natgillin/translations-raw huggingface dataset:
This section shall include a discussion of the effects found in the preceding sections, which shall relate those effects 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 pri predhodnih oddelkih, povezanih z vrsto in obsegom izpostavljenosti ljudi zdravilu, da se lahko oblikuje ustrezno opozorilo uporabnikom in določijo drugi ukrepi za obvladovanje tveganja.
For immunological veterinary medicinal products, it will normally not be necessary to undertake a study of residues.
Pri imunoloških zdravilih za uporabo v veterinarski medicini se študija ostankov ponavadi ne izvaja.
However, where adjuvants and/or preservatives are used in the manufacture of immunological veterinary medicinal products, consideration shall be given to the possibility of any residue remaining in the foodstuffs.
Vendar kadar se pri izdelavi imunoloških zdravil za uporabo v veterinarski medicini uporabljajo dodatki in/ali konzervansi, se upošteva možnost, da so ostanki še vedno v živilih.
If necessary, the effects of such residues shall be investigated.
Po potrebi se preučijo učinki takšnih ostankov.
A proposal for a withdrawal period shall be made and its adequacy shall be discussed in relation to any residue studies which have been undertaken.
Pripravi se predlog karence za zdravilo, njegova ustreznost pa se obrazloži v povezavi z drugimi opravljenimi študijami o ostankih.
If there is a compatibility statement with other veterinary immunological products in the summary of product characteristics the safety of the association shall be investigated.
Če je v povzetku značilnosti zdravila izjava o ustreznosti drugih zdravil za uporabo v veterinarski medicini, se preuči varnost skupnega delovanja.
Any other known interactions with veterinary medicinal products shall be described.
Opišejo se vsi znani medsebojni vplivi z drugimi zdravili za uporabo v veterinarski medicini.
Unless justified, results from laboratory studies shall be supplemented with data from field studies, using batches according to the manufacturing process described in the marketing authorisation application.
Rezultati laboratorijskih študij se predložijo skupaj s podatki iz terenskih študij z uporabo serij v skladu s postopki izdelave, opisanimi v vlogi za pridobitev dovoljenja za promet z zdravilo, razen če ni drugače utemeljeno.
Both safety and efficacy may be investigated in the same field studies.
Pri istih terenskih študijah se lahko preučujeta varnost in učinkovitost.
The purpose of the environmental risk assessment is to assess the potential harmful effects, which the use of the product may cause to the environment and to identify any precautionary measures, which may be necessary to reduce such risks.
Namen ocene tveganja za okolja je oceniti mogoče škodljive učinke, ki jih lahko povzroči uporaba zdravila na okolje, ter določiti previdnostne ukrepe, potrebne za zmanjšanje takega tveganja.
The details of the assessment shall be provided in accordance with established guidance.
Podatki iz ocene se predložijo v skladu z uveljavljenimi 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:
V oceni se navede mogoča izpostavljenost okolja zdravilu in stopnja 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 the environmental system,
načina dajanja zdravila, še zlasti obseg mogočega prehajanja zdravila v okoljske sisteme,
the possible excretion of the product, its active substances into the environment by treated animals, persistence in such excreta,
mogoče izločanje zdravila in njegovih zdravilnih učinkovin iz zdravljenih živalih v okolje ter obstojnost teh izločkov,
the disposal of unused or waste product.
odlaganje neuporabljenih ali odpadnih zdravil.
In the case of live vaccine strains which may be zoonotic, the risk to humans shall be assessed.
Pri živih sevih cepiva, ki so morda zoonotska, se oceni tveganje za ljudi.
Where the conclusions of the first phase indicate potential exposure of the environment to the product, the applicant shall proceed to the second phase and evaluate the potential risk(s) that the veterinary medicinal product might pose to the environment.
Kadar sklepne ugotovitve prve stopnje nakazujejo mogočo izpostavljenost okolja zdravilu, predlagatelj izvede še drugo stopnjo ter oceni mogoča tveganja zdravila za uporabo v veterinarski medicini za okolje.
Where necessary, further investigations on the impact of the product (soil, water, air, aquatic systems, non-target organisms) shall be carried out.
Kadar je potrebno, se izvedejo nadaljnje študije o vplivih zdravila (zemlja, voda, zrak, vodni sistemi, neciljni organizmi).
