FrancophonIA/ELRC3.0 huggingface dataset:
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:
Slovenian: Veljaven povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo je zadnja verzija, sprejeta s strani Koordinacijske skupine s sledečimi spremembami:
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).
Slovenian: Vendar pa je razmerje med hranjenimi in nehranjenimi muhami v laboratorijski študiji, opisani zgoraj, pri zdravljenih psih nižje (povprečje 0,3, razpon od 0,1 do 0,4) kot pri nezdravljenih živalih (povprečje 9,0, razpon od 3,3 do 15,6).
English: The study ran between March 2011 and April 2012, with a post-treatment phase commencing April 2012 and completing October 2012.
Slovenian: Študija je potekala od marca 2011 do aprila 2012, pri čemer se je stopnja po zdravljenju začela aprila 2012 in končala oktobra 2012.
English: The Atrium, Blackthorn Road, Dublin 18, Ireland
Slovenian: Bayer Ltd., The Atrium, Blackthorn Road, Dublin 18, Ireland
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.
Slovenian: Živali so bile testirane za leishmaniozo z uporabo vzorcev krvi in tkiva kože, odvzetimi na dan 0 julija 2011, septembra 2011, novembra 2011, aprila 2012 in oktobra 2012.
English: Bayer Portugal, Lda., Rua Quinta do Pinheiro,
Slovenian: Portugalska Bayer Portugal, Lda., Rua Quinta do
English: Seresto and its associated name Foresto (thereinafter “Seresto”) is a medicated collar containing 10% imidacloprid and 4.5% flumethrin.
Slovenian: Zdravilo Seresto in povezano ime Foresto (v nadaljnjem besedilu: zdravilo Seresto) je ovratnica z zdravilom, ki vsebuje 10% imidakloprida in 4,5% flumetrina.
English: The anti-feeding efficacy demonstrated for Seresto is, therefore, considered insufficient for the inclusion of a direct repellent claim against P. perniciosus.
Slovenian: Učinkovitost pri preprečevanju hranjenja, dokazana za zdravilo Seresto, torej šteje za nezadostno za vključitev trditve o neposrednem repelentnem učinkovanju proti P. perniciosus.
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.
Slovenian: Pri večini psov v okoliščinah običajnih gospodinjstev v državah, endemičnih za leishmaniozo, bi pričakovali, da bodo peščenim muham, okuženim z leishmaniozo, izpostavljeni v bistveno manjšem obsegu, zato se je zdelo, da bo rezultate mogoče zanesljivo razširiti na splošno ciljno populacijo.
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.
Slovenian: Med potekom postopka je indikacijo popravila referenčna država članica, ki je navedla, da je „dokaz učinkovitosti zdravila proti peščenim muham v celotni sezoni prvi pogoj za navedeno posredno preprečevanje prenosa L. infantum.
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.
Slovenian: Indicirana je za zdravljenje in preprečevanje infestacij z bolhami, klopi in ušmi pri psih in mačkah ter zagotavlja posredno zaščito pred prenosom patogenov Babesia canis vogeli in Ehrlichia canis s klopom prenašalcem Rhipicephalus sanguineus, s čimer zmanjšuje tveganje za pasjo babeziozo in pasjo erlihiozo v obdobju sedmih mesecev.
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.
Slovenian: Vendar pa se je odbor CVMP strinjal, da predstavljajo v študijah uporabljene terenske okoliščine v smislu izpostavljenosti okuženim peščenim muham „primer najslabšega scenarija“: raven izpostavljenosti okuženim peščenim muham je bila visoka (stopnja pojavnosti pri nezdravljenih psih je segala od 46,2 do 67,0%); psi so bili podnevi in ponoči zunaj, kar je vodilo v neomejen stik med gostiteljem in prenašalcem; nezdravljeni psi na območju študije, ki niso bili vključeni v študijo, so pomenili dodaten vir leishmanioze.
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.
