natgillin/translations-raw huggingface dataset:
Overall summary of the scientific evaluation of Seresto and its associated name Foresto (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Seresto in povezanega imena Foresto (glejte Prilogo I)
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).
Vsak pes je bil trinajstkrat izpostavljen 80 samicam peščene muhe (D7, 14, 21, 28, 56, 84, 112, 140, 166, 196, 208, 215 in 222).
The study duration was 300 days ± 10 days, and the treated animals wore the collar for the first 210 ± 10 days of this period.
Študija je trajala 300 dni ± 10 dni, zdravljene živali pa so ovratnico nosile prvih 210 ± 10 dni v tem obdobju.
An animal was considered positive for leishmaniosis if positive to one or more tests used.
Žival je bila ocenjena kot pozitivna za leishmaniozo, če je bila pozitivna pri eni ali več uporabljenih preiskav.
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.
Skratka, Združeno kraljestvo je menilo, da učinkovitost zdravila Seresto za predlagano indikacijo ni dovolj dokazana in da bi sprejem te indikacije lahko pomenil resno tveganje za zdravje živali in ljudi.
In this laboratory study, 14 dogs were randomised to either treatment with Seresto collar (n=7) or untreated control (n=7).
V tej laboratorijski študiji je bilo 14 psov randomiziranih na zdravljenje z ovratnico z zdravilom Seresto (n = 7) ali nezdravljeno kontrolo (n = 7).
12 SPECIAL WARNING(S)
12 POSEBNO(A) OPOZORILO(A)
List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravila za uporabo v veterinarski medicini, živalskih vrst, poti uporabe, imetnika dovoljenja za promet v državah članicah
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.
Ker pa so bile izvedene v zavetiščih za živali v južni Italiji, je Združeno kraljestvo menilo, da ugotovitev teh študij o prenosu leishmanioze ni mogoče prenesti na vsa območja EU, na katerih je bolezen endemična.
This is a variation application for an already-authorised product (Seresto); no further risks have been identified in the studies provided.
To je vloga za spremembo za že odobreno zdravilo (zdravilo Seresto); v predloženih študijah niso bila ugotovljena nobena nadaljnja tveganja.
The benefit-risk balance for the agreed indication is considered favourable.
Razmerje med tveganji in koristmi pri sprejeti indikaciji je ugodno.
1 Guideline Demonstration of Efficacy of Ectoparasiticides (7AE17a) - link
1 Guideline Demonstration of Efficacy of Ectoparasiticides (7AE17a) - link leishmanioze.
Of the thirteen assessment time points, an anti-feeding efficacy above 80% was only achieved on three occasions.
Od trinajstih časovnih točkah ocenjevanja je bila učinkovitost, večja od 80%, pri preprečevanju hranjenja dosežena samo trikrat.
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.
V skladu s smernicami 7AE17a in EMEA/CVMP/EWP/005/2000-Rev.2 je treba terenske študije opraviti na vsaj dveh geografskih območjih, proučevana populacija živali pa mora predstavljati ciljno populacijo.
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.
V istih študijah je stopnja pojavnosti pri nezdravljenih psih (60,7%, 46,2% in 67,0%) v uporabljenih terenskih okoliščinah pokazala velik okužbeni pritisk.
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.
Zdravljeni psi so bili v obdobju študije stalno zdravljeni z zdravilom Seresto, pri čemer je bila ovratnica po potrebi zamenjana zaradi rasti živali ali skladno z navodili za uporabo zdravila.
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.
Poleg tega so z dokazovanjem te trditve povezane določene težave: trenutno ni potrjenega laboratorijskega modela, ki lahko dokaže učinkovitost veterinarskega zdravila proti leishmaniozi.
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.
Študija je potekala med aprilom/majem in decembrom 2013 (približno osem mesecev), nato pa je do aprila/maja 2014 potekala stopnja po zdravljenju.
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.
Prag učinkovitosti od 80 do 100% (po možnosti 90%), kot je priporočeno v smernicah Dokazovanje učinkovitosti ektoparaziticidov (7AE17a),1 ni bil dosežen v dovolj časovnih točkah.
The amended summary of product characteristics, labelling and package leaflet are set out in Annex III.
Spremenjeni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so navedeni v Prilogi III.
According to Guideline 7AE17a, the threshold of efficacy for Diptera should be 80-100% (preferably more than 90%).
V skladu s smernicami 7AE17a bi moral biti prag učinkovitosti pri dvokrilcih 80-100% (po možnosti več kot 90%).
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).
