must give adequate reasons for doing so.
Slovenian: Če pa, ob upoštevanju predlaganega trajanja uporabe pri ljudeh, raziskovalec meni, da je primerno, da se poskusi izvajajo daljši ali krajši čas kot je navedeno zgoraj, mora navesti ustrezne razloge za tako odločitev.
English: Reasons should also be given for the dosages chosen.
Slovenian: Navesti je treba tudi razloge za izbrana odmerjanja.
English: Repeated dose toxicity tests shall be carried out on two species of mammals one of which must be a non-rodent.
Slovenian: Preskusi toksičnosti pri večkratnih odmerkih se izvajajo na dveh vrstah sesalcev, od katerih ena ne sme biti glodalec.
English: The choice of route(s) of administration employed shall depend on the intended therapeutic use and the possibilities of systemic absorption.
Slovenian: Izbor poti uporabe zdravila je odvisen od namena terapevtske uporabe in možnosti sistemske absorpcije.
English: The method and frequency of dosage shall be clearly stated.
Slovenian: Način in pogostnost odmerkov se jasno opredelita.
English: The maximum dose should be chosen so as to bring harmful effects to light.
Slovenian: Največji odmerek je treba izbrati tako, da se izrazijo škodljivi učinki.
English: The lower doses will then enable the animal's tolerance of the product to be determined.
Slovenian: Nižji odmerki bodo omogočili določitev tolerance živali na zdravilo.
English: Wherever possible, and always in experiments on small rodents, the design of the experiment and the control procedures must be suited to the scale of the problem being tackled and enable fiducial limits to be determined.
Slovenian: Kadarkoli je mogoče, toda vselej pri poskusih na malih glodalcih, je treba načrt poskusa in kontrolnih postopkov prilagoditi obsegu problema, ki se preučuje, ter omogočiti, da se določijo meje zanesljivosti.
English: The evaluation of the toxic effects shall be based on observation of behaviour, growth, haematological and biochemical tests, especially those relating to the excretory mechanism, and also on autopsy reports and accompanying histological data.
Slovenian: Toksične učinke se ovrednoti na podlagi opazovanja vedenja, rasti, hematoloških in biokemičnih preskusov, zlasti tistih, povezanih z mehanizmi izločanja, in tudi na podlagi poročil obdukcije ter spremljajočih histoloških podatkov.
English: The choice and range of each group of tests will depend on the species of animal used and the state of scientific knowledge at the time.
Slovenian: Izbira in območje posamezne skupine preskusov je odvisna od uporabljene živalske vrste ter od stanja znanstvenih dognanj v tistem času.
English: In the case of new combinations of known substances that have been investigated in accordance with the provisions of this Directive, the chronic long-term tests may, except where acute and sub-acute toxicity tests have demonstrated potentiation or novel toxic effects, be suitably modified by the investigator who shall submit his reasons for such modification.
Slovenian: Pri novih kombinacijah znanih snovi, ki so se preučevale v skladu z določbami te direktive, lahko raziskovalec kronične dolgotrajne preskuse ustrezno spremeni, razen kadar so preskusi akutne in sub-akutne toksičnosti pokazali povečane ali nove toksične učinke, vendar mora predložiti razloge za tako spremembo.
English: Examination of reproductive function
Slovenian: Preučevanje vpliva na sposobnost razmnoževanja
English: If the results of other tests reveal anything suggesting harmful effects on progeny or impairment of male or female reproductive function, this shall be investigated by appropriate tests.
Slovenian: Če rezultati drugih preskusov razkrijejo karkoli, kar bi kazalo na neželene učinke na potomstvo ali zmanjšanja sposobnosti razmnoževanja pri samcih ali samicah, se to preveri z ustreznimi preskusi.
English: Embryo/foetal and perinatal toxicity
Slovenian: Toksičnost za zarodek/plod in obporodna toksičnost
English: This investigation comprises a demonstration of the toxic and especially the teratogenic effects observed in the issue of conception when the medicinal product under investigation has been administered to the female during pregnancy.
Slovenian: Ta raziskava vključuje prikaz toksičnih in zlasti teratogenih učinkov, opaženih pri spočetju, ko se preiskovano zdravilo daje samici med nosečnostjo.