In the case of veterinary medicinal products 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 zdravilo za uporabo v veterinarski medicini, ki vsebuje gensko spremenjene organizme ali je iz njih sestavljeno, se priloži dokumentacija, ki je zahtevana v skladu s členom 2 in delom C Direktive 2001/18/ES.
The purpose of the trials described in this Part is to demonstrate or to confirm the efficacy of the immunological veterinary medicinal product.
Namen preskušanj, ki jih opisuje ta del, je dokazati ali potrditi učinkovitost imunoloških zdravil za uporabo v veterinarski medicini.
All claims made by the applicant with regard to the properties, effects and use of the product, shall be fully supported by results of specific trials contained in the application for marketing authorisation.
Vse trditve predlagatelja glede lastnosti, učinkov ter uporabe zdravila se podprejo z rezultati posebnih preskušanj, ki se priložijo vlogi za pridobitev dovoljenja za promet z zdravilom.
All efficacy trials shall be conducted in accordance with a fully considered detailed protocol, which shall be recorded in writing prior to commencement of the trial.
Vsi preskusi učinkovitosti se izvedejo ob doslednem upoštevanju podrobnega protokola preskušanja, ki se pripravi v pisni obliki pred začetkom preskušanja.
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.
Dobro počutje poskusnih živali je pod veterinarskim nadzorom ter se v celoti upošteva pri pripravi katerega koli protokola preskušanja ter skozi celotno izvajanje preskušanja.
Pre-established systematic written procedures for the organisation, conduct, data collection, documentation and verification of efficacy trials shall be required.
Zahtevajo se predhodni sistematični pisni postopki za organizacijo, izvajanje, zbiranje podatkov, dokumentacijo ter preverjanje preskusov učinkovitosti.
Field trials shall be conducted in accordance with established principles of good clinical practice, unless otherwise justified.
Terenska preskušanja se izvajajo v skladu z uveljavljenimi načeli dobre laboratorijske prakse, razen če je utemeljeno drugače.
The choice of antigens or vaccine strains shall be justified on the basis of epizoological data.
Izbor antigenov ali sevov cepiva se utemelji na podlagi epizooloških podatkov.
Efficacy trials carried out in the laboratory shall be controlled trials, including untreated control animals unless this is not justified for animal welfare reasons and efficacy can be otherwise demonstrated.
Preskusi učinkovitosti, izvedeni v laboratoriju, so kontrolni preskusi, ki vključujejo nezdravljene kontrolne živali, razen če to ni utemeljeno zaradi dobrega počutja živali in se učinkovitost lahko drugače dokaže.
In general, these laboratory trials shall be supported by trials carried out in field conditions, including untreated control animals.
Na splošno se ta laboratorijska preskušanja podprejo s preskušanji, izvedenimi v terenskih razmerah, vključno z nezdravljenimi kontrolnimi živalmi.
All trials shall be described in sufficiently precise details so as to be reproducible in controlled trials, carried out at the request of the competent authorities.
Vsa preskušanja se opišejo dovolj podrobno, da se lahko ponovijo v kontrolnih preskušanjih, ki se izvedejo na zahtevo pristojnih organov.
The investigator shall demonstrate the validity of all the techniques involved.
Preiskovalec dokaže veljavnost vseh uporabljenih tehnik.
All results obtained, whether favourable or unfavourable, shall be reported.
Poroča se o vseh ugotovljenih ugodnih ali neugodnih rezultatih.
The efficacy of an immunological veterinary medicinal product shall be demonstrated for each category of target animal species recommended for vaccination, by each recommended route of administration and using the proposed schedule of administration.
Učinkovitost imunološkega zdravila za uporabo v veterinarski medicini se dokaže za vsako kategorijo ciljne živalske vrste, za katero se priporoča cepljenje, in to za vsak priporočen način dajanja zdravila in ob uporabi predlagane sheme dajanja zdravila.
The influence of passively acquired and maternally derived antibodies on the efficacy of a vaccine shall be adequately evaluated, if appropriate.
Vpliv pasivno pridobljenih protiteles in maternalnih protiteles na učinkovitost cepiva se po potrebi ustrezno oceni.
Unless justified, the onset and duration of immunity shall be established and supported by data from trials.
Začetek in trajanje imunosti se določi in podpre s podatki iz preskušanj, razen če je utemeljeno drugače.
