FrancophonIA/ELRC3.0 huggingface dataset:
English: Use of the veterinary medicinal product deviating from instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other fluoroquinolones due to the potential for cross-resistance.
Croatian: Primjena veterinarsko medicinskih proizvoda koja odstupa od uputa danih u SPC može povećati prevalenciju bakterija otpornih na fluorokinolone i može smanjiti djelotvornost liječenja s drugim fluorokinolonima uslijed potencijalne unakrsne otpornosti.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 120 mg pradofloxacin.
Croatian: SASTAV DJELATNIH TVARI Svaka tableta sadrži 120 mg pradofloksacina.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Aluminium blister of 7 tablets (60 mg)
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA BLISTERIMA ILI TRAKAMA Aluminijski blister (60 mg)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 25 mg/ml oral suspension for cats
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Veraflox 25 mg/ml peroralna suspenzija za mačke
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Aluminium blister of 7 tablets (15 mg)
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA BLISTERIMA ILI TRAKAMA Aluminijski blister (15 mg)
English: Do not use in dogs during pregnancy and lactation (see section 4.7).
Croatian: Ne primjenjivati kod pasa tijekom gravidnosti i laktacije (vidi odjeljak 4.7).
English: Do not use in cats during pregnancy and lactation (see section 4.7).
Croatian: Ne primjenjivati kod mačaka tijekom gravidnosti i laktacije (vidi odjeljak 4.7).
English: PACKAGE SIZE - 15 ml bottle and a 3ml oral dosing syringe
Croatian: VELIČINA PAKOVANJA 15 ml bočica polipropilenska šprica za peroralno doziranje od 3 ml
English: Staphylococcus intermedius group (including S. pseudintermedius)
Croatian: Staphylococcus intermedius skupina (uključujući S. pseudintermedius)
English: Use of the veterinary medicinal product deviating from instructions given in the summary of product characteristics (SPC) may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other fluoroquinolones due to the potential for crossresistance.
Croatian: Primjena veterinarsko-medicinskih proizvoda koja odstupa od uputa navedenih u sažetku opisa svojstava (SPC) može povećati prevalenciju bakterija otpornih na fluorokinolone i može smanjiti djelotvornost liječenja s drugim fluorokinolonima uslijed potencijalne unakrsne otpornosti.
English: Lactation:
Croatian: Predoziranje:
English: Do not use in dogs with central nervous system (CNS) disorders, such as epilepsy, as fluoroquinolones could possibly cause seizures in predisposed animals.
Croatian: Ne primjenjivati kod pasa s poremećajima središnjeg živčanog sustava (CNS), kao što su epilepsija, jer fluorokinoloni mogu eventualno izazvati napadaje kod predisponiranih životinja.
English: The recommended dose is 3 mg/kg bodyweight of pradofloxacin once daily according to the following tables.
Croatian: Preporučena doza iznosi 3 mg/kg tjelesne mase pradofloksacina jednom dnevno.
English: The safety of this veterinary medicinal product has not been established during pregnancy and lactation.
Croatian: Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena kod mačaka za vrijeme graviditeta i laktacije.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 15 mg tablets for dogs and cats pradofloxacin
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Veraflox 15 mg tablete za pse i mačke pradofloksacin
English: Do not use in cats with central nervous system (CNS) disorders, such as epilepsy, as fluoroquinolones could potentially cause seizures in predisposed animals.
Croatian: Ne primjenjivati kod mačaka s poremećajima središnjeg živčanog sustava (CNS), kao što su epilepsija, jer fluorokinoloni mogu eventualno izazvati napadaje kod predisponiranih životinja.
English: The safety of Veraflox has not been established during pregnancy and lactation in dogs.
Croatian: Neškodljivost Verafloxa nije dokazana tijekom graviditeta i laktacije kod pasa i mačaka.
English: • acute infections of the upper respiratory tract caused by susceptible strains of Pasteurella multocida, Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius).
