FrancophonIA/ELRC3.0 huggingface dataset:
English: The susceptibility patterns determined in these studies were of a wild-type pattern indicating that no resistance had developed in the period investigated.
Croatian: Obrasci osjetljivosti ustanovljeni u tim ispitivanjima bili su obrasci divljeg tipa koji su pokazivali da se tijekom ispitivanog razdoblja nije razvila rezistencija.
English: Statement of the active substance (s) and other ingredients Each g contains:
Croatian: Kvalitativni i kvantitativni sastav djelatne(ih) tvari i drugih sastojaka Svaki gram sadržava:
English: Indication(s)
Croatian: Indikacija(e)
English: This includes the specification of target pathogens, replacement of the prevention claim by metaphylaxis and clear dose recommendations based on mg tiamulin hydrogen fumarate/kg body weight for each target species and indication as well as prudent use recommendations for antimicrobial veterinary medicinal products authorised in the EU.
Croatian: To uključuje specifikaciju ciljnih patogena, zamjenu potrebe za prevencijom onom za metafilaksu i jasnim preporukama za doziranje na temelju mg tiamulin hidrogenfumarata / kg tjelesne težine za svaku ciljnu vrstu i indikacije, a također i razboritu primjenu preporuka danih za antimikrobne veterinarsko-medicinske lijekove odobrene u Europskoj uniji.
English: When medicating large volumes of water, prepare a concentrated solution first and then dilute to the required final concentration.
Croatian: Kad proizvod stavljate u veliku količinu vode, najprije pripremite koncentriranu otopinu, a zatim je razrijedite na potrebnu konačnu koncentraciju.
English: Water soluble granules
Croatian: Vodotopljive granule
English: Tiamulin MICs are high against A. pleuropneumoniae.
Croatian: MIK-ovi za tiamulin visoki su protiv A. pleuropneumoniae.
English: Risks for users were considered low and adequate information is included in the product information to ensure the safety for the user.
Croatian: Rizici za korisnike smatraju se malim, a u informacije o VMP-u uključene su odgovarajuće informacije kako bi se osigurala sigurnost primjene za korisnike.
English: = ___ mg product per litre of drinking water
Croatian: = ___ mg proizvoda po litri vode za piće
English: Animals with reduced water intake and/or in a debilitated condition should be treated parenterally.
Croatian: Životinje koje unose manje vode i/ili su oslabljenog stanja treba liječiti parenteralno.
English: 45% w/w tiamulin w/w)
Croatian: Tiamulinfumarat 45% w/w tiamulin w/w)
English: • Eggs: Zero days
Croatian: Jaja: Nula dana
English: No specific artificial challenge studies were available.
Croatian: Specifična ispitivanja umjetno izazvanih zaraza nisu bila dostupna.
English: Lesion score reduction and reduction in microbiological re-isolation varied from 55% to 100% for prevention/metaphylaxis but were as low as 33% to 67% for treatment of M. gallisepticum.
Croatian: Smanjeni rezultat za lezije i smanjenje ponovne mikrobiološke izolacije varirali su od 55 % do 100 % za prevenciju/metafilaksu, ali u slučaju liječenja M. gallisepticum iznosili su samo od 33 % do 67 %.
English: The in vitro susceptibility of M. gallisepticum and M. synoviae from chickens and turkeys was tested intwo studies with isolates from European Member States collected from 2005-2007, and 2010-2013, and in one study with global isolates collected before 1997.
Croatian: Osjetljivost in vitro za M. gallisepticum i M. synoviae u pilića i purana testirana je u dvama ispitivanjima s izolatima iz država članica Europske unije prikupljenima između 2005. i 2007. te 2010. i 2013. i u jednom ispitivanju s globalnim izolatima prikupljenima prije 1997.
English: Severe growth depression or death may result.
Croatian: Može doći do znatnog zaostajanja u rastu ili uginuća.
English: People with known hypersensitivity to tiamulin should administer the veterinary medicinal product with caution.
