FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Stoga, iako je zaključak da tvrdnju „znatno smanjenje pojave infekcije patogenom Leishmania infantum tijekom najviše osam mjeseci zbog repelentnog djelovanja proizvoda (sprječava hranjenje) na pješčane mušice” ne bi trebalo uključiti u sažetak opisa svojstava VMP-a, smatralo se da je prihvatljiva izmijenjena indikacija koja točno odražava dostavljene podatke, odnosno „smanjenje rizika od infekcije patogenom Leishmania infantum prenošenjem pješčanim mušicama tijekom najviše osam mjeseci”.
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.
Croatian: Nakon što je razmotrio sve dostavljene podatke i podnesene argumente, CVMP je smatrao da, iako nositelj odobrenja za stavljanje lijeka u promet nije dokazao da Seresto ima zadovoljavajuću repelentnu djelotvornost protiv P. perniciosus koja bi išla u prilog tvrdnji o izravnom repelentu protiv tog parazita, dostavljena ispitivanja dokazuju da se kod pasa liječenih Serestom znatno rjeđe pojavljuje infekcija patogenom L. infantum, što je rezultat smanjenog prenošenja pješčanom mušicom kao vektorom.
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%).
Croatian: Prilikom upotrebe apsolutnog broja pješčanih mušica za izračun djelotvornosti primjenom Abbottove formule u skladu s preporukom iz Smjernica za ispitivanje i ocjenjivanje djelotvornosti antiparazitskih tvari u liječenju i sprječavanju infestacija krpeljima i buhama kod pasa i mačaka (EMA/CVMP/EWP/005/2000-Rev.2)2, rezultati u pogledu sprječavanja hranjenja u prosjeku su iznosili 75,1% tijekom razdoblja ispitivanja (65% - 89%).
English: As a result, bites by sand flies may occur, and the transmission of Leishmania infantum cannot be completely excluded.
Croatian: Stoga su ugrizi papatača mogući i prijenos Leishmania infantum se ne može u potpunosti isključiti.
English: In support of this application, the MAH provided laboratory and field studies.
Croatian: U prilog tom zahtjevu nositelj odobrenja za stavljanje lijeka u promet dostavio je laboratorijska i terenska ispitivanja.
English: Belgium Bayer SA-NV, J.E.
Croatian: Bayer SA-NV, J.E.
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.
Croatian: Tri terenska ispitivanja, provedena u okruženjima s visokim infekcijskim pritiskom u pogledu lišmanioze, dokazala su da je pojava novih slučajeva zaraze patogenom L. infantum znatno smanjena kod pasa liječenih Serestom.
English: As a result, bites by sand flies may occur, and the transmission of L. infantum cannot be completely excluded.
Croatian: Stoga se mogu pojaviti ugrizi pješčanih mušica te se prenošenje patogena L. infantum ne može u potpunosti isključiti.
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).
Croatian: Redoviti niski omjeri nahranjenih i nenahranjenih pješčanih mušica zabilježeni kod liječenih pasa, u usporedbi s visokim i promjenjivim omjerima nahranjenih i nenahranjenih pješčanih mušica kod neliječenih životinja, dokaz su da upotreba VMP-a Seresto na liječenim psima ima održiv i stalan repelentan učinak protiv pješčanih mušica (P. perniciosus).
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”.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet podnio je zahtjev za izmjenu odobrenja kojim traži dodavanje nove terapijske indikacije: „Neizravna zaštita od prenošenja patogena Leishmania infantum pješčanim mušicama (Phlebotomus perniciosus), čime se rizik od lišmanioze pasa smanjuje tijekom sedam do osam mjeseci”.
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%.
Croatian: Dostavljena tri terenska ispitivanja dokazala su da se, ovisno o infekcijskom pritisku pješčanih mušica, upotrebom VMP-a Seresto rizik od infekcije patogenom L. infantum smanjio za 88,3% do 100%.
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.
Croatian: Životinje su testirane na lišmaniozu, pri čemu su uzorci krvi i kožnog tkiva prikupljeni nultoga dana ispitivanja te 120., 210. i 360. dana ispitivanja (odnosno u fazi nakon liječenja), a uzorci koštane srži nultoga dana ispitivanja te 210. i 300. dana ispitivanja.
