natgillin/translations-raw huggingface dataset:
Where relevant, data on the potential emergence of resistant organisms of clinical relevance are necessary for veterinary medicinal products.
Kadar so na voljo podatki o mogočem nastanku odpornih organizmov, ki so klinično pomembni, se priložijo k vlogi za zdravila za uporabo v veterinarski medicini.
Measures to limit resistance development from the intended use of the veterinary medicinal product shall be proposed by the applicant.
Predlagatelj predlaga ukrepe za omejitev razvoja odpornosti zaradi predvidene uporabe zdravila za uporabo v veterinarski medicini.
Where relevant, cross reference shall be made to data set out in Part 3.
Kadar je ustrezno, se navedejo sklicevanja na podatke iz dela 3.
Basic pharmacokinetic data concerning a new active substance are required in the context of assessment of the clinical safety and efficacy of the veterinary medicinal product.
Pri oceni klinične varnosti in učinkovitosti zdravila za uporabo v veterinarski medicini so zahtevani osnovni farmakokinetični podatki.
The objectives of pharmacokinetic studies in the target animal species can be divided into three main areas:
Cilji farmakokinetičnih študij na ciljni živalski vrsti se lahko razdelijo na tri glavna področja:
descriptive pharmacokinetics leading to the determination of basic parameters.;
opisna farmakokinetika prispeva k določanju osnovnih parametrov;
use of these parameters to investigate the relationships between dosage regimen, plasma and tissue concentration over time and pharmacological, therapeutic or toxic effects;
uporaba teh parametrov za raziskavo razmerij med režimom odmerjanja, plazemsko koncentracijo ter koncentracijo v tkivih ter farmakološkimi, terapevtskimi ali toksičnimi učinki;
where appropriate, to compare the kinetics between different target species and to explore possible species differences having an impact on target animal safety and efficacy of the veterinary medicinal product.
kadar je ustrezno, primerjava kinetike pri različnih ciljnih vrstah in ugotavljanje mogočih razlik v vrsti, ki vplivajo na varnost ciljne živali in učinkovitost zdravila za uporabo v veterinarski medicini pri ciljni živali.
In the target animal species, pharmacokinetic studies are, as a rule, necessary as a complement to the pharmacodynamic studies to support the establishment of effective dosage regimens (route and site of administration, dose, dosing interval, number of administrations, etc.).
Pri ciljni živalski vrsti so študije farmakokinetike po pravilu potrebne za dopolnitev farmakodinamičnih študij za podporo določitvi učinkovitih režimov odmerjanja (način in mesto dajanja, odmerek, časovni interval med dajanji, število dajanj itd.).
Additional pharmacokinetic studies may be required to establish dosage regimens according to certain population variables.
Dodatne farmakokinetične študije so včasih potrebne za določitev režimov odmerjanja v skladu z nekaterimi značilnostmi populacije.
Where pharmacokinetic studies have been submitted under Part 3 cross reference to such studies may be made.
Kadar se farmakokinetične študije predložijo v skladu z delom 3, se lahko navedejo sklicevanja na takšne študije.
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.
Pri novih kombinacijah znanih snovi, ki so bile preučevane v skladu z določbami te direktive, se farmakokinetične študije fiksnih kombinacij ne zahtevajo, če se lahko utemelji, da dajanje zdravilnih učinkovin v fiksni kombinaciji ne spreminja njihovih farmakokinetičnih lastnosti.
Appropriate bioavailability studies shall be undertaken to establish bioequivalence:
Za določitev bioekvivalence se izvedejo ustrezne študije biološke uporabnosti:
when comparing a reformulated veterinary medicinal product with the existing one,
kadar se primerja reformulirano zdravilo za uporabo v veterinarski medicini z obstoječim,
where necessary for the comparison of a new method or route of administration with an established one.
kadar so potrebne za primerjavo nove metode ali načina dajanja zdravila z obstoječim.
The local and systemic tolerance of the veterinary medicinal product shall be investigated in the target animal species.
Preuči se lokalna in sistemska toleranca zdravila za uporabo v veterinarski medicini pri ciljni živalski vrsti.
The purpose of these studies is to characterise signs of intolerance and to establish an adequate margin of safety using the recommended route(s) of administration.
Namen teh študij je opredeliti znake netolerance in določiti ustrezno mejo varnosti pri uporabi priporočenih načinov dajanja.
