FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: descriptive pharmacokinetics leading to the evaluation of basic parameters such as body clearance, volume(s) of distribution, mean residence time, etc;
Slovenian: opisno farmakokinetiko, ki vodi do ocene osnovnih parametrov, kot so izčiščenje iz telesa, volumen(ni) za distribucijo, srednji čas prisotnosti itd.
English: use of these parameters to investigate the relationships between dosage regimen, plasma and tissue concentration and pharmacologic, therapeutic or toxic effects.
Slovenian: uporabo teh parametrov za raziskavo odnosov med režimom odmerjanja, plazemsko koncentracijo ter koncentracijo v tkivih ter farmakološkimi, terapevtskimi ali toksičnimi učinki.
English: In target species, pharmacokinetic studies are, as a rule, necessary in order to employ drugs with the greatest possible efficacy and safety.
Slovenian: Pri ciljnih živalskih vrstah so farmakokinetične študije po pravilu potrebne zato, da bi uporabljali zdravila kar najbolj učinkovito in varno.
English: Such studies are especially useful to assist the clinician in establishing dosage regimens (route and site of administration, dose, dosing interval, number of administrations, etc.) and to adopt dosage regimens according to certain population variables (e.g. age, disease).
Slovenian: Take študije so še posebno koristne kot pomoč klinikom pri določanju režima odmerjanja (način ter mesto dajanja, časovni intervali med odmerki, število dajanj zdravila itd.) ter za prilagajanje režima odmerjanja glede na določene različnosti v populaciji (npr. starost, bolezen).
English: Such studies can be more efficient in number of animals and generally provide more information than classical dose titration studies.
Slovenian: Tovrstne študije so pri več živali lahko bolj učinkovite ter na splošno lahko dajo več informacij kot klasične študije titracije odmerkov.
English: In the case of new combinations of known substances which have been investigated in accordance with the provisions of this Directive, pharmacokinetic studies of the fixed combination are not required if it can be justified that the administration of the active substances as a fixed combination does not change their pharmacokinetic properties.
Slovenian: Pri novih kombinacijah znanih snovi, ki so bile preučevane v skladu z določili te direktive, se farmakološke študije fiksnih kombinacij ne zahtevajo, če se lahko upraviči, da dajanje zdravilnih učinkovin v fiksni kombinaciji ne bo spremenila njihovih farmakokinetičnih lastnosti.
English: Bioavailability/bioequivalence
Slovenian: A.2.1 Biološka razpoložljivost/bioekvivalenca
English: Appropriate bioavailability studies shall be undertaken to establish bioequivalence:
Slovenian: Za določitev bioekvivalence je treba izvesti ustrezne študije biološke razpoložljivosti:
English: when comparing a reformulated medicinal product with the existing one,
Slovenian: kadar se primerja reformulirano zdravilo z obstoječim,
English: when comparing a new method or route of administration with an established one,
Slovenian: kadar se primerja novo metodo ali način dajanja zdravila z obstoječim,
English: in all cases referred to in Article 13(1).
Slovenian: v vseh primerih iz člena 13(1).
English: TOLERANCE IN THE TARGET SPECIES OF ANIMAL
Slovenian: TORELANCA PRI CILJNIH ŽIVALSKIH VRSTAH
English: The purpose of this study, which shall be carried out with all animal species for which the medicinal product is intended, is to carry out in all such animal species local and general tolerance trials designed to establish a tolerated dosage wide enough to allow an adequate safety margin and the clinical symptoms of intolerance using the recommended route or routes, in so far as this may be achieved by increasing the therapeutic dose and/or the duration of treatment.
Slovenian: Namen te študije, ki jo je treba izvesti pri vseh živalskih vrstah, ki jim je zdravilo namenjeno, je izvedba preskusov lokalne in splošne tolerance pri vseh takih živalskih vrstah zato, da bi se ugotovilo tolerirano odmerjanje, ki bo dovolj široko, da bi omogočilo varnosti pas in klinične znake netolerance pri priporočenem načinu(nih) dajanja zdravila, kolikor je to mogoče doseči s povečevanjem terapevtskega odmerka in/ali trajanjem zdravljenja.
English: The report on the trials shall contain as many details as possible of the expected pharmacological effects and the adverse reactions;
Slovenian: Poročilo o preskusih mora vsebovati kar se da največ podrobnosti o pričakovanih farmakoloških učinkih ter škodljivih učinkih;
English: the latter shall be assessed with due regard to the fact that the animals used may be of very high value.
Slovenian: slednje je treba oceniti z dolžnim upoštevanjem dejstva, da imajo morda uporabljene živali visoko vrednost.