English: Although up to the present these tests have had only a limited predictive value in regard to the application of the results to human beings, they are thought to provide important information where the results show effects such as resorptions and other anomalies.
Slovenian: Čeprav so do nedavnega ti preskusi imeli le omejeno napovedno vrednost v zvezi z uporabo rezultatov pri ljudeh, pa vseeno dajejo pomembne podatke, kadar rezultati kažejo učinke kot so resorpcija in druge nepravilnosti.
English: Omission of these tests, either because the medicinal product will not normally be used by women capable of child-bearing or for other reasons, must be adequately justified.
Slovenian: Opustitev teh preskusov, ker zdravila običajno ne bodo uporabljale ženske v rodni dobi ali iz drugih razlogov, je treba ustrezno utemeljiti.
English: Embryo/foetal toxicity studies shall normally be conducted on two mammalian species, one of which should be other than a rodent.
Slovenian: Študije toksičnosti za zarodek/plod je običajno treba izvajati na dveh vrstah sesalcev, od katerih ena ni glodalec.
English: Peri- and postnatal studies shall be conducted in at least one species.
Slovenian: Obporodne in postnatalne študije se izvajajo na najmanj eni živalski vrsti.
English: Where metabolism of a medicinal product in a particular species is known to be similar to that in man, it is desirable to include this species.
Slovenian: Kadar je presnova zdravila pri določeni vrsti podobna človeški, je zaželeno, da se ta živalska vrsta vključi.
English: Also, it is desirable that one of the species is the same as in the repeated dose toxicity studies.
Slovenian: Prav tako je zaželeno, da je ena od živalskih vrst enaka kot pri preskusih toksičnosti pri večkratnih odmerkih.
English: The details of the test (number of animals, amounts administered, timing of administration and criteria for evaluation of results) shall depend on the state of scientific knowledge at the time when the application is lodged, and the level of statistical significance that the results must attain.
Slovenian: Podrobnosti preskusa (število živali, količine uporabljenega zdravila, časovni razpored dajanja zdravila ter merila za vrednotenje rezultatov) so odvisne od stanja znanstvenih dognanj v času predložitve vloge ter ravni statistične značilnosti, ki jo morajo rezultati doseči.
English: The purpose of the study of mutagenic potential is to reveal the changes which a substance may cause in the genetic material of individuals or cells and which have the effect of making successors permanently and hereditarily different from their predecessors.
Slovenian: Namen študije mutagenega potenciala je odkriti spremembe, ki jih snov lahko povzroči v genetskem materialu pri posameznikih ali celicah in imajo učinek, da se potomci trajno in dedno razlikujejo od svojih prednikov.
English: This study is obligatory for any new substance.
Slovenian: Ta študija je obvezna za vsako novo snov.
English: The number and types of results and the criteria for their evaluation shall depend on the state of scientific knowledge at the time when the application is lodged.
Slovenian: Število in vrste rezultatov ter merila za njihovo vrednotenje je odvisno od stanja znanstvenih dognanj v času predložitve vloge.
English: Carcinogenic potential
Slovenian: Rakotvorni potencial
English: Tests to reveal carcinogenic effects shall normally be required:
Slovenian: Preskusi za odkrivanje rakotvornih učinkov se običajno zahtevajo pri:
English: in respect of substances having a close chemical analogy with known carcinogenic or cocarcinogenic compounds;
Slovenian: snoveh, ki so kemijsko zelo podobne znanim rakotvornim in ko-rakotvornim spojinam;
English: in respect of substances which have given rise to suspicious changes during the long-term toxicological tests;
Slovenian: snoveh, zaradi katerih je prišlo do sum zbujajočih sprememb med dolgotrajnimi toksikološkimi preskusi;
English: in respect of substances which have given rise to suspicious results in the mutagenic-potential tests or in other short-term carcinogenicity tests.
Slovenian: snoveh, zaradi katerih je prišlo do sum zbujajočih rezultatov pri preskušanju mutagenega potenciala ali pri drugih kratkotrajnih preskusih rakotvornosti.
