natgillin/translations-raw huggingface dataset:
In breeders on 0.025% tiamulin hydrogen fumarate the average serum level was 0.36 µg/ml (range 0.22-0.5 µg/ml). 
Pri vzrejnih pticah, ki so prejele 0,025 % tiamulinijevega hidrogenfumarata, je bila povprečna serumska koncentracija 0,36 µg/ml (razpon 0,22-0,5 µg/ml).
Laying birds: Can be used in laying chickens and in breeding chickens and turkeys. 
Lahko se uporablja pri piščancih v obdobju nesnosti ter pri vzrejnih piščancih in puranih.
When administered in the drinking water at 125, 250, or 500 ppm the estimated dose rates ranged from as low as 22 mg tiamulin hydrogen fumarate/kg body weight to a maximum of 102 mg tiamulin hydrogen fumarate/kg body weight. 
Ko so ga dajali v pitni vodi v vsebnosti 125, 250 ali 500 ppm, so bili ocenjeni odmerki v razponu od najmanj 22 mg tiamulinijevega hidrogenfumarata/kg telesne mase do največ 102 mg tiamulinijevega hidrogenfumarata/kg telesne mase.
Clinical efficacy in the treatment of Porcine Colonic Spirochaetosis (colitis) caused by B. pilosicoli was demonstrated in three field trials. 
Klinično učinkovitosti pri zdravljenju spirohetoze debelega črevesa (kolitisa) pri prašičih, ki jo povzroča B. pilosicoli, so dokazali v treh terenskih študijah.
Clinical efficacy in the treatment of swine dysentery caused by B. hyodysenteriae was demonstrated in two artificial infection studies and in a series of six field trials. 
Klinično učinkovitost pri zdravljenju prašičje dizenterije, ki jo povzroča B. hyodysenteriae, so dokazali v dveh študijah z umetno okužbo in v seriji šestih terenskih preskušanj.
The CVMP agreed that although there is limited data for M. synoviae in comparison with M. gallisepticum, the available information from the studies provided is sufficient to support the conclusion that Denagard 45% at a dose of 25 mg tiamulin hydrogen fumarate (equivalent to 55.6 mg of product)/kg body weight for three to five consecutive days would be efficacious in the treatment and metaphylaxis of Airsacculitis and Infectious Synovitis caused by M. synoviae. 
Odbor CVMP se je strinjal, da kljub omejenim podatkom za M. synoviae v primerjavi z M. gallisepticum razpoložljive informacije iz predloženih študij zadoščajo za potrditev zaključka, da je zdravilo Denagard 45% v odmerku 25 mg tiamulinijevega hidrogenfumarata (kar ustreza 55,6 mg zdravila)/kg telesne mase v obdobju treh do petih dni učinkovito pri zdravljenju in metafilaksi vnetja zračnih vrečk in infekcijskega sinovitisa, ki ju povzroča M. synoviae.
At 250 ppm tiamulin hydrogen fumarate administered for three days significant improvements in clinical endpoints, pathological signs and elimination of M. gallisepticum were shown. 
Dokazali so, da tiamulinijev hidrogenfumarat v odmerku 250 ppm, ki so ga dajali tri dni, povzroči pomembno izboljšanje kliničnih opazovanih dogodkov, bolezenskih znakov in odstranitev M. gallisepticum.
For the lower dose (8.8 mg tiamulin hydrogen fumarate per kg body weight for up to five days) a study was conducted in 20 pigs treated via drinking water under field conditions. 
Pri manjšem odmerku (8,8 mg tiamulinijevega hidrogenfumarata na kg telesne mase v obdobju do petih dni) so študijo izvedli pri 20 prašičih, ki so jih zdravili s pitno vodo v terenskih pogojih.
In the newer European strains and the older global isolates MIC ranges were similar for M. gallisepticum ranging from 0.001 - 0.037 µg/ml with MIC50s of 0,001 and 0.008 µg/ml and MIC90s of 0.025 and 0.031 µg/ml. 