English: The medicinal product shall be administered at least via the recommended route of administration.
Slovenian: Zdravila je treba dajati vsaj na priporočen način dajanja.
English: RESISTANCE
Slovenian: REZISTENCA
English: Data on the emergence of resistant organisms are necessary in the case of medicinal products used for the prevention or treatment of infectious diseases or parasitic infestations in animals.
Slovenian: V primeru uporabe zdravil za preventivo ali zdravljenje infekcijskih bolezni ali parazitskih infestacij pri živalih, so potrebni podatki o pojavljanju rezistentnih organizmov.
English: Clinical requirements
Slovenian: Klinične zahteve
English: General principles
Slovenian: Splošne zahteve
English: The purposes of clinical trials are to demonstrate or substantiate the effect of the veterinary medicinal product after administration of the recommended dosage, to specify its indications and contra-indications according to species, age, breed and sex, its directions for use, any adverse reactions which it may have and its safety and tolerance under normal conditions of use.
Slovenian: Namen kliničnih preskušanj je dokazati ali podkrepiti učinek zdravila za uporabo v veterinarski medicini po dajanju zdravila v priporočenih odmerkih. S tem se določijo indikacije in kontraindikacije glede na živalsko vrsto, starost, pasmo in spol, navodila za uporabo, škodljivi učinki, ki bi jih proizvod lahko imel ter varnost proizvoda in toleranca v normalnih pogojih uporabe.
English: Unless justified, clinical trials shall be carried out with control animals (controlled clinical trials).
Slovenian: Razen v upravičenem primeru se morajo klinična preskušanja izvesti s kontrolnimi živalmi (kontrolirana klinična preskušanja).
English: The effect obtained should be compared with a placebo or with absence of treatment and/or with the effect of an authorized medicinal product known to be of therapeutic value.
Slovenian: Pridobljene učinke je treba primerjati s placebo ali z odsotnostjo zdravljenja in/ali z učinki zdravila, ki ima dovoljenje za promet, pri katerem je terapevtska vrednost znana.
English: All the results obtained, whether positive or negative, shall be reported.
Slovenian: O vseh pridobljenih rezultatih, pozitivnih ali negativnih, je treba poročati.
English: The methods used to make the diagnosis shall be specified.
Slovenian: Treba je specificirati uporabljene metode za postavitev diagnoze.
English: The results shall be set out by making use of quantitative or conventional clinical criteria.
Slovenian: Rezultate je treba določiti z uporabo kvantitativnih ali konvencionalnih kliničnih meril.
English: Adequate statistical methods shall be used and justified.
Slovenian: Uporabiti in upravičiti je treba ustrezne statistične metode.
English: In the case of a veterinary medicinal product intended primarily for use as a performance enhancer, particular attention shall be given to:
Slovenian: Pri zdravilu za uporabo v veterinarski medicini, namenjenemu primarno za spodbujanje proizvodnosti, je potrebno pozornost posvetiti predvsem:
English: the yield of animal produce,
Slovenian: donosnosti živalskega proizvoda,
English: the quality of animal produce (organoleptic, nutritional, hygienic and technological qualities),
Slovenian: kakovosti živalskega proizvoda (organoleptična, hranilna, higienska in tehnološka kakovost),
English: nutritional efficiency and growth of animal,
Slovenian: hranilni učinkovitost ter rasti živali,
English: the general status of health of the animal.
Slovenian: splošnemu zdravstvenemu stanje živali.
English: Experimental data shall be confirmed by data obtained under practical field conditions.
Slovenian: Eksperimentalne podatke je treba potrditi s podatki, ki so pridobljeni v praktičnih pogojih na terenu.
English: Where, in respect of particular therapeutic indications, the applicant can show that he is unable to provide comprehensive data on therapeutic effect because:
Slovenian: V primeru, če za določene terapevtske indikacije predlagatelj lahko dokaže, da ne more predložiti izčrpnih podatkov o terapevtskem učinku zato ker:
English: the indications for which the medicinal product in question is intended are encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence;
Slovenian: se indikacije, za katere je zadevno zdravilo namenjeno, pojavljajo zelo redko, tako da od predlagatelja ni možno pričakovati, da bo predložil izčrpne dokaze;
English: in the present state of scientific knowledge, comprehensive information cannot be provided;
Slovenian: glede na stanje znanstvenega napredka izčrpne informacije niso možne,
English: the marketing authorization may only be granted subject to the following conditions:
Slovenian: se dovoljenje za promet z zdravilom lahko izda pod naslednjimi pogoji:
English: the medicinal product in question is to be supplied on veterinary prescription only and may, in certain cases, be administered only under strict veterinary supervision;
Slovenian: zadevno zdravilo se sme izdajati samo na veterinarski recept ter ga lahko v določenih primerih dajemo samo pod strogim veterinarskim nadzorom;
English: the package insert and any other information must draw the attention of the veterinary practitioner to the fact that, in certain specified respects, the particulars available concerning the medicinal product in question are as yet incomplete.