The efficacy of each of the components of multivalent and combined immunological veterinary medicinal products shall be demonstrated.
Dokaže se učinkovitost vsake sestavine večvalentega in kombiniranega imunološkega zdravila za uporabo v veterinarski medicini.
If the product is recommended for administration in combination with or at the same time as another veterinary medicinal product, they shall be shown to be compatible.
Če je zdravilo priporočeno za dajanje v kombinaciji ali istočasno z nekim drugim zdravilom za uporabo v veterinarski medicini, se dokaže, da sta kompatibilna.
Whenever a product forms part of a vaccination scheme recommended by the applicant, the priming or booster effect or the contribution of the veterinary immunological product to the efficacy of the scheme as a whole shall be demonstrated.
Kadar koli je zdravilo del sheme cepljenja, ki jo priporoča predlagatelj, se dokaže sprožilni ali poživilni učinek ali kako zdravilo prispeva k učinkovitosti sheme v celoti.
The dose to be used shall be the quantity of the product to be recommended for use and the batch used for efficacy testing shall be taken from a batch or batches produced according to the manufacturing process described in Part 2 of the application.
Odmerek, ki se uporabi, je količina zdravila, ki je priporočena za uporabo, serija, ki se uporabi pri preskušanju učinkovitosti, pa je ena od serij, pripravljenih v skladu s postopkom izdelave, opisanim v delu 2 vloge.
If there is a compatibility statement with other immunological products in the summary of product characteristics, the efficacy of the association shall be investigated.
Če je v povzetku značilnosti zdravila izjava o ustreznosti drugih imunoloških zdravil za uporabo v veterinarski medicini, se preuči učinkovitost skupnega delovanja.
Any other known interactions with any other veterinary medicinal products shall be described.
Opišejo se vsi drugi znani medsebojni vplivi z drugimi zdravili za uporabo v veterinarski medicini.
Concurrent or simultaneous use may be allowed if supported by appropriate studies.
Hkratna ali simultana uporaba se lahko odobri, če je podprta z ustreznimi študijami.
For diagnostic immunological veterinary medicinal products administered to animals, the applicant shall indicate how reactions to the product are to be interpreted.
Pri diagnostičnih imunoloških zdravilih za uporabo v veterinarski medicini, ki se dajejo živalim, predlagatelj navede način razlage reakcij na zdravilo.
For vaccines intended to allow a distinction between vaccinated and infected animals (marker vaccines), where the efficacy claim is reliant on in vitro diagnostic tests, sufficient data on the diagnostic tests shall be provided to allow adequate assessment of the claims related to the marker properties.
Za cepiva, ki so namenjena razlikovanju med cepljenimi in okuženimi živalmi (markirna cepiva), se predložijo zadostni podatki o diagnostičnih preskusih, kadar je trditev o učinkovitosti podprta z in vitro diagnostičnimi preskusi, da se ustrezno ocenijo trditve o markirnih lastnostih.
In principle, demonstration of efficacy shall be undertaken under well-controlled laboratory conditions by challenge after administration of the immunological veterinary medicinal product to the target animal under the recommended conditions of use.
Učinkovitost se praviloma dokaže pod dobro kontroliranimi laboratorijskimi pogoji s stimulacijo po dajanju imunološkega zdravila za uporabo v veterinarski medicini ciljni živali pod priporočenimi pogoji uporabe.
Insofar as possible, the conditions under which the challenge is carried out shall mimic the natural conditions for infection.
V kolikor je mogoče, so pogoji stimulacije podobni naravnim pogojem za okužbo.
Details of the challenge strain and its relevance shall be provided.
Predložijo se podatki o stimulacijskem sevu in njegovi pomembnosti.
For live vaccines, batches containing the minimum titre or potency shall be used unless justified.
Pri živih cepivih se uporabijo serije z najnižjim titrom ali potenco, razen če je utemeljeno drugače.
For other products, batches containing the minimum active content shall be used unless otherwise justified.
Pri drugih zdravilih se uporabijo serije z najnižjo vsebnostjo zdravilne učinkovine, razen če je utemeljeno drugače.
If possible, the immune mechanism (cell-mediated/humoral, local/general classes of immunoglobulin) which is initiated after the administration of the immunological veterinary medicinal product to target animals by the recommended route of administration shall be specified and documented.