Pri novejših evropskih sevih in starejših globalnih izolatih M. gallisepticum so bili razponi MIK podobni, in sicer med 0,001 in 0,037 µg/ml, z MIK50s 0,001 in 0,008 µg/ml in MIK90s 0,025 in 0,031 µg/ml.
In the older European data there was a wider range of MICs for M. gallisepticum (<0.004 and >256 µg/ml) with a MIC50 of 0,008 µg/ml and a MIC90 of 1 µg/ml. 
Pri starejših evropskih podatkih je bil pri M. gallisepticum večji razpon MIK (< 0,004 in > 256 µg/ml), z MIK50 0,008 µg/ml in MIC90 1 µg/ml.
Fresh solutions of tiamulin-medicated drinking water should be made up each day. 
Vsak dan pripravite svežo raztopino vode za pitje z dodanim tiamulinom.
Colon contents concentrations of tiamulin have been estimated at 3.41 µg/ml following administration of tiamulin hydrogen fumarate at 8.8 mg/kg body weight. 
Ocenjena koncentracija tiamulina v vsebini debelega črevesa je 3,41 µg/ml po dajanju tiamulinijevega hidrogenfumarata v odmerku 8,8 mg/kg telesne mase.
Use in drinking water or in feed 
zrnca prašiči dajanje v vodo za pitje ali v krmo
Tiamulin, which has not been absorbed or metabolised, passes down the intestines to the colon. 
Neabsorbirani ali nepresnovljeni tiamulin prehaja skozi prebavila v debelo črevo in se tam koncentrira.
• Meat and offal: 6 days 
• Meso in organi: 6 dni
Animals received a mean dose of 29 mg tiamulin hydrogen fumarate /kg body weight for five days via drinking water; this 
Živali so prejele povprečni odmerek 29 mg tiamulinijevega hidrogenfumarata/kg telesne mase v obdobju petih dni s pitno vodo.
In European isolates collected between 1990 and 2012 the minimum inhibitory concentration (MICs) ranged from ≤0.016 µg/ml to >16 µg/ml, with MIC50 of ≤0.063 µg/ml to 4 µg/ml and MIC90 of ≤0.016 µg/ml to >16 µg/ml. 
Pri evropskih izolatih, zbranih med letoma 1990 in 2012, je bila minimalna inhibitorna koncentracija (MIK) v razponu med ≤ 0,016 µg/ml in > 16 µg/ml, MIK50 v razponu med ≤ 0,063 µg/ml in 4 µg/ml ter MIK90 v razponu med ≤ 0,016 µg/ml in > 16 µg/ml.
Withdrawal periods were calculated based on residue concentrations in liver and using the 99/95 tolerance interval to account for one residue concentration above the MRL at day 3 after treatment, resulting in a withdrawal period of 6 days calculated using the WT1.4 calculation program. 
Karenco so izračunali na podlagi koncentracij ostankov v jetrih s tolerančnim intervalom 99/95, s čimer so upoštevali eno koncentracijo ostankov, ki je presegala najvišje mejne koncentracije ostankov 3. dan po zdravljenju.
The actual doses in mg/kg body weight were estimated at 8.8 mg mg tiamulin hydrogen fumarate/kg body weight. 
Ocenili so, da je dejanski odmerek v mg/kg telesne mase 8,8 mg tiamulinijevega hidrogenfumarata/kg telesne mase.
Clinical efficacy in the treatment of Porcine Proliferative Enteropathy (ileitis) caused by L. intracellularis was demonstrated in three artificial infection studies and one field trial. 
Klinično učinkovitost zdravljenja prašičje proliferativne enteropatije (ileitisa), ki jo povzroča L. intracellularis, so dokazali v treh študijah z umetno okužbo in enem terenskem preskušanju.
For meat and offal from turkey, a GLP-compliant residue depletion study was provided. 
Za meso in notranje organe puranov je bila predložena študija izločanja ostankov, skladna z dobro laboratorijsko prakso.
The indication Pleuropneumonia caused by A. pleuropneumoniae was supported by in vitro susceptibility data and by artificial infection studies. 