Slovenian: Opozoriti je treba, da smernice 7AE17a vsebujejo splošna navodila, vključno s pragom učinkovitosti proti dvokrilcem (Diptera), vendar pa niso bile oblikovane s ciljem usmerjanja glede študij za podporo vlog v povezavi z vektorsko prenosljivimi boleznimi, kot je preprečevanje pasje
English: Scientific conclusions and grounds for the granting of the variation of the marketing authorisations
Slovenian: Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravilom
English: Bayer Hungaria Kft., 1123 Budapest, Alkotás u.50,
Slovenian: Madžarska Bayer Hungaria Kft., 1123 Budapest,
English: Special warnings for each target species
Slovenian: Posebna opozorila za vsako živalsko vrsto
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.
Slovenian: Združeno kraljestvo je menilo, da je treba za vsako bolezen, ki jo prenaša prenašalec, pred sprejemom indikacije dokazati tudi učinkovitost proti prenašalcu.
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.
Slovenian: Na dan 0 je bilo vključenih skupno 279 psov različnih pasem, starih od dveh do 96 mesecev, 219 od katerih je bilo vključenih v izračun učinkovitosti.
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.
Slovenian: Ovratnica naj bo nameščena tik pred začetkom obdobja aktivnosti peščenih muh, ki so prenašalke Leishmania infantum, v času sezone in neprekinjeno v obdobju tveganja za infekcijo.
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.
Slovenian: Na študijski dan 0 so bili odvzeti brisi veznice, vzorci kostnega mozga pa so bili odvzeti na študijski dan 0 aprila 2012 in oktobra 2012.
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.
Slovenian: Vključevala je skupno 122 psov več pasem, starih od enega meseca in pol do šest mesecev (večinoma mladičev), ki so bili vključeni ob različnih dnevih med marcem in majem 2011.
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.
Slovenian: Na podlagi predloženih podatkov je odbor CVMP zaključil, da je bila učinkovitost zdravila Seresto in povezanega imena Foresto, kar zadeva zmanjševanje okužbe s parazitom L. infantum, dokazana ter da je razmerje med tveganji in koristmi ugodno.
English: As a result, bites by sand flies may occur, and the transmission of L. infantum cannot be completely excluded.
Slovenian: Zato se ugrizi peščenih muh lahko pojavljajo, prenosa parazita L. infantum pa ni mogoče popolnoma izključiti.
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.
Slovenian: Kar zadeva zahtevane podatke za dokaz repelentne (preprečevanje hranjenja) učinkovitosti proti P. perniciosus, se Združeno kraljestvo ni strinjalo, da laboratorijski podatki imetnika dovoljenja za promet z zdravilom upravičujejo vključitev indikacije proti prenašalcu peščeni muhi.
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.
Slovenian: Kar zadeva izide treh terenskih študij, ki jih je predstavil imetnik dovoljenja za promet z zdravilom, so lahko vse tri študije pokazale, da je uporaba zdravila Seresto privedla do pomembnega zmanjšanja pojavljanja okužbe s parazitom L. infantum v daljšem obdobju (od sedem do osem mesecev), s splošno povprečno učinkovitostjo ovratnice pri preprečevanju leishmanioze 93,4% v prvi terenski študiji, 100% v drugi terenski študiji in 88,3% v tretji terenski študiji, ocenjeno s stopnjo pojavnosti.
English: Add the following text in the relevant sections of the product information:
Slovenian: Dodaj besedilo v ustrezna poglavja povzetka glavnih značilnosti zdravila:
English: Relevant information relating to the supporting studies should be added to the SPC.
Slovenian: V povzetek glavnih značilnosti zdravila je treba vključiti ustrezne informacije, povezane s podpornimi študijami.
English: Luxembourg Bayer SA-NV, J.E.
Slovenian: Luksemburg Bayer SA-NV, J.E.
English: Animals were tested for leishmaniosis with samples of blood and skin tissue being collected on study days 0, 120, 210, and 360 (i.e. in the post-treatment phase), and samples of bone marrow collected on study days 0, 210, and 300.
