FrancophonIA/ELRC3.0 huggingface dataset:
English: How is Hulio used?
Croatian: Kako se Hulio koristi?
English: TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Hulio is used to treat.
Croatian: TNF sudjeluje u nastajanju upale i pronađen je u velikim koncentracijama u bolesnika koje se liječi lijekom Hulio.
English: Laboratory studies comparing Hulio with the reference medicine Humira have shown that the active substance in Hulio is highly similar to that in Humira in terms of structure, purity and biological activity.
Croatian: Laboratorijska ispitivanja u kojima su uspoređivani lijekovi Hulio i Humira pokazala su da je djelatna tvar u lijeku Hulio vrlo slična djelatnoj tvari u lijeku Humira u pogledu strukture, čistoće i biološke aktivnosti.
English: All these data were considered sufficient to conclude that Hulio will behave in the same way as Humira in terms of effectiveness and safety in its approved uses.
Croatian: Svi ti podatci smatraju se dovoljnima za donošenje zaključka da će lijek Hulio za odobrene indikacije djelovati na isti način kao lijek Humira u pogledu djelotvornosti i sigurnosti.
English: In addition, a study in patients with rheumatoid arthritis has shown that the effects of the medicine are equivalent to those of Humira in this condition.
Croatian: Nadalje, u ispitivanju na bolesnicima s reumatoidnim artritisom utvrđeno je da je djelotvornost tog lijeka jednaka djelotvornosti lijeka Humira pri liječenju tog stanja.
English: What benefits of Hulio have been shown in studies?
Croatian: Koje su koristi od lijeka Hulio utvrđene u ispitivanjima?
English: How does Hulio work?
Croatian: Kako djeluje Hulio?
English: Eye specialists treating uveitis should also take advice from doctors who have experience of using adalimumab.
Croatian: Očni specijalisti koji liječe uveitis trebali bi također poslušati savjete liječnika s iskustvom u primjeni lijeka Hulio.
English: For more information about using Hulio, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Hulio pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: • plaque psoriasis (a disease causing red, scaly patches on the skin);
Croatian: • plak psorijaze (bolesti koja uzrokuje crvene, ljuskave mrlje na koži)
English: Studies have also shown that giving Hulio produces similar levels of the active substance in the body to giving Humira.
Croatian: Ispitivanja su utvrdila i da se primjenom lijeka Hulio stvaraju slične razine djelatne tvari u tijelu kao i primjenom lijeka Humira.
English: • rheumatoid arthritis (a disease causing inflammation of the joints);
Croatian: • reumatoidnog artritisa (bolesti koja uzrokuje upalu zglobova);
English: • Crohn's disease (a disease causing inflammation of the gut);
Croatian: • Crohnove bolesti (bolesti koja uzrokuje upalu crijeva)
English: For the full list of side effects and restrictions with Hulio, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Hulio potražite u uputi o lijeku.
English: • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
Croatian: • ulceroznog kolitisa (bolesti koja uzrokuje upalu i čireve na stijenci želuca)
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints);
Croatian: • psorijatičnog artritisa (bolesti koja uzrokuje crvene ljuskave mrlje na koži i upalu zglobova)
English: • hidradenitis suppurativa (acne inversa), a long-term skin disease that causes lumps, abscesses (collections of pus) and scarring on the skin;
Croatian: • gnojnog hidradenitisa (acne inversa), kronične bolesti kože koja uzrokuje kvržice, apscese
English: To be determined by Member States following EC decision
Croatian: Utvrđuju države članice slijedom odluke Europske komisije
English: The national competent authorities, coordinated by the reference Member State, if applicable, shall ensure that the following conditions are fulfilled by the marketing authorisation holders:
Croatian: Ako je primjenjivo, nacionalna nadležna tijela, koja koordinira referentna država članica osiguravaju da nositelj odobrenja za stavljanje u promet ispunjava sljedeće uvjete:
English: The MAHs should circulate a DHPC in accordance with the agreed key messages.
Croatian: Nositelji odobrenja za stavljanje u promet trebali bi dostaviti izravno pismo zdravstvenim radnicima (DHPC) u skladu s dogovorenim ključnim porukama.