Slovenian: navodilo za uporabo ter druge informacije morajo opozarjati veterinarja na dejstvo, da, v nekaterih določenih okoliščinah, podrobni razpoložljivi podatki, ki se nanašajo na zdravilo, niso popolni.
English: Performance of trials
Slovenian: Izvedba preskušanj
English: All veterinary clinical trials shall be conducted in accordance with a fully considered detailed trial protocol which shall be recorded in writing prior to commencement of the trial.
Slovenian: Vsa veterinarska klinična preskušanja se morajo opraviti ob doslednem upoštevanju podrobnega protokola preskušanja, ki mora biti pred preskušanjem zapisan.
English: The welfare of the trial animals shall be subject to veterinary supervision and shall be taken fully into consideration during the elaboration of any trial protocol and throughout the conduct of the trial.
Slovenian: Zaščita pred mučenjem poskusne živali mora biti pod nadzorom veterinarja ter jo je treba pri načrtovanju protokola preskušanja ter med izvajanjem preskušanja dosledno upoštevati.
English: Pre-established systematic written procedures for the organization, conduct, data collection, documentation and verification of clinical trials shall be required.
Slovenian: Potrebna je sistematična predhodna pisna izdelava postopkov za organizacijo, izvajanje, zbiranje podatkov, dokumentacijo ter preverjanje kliničnih preskušanj.
English: Before the commencement of any trial, the informed consent of the owner of the animals to be used in the trial shall be obtained and documented.
Slovenian: Pred začetkom preskušanj je treba pridobiti in dokumentirati soglasje lastnika živali, ki bodo uporabljene v preskušanju.
English: In particular, the animal owner shall be informed in writing of the consequences of participation in the trial for the subsequent disposal of treated animals or for the taking of foodstuffs from treated animals.
Slovenian: Še posebno mora biti lastnik živali pisno obveščen o posledicah sodelovanja v preskušanju glede poznejše oddaje zdravljene živali ali pridobivanja živil iz tako zdravljene živali.
English: A copy of this notification, countersigned and dated by the animal owner, shall be included in the trial documentation.
Slovenian: Kopijo tega obvestila, podpisano in datirano s strani lastnika živali, je treba vključiti v dokumentacijo o preskušanju.
English: Unless the trial is conducted with a blind design, the provisions of Articles 58, 59 and 60 concerning the labelling of veterinary medicinal products shall apply by analogy to the labelling of formulations intended for use in veterinary clinical trials.
Slovenian: Razen v primeru, če se preskušanje izvaja s slepim testom, se morajo uporabiti določila členov 58, 59 ter 60 glede označevanja zdravil za uporabo v veterinarski medicini po analogiji za označevanje formulacij, ki so namenjene uporabi v veterinarskih kliničnih preskušanjih.
English: In all cases, the words "for veterinary clinical trial use only" shall appear prominently and indelibly upon the labelling.
Slovenian: V vseh primerih je potreben na nalepki jasen in neizbrisen napis "samo za veterinarsko klinično preskušanje".
English: Chapter III
Slovenian: Poglavje III
English: Particulars and documents
Slovenian: Podrobni podatki in dokumentacija
English: As in any scientific work, the dossier on efficacy shall include an introduction defining the subject accompanied by any useful bibliographical documentation.
Slovenian: Tako kot pri vsakem znanstvenem delu, mora dokumentacija o učinkovitosti vsebovati uvod, ki opredeljuje predmet, spremljati pa ga mora vsa koristna bibliografska dokumentacija.
English: All pre-clinical and clinical documentation must be sufficiently detailed to enable an objective judgement to be made.
Slovenian: Vsa predklinična in klinična dokumentacija mora biti dovolj podrobna, da bi omogočala objektivno oceno.
English: All studies and trials must be reported, whether favourable or unfavourable to the applicant.
Slovenian: O vseh študijah in preskušanjih je treba izdelati poročilo, bodisi da je ugodno ali neugodno za predlagatelja.