This may be achieved by increasing the therapeutic dose and/or the duration of treatment.
To se lahko doseže s povečevanjem terapevtskega odmerka in/ali trajanja zdravljenja.
The report on the trials shall contain details of all expected pharmacological effects and all adverse reactions.
Poročilo o preskušanju vključuje podrobne podatke o vseh predvidenih farmakoloških učinkih in vseh neželenih učinkih.
The purpose of clinical trials is to demonstrate or substantiate the effect of the veterinary medicinal product after administration at the proposed dosage regimen via the proposed route of administration and to specify its indications and contra-indications according to species, age, breed and sex, its directions for use as well as any adverse reactions which it may have.
Namen kliničnih preskušanj je dokazati ali podkrepiti učinek zdravila za uporabo v veterinarski medicini pri dajanju zdravila v priporočenih odmerkih in na priporočene načine ter določiti indikacije in kontraindikacije glede na vrsto, starost, pasmo in spol, navodila za uporabo ter neželene učinke.
Experimental data shall be confirmed by data obtained under normal field conditions.
Eksperimentalni podatki se potrdijo s podatki, pridobljenimi v normalnih pogojih na terenu.
Unless justified, clinical trials shall be carried out with control animals (controlled clinical trials).
Razen če je utemeljeno drugače, se klinična preskušanja izvedejo s kontrolnimi živalmi (kontrolirana klinična preskušanja).
The efficacy results obtained should be compared with those from the target animal species that have received a veterinary medicinal product authorised in the Community for the same indications for use in the same target animal species, or a placebo or no treatment.
Pridobljene rezultate učinkovitosti je treba primerjati z rezultati, pridobljenimi na ciljni živalski vrsti, ki je prejela zdravilo za uporabo v veterinarski medicini, odobreno v Skupnosti za enake indikacije uporabe pri ciljni živalski vrsti, ali placebo ali ni bila zdravljena.
All the results obtained, whether positive or negative, shall be reported.
Poroča se o vseh pozitivnih ali negativnih rezultatih.
Established statistical principles shall be used in protocol design, analysis and evaluation of clinical trials, unless justified.
Razen če je utemeljeno drugače, se pri načrtovanju protokola, analizi in oceni kliničnih preskušanj uporabljajo uveljavljena statistična načela.
In the case of a veterinary medicinal product intended primarily for use as a performance enhancer, particular attention shall be given to:
Pri zdravilu za uporabo v veterinarski medicini, namenjenemu primarno za spodbujanje proizvodnosti, se pozornost nameni predvsem:
the yield of animal produce,
donosnosti živalskega proizvoda;
the quality of animal produce (organoleptic, nutritional, hygienic and technological qualities),
kakovosti živalskega proizvoda (organoleptična, hranilna, higienska in tehnološka kakovost);
nutritional efficiency and growth of target animal species,
hranilni učinkovitost ter rasti ciljne živalske vrste;
general health status of the target animal species.
splošnemu zdravstvenemu stanju ciljne živalske vrste.
All veterinary clinical trials shall be conducted in accordance with a detailed trial protocol.
Vsa veterinarska klinična preskušanja se izvajajo v skladu s podrobnimi protokoli preskušanja.
Clinical field trials shall be conducted in accordance with established principles of good clinical practice, unless otherwise justified.
Razen če je utemeljeno drugače, se klinična terenska preskušanja izvajajo v skladu z uveljavljenimi načeli dobre laboratorijske prakse.
Before the commencement of any field trial, the informed consent of the owner of the animals to be used in the trial shall be obtained and documented.
Pred začetkom vsakega terenskega preskušanja se pridobi in dokumentira soglasje lastnika živali, ki se uporabljajo v preskušanju.
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.
Še zlasti se lastnika živali pisno obvesti o posledicah sodelovanja v preskušanju glede poznejše oddaje zdravljene živali ali pridobivanja živil iz tako zdravljene živali.
A copy of this notification, countersigned and dated by the animal owner, shall be included in the trial documentation.
Kopija tega obvestila, ki ga lastnik živali podpiše in datira, se vključi v dokumentacijo o preskušanju.
Unless the field trial is conducted with a blind design, the provisions of Articles 55, 56 and 57 shall apply by analogy to the labelling of formulations intended for use in veterinary field trials.