Croatian: • Akutne infekcije gornjih dišnih prohoda uzrokovane osjetljivim sojevima Pasteurella multocida, Escherichia coli i skupine Staphylococcus intermedius (uključujući S. pseudintermedius).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 60 mg pradofloxacin.
Croatian: SASTAV DJELATNIH TVARI Svaka tableta sadržava 60 mg pradofloksacina.
English: Reading RG2 6AD-UK Tel: +44 (0)118 206 3000
Croatian: Tel: +44 (0)118 206 3000
English: Infections of the skin:
Croatian: Infekcije rana i apscesi
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg pradofloxacin.
Croatian: SASTAV DJELATNIH TVARI Svaka tableta sadržava 15 mg pradofloksacina.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 15 mg tablets for dogs and cats Veraflox 60 mg tablets for dogs Veraflox 120 mg tablets for dogs
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Veraflox 15mg tablete za pse i mačke Veraflox 60 mg tablete za pse
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Oral suspension containing 25 mg/ml pradofloxacin Preservative: Sorbic acid (E200) 2 mg/ml
Croatian: Peroralna suspenzija sadrži 25 mg/ml pradofloksacina Konzervans: sorbinska kiselina (E200) 2 mg/ml Žućkasta do bež suspenzija.
English: ROUTE(S) OF ADMINISTRATION Oral use.
Croatian: PUT(EVI) PRIMJENE Peroralna primjena.
English: • wound infections and abscesses caused by susceptible strains of Pasteurella multocida and the
Croatian: • Akutne infekcije gornjih dišnih prohoda uzrokovane osjetljivim sojevima Pasteurella multocida,
English: Treatment of: • acute infections of the upper respiratory tract caused by susceptible strains of Pasteurella multocida, Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius).
Croatian: Liječenje akutnih infekcija gornjih dišnih prohoda uzrokovanih osjetljivim sojevima Pasteurella multocida, Escherichia coli i skupine Staphylococcus intermedius (uključujući S. pseudintermedius).
English: However the product should not be used in cats with persisting articular cartilage lesions, as these lesions may worsen during treatment with fluoroquinolones.
Croatian: Međutim proizvod se ne bi trebao primjenjivati kod mačaka s dugotrajnim ozljedama zglobne hrskavice, jer se ozljede mogu pogoršati tijekom liječenja s fluorokinolonima.
English: Pasteurella multocida, Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius).
Croatian: Escherichia coli i skupine Staphylococcus intermedius (uključujući S. pseudintermedius).
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/107/001-012
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/10/107/001-012
English: The safety of Veraflox has not been established in queens during pregnancy and lactation.
Croatian: Neškodljivost Verafloxa nije dokazana tijekom graviditeta i laktacije.
English: However, the product must not be used in cats with persisting articular cartilage lesions, as these lesions may worsen during treatment with fluoroquinolones.
Croatian: Međutim, proizvod se ne smije primjenjivati kod mačaka s dugotrajnim ozljedama zglobne hrskavice, jer se ozljede mogu pogoršati tijekom liječenja s fluorokinolonima.
English: EXPIRY DATE EXP {month/year} Once opened, use by ________
Croatian: Jednom otvoreno, primijeniti do____________
English: Do not use in dogs with persisting articular cartilage lesions, since lesions may worsen during treatment with fluoroquinolones.
Croatian: Ne primjenjivati kod pasa s postojanim oštećenjima zglobnih hrskavica, jer se oštećenja mogu pogoršati tijekom liječenja fluorokinolonima.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 120 mg tablets pradofloxacin
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Veraflox 120 mg pradofloksacin
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/107/013-014
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/10/107/013-014
English: The duration of treatment depends on the severity of the infection and how well the medicine works in your pet. For most infections the following durations of treatment are recommended:
Croatian: Trajanje liječenja ovisi o težini infekcije i tome koliko dobro djeluje kod vašeg ljubimca.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 15 mg tablets pradofloxacin
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Veraflox 15 mg pradofloksacin
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 60 mg tablets pradofloxacin
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Veraflox 60 mg pradofloksacin
English: Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Croatian: Ne primjenjivati u slučajevima preosjetljivosti na djelatnu tvar ili neku od pomoćnih tvari..