English: Special media and atmosphere are required and the incubation period is long (7-10 days).
Croatian: Potrebni su posebni mediji i okruženje, a razdoblje inkubacije je dugo (7 - 10 dana).
English: The assay time has been reduced to hours as opposed to almost two weeks needed for the conventional culture.
Croatian: Vrijeme testiranja skraćeno je na sate nasuprot vremenu od gotovo dva tjedna potrebna za konvencionalnu kulturu.
English: These findings have since been verified.
Croatian: Ti su nalazi otada potvrđeni.
English: The clinical signs vary but the milk loss is usually significant.
Croatian: Klinički znakovi se razlikuju, ali gubitak mlijeka obično je značajan.
English: In case of old products where data are sparse indications should be reviewed and revised, based on the current scientific knowledge, where appropriate.
Croatian: U slučaju starih proizvoda za koje su podaci malobrojni, indikacije je potrebno analizirati i revidirati na temelju sadašnjih znanstvenih saznanja gdje je odgovarajuće.
English: 4.2 Indication(s) for use
Croatian: 4.2 Indikacija(e) za upotrebu
English: Monitoring the lack of efficacy is a part of the veterinary pharmacovigilance system.
Croatian: Praćenje nedostatka djelotvornosti dio je sustava veterinarske farmakovigilancije.
English: 29% of the composite samples (81/280) and 43% of the quarter milk samples (433/1008) did not yield growth of Mycoplasma.
Croatian: Od kompozita uzoraka, 29 % (81/280) i 43 % uzoraka mlijeka iz četvrtine vimena (433/1008) nije pokazalo rast mikoplazme.
English: Details of the treatment experiments are scarce, but altogether he described the results as unrewarding.
Croatian: Pojedinosti o liječenju je malo, ali je on sveukupno opisao rezultate kao neprocjenjive.
English: The authors concluded that the risk of misdiagnosis is increased if multiple milk samples are not tested.
Croatian: Autori su zaključili da je rizik od pogrešne dijagnoze veći ako se ne testiraju višestruki uzorci mlijeka.
English: Mycoplasmas do not grow on conventional media; this hampers the diagnosis.
Croatian: Mikoplazme ne rastu u konvencionalnim medijima, a to otežava dijagnozu.
English: The pathogen is highly contagious and causes severe economic losses.
Croatian: Patogen je izuzetno zarazan i uzrokuje teške gospodarske gubitke.
English: Current technologies such as Polymerase Chain Reaction (PCR) have enabled significantly quicker identification of M. bovis.
Croatian: Sadašnje tehnologije kao što je lančana reakcija polimeraze (PCR) omogućile su značajno bržu identifikaciju bakterije M. bovis.
English: He reported testing various antimicrobials, including tylosin.
Croatian: Zabilježio je testiranje različitih antimikrobnih lijekova, uključujući tilozin.
English: The Committee concluded that indications for use should preferably be restricted to those for which efficacy has been proven and general indications without a solid clinical basis should be avoided.
Croatian: Povjerenstvo je zaključilo kako je poželjno da se indikacije za upotrebu ograniče na one za koje je djelotvornost dokazana, a opće indikacije bez čvrste kliničke osnove treba izbjegavati.
English: Furthermore, this indication should not be granted for the pending marketing authorisation applications (see Annex I).
Croatian: Nadalje, ta se indikacija ne smije odobriti ni u zahtjevima za odobrenje lijekova koji čekaju odobrenje (vidjeti Dodatak I).
English: Often more than one quarter is affected and there is a marked drop in milk production.
Croatian: Često je zahvaćeno više od jedne četvrtine vimena, a posljedica je izrazito smanjenje proizvodnje mlijeka.
English: Since then it has spread to cattle worldwide and is known to cause severe economic losses in the herds affected.
Croatian: Otada se proširila među stokom posvuda u svijetu i poznato je da je prouzročila teške gospodarske gubitke u zahvaćenim stadima.
English: A negative cultivation result after treatment could, before, have been falsely interpreted as bacteriological cure although at present it is known merely to be a characteristic of the infection.