Slovenian: Živali so bile testirane za leishmaniozo z vzorci krvi in tkiva kože, odvzetimi na študijske dneve 0, 120, 210 in 360 (tj. na stopnji po zdravljenju), ter z vzorci kostnega mozga, odvzetimi na študijske dneve 0, 210 in 300.
English: Annex III
Slovenian: Priloga III
English: The third field study was a double positive and negative controlled, partially blinded, randomised multicentre field study.
Slovenian: Tretja terenska študija je bila dvojno pozitivna in negativno nadzorovana, delno slepa, randomizirana multicentrična terenska študija.
English: The anti-feeding results, when using the absolute numbers of sand flies to calculate efficacy using the Abbott's formula as per the recommendation of Guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats (EMA/CVMP/EWP/005/2000-Rev.2)2, averaged 75.1% over the study period (65%-89%).
Slovenian: Rezultati pri preprečevanju hranjenja, dobljeni z uporabo absolutnega števila peščenih muh za izračun učinkovitosti po Abbottovi formuli, kot to priporočajo Smernice za preskušanje in ocenjevanje učinkovitosti antiparazitikov pri zdravljenju in preprečevanju infestacij s klopi in bolhami pri psih in mačkah (EMA/CVMP/EWP/005/2000-Rev. 2)2, so v študijskem obdobju povprečno znašali 75,1% (65-89%).
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.
Slovenian: Pozitivne živali so bile opredeljene kot živali, ki so bile ob koncu študije pozitivne pri eni ali več od naslednjih preiskav: seroloških preiskavah za protitelesa proti parazitu Leishmania infantum (IFAT) v krvnem obtoku, citoloških preiskavah/PCR vzorca tkiva kože in citoloških preiskavah/PCR aspirata kostnega mozga.
English: Grounds for the granting of the variation of the marketing authorisations
Slovenian: Podlaga za spremembo pogojev dovoljenj za promet
English: Having considered all of the data and argumentation submitted, it was the opinion of the CVMP that, although the MAH has not demonstrated that Seresto has satisfactory anti-feeding efficacy against P. perniciosus that would support a direct repellent claim against this parasite, the studies provided demonstrate that dogs treated with Seresto have a significant reduction in the occurrence of infection with L. infantum as a result of reduced transmission by the sand fly vector.
Slovenian: Ob upoštevanju vseh predloženih podatkov in utemeljitev je odbor CVMP menil, da imetnik dovoljenja za promet z zdravilom sicer ni dokazal, da zdravilo Seresto zadovoljivo zavira hranjenje parazita P. perniciosus, da bi lahko podprl trditev o neposrednem repelentnem delovanju proti temu parazitu, vendar pa predložene študije dokazujejo, da je pri psih, zdravljeni z zdravilom Seresto, pojavljanje okužbe s parazitom L. infantum zaradi zmanjšanega prenosa s prenašalcem peščeno muho bistveno manjše.
English: The first study was a negatively-controlled, randomised, multicentre field study, which was partially blinded.
Slovenian: Prva študija je bila negativno kontrolirana, randomizirana, multicentrična terenska študija, ki je bila delno slepa.
English: The consistently low fed to unfed ratios observed in treated dogs, compared to the high and variable fed to unfed ratios in untreated animals, demonstrate that the use of Seresto confers on treated dogs a sustained and consistent anti-feeding effect against sand flies (P. perniciosus).
Slovenian: Stalno nizka razmerja med hranjenimi in nehranjenimi peščenimi muhami pri zdravljenih psih, v primerjavi z visokimi in spremenljivimi razmerji med hranjenimi in nehranjenimi muhami pri nezdravljenih živalih, kažejo, da zdravilo Seresto pri zdravljenih psih dolgotrajno in dosledno zavira hranjenje peščenih muh (P. perniciosus).
English: The influence of shampooing or water immersion regarding the transmission of canine leishmaniosis has not been examined.
Slovenian: Vpliv šamponiranja ali potapljanja v vodo glede prenosa pasje leišmanijoze ni bil raziskan.
