natgillin/translations-raw huggingface dataset:
The European Commission granted a marketing authorisation valid throughout the European Union, for Gonazon to Intervet International BV on 22 July 2003. 
Evropska komisija je dovoljenje za promet z zdravilom Gonazon, veljavno po vsej Evropski uniji, odobrila družbi Intervet International BV dne 22. julija 2003.
The implant may be administered to bitches from the age of four months (blocking reproductive function for an average of 12 months) to 6 years (blocking reproductive function for an average of 11 months). 
Implantat se lahko daje psicam od starosti štirih mesecev (povprečno trajanje blokade razmnoževalne funkcije je 12 mesecev) do 6 let (povprečno trajanje blokade razmnoževalne funkcije je 11 mesecev).
The main measure of effectiveness was the speed of response to treatment and the advance in time and synchronisation of the spawning period. 
Glavno merilo učinkovitosti je bila hitrost odziva na zdravljenje ter časovno napredovanje in sinhronizacija drstenja.
Gonazon implants were authorised by an extension application, granted by the European Commission in January 2007. 
Implantati Gonazon so bili odobreni z vlogo za razširitev indikacije, ki jo je Evropska Komisija podelila januarja 2007.
Operators should wash their hands after use of the product. 
Osebe, ki dajejo zdravilo, si morajo po uporabi zdravila umiti roke.
The CVMP recommended that Gonazon should be given a marketing authorisation. 
CVMP je zato priporočil, da se za zdravilo Gonazon odobri dovoljenje za promet.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion 
Če želite več informacij o podlagi za priporočila CVMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
Good efficacy has been demonstrated for the prevention of heat and ovulation in adult bitches aged up to 7 years during the one or two years of treatment. 
Izkazana je bila dobra učinkovitost pri preprečevanju gonitve in ovulacije pri odraslih psicah do starosti 7 let v teku enega ali dveh let zdravljenja.
What benefit has Gonazon shown during the studies? 
Kakšne koristi je zdravilo Gonazon izkazalo med raziskavami?
What is the risk associated with Gonazon? 
Kakšna tveganja so povezana z zdravilom Gonazon?
Data on the return to oestrus, ovulatory oestrus and subsequent fertility once treatment has ended (i.e. once the implant had been removed) were limited, especially for repeated treatment. 
Na voljo so bili samo omejeni podatki o povratku estrusa, ovulacijskega estrusa in plodnosti po končanem zdravljenju (tj. ko je implantat odstranjen), še posebej pri ponovljenem zdravljenju.
In case of accidental contact with either the skin or the eyes, rinse thoroughly with water. 
V primeru nenamernega stika s kožo ali očmi prizadeto mesto temeljito izperite z vodo.
Following anaesthesia, the fish are injected intraperitoneally (into the area that contains the abdominal organs) along the central line, 1/2 to 1 fin length in front of the pelvic fin base. 
Po anesteziji dobijo ribe intraperitonealno injekcijo (injekcijo v predel, kjer so trebušni organi) vzdolž osrednje linije, 1/2 do 1 dolžine plavuti pred osnovo pelvične plavuti.
In bitches, the results of two field studies with Gonazon implants were provided, one investigating a single administration, another one the repeated application over a second year. 
Pri psicah so bili predloženi rezultati dveh terenskih raziskav implantatov Gonazon, pri čemer je ena preučevala enkratno uporabo, druga pa ponovljeno aplikacijo v naslednjem letu.
Bitches treated with Gonazon generally failed to display heat during the study compared to bitches who did not receive the treatment. 
Psice, ki so bile zdravljene z zdravilom Gonazon, med raziskavo v splošnem niso kazale znakov gonitve v primerjavi s psicami, ki niso bile zdravljene.
Gonazon implant is rectangular in shape, off white, with dimensions of 14x3x1 mm. 
Implantat Gonazon je pravokotne oblike sivo-bele barve velikosti 14x3x1 mm.
Why has Gonazon been approved? 
Zakaj je bilo zdravilo Gonazon odobreno?
Gonazon contains azagly-nafarelin, which is an analogue of a natural hormone called gonadotrophinreleasing hormone (GnRH). 
Zdravilo Gonazon vsebuje azagli-nafarelin, ki je analog naravnega hormona, imenovanega gonadotropin sproščajoči hormon (GnRH).
Gonazon is authorised as a concentrate that is made into a solution for injection for salmonid fish and also as an implant for dogs. 
Zdravilo Gonazon je odobreno kot koncentrat za pripravo raztopine za injiciranje za salmonidne vrste rib in kot implantat za psice.
If the concentrated solution or the diluted solution is spilled onto the skin or into the eyes, or the implant is accidentally self-injected, medical advice should be sought immediately. 
Če pride koncentrirana ali razredčena raztopina v stik s kožo ali v oči oziroma če si implantat nenamerno injicirate, je treba nemudoma poiskati zdravniško pomoč.
In fish, the results of the trials showed that Gonazon was effective to induce and synchronise ovulation. 
Pri ribah so rezultati študij pokazali, da je bilo zdravilo Gonazon učinkovito pri indukciji in sinhronizaciji ovulacije.
Gonazon contains the active substance azagly-nafarelin. 
Zdravilo Gonazon vsebuje zdravilno učinkovino azagli-nafarelin.
In fish, the injection of Gonazon may be associated with a reduction in fecundity (ability to breed), egg quality and survival to the eyed-egg stage. 
Pri ribah utegne biti injekcija zdravila Gonazon povezana z manjšo plodnost (ploditveno sposobnost), slabšo kakovostjo iker in slabše preživetje do faze z očmi.
In bitches, it has been demonstrated that the insertion of a Gonazon implant will prevent heat and ovulation in adult bitches aged up to 7 years during the one or two years of treatment. 
Pri psicah je bilo pokazano, da vstavljanje implantata Gonazon preprečuje gonitev in ovulacijo pri odraslih psicah do starosti 7 let v teku enega ali dveh let zdravljenja.
In fish, Gonazon is used to induce and synchronise ovulation (egg production) in female salmonids such as Atlantic salmon, rainbow trout, brown trout and Arctic charr for the production of eyed-eggs and fry. 
Pri ribah se zdravilo Gonazon uporablja za indukcijo in sinhronizacijo ovulacije (proizvodnjo iker) pri plemenkah salmonidnih rib, kot so atlantski losos, kalifornijska postrv ali šarenka, rjava postrv in jezerska zlatovčica, za proizvodnjo iker v fazi z očmi in ribjega zaroda.
The package leaflet or the label should be shown to the doctor. 
Zdravniku je treba pokazati Navodila za uporabo ali nalepko.
Operators should wear gloves when mixing the concentrate solution or handling the implant and avoid self injection. 
Osebe, ki dajejo zdravilo, morajo pri mešanju raztopine koncentrata ali pri rokovanju z implantatom nositi rokavice in paziti da bi ne prišlo do samoinjiciranja.
What is Gonazon used for? 
Za kaj se zdravilo Gonazon uporablja?
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Gonazon are greater than any risks for the induction and synchronisation of ovulation for the production of eyed-eggs and fry. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je sklenil, da so koristi zdravila Gonazon pri indukciji in sinhronizaciji ovulacije za proizvodnjo iker v fazi z očmi in ribjega zaroda večje od morebitnih tveganj.
GnRH controls reproduction in fish by increasing the secretion of the gonadotrophins controlling egg production. 
GnRH uravnava reprodukcijo pri ribah, tako da poveča izločanje gonadotropinov, ki nadzorujejo proizvodnjo iker.
In fish, Gonazon has been studied in three studies of rainbow trout, two studies of Altlantic salmon, and one study of Arctic charr. 
Pri ribah je bilo zdravilo Gonazon raziskano v okviru treh raziskav šarenke, dveh raziskav atlantskega lososa in ene raziskave jezerske zlatovčice.
In some cases this can be caused by use of Gonazon too early in the spawning season. 
V nekaterih primerih lahko to povzroči prezgodnja uporabe zdravila Gonazon v obdobju odlaganja iker.
Gonazon implants are effective in prevention of gonadal function via long term blockade of gonadotrophin synthesis. 
Implantati Gonazon so učinkoviti pri preprečevanju gonadne funkcije na podlagi dolgotrajne blokade sinteze gonadotropina.
The use of Gonazon while not necessarily improving reproductive performance over the course of the spawning season, by synchronising spawning will shorten the time span dedicated to eyed egg production. 
Uporaba zdravila Gonazon ne izboljšuje nujno razmnoževalnega učinka v obdobju drstenja, vendar pa s sinhronizacijo odlaganja iker skrajša časovno obdobje, namenjeno proizvodnji iker v fazi oči.
In dogs, administration of higher doses of GnRH agonists over a period of time desensitises the pituitary gland with the result that release of gonadotrophins is suppressed, leading to a suppression of reproductive function. 
Pri psicah vodi dolgotrajno dajanje večjih odmerkov agonistov GnRH do desenzibilizacije hipofize, kar povzroči zaviranje izločanja gonadotropinov, to pa vodi do supresije razmnoževalne funkcije.
How has Gonazon been studied? 
Kako je bilo zdravilo Gonazon raziskano?
In bitches, Gonazon works by inhibition of the production of sex steroids and may be associated with rare cases of vaginitis in prepubertal females. 
Pri psicah zdravilo Gonazon zavira nastajanje spolnih steroidov in v redkih primerih utegne povzročiti vaginitis pri psicah pred puberteto.
How does Gonazon work? 
Kako zdravilo Gonazon deluje?
What is Gonazon? 
Kaj je zdravilo Gonazon?
In bitches, Gonazon is also indicated for the prevention of gonadal function via long term blockade of gonadotrophin synthesis. 
Pri psicah je zdravilo Gonazon indicirano tudi za preprečevanje gonadne funkcije z dolgotrajno blokado sinteze gonadotropina.
Gonazon is injected subcutaneously, in the region of the umbilicus. 
Zdravilo Gonazon se injicira podkožno v predel popka.
This reference product was approved through the centralised procedure and has been marketed in Europe since November 1995. 
Referenčno zdravilo je bilo odobreno s centraliziranim postopkom in je v Evropi v prometu od novembra 1995.
The applicant was invited to attend an oral explanation before the CHMP on the 15 February 2011 to defend their position with respect to their arguments presented in their responses. 
Predlagatelj je bil povabljen, da dne 15. februarja 2011 CHMP poda ustna pojasnila v zagovor svojih stališč v zvezi z argumenti, predstavljenimi v odgovorih.
An additional benefit of a bioequivalence study prior to marketing authorisation would thus be that such a study would provide at least some reassurance with respect to safety. 
Dodatna prednost študije biološke enakovrednosti pred odobritvijo dovoljenja za promet z zdravilom bi bila tudi v tem, da bi takšna študija dala vsaj neke vrste potrditev glede varnosti.
Overall summary of the scientific evaluation of Docetaxel Teva Generics (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravila Docetaxel Teva Generics (glejte Dodatek I)
The necessity of human data was also discussed - focussing on at least the first 3 hours, since in vitro data does not predict the rate of release in human blood. 
Razpravljali so tudi o potrebi po podatkih pri ljudeh, s poudarkom na vsaj prvih treh urah, saj podatki in vitro ne predvidevajo hitrosti sproščanja v kri pri ljudeh.
The difference in composition is too pronounced for a conclusion that this difference may not have an impact in vivo. 
Razlika v sestavi je preveč izrazita za sklepanje, da zaradi razlik ne bi prišlo do učinka in vivo.
The Applicant discussed these issues in their responses to the Referral List of Outstanding Issues (LoOI), as discussed below: 
Predlagatelj je ta vprašanja obravnaval v odgovorih na seznam odprtih vprašanj iz napotitve, kot je navedeno v nadaljevanju:
The Applicant provided compelling arguments that the CMC in plasma is much higher than the often reported CMC in water of 0.012 mM. 
Predlagatelj je predložil prepričljive argumente, da je vrednost CMC v plazmi precej višja kot CMC v vodi, ki je 0,012 mM in o kateri se pogosto poroča.
The results of the in vitro studies can now be considered in line with current expectations based on thorough evaluation of the available physicochemical data on this subject, as provided in the responses to the referral LoOI. 
Rezultati študij in vitro se zdaj lahko upoštevajo v skladu s trenutnimi pričakovanji na podlagi temeljite ocene razpoložljivih fizikalno-kemičnih podatkov o tem, kot je bilo predloženo v odgovorih na seznam odprtih vprašanj iz napotitve.
Further evidence was also presented that the clinical data on free fraction during infusion do not support any transient effects on free fraction (Acharya et al., 2004). 
Predstavljeni so bili tudi dodatni dokazi, da klinični podatki o prosti frakciji med infuzijo ne povzročajo prehodnih učinkov na proste frakcije (Acharya et al, 2004).
The data presented by the applicant was not considered to be sufficient to claim similarity, and as this is a new complex formulation clinical data was considered to be necessary. 
Podatki, ki jih je predložil predlagatelj, niso ustrezno utemeljili podobnosti, in ker je to nova kompleksna formulacija, so ocenili, da so potrebni klinični podatki.
The proposed formulation is adequately justified (aimed at obtaining comparable exposure to docetaxel, whereas no improved benefit-risk is claimed by the Applicant) 
Predlagana formulacija je ustrezno utemeljena (s ciljem doseči primerljivo izpostavljenost docetakselu, pri čemer predlagatelj ne navaja izboljšanega razmerja med koristmi in tveganji).
In the second round of this Referral, it was made clear that it is very unlikely that polysorbate 80 micelles remain present for 3 hours after infusion of Taxotere, with possible effect on Docetaxel pharmacokinetics. 
V drugem krogu te napotitve je bilo razkrito, da ni zelo verjetno, da bi miceli polisorbata 80 ostali prisotni tri ure po infundiranju zdravila Taxotere, kar bi lahko vplivalo na farmakokinetiko docetaksela.
Moreover, polysorbate 80 micelles are very unstable and will disappear rapidly due to hydrolyses and metabolism by plasma carboxyesterases. 
Poleg tega so miceli polisorbata 80 zelo nestabilni in bodo zaradi hidrolize in presnavljanja plazemske karboksiesteraze hitro izginili.
The lack of safety issues caused by these excipients was also supported by animal data. 
Odsotnost vprašanja glede varnosti zaradi teh pomožnih snovi so podprli tudi podatki pri živalih.
The ‘generic' principle is that under those conditions of comparable exposure, no difference in efficacy and active substance (docetaxel)-related safety is expected. 
Načelo „generičnosti“ pomeni, da v primerljivih pogojih izpostavljenosti ni pričakovane nobene razlike v učinkovitosti in varnosti v zvezi z zdravilno učinkovino (docetaksel).
Furthermore, the robustness of the provided animal data, and the level of extrapolation from the in vitro data to the in vivo situation was assessed. 
Ocenjena je bila tudi trdnost predloženih podatkov pri živalih in stopnja ekstrapolacije iz podatkov in vitro v situacijo in vivo.
The reference product is Taxotere, concentrate and solvent for solution for infusion (20 mg and 80 mg), by Sanofi-Aventis France. 
Referenčno zdravilo je Taxotere, koncentrat in vehikel za raztopino za infundiranje (20 mg in 80 mg) družbe Sanofi-Aventis, Francija.
However taking into account the literature data presented by the applicant, it was noted by some members of the CHMP that according to the data by Wang et al (2010), the CMC of polysorbate 80 in human plasma protein concentration was not substantially greater than the clinically relevant range of post-infusion levels of polysorbate 80 (from Taxotere) reported by Webster et al (1997). 
Ob upoštevanju literature, ki jo je predložil predlagatelj, so nekateri člani CHMP menili, da v skladu s podatki avtorja Wang et al (2010), vrednost CMC polisorbata 80 v koncentraciji plazemskih beljakovin pri ljudeh ni bila bistveno večja od klinično pomembnega razpona ravni polisorbata 80 (iz zdravila Taxotere) po infuziji, o kateri je poročal avtor Webster et al (1997).
Therefore the risk-benefit balance for Docetaxel Teva Generics is positive. 
Zato je razmerje med koristmi in tveganji pri zdravilu Docetaxel Teva Generics pozitivno.
Nevertheless taking into account all the information available in the case of Docetaxel Teva Generics, i.e the applicant's data, the evidence from literature submitted in support, as well the arguments presented at the oral explanation, the majority of the CHMP was of the view that sufficient reassurance is provided by the applicant that systemic exposure to the active ingredient between the innovator Taxotere and Docetaxel Teva Generics indeed is the same, and therefore safety and efficacy related to docetaxel will be the same as well. 
Ob upoštevanju vseh razpoložljivih podatkov v primeru zdravila Docetaxel Teva Generics, tj. podatkov predlagatelja, dokazov iz literature, predloženih v podporo, ter argumentov, predstavljenih pri ustnih pojasnilih, je večina članov CHMP menila, da je predlagatelj predložil zadostna zagotovila o enaki sistemski izpostavljenosti zdravilni učinkovini pri inovatorskem zdravilu Taxotere in zdravilu Docetaxel Teva Generics ter da bosta zato varnost in učinkovitost, povezani z docetakselom, prav tako enaki.
Since the formulation of Docetaxel Teva Generics is different from the originator, different release characteristics and in vivo pharmacokinetic profile cannot be ruled out. 
Ker je formulacija zdravila Docetaxel Teva Generics drugačna od originatorja, ni mogoče izključiti drugačnih značilnosti sproščanja in farmakokinetičnega profila in vivo.
Docetaxel (N-Debenzoyl-N-tert-butoxycarbonyl-10-deacetyl taxol) is a semi-synthetic taxane with cytotoxic anti-neoplastic activity. 
Docetaksel (N-debenzoil-N-terc-butoksikarbonil-10-deacetil taksol) je polsintezni taksan s citotoksičnim protineoplastičnim učinkom.
Therefore, the putative increased free docetaxel fraction by polysorbate 80 micelles does not appear to be present, and thus not relevant for the actual situation. 
Tako kaže, da domnevno povečani delež proste frakcije docetaksela zaradi micelov polisorbata 80 ni prisoten in posledično ni pomemben za dejansko stanje.
Published data show that the concentration of polysorbate 80 following infusion of Taxotere in actual patients falls down to below the critical micelle concentration (CMC) in plasma immediately during infusion. 
Objavljeni podatki kažejo, da koncentracija polisorbata 80 po infuziji zdravila Taxotere pri resničnih bolnikih takoj po infundiranju pade pod mejo kritične koncentracije micelov (CMC) v plazmi.
Concerns were expressed that the formulations (cyclodextrin complexes vs. traditional micelles) are different, and that this generic docetaxel formulation had never been given to man. 
Izraženi so bili zadržki zaradi različnih formulacij (kompleksi ciklodekstrina proti klasičnim micelom) in da ta generična formulacija docetaksela še nikoli ni bila uporabljena pri ljudeh.
Since the pharmaceutical form of the Docetaxel Teva Generics (powder for solution for infusion) differs from the reference product (concentrate for solution for infusion) a hybrid application marketing authorisation application (MAA) for Docetaxel Teva Generics 20 mg / 80 mg, Powder and Solvent for Solution for Infusion, 20 mg and 80 mg was submitted, in accordance with Directive 2001/83/EC, article 10(3). 
Ker se farmacevtska oblika zdravila Docetaxel Teva Generics (prašek za raztopino za infundiranje) razlikuje od referenčnega zdravila (koncentrat za raztopino za infundiranje), je bila vloga za dovoljenje za promet z zdravilom Docetaxel Teva Generics 20 mg/80 mg, prašek in vehikel za raztopino za infundiranje, 20 mg in 80 mg predložena v obliki hibridne vloge v skladu s členom 10(3) Direktive 2001/83/ES.
In this respect it was the RMS's view that, the fact that a different methodology was applied to avoid docetaxel precipitation in the infusion bag (i.e., using HP-b-CD aggregates and povidone K-12 in case of Docetaxel Teva Generics instead of polysorbate micelles in case of Taxotere), does not impair this conclusion of comparable efficacy, since this conclusion is based on the final exposure of the identical active substance -docetaxel, in both formulations. 
V zvezi s tem je referenčna država članica menila, da dejstvo, da je za preprečevanje obarjanja docetaksela v infuzijski vrečki uporabljena drugačna metodologija (na primer uporaba agregatov HP-b-CD in povidona K-12 v primeru zdravila Docetaxel Teva Generics namesto micel polisorbata v primeru zdravila Taxotere), ne vpliva na sklepanje o primerljivi učinkovitosti, saj ta sklep temelji na končni izpostavljenosti enaki zdravilni učinkovini - v obeh formulacijah docetakselu.
The excipients povidone K-12 and HP-b-CD that are used in Docetaxel Teva Generics, but are not used in Taxotere, are known from other medicinal products, and no safety issues are expected. 
Pomožni snovi povidon K-12 in HP-b-CD, ki se uporabljata pri zdravilu Docetaxel Teva Generics, pri zdravilu Taxotere pa ne, sta znani iz drugih zdravil, tako da v zvezi z njima ni pričakovati varnostnih vprašanj.
Supportive PD and PK data were obtained from animal models, and indicate comparability with respect to docetaxel pharmacokinetics (rat, monkey), pharmacodynamics and toxicological parameters. 
Iz živalskih modelov so bili pridobljeni tudi podporni farmakodinamični in farmakokinetični podatki, ki kažejo primerljivost farmakokinetičnih (podgana, opica), farmakodinamičnih in toksikoloških parametrov docetaksela.
The CHMP has recommended the granting of the marketing authorisation for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Docetaxel Teva Generics and associated names (see Annex I). 
CHMP je priporočil odobritev dovoljenja za promet z zdravilom, katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostanejo enaki zadnjim različicam, pripravljenim v postopku Usklajevalne skupine in navedenim v Dodatku III za zdravilo Docetaxel Teva Generics in povezana imena (glejte Dodatek I).
• This assumption is supported by the non-clinical animal data; 
• To predpostavko podpirajo tudi neklinični podatki pri živalih.
This increased CMC makes it less likely that polysorbate micelles are indeed present in the blood stream, even very shortly after infusion. 
Zaradi te povečane vrednosti CMC je verjetnost, da so miceli polisorbata dejansko prisotni v krvnem obtoku, tudi zelo kratek čas po infuziji, zelo majhna.
The reference formulation contains polysorbate 80 as an excipient, while the generic formulation contains povidone K12, hydroxypropylbetadex (HP-b-CD) and glucose monohydrate as excipients. 
Referenčna formulacija kot pomožno snov vsebuje polisorbat 80, medtem ko so pomožne snovi v generični formulaciji povidon K12, hidroksipropilbetadeks (HPb-CD) in glukoza monohidrat.
Pharmaceutical quality of Docetaxel Teva Generics is comparable to that of Taxotere. 
Farmacevtska kakovost zdravila Docetaxel Teva Generics je primerljiva farmacevtski kakovosti zdravila Taxotere.
The absence of a relevant effect is in line with in vitro data obtained within this application, where in a head to head comparison no difference in free docetaxel in relation to dilution factors was observed for Taxotere, and the same lack of effect was observed for Docetaxel Teva Generics. 
Odsotnost pomembnih učinkov je v skladu s podatki in vitro, pridobljenimi v tej vlogi, pri čemer ni bilo odkritih nobenih razlik pri primerjavi prostega docetaksela v zvezi z dejavniki redčenja pri zdravilu Taxotere, podobna odsotnost učinka pa je bila opažena tudi pri zdravilu Docetaxel Teva Generics.