English: Records of pre-clinical observations
Slovenian: Podatki o predkliničnih opažanjih
English: Wherever possible, particulars shall be given of the results of:
Slovenian: Če je le možno, je treba podati podrobne podatke o rezultatih:
English: tests demonstrating pharmacological actions;
Slovenian: preskusov, ki prikazujejo farmakološke učinke;
English: tests demonstrating the pharmacological mechanisms underlying the therapeutic effect;
Slovenian: preskusov, ki prikazujejo farmakološke mehanizme, ki podpirajo terapevtske učinke;
English: tests demonstrating the main pharmacokinetic processes.
Slovenian: preskusov, ki prikazujejo glavne farmakokinetične procese.
English: Should unexpected results occur during the course of the tests, these should be detailed.
Slovenian: Če bi se pojavili nepričakovani rezultati med trajanjem preskušanja, jih je treba natančno opisati.
English: Additionally the following particulars shall be provided in all pre-clinical studies:
Slovenian: Dodatno je treba predložiti naslednje podrobne podatke za vse predklinične študije:
English: a summary;
Slovenian: povzetek;
English: a detailed experimental protocol giving a description of the methods, apparatus and materials used, details such as species, age, weight, sex, number, breed or strain of animals, identification of animals, dose, route and schedule of administration;
Slovenian: podroben eksperimentalni protokol z opisom metod, opreme ter uporabljenih materialov, podatke kot so živalska vrsta, starost, teža, spol, pasma ali rod živali, identifikacija živali, odmerek, način ter načrt dajanja zdravila;
English: a statistical analysis of the results where relevant;
Slovenian: statistično analizo rezultatov, kjer je to relevantno;
English: an objective discussion of the results obtained, leading to conclusions on the safety and efficacy of the product.
Slovenian: objektivno razpravo o pridobljenih rezultatih s sklepom o varnosti in učinkovitosti zdravila;
English: Total or partial omission of these data must be explained.
Slovenian: Popolno ali delno opuščanje teh podatkov je treba obrazložiti.
English: Records of clinical observations
Slovenian: Podatki o kliničnih opažanjih
English: All the particulars shall be supplied by each of the investigators on individual record-sheets in the case of individual treatment and collective record-sheets in the case of collective treatment.
Slovenian: Vse podrobne podatke mora vsak preiskovalec podati v primeru individualnega zdravljenja kot ločeno individualno poročilo, ali, v primeru skupinskega zdravljenja, kot skupno poročilo.
English: The particulars supplied shall take the following form:
Slovenian: Podrobni podatki morajo biti v naslednji obliki:
English: name, address, function and qualifications of investigator in charge;
Slovenian: ime, naslov, funkcija in usposobljenost pooblaščenega preiskovalca;
English: place and date of treatment;
Slovenian: kraj in datum zdravljenja;
English: name and address of owner of the animals;
Slovenian: ime in naslov lastnika živali;
English: details of the trial protocol giving a description of the methods used, including methods of randomization and blinding, details such as the route of administration, schedule of administration, the dose, identification of trial animals, species, breeds or strains, age, weight, sex, physiological status;
Slovenian: podrobnosti o protokolu preskušanja z opisom uporabljenih metod, vključno z metodo naključnega izbora ter slepega preskušanja, podrobnosti o načinu dajanja zdravila, časovnem razporedu dajanja zdravila, odmerkih, identifikaciji poskusnih živali, živalski vrsti, pasmi in rodu, starosti, teži, spolu, fiziološkem stanju;
English: method of rearing and feeding, stating the composition of the feed and the nature and quantity of any additives contained in the feed;
Slovenian: metoda vzreje ter hranjenja z navedbo sestave krme ter z navedbo lastnosti in količine kakršnih koli dodatkov, ki jih krma vsebuje;
English: case history (as full as possible), occurrence and course of any inter-current diseases;
Slovenian: zgodovina primera (čim bolj izčrpno), pojav in potek trenutne bolezni;
English: diagnosis and means used to make it;
Slovenian: diagnoza ter sredstva, uporabljena za postavitev diagnoze;
English: symptoms and severity of the disease, if possible according to conventional criteria;
Slovenian: simptomi ter resnost bolezni, po možnosti v skladu z običajnimi merili;
English: the precise identification of the clinical trial formulation used in the trial;
Slovenian: točna identifikacija formulacije, uporabljene v kliničnem preskušanju;
English: dosage of the medicinal product, method, route and frequency of administration and precautions, if any, taken during administration (duration of injection, etc.);
Slovenian: odmerek zdravila, metoda, način in pogostost dajanja zdravila ter previdnostni ukrepi, če so bili uporabljeni med dajanjem zdravila (trajanje vbrizgavanja itd.).