English: Dosages
Croatian: NUSPOJAVE
English: MARKETING AUTHORISATION NUMBER EU/2/10/107/014
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/10/107/014
English: A. LABELLING
Croatian: IZVJEŠĆE O MRL
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 120 mg tablets for dogs pradofloxacin
Croatian: Veraflox 120 mg tablete za pse pradofloksacin
English: MARKETING AUTHORISATION NUMBER EU/2/10/107/013
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/10/107/013
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle label (15 ml oral suspension)
Croatian: Etiketa na bočici (15 ml peroralna suspenzija)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle label (30 ml oral suspension)
Croatian: Etiketa na bočici (30 ml peroralna suspenzija)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 60 mg tablets for dogs pradofloxacin
Croatian: Veraflox 60 mg tablete za pse pradofloksacin
English: Number of strains
Croatian: Broj sojeva
English: TARGET SPECIES Dogs, cats
Croatian: CILJNE VRSTE ŽIVOTINJA Mačke.
English: The variation procedure started on 16 May 2012.
Croatian: Postupak izmjene započeo je 16. svibnja 2012.
English: The results showed efficacy above 95% except on day 7 (94.5%) and day 28 (87.5%).
Croatian: Rezultati su pokazali djelotvornost iznad 95% osim na 7. dan (94,5%) i 28. dan (87,5%).
English: The application was submitted to France as reference Member State and to Austria, Belgium, Denmark, Germany, Greece, Ireland, Italy, Luxembourg, Portugal, Slovenia, Spain and United Kingdom as concerned Member States.
Croatian: Zahtjev je predan u Francuskoj kao referentnoj državi članici i u Austriji, Belgiji, Danskoj, Njemačkoj, Grčkoj, Irskoj, Italiji, Luksemburgu, Portugalu, Sloveniji, Španjolskoj i Ujedinjenom Kraljevstvu kao državama članicama.
English: 6-8 weeks immatures
Croatian: 6-8 tjedana, nezreli
English: 00330 Helsinki Finland
Croatian: 00330 Helsinki Finska
English: The data did not show any strong signal that any interaction between the active substances that might be present would lead to significantly lower efficacy.
Croatian: Podaci nisu pokazali nikakav snažni signal da bi bilo koja prisutna interakcija između djelatnih tvari mogla uzrokovati znatno slabiju djelotvornost.
English: This issue remained unsolved and therefore a CMD(v) procedure under Article 13 of Commission Regulation (EC) No 1234/2008 started on 14 January 2013.
Croatian: Ovo pitanje ostalo je neriješeno pa je stoga CMD(v) postupak u skladu s člankom 13 Uredbe komisije (EK) br. 1234/2008 započeo 14. siječnja 2013. godine.
English: 4.2 Indications for use, specifying the target species In cattle:
Croatian: 4.2 Indikacije za primjenu, navesti ciljne vrste životinja Goveda:
English: Efficacy against lice
Croatian: Djelotvornost protiv ušiju
English: Adult stage
Croatian: Adultni stadij
English: In absence of a strong signal, these data can be considered supportive data of the clinical data analysed below.
Croatian: U nedostatku snažnog signala, ti podaci ne mogu se smatrati potporom u nastavku analiziranih kliničkih podataka.
English: F - 75668 Paris Cedex 14 France
Croatian: F - 75668 Paris Cedex 14
English: As the reference and concerned Member States were not able to reach an agreement in respect of the variation, on 3 April 2013, Belgium initiated a referral procedure under Article 13(2) of Commission Regulation (EC) No 1234/2008.
Croatian: S obzirom da se referentna i države članice nisu mogle dogovoriti u vezi izmjene, 3. travnja 2013. godine Belgija je započela postupak procjene u skladu s člankom 13(2) Uredbe komisije (EK) br. 1234/2008.