Razen če se preskušanje izvaja s slepim preskusom, se za označevanje formulacij, namenjenih za uporabo v veterinarskih terenskih preskušanjih, uporabljajo določbe členov 55, 56 in 57.
In all cases, the words “for veterinary field trial use only” shall appear prominently and indelibly upon the labelling.
V vseh primerih je na nalepki jasen in neizbrisen napis ‚samo za veterinarsko terensko preskušanje‘.
The dossier on efficacy shall include all pre-clinical and clinical documentation and/or results of trials, whether favourable or unfavourable to the veterinary medicinal products, in order to enable an objective overall assessment of the risk/benefit balance of the product.
Dokumentacija o učinkovitosti vključuje vso predklinično in klinično dokumentacijo in/ali rezultate preskušanj, ugodne ali neugodne za zdravila za uporabo v veterinarski medicini, da se omogoči objektivna celotna ocena tveganj/koristi zdravila.
Wherever possible, particulars shall be given of the results of:
Kadar je mogoče, se podajo podrobni podatki o rezultatih:
tests demonstrating pharmacological actions;
preskusov, ki preučujejo farmakološka delovanja;
tests demonstrating the pharmacodynamic mechanisms underlying the therapeutic effect;
preskusov, ki preučujejo farmakodinamične mehanizme, ki podpirajo terapevtske učinke;
tests demonstrating the main pharmacokinetic profile;
preskusov, ki preučujejo glaven farmakokinetični profil;
tests demonstrating target animal safety;
preskuse, ki preučujejo varnost ciljne živali;
tests investigating resistance.
preskuse, ki preučujejo odpornost.
Should unexpected results occur during the course of the tests, these should be detailed.
Če se med preskusi pojavijo nepričakovani rezultati, jih je treba natančno opisati.
Additionally, the following particulars shall be provided in all pre-clinical studies:
Poleg tega se predložijo naslednji podrobni podatki za vse predklinične študije:
a summary;
povzetek;
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;
podroben eksperimentalni protokol z opisom uporabljenih metod, opreme in materialov, podatke kot so vrsta, starost, teža, spol, število, pasma ali rod živali, identifikacija živali, odmerek, način ter načrt dajanja zdravila;
a statistical analysis of the results, where relevant;
kadar je ustrezno, statistična analiza rezultatov;
an objective discussion of the results obtained, leading to conclusions on the efficacy and safety of the veterinary medicinal product.
objektivna razprava pridobljenih rezultatov s sklepom o učinkovitosti in varnosti zdravila za uporabo v veterinarski medicini.
Total or partial omission of any of these data shall be justified.
Popolna ali delna opustitev teh podatkov se utemelji.
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.
Vsak preiskovalec poda vse podrobne podatke pri individualnem zdravljenju kot ločeno individualno poročilo, pri skupinskem zdravljenju pa kot skupno poročilo.
The particulars supplied shall take the following form:
Navedejo se naslednji podrobni podatki:
name, address, function and qualifications of investigator in charge;
ime, naslov, funkcija in izobrazba pooblaščenega preiskovalca;
place and date of treatment; name and address of owner of the animals;
kraj in datum zdravljenja; ime in naslov lastnika živali;
details of the clinical trial protocol giving a description of the methods used, including methods of randomisation 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;
podatki o protokolu kliničnega preskušanja z opisom uporabljenih metod, vključno z metodami naključnega izbora ter slepega preskušanja, podatki o načinu dajanja zdravila, časovnem razporedu dajanja zdravila, odmerkih, identifikaciji poskusnih živali, vrsti, pasmi ali rodu, starosti, teži, spolu, fiziološkem stanju;
method of animal management and feeding, stating the composition of the feed and the nature and quantity of any feed additives;
metoda gospodarjenja z živalmi ter njihovega hranjenja z navedbo sestave krme ter lastnosti in količine kakršnih koli krmnih dodatkov;
case history (as full as possible), including occurrence and course of any intercurrent diseases;
zgodovina primera (čim bolj izčrpno), vključno s pojavom in potekom trenutne bolezni;
diagnosis and means used to make it;
diagnoza ter sredstva, uporabljena za postavitev diagnoze;
clinical signs, if possible according to conventional criteria;
klinični znaki, po možnosti v skladu z uveljavljenimi načeli;
precise identification of the formulation of the veterinary medicinal product used in the clinical trial and the physical and chemical test results for the relevant batch(es);
natančen opis formulacije zdravila za uporabo v veterinarski medicini, uporabljenega v kliničnem preskušanju, ter fizikalnih in kemijskih rezultatov poskusa za ustrezne serije;
dosage of the veterinary medicinal product, method, route and frequency of administration and precautions, if any, taken during administration (duration of injection, etc.);