English: duration of treatment and period of subsequent observation;
Slovenian: trajanje zdravljenja ter čas opazovanja, po zdravljenju;
English: all details concerning medicinal products (other than that under study) which have been administered during the period of examination, either prior to or concurrently with the test product and, in the latter case, details of the interactions observed;
Slovenian: vse podrobnosti o zdravilih (razen tistih, ki so vključena v študiji) in so bila uporabljena med časom preskušanja, bodisi pred ali sočasno s preskušanim zdravilom ter v slednjem primeru, opažanja o medsebojnem delovanju;
English: all results of the clinical trials (including unfavourable or negative results) with a full statement of the clinical observations and the results of the objective tests of activity (laboratory analyses, physiological tests), required to evaluate the application;
Slovenian: vsi rezultati kliničnih preskušanj (vključno z ugodnimi ali neugodnimi rezultati) s polnim opisom kliničnih opažanj ter rezultatov objektivih preskusov o aktivnosti (laboratorijske analize, fiziološki preskusi), ki se zahtevajo za oceno vloge;
English: the techniques used must be specified, and the significance of any variations in the results explained (e.g. variance in method, variance between individuals or the effects of the medication);
Slovenian: specificirane morajo biti tehnike ter pomen odstopanj pri rezultatih (npr. odstopanja pri metodah, odstopanja pri posameznih primerih ali učinkih zdravil);
English: demonstration of the pharmacodynamic effect in animals shall not in itself suffice to justify conclusions concerning any therapeutic effect;
Slovenian: prikaz farmakodinamičnih učinkov pri živalih samo po sebi ni dovolj za opravičevanje sklepov glede terapevtskega učinka;
English: all particulars of any unintended effects, whether harmful or not, and of any measures taken in consequence;
Slovenian: vsi podrobni podatki o nenamernih učinkih, ne glede na to ali so škodljivi ali ne, ter o vseh posledičnih ukrepih;
English: the cause-and-effect relationship shall be investigated if possible;
Slovenian: če je možno, je treba raziskati odnos med vzroki in posledicami;
English: effect of animals' performance (e.g. egg-laying, milk production and reproductive function);
Slovenian: učinek na proizvodnost živali (npr. valjenje jajc, proizvodnja mleka, ter reproduktivne funkcije);
English: effects on the quality of foodstuffs obtained from treated animals, particularly in the case of medicinal products intended for use as performance enhancers;
Slovenian: učinki na kakovost živil, pridobljenih iz zdravljenih živali, posebno v primeru zdravil, ki jih uporabljamo kot spodbujevalce proizvodnosti;
English: a conclusion on each individual case or, where collective treatment is concerned, on each collective case.
Slovenian: sklep za vsak posamezen primer, ali kjer gre za skupinsko zdravljenje, za vsak skupinski primer.
English: Omission of one or more items (a) to (p) shall be justified.
Slovenian: Opustitev ene ali več postavk je treba opravičiti.
English: The marketing authorization holder shall make all necessary arrangements to ensure that the original documents, which formed the basis of the data supplied, are kept for at least five years after the veterinary medicinal product is no longer authorized.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora izvesti vse potrebno,da se originalni dokumenti, ki so osnova predloženih podatkov, hranijo najmanj pet let po izteku dovoljenja za promet z zdravilom za uporabo v veterinarski medicini.
English: Summary and conclusions of clinical observations
Slovenian: Povzetek in zaključki kliničnih opažanj
English: In respect of each clinical trial, the clinical observations shall be summarized in a synopsis of the trials and the results thereof, indicating in particular:
Slovenian: Za vsako klinično preskušanje je treba izdelati strnjen pregled in povzetek vseh preskušanj ter rezultatov, še posebno pa je treba izpostaviti:
English: the number of controls, the number of animals treated either individually or collectively, with a breakdown according to species, breed or strain, age and sex;
Slovenian: število kontrol, število zdravljenih živali, bodisi individualno ali skupinsko, posebej glede na živalsko vrsto, pasmo ali rod, starost in spol;
English: the number of animals withdrawn prematurely from the trials and the reasons for such withdrawal;
Slovenian: število živali, ki so bile predčasno izločene iz preskušanj ter razloge za izločitev;
English: in the case of control animals, whether they have:
Slovenian: za kontrolne živali podatke o tem ali:
English: received no treatment;
Slovenian: niso bile zdravljene;
English: received a placebo;
Slovenian: so prejele placebo;
English: received another authorized medicinal product of known effect;
Slovenian: so prejele kako drugo zdravilo z dovoljenjem za promet z znanim učinkom;
English: received the active substance under investigation in a different formulation or by a different route;
Slovenian: so prejele zdravilno učinkovino, ki se preskuša, v drugačni formulaciji ali na drugačen način;