Če je mogoče, se opredeli in dokumentira imunski mehanizem (celično/humoralni, lokalno/sistemski imunoglobulinski razredi), ki se sproži po dajanju imunološkega zdravila za uporabo v veterinarski medicini ciljni živali na priporočen način.
Unless justified, results from laboratory trials shall be supplemented with data from field trials, using batches representative of the manufacturing process described in the marketing authorisation application.
Rezultati laboratorijskih preskušanj se dopolnijo s podatki terenskih preskušanj z uporabo serij, značilnih za postopek izdelave, opisan v vlogi za pridobitev dovoljenja za promet z zdravilo, razen če ni drugače utemeljeno.
Both safety and efficacy may be investigated in the same field study.
Pri isti terenski študiji se lahko preučujeta varnost in učinkovitost.
Where laboratory trials cannot be supportive of efficacy, the performance of field trials alone may be acceptable.
Kadar laboratorijska preskušanja ne dokazujejo učinkovitosti, je lahko sprejemljiva tudi samo izvedba terenskih preskušanj.
The dossier of the safety and efficacy studies shall include an introduction defining the subject and indicating the tests which have been carried out in compliance with Parts 3 and 4 as well as a summary, with detailed references to the published literature.
Dokumentacija o študijah varnosti in učinkovitosti vsebuje uvod, v katerem je opredeljen predmet študije in so predstavljeni preskusi, izvedeni v skladu z deloma 3 in 4, ter povzetek in natančna sklicevanja na objavljeno literaturo.
This summary shall contain an objective discussion of all the results obtained and lead to a conclusion on the safety and efficacy of the immunological veterinary medicinal product.
Ta povzetek vsebuje objektivno razpravo o vseh ugotovljenih rezultatih in vodi v sklepno ugotovitev o varnosti in učinkovitosti imunološkega zdravila za uporabo v veterinarski medicini.
Omission of any tests or trials listed shall be indicated and discussed.
Opustitev katerega koli preskusa ali preskušanja se navede in obrazloži.
The following shall be provided for all studies:
Za vse študije se predloži naslednje:
the name of the body having carried out the studies;
ime organa, ki je študije izvajal;
a detailed experimental protocol giving a description of the methods, apparatus and materials used, details such as species or breed of animals, categories of animals, where they were obtained, their identification and number, the conditions under which they were housed and fed (stating, inter alia, whether they were free from any specified pathogens and/or specified antibodies, the nature and quantity of any additives contained in the feed), dose, route, schedule and dates of administration, a description and a justification of the statistical methods used;
podroben protokol poskusa z opisom uporabljenih metod, opreme in materialov, podatke, kot so živalska vrsta ali pasma, kategorija živali, izvor živali, identifikacija in številka živali, pogoji, pod katerimi so živali bile vzrejene in krmljene (med drugim se navede, ali so bile proste določenih patogenih organizmov in/ali protiteles, vrsta in količina krmnih dodatkov, ki jih je vsebovala krma), odmerek, način dajanja zdravila, shema dajanja zdravila ter datumi dajanja zdravila ter opis in obrazložitev uporabljenih statističnih metod;
in the case of control animals, whether they received a placebo or no treatment;
za kontrolne živali podatek, ali so dobile placebo ali niso prejele ničesar;
in the case of treated animals and where appropriate, whether they received the test product or another product authorised in the Community
za zdravljene živali in kadar je ustrezno, ali so prejele preskusno zdravilo ali drugo zdravilo, odobreno v Skupnosti;
all general and individual observations and results obtained (with averages and standard deviations), whether favourable or unfavourable.
vse splošne in posamezne ugotovitve ter ugodni in neugodni ugotovljeni rezultati (s povprečji in standardnimi odstopanji).
The data shall be described in sufficient detail to allow the results to be critically evaluated independently of their interpretation by the author.
Podatki se natančno opišejo, da se lahko rezultati kritično ocenijo neodvisno od razlage avtorja.
The raw data shall be presented in tabular form.
Neobdelani podatki se predložijo v obliki tabele.