English: In the case of the sand fly and L. infantum, the active substances in Seresto, imidacloprid and flumethrin, have no known efficacy against the Leishmania parasite and therefore any preventative efficacy against leishmaniosis would be purely as a result of efficacy against the sand fly.
Slovenian: V primeru peščene muhe in parazita L. infantum zdravilni učinkovini v zdravilu Seresto, imidakloprid in flumetrin, nimata znane učinkovitosti proti parazitu Leishmania in bi bilo vsakršno preprečevanje leishmanioze izključno posledica učinkovitosti proti peščeni muhi.
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.
Slovenian: Vključenih je bilo skupno 224 psov več pasem, starih od 7 do 77 tednov, v ogradah, ki so bile randomizirane na eno od štirih skupin.
English: Amendments in the relevant sections of the summary of product characteristics and package leaflet
Slovenian: Spremembe ključnih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo
English: In support of the efficacy of Seresto relating to the transmission or occurrence of Leishmania infantum in dogs, the MAH provided three field studies.
Slovenian: V podporo učinkovitosti zdravila Seresto v povezavi s prenašanjem ali pojavljanjem parazita Leishmania infantum pri psih je imetnik dovoljenja za promet z zdravilom predložil tri terenske študije.
English: 4 INDICATIONS
Slovenian: 4 INDIKACIJA(E)
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.
Slovenian: Učinkovitost repelentov je bila ocenjena s primerjavo števila hranjenih samic peščene muhe pri zdravljenih živalih s številom hranjenih samic peščene muhe pri nezdravljenih živalih.
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;
Slovenian: • odbor CVMP je ocenil, da učinkovitost zdravila Seresto in povezanega imena Foresto, kar zadeva repelentno (zaviranje hranjenja) učinkovanje proti peščenim muham (Phlebotomus perniciosus) v predloženih laboratorijskih študijah ni bila ustrezno dokazana;
English: A claim for ‘reduction of the risk of infection with Leishmania infantum via transmission by sand flies for up to 8 months' has been adequately demonstrated.
Slovenian: Trditev o „zmanjševanju tveganja za okužbo s parazitom Leishmania infantum s prenosom s peščenimi muhami v obdobju do osem mesecev“ je bila ustrezno dokazana.
English: The marketing authorisation holder (MAH) submitted a variation application to add a new therapeutic indication: “Indirect protection against the transmission of pathogen Leishmania infantum by sand flies (Phlebotomus perniciosus) thereby reducing the risk of canine leishmaniosis for 7 to 8 months”.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil vlogo za spremembo pogojev dovoljenj, da bi dodal novo terapevtsko indikacijo: „posredna zaščita pred prenosom patogena Leishmania infantum s peščenimi muhami (Phlebotomus perniciosus), s čimer se tveganje za pasjo leishmaniozo zmanjša v sedmih do osmih mesecih“.
English: Efficacy evaluation was based on the comparison of the percentage of animals infected by L. infantum in the treated and untreated groups at the end of the study.
Slovenian: Ocena učinkovitosti je temeljila na primerjavi odstotka živali, okuženih s parazitom L. infantum, v zdravljeni in nezdravljeni skupini ob koncu študije.
English: Belgium Bayer SA-NV, J.E.
Slovenian: Bayer SA-NV, J.E.
English: • the CVMP considered that the efficacy of Seresto, and its associated name Foresto, relating to the transmission or occurrence of Leishmania infantum in dogs has been satisfactorily demonstrated in the field studies provided;
Slovenian: • odbor CVMP je ocenil, da je bila učinkovitost zdravila Seresto in povezanega imena Foresto, kar zadeva prenos ali pojavljanje parazita Leishmania infantum pri psih, v predloženih terenskih študijah zadovoljivo dokazana;
English: Mommaertslaan 14 1831 Diegem (Machelen),
Slovenian: 1831 Diegem (Machelen), Belgium
English: The MAH also provided an alternative analysis of the laboratory data from all 3 studies using ratios of fed to unfed sand flies for efficacy calculation.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil tudi nadomestno analizo laboratorijskih podatkov iz vseh treh študij, pri čemer je za izračun učinkovitosti uporabil razmerja med hranjenimi in nehranjenimi peščenimi muhami.