Croatian: Osobe preosjetljive na tiamulin trebaju oprezno primjenjivati veterinarsko-medicinski proizvod.
English: In case of accidental ingestion, seek medical advice immediately and show the label to the physician.
Croatian: U slučaju nehotičnog gutanja odmah potražiti pomoć liječnika i pokažite mu etiketu.
English: Clinical case reports did suggest that M. synoviae was treated effectively in a French study, and Hungarian and UK studies showed that M. meleagridis was also effectively treated causing reductions in clinical signs, airsacculitis and sinusitis.
Croatian: Izvješća kliničkih ispitivanja ukazuju na to da je M. synoviae učinkovito liječena u francuskom ispitivanju, a ispitivanja u Mađarskoj i Velikoj Britaniji pokazala su da je M. meleagridis također učinkovito liječena, dovodeći do smanjenja kliničkih znakova, aerosakulitisa i sinusitisa.
English: Germany referred the issue due to divergent national decisions having been taken by the EU Member States resulting in discrepancies in the product information for Denagard 45%.
Croatian: Njemačka je kao problem navela različite nacionalne odluke država članica EU-a koje su dovele do nedosljednosti u informacijama o veterinarsko-medicinskom proizvodu za Denagard 45 %.
English: Due to the irritant properties, it is also recommended to wear a dust mask to minimise inhalation exposure.
Croatian: Zbog iritacijskih svojstava preporučuje se nositi i masku za lice kako bi se maksimalno smanjila mogućnost udisanja proizvoda.
English: From each individual pig, specimens from liver and muscle were collected and analysed for 8-α-hydroxymutilin using a validated LCMS-MS analytical method.
Croatian: Za svaku pojedinu svinju prikupljeni su uzorci jetre i mišića i analizirani na 8α-hidroksimutilin primjenom validirane LCMS-MS analitičke metode.
English: Severe growth depression, ataxia, paralysis or death may result.
Croatian: ataksiju, paralizu ili uginuće.
English: There was some variation in the clinical results and there was a reported reduction in water intake with tiamulin in the drinking water.
Croatian: Bilo je nekih varijacija u kliničkim rezultatima i zabilježen je manji unos vode za piće kada se u vodi nalazio tiamulin.
English: Bactericidal concentrations can be reached but vary according to the bacterium.
Croatian: Baktericidne koncentracije mogu se postići, ali variraju ovisno o mikroorganizmu.
English: Remove contaminated feed as soon as possible and replace with feed not containing the tiamulinincompatible ionophores.
Croatian: Kontaminiranu hranu što prije uklonite i zamijenite hranom koja ne sadrži ionofore koji su nespojivi s tiamulinom.
English: The animals treated showed significant improvements in clinical endpoints such as diarrhoea score, feed conversion efficiency, average daily gain, and bacterial shedding was completely stopped (not examined in all studies).
Croatian: Liječene životinje pokazale su značajna poboljšanja u kliničkim ishodima kao što su rezultat za proljev, djelotvornost pretvaranja hrane, prosječno dnevno dobivanje na težini, a širenje bakterija potpuno je zaustavljeno (nije bilo ispitano u svim ispitivanjima).
English: Marketing authorisation holders
Croatian: Nositelji odobrenja za stavljanje u promet
English: It has been noted that Denagard 45% and its associated names do not have the same product information across the Member States with respect to e.g. target species, indications, posology and withdrawal periods
Croatian: Uočeno je da Denagard 45 % i povezani nazivi nemaju jednake informacije o veterinarskomedicinskom proizvodu u svim državama članicama s obzirom na npr. ciljne vrste životinja, indikacije, doziranje i razdoblja karencije.
English: Groups of birds were sacrified at 0 hours, 8 hours, 1 day, 2 days, 3 days and 5 days after withdrawal of treatment and samples from muscle (mixed samples from breast and leg), liver, skin and underlying subcutaneous fat were taken for residue analysis.