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.
Croatian: U prilog djelotvornosti VMP-a Seresto u pogledu prenošenja ili pojave Leishmania infantum kod pasa, nositelj odobrenja za stavljanje lijeka u promet dostavio je tri terenska ispitivanja.
English: The second field study was a negatively-controlled, single centre, partially-blinded, clinical field study.
Croatian: Drugo je terensko ispitivanje bilo negativno kontrolirano, jednocentrično, djelomično slijepo, kliničko terensko ispitivanje.
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.
Croatian: Životinje su definirane kao neinficirane parazitom Leishmania ako su bile seronegativne na cirkulirajuća protutijela protiv patogena L. infantum i negativne na PCR uzoraka kožnog tkiva i aspirata koštane srži.
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.
Croatian: Ocjena djelotvornosti temeljila se na usporedbi postotka životinja zaraženih patogenom L. infantum u liječenoj i neliječenoj skupini na kraju ispitivanja.
English: The benefit-risk assessment is made on this basis.
Croatian: Na temelju toga provedena je procjena omjera koristi i rizika.
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.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet dostavio je i alternativnu analizu laboratorijskih podataka iz svih triju ispitivanja u kojoj je za izračun djelotvornosti upotrijebljen omjer nahranjenih i nenahranjenih pješčanih mušica.
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.
Croatian: U slučaju pješčane mušice i patogena L. infantum nije poznato jesu li djelatne tvari u VMP-u Seresto, imidakloprid i flumetrin, djelotvorne protiv parazita Leishmania te bi stoga svaka preventivna djelotvornost u pogledu lišmanioze bila isključivo rezultat djelotvornosti protiv pješčane mušice.
English: Reduction of the risk of infection with Leishmania infantum via transmission by sand flies for up to 8 months.
Croatian: Smanjenje rizika od infekcije s Leishmania infantum koju prenose papatači do 8 mjeseci.
English: The indication proposed by the RMS, and agreed by the majority of the concerned Member States (CMSs), at the referral stage was “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.”
Croatian: Indikacija koju je predložila referentna država članica i s kojom se složila većina predmetnih država članica glasila je u fazi upućivanja: „Znatno smanjenje pojave infekcije patogenom Leishmania infantum tijekom najviše osam mjeseci zbog repelentnog djelovanja proizvoda (sprječava hranjenje) na pješčane mušice.”
English: The application was submitted as a Type II variation for the addition of the new therapeutic indication ‘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'.
Croatian: Zahtjev je podnesen kao izmjena tipa II. za dodavanje nove terapijske indikacije „znatno smanjenje pojave infekcije patogenom Leishmania infantum tijekom najviše osam mjeseci zbog repelentnog djelovanja proizvoda (sprječava hranjenje) na pješčane mušice”.
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.
Croatian: Tvrdnja „smanjenje rizika od infekcije patogenom Leishmania infantum prenošenjem pješčanim mušicama tijekom najviše osam mjeseci” dokazana je na odgovarajući način.
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;
Croatian: • CVMP smatra da je djelotvornost VMP-a Seresto i pridruženog imena Foresto u pogledu prenošenja ili pojave patogena Leishmania infantum kod pasa u dostavljenim terenskim ispitivanjima dokazana u zadovoljavajućoj mjeri;
English: The amended summary of product characteristics, labelling and package leaflet are set out in Annex III.
Croatian: Izmijenjeni sažetak opisa svojstava VMP-a, označivanje i uputa o VMP-u navedeni su u Dodatku III.
English: Although a significant reduction in the incidence of L. infantum in dogs has been demonstrated, the product has shown variable repellent (anti-feeding) and insecticidal efficacy against the sand fly P. perniciosus.
Croatian: Iako je dokazano znatno smanjenje incidencije L. infantum kod pasa, proizvod je pokazao varijabilnu repelentnu (sprječava hranjenje) i insekticidnu djelotvornost protiv pješčane mušice P. perniciosus.