English: Such tests may also be required in respect of substances to be included in medicinal products likely to be administered regularly over a prolonged period of a patient's life.
Slovenian: Ti preskusi se lahko zahtevajo tudi za snovi, ki bodo vključene v zdravila in jih bo verjetno bolnik redno jemal daljše obdobje svojega življenja.
English: The state of scientific knowledge at the time when the application is lodged shall be taken into account when determining the details of the tests.
Slovenian: Pri določanju podrobnosti preskusov se upošteva stanje znanstvenih dognanj v času predložitve vloge.
English: This heading covers the variations caused by the medicinal product in the functions of the physiological systems, whether these functions are normal or experimentally modified.
Slovenian: To poglavje vključuje spremembe, ki jih zdravilo povzroča v delovanju fizioloških sistemov, bodisi da je to delovanje običajno ali poskusno spremenjeno.
English: This study shall follow two distinct lines of approach.
Slovenian: Študija sledi dvema ločenima smerema pristopa.
English: Firstly, the actions on which the recommended application in therapeutic practice is based shall be adequately described.
Slovenian: Prvič, se ustrezno opiše delovanje, na katerem temelji priporočena uporaba v terapevtski praksi.
English: The results shall be expressed in quantitative terms using, (e.g. dose-effect curves, time-effect curves etc.), and wherever possible, compared with data relating to a substance whose activity is known.
Slovenian: Rezultati se izrazijo s količinskimi izrazi (npr. krivulje učinka v odvisnosti od odmerka, krivulje učinka v odvisnosti od časa, itd.), ter se, kadarkoli je mogoče, primerjajo s podatki o snovi z znano aktivnostjo.
English: Where a higher therapeutic potency is being claimed for a substance, the difference shall be demonstrated and shown to be statistically significant.
Slovenian: Kadar se za snov trdi, da ima večjo terapevtsko moč, se razlika dokaže in prikaže kot statistično značilna.
English: Secondly, the investigator shall provide a general pharmacological characterization of the substance, with special reference to adverse reactions.
Slovenian: Drugič, raziskovalec predloži splošno farmakološko opredelitev snovi, s posebnim ozirom na neželene učinke.
English: In general, the main functions of the physiological systems should be investigated.
Slovenian: Na splošno je treba raziskati glavne funkcije fizioloških sistemov.
English: The depth of this investigation must be increased as the doses liable to produce adverse reactions approach those producing the main effect for which the substance is being proposed.
Slovenian: Poglobljenost raziskave je treba še povečati, ko se odmerki, ki bi lahko povzročili neželene učinke, približajo odmerkom, ki povzročajo glavni učinek, za katerega se predlaga uporaba snovi.
English: The experimental techniques, unless they are standard procedures, must be described in such detail as to allow them to be reproduced, and the investigator must establish their validity.
Slovenian: Poskusne postopke, razen če gre za standardne postopke, je treba opisati tako podrobno, da jih je mogoče ponoviti, raziskovalec pa mora potrditi njihovo veljavnost.
English: The experimental results shall be set out clearly and, when relevant to the test, their statistical significance quoted.
Slovenian: Poskusne rezultate se jasno izrazi in, če je pomembno za preskus, navede njihova statistična značilnost.
English: Unless good reasons are given to the contrary, any quantitative modification of responses resulting from repeated administration of the substance shall be investigated.
Slovenian: Razen če ni tehtnih razlogov za nasprotno, se preverijo vse količinske spremembe odzivov, ki so rezultat večkratnega dajanja snovi.
English: Tests on combinations of active substances may be prompted either by pharmacological premisses or by indications of therapeutic effect.
Slovenian: Preskuse kombinacij zdravilnih učinkovin se lahko spodbuja s farmakološkimi premisami ali z navedbami terapevtskega učinka.
English: In the first case, the pharmacodynamic study shall demonstrate those interactions which might make the combination of value in therapeutic use.
Slovenian: V prvem primeru študija farmakodinamike pokaže tiste interakcije, ki bi lahko pokazale pomembnost kombinacije v terapevtski uporabi.