Croatian: Negativni rezultati kultivacije nakon liječenja mogli su se prije pogrešno protumačiti kao bakteriološko izlječenje, iako se sada zna da je to samo bila karakteristika infekcije.
English: It is active mostly against Gram-positive bacteria and mycoplasmas.
Croatian: Djeluje uglavnom protiv gram-pozitivnih bakterija i mikoplazmi.
English: Instead several comprehensive review articles dealing with mycoplasma mastitis have been published (Pfützner and Sachse (1996)4, Nicholas and Ayling (2003)5, Gonzalez and Wilson (2003)6, Maunsell et al. (2011)7, Fox (2012)8, Nicholas et al. (2016)9).
Croatian: Umjesto toga, objavljeno je nekoliko opsežnih preglednih članaka koji su se bavili mikoplazmatskim mastitisom (Pfützner and Sachse (1996.)4, Nicholas and Ayling (2003.)5, Gonzalez and Wilson (2003.)6, Maunsell et al. (2011.)7, Fox (2012.)8, Nicholas et al. (2016.)9).
English: 1996, 15(4), 1477-1494 5 Nicholas RAJ and Ayling R 2003.
Croatian: Off. int. Epiz. 1996, 15(4), 1477-1494 5 Nicholas RAJ and Ayling R 2003.
English: Infected cows may remain externally normal with few clinical signs, even in severe cases.
Croatian: Zaražene krave mogu izgledati normalno i pokazivati samo nekoliko kliničkih znakova, čak i u teškim slučajevima.
English: Jasper was also one of the first to question the efficacy of antimicrobials in the treatment of mycoplasma mastitis.
Croatian: Jasper je također bio jedan od prvih koji je doveo u pitanje djelotvornost antimikrobnih lijekova u liječenju mikoplazmatskog mastitisa.
English: The major pathogen among the genera is Mycoplasma bovis that was first isolated from bovine mastitis in the USA in the 1960s.
Croatian: Glavni patogen među rodovima je bakterija Mycoplasma bovis koja je prvi put izolirana iz mastitisa goveda u SAD-u tijekom 1960-ih.
English: The dose 3 g/cow/day is within the dose range widely authorised in Europe i.e. 4-10 mg/kg/day i.m.
Croatian: Doza od 3 g/krava/dan unutar je raspona doza koje su odobrene u velikom dijelu Europe, tj. 4 - 10 mg/kg/dan i.m.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration and applicants/marketing authorisation holders in the Member States
Croatian: Popis naziva, farmaceutskih oblika, jačina veterinarskomedicinskih proizvoda,životinjskih vrsta, putova primjene, podnositelja zahtjeva/nositelja odobrenja za stavljanje lijeka u promet u državama članicama
English: It is a major problem for milk production and animal welfare in the herds affected, and causes severe economic losses.
Croatian: To je glavni problem u proizvodnji mlijeka i utječe na dobrobit životinja u stadu te uzrokuje teške gospodarske gubitke.
English: INN Pharmaceutical form
Croatian: Farmaceutski oblik
English: It is ineffective against Enterobacteriaceae.
Croatian: Neučinkovit je protivEnterobacteriaceae.
English: ESPECIALIDADES VETERINARIAS, S.A. A. Fuencarral Alcobendas km 15 700 Edificio Europa I Portal 3 2º5
Croatian: ESPECIALIDADES VETERINARIAS, S.A. A. Fuencarral Alcobendas km 15 700 Edificio Europa
English: Maunsell FP, Woolums AR, Francoz D, Rosenbuch RF, Step DL, Wilson DJ, Janzen ED 2011.
Croatian: Maunsell FP, Woolums AR, Francoz D, Rosenbuch RF, Step DL, Wilson DJ, Janzen ED 2011. ACVIM Consensus Statement:
English: It is generally accepted that all use of antimicrobials increases the risk of antimicrobial resistance and thus to minimise the risk of transmission of those resistance to the public and animals all unnecessary use should be carefully avoided.
Croatian: Opće je prihvaćeno da svaka primjena antimikrobnih sredstava povećava rizik od antimikrobne rezistencije te stoga, kako bi se minimizirao rizik od prijenosa te rezistencije na opću populaciju i životinje, svaku upotrebu koja nije nužna treba pažljivo izbjeći.