English: This was not an unusual finding as egg hatch is rapid and can result in a high lice count.
Croatian: To nije bio neobičan nalaz jer je leženje jajašca ubrzano i može rezultirati u velikom broju jajašca.
English: For the time point prior to day 28 and the only immediately after that, efficacy was complete for this animal, indicating no apparent lack of efficacy.
Croatian: Za vremensku točku prije 28. dana i neposredno nakon toga, djelotvornost je bila poptuna za ovu životinju ukazujući naočiti izostanak djelotvornosti.
English: Pharmacokinetic data
Croatian: Farmakokinetički podaci
English: Ramsgate Road Sandwich CT13 9NJ United Kingdom
Croatian: Ramsgate Road Sandwich CT13 9NJ Velika Britanija
English: List of the names, pharmaceutical form, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Croatian: Lista imena, farmaceutskih oblika, jačina veterinarsko medicinskog proizvoda, vrste životinja, putevi primjene, podnositelji/nositelji odobrenja za stavljanje u promet u zemljama članicama
English: The latter lower efficacy coincided with an apparent egg hatch on one treated animal where 50 lice were detected.
Croatian: Kasnija slabija djelotvornost podudarala se s očitim leženjem jajašca na jednoj liječenoj životinji gdje je detektirano 50 ušiju.
English: Inhibited stages
Croatian: Inhibirani stadij
English: NEMATODES
Croatian: NEMATODI
English: Floridsdorfer Hauptstraße 1 A - 1210 Wien
Croatian: Austria G.m.b.H. Floridsdorfer Hauptstraße 1 A - 1210 Wien
English: 1 CVMP guideline on specific efficacy requirements for ectoparasiticides in cattle (EMEA/CVMP/625/03)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004643.pdf
Croatian: 1 Smjernice CVMP o specifičnim zahtjevima za djelotvornost ektoparazitika u stoke (EMEA/CVMP/625/03)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004643.pdf
English: ECTOPARASITES Linognathus vituli Bovicola bovis Solenopotes capillatus
Croatian: Linognathus vituli Bovicola bovis Solenopotes capillatus
English: Pfizer Holding France 23-25 avenue du Docteur Lannelongue
Croatian: Francuska Pfizer Holding France 23-25 avenue du Docteur Lannelongue
English: Efficacy was also observed in respect to Bovicola bovis, however due to the lower infestation inconsistency of findings on some days, the data can only be used as supportive information.
Croatian: Djelotvornost je također uočena s obzirom na vrstu Bovicola bovis, međutim zbog slabije nedosljednosti između podataka o infestaciji, podaci se mogu koristiti samo kao potporne informacije.
English: During the variation procedure a potential serious risk to animal health was identified by Belgium and in particular that the efficacy against the lice species had been insufficiently substantiated.
Croatian: Tijekom postupka izmjene potencijalni ozbiljni rizik za zdravlje životinja identificiran je u Belgiji s posebnim naglaskom na činjenicu da djelotvornost protiv vrsta ušiju nije dovoljno dokazana.
English: While acknowledging the absence of commingling of the animals which is a worst-case-scenario according to the CVMP guideline on specific efficacy requirements for ectoparasiticides in cattle (EMEA/CVMP/625/03)1, as a limitation in the study, the CVMP considered the study well conducted.
Croatian: Dok istovremeno priznaje nedostatak međusobnog miješanja životinja što je najgori mogući scenarij u skladu sa smjernicama CVMP o specifičnim zahtjevima za djelotvornost za ektoparazitike na stoci (EMEA/CVMP/625/03)1 što je ograničenje za ovo ispitivanje, CVMP je smatrao da je ispitivanje dobro provedeno.
English: Gastro-intestinal nematodes: Haemonchus placei Ostertagia ostertagi Trichostrongylus axei Nematodirus helvetianus Cooperia oncophora Cooperia punctata Oesophagostomum radiatum Bunostomum phlebotomum Respiratory tract nematode: Dictyocaulus viviparus TREMATODES
Croatian: Želučano-crijevni nematodi: Haemonchus placei Ostertagia ostertagi Trichostrongylus axei Nematodirus helvetianus Cooperia oncophora Cooperia punctata Oesophagostomum radiatum Bunostomum phlebotomum Plućni nematodi: Dictyocaulus viviparus TREMATODI Metilji:
English: de Europa 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Spain
Croatian: Avda. de Europa 20 B Parque Empresarial La Moraleja
English: The CVMP concluded that a second dose confirmatory study for Linognatus vituli or the other lice species was deemed not to be necessary based on the data from the confirmatory study and moxidectin's efficacy demonstrated on all other lice species as well as in the literature, even if Linognatus vituli is not considered as being the dose-limiting species.
Croatian: CVMP je zaključio da potvrdno ispitivanje druge doze za Linognatus vituli ili druge vrste uši nije bilo potrebno na temelju podataka iz potvrdnog ispitivanja, a djelotvornost moksidektina dokazana je za sve druge vrste uši kao i za literaturu čak i ako se vrsta Linognatus vituli ne smatra onom koja ograničava dozu.
English: Luxembourg Pfizer Animal Health s.a. Rue Laid Burniat 1
Croatian: Luksemburg Pfizer Animal Health s.a. Rue Laid Burniat 1
English: The comparable efficacy of the moxidectin/triclabendazole pour-on combination product (Cydectin TriclaMox) compared to moxidectin alone in the same vehicle was studied in a pharmacokinetics trial.
Croatian: Usporediva djelotvornost poliv kombinacije moksidektina/triklabendazola (Cydectin TriclaMox) u usporedbi sa samim moksidektinom u istom nosaču ispitan je u farmakokinetičkom ispitivanju.
English: Pfizer Hellas AE Mesogion Avenue 243 154 51 N. Psychiko Athens
Croatian: Pfizer Hellas AE Mesogion Avenue 243 154 51 N.
English: Scientific conclusions and grounds for the variation to the terms of the marketing authorisations
Croatian: Znanstveni zaključci i razlozi za izmjenu uvjeta odobrenja za stavljanje u promet veterinarsko-medicinskog proizvoda
English: Via Isonzo 71 04100 Latina Italy
Croatian: Pfizer Italia S.r.l. Via Isonzo 71 04100 Latina Italija
English: Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet
Croatian: Dodatci u relevantnim dijelovima sažetka opisa svojstava, označavanju i uputi
English: Marketing authorisation holder
Croatian: Podnositelji/nositelji odobrenja za stavljanje u promet
English: The CVMP based the extrapolation of the efficacy of the product on Linognatus vituli to the two other lice species proposed (Bovicola bovis and Solenopotes capillatus) on the results of a dose determination study with the monoproduct containing moxidectin as active substance where the three proposed claimed lice species were shown to be controlled (>95 % except for Solenopotes capillatus adult before day 21) at half dose for the monoproduct (0.25 mg/kg bw instead of 0.5 mg/kg bw), supported by the pharmacokinetics finding giving no strong signal of interaction between the two active substances in Cydectin TriclaMox.
Croatian: CVMP je temeljio ekstrapolaciju djelotvornosti proizvoda za vrstu Linogatus vituli na druge dvije predložene vrste ušiju (Bovicola bovis i Solenopotes capillatus) na rezultatima studije određivanja doze s monoproizvodom koji sadrži moksidektin kao djelatnu tvar u kojoj su tri predložene vrste uši prikazane kao kontrolirane (>95% osim za odraslu jedinku Solenopotes capillatus prije 21. dana) pri polovici doze za monoproizvod (0,25 mg/kg tjelesne težine umjesto 0,5 mg/kg tjelesne težine), što su podržali farmakokinetički nalazi bez snažnog signala za interakciju između dvije djelatne tvari u Cydectinu TriclaMox.
English: Cydectin TriclaMox
Croatian: Cydectin TriclaMox Moxidectin Triclabendazole
English: Pfizer Animal Health submitted an application for a type II variation to add a new indication against lice species (Linognatus vituli, Bovicola bovis and Solenopotes capillatus) and reference was made to the monoproduct, Cydectin pour-on containing moxidectin alone and for which the claim against lice was already granted.
Croatian: Pfizer Animal Health predao je zahtjev za izmjenu tipa II kako bi se dodala nova indikacija protiv vrste ušiju (Linognatus vituli, Bovicola bovis i Solenopotes capillatus), a referentni lijek je bio monoproizvod Cydektin poliv koji sadrži sam moksidektin, već odobren kao sredstvo protiv ušiju.
English: Based on (i) the comparable pharmacokinetic profiles for moxidectin when administered as the combination product compared with moxidectin alone in the same vehicle, (ii) the findings of the confirmatory study with Linognatus vituli and (iii) the data from the original moxidectin 0.5% pour-on dossier showing that Linognatus vituli, Bovicola bovis and Solenopotes capillatus were sensitive to moxidectin at half the recommended dose rate (0.25 mg/kg), the CVMP considered that a satisfactory efficacy towards Linognatus vituli, Bovicola bovis and Solenopotes capillatus can be expected in the field for Cydectin TriclaMox.
Croatian: Na temelju (i) usporednih farmakokinetičkih profila za kombinaciju moksidektina u usporedbi sa samim moksidektinom u istom nosaču, (ii) nalaza potvrdnog ispitivanja s vrstom Linognatus vituli i (iii) podataka iz izvornog dosjea poliva moksidektina 0,5% koji pokazuju da su vrste Linognatus vituli, Bovicola bovis i Solenopotes capillatus bile osjetljive na moksidektin pri polovici preporučene doze (0,25 mg/kg), CVMP je smatrao da se može očekivati zadovoljavajuća djelotvornost na terenu lijeka Cydectin TriclaMox protiv vrsta Linognatus vituli, Bovicola bovis i Solenopotes capillatus.
English: A confirmatory trial was provided where the efficacy of moxidectin/triclabendazole pour-on combination in cattle was studied at the recommended dose rate of Cydectin TriclaMox (0.5 mg moxidectin/20 mg triclabendazole/kg body weight) against natural infestations of sucking and/or biting lice, with emphasis primarily on Linognatus vituli and secondarily on Bovicola bovis by comparison with a placebo-treated control group.
Croatian: Provedeno je potvrdno ispitivanje u kojem je proučavana djelotvornost poliva kombinacije moksidektina/triklorbendazola u stoke pri preporučenom doziranju Cydectin TriclaMox-a (0,5 mg moksidektina/20 mg triklorbendazola/kg tjelesne težine) protiv prirodne infestacija sisajućim ili grizućim ušima,prvenstveno protiv Linognatus vituli i potom protiv Bovicola bovis usporedbom sa skupinom liječenom placebom.
English: Cydectin TriclaMox pour-on solution is a veterinary medicinal product containing 5 mg moxidectin per ml and 200 mg triclabendazole per ml.
Croatian: Cydectin TriclaMox poliv otopina je veterinarsko-medicinski proizvod koji sadrži 5 mg moksidektina po ml i 200 mg triklabendazola po ml.
English: Parasite
Croatian: Paraziti
English: PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU
English: In order to address the concerns raised by Belgium the MAH provided data to support the noninterference between triclabendazole and moxidectin, a clinical study regarding the efficacy against Linognatus vituli and Bovicola bovis and literature on the efficacy of moxidectin against lice species.
Croatian: Kako bi se ispitale razlozi za zabrinutost u Belgiji nositelj odobrenja predao je podatke o izostanku interferencije između triklabendazola i moksidektina, kliničko ispitivanje u vezi djelotvornosti protiv vrstaLinognatus vituli i Bovicola bovis i literaturne podatke o moksidektinu protiv ušiju.