natgillin/translations-raw huggingface dataset:
The format and means of dissemination, of this material should be discussed by the MAH with the appropriate learned societies. 
Oblika in način razdeljevanja tega gradiva morata biti dogovorjena med imetnikom dovoljenja za promet z zdravilom in ustreznimi izobraževanimi ustanovami.
Eggs were sampled twice daily. 
Jajca so vzorčili dvakrat dnevno.
Three distinct multi-resistant strains were isolated. 
Izolirani so bili trije različni, večkratno odporni izolati.
No specific artificial challenge studies were available. 
Na voljo ni bilo posebnih študij z umetno izpostavitvijo.
These were achieved at about 2-4 hours after dosing. 
Ti vrednosti sta bili doseženi v 2-4 urah po odmerjanju.
It has been authorised in 16 EU Member States. 
Dovoljenje za promet z zdravilom ima v 16 državah članicah.
If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of target bacteria. 
Če to ni mogoče, mora zdravljenje temeljiti na lokalnih (regionalnih, na ravni kmetije) epidemioloških podatkih o dovzetnosti ciljnih bakterij.
The words “For animal treatment only” and conditions or restrictions regarding supply and use, if applicable 
Besedilo “Samo za živali” in pogoji ali omejitve glede oskrbe in uporabe, če je smiselno
No resistant strains were found. 
Odpornih sevov niso našli.
In these studies doses were expressed as concentrations in drinking water. 
V teh študijah so bili odmerki izraženi kot koncentracija v pitni vodi.
The resistance situation for these pathogens is considered favourable. 
Odpornost pri teh patogenih velja za ugodno.
The recommended harmonised indications and dosing regimens have not been extended and consequently the use of the product as recommended in the product information should not lead to increased exposure of the environment. 
Priporočene usklajene indikacije in režimi odmerjanja niso bili razširjeni, zato uporaba zdravila v skladu s priporočilom v informacijah o zdravilu ne bi smela privesti do večje izpostavljenosti okolja.
When medicating large volumes of water, prepare a concentrated solution first and then dilute to the required final concentration. 
Pri pripravi večjih količin vode z dodanim zdravilom najprej pripravite koncentrirano raztopino in jo nato razredčite do potrebne končne koncentracije.
This suggests that reduced sensitivity of individual Lawsonia strains can occur but as there have been no reported adverse events in the EU regarding treatment of ileitis failures it suggests that such reduced sensitivity has not developed extensively in the EU. 
To kaže, da je zmanjšana občutljivost posameznih sevov rodu Lawsonia možna, a ker v EU še niso poročali o neželenih učinkih v zvezi z neuspešnim zdravljenjem ileitisa, kaže, da se v EU zmanjšana občutljivost še ni pojavila v večjem obsegu.
ATC vet code: QJ 01 XQ 01 
Oznaka ATC vet: QJ01XQ01
Overall summary of the scientific evaluation of Denagard 45% and its associated names (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravila Denagard 45% in povezanih imen (glejte Prilogo I)
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%. 
Nemčija je zadevo napotila zaradi različnih nacionalnih odločitev, ki so jih sprejele države članice, kar je privedlo do razlik med informacijami o zdravilu za zdravilo Denegard 45%.
It does not appear to have any adverse effect on overall performance of the birds or efficacy of the veterinary medicinal product but water intake should be monitored at frequent intervals, especially in hot weather. 
Ni videti, da bi to imelo neželene učinke na splošno zmogljivost ptic ali učinkovitost zdravila za uporabo v veterinarski medicini, vendar je treba vnos vode pogosto spremljati, zlasti v vročem vremenu.
Tiamulin has been shown to act at the 70S ribosome level and the primary binding sites are on the 50S subunit. 
Tiamulin dokazano deluje na ravni ribosoma 70S, primarna vezavna mesta pa so na podenoti 50S.
Residues in eggs were well below the MRL at all time points. 
Ostanki v jajcih so bili v vseh časovnih točkah precej pod najvišjimi mejnimi vrednostmi ostankov.
The actual doses in mg/kg body weight could only be estimated. 
Dejanske odmerke v mg/kg telesne mase je bilo mogoče le oceniti.
Marketing authorisation holders 
Imetnik dovoljenja za promet
The harmonised product information of Denagard 45% contains the necessary information to ensure the safe and effective use of the product. 
Usklajene informacije o zdravilu Denagard 45% vsebujejo potrebne informacije za zagotavljanje varne in učinkovite uporabe zdravila.