English: M. bovis is a highly contagious udder pathogen that is easily spread.
Croatian: M. bovis je izuzetno zarazan patogen vimena koji se lako širi.
English: Tylosin and its phosphate and tartrate salts are used in veterinary medicines for the treatment of conditions caused by sensitive organisms.
Croatian: Tilozin i njegovi fosfati te tartaratne soli koriste se u veterinarskim lijekovima za liječenje stanja prouzročenih osjetljivim organizmima.
English: Mycoplasma is also easily spread via infected milk or milking equipment; thus, undetected or inefficiently treated mastitis in a cow may eventually lead to multiple infections in animals of different ages.
Croatian: Mikoplazma se također lako širi putem zaraženog mlijeka ili pribora za mlijeko, stoga, neotkriven ili neučinkovito liječeni mastitis u krava može naposljetku dovesti do višestrukih infekcija u životinja različite starosti.
English: In addition to the spread to other quarters, hematologic dissemination of mycoplasma to other parts of the body, e.g. joints, respiratory tract and ears, is possible.
Croatian: Osim širenja na druge četvrtine vimena, mikoplazma se može širiti hematološkim putem na druge dijelove tijela, npr. zglobove, dišni sustav i uši.
English: Affected milk may seem normal but it may also be purulent and/or have abnormal and discoloured secretions.
Croatian: Zaraženo mlijeko može se činiti normalno, ali može biti i purulentno i/ili sadržavati abnormalne izlučevine promijenjene boje.
English: Rev. sci. tech. Off. int. Epiz.
Croatian: Rev. sci. tech.
English: Screening of bulk tank milk can be used to detect infection in the herd and by pooled and/or individual sampling the carrier animals and the new infections are further tracked down.
Croatian: Testiranje tankova za mlijeko može poslužiti za detekciju infekcije u stadu, a objedinjenim i/ili pojedinačnim uzorkovanjem dalje se ulazi u trag životinjama koje prenose infekciju i novim infekcijama.
English: Tylosin is a macrolide antibiotic which is produced by Streptomyces fradiae.
Croatian: Tilozin je makrolidni antibiotik koji proizvodi bakterija Streptomyces fradiae.
English: Despite the improved diagnostic technologies, a major challenge in the diagnosis of mycoplasma mastitis (and in assessing success of antimicrobial treatment) remains that the pathogen may be shed intermittently in the milk of infected cows.
Croatian: Unatoč poboljšanim dijagnostičkim tehnologijama, glavni izazov u postavljanju dijagnoze mikoplazmatskog mastitisa (i u procjeni uspjeha antimikrobnog liječenja) ostaje činjenica da se patogen može širiti na mahove, putem mlijeka zaraženih krava.
English: Mycoplasma bovis infections in cattle; J Vet Intern Med; 2011: 25:772-783 8 Fox LK 2012.
Croatian: Mycoplasma bovis infections in cattle; J Vet Intern Med; 2011: 25:772-783 8 Fox LK 2012. Mycoplasma mastitis: causes, transmission and control.
English: Via Gramsci, 731/733 50019 Sesto Fiorentino Firenze
Croatian: ELI LILLY ITALIA S.p.A. Via Gramsci, 731/733 50019 Sesto Fiorentino Firenze
English: In 1977 Jasper 2 described natural resolution of the disease as unpredictable and recognised the danger of intermittently shedding cows.
Croatian: Jasper 2 je opisao kako se prirodni nestanak bolesti ne može predvidjeti, i prepoznao opasnost od povremenog širenja bolesti.
English: Mastitis caused by M. bovis differs in several ways from infections caused by the majority of the more common mastitis pathogens (e.g. Streptococcus spp., Staphylococcus spp.).
Croatian: Mastitis prouzročen bakterijom M. bovis razlikuje se na nekoliko načina od infekcija koje uzrokuje većina češćih patogena mastitisa (npr. Streptococcus spp., Staphylococcus spp.).
English: Finland noted that in the current scientific literature there is no support for the indication 'bovine mastitis caused by Mycoplasma bovis', but instead it is widely stated that there are no antimicrobial treatment options for bovine mastitis caused by mycoplasma.