Indikacijo plevropnevmonije, ki jo povzroča A. pleuropneumoniae, podpirajo podatki o občutljivosti in vitro in študije z umetno okužbo.
At 55 mg tiamulin hydrogen fumarate/kg body weight given daily for 14 days, a transient salivation and slight gastric irritation occurred. 
Pri odmerku 55 mg tiamulinijevega hidrogenfumarata/kg telesne mase, ki so ga dajali 14 dni, je prišlo do prehodnega slinjenja in rahlega draženja želodca.
Tiamulin hydrogen fumarate 
tiamulinijev hidrogenfumarat
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different 
Ime in naslov imetnika dovoljenja za promet z zdravilom ter proizvajalec zdravila,
Target species pigs, indications and posology 
Ciljna vrsta prašiči, indikacije in odmerjanje
antibacterial for systemic use / Pleuromutilins / tiamulin 
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje bakterijskih infekcij/plevromutilini/tiamulin.
• Meat and offal: 2 days 
• Meso in organi: 2 dni
Tiamulin hydrogen fumarate 450 mg 
Vsak gram vsebuje: tiamulinijev hidrogenfumarat 450 mg
McOrist et al. (1995)3 examined three strains of L. intracellularis to find intracellular MIC (iMIC) and extracellular MIC (eMIC) 
(1995)3 so preučevali tri seve L. intracellularis in ugotovili, da sta znotrajcelična MIK (iMIK) in zunajcelična MIK (eMIK) tiamulina 4 µg/ml.
During this referral, adequate data have been submitted to support the following indications: Pigs 
Ocena koristi V tej napotitvi so bili predloženi ustrezni podatki v podporo naslednjim indikacijam:
• the CVMP reviewed the summary of product characteristics, labelling and package leaflet proposed by the marketing authorisation holders and considered all the overall submitted data; the CVMP has recommended the amendment of the marketing authorisations for Denagard 45% and its associated names as referred in Annex I for which the summary of product characteristics, labelling and package leaflet are set out in Annex III. 
odbor CVMP je priporočil spremembo dovoljenj za promet z zdravilom za zdravilo Denagard 45% in povezana imena, navedena v Prilogi I, za katera so v Prilogi III navedeni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo.
Artificial challenge studies were carried out using tiamulin inclusion rates in drinking water ranging from 120 to 180 ppm equivalent to doses of 20 to 40 mg tiamulin hydrogen fumarate/kg body weight. 
Opravljene so bile študije z umetno izpostavitvijo, v katerih je bila uporabljena vsebnost tiamulina v pitni vodi med 120 in 180 ppm, kar ustreza odmerkom od 20 do 40 mg tiamulinijevega hidrogenfumarata/kg telesne mase.
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. 
Pri vsakem prašiču so odvzeli vzorce jeter in mišic ter v njih analizirali vsebnost 8-α-hidroksimutilina z validirano analitsko metodo LCMS-MS. Na podlagi koncentracij ostankov v jetrnem tkivu so izračunali karenco 4 dni, in sicer z računskim programom WT1.4 in nastavljenimi vrednostmi pod mejo določljivosti pri polovičnih vrednostih meje določljivosti v skladu z navodili odbora CVMP „Pristop k usklajevanju karenc“ (EMEA/CVMP/036/95)9.
The words “Keep out of the sight and reach of children” Keep out of the sight and reach of children. 
Besedilo “Zdravilo shranjujte nedosegljivo otrokom” Zdravilo shranjujte nedosegljivo otrokom.
Aluminium foil sachets of 55.6 g and 111.2 g 
Vrečke iz aluminijaste folije, ki vsebujejo 55,6 g in 111,2 g. Oblikovana vrečka iz folije, ki vsebuje 1112 g in 5000 g.
The presence of the disease in the herd must be established before the product is used. 
Pred uporabo zdravila je treba ugotoviti prisotnost bolezni v čredi.
Dose-related reductions in mortality, average lung lesion area and A. pleuropneumoniae re-isolation but no complete clinical cure were observed at lower doses (20 mg). 