Croatian: Skupine ptica bile su žrtvovane 0 sati, 8 sati, 1 dan, 2 dana, 3 dana i 5 dana poslije prestanka liječenja, a uzorci mišića (miješani uzorci uzeti iz prsiju i noge), jetre, kože i potkožnog masnog tkiva uzeti su za analizu rezidua.
English: It has been shown to concentrate in the lung, polymorphonuclear leucocytes and also in liver, where it is metabolised and excreted (70-85%) in the bile, the remainder is excreted via the kidney (15-30%).
Croatian: Koncentrira se u plućima, polimorfonuklearnim leukocitima te jetri, gdje se metabolizira i izlučuje (70 - 85 %) u žuči, a ostatak se izlučuje putem bubrega (15 - 30 %).
English: Tiamulin, which has not been absorbed or metabolised, passes down the intestines to the colon.
Croatian: Tiamulin koji nije resorbiran ili metaboliziran prolazi tankim crijevom u kolon.
English: 9 CVMP note for guidance “Approach towards harmonisation of withdrawal periods” (EMEA/CVMP/036/95) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004428.pdf dose was in excess of the indicated dose (25 mg tiamulin hydrogen fumarate).
Croatian: 9 CVMP note for guidance “Approach towards harmonisation of withdrawal periods” (EMEA/CVMP/036/95) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004428.pdf
English: A contraindication for specific ionophores is included in the product information.
Croatian: Kontraindikacija za specifične ionofore uključena je u informacije o VMP-u.
English: Tiamulin hydrogen fumarate is considered to have an adequate therapeutic index in the pig and a minimum lethal dose has not been established.
Croatian: Tiamulinfumarat ima odgovarajući terapijski indeks u svinja, a minimalna smrtonosna doza nije određena.
English: Increased MICs against B. hyodysenteriae isolates in different European Member States give rise for concern as there are only limited antimicrobials left for the treatment of swine dysentery.
Croatian: Povećani MIK-ovi protiv izolata B. hyodysenteriae u različitim državama članicama Europske unije potiču zabrinutost jer je preostao samo ograničeni broj antimikrobnih lijekova za liječenje dizenterije svinja.
English: During this referral and considering the scope of the procedure, adequate data have been submitted to support the following posology:
Croatian: Tijekom ovog arbitražnog postupka te razmatrajući opseg postupka, odgovarajući podaci dostavljeni su kako bi potkrijepili sljedeće doziranje:
English: Satisfactory withdrawal periods have been set to provide assurance of consumer safety.
Croatian: Zadovoljavajuća razdoblja karencije određena su kako bi se osigurala sigurnost potrošača.
English: The tiamulin MIC data determined for the available EU Lawsonia strains are all below the estimated ileal tiamulin contents of 0.63 μg/ml.
Croatian: Podaci za MIK tiamulina određeni za dostupne EU sojeve Lawsonia ispod su procijenjenog sadržaja tiamulina u tankom crijevu od 0,63 μg/ml.
English: The main areas of disharmony in the existing product information relate to target species, indications, posology and withdrawal periods.
Croatian: Glavna područja neslaganja u postojećim informacijama o VMP-u odnose se na ciljne vrste životinja, indikacije, doziranje i razdoblja karencije.
English: administered in the drinking water gave a mycoplasmacidal effect at MIC90, reduced lung lesions and eliminated the organism in some cases.
Croatian: Višim dozama primjenjivanim u vodi za piće postignut je mikoplazmacidni učinak kod MIK90, smanjene su lezije pluća i uklonjen je uzročnik u nekim slučajevima.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Tiamulin hydrogen fumarate
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Djelatna tvar: Tiamulinfumarat
English: The indications in turkeys were supported by in vitro susceptibility data from the same three studies as in chickens and limited susceptibility data on M. meleagridis, a limited number of artificial infection and field studies, and a number of case reports published in the late 1970s and early 1980s.