Croatian: Finska je uočila da u postojećoj znanstvenoj literaturi nije potkrijepljena indikacija „mastitis goveda prouzročen bakterijom Mycoplasma bovis”, nego se umjesto toga u velikoj mjeri navodi da za mastitis goveda prouzročen mikoplazmama ne postoje opcije antimikrobnog liječenja.
English: M. bovis is a highly contagious udder pathogen which typically causes mastitis that affects several quarters as it is capable of hematologic dissemination.
Croatian: M. bovis je izuzetno zarazan patogen vimena, a obično uzrokuje mastitis koji zahvaća nekoliko četvrtina vimena jer se može širiti hematološkim putem.
English: As the aforementioned indications have been included in the product information of these veterinary medicinal products for many years, the Committee considered that information on the removal of the indication should be given, thus the following warning sentence should be added to the product information: ‘The efficacy data do not support the use of tylosin for the treatment of bovine mastitis caused by Mycoplasma spp.
Croatian: Kako su prethodno navedene indikacije uključene u informacije o tim veterinarsko-medicinskim proizvodima već niz godina, Povjerenstvo je smatralo da je uklanjanje indikacije potrebno obrazložiti , dakle, u informacije o lijeku treba dodati sljedeću rečenicu upozorenja: „Podaci o djelotvornosti ne podupiru primjenu tilozina za liječenje mastitisa goveda prouzročenog bakterijom Mycoplasma spp.”.
English: The use of tylosin as a veterinary medicine has been discussed in the CVMP reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal health (EMA/CVMP/SAGAM/741087/2009)1.
Croatian: O primjeni tilozina kao veterinarskog lijeka raspravljalo se u pisanom mišljenju CVMP-a o upotrebi makrolida, linkosamida i streptogramina (MLS) u životinja koje proizvode hranu u Europskoj uniji: razvoj rezistencije i utjecaj na zdravlje ljudi i životinja (EMA/CVMP/SAGAM/741087/2009)1.
English: Cattle Calves Sheep Goats Pigs Dogs
Croatian: Stoka Ovce Koze Svinje
English: A thorough literature search to find new data on the efficacy of tylosin in the treatment of mycoplasma mastitis revealed no original studies.
Croatian: Temeljitim pretraživanjem literature, kako bi se pronašli novi podaci o djelotvornosti tilozina za liječenje mikoplazmatskog mastitisa, nisu nađena izvorna ispitivanja.
English: Macrolides are categorised as critically important antimicrobials both in human and veterinary medicine however tylosin is not used in human medicine.
Croatian: Makrolidi su kategorizirani kao ključno važna antimikrobna sredstva i za lijekove za primjenu u ljudi i za veterinarske lijekove, međutim, tilozin ne služi za primjenu u ljudi.
English: Tylosin belongs to macrolides which have been classified as critically important antimicrobials both in veterinary and human medicine.
Croatian: Tilozin pripada skupini makrolida koji su i u humanoj i veterinarskoj medicini klasificirani kao kritično važna antimikrobna sredstva.
English: Lilly Portugal - Produtos Farmacêuticos, Ldª R. Cesário Verde, 5 - piso 4 Linda-a-Pastora 2790-326 Queijas Portugal
Croatian: Cesário Verde, 5 - piso 4 Linda-a-Pastora 2790-326 Queijas Portugal
English: In the study by Biddle et al., 20033, milk samples were collected daily for 28 days from 10 Mycoplasma spp.
Croatian: U ispitivanju koje su proveli Biddle et al., 2003.3, uzorci mlijeka skupljani su dnevno tijekom 28 dana od 10 krava mljekara zaraženih bakterijom Mycoplasma spp. i izravno stavljeni na ploču s agarom mikoplazme kako bi se procijenili obrasci širenja.
English: United Kingdom Vetoquinol UK Ltd Vetoquinol House
Croatian: Vetoquinol UK Ltd Vetoquinol House Great Slade
English: The common view shared in these reviews is that mycoplasma mastitis is untreatable or unresponsive to antimicrobial treatment and that quick identification of infected animals is crucial to prevent the spread of the pathogen in the herd.