odmerek zdravila za uporabo v veterinarski medicini, metoda, način in pogostost dajanja zdravila ter kakršni koli previdnostni ukrepi, ki so bili sprejeti med dajanjem zdravila (trajanje vbrizgavanja itd.);
duration of treatment and period of subsequent observation;
trajanje zdravljenja ter čas opazovanja po zdravljenju;
all details concerning other veterinary medicinal products 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 any interactions observed;
vsi podatki o drugih zdravilih za uporabo v veterinarski medicini, ki so bila uporabljena med preskušanjem, pred ali sočasno s preskušanim zdravilom, ter v slednjem primeru, podrobne podatke o kakršnih koli ugotovljenih medsebojnih vplivih;
all results of the clinical trials, fully describing the results based on the efficacy criteria and end points specified in the clinical trial protocol and including the results of the statistical analyses, if appropriate;
vsi rezultati kliničnih preskušanj, ki v celoti opisujejo rezultate na podlagi meril učinkovitosti in končnih točk, opredeljenih v protokolu kliničnega preskusa, ter po potrebi rezultati statističnih analiz;
all particulars of any unintended event, whether harmful or not, and of any measures taken in consequence; the cause-and-effect relationship shall be investigated if possible;
vsi podrobni podatki o kakršnih koli nenamernih učinkih, škodljivih ali ne, ter o vseh posledičnih ukrepih; če je mogoče, se razišče povezava med vzroki in posledicami;
effect on animals’ performance if appropriate;
po potrebi učinek na proizvodnost živali;
effects on the quality of foodstuffs obtained from treated animals, particularly in the case of veterinary medicinal products intended for use as performance enhancers;
učinki na kakovost živil, pridobljenih iz zdravljenih živali, zlasti v primeru zdravil za uporabo v veterinarski medicini, ki so namenjena uporabi kot spodbujevalci proizvodnosti;
a conclusion on the safety and efficacy in each individual case or, summarised in terms of frequencies or other appropriate variables where specific mass treatment is concerned.
sklep o varnosti in učinkovitosti v vsakem posameznem primeru ali povzetek pogostosti ali drugih ustreznih parametrov, ki zadevajo specifično skupinsko zdravljenje.
Omission of one or more items (a) to (p) shall be justified.
Opustitev ene ali več postavk od (a) do (p) se utemelji.
The marketing authorisation 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 authorised.
Imetnik dovoljenja za promet z zdravilom zagotovi, da se originalni dokumenti, ki predstavljajo podlago za predložene podatke, hranijo vsaj pet let po tem, ko zdravilo za uporabo v veterinarski medicini ni več odobreno.
In respect of each clinical trial, the clinical observations shall be summarised in a synopsis of the trials and the results thereof, indicating in particular:
Pri vsakem kliničnem preskusu se klinične ugotovitve strnejo v povzetek preskusov in rezultatov, v katerem so navedeni predvsem:
the number of control and test animals treated either individually or collectively, with a breakdown according to species, breed or strain, age and sex;
število kontrolnih in preskusnih živali, zdravljenih posamezno ali skupinsko, razdeljenih glede na vrsto, pasmo ali rod, starost in spol;
the number of animals withdrawn prematurely from the trials and the reasons for such withdrawal;
število živali, ki so bile predčasno izločene iz preskušanj ter razlogi za izločitev;
in the case of control animals, whether they have:
za kontrolne živali podatki o tem, ali:
received no treatment, or
niso prejele ničesar ali
received a placebo, or
so prejele placebo ali
received another veterinary medicinal product authorised in the Community for the same indication for use in the same target animal species, or
so prejele drugo zdravilo za uporabo v veterinarski medicini, odobreno v Skupnosti za uporabo za isto indikacijo pri isti ciljni živalski vrsti, ali
received the same active substance under investigation in a different formulation or by a different route;
so prejele isto zdravilno učinkovino, ki se preskuša, v drugačni formulaciji ali na drugačen način;
the frequency of observed adverse reactions;
pogostost ugotovljenih neželenih učinkov;
observations as to the effect on animal performance, if appropriate;
ugotovitve o vplivu na proizvodnost živali, kadar je ustrezno;
details concerning test animals which may be at increased risk owing to their age, their mode of rearing or feeding, or the purpose for which they are intended, or animals the physiological or pathological condition of which requires special consideration;
podatki o poskusnih živalih, pri katerih je tveganje povečano zaradi njihove starosti, načina gojenja ali hranjenja ali namena njihove uporabe, ali živalih, pri katerih fiziološko ali patološko stanje zahteva posebno obravnavo;
a statistical evaluation of the results.