Croatian: Indikacije u purana bile su potkrijepljene podacima osjetljivosti in vitro iz tri ista ispitivanja koja su provedena u pilića i ograničenim podacima o osjetljivosti na M. meleagridis, ograničenim brojem podataka iz umjetno izazvane zaraze i ispitivanja na terenu te nekoliko studija slučaja objavljenih kasnih 1970-ih i ranih 1980-ih.
English: To ensure the correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
Croatian: Kako bi osigurali primjenu odgovarajuće doze, treba što je točnije moguće odrediti tjelesnu težinu životinja da bi se izbjegla primjena premale doze.
English: It can be as little as two times the MIC for Brachyspira hyodysenteriae and Actinobacillus pleuropneumoniae but as high as 50100 times the bacteriostatic level for Staphylococcus aureus.
Croatian: Mogu biti do dvaput veće od vrijednosti MIK za Brachyspira hyodysenteriae i Actinobacillus pleuropneumoniae te 50 - 100 puta veće od bakteriostatske razine za Staphylococcus aureus.
English: Considering all data available, the epidemiological cut-off value appeared to be at 0.5 µg/ml while less susceptible strains grouped at ≥2.0 µg/ml.
Croatian: Uzimajući u obzir sve raspoložive podatke, činilo se da je epidemiološka granična vrijednost 0,5 µg/ml, dok su manje osjetljivi sojevi grupirani na ≥ 2,0 µg/ml.
English: The risk for users is related to the potential for contamination of the user's eyes and topical exposure of skin when preparing the product for administration.
Croatian: Rizik za korisnike odnosi se na mogućnost kontaminacije očiju i topikalne izloženosti kože kada se veterinarsko-medicinski proizvod priprema za primjenu.
English: Further studies showed a 95% lesion reduction for prevention and 74% during treatment at around the proposed dose of 40 mg tiamulin hydrogen fumarate/kg body weight given in the drinking water.
Croatian: Daljnja ispitivanja pokazala su smanjenje lezija od 95 % za prevenciju i 74 % tijekom liječenja primjenom približno preporučene doze od 40 mg tiamulin hidrogenfumarata/kg tjelesne težine davane u vodi za piće.
English: The liver residue data were subjected to log-linear regression using the WT1.4 calculation program and the resulting withdrawal period was 42 hours, rounded up to two days.
Croatian: Podaci za rezidue u jetri podvrgnuti su log-linearnoj regresiji primjenom programa za izračun WT1.4, a posljedično razdoblje karencije iznosilo je 42 sata, zaokruženo na do dva dana.
English: It appears to be concentration-dependent with 500 mg tiamulin hydrogen fumarate (equivalent to 1.11 g of product) in 4 litres of water reducing intake by approximately 10% and 500 mg tiamulin hydrogen fumarate (equivalent to 1.11 g of product) in 2 litres of water by 15% in chickens.
Croatian: Čini se da ovisi o koncentraciji pa 500 mg tiamulinfumarata (ekvivalentno 1,11 g proizvoda) u 4 litre vode može smanjiti unos vode kod kokoši za približno 10 %, a 500 mg tiamulinfumarata (ekvivalentno 1,11 g proizvoda) u 2 litre vode za 15 %.
English: In order to avoid interactions between the ionophores and tiamulin, the veterinarian and farmer should check that the feed label does not state that it contains salinomycin, monensin and narasin.
Croatian: Kako bi izbjegli interakcije između ionofora i tiamulina veterinar i poljoprivrednik moraju provjeriti je li na etiketi navedeno da sadrži salinomicin, monenzin i narazin.
English: Denagard 45% is generally well tolerated in the target species and appropriate information is included in the product information.
Croatian: Ciljne vrste životinja uglavnom dobro podnose Denagard 45 %, a odgovarajuće informacije uključene su u informacije o VMP-u.
English: Field exposure to tiamulin at around the proposed dose rate of 25 mg/kg body weight yielded a 100% microbiological response.
Croatian: U ispitivanjima na terenu, izloženost tiamulinu oko preporučene doze od 25 mg/kg tjelesne težine dovela je do 100%-tnog mikrobiološkog odgovora.