Uporaba razmerja med hranjenimi in nehranjenimi peščenimi muhami v Abbottovi formuli ne šteje za sprejemljivo metodo za izračun učinkovitosti v odstotkih, saj so bila razmerja za približno oceno tveganj (verjetnosti) uporabljena nepravilno.
In support of this application, the MAH provided laboratory and field studies.
V podporo tej vlogi je imetnik dovoljenja za promet z zdravilom predložil laboratorijske in terenske študije.
Seresto contains the active substances imidacloprid 10% and flumethrin 4.5%.
Zdravilo Seresto vsebuje zdravilni učinkovini imidakloprid 10% in flumetrin 4,5%.
The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Veljaven povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo je zadnja verzija, sprejeta s strani Koordinacijske skupine s sledečimi spremembami:
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).
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).
The study ran between March 2011 and April 2012, with a post-treatment phase commencing April 2012 and completing October 2012.
Študija je potekala od marca 2011 do aprila 2012, pri čemer se je stopnja po zdravljenju začela aprila 2012 in končala oktobra 2012.
The Atrium, Blackthorn Road, Dublin 18, Ireland
Bayer Ltd., The Atrium, Blackthorn Road, Dublin 18, Ireland
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.
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.
Bayer Portugal, Lda., Rua Quinta do Pinheiro,
Portugalska Bayer Portugal, Lda., Rua Quinta do
Seresto and its associated name Foresto (thereinafter “Seresto”) is a medicated collar containing 10% imidacloprid and 4.5% flumethrin.
Zdravilo Seresto in povezano ime Foresto (v nadaljnjem besedilu: zdravilo Seresto) je ovratnica z zdravilom, ki vsebuje 10% imidakloprida in 4,5% flumetrina.
The anti-feeding efficacy demonstrated for Seresto is, therefore, considered insufficient for the inclusion of a direct repellent claim against P. perniciosus.
Učinkovitost pri preprečevanju hranjenja, dokazana za zdravilo Seresto, torej šteje za nezadostno za vključitev trditve o neposrednem repelentnem učinkovanju proti P. perniciosus.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
Scientific conclusions and grounds for the granting of the variation of the marketing authorisations
Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravilom
Bayer Hungaria Kft., 1123 Budapest, Alkotás u.50,
Madžarska Bayer Hungaria Kft., 1123 Budapest,
Special warnings for each target species
Posebna opozorila za vsako živalsko vrsto
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.
Združeno kraljestvo je menilo, da je treba za vsako bolezen, ki jo prenaša prenašalec, pred sprejemom indikacije dokazati tudi učinkovitost proti prenašalcu.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
As a result, bites by sand flies may occur, and the transmission of L. infantum cannot be completely excluded.
Zato se ugrizi peščenih muh lahko pojavljajo, prenosa parazita L. infantum pa ni mogoče popolnoma izključiti.
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.
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.
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.
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.
Add the following text in the relevant sections of the product information:
Dodaj besedilo v ustrezna poglavja povzetka glavnih značilnosti zdravila:
Relevant information relating to the supporting studies should be added to the SPC.
V povzetek glavnih značilnosti zdravila je treba vključiti ustrezne informacije, povezane s podpornimi študijami.
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.
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.
The third field study was a double positive and negative controlled, partially blinded, randomised multicentre field study.
Tretja terenska študija je bila dvojno pozitivna in negativno nadzorovana, delno slepa, randomizirana multicentrična terenska študija.
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%).
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%).
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.
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.
Grounds for the granting of the variation of the marketing authorisations
Podlaga za spremembo pogojev dovoljenj za promet
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.
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.
The first study was a negatively-controlled, randomised, multicentre field study, which was partially blinded.
Prva študija je bila negativno kontrolirana, randomizirana, multicentrična terenska študija, ki je bila delno slepa.
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).
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).
The influence of shampooing or water immersion regarding the transmission of canine leishmaniosis has not been examined.
Vpliv šamponiranja ali potapljanja v vodo glede prenosa pasje leišmanijoze ni bil raziskan.
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.
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.
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.
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.
Amendments in the relevant sections of the summary of product characteristics and package leaflet
Spremembe ključnih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo
In support of the efficacy of Seresto relating to the transmission or occurrence of Leishmania infantum in dogs, the MAH provided three field studies.
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.
4 INDICATIONS
4 INDIKACIJA(E)
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.
Učinkovitost repelentov je bila ocenjena s primerjavo števila hranjenih samic peščene muhe pri zdravljenih živalih s številom hranjenih samic peščene muhe pri nezdravljenih živalih.
• 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;
• 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;
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.
Trditev o „zmanjševanju tveganja za okužbo s parazitom Leishmania infantum s prenosom s peščenimi muhami v obdobju do osem mesecev“ je bila ustrezno dokazana.