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.
Slovenian: Podatki iz treh terenskih kliničnih študij izvedenih v Leishmania infantum endemičnih področjih, kažejo na znatno zmanjšanje tveganja za prenos Leishmanium infantum iz peščenih muh pri zdravljenih psih v primerjavi z nezdravljenimi psi.
English: Three field studies, performed in situations with high infection pressure for leishmaniosis, demonstrated that the occurrence of new cases of L. infantum is significantly reduced in dogs treated with Seresto.
Slovenian: Tri terenske študije, opravljene v okoliščinah velikega okužbenega pritiska, so pokazale, da je pojavljanje novih primerov L. infantum pri psih, zdravljenih z zdravilom Seresto, pomembno manjše.
English: As a result, bites by sand flies may occur, and the transmission of Leishmania infantum cannot be completely excluded.
Slovenian: Kljub temu lahko pride do ugriza peščene muhe in prenos Leishmanium infantum ni izključen.
English: Therefore, whilst it was concluded that the claim ‘to significantly reduce the occurrence of infection with Leishmania infantum for up to 8 months due to repellent (anti-feeding) action of the product on sand flies' should not be included in the SPC, an amended indication, which accurately reflects the data provided, ‘reduction of the risk of infection with Leishmania infantum via transmission by sand flies for up to 8 months' was considered acceptable.
Slovenian: To pomeni, da je bilo zaključeno, da se trditev „za pomembno zmanjšanje pojavljanja okužbe s parazitom Leishmania infantum v obdobju do osem mesecev zaradi repelentnega (zaviranje hranjenja) učinkovanja zdravila na peščene muhe“ ne vključi v povzetek glavnih značilnosti zdravila, sprejemljiva pa je popravljena indikacija, ki ustrezno odraža predložene podatke, „zmanjševanje tveganja za okužbo s parazitom Leishmania infantum s prenosom s peščenimi muhami v obdobju do osem mesecev.“
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%.
Slovenian: Glede na prisotnost dejavnikov okužbe znaša učinkovitost zdravila za zmanjšanje tveganja za leišmanijozo od 88,3 do
English: Animals were defined as noninfected by Leishmania when seronegative for circulating anti-L. infantum antibodies and negative to PCR of skin tissue and bone marrow aspirate samples.
Slovenian: Živali so bile opredeljene kot neokužene s parazitom Leishmania, če so bile seronegativne za protitelesa proti L. infantum in negativne pri PCR vzorcev tkiva kože in aspirata kostnega mozga.
English: The second field study was a negatively-controlled, single centre, partially-blinded, clinical field study.
Slovenian: Druga terenska študija je bila negativno kontrolirana, enocentrična, delno slepa klinična terenska študija.
English: The three field studies provided demonstrated that, depending on the infection pressure by sand flies, use of Seresto reduced the risk of infection with L. infantum by 88.3-100%.
Slovenian: Tri predložene terenske študije so pokazale, da je uporaba zdravila Seresto tveganje za okužbo z L. infantum zmanjšala za 88,3-100%, odvisno od okužbenega pritiska peščene muhe.
English: Efficacy evaluation for Seresto was based on the comparison of the percentage of animals infected by L. infantum in the Seresto treated and untreated groups at the end of the study.
Slovenian: Ocena učinkovitosti zdravila Seresto je temeljila na primerjavi odstotka živali, okuženih s parazitom L. infantum, v skupini, zdravljeni z zdravilom Seresto, in nezdravljeni skupini ob koncu študije.
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.
Slovenian: Podatki študij učinkovitosti zdravila proti peščenim muham (Phlebotomus perniciosus) kažejo variabilno repelentno (preprečevanje hranjenja) učinkovitost v območju od 65 do 89% v obdobju 7-8 mesecev od namestitve ovratnice.