English: Manufacturer's batch number <Batch> <Lot> {number}
Croatian: <Serija> <Lot> {broj}
English: The situation is transient and recovery normally occurs within 35 days following withdrawal of tiamulin treatment.
Croatian: Ta situacija je prolazna i do oporavka obično dolazi 3 - 5 dana nakon prestanka primjene tiamulina.
English: The feed should be removed and replaced with fresh feed not containing the anticoccidials monensin, salinomycin or narasin.
Croatian: Hranu treba ukloniti i zamijeniti svježom, koja ne sadržava kokcidiostatike monenzin, salinomicin ili narazin.
English: Although VICH guideline GL48 on Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: marker residue depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009) recommends sampling eggs until at least 12 days after the end of treatment, data from two other studies (one of which measured tiamulin-like activity using a microbiological method and the other of which measured total radioactive residues) indicate that tiamulin levels in eggs peak immediately after the end of treatment and consequently there is no concern that increased tiamulin levels in eggs will occur at time points beyond those measured in the pivotal residue depletion study.
Croatian: Iako smjernica VICH GL48 o ispitivanjima za procjenu metabolizma i rezidualne kinetike veterinarskih lijekova u životinja koje služe za proizvodnju hrane: ispitivanja markera deplecije rezidua kako bi se ustanovila razdoblja karencije lijeka (EMA/CVMP/VICH/463199/2009) preporučuje da se jaja ne uzorkuju do najmanje 12 dana poslije završetka liječenja, podaci dvaju drugih ispitivanja (od kojih je jedno pomoću mikrobiološke metode izmjerilo aktivnost poput tiamulina, a drugo je mjerilo ukupne rezidue radioaktivnosti) pokazuju da razina tiamulina u jajima postiže vršnu vrijednost neposredno nakon završetka liječenja.
English: A withdrawal period of 4 days was calculated based on residue concentrations in liver tissues using the WT1.4 calculation program and setting values below limit of quantification (LOQ) at ½ LOQ according to the CVMP note for guidance “Approach towards harmonisation of withdrawal periods” (EMEA/CVMP/036/95)9.
Croatian: Razdoblje karencije od 4 dana izračunato je na temelju koncentracija rezidua u tkivu jetre pomoću programa WT1.4 te određivanjem vrijednosti ispod granice kvantifikacije (eng. limit of quantification, LOQ) pri ½ LOQ, prema napomeni CVMP-a za smjernice za usklađivanje razdoblja karencije “Approach towards harmonisation of withdrawal periods” („Pristup prema usklađivanju razdoblja karencije” (EMEA/CVMP/036/95)9.
English: A. COMBINED LABEL-LEAFLET
Croatian: KOMBINIRANO OZNAČAVANJE-UPUTA
English: Due to technical constraints the susceptibility of Lawsonia intracellularis is difficult to test in vitro.
Croatian: Zbog tehničkih ograničenja osjetljivost bakterije Lawsonia intracellularis teško je testirati in vitro.
English: Dose (mg product per kg body weight per day)
Croatian: Doza (mg proizvoda po kilogramu t.m. na dan)
English: In order to obtain the correct dosage, the concentration of tiamulin has to be adjusted accordingly.
Croatian: Kako bi osigurali odgovarajuću dozu, treba prilagoditi koncentraciju tiamulina.
English: Zero days
Croatian: nula dana
English: Tiamulin hydrogen fumarate is well absorbed in the pig (over 90%) following oral administration and widely distributed through the body.
Croatian: Nakon primjene kroz usta tiamulinfumarat dobro se resorbira u svinji (više od 90 %) i raspodjeljuje po čitavom tijelu.
English: Denagard 45% is also effective in the treatment of Pleuropneumonia caused by A. pleuropneumoniae in pigs.
Croatian: Denagard 45 % učinkovit je i u liječenju pleuropneumonije prouzročene bakterijom A. pleuropneumoniae u svinja.