26 Rue de la Chapelle 68330 Huningue France 
Elanco France SAS 26 Rue de la Chapelle 68330 Huningue Francija
Bactericidal concentrations can be reached but vary according to the bacterium. 
Baktericidne koncentracije se lahko dosežejo, vendar so odvisne od bakterije.
Remove contaminated feed as soon as possible and replace with feed not containing the tiamulinincompatible ionophores. 
Odstranite kontaminirano krmo takoj, ko je mogoče, in jo zamenjajte s krmo, ki ne vsebuje s tiamulinom nezdružljivih ionoforjev.
The in vitro susceptibility data available to support the indication are limited. 
Podatki o občutljivosti in vitro v podporo indikaciji so omejeni.
Users are advised to take appropriate precautions when handling the product in order to avoid exposure. 
Uporabnikom se svetuje, naj med ravnanjem z zdravilom upoštevajo ustrezne previdnostne ukrepe, da se izognejo izpostavljenosti.
Due to the irritant properties, it is also recommended to wear a dust mask to minimise inhalation exposure. 
Zaradi dražilnih lastnosti je priporočljiva tudi uporaba protiprašne maske, da se zmanjša inhalacijska izpostavljenost.
Risks for users were considered low and adequate information is included in the product information to ensure the safety for the user. 
Tveganja za uporabnike so bila ocenjena kot nizka, informacije o zdravilu pa vsebujejo ustrezne informacije za zagotavljanje varnosti uporabnikov.
Pigs were treated at the intended dose and sacrificed 24 hours, 3, 4, 5 and 6 days after last administration. 
Prašiče so zdravili s predvidenim odmerkom in jih nato 24 ur, 3, 4, 5 in 6 dni po zadnjem odmerku žrtvovali.
Excretion is mainly via the bile (55-65%) and kidney (15-30%) as mainly microbiologically inactive metabolites and is quite rapid, 99% of the dose within 48 hours. 
Izločanje poteka predvsem z žolčem (55-65 %) in skozi ledvice (15-30 %), v glavnem v obliki mikrobiološko neaktivnih presnovkov, in je precej hitro, saj se 99 % odmerka izloči v 48 urah.
Animals with reduced water intake and/or in a debilitated condition should be treated parenterally. 
Živali z zmanjšanim vnosom vode in/ali poslabšanim splošnim zdravstvenim stanjem je treba zdraviti parenteralno.
Recent M. meleagridis-isolates are difficult to obtain as it was eradicated from most breeding flocks and only rarely occurs in the field. 
Novejše izolate M. meleagridis je težko pridobiti, saj je bila bakterija pri večini matičnih jat izkoreninjena, na terenu pa je redka.
The single mode susceptibility pattern suggested that there has been little resistance development to date. 
En sam način občutljivosti kaže, da se je odpornost do zdaj le malo razvijala.
It appears to inhibit microbial protein production by producing biochemically inactive initiation complexes, which prevent elongation of the polypeptide chain. 
Kaže, da zavira tvorbo mikrobnih beljakovin tako, da proizvaja biokemijsko neaktivne iniciacijske komplekse, ki preprečujejo podaljševanje polipeptidne verige.
Shelf life after dilution or reconstitution according to directions: The solution remains stable for 24 hours. 
Rok uporabnosti po razredčenju ali rekonstituciji v skladu z navodili: Raztopina ostane stabilna 24 ur.
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. 
To vključuje opredelitev ciljnih patogenov, zamenjavo predhodne trditve o preprečevanju z metafilakso in jasna priporočila za odmerjanje na podlagi mg tiamulinijevega hidrogenfumarata/kg telesne mase za vsako ciljno vrsto in indikacijo ter priporočila za preudarno rabo protimikrobnih zdravil za uporabo v veterinarski medicini, odobrenih v EU.
On 25 August 2015 Germany submitted a referral notification in accordance with Article 34(1) of Directive 2001/82/EC, to the CVMP/European Medicines Agency for Denagard 45% and its associated names (thereafter called Denagard 45%). 
Nemčija je 25. avgusta 2015 odboru CVMP Evropski agenciji za zdravila v skladu s členom 34(1) Direktive 2001/82/ES predložila obvestilo o napotitvi za zdravilo Denegard 45% in povezana imena (v nadaljevanju zdravilo Denegard 45%).
Do not use in cases of hypersensitivity to the active substance or to the excipient. 
Ne uporabite v primerih preobčutljivosti na učinkovino ali na katero koli pomožno snov.