Croatian: Zajedničko stajalište u tim preglednim člancima jest da se mikoplazmatski mastitis ne može liječiti ili da ne reagira na liječenje antimikrobnim lijekovima te da je za sprječavanje širenja patogena u stadu presudna brza identifikacija zaraženih životinja.
English: causes a variety of infections including respiratory disease, otitis media, arthritis and mastitis in cattle worldwide.
Croatian: Mycoplasma spp. uzrokuje raznovrsne infekcije uključujući respiratorne bolesti, otitis media, artritis i mastitis u stoke diljem svijeta.
English: Applicant/Marketing authorisation holder
Croatian: Podnositelj zahtjeva / nositelj odobrenja za stavljanje lijeka u promet
English: 288 02 Nymburk
Croatian: Zámečnická 411 288 02 Nymburk Czech Republic
English: Czech Republic
Croatian: Slovačka Republika
English: The aim of the referral procedure was to consider the available data and current scientific knowledge regarding the efficacy of parenterally administered tylosin formulations authorised for the treatment of bovine mastitis caused by Mycoplasma spp..
Croatian: Cilj je arbitražnog postupka razmotriti dostupne podatke i sadašnja znanstvena saznanja s obzirom na djelotvornost parenteralne primjene pripravaka tilozina odobrenih za liječenje mastitisa goveda prouzročenog bakterijom Mycoplasma spp.
English: Internationally agreed methodology on sensitivity testing was not available at the time when tylosin was first authorised for veterinary use and there is none to date.
Croatian: Iz istih razloga teško je i testiranje osjetljivosti na bakteriju Mycoplasma spp. U vrijeme kad je tilozin prvi put odobren za veterinarsku upotrebu, nije postojala ni jedna međunarodno prihvaćena metodologija testiranja osjetljivosti, a nema je ni danas.
English: The proportion of cows that were found to be M. bovis positive after 5 days of tylosin treatment (3g/cow/day i.m.)
Croatian: Udio krava za koje se ustanovilo da pozitivne na M. bovis nakon 5 dana liječenja tilozinom (3 g/krava na dan i.m.) bio je čak 53 % (8/15) (Jasper (1977)).
English: In cases where the indication for a particular product specifies the mastitis pathogen as Mycoplasma bovis, the dosing instruction should also be deleted.
Croatian: U slučajevima u kojima indikacija za određeni lijek navodi bakteriju Mycoplasma bovis kao patogen mastitisa, upute za doziranje također treba izbrisati.
English: In cases where the indication for a particular product specifies the mastitis pathogen as Mycoplasma bovis, the indication should also be deleted.
Croatian: U slučajevima u kojima indikacija za određeni lijek navodi bakteriju Mycoplasma bovis kao patogen mastitisa, tu indikaciju također treba izbrisati.
English: Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet
Croatian: Znanstveni zaključci i razlozi za izmjenu sažetka opisa svojstava, označavanja i uputa o VMP-u
English: Mycoplasma bovis as an agent of mastitis, pneumonia, arthritis and genital disorders in cattle.
Croatian: 4 Pfützner H. and Sachse K. 1996. Mycoplasma bovis as an agent of mastitis, pneumonia, arthritis and genital disorders in cattle.
English: or ‘bovine mastitis caused by Mycoplasma bovis' are deleted from the indication of parenteral tylosin products, the Committee considered that the benefit-risk of these products could continue to be regarded as positive.
Croatian: Pod uvjetom da su indikacije „mastitis goveda prouzročen bakterijom Mycoplasma spp.” ili „mastitis goveda prouzročen bakterijom Mycoplasma bovis” izbrisane iz indikacije za parenteralne lijekove s tilozinom, Povjerenstvo smatra da se omjer koristi i rizika tih lijekova i dalje može smatrati pozitivnim.
English: 189 Lure Cedex
Croatian: Magny-Vernois B.P. 189 Lure Cedex
English: causes respiratory infections, arthritis and otitis (media) both in young and old cattle.
Croatian: Osim mastitisa, Mycoplasma spp. uzrokuje respiratone infekcije, artritis i otitis (media) i u mlade i stare stoke.