English: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e)) - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
English: Administered for five days these doses caused significant improvements in clinical endpoints (e.g. feed conversion efficiency, average daily gain, diarrhoea score) and pathological signs though complete elimination of L. intracellularis could not be achieved.
Croatian: Te doze, primjenjivane tijekom pet dana, dovele su do značajnih poboljšanja u kliničkim ishodima (npr. djelotvornost pretvaranja hrane, prosječni dnevni prirast, rezultat za proljev) i patološkim znakovima, iako se potpuna eliminacija bakterije L. intracellularis nije mogla postići.
English: Animals should not receive products containing monensin, salinomycin or narasin during or at least 7 days before or after treatment with tiamulin.
Croatian: Životinje ne bi smjele primati proizvode koji sadržavaju monenzin, salinomicin ili narazin tijekom primjene tiamulina ili najmanje 7 dana prije ili poslije primjene tiamulina.
English: Aluminium foil sachets of 55.6 g and 111.2 g
Croatian: Vrećice od aluminijske folije od 55,6 g i 111,2 g.
English: Tiamulin hydrogen fumarate is well absorbed in chickens (70-95%) after oral administration and reaches peak concentrations in 2-4 hours (Tmax 2.85 hours).
Croatian: Nakon primjene kroz usta tiamulinfumarat dobro se resorbira kod kokoši (70 - 95 %), a najviše koncentracije postiže nakon 2 - 4 sata (Tmax 2,85 sati).
English: At higher doses (40 mg) no deaths, significantly reduced lung lesion scores, as well as no A. pleuropneumoniae re-isolation, indicating a strong bactericidal effect, were observed.
Croatian: Pri višim dozama (40 mg) opaženo je da nema smrtnosti, rezultati za lezije pluća značajno su se smanjili, a ni bakterija A. pleuropneumoniae nije bila ponovno izolirana, što ukazuje na snažan baktericidni učinak.
English: In turkeys, it is more marked, with approximately 20% reduction and therefore it is recommended not to exceed a concentration of 500 mg tiamulin hydrogen fumarate in 2 litres of the drinking water.
Croatian: Kod pura je to izraženije, uz smanjenje za otprilike 20 %, pa se ne preporučuje koncentracija tiamulinfumarata veća od 500 mg u 2 litre vode za piće.
English: At 150 mg tiamulin hydrogen fumarate/kg body weight no central nervous system effects were noted except for tranquillisation.
Croatian: Pri dozi od 150 mg tiamulinfumarata po kilogramu tjelesne mase nisu primijećeni drugi učinci na središnji živčani sustav osim smirenja.
English: Regarding poultry, there is a relatively high therapeutic index with tiamulin hydrogen fumarate and the likelihood of an overdose is considered remote especially as water intake and hence tiamulin hydrogen fumarate intake is reduced if abnormally high concentrations are given.
Croatian: Kod peradi terapijski indeks tiamulinfumarata relativno je visok, a mogućnost predoziranja niska je, posebice zato što se unos vode, a time i unos tiamulinfumarata, smanjuje ako se primijene neuobičajeno visoke koncentracije.
English: At 0, 24, 36 and 48 hours after the last treatment, animals were necropsied and the entire liver was analysed for 8-α-hydroxymutilin based on a GC analytical method.
Croatian: Nakon što je od posljednje terapije prošlo 0, 24, 36 i 48 sati, životinje su podvrgnute obdukciji i analizirana im je cijela jetra na 8-α-hidroksimutilin pomoću analitičke metode plinske kromatografije.
English: Meat and offal: 2 days Eggs:
Croatian: Meso i jestive iznutrice: 2 dana Jaja:
English: Overall, the benefit-risk balance of Denagard 45% is considered positive subject to the recommended changes in the product information (see Annex III).
Croatian: Sveukupno gledano, omjer koristi i rizika za Denagard 45 % smatra se povoljnim uz preporučene promjene u informacijama o VMP-u (vidjeti Prilog III).