Pri manjšem odmerku (20 mg) so opazili od odmerka odvisno zmanjšanje umrljivosti, povprečne površine pljučnih lezij in ponovne izolacije A. pleuropneumoniae, ne pa popolne klinične ozdravitve.
For edible tissues and based on residue concentrations in liver, a withdrawal period of 26.2 hours was calculated using the WT1.4 calculation program, rounded up to 2 days.). 
Na podlagi koncentracij ostankov v jetrih so z računskim programom WT1.4 za užitna tkiva določili karenco 26,2 ure (zaokroženo na 2 dni).
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE - COMBINED LABEL AND PACKAGE LEAFLET 
PODATKI KI MORAJO BITI NAVEDENE NA STIČNI OVOJNINI - ZDRUŽENA STIČNA
In the field trials tiamulin was administered at inclusion rates of 125 - 250 ppm and estimated doses from 13.3 - 32.5 mg tiamulin hydrogen fumarate/kg body weight for three days. 
V terenskih preskušanjih je bila uporabljena vsebnost tiamulina 125-250 ppm in ocenjeni odmerki 13,3-32,5 mg tiamulinijevega hidrogenfumarata/kg telesne mase v obdobju treh dni.
The indication Porcine Colonic Spirochaetosis (colitis) caused by B. pilosicoli was supported by in vitro susceptibility data and field studies. 
Indikacijo spirohetoze debelega črevesa (kolitisa) pri prašičih, ki jo povzroča B. pilosicoli, podpirajo podatki o občutljivosti in vitro in terenske študije.
• Infectious Sinusitis and Airsacculitis caused by M. gallisepticum, M. synoviae and M. meleagridis: 40 mg tiamulin hydrogen fumarate (equivalent to 88.9 mg of product)/kg body weight administered daily for the period of 3 to 5 consecutive days 
• Infekcijski sinusitis in vnetje zračnih vrečk, ki ju povzročajo M. gallisepticum, M. synoviae in M. meleagridis: Dnevni odmerek 40 mg tiamulinijevega hidrogenfumarata (kar ustreza 88,9 mg zdravila)/kg telesne mase v obdobju 3 do 5 dni zaporedoma.
In these studies the MICs ranged from ≤0.008-64 µg/ml, with MIC50s of ≤0.062 µg/ml up to 0.125 µg/ml and MIC90s of 0.25 µg/ml up to 8 µg/ml. 
V teh študijah so bile MIK v razponu med ≤ 0,008 in 64 µg/ml, MIK50 v razponu med ≤ 0,062 µg/ml in 0,125 µg/ml ter MIK90 v razponu med 0,25 µg/ml in 8 µg/ml.
• Chronic Respiratory Disease caused by M. gallisepticum and Airsacculitis and Infectious Synovitis caused by M. synoviae: 25 mg tiamulin hydrogen fumarate (equivalent to 55.6 mg of product)/kg body weight administered daily for the period of 3 to 5 consecutive days. 
• Kronična respiratorna bolezen, ki jo povzroča M. gallisepticum, ter vnetje zračnih vrečk in infekcijski sinovitis, ki ju povzroča M. synoviae: Dnevni odmerek 25 mg tiamulinijevega hidrogenfumarata (kar ustreza 55,6 mg zdravila)/kg telesne mase v obdobju 3 do 5 dni zaporedoma.
Turkeys Meat and offal: 6 days 
Purani Meso in organi: 6 dni.
iii) For the treatment of Porcine Proliferative Enteropathy (ileitis) caused by Lawsonia intracellularis. 
iii) Za zdravljenje proliferativne enteropatije (ileitisa) pri prašičih, ki jo povzroča Lawsonia intracellularis.
Tiamulin has been shown to interact with ionophores such as monensin, salinomycin and narasin and may result in signs indistinguishable from an ionophore toxicosis. 
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Tiamulin dokazano medsebojno deluje z ionoforji, kot so monenzin, salinomicin in narazin, kar lahko povzroči znake, ki jih ni mogoče ločiti od zastrupitve z ionoforji.
Water intake may be depressed during the administration of tiamulin in birds. 