By way of explanation and illustration, the results may be accompanied by reproductions of recordings, photomicrographs, etc;
Rezultate lahko spremljajo razlage in ilustracije v obliki kopij zapisov, fotomikrografov itd.;
the nature, frequency and duration of observed adverse reactions;
lastnosti, pogostost in trajanje ugotovljenih neželenih učinkov;
the number of animals withdrawn prematurely from the studies and reasons for such withdrawal;
število živali, predčasno izločenih iz študij, ter razloge za takšno izločitev;
a statistical analysis of the results, where such is called for by the test programme, and variance within the data;
statistična analiza rezultatov, kadar to zahteva program preskušanja, in razlike v podatkih;
occurrence and course of any intercurrent disease;
pojav in potek morebitne bolezni, ki se je medtem pojavila;
all details concerning veterinary medicinal products (other than the product under study), the administration of which was necessary during the course of the study;
vsi podatki o zdravilih za uporabo v veterinarski medicini (razen tistih, ki se jih preskuša), ki jih je bilo treba dajati med potekom študije;
an objective discussion of the results obtained, leading to conclusions on the safety and efficacy of the product.
objektivno razpravo o ugotovljenih rezultatih, na podlagi katere je mogoč sklep o varnosti in učinkovitosti zdravila.
Particulars concerning field studies shall be sufficiently detailed to enable an objective judgement to be made.
Podrobni podatki o terenskih študijah so dovolj podrobni, da je možna objektivna ocena.
They shall include the following:
Podatki vključujejo naslednje:
name, address, function and qualifications of the investigator in charge;
ime, naslov, funkcijo in izobrazbo pooblaščenega preiskovalca;
place and date of administration, identity code that can be linked to the name and address of the owner of the animal(s);
kraj in datum dajanja zdravila, identifikacijsko številko, s katero se lahko ugotovi ime in naslov lastnika živali;
details of the trial protocol, giving a description of the methods, apparatus and materials used, details such as the route of administration, the schedule of administration, the dose, the categories of animals, the duration of observation, the serological response and other investigations carried out on the animals after administration;
podatke o protokolu preskušanja z opisom uporabljenih metod, opreme in materialov, podatke o načinu dajanja zdravila, shemi dajanja zdravila, odmerku, kategorijah živali, trajanju opazovanja, serološki odziv ter druge preiskave, izvedene na živalih po dajanju zdravila;
identification of the treated and control animals (collective or individual, as appropriate), such as species, breeds or strains, age, weight, sex, physiological status;
identifikacijo zdravljenih in kontrolnih živalih (skupinsko ali individualno, kakor je ustrezno), kot so vrsta, pasma ali rod, starost, teža, spol, fiziološko stanje;
a brief description of the method of rearing and feeding, stating the nature and quantity of any additives contained in the feed;
kratek opis metode reje in krmljenja z navedbo lastnosti in količin dodatkov v krmi;
all the particulars on observations, performances and results (with averages and standard deviation); individual data shall be indicated when tests and measurements on individuals have been carried out;
vse podrobne podatke o ugotovitvah, delovanju ter rezultatih (z navedbo povprečij in standardnih odstopanj); navedejo se posamezni podatki, kadar so bili preskusi in meritve opravljeni na posameznih živalih;
all observations and results of the studies, whether favourable or unfavourable, with a full statement of the observations and the results of the objective tests of activity required to evaluate the product; the techniques used must be specified and the significance of any variations in the results explained;
vse ugotovitve in ugodni ali neugodni rezultati študij z izčrpnim poročilom o ugotovitvah in rezultatih objektivnih preskusov aktivnosti, potrebnih za oceno zdravila; uporabljene tehnike se morajo specificirati ter pojasniti pomen razhajanj pri rezultatih;
effects on the animals’ performance;
učinke na proizvodnost živali;
all details concerning veterinary medicinal products (other than the product under study) which have been administered either prior to or concurrently with the test product or during the observation period; details of any interactions observed;
vse podatke o zdravilih za uporabo v veterinarski medicini (razen tistih, ki se jih preskuša), ki so bila dana živali pred ali hkrati s preskušanim zdravilom ali med dobo opazovanja; podatke o kakršnih koli ugotovljenih medsebojnih vplivih;
The bibliographical references cited in the summary mentioned under Part 1 shall be listed in detail and copies shall be provided.
Bibliografska sklicevanja, navedena v povzetku, opredeljenem v delu 1, se podrobno navedejo, in predložijo se kopije.