The susceptibility patterns determined in these studies were of a wild-type pattern indicating that no resistance had developed in the period investigated. 
Občutljivost,ugotovljena v teh študijah, je bila podobna kot občutljivost divjega tipa, kar kaže, da se v preučevanem obdobju odpornost ni razvila.
The epidemiological cut-off value was considered at 16 µg/ml which corresponds to the current Clinical and Laboratory Standards Institute (CLSI) standard (S ≤16 µg/ml, R ≥32 µg/ml). 
Epidemiološka mejna vrednost je bila ocenjena kot 16 µg/ml, kar ustreza trenutnemu standardu Inštituta za klinične in laboratorijske standarde (CLSI) (S ≤ 16 µg/ml, R ≥ 32 µg/ml).
List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration, marketing authorisation holders in the Member States 
Seznam imen, farmacevtske oblike, jakosti zdravila za uporabo v veterinarski medicine, živalskih vrst, načina uporabe, imetnikov dovoljenja za promet v državah članicah
Wattanaphansak et al. (2009)5, tested 10 isolates of L. intracellularis (six from USA, four from Europe). 
(2009)5 so testirali 10 izolatov L. intracellularis (šest iz ZDA, štiri iz Evrope).
The feed should be tested for the ionophores prior to use if there is any suspicion that contamination of the feed might occur. 
Pred uporabo krme je treba le-to testirati na vsebnost ionoforjev, če obstaja kakršen koli sum na kontaminacijo krme.
2370 Arendonk Belgium 
Hoge Mauw 900 2370 Arendonk Belgija
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. 
Občutljivost in vitro M. gallisepticum in M. synoviae pri piščancih in puranih so testirali v dveh študijah z izolati iz držav članic, zbranih v obdobjih 2005-2007 in 2010-2013, in v eni študiji z globalnimi izolati, zbranimi pred letom 1997.
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. 
Tveganje za uporabnike je povezano z možnostjo kontaminacije uporabnikovih oči in lokalne izpostavljenosti kože med pripravo zdravila za uporabo.
Susceptibility testing of L. intracellularis is challenging since this is an obligate intracellular organism. 
Testiranje občutljivosti L. intracellularis je težavno, saj gre za obligatni znotrajcelični organizem.
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. 
Zmanjšanje lezij in zmanjšanje ponovne izolacije mikroorganizmov je bilo v razponu od 55 % do 100 % pri preprečevanju/metafilaksi, pri zdravljenju M. gallisepticum pa je bilo manjše, in sicer od 33 % do 67 %.
The MIC50 was considered high, but the isolates presented a wild-type susceptibility pattern suggesting lack of resistance. 
MIK50 je bil ocenjen kot visok, vendar so imeli izolati občutljivost divjega tipa, kar pomeni odsotnost odpornosti.
To ensure the correct dosage, body weight should be determined as accurately as possible to avoid underdosing. 
Za zagotovitev pravilnega odmerka je treba čim natančneje določiti telesno maso, da ne pride do premajhnega odmerjanja.
A number of isolates in Korea and Thailand may have higher iMIC figures than previously reported in the EU and USA by Wattanaphansak et al. (2009). 
Številni izolati v Koreji in na Tajskem imajo morda višje vrednosti iMIK od tistih, o katerih so iz EU in ZDA predhodno poročali Wattanaphansak idr.
People with known hypersensitivity to tiamulin should administer the veterinary medicinal product with caution. 
Osebe z znano preobčutljivostjo na tiamulin naj zdravilo za uporabo v veterinarski medicini dajejo previdno.
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. 
Zvišanje MIK proti izolatom B. hyodysenteriae v različnih državah članicah je zaskrbljujoče, saj je za zdravljenje prašičje dizenterije na voljo le še omejeno število protimikrobnih zdravil.
The dosage of the product to be incorporated should be established according to the following formula: 
Odmerek dodanega zdravila se določi po naslednji formuli:
ALUMINIUM LAMINATE BAG 
ALUMINIJASTA LAMINIRANA VREČKA
The susceptibility of B. pilosicoli towards tiamulin was investigated in three studies. 
Občutljivost B. pilosicoli za tiamulin so preučevali v treh študijah.
Severe growth depression, ataxia, paralysis or death may result. 
Lahko pride do hudega zaostajanja v rasti, ataksije, paralize ali pogina.
Currently further isolates have been tested from Korea (Yeh et al., 2011)6, Brazil and from Thailand (MAH proprietary data, 2016). 
Testirali so še druge izolate, in sicer iz Koreje (Yeh idr., 2011)6, Brazilije in s Tajske (lastniški podatki imetnika dovoljenja za promet z zdravilom, 2016).
Based on the residue depletion data available the following withdrawal periods are recommended: 
Na podlagi razpoložljivih podatkov o izločanju ostankov se priporočajo naslednje karence:
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. 
Indikacije pri puranih podpirajo podatki o občutljivosti in vitro iz istih treh študij kot pri piščancih in omejeni podatki o občutljivosti za M. meleagridis, omejeno število študij z umetno okužbo in terenskih študij ter številna poročila o primerih, objavljena v poznih 70. in zgodnjih 80. letih 20. stoletja.
Ninety three isolates of B. pilosicoli collected in Sweden (Pringle et al. 20061), 33 isolates collected in UK, Spain and Germany (MAH proprietary data 2008) as well as 324 isolates collected in Sweden between 2002 and 2010 (Pringle et al. 20122) were tested. 
Testirali so 93 izolatov B. pilosicoli, zbranih na Švedskem (Pringle idr., 20061), 33 izolatov, zbranih v Združenem kraljestvu, Španiji in Nemčiji (lastniški podatki imetnika dovoljenja za promet z zdravilom iz leta 2008) ter 324 izolatov, zbranih na Švedskem med letoma 2002 in 2010 (Pringle idr., 20122).
• Eggs: Zero days 
• Jajca: Nič dni
Tiamulin MICs are high against A. pleuropneumoniae. 
MIK tiamulina proti A. pleuropneumoniae so visoke.
If signs of intoxication do occur promptly remove the medicated water and replace with fresh water. 
Če se pojavijo znaki zastrupitve, takoj odstranite vodo z dodanim zdravilom in jo zamenjajte s svežo vodo.
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. 
Čeprav smernica VICH GL48 o študijah za vrednotenje presnove in kinetike ostankov zdravil za uporabo v veterinarski medicini pri živalih za proizvodnjo živil: študije o izločanju ostankov označevalcev za ugotavljanje karence zdravil (EMA/CVMP/VICH/463199/2009) priporoča vzorčenje jajc vsaj še 12 dni po koncu zdravljenja, podatki iz drugih dveh študij (od katerih so v eni merili tiamulinu podobno aktivnost z mikrobiološko metodo, v drugi pa skupne radioaktivne ostanke) kažejo, da je raven tiamulina v jajcih najvišja po koncu zdravljenja, zato ni skrbi, da bi se zvišane ravni tiamulina v jajcih pojavile pozneje kot ob časovnih točkah, izmerjenih v ključni študiji izločanja ostankov.
A contraindication for specific ionophores is included in the product information. 
V informacije o zdravilu je vključena kontraindikacija za določene ionoforje.
The main areas of disharmony in the existing product information relate to target species, indications, posology and withdrawal periods. 
Glavna področja neskladij v obstoječih informacijah o zdravilu se nanašajo na ciljne živalske vrste, indikacije, odmerjanje in karenco.
The tiamulin MIC data determined for the available EU Lawsonia strains are all below the estimated ileal tiamulin contents of 0.63 μg/ml. 
Podatki o MIK za tiamulin, ugotovljeni za razpoložljive seve rodu Lawsonia v EU, so vsi pod ocenjeno vsebnostjo tiamulina v ileumu, ki je 0,63 μg/ml.
It distributes widely through the body and has been shown to concentrate in the liver and kidney (sites of excretion) and in the lung (30 times serum level). 
Porazdeli se po vsem telesu in se dokazano koncentrira v jetrih in ledvicah (mesti izločanja) ter v pljučih (30-kratna serumska koncentracija).
Dose (mg product per kg body weight per day) 
odmerek (mg zdravila na kg telesne mase na dan)
4.7 Use during pregnancy, lactation or lay 
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Brejost in laktacija:
Overall, the benefit-risk balance of Denagard 45% is considered positive subject to the recommended changes in the product information (see Annex III). 
Splošno razmerje med tveganji in koristmi za zdravilo Denagard 45% je bilo ocenjeno kot pozitivno, pod pogojem, da se upoštevajo priporočene spremembe informacij o zdravilu (glejte Prilogo III).
On very rare occasions erythema or mild oedema of the skin may occur in pigs following the use of tiamulin. 
Zelo redko se lahko pojavita eritem ali blag edem kože pri prašičih po uporabi tiamulina.
The situation is transient and recovery normally occurs within 35 days following withdrawal of tiamulin treatment. 
Gre za prehodno stanje in v 3-5 dneh po prenehanju zdravljenja s tiamulinom običajno pride do okrevanja.
Manufacturer's batch number <Batch> <Lot> {number} 
Proizvajalčeva številka serije Serija: {številka}
administered in the drinking water gave a mycoplasmacidal effect at MIC90, reduced lung lesions and eliminated the organism in some cases. 
Večji odmerki, dani v pitno vodo, so imeli mikoplazmaciden učinek pri MIK90, zmanjšali so pljučne lezije in v nekaterih primerih odstranili mikroorganizme.
Tiamulin hydrogen fumarate is well absorbed in the pig (over 90%) following oral administration and widely distributed through the body. 
Tiamulinijev hidrogenfumarat se pri prašičih po peroralnem vnosu dobro absorbira (več kot 90 %) in se porazdeli po vsem telesu.
Denagard 45% is also effective in the treatment of Pleuropneumonia caused by A. pleuropneumoniae in pigs. 
Zdravilo Denagard 45% je učinkovito tudi pri zdravljenju plevropneumonije pri prašičih, ki jo povzroča A. pleuropneumoniae.
The feed should be removed and replaced with fresh feed not containing the anticoccidials monensin, salinomycin or narasin. 
Krmo je treba odstraniti in jo zamenjati s svežo krmo, ki ne vsebuje kokcidiostatikov monenzina, salinomicina in narazina.
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). 
Piščanci Tiamulinijev hidrogenfumarat se pri piščancih po peroralnem vnosu dobro absorbira (70-95 %) in doseže največje koncentracije po 2-4 urah (tmax 2,85 h).
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. 
Klinična poročila kažejo, da so v francoski študiji uspešno zdravili M. synoviae, v madžarski in britanski študiji pa so uspešno zdravili tudi M. meleagridis, saj je prišlo do zmanjšanja kliničnih znakov, vnetja zračnih vrečk in sinusitisa.
During this referral and considering the scope of the procedure, adequate data have been submitted to support the following posology: 
V tej napotitvi in glede na namen napotitve so bili predloženi ustrezni podatki v podporo naslednjemu odmerjanju:
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). 
Pri zdravljenih živalih je prišlo do pomembnega izboljšanja kliničnih opazovanih dogodkov, kot so resnost driske, učinkovitost presnavljanja krme, povprečni dnevni prirast telesne mase, izločanje bakterij iz telesa pa se je popolnoma ustavilo (česar niso preučevali v vseh študijah).
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. 
Pri večjem odmerku (40 mg) niso opazili nobene smrti, pomembno zmanjšan izid pljučnih lezij in nobene ponovne izolacije A. pleuropneumoniae, kar kaže na močan baktericidni učinek.
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. 
Nadaljnje študije so pokazale zmanjšanje lezij za 95 % pri preprečevanju in za 74 % pri zdravljenju s približno predlaganim odmerkom 40 mg tiamulinijevega hidrogenfumarata/kg telesne mase, danega s pitno vodo.
The LD5 is 1090 mg/kg body weight for chickens and 840 mg/kg body weight for turkeys. 
LD5 je 1090 mg/kg telesne mase pri piščancih in 840 mg/kg telesne mase pri puranih.
Appropriate guidance has been included in the product information to mitigate the risk. 
V informacije o zdravilu so dodana ustrezna navodila za zmanjševanje tveganja.
(equivalent to tiamulin 365 mg/g) Excipients: 
(kar ustreza 365 mg tiamulina na g) Pomožne snovi:
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. 
Da bi se izognili medsebojnemu delovanju med ionoforji in tiamulinom, morata veterinar in kmet preveriti nalepko na krmi, da le-ta ne vsebuje salinomicina, monenzina in narazina.
The clinical signs of acute toxicity in chickens are - vocalisation, clonic cramps and lying in a lateral position, and in turkeys - clonic cramps, lateral or dorsal position, salivation and ptosis. 
Klinični znaki akutne toksičnosti pri piščancih so vokalizacija, klonični krči in ležanje na strani, pri puranih pa klonični krči, ležanje na strani ali hrbtu, slinjenje in ptoza.
Target animal safety can be compromised in case of inadvertent coadministration of ionophores such as monensin, salinomycin, and narasin. 
Varnost ciljnih živali je lahko ogrožena v primeru nenamerne sočasne uporabe ionoforjev, kot so monenzin, salinomicin in narazin.