statistična analiza rezultatov.
Finally, the investigator shall draw general conclusions on the efficacy and safety of the veterinary medicinal product under the proposed conditions of use, and in particular any information relating to indications and contraindications, dosage and average duration of treatment and where, appropriate, any interactions observed with other veterinary medicinal products or feed additives as well as any special precautions to be taken during treatment and the clinical symptoms of overdosage, when observed.
Na koncu preiskovalec pripravi splošne sklepne ugotovitve o učinkovitosti in varnosti zdravila za uporabo v veterinarski medicini pod predlaganimi pogoji uporabe in predloži kakršne koli informacije o indikacijah in kontraindikacijah, odmerkih, povprečnem trajanju zdravljenja, kadar je ustrezno, kakršnih koli ugotovljenih medsebojnih vplivih z drugimi zdravili za uporabo v veterinarski medicini ali krmnimi dodatki, ter o posebnih previdnostnih ukrepih, ki jih je treba upoštevati med zdravljenjem, ter kliničnih simptomih prevelikega odmerjanja, kadar so ugotovljeni.
In the case of fixed combination products, the investigator shall also draw conclusions concerning the safety and the efficacy of the product when compared with the separate administration of the active substances involved.
Pri zdravilih s fiksno kombinacijo preiskovalec pripravi tudi sklepne ugotovitve o varnosti in učinkovitosti zdravila v primerjavi z ločenim dajanjem zdravilnih učinkovin, ki so vključene v zdravilo.
Without prejudice to specific requirements laid down by Community legislation for the control and eradication of specific infectious animal diseases, the following requirements shall apply to immunological veterinary medicinal products, except when the products are intended for use in some species or with specific indications as defined in Title III and in relevant guidelines.
Brez poseganja v posebne zahteve iz zakonodaje Skupnosti za nadzor in izkoreninjenje posebnih nalezljivih živalskih bolezni se naslednje zahteve uporabljajo za imunološka zdravila za uporabo v veterinarski medicini, razen ko so zdravila namenjena uporabi pri nekaterih vrstah ali za posebne indikacije, opredeljene v naslovu III in ustreznih smernicah.
The immunological veterinary medicinal product, which is the subject of the application, shall be identified by name and by name of the active substance(s), together with the biological activity, potency or titre, the pharmaceutical form, the route and method if appropriate of administration and a description of the final presentation of the product, including packaging, labelling and leaflet.
Imunološko zdravilo za uporabo v veterinarski medicini, ki je predmet vloge, se opredeli z lastnim imenom in imeni zdravilnih učinkovin, biološko aktivnostjo, potenco ali titrom, farmacevtsko obliko, načinom dajanja zdravila, kadar je ustrezno, ter opisom končnega pakiranja zdravila, ki vključuje ovojnino, oznake in navodila za uporabo.
Diluents may be packed together with the vaccine vials or separately.
Topila se lahko pakirajo skupaj s stekleničko cepiva ali ločeno.
Information on diluents needed for making the final vaccine preparation shall be included in the dossier.
Informacije o topilih, potrebne za pripravo končnega pripravka cepiva, se vključijo v vlogo.
An immunological veterinary medicinal product is regarded as one product even when more than one diluent is required so that different preparations of the final product can be prepared, which may be for administration by different routes or methods of administration.
Imunološko zdravilo za uporabo v veterinarski medicini se šteje kot eno zdravilo, tudi če je potrebnih več topil za pripravo različnih pripravkov končnega zdravila, ki se lahko dajejo na različnega načine ali z različnimi metodami.