English: In the second case, where scientific justification for the combination is sought through therapeutic experimentation, the investigation shall determine whether the effects expected from the combination can be demonstrated in animals, and the importance of any collateral effects shall at least be investigated.
Slovenian: V drugem primeru, kadar se znanstvena utemeljitev za kombinacijo ugotavlja s pomočjo terapevtskih poskusov, raziskava določi, ali se pričakovani učinki kombinacije lahko dokažejo na živalih, in preveri pomembnost vseh dodatnih učinkov.
English: If a combination includes a novel active substance, the latter must previously have been studied in depth.
Slovenian: Če kombinacija vključuje novo zdravilno učinkovino, je snov treba predhodno temeljito preučiti.
English: Pharmacokinetics means the study of the fate of the active substance within the organism, and covers the study of the absorption, distribution, biotransformation and excretion of the substance.
Slovenian: Farmakokinetika vključuje študijo obnašanja zdravilne učinkovine v organizmu in zajema študijo absorpcije, porazdelitve, biotransformacije in izločanja snovi.
English: The study of these different phases may be carried out both by means of physical, chemical or biological methods, and by observation of the actual pharmacodynamic activity of the substance itself.
Slovenian: Študijo teh različnih faz je mogoče izvesti s fizikalnimi, kemijskimi ali biološkimi metodami in z opazovanjem dejanskega farmakodinamičnega delovanja snovi same.
English: Information on distribution and elimination (i.e. biotransformation and excretion) shall be necessary in all cases where such data are indispensable to determine the dosage for humans, and in respect of chemotherapeutic substances (antibiotics, etc.) and substances whose use depends on their non-pharmacodynamic effects (e.g. numerous diagnostic agents, etc.).
Slovenian: Podatki o porazdelitvi in eliminaciji (t.j. biotransformacija in izločanje) so potrebni v vseh primerih, kjer so taki podatki nujno potrebni za določanje odmerka pri ljudeh ter pri kemoterapevtikih (antibiotikih, itd.) ter snoveh, katerih uporaba je odvisna od njihovih nefarmakodinamičnih učinkov (npr. številni sredstva za diagnostiko, itd.).
English: Pharmacokinetic investigation of pharmacologically active substances is necessary.
Slovenian: Potrebna je farmakokinetična raziskava farmakološko zdravilnih učinkovin.
English: In the case of new combinations of known substances which have been investigated in accordance with the provisions of this Directive, pharmacokinetic studies may not be required, if the toxicity tests and therapeutic experimentation justify their omission.
Slovenian: V primeru novih kombinacija znanih snovi, raziskanih v skladu z določili te direktive, farmakokinetične študije niso nujno potrebne, če se njihovo opustitev utemelji s preskusi toksičnosti ter terapevtskimi poskusi.
English: The purpose of local tolerance studies is to ascertain whether medicinal products (both active substances and excipients) are tolerated at sites in the body which may come into contact with the medicinal product as a result of its administration in clinical use.
Slovenian: Namen študij o lokalni toleranci zdravila je preveriti prenašanje zdravil (tako zdravilnih učinkovin kot pomožnih snovi) na delih telesa, ki lahko pridejo v stik z zdravilom kot rezultat dajanja zdravila v klinični uporabi.
English: The testing strategy shall be such that any mechanical effects of administration or purely physico-chemical actions of the product can be distinguished from toxicological or pharmacodynamic ones.
Slovenian: Strategija preskusov mora biti taka, da je mogoče razlikovati mehanske učinke dajanja zdravila ali samo fizikalno-kemijsko delovanje zdravila od toksikološkega ali farmakodinamičnega delovanja.
English: Well-established medicinal use
Slovenian: Dobro uveljavljena medicinska uporaba
English: For the purpose of demonstrating, pursuant to Article 10(1)(a)(ii), that the component(s) of a medicinal product have a well established use, with an acceptable level of safety, the following specific rules shall apply:
Slovenian: Za dokazovanje na podlagi člena 10(1)(a)(ii), da ima(jo) sestavina(e) zdravila dobro uveljavljeno uporabo, s sprejemljivo ravnijo varnosti, se uporabljajo naslednja posebna pravila: