natgillin/translations-raw huggingface dataset:
the active substance or metabolites may enter foodstuffs obtained from the treated animal.
zdravilna učinkovina ali presnovek lahko vstopi v živilo, pridobljeno iz zdravljene živali.
For particular groups of substances or if the effects observed during repeated dose studies in animals include changes indicative of e.g. immunotoxicity, neurotoxicity- or, endocrine dysfunction, further testing shall be required, e.g. sensitisation studies or delayed neurotoxicity tests.
Za posebne skupine snovi ali če se v študijah z večkratnim odmerkom pri živalih pojavijo spremembe, ki nakazujejo npr. imunotoksičnost, nevrotoksičnost ali motnjo hormonske funkcije, so zahtevani nadaljnji preskusi, kot so študije občutljivosti ali preskusi pozne nevrotoksičnosti.
Depending on the nature of the product, it may be necessary to conduct additional studies to assess the underlying mechanism of the toxic effect or the irritation potential.
Glede na naravo zdravila je morda treba izvesti dodatne študije za oceno mehanizma, ki povzroča toksični učinek ali lahko draži.
Such studies shall usually be conducted with the final formulation.
Takšne študije se ponavadi izvedejo s končno formulacijo.
The state of scientific knowledge and established guidance shall be taken into account when designing such studies and evaluating their results.
Pri načrtovanju takšnih študij ter oceni rezultatov se upoštevajo trenutna znanstvena spoznanja in uveljavljene smernice.
The potential microbiological risk presented by residues of antimicrobial compounds for the human intestinal flora shall be investigated in accordance with established guidance.
V skladu z uveljavljenimi smernicami se preuči mogoče mikrobiološko tveganje, ki ga za črevesno floro človeka predstavljajo ostanki protimikrobnih spojin.
In certain cases, it may be necessary to carry out tests to determine whether microbiologically active residues may interfere in technological processes in the industrial processing of foodstuff.
V nekaterih primerih je morda treba izvesti preskuse za ugotovitev, ali mikrobiološki aktivni ostanki morda vplivajo na tehnološke postopke v industrijski predelavi živil.
Information shall be provided showing whether the pharmacologically active substances of the veterinary medicinal product are used as medicinal products in human therapy; if this is so, a compilation shall be made of all the effects observed (including adverse reactions) in humans and of their cause, to the extent that they may be important for the assessment of the safety of the veterinary medicinal product, where appropriate including results from published studies; where constituents of the veterinary medicinal products are themselves not used or are no longer used as medicinal products in human therapy, the reasons shall be stated.
Predložijo se informacije o tem, ali se farmakološke aktivne snovi v zdravilu za uporabo v veterinarski medicini uporabljajo kot zdravila pri zdravljenju ljudi; če da, se pripravi poročilo o vseh ugotovljenih učinkih (vključno s neželenimi reakcijami) pri ljudeh ter o vzrokih učinkov, ki je lahko pomembno za oceno varnosti zdravila za uporabo v veterinarski medicini, kjer je to ustrezno, in v katerega se vključijo rezultati iz objavljenih študij; kadar se sestavine zdravila za uporabo v veterinarski medicini same kot take ne uporabljajo ali se ne uporabljajo več kot zdravila pri zdravljenju ljudi, se navedejo razlogi.
Data on the potential emergence of resistant bacteria of relevance for human health are necessary in the case of veterinary medicinal products.
Za zdravila za uporabo v veterinarski medicini so potrebni podatki o mogočem razvoju odpornih bakterij, pomembnih za zdravje ljudi.
The mechanism of the development of such resistance is particularly important in this regard.
Pri tem je zlasti pomemben mehanizem razvoja takšne odpornosti.
Where necessary, measures to limit resistance development from the intended use of the veterinary medicinal product shall be proposed.
Po potrebi se predlagajo ukrepi za omejitev razvoja odpornosti zaradi predvidene uporabe zdravila za uporabo v veterinarski medicini.
Resistance relevant for clinical use of the product shall be addressed in accordance with Part 4.
V skladu z delom 4 se preuči odpornost, ki je pomembna za klinično uporabo zdravila.
Where relevant, cross reference shall be made to the data set out in Part 4.
Po potrebi se navedejo sklicevanja na podatke iz dela 4.
This section shall include a discussion of the effects found in the preceding sections and relate this to the type and extent of human exposure to the product with a view to formulating appropriate user warnings and other risk management measures.
Ta oddelek vključuje razpravo o učinkih, ugotovljenih v predhodnih oddelkih, povezanih z vrsto in obsegom izpostavljenosti ljudi zdravilu, da se lahko oblikuje ustrezno opozorilo uporabnikom in določijo drugi ukrepi za obvladovanje tveganja.
An environmental risk assessment shall be performed to assess the potential harmful effects, which the use of the veterinary medicinal product may cause to the environment and to identify the risk of such effects.
Ocena tveganja za okolje se izvede, da se ocenijo mogoči škodljivi učinki, ki jih ima lahko uporaba zdravila za uporabo v veterinarski medicini na okolje, in določi tveganje takšnih učinkov.
The assessment shall also identify any precautionary measures which may be necessary to reduce such risk.
V oceni se navedejo vsi varstveni ukrepi, ki so morda potrebni za zmanjšanje takšnega tveganja.
This assessment shall normally be conducted in two phases.
Ta ocena se ponavadi izvede v dveh stopnjah.
The first phase of the assessment shall always be performed.
Prva stopnja ocene je vedno obvezna.
The details of the assessment shall be provided in accordance with accepted guidance.
Podrobni podatki ocene se predložijo v skladu s sprejetimi smernicami.
It shall indicate the potential exposure of the environment to the product and the level of risk associated with any such exposure taking into account in particular the following items:
Vključujejo mogočo izpostavljenost okolja zdravilu in stopnjo tveganja zaradi kakršne koli takšne izpostavljenosti ob upoštevanju zlasti naslednjih točk:
the target animal species, and the proposed pattern of use,
ciljne živalske vrste in predlaganega načina uporabe,
the method of administration, in particular the likely extent to which the product will enter directly into environmental systems,
načina dajanja zdravila, še zlasti verjetnega obsega, v katerem bo zdravilo neposredno prišlo v okoljske sisteme,
the possible excretion of the product, its active substances or relevant metabolites into the environment by treated animals; persistence in such excreta,
možnosti izločanja zdravila, njegovih zdravilnih učinkovin ali ustreznih presnovkov v okolje prek zdravljenih živali; obstojnosti v takih izločkih,
the disposal of unused veterinary medicinal product or other waste product.
odstranjevanja neuporabljenih zdravil za uporabo v veterinarski medicini ali drugih odpadkov.
In the second phase, further specific investigation of the fate and effects of the product on particular ecosystems shall be conducted, in accordance with established guidance.
V drugi stopnji se v skladu z uveljavljenimi smernicami izvedejo nadaljnje specifične raziskave o vplivu in učinkih zdravila na posebne ekosisteme.
The extent of exposure of the product to the environment, and the available information about the physical/chemical, pharmacological and/or toxicological properties of the substance(s) concerned, including metabolites in case of an identified risk, which has been obtained during the conduct of the other tests and trials required by this Directive, shall be taken into consideration.
Upoštevajo se obseg izpostavitve okolja zdravilu in razpoložljive informacije o fizikalno/kemijskih, farmakoloških in/ali toksikoloških lastnosti zadevnih snovi, vključno z metaboliti v primeru ugotovljenega tveganja, ki so bile pridobljene pri izvajanju drugih preskusov in preskušanj, ki jih zahteva ta direktiva.
In the case of a veterinary medicinal product containing or consisting of genetically modified organisms the application shall also be accompanied by the documents required under Article 2 and Part C of Directive 2001/18/EC.
Vlogi za pridobitev dovoljenja z zdravilom za uporabo v veterinarski medicini, ki vsebuje gensko spremenjene organizme ali je iz njih sestavljeno, se priložijo dokumenti, ki so zahtevani v skladu s členom 2 in delom C Direktive 2001/18/ES.
The dossier of safety tests shall include the following:
Dokumentacija o preskusih varnosti vključuje:
an index of all studies included in the dossier,
navedbo vseh študij, vključenih v dokumentacijo,
a statement confirming that all data known by the applicant at the time of submission, whether favourable or unfavourable, are included,
izjavo, ki potrjuje, da je predlagatelj vključil vse ugodne in neugodne podatke, ki jih pozna ob predložitvi,
a justification for the omission of any type of study,
utemeljitev izpustitve kakršne koli vrste študije,
an explanation of the inclusion of an alternative type of study,
obrazložitev vključitve nadomestne vrste študije,
a discussion of the contribution that any study that pre-dates studies performed in line with good laboratory practice (GLP) according to Directive 2004/10/EC can make to the overall risk assessment.
razpravo o tem, kako na celotno oceno tveganja vplivajo študije, ki so bile izvedene pred študijami, izvedenimi v skladu z dobro laboratorijsko prakso (DLP) v skladu z Direktivo 2004/10/ES.
Each study report shall include:
Vsako poročilo o študiji vključuje:
a copy of the study plan (protocol),
kopijo načrta študije (protokola),
a statement of compliance with good laboratory practice, where applicable,
po potrebi izjavo o upoštevanju dobre laboratorijske prakse,
a description of the methods, apparatus and materials used,
opis uporabljenih metod, naprav in materialov,
a description and justification of the test system,
opis in utemeljitev sistema preskusa,
a description of the results obtained, in sufficient detail to allow the results to be critically evaluated independently of their interpretation by the author,
podroben opis pridobljenih rezultatov, da lahko neodvisni ocenjevalec ali avtor kritično oceni rezultate,
a statistical analysis of the results where appropriate,
po potrebi statistično analizo rezultatov,
a discussion of the results, with comment on observed and no-observed-effect levels, and on any unusual findings,
razpravo o rezultatih s pripombami o ugotovljenih ali neugotovljenih ravneh učinka in o nenavadnih ugotovitvah,
a detailed description and a thorough discussion of the results of the study of the safety profile of the active substance, and its relevance for the evaluation of potential risks presented by residues to humans.
podroben opis ter temeljito razpravo o rezultatih študije o varnosti zdravilne učinkovine ter njeni pomembnosti za oceno mogočih tveganj, ki jih predstavljajo ostanki za ljudi.
For the purposes of this Annex, the definitions of Council Regulation (EEC) No 2377/90 [13] shall apply.The purpose of studying the depletion of residues from the edible tissues or of eggs, milk and honey derived from treated animals is to determine under what conditions and to what extent residues may persist in foodstuffs produced from these animals.
V tej prilogi se uporabljajo opredelitve iz Uredbe Sveta (EGS) št. 2377/90 [13].Namen preučevanja izločanja ostankov iz užitnih tkiv ali jajc, mleka in meda, pridobljenih od zdravljenih živali, je ugotoviti, pod kakšnimi pogoji in v kakšni količini lahko ostanki ostanejo v živilih, proizvedenih od teh živali.
In addition, the studies shall enable the determination of a withdrawal period.
Poleg tega je namen študij določiti karenco.
In the case of veterinary medicinal products intended for use in food-producing animals, the residue documentation shall show:
Za zdravila za uporabo v veterinarski medicini, namenjena za uporabo pri živalih za proizvodnjo živil, se v dokumentaciji o ostankih navede naslednje:
to what extent, and how long, do residues of the veterinary medicinal product or its metabolites persist in the edible tissues of the treated animal or in milk, eggs and/or honey obtained therefrom;
količina ostankov in kako dolgo ostanki zdravil za uporabo v veterinarski medicini ali njihovi presnovki ostanejo v tkivih zdravljene živali ali v mleku, jajcih in/ali medu, ki so pridobljeni iz take živali;
that in order to prevent any risk to the health of the consumer of foodstuffs from 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;
da je mogoče določiti realno karenco, ki jo je mogoče ugotoviti pod praktičnimi pogoji kmetovanja, da se tako prepreči tveganje za zdravje potrošnika živil, pridobljenih od zdravljenih živali, ali težave pri industrijski predelavi živil;
that the analytical method(s) used in the residues depletion study are sufficiently validated to provide the necessary reassurance that the residues data submitted are suitable as the basis for a withdrawal period.
da so analitske metode, uporabljene pri študijah izločanja ostankov, zadostno potrjene, da lahko zagotovijo, da se predloženi podatki o ostankih lahko uporabijo za določanje karence.
A summary of the pharmacokinetic data shall be submitted with cross reference to the pharmacokinetic studies in target species submitted in Part 4.
Povzetek farmakokinetičnih podatkov se predloži s sklicevanjem na farmakokinetične študije na ciljni vrsti, navedene v delu 4.
The full study report does not need to be submitted.
Celotnega poročila o študiji ni treba predložiti.
The purpose of pharmacokinetic studies with respect to residues of veterinary medicinal products is to evaluate the absorption, distribution, metabolism and excretion of the product in the target species.
Namen farmakokinetičnih študij ostankov zdravil za uporabo v veterinarski medicini je ocena absorpcije, porazdelitve, presnove ter izločanja zdravila v ciljni vrsti.
The final product, or a formulation, which has comparable characteristics in terms of bioavailability as the final product, shall be administered to the target animal species at the maximum recommended dose.
Končno zdravilo ali formulacija, ki ima primerljive lastnosti glede biološke uporabnosti, se ciljni živalski vrsti daje v največjem priporočenem odmerku.
Having regard to the method of administration, the extent of absorption of the veterinary medicinal product shall be fully described.
Glede na način dajanja zdravila se podrobno opiše obseg absorpcije zdravila za uporabo v veterinarski medicini.
If it is demonstrated that systemic absorption of products for topical application is negligible, further residue studies will not be required.
Če se dokaže, da je sistemska absorpcija zdravil za lokalno uporabo zanemarljiva, nadaljnje študije o ostankih niso potrebne.
The distribution of the veterinary medicinal product in the target animal shall be described; the possibility of plasma protein binding or passage into milk or eggs and of the accumulation of lipophilic compounds shall be considered.
Opiše se porazdelitev zdravila za uporabo v veterinarski medicini v ciljni živali; upoštevajo se možnost vezave na plazemske beljakovine, prenos v mleko ali jajca ter kopičenje lipofilnih spojin.
The pathways for the excretion of the product from the target animal shall be described.
Opišejo se poti izločanja zdravila iz ciljne živali.
The major metabolites shall be identified and characterised.
Navedejo se glavni presnovki in opišejo se njihove lastnosti.
The purpose 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.
Namen tovrstnih študij, ki merijo hitrost izločanja ostankov iz ciljne živali po zadnjem dajanju zdravila, je določitev karence.
At a sufficient number of times after the test animal has received the final dose of the veterinary medicinal product, the quantities of residues present shall be determined by validated analytical methods; the technical procedures and the reliability and sensitivity of the methods employed shall be specified.
S potrjeno analitsko metodo se z zadostno pogostostjo določi količina ostankov, prisotnih v preskusni živali potem, ko je prejela zadnji odmerek zdravila za uporabo v veterinarski medicini; opišejo se tehnični postopki ter zanesljivost in občutljivost uporabljenih metod.
The analytical method(s) used in the residues depletion study (studies) and its (their) validation shall be described in detail.
Podrobno se opišejo analitske metode, uporabljene v študijah izločanja ostankov, in njihove potrditve.
The following characteristics shall be described:
Opišejo se naslednje lastnosti:
precision,
točnost,
limit of detection,
meja zaznavnosti,
limit of quantification,
meja določljivosti,
practicability and applicability under normal laboratory conditions,
praktičnost in uporabnost pod normalnimi laboratorijskimi pogoji,
susceptibility to interference,
dovzetnost za motnje,
stability of incurred residues.
stabilnost nastalih ostankov.
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.
Primernost predlaganih analitskih metod se oceni glede na trenutna znanstvena in tehnična spoznanja ob predložitvi vloge.
The analytical method shall be presented in an internationally agreed format.
Analitska metoda se predloži v mednarodno dogovorjeni obliki.
An identification of the veterinary medicinal product(s) used in the testing shall be provided, including:
Predloži se identifikacija zdravil za uporabo v veterinarski medicini, ki vključuje:
composition,
sestavo,
the physical and chemical (potency and purity) test results for the relevant batch(es),
rezultate fizikalnih in kemijskih preskusov (potenca in čistost) za ustrezne serije,
batch identification,
identifikacijo serije,
relationship to the final product,
povezanost s končnim zdravilom,
specific activity and radio-purity of labelled substances,
specifično aktivnost ter radiočistost označenih snovi,
position of labelled atoms in the molecule.
lego označenih atomov v molekuli.
The dossier of residue tests shall include:
Dokumentacija o preskusih ostankov vključuje:
a discussion of the contribution that any study that pre-dates GLP can make to the overall risk assessment,
razpravo o tem, kako na celotno oceno tveganja vplivajo študije, ki so bile izvedene pred začetkom veljavnosti dobre laboratorijske prakse,
a withdrawal period proposal.
predlog za karenco.
a discussion of the results,
razpravo o rezultatih,
an objective discussion of the results obtained, 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.
objektivno razpravo o dobljenih rezultatih in predlogih karence, ki so potrebni za zagotovitev, da v živilih, pridobljenih od zdravljenih živali, ni ostankov, ki bi lahko bili nevarni za potrošnike.
The particulars and documents, which shall accompany applications for marketing authorisations pursuant to the third indent of Article 12(3)(j) shall be submitted in accordance with the requirements below.
Podrobni podatki in dokumenti, ki so priloženi vlogam za pridobitev dovoljenja za promet z zdravilom v skladu s tretjo alineo člena 12(3)(j), se predložijo v skladu s spodaj naštetimi zahtevami.
Pre-clinical studies are required to establish the pharmacological activity and the tolerance of the product.
Predklinične študije so zahtevane za določitev farmakološke aktivnosti in tolerance zdravila.
The pharmacodynamic effects of the active substance(s) included in the veterinary medicinal product shall be characterised.
Opredelijo se farmakodinamični učinki zdravilnih učinkovin v zdravilu za uporabo v veterinarski medicini.
First, the mechanism of action and the pharmacological effects on which the recommended application in practice is based shall be adequately described.
Ustrezno se opiše mehanizem delovanja ter farmakološki učinki, na katerih temelji priporočena praktična uporaba.
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.
Rezultati se izrazijo kvantitativno (na primer z uporabo krivulje učinek-odmerek, krivulje čas-učinek itd.) ter, kjer je to mogoče, v primerjavi s snovjo, katere aktivnost je dobro znana.
Where a higher efficacy is being claimed for an active substance, the difference shall be demonstrated and shown to be statistically significant.
Kadar se trdi, da je zdravilna učinkovina bolj učinkovita, se prikaže razlika in dokaže statistična značilnost.
Secondly, an overall pharmacological assessment of the active substance shall be provided, with special reference to the possibility of secondary pharmacological effects.
Predloži se celotna farmakološka ocena zdravilne učinkovine, s posebnim poudarkom na mogočih sekundarnih farmakoloških učinkih.
In general, the effects on the main body functions shall be investigated.
Na splošno se preučijo učinki na glavne funkcije organizma.
Any effect of the other characteristics of the products (such as the route of administration or formulation) on the pharmacological activity of the active substance shall be investigated.
Preuči se kakršen koli vpliv lastnosti zdravila (kot je način dajanja ali formulacija) na farmakološko aktivnost zdravilne učinkovine.
The investigations shall be intensified where the recommended dose approaches a dose likely to produce adverse reactions.
Preiskave se okrepijo, kadar se priporočeni odmerek približuje tistemu, ki bi lahko povzročil neželene učinke.
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.
Eksperimentalne tehnike, razen če gre za standardne postopke, se opišejo natančno, da jih je mogoče ponoviti, in preiskovalec določi njihovo veljavnost.
The experimental results shall be set out clearly and, for certain types of tests, their statistical significance quoted.
Eksperimentalni rezultati se jasno predstavijo ter se za določene vrste preskusov navede statistična značilnost.
Unless good reasons are given to the contrary, any quantitative modification of responses resulting from repeated administration of the substance shall also be investigated.
Razen če so podani utemeljeni nasprotni razlogi, se preučijo kvantitativne spremembe odzivov, ki so posledica večkratnega dajanja zdravila.
Fixed combinations may be prompted either on pharmacological grounds or by clinical indications.
Fiksne kombinacije se lahko razvijejo na podlagi farmakoloških temeljev ali kliničnih indikacij.
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.
V prvem primeru farmakodinamične in/ali farmakokinetične študije izkazujejo tiste medsebojne vplive, zaradi katerih bi lahko bila kombinacija klinično uporabna.
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.
V drugem primeru, kadar se ugotavlja znanstvena razlaga za farmacevtske kombinacije s kliničnimi eksperimenti, raziskava določi, ali bodo pričakovani učinki kombinacije lahko prikazani na živalih, in preveri se vsaj pomembnost neželenih učinkov.
If a combination includes a new active substance, the latter shall have been previously studied in depth.
Če kombinacija vključuje novo zdravilno učinkovino, se ta zdravilna učinkovina predhodno natančno preuči.