English: The MAH has provided three GCP-compliant laboratory studies, conducted in order to determine the anti-feeding and insecticidal efficacy of the test product against sand flies.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet dostavio je tri laboratorijska ispitivanja provedena u skladu s dobrom kliničkom praksom kako bi se utvrdila repelentna i insekticidna djelotvornost ispitivanog proizvoda protiv pješčanih mušica.
English: For the protective claim sought, demonstration of an anti-feeding activity for Seresto against sand flies was considered a prerequisite by the CVMP as the active substances in the Seresto collar, imidacloprid and flumethrin, have no known efficacy against Leishmania and therefore, any preventative efficacy against leishmaniosis is purely a result of efficacy against the sand fly.
Croatian: U pogledu tvrdnje o zaštiti CVMP je smatrao da je za Seresto nužno dokazati djelovanje kojim se sprječava hranjenje pješčanih mušica s obzirom na to da nije poznato jesu li djelatne tvari u ovratniku Seresto, imidakloprid i flumetrin, djelotvorne protiv parazita Leishmania te je stoga svaka preventivna djelotvornost u pogledu lišmanioze isključivo rezultat djelotvornosti protiv pješčane mušice.
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.
Croatian: Ocjena djelotvornosti VMP-a Seresto temeljila se na usporedbi postotka životinja zaraženih patogenom L. infantum u skupini liječenoj Serestom i u neliječenoj skupini na kraju ispitivanja.
English: Although a significant reduction in the incidence of Leishmania infantum in dogs has been demonstrated, the product has shown variable repellent (anti-feeding) and insecticidal efficacy against the sand fly Phlebotomus perniciosus.
Croatian: Iako je dokazano značajno smanjenje incidencije Leishmania infantum kod pasa, proizvod je pokazao varijabilan repelentni (anti feeding) i insekticidni učinak na papatače Phlebotomus perniciosus.
English: the CVMP has recommended the granting of the variation of the marketing authorisations for Seresto and its associated name Foresto with amendment to the summary of product characteristics, labelling and package leaflet of the reference Member State.
Croatian: • CVMP smatra da redoviti niski omjeri nahranjenih i nenahranjenih ženskih jedinki pješčanih mušica zabilježeni u laboratorijskim ispitivanjima podupiru rezultate terenskih ispitivanja; CVMP preporučuje da se odobri izmjena odobrenja za stavljanje lijeka u promet za Seresto i pridruženo ime Foresto uvođenjem izmjene sažetka opisa svojstava VMP-a, označivanja i uputa o VMP-u koju je predložila referentna država članica.
English: Amendments in the relevant sections of the summary of product characteristics and package leaflet
Croatian: Nadopune odgovarajućih odjeljaka sažetka opisa svojstava i upute o VMP-u
English: 2 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) - link skin tissue being collected on study days 0, 90, 180, 210, and 300 (i.e. in the post-treatment phase), and samples of bone marrow collected on study days 0 and D300.
Croatian: 2 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) - link
English: Marketing authorisation holder
Croatian: Nositelj odobrenja Izmišljeno ime
English: Seresto vet. 4,5/2,03 g panta koirille yli 8 kg
Croatian: 4,5/2,03 g panta koirille yli 8 kg
English: Foresto 4.50 g + 2.03 g, g zgardă antiparazitară pentru câini >8 kg
Croatian: Foresto 4,50 g + 2,03 g, zgardă antiparazitară pentru câini >8 kg
English: Seresto vet. 1,25 g/ 0,56 g hálsband fyrir hunda ≤8 kg.
Croatian: 1,25 g/ 0,56 g hálsband fyrir hunda ≤8 kg.
English: Seresto vet. 1,25 g/ 0,56 g hálsband fyrir ketti og hunda ≤8 kg
Croatian: 1,25 g/ 0,56 g hálsband fyrir ketti og hunda ≤8 kg
English: Seresto vet. 1,25 g / 0,56 g halsbånd til katt og hund ≤8 kg
Croatian: 1,25 g / 0,56 g halsbånd til katt og hund ≤8 kg
English: Seresto vet. 4,5 g / 2,03 g halsbånd til hunde >8 kg
Croatian: 4,5 g / 2,03 g halsbånd til hunde >8 kg
English: This summary was last updated in February 2015.
Croatian: Ovaj sažetak je posljednji put ažuriran u veljači 2015.
English: EMA/166222/2011 EMEA/V/C/002009
Croatian: EMA/243199/2015 EMEA/H/C/002009
English: Cattle may also experience pain at the time of injection.
Croatian: Goveda mogu također osjetiti bol u trenutku injekcije.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Croatian: Ako želite više informacija na temelju preporuka CVMP-a, pročitajte znanstvenu raspravu (također dio EPAR-a).
English: When used to prevent BRD, the presence of the disease in the herd should be confirmed before use.
Croatian: Ako se koristi za sprječavanje BRD-a, prisutnost bolesti u krdu se potvrđuje prije uporabe.
English: The animal should be monitored and if signs of respiratory problems are still present after two days (pigs) or two to three days (cattle), the treatment should be switched to another antibiotic.
Croatian: Životinju treba pratiti, te ako su prisutni znakovi respiratornih problema nakon dva dana (svinje) ili dva do tri dana (goveda), terapiju treba zamijeniti drugim antibioticima.
English: This means that the antibiotic may no longer work on bacteria infecting either animals or humans.
Croatian: To znači da antibiotik više ne djeluje na bakteriju koja inficira životinje ili ljude.
English: The withdrawal period for meat is nine days for pigs and 47 days for cattle.
Croatian: Razdoblje karencije za meso iznosi devet dana za svinje i 47 dana za goveda.
English: The dose to use is calculated according to the animal's weight.
Croatian: Doza koja će se koristiti izračunava se u skladu s tjelesnom masom životinje.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Zuprevo on 6 May 2011.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Zuprevo na snazi u Europskoj uniji od 6. svibnja 2011.
English: Antibiotic resistance is the ability of bacteria to grow in the presence of an antibiotic that would normally kill them or limit their growth.
Croatian: Rezistencija na antibiotike je sposobnost rasta bakterija uz prisutnost antibiotika koji bi ih inače ubili ili ograničili njihov rast.
English: In case of accidental contact, the skin should be washed immediately with soap and water, and the eyes flushed with clean water.
Croatian: Ako slučajno dođe do dodira s kožom, odmah oprati kožu sapunom i vodom, a oči isprati čistom vodom.
English: This document is a summary of the European Public Assessment Report.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije.
English: This medicine is not allowed to be used in animals producing milk for human consumption.
Croatian: Ovaj lijek nije odobren za primjenu u životinja koje proizvode mlijeko za primjenu u ljudskoj prehrani.
English: Other information about Zuprevo:
Croatian: Ostale informacije o lijeku Zuprevo:
English: The treatment studies looked at the improvement of the signs of respiratory disease and the prevention studies looked at the absence of signs of infection (fever, respiratory or behaviour abnormalities) in animals exposed to infection.
Croatian: Ispitivanja terapija istražila su poboljšanje znakova respiratorne bolesti, a ispitivanja prevencije istražila su odsutnost znakova infekcije (vrućice, respiratornih abnormalnosti ili bihevioralnih abnormalnosti) u životinja izloženih infekciji.
English: Zuprevo is available as a solution for injection containing tildipirosin 40 mg/ml (for pigs) or 180 mg/ml (for cattle).
Croatian: Zuprevo je dostupan kao otopina za injekciju koja sadrži tildipirosin 40 mg/ml (za svinje) ili 180 mg/ml (za goveda).
English: Animals treated with Zuprevo may develop a swelling at the site of the injection, especially when larger volumes are used, therefore each injection is limited to a maximum volume (5 ml in pigs and 10 ml in cattle).
Croatian: Životinje liječene VMP-om Zuprevo mogu razviti otok u mjestu injekcije, posebice ako se koriste veliki volumeni, stoga je svaka injekcija ograničena na maksimalan volumen (5 ml u svinja i 10 ml u goveda).
English: 229 pigs were treated with Zuprevo and 227 pigs were untreated controls that received saline.
Croatian: 229 svinja liječeno je VMP-om Zuprevo, a 227 svinja koje nisu liječene primile su fiziološku otopinu.
English: Zuprevo should not be used in animals that are hypersensitive (allergic) to macrolide antibiotics or to any of the excipients.
Croatian: Zuprevo se ne smije koristiti u životinja koje su preosjetljive (alergične) na makrolidne antibiotike ili na bilo koju pomoćnu tvar.
English: The CVMP concluded that the benefits of Zuprevo outweigh the risks for the approved indications and recommended that Zuprevo be given a marketing authorisation.
Croatian: CVMP zaključio je da koristi VMP-a Zuprevo nadmašuju rizike za odobrene indikacije i preporučio je da se odobrenje za stavljanje VMP-a u promet dodijeli VMP-u Zuprevo.
English: In the field studies, the medicine was compared with other antibiotics used in these diseases (tulathromycin or florfenicol).
Croatian: U slučaju terenskog ispitivanja, lijek je uspoređen s drugim antibioticima koji se koriste u slučaju ovih bolesti (tulatromicin ili florfenicol).
English: The medicine should not be given into a blood vessel.
Croatian: VMP se ne smije primjenjivati u krvnu žilu.
English: The effectiveness of Zuprevo used for treatment and metaphylaxis of SRD in diseased pigs as well as in clinically healthy in-contact pigs was investigated in a field study in which an outbreak of SRD was confirmed with at least 30% of the pens showing clinical signs of SRD, including at least 10% of animals per pen within 1 day or 20% within 2 days or 30% within 3 days.
Croatian: Djelotvornost lijeka Zuprevo u slučaju primjene za potrebe terapije i metafilakse SRD-a u dijagnosticiranih svinja kao i u klinički zdravih svinja koje dolaze u kontakt ispitana je u terenskom ispitivanju u kojem su izbijanja SRD-a potvrđena pri čemu je najmanje 30% torova pokazivalo je kliničke znakove SRD-a, uključujući najmanje 10% životinja po toru unutar 1 dana ili 20% unutar 2 dana ili 30% unutar 3 dana.
English: It works by blocking the bacterias' ribosomes, the parts of the cell where proteins are produced, and blocking the growth of bacteria.
Croatian: Djeluje inhibirajući ribosome bakterija, dijelove stanice u kojima se proizvode proteini, te inhibirajući rast bakterija.
English: Zuprevo is a veterinary medicine that contains tildipirosin.
Croatian: Zuprevo je veterinarsko-medicinski proizvod koji sadrži tildipirosin.
English: The swelling can last for up to three days in pigs, and one to two weeks in cattle.
Croatian: Otok može potrajati do tri dana u svinja, te jednog do dva dana u goveda.
English: Zuprevo is an antibiotic that belongs to the group ‘macrolides'.
Croatian: Zuprevo je antibiotik koji se ubraja u grupu "makrolida".
English: Information on the prescription status of this product may be found on the label/outer package.
Croatian: Informacije o tome je li za ovaj proizvod potreban veterinarski recept nalaze se na etiketi/vanjskom dijelu pakiranja.
English: When Zuprevo was used for treatment and metaphylaxis of SRD in diseased and clinically healthy incontact pigs approximately 86% of the healthy pigs remained free of clinical signs of disease compared with approximately 65% of pigs in the untreated control group.
Croatian: Ako se Zuprevo koristi za terapiju i metafilaksu SRD-a u bolesnih i klinički zdravih svinja koje dolaze u kontakt, otprilike 86% zdravih svinja nije pokazalo kliničke znakove bolesti u usporedbi s otprilike 65% svinja u neliječenoj kontrolnoj grupi.
English: Why has Zuprevo been approved?
Croatian: Zašto je Zuprevo odobren?
English: Zuprevo is an antibiotic used in pigs to treat swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis.
Croatian: Zuprevo je antibiotik koji se koristi za liječenje dišnih bolesti svinja (DBS) povezanih s Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica i Haemophilus parasuis.