natgillin/translations-raw huggingface dataset:
Safety of the administration of one dose
Kadar se imunološko zdravilo za uporabo v veterinarski medicini daje večkrat kot del osnovne sheme cepljenja, se izvede študija ponovljenega dajanja enega odmerka, da se ugotovijo kakršni koli neželeni učinki, ki jih je povzročilo takšno dajanje.
The immunological veterinary medicinal product shall be administered at the recommended dose and by each recommended route of administration to animals of each species and category in which it is intended for use, including animals of the minimum age of administration.
Ti preskusi se izvedejo pri najbolj občutljivih kategorijah ciljne vrste (kot so nekatere pasme in starostne skupine), zdravilo pa se daje po priporočeni poti.
The animals shall be observed and examined for signs of systemic and local reactions.
Živali se opazujejo in pregledujejo na znake sistemskih ali lokalnih reakcij najmanj 14 dni po zadnjem dnevu dajanja zdravila.
Where appropriate, these studies shall include detailed post-mortem macroscopic and microscopic examinations of the injection site.
Pregled reprodukcijske sposobnosti
Other objective criteria shall be recorded, such as rectal temperature and performance measurements.
Pregled sposobnosti razmnoževanja se izvede, kadar podatki nakazujejo, da bi lahko vhodna snov, iz katere se zdravilo izdeluje, predstavljala mogoč dejavnik tveganja.
The animals shall be observed and examined until reactions may no longer be expected, but in all cases, the observation and examination period shall be at least 14 days after administration.
Sposobnost razmnoževanja samcev ter brejih in nebrejih samic se preuči tako, da se uporabi priporočen odmerek in najbolj občutljiva pot uporabe.
This study may be part of the repeated dose study required under point 3 or omitted if the results of the overdose study required under point 2 have revealed no signs of systemic or local reactions.
Poleg tega se preučijo škodljivi učinki na potomstvo, kot tudi teratogeni in abortivni učinki.
Safety of one administration of an overdose
Te študije so lahko del študij varnosti iz točk 1, 2 in 3 ali terenskih študij iz oddelka C.
Only live immunological veterinary medicinal products require overdose testing.
Pregled imunoloških funkcij
An overdose of the immunological veterinary medicinal product shall be administered by each recommended route(s) of administration to animals of the most sensitive categories of the target species, unless the selection of the most sensitive of several similar routes is justified.
Kadar bi imunološko zdravilo za uporabo v veterinarski medicini lahko imelo neželen učinek na imunski odziv cepljene živali ali njenega potomstva, se izvedejo ustrezni preskusi imunoloških funkcij.
In the case of immunological veterinary medicinal products administered by injection, the doses and route(s) of administration shall be chosen to take account of the maximum volume, which can be administered at any one single injection site.
Posebne zahteve za živa cepiva
The animals shall be observed and examined for at least 14 days after administration for signs of systemic and local reactions.
Širjenje seva cepiva
Other criteria shall be recorded, such as rectal temperature and performance measurements.
Preuči se širjenje seva cepiva iz cepljene na necepljene ciljne živali, in sicer z uporabo priporočene poti uporabe, pri katerem bi najverjetneje prišlo do širjenja.
Where appropriate, these studies shall include detailed post-mortem macroscopic and microscopic examinations of the injection site if this has not been done under point 1.
Poleg tega je morda treba preučiti razširitev na neciljne živalske vrste, ki bi lahko bile zelo dovzetne za živi sev cepiva.
Safety of the repeated administration of one dose
Razširitev v cepljeni živali
In the case of immunological veterinary medicinal products to be administered more than once, as part of the basic vaccination scheme, a study of the repeated administration of one dose shall be required to reveal any adverse effects induced by such administration.
Blato, urin, mleko, jajca, izločki iz nosu in ust ter druge izločki se preskusijo na prisotnost organizmov, kakor je ustrezno.
These tests shall be carried out on the most sensitive categories of the target species (such as certain breeds, age groups), using each recommended route of administration.
Poleg tega se lahko zahtevajo študije razširitve seva cepiva v telesu, s posebno pozornostjo na predilekcijskih mestih za razmnoževanje organizmov.
The animals shall be observed and examined for at least 14 days after the last administration for signs of systemic and local reactions.
Pri živih cepivih za zoonoze v smislu Direktive 2003/99/ES Evropskega parlamenta in Sveta, ki se uporabljajo pri živalih za proizvodnjo živil, te študije zlasti upoštevajo obstojnost organizmov na mestu vbrizgavanja.
Examination of reproductive performance
Reverzija virulence atenuiranih cepiv
Examination of reproductive performance shall be considered when data suggest that the starting material from which the product is derived may be a potential risk factor.
Vračanje virulence se preuči z matično kulturo.
Reproductive performance of males and non-pregnant and pregnant females shall be investigated with the recommended dose and by the most sensitive route of administration.
Če matična kultura ni na voljo v zadostni količini, se pregleda matična snov iz najnižje ravni prenosa, ki se uporablja pri izdelavi.
In addition, harmful effects on the progeny, as well as teratogenic and abortifacient effects, shall be investigated.
Uporaba drugega prenosa se utemelji.
These studies may form part of the safety studies described in points 1, 2, 3 or of the field studies provided for in Section C.
Začetno cepljenje se izvede po poti uporabe, pri kateri bi najverjetneje prišlo do vračanja virulence.
Examination of immunological functions
Pri petih skupinah ciljnih živalih se opravijo zaporedni prenosi, razen če je utemeljeno, da se opravi več prenosov, ali je organizem prej zapustil preskusne živali.
Where the immunological veterinary medicinal product might adversely affect the immune response of the vaccinated animal or of its progeny, suitable tests on the immunological functions shall be carried out.
Kadar se organizem ne razmnožuje ustrezno, se v ciljni vrsti opravi najvišje možno število prenosov.
Special requirements for live vaccines
Biološke lastnosti seva cepiva
Spread of the vaccine strain
Morda so potrebni še drugi preskusi za določanje čim natančnejših bioloških lastnosti seva cepiva (npr. nevrotropizem).
Spread of the vaccine strain from vaccinated to unvaccinated target animals shall be investigated, using the recommended route of administration most likely to result in the spread.
Rekombinacija ali genomske preureditve sevov
Moreover, it may be necessary to investigate the spread to non-target animal species which could be highly susceptible to a live vaccine strain.
Obrazloži se verjetnost rekombinacije ali genomske preureditve z divjimi ali drugimi sevi.
Dissemination in the vaccinated animal
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.
Faeces, urine, milk, eggs, oral, nasal and other secretions shall be tested for the presence of the organism as appropriate.
Študija ostankov
Moreover, studies may be required of the dissemination of the vaccine strain in the body, with particular attention being paid to the predilection sites for replication of the organism.
Pri imunoloških zdravilih za uporabo v veterinarski medicini se študija ostankov ponavadi ne izvaja.
In the case of live vaccines for zoonoses within the meaning of Directive 2003/99/EC of the European Parliament and of the Council to be used for food producing animals, these studies must shall take particularly into account the persistence of the organism at the injection site.
Vendar kadar se pri proizvodnji imunoloških zdravil za uporabo v veterinarski medicini uporabljajo dodatki in/ali konzervansi, se upošteva možnost, da so ostanki še vedno v živilih.
Reversion to virulence of attenuated vaccines
Po potrebi se preučijo učinki takšnih ostankov.
Reversion to virulence shall be investigated with the master seed.
Pripravi se predlog karence za zdravilo, njegova ustreznost pa se obrazloži v povezavi z drugimi opravljenimi študijami o ostankih.
If the master seed is not available in sufficient quantity the lowest passage seed used for the production shall be examined.
Medsebojni vplivi
Use of another passage option shall be justified.
Če je v povzetku značilnosti zdravila izjava o ustreznosti drugih zdravil za uporabo v veterinarski medicini, se preuči varnost skupnega delovanja.
The initial vaccination shall be carried out using the route of administration most likely to lead to reversion to virulence.
Opišejo se vsi znani medsebojni vplivi z drugimi zdravili za uporabo v veterinarski medicini.
Serial passages shall be made in target animals through five groups of animals, unless there is justification to make more passages or the organism disappears from the test animals sooner.
C. TERENSKE ŠTUDIJE
Where the organism fails to replicate adequately, as many passages as possible shall be carried out in the target species.
Rezultati laboratorijskih študij se predložijo skupaj s podatki iz terenskih študij z uporabo serij v skladu s proizvodnimi postopki, opisanimi v vlogi za pridobitev dovoljenja za promet z zdravilo, razen če ni drugače utemeljeno.
Biological properties of the vaccine strain
Pri istih terenskih študijah se lahko preučujeta varnost in učinkovitost.
Other tests may be necessary to determine as precisely as possible the intrinsic biological properties of the vaccine strain (e.g. neurotropism).
D. OCENA TVEGANJA ZA OKOLJE
Recombination or genomic reassortment of strains
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 probability of recombination or genomic reassortment with field or other strains shall be discussed.
Podatki iz ocene se predložijo v skladu z uveljavljenimi smernicami.
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.
V oceni se navede mogoča izpostavljenost okolja zdravilu in stopnja tveganja zaradi kakršne koli takšne izpostavljenosti ob upoštevanju zlasti naslednjih točk:
Study of residues
ciljne živalske vrste in predlaganega vzorca uporabe,
For immunological veterinary medicinal products, it will normally not be necessary to undertake a study of residues.
pot uporabe, še zlasti obseg mogočega prehajanja zdravila v okoljske sisteme,
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.
mogočega izločanja zdravila in njegovih učinkovin iz zdravljenih živalih v okolje ter obstojnost v teh izločkih,
If necessary, the effects of such residues shall be investigated.
odlaganja neuporabljenih ali odpadnih proizvodov.
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.
Pri živih sevih cepiva, ki so morda zoonotska, se oceni tveganje za ljudi.
Interactions
Kadar sklepne ugotovitve iz prve stopnje nakazujejo mogočo izpostavljenost okolja proizvodu, predlagatelj izvede še drugo stopnjo ter oceni mogoča tveganja pri zdravilu za uporabo v veterinarski medicini za okolje.
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.
Po potrebi se izvedejo nadaljnje raziskave o vplivih proizvoda na zemljo, vodo, zrak, vodne sisteme in neciljne organizme.
Any other known interactions with veterinary medicinal products shall be described.
E. OCENA, POTREBNA ZA ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI, KI VSEBUJEJO GENSKO SPREMENJENE ORGANIZME ALI SO IZ NJIH SESTAVLJENA
C. FIELD STUDIES
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.
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.
Preskusi učinkovitosti
Both safety and efficacy may be investigated in the same field studies.
Namen preskušanj, ki jih opisuje ta del, je dokazati ali potrditi učinkovitost imunoloških zdravil za uporabo v veterinarski medicini.
D. ENVIRONMENTAL RISK ASSESSMENT
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.
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.
Izvedba preskušanj
The details of the assessment shall be provided in accordance with established guidance.
Vsi preskusi učinkovitosti se izvedejo ob doslednem upoštevanju podrobnega protokola preskušanja, ki se pripravi v pisni obliki pred začetkom preskušanja.
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:
Dobro počutje poskusnih živali je pod veterinarskim nadzorom ter se v celoti upošteva pri pripravi katerega koli protokola preskušanja ter skozi celotno izvajanje preskušanja.
the target animal species and the proposed pattern of use,
Zahtevajo se predhodni sistematični pisni postopki za organizacijo, izvajanje, zbiranje podatkov, dokumentacijo ter preverjanje preskusov učinkovitosti.
the method of administration, in particular the likely extent to which the product will enter directly into the environmental system,
Terenska preskušanja se izvajajo v skladu z uveljavljenimi načeli dobre laboratorijske prakse, razen če je utemeljeno drugače.
the possible excretion of the product, its active substances into the environment by treated animals, persistence in such excreta,
A. SPLOŠNE ZAHTEVE
the disposal of unused or waste product.
Izbor antigenov ali sevov cepiva se utemelji na podlagi epizooloških podatkov.
In the case of live vaccine strains which may be zoonotic, the risk to humans shall be assessed.
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.
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.
Na splošno se te laboratorijske študije lahko podprejo s preskušanji, izvedenimi na terenu, ki vključujejo nezdravljene kontrolne živali.
Where necessary, further investigations on the impact of the product (soil, water, air, aquatic systems, non-target organisms) shall be carried out.
Vsa preskušanja se opišejo dovolj podrobno, da se lahko ponovijo v kontrolnih preskušanjih, ki se izvedejo na zahtevo pristojnih organov.
E. ASSESSMENT REQUIRED FOR VETERINARY MEDICINAL PRODUCTS CONTAINING OR CONSISTING OF GENETICALLY MODIFIED ORGANISMS
Preiskovalec dokaže veljavnost vseh uporabljenih tehnik.
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.
Poroča se o vseh ugotovljenih ugodnih ali neugodnih rezultatih.
Efficacy tests
Učinkovitost imunološkega zdravila za uporabo v veterinarski medicini se dokaže za vsako kategorijo ciljne živalske vrste, za katero se priporoča cepljenje, in to za vsako priporočeno pot uporabe in ob uporabi predlagane sheme dajanja zdravila.
The purpose of the trials described in this Part is to demonstrate or to confirm the efficacy of the immunological veterinary medicinal product.
Vpliv pasivno pridobljenih protiteles in maternalnih protiteles na učinkovitost cepiva se po potrebi ustrezno oceni.
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.
Začetek in trajanje imunosti se določi in podpre s podatki iz preskušanj, razen če je utemeljeno drugače.
Performance of trials
Dokaže se učinkovitost vsake sestavine večvalentega in kombiniranega imunološkega zdravila za uporabo v veterinarski medicini.
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.
Če je zdravilo priporočeno za dajanje v kombinaciji ali istočasno z nekim drugim zdravilom za uporabo v veterinarski medicini, se dokaže, da sta kompatibilna.
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.
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.
Pre-established systematic written procedures for the organisation, conduct, data collection, documentation and verification of efficacy trials shall be required.
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 proizvodnim postopkom, opisanim v delu 2 vloge.
Field trials shall be conducted in accordance with established principles of good clinical practice, unless otherwise justified.
Če je v povzetku značilnosti zdravila izjava o ustreznosti drugih imunoloških zdravil za uporabo v veterinarski medicini, se preuči učinkovitost skupnega delovanja.
A. GENERAL REQUIREMENTS
Opišejo se vsi drugi znani medsebojni vplivi z drugimi zdravili za uporabo v veterinarski medicini.
The choice of antigens or vaccine strains shall be justified on the basis of epizoological data.
Hkratna ali simultana uporaba se lahko odobri, če je podprta z ustreznimi študijami.
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.
Pri diagnostičnih imunoloških zdravilih za uporabo v veterinarski medicini, ki se dajejo živalim, predlagatelj navede način razlage reakcij na zdravilo.
In general, these laboratory trials shall be supported by trials carried out in field conditions, including untreated control animals.
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.
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.
B. LABORATORIJSKA PRESKUŠANJA
The investigator shall demonstrate the validity of all the techniques involved.
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.
All results obtained, whether favourable or unfavourable, shall be reported.
V kolikor je mogoče, so pogoji stimulacije podobni naravnim pogojem za okužbo.
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.
Predložijo se podatki o stimulacijskem sevu in njegovi pomembnosti.
The influence of passively acquired and maternally derived antibodies on the efficacy of a vaccine shall be adequately evaluated, if appropriate.
Pri živih cepivih se uporabijo serije z najnižjim titrom ali potenco, razen če je utemeljeno drugače.
Unless justified, the onset and duration of immunity shall be established and supported by data from trials.
Pri drugih zdravilih se uporabijo serije z najnižjo vsebnostjo zdravilne učinkovine, razen če je utemeljeno drugače.
The efficacy of each of the components of multivalent and combined immunological veterinary medicinal products shall be demonstrated.
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 po priporočeni poti.
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.
C. TERENSKA PRESKUŠANJA
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.
Rezultati laboratorijskih preskušanj se dopolnijo s podatki terenskih preskušanj z uporabo serij, značilnih za proizvodni postopek, opisan v vlogi za pridobitev dovoljenja za promet z zdravilo, razen če ni drugače utemeljeno.
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.
Pri isti terenski študiji se lahko preučujeta varnost in učinkovitost.
If there is a compatibility statement with other immunological products in the summary of product characteristics, the efficacy of the association shall be investigated.
Kadar laboratorijska preskušanja ne dokazujejo učinkovitosti, je lahko sprejemljiva tudi samo izvedba terenskih preskušanj.
Any other known interactions with any other veterinary medicinal products shall be described.
DEL 5
Concurrent or simultaneous use may be allowed if supported by appropriate studies.
A. UVOD
For diagnostic immunological veterinary medicinal products administered to animals, the applicant shall indicate how reactions to the product are to be interpreted.
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.
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.
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.
B. LABORATORY TRIALS
Opustitev katerega koli preskusa ali preskušanja se navede in obrazloži.
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.
B. LABORATORIJSKE ŠTUDIJE