FrancophonIA/ELRC3.0 huggingface dataset:
English: 400 South Oak Way Green Park Reading
Croatian: Bayer plc, 400 South Oak Way Green Park Reading
English: All risks relating to the target animal, the user and the environment are adequately addressed in the product literature.
Croatian: Svi rizici povezani s ciljnim životinjama, korisnicima i okolišem primjereno su obrađeni u literaturi o proizvodu.
English: The dogs were each infested with 80 female sand flies on 13 occasions (D7, 14, 21, 28, 56, 84, 112, 140, 166, 196, 208, 215, and 222).
Croatian: Svaki je pas zaražen s 80 ženskih jedinki pješčanih mušica u 13 navrata (7., 14., 21., 28., 56., 84., 112., 140., 166., 196., 208., 215. i 222. dan).
English: Netherlands Bayer B.V., Animal Health Division Energieweg 1
Croatian: Nizozemska Bayer B.V., Animal Health Division Energieweg 1
English: This is a variation application for an already-authorised product (Seresto); no further risks have been identified in the studies provided.
Croatian: Ovo je zahtjev za izmjenu već odobrenog proizvoda (Seresto); u dostavljenim ispitivanjima nisu utvrđeni dodatni rizici.
English: The study duration was 300 days ± 10 days, and the treated animals wore the collar for the first 210 ± 10 days of this period.
Croatian: Ispitivanje je trajalo 300 dana ± 10 dana, a liječene životinje nosile su ovratnik prvih 210 ± 10 dana u tom razdoblju.
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Croatian: Popis naziva, farmaceutskih oblika, jačina veterinarskomedicinskih proizvoda, životinjskih vrsta, putova primjene, nositelja odobrenja za stavljanje veterinarsko-medicinskih proizvoda u promet u državama članicama
English: Therefore, the new indication of prevention of transmission of L. infantum can only be accepted if the vector, i.e. P. perniciosus would also be part of the clinical indication'.
Croatian: Stoga se nova indikacija sprječavanja prenošenja patogena L. infantum može prihvatiti samo ako je i vektor, odnosno P. perniciosus, dio kliničke indikacije”.
English: An animal was considered positive for leishmaniosis if positive to one or more tests used.
Croatian: Životinja se smatrala pozitivnom na lišmaniozu ako je bila pozitivna na jedan ili više primijenjenih testova.
English: In summary, the UK considered that the efficacy of Seresto for the proposed indication has not been sufficiently demonstrated and that accepting the indication could pose a serious risk to animal and human health.
Croatian: Ukratko, Ujedinjena Kraljevina smatrala je da djelotvornost VMP-a Seresto nije dovoljno dokazana za predloženu indikaciju i da bi prihvaćanje indikacije moglo predstavljati ozbiljnu opasnost za zdravlje životinja i ljudi.
English: Due to the use of a very low sample size in two of the studies, only one study was considered to have produced reliable results and so the following comments are based on just this study.
Croatian: Zbog upotrebe vrlo male veličine uzorka u dvama ispitivanjima, samo se za jedno ispitivanje smatralo da je dalo pouzdane rezultate te se napomene u nastavku temelje isključivo na tom ispitivanju.
English: The benefit-risk balance for the agreed indication is considered favourable.
Croatian: Omjer koristi i rizika za dogovorenu indikaciju smatra se povoljnim.
English: Both Guideline 7AE17a and Guideline EMEA/CVMP/EWP/005/2000-Rev.2 state that field studies should be performed in at least two geographical regions and the animal population studied should be representative of the target population.
Croatian: U Smjernicama 7AE17a i Smjernicama EMEA/CVMP/EWP/005/2000-Rev.2 navedeno je da se terenska ispitivanja trebaju provoditi u najmanje dvjema zemljopisnim regijama i da ispitivana životinjska populacija treba biti reprezentativna u odnosu na ciljnu populaciju.
English: The study ran between April/May and December 2013 (approximately eight months), and there was a post-treatment phase which ran until April/May 2014.
Croatian: Ispitivanje se provodilo od travnja/svibnja 2013. do prosinca 2013. (otprilike osam mjeseci), a faza nakon liječenja trajala je do travnja/svibnja 2014.
English: Animal species
Croatian: Ciljne vrste životinja
English: However, as they were conducted in animal shelters in Southern Italy, the UK considered that it is not possible to extrapolate the findings from these studies relating to transmission of leishmaniosis to all areas of the EU where the disease is endemic.
Croatian: Međutim, budući da su se provodila u skloništima za životinje u južnoj Italiji, Ujedinjena Kraljevina smatrala je da nalaze tih ispitivanja u pogledu prenošenja lišmanioze nije moguće ekstrapolirati na sva područja EU-a u kojima je ta bolest endemska.
English: In this laboratory study, 14 dogs were randomised to either treatment with Seresto collar (n=7) or untreated control (n=7).
Croatian: U tom je laboratorijskom ispitivanju 14 pasa randomizirano u skupinu koja se liječila ovratnikom Seresto (n = 7) ili u neliječenu kontrolnu skupinu (n = 7).
English: All three field studies were performed in animal shelter situations within a limited geographical area.
Croatian: Sva tri terenska ispitivanja provedena su u okruženju skloništa za životinje na ograničenom zemljopisnom području.
English: Czech Republic
Croatian: Republika Češka
English: Scientific conclusions and grounds for the granting of the variation of the marketing authorisations
Croatian: Znanstveni zaključci i razlozi za odobrenje izmjene odobrenja za stavljanje lijeka u promet
English: The efficacy threshold of 80-100% (preferably 90%) as recommended in the guideline Demonstration of Efficacy of Ectoparasiticides (7AE17a)1 was not met at sufficient time points.
Croatian: Prag djelotvornosti od 80% do 100% (po mogućnosti 90%) koji se preporučuje u smjernicama Dokazivanje djelotvornosti ektoparaziticida (7AE17a)1 nije bio postignut dovoljno često.
English: According to Guideline 7AE17a, the threshold of efficacy for Diptera should be 80-100% (preferably more than 90%).
Croatian: Prema Smjernicama 7AE17a, prag djelotvornosti za dvokrilce trebao bi iznositi od 80% do 100% (po mogućnosti više od 90%).
English: The United Kingdom considered that, for any vector-borne disease, before an indication can be accepted, demonstration of efficacy against the vector must also be established.
Croatian: Ujedinjena Kraljevina smatrala je da je za svaku bolest koja se prenosi vektorima prije prihvaćanja indikacije potrebno dokazati i djelotvornost protiv vektora.
English: The use of fed to unfed female sand flies ratios in Abbott's formula is not considered acceptable as a method for calculation of percentage efficacy as ratios have been used incorrectly to approximate risks (probabilities).
Croatian: Upotreba omjera nahranjenih i nenahranjenih ženskih jedinki pješčanih mušica u Abbottovoj formuli ne smatra se prihvatljivom metodom izračuna postotka djelotvornosti jer se omjeri upotrebljavaju pogrešno kako bi se dao približan prikaz rizika (vjerojatnost).
English: Furthermore, there are specific difficulties inherent in the demonstration of such a claim: there is, at present, no validated laboratory model which can determine the efficacy of a veterinary medicinal product against leishmaniosis.
Croatian: Nadalje, postoje konkretne poteškoće svojstvene dokazivanju takve tvrdnje, a jedna je od njih da trenutačno ne postoji provjeren laboratorijski model kojim se može utvrditi djelotvornost veterinarsko-medicinskog proizvoda protiv lišmanioze.
English: 12 SPECIAL WARNING(S)
Croatian: 12 POSEBNA UPOZORENJA
English: In the same studies, the incidence density rates in untreated dogs (60.7%, 46.2% and 67.0% respectively) demonstrated the high infection pressure present in the field situations used.
Croatian: U istim je ispitivanjima stopama incidencije kod neliječenih pasa (koje redom iznose 60,7%, 46,2% i 67,0%) dokazano postojanje visokog infekcijskog pritiska u terenskim okruženjima iz ispitivanja.
English: Of the thirteen assessment time points, an anti-feeding efficacy above 80% was only achieved on three occasions.
Croatian: Od ukupno trinaest vremenskih točaka procjene, samo je u tri navrata postignuta repelentna djelotvornost iznad 80%.
English: However, the ratio of fed to unfed sand flies in the laboratory study described above is lower in treated dogs (mean 0.3, range 0.1 to 0.4) when compared to untreated animals (mean 9.0, range 3.3 to 15.6).
Croatian: Međutim, omjer nahranjenih i nenahranjenih pješčanih mušica u prethodno opisanom laboratorijskom ispitivanju niži je kod liječenih pasa (srednja vrijednost = 0,3, raspon = 0,1 do 0,4) nego kod neliječenih životinja (srednja vrijednost = 9,0, raspon = 3,3 do 15,6).
English: Seresto contains the active substances imidacloprid 10% and flumethrin 4.5%.
Croatian: Seresto sadržava djelatne tvari imidakloprid (10%) i flumetrin (4,5%).
English: Treated dogs were continually treated with Seresto throughout the study period, with the collar being replaced as necessary due to growth of the animal or according to the label instructions for the product.
Croatian: Liječeni psi bez prekida su se liječili VMP-om Seresto tijekom cijelog ispitivanja, a ovratnik je zamjenjivan prema potrebi zbog rasta životinje ili u skladu s uputama za proizvod.
English: The study ran between March 2011 and April 2012, with a post-treatment phase commencing April 2012 and completing October 2012.
Croatian: Ispitivanje se provodilo između ožujka 2011. i travnja 2012., a faza nakon liječenja počela je u travnju 2012. i završila u listopadu 2012.
English: It is indicated for the treatment and prevention of infestations with fleas, ticks, and lice in dogs and cats, and provides indirect protection against the transmission of the pathogens Babesia canis vogeli and Ehrlichia canis from the vector tick Rhipicephalus sanguineus, thereby reducing the risk of canine babesiosis and canine ehrlichiosis for 7 months.
Croatian: Indiciran je za liječenje i sprječavanje infestacija buhama, krpeljima i ušima kod pasa i mačaka te pruža neizravnu zaštitu od prenošenja patogena Babesia canis vogeli i Ehrlichia canis s krpelja vektora Rhipicephalus sanguineus, čime se rizik od babezioze pasa i erlihioze pasa smanjuje tijekom sedam mjeseci.
English: However, it was agreed by the CVMP that the field situations used in the studies submitted represent a ‘worst case scenario' in terms of exposure to infected sand flies: there was a high level of exposure to infected sand flies (incidence density rates in untreated dogs varied between 46.2 to 67.0%); dogs were housed outside throughout the day and night leading to unrestricted contact between the host and the vector; untreated dogs housed at the study area but not enrolled in the study constituted an additional reservoir for leishmaniosis.
Croatian: Međutim, CVMP se složio da terenska okruženja iz ispitivanja predstavljaju „najgori mogući scenarij” u pogledu izloženosti zaraženim pješčanim mušicama: postojala je visoka razina izloženosti zaraženim pješčanim mušicama (stopa incidencije kod neliječenih pasa varirala je između 46,2% i 67,0%); psi su bili smješteni na otvorenom tijekom dana i noći, što je dovelo do neograničenog kontakta između domaćina i vektora; neliječeni psi koji su bili smješteni na području ispitivanja, ali ne i uključeni u ispitivanje predstavljali su dodatan izvor lišmanioze.
English: Overall summary of the scientific evaluation of Seresto and its associated name Foresto (see Annex I)
Croatian: Cjelokupni sažetak znanstvene ocjene veterinarskomedicinskog proizvoda Seresto i pridruženog imena Foresto (vidjeti Dodatku I.)
English: The collar should be applied just before the beginning of the period of activity of sand fly vectors corresponding to the Leishmania infantum transmission season and worn continuously throughout the risk period.
Croatian: Ovratnik je potrebno aplicirati prije početka razdoblja aktivnosti vektora papatača koji su odgovorni za prijenos Leishmania infantum i nositi neprestano tijekom razdoblja rizika od infekcije.
English: The influence of shampooing or water immersion regarding the transmission of canine leishmaniosis has not been examined.
Croatian: Utjecaj šamponiranja ili uranjanja u vodu na prijenos lišmanioze nisu ispitani.
English: Benefit assessment
Croatian: Procjena koristi
English: It should be noted that Guideline 7AE17a provides general guidance including a threshold for efficacy against Diptera, but was not established with the aim of providing guidance on studies to support claims relating to vector-borne diseases such as reduction of canine leishmaniosis.
Croatian: Valja napomenuti da se u Smjernicama 7AE17a pružaju opće smjernice, uključujući prag djelotvornosti protiv dvokrilaca, ali one nisu sastavljene s ciljem pružanja smjernica za ispitivanja kojima se podupiru tvrdnje u pogledu bolesti koje se prenose vektorima, kao što je smanjenje lišmanioze pasa.
English: The anti-feeding efficacy demonstrated for Seresto is, therefore, considered insufficient for the inclusion of a direct repellent claim against P. perniciosus.
Croatian: Stoga se dokazana repelentna djelotvornost VMP-a Seresto smatra nedovoljnom za uključivanje tvrdnje o izravnom repelentu protiv P. perniciosus.
English: Animals were tested for leishmaniosis with samples of blood and skin tissue being collected on study day 0, in July 2011, September 2011, November 2011, April 2012, and October 2012.
Croatian: Životinje su testirane na lišmaniozu, pri čemu su uzorci krvi i kožnog tkiva prikupljeni nultoga dana ispitivanja, u srpnju 2011., rujnu 2011., studenome 2011., travnju 2012. i listopadu 2012.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Croatian: Valjani Sažetak opisa svojstava proizvoda, označavanje i uputa o veterinarsko-medicinskom proizvodu konačne su inačice sastavljene tijekom postupka skupine za koordinaciju i sadrže sljedeće dodatke:
English: A total of 224 dogs, of several breeds and aged between 7 and 77 weeks, were enrolled, blocked by pens and pens were randomised to one of four groups.
Croatian: Ukupno su bila uključena 224 psa raznih pasmina, starosti od 7 do 77 tjedana, koji su se odvojili oborima, a obori su randomizirani u jednu od četiriju skupina.
English: Depending on the infection pressure by sand flies the efficacy in the reduction of the risk of infection with leishmaniosis ranged from 88.3 to 100%.
Croatian: Ovisno o pritisku infekcije papatačima, učinkovitost na smanjenje rizika od infekcije lišmanijazom iznosila je 88.3 do 100%.
English: Luxembourg Bayer SA-NV, J.E.
Croatian: Luksemburg Bayer SA-NV, J.E.
English: Relevant information relating to the supporting studies should be added to the SPC.
Croatian: Relevantne informacije povezane s potpornim ispitivanjima trebale bi se dodati u sažetak opisa svojstava VMP-a.
English: A total of 279 dogs, of several breeds and aged between 2 and 96 months, were enrolled on day 0, with 219 of these dogs included in the efficacy calculation.
Croatian: Od nultog je dana u ispitivanje bilo uključeno ukupno 279 pasa raznih pasmina, starosti od 2 do 96 mjeseci, a 219 njih uključeno je u izračun djelotvornosti.
English: Repellent efficacy was assessed by comparing the number of fed female sand flies in the treated animals to the number of fed female sand flies in the untreated animals.
Croatian: Repelentna djelotvornost ocijenjena je usporedbom broja nahranjenih ženskih jedinki pješčanih mušica kod liječenih životinja s brojem nahranjenih ženskih jedinki pješčanih mušica kod neliječenih životinja.
English: Seresto and its associated name Foresto (thereinafter “Seresto”) is a medicated collar containing 10% imidacloprid and 4.5% flumethrin.
Croatian: Veterinarsko-medicinski proizvod Seresto i pridruženo ime Foresto (dalje u tekstu: Seresto) ovratnik je za životinje s dodatkom lijekova koji sadržava 10% imidakloprida i 4,5% flumetrina.
English: Regarding the data requirement for the demonstration of repellent (anti-feeding) efficacy against P. perniciosus, the UK did not accept that the laboratory data submitted by the MAH for the product justify the inclusion of an indication against the sand fly vector.
Croatian: Kada je riječ o zahtjevu u pogledu podataka za dokazivanje repelentne djelotvornosti (sprječava hranjenje) protiv P. perniciosus, Ujedinjena Kraljevina nije prihvatila da se laboratorijskim podatcima koje je nositelj odobrenja za stavljanje lijeka u promet dostavio za proizvod može opravdati uključivanje indikacije protiv vektora pješčane mušice.
English: Laboratory studies did not demonstrate a sufficient anti-feeding (repellent) effect against sand flies (P. perniciosus) to support a direct indication against the sand fly.
Croatian: Laboratorijska ispitivanja nisu dokazala dostatan repelentan učinak (sprječava hranjenje) protiv pješčanih mušica (P. perniciosus) da bi se poduprla izravna indikacija protiv pješčanih mušica.
English: A total of 122 dogs, of several breeds aged between 1.5 and 6 months, were enrolled (mostly as litters) on individual start dates between March and May 2011.
Croatian: Između ožujka i svibnja 2011. na pojedine su datume početka u ispitivanje uključena (uglavnom kao štenad) ukupno 122 psa raznih pasmina, starosti od 1,5 do 6 mjeseci.
English: Data from 3 clinical field studies performed in endemic areas indicate a significant reduction in the risk of Leishmania infantum transmission by sand flies in treated dogs compared to non-treated dogs.
Croatian: Podaci iz 3 klinička terenska ispitivanja obavljena u endemskim područjima pokazala su značajno smanjenje rizika od prijenosaf Leishmania infantum papatačima kod tretiranih pasa u odnosu na netretirane.
English: However, the consistently low ratios of fed to unfed females seen in the laboratory studies are considered supportive of the field studies results.
Croatian: Međutim, smatra se da redoviti niski omjeri nahranjenih i nenahranjenih ženskih jedinki zabilježeni u laboratorijskim ispitivanjima podupiru rezultate terenskih ispitivanja.
English: Most dogs in normal household situations in countries endemic for leishmaniosis would be expected to be exposed to sand flies infected with leishmaniosis to a substantially lower extent, and therefore it was considered possible to extrapolate the results with confidence to the general target population.
Croatian: Očekuje se da je većina pasa u uobičajenom kućnom okruženju u zemljama u kojima je lišmanioza endemska znatno manje izložena pješčanim mušicama zaraženima lišmaniozom te se stoga smatra da je rezultate moguće pouzdano ekstrapolirati na opću ciljnu populaciju.
English: Positive animals were defined as the animals that at study completion were positive to one or more of the following tests: serology for circulating anti-Leishmania-infantum-antibodies (IFAT), cytology/PCR on skin tissue sample, and cytology/PCR of bone marrow aspirate.
Croatian: Pozitivne životinje definirane su kao životinje koje su po završetku ispitivanja bile pozitivne na najmanje jedan od sljedećih testova: serološki test na cirkulirajuća protutijela protiv patogena Leishmania infantum (IFAT), citologija / lančana reakcija polimerazom (PCR) na uzorku kožnog tkiva i citologija / PCR aspirata koštane srži.
English: Conjunctival swabs were collected on study day 0 and samples of bone marrow were collected on study day 0, in April 2012, and October 2012.
Croatian: Brisevi konjunktive prikupljeni su nultoga dana ispitivanja, a uzorci koštane srži prikupljeni su nultoga dana ispitivanja, u travnju 2012. i listopadu 2012.
English: Grounds for the granting of the variation of the marketing authorisations
Croatian: Razlozi za odobrenje izmjene odobrenja za stavljanje lijeka u promet
English: Regarding the results of the three field studies presented by the MAH, all three studies were able to demonstrate that use of Seresto led to a significant reduction in the occurrence of infection with L. infantum over a sustained period (between 7 and 8 months), with overall mean efficacies of the collar in preventing leishmaniosis of 93.4% in the first field study, 100% in the second field study, and 88.3% in the third field study as evaluated by the incidence density rate.
Croatian: Što se tiče rezultata triju terenskih ispitivanja koje je dostavio nositelj odobrenja za stavljanje lijeka u promet, sva su tri ispitivanja dokazala da je upotreba VMP-a Seresto dovela do znatnog smanjenja pojave infekcije patogenom L. infantum tijekom duljeg razdoblja (između sedam i osam mjeseci), pri čemu sveukupna srednja vrijednost djelotvornosti ovratnika u sprječavanju lišmanioze iznosi 93,4% u prvom terenskom ispitivanju, 100% u drugom terenskom ispitivanju i 88,3% u trećem terenskom ispitivanju u skladu s ocjenama na temelju stope incidencije.
English: Based on the data presented, the CVMP concluded that the efficacy of Seresto, and its associated name Foresto, with regard to a reduction of infection with L. infantum has been demonstrated, and that the benefit-risk balance is favourable.
Croatian: Na temelju dostavljenih podataka CVMP je zaključio da je djelotvornost VMP-a Seresto i pridruženog imena Foresto u pogledu smanjenja infekcije patogenom L. infantum dokazana i da je omjer koristi i rizika povoljan.
English: During the course of the procedure, the indication was amended by the reference Member State (RMS) who stated that ‘the demonstration of efficacy of the product against the sand flies over the whole season is a prerequisite for the claimed indirect prevention of transmission of L. infantum.
Croatian: Tijekom postupka indikaciju je izmijenila referentna država članica koja je navela da je „dokazivanje djelotvornosti proizvoda protiv pješčanih mušica tijekom cijele sezone preduvjet za tvrdnju o neizravnom sprječavanju prenošenja patogena L. infantum.
English: Data from efficacy studies against sand flies (Phlebotomus perniciosus) showed a variable sand fly repellent (anti-feeding) efficacy ranging from 65 to 89% for 7-8 months following initial application of the collar.
Croatian: Podaci iz studija učinkovitosti na papatače (Phlebotomus perniciosus) pokazali su varijabilan repelentni učinak (anti feeding) u rasponu 65 do 89% tijekom 7-8 mjeseci nakon aplikacije ovratnika.
English: The first study was a negatively-controlled, randomised, multicentre field study, which was partially blinded.
Croatian: Prvo je ispitivanje bilo negativno kontrolirano, randomizirano, multicentrično terensko ispitivanje koje je bilo djelomično slijepo.
English: • the CVMP considered that the efficacy of Seresto, and its associated name Foresto, relating to repellent (anti-feeding) activity against sand flies (Phlebotomus perniciosus) has not been satisfactorily demonstrated in the laboratory studies provided;
Croatian: • CVMP smatra da djelotvornost VMP-a Seresto i pridruženog imena Foresto u pogledu repelentnog djelovanja (sprječava hranjenje) protiv pješčanih mušica (Phlebotomus perniciosus) nije u zadovoljavajućoj mjeri dokazana u dostavljenim laboratorijskim ispitivanjima;
English: The third field study was a double positive and negative controlled, partially blinded, randomised multicentre field study.
Croatian: Treće je terensko ispitivanje bilo dvostruko pozitivno i negativno kontrolirano, djelomično slijepo, randomizirano multicentrično terensko ispitivanje.
English: Summary of product characteristics
Croatian: Sažetak opisa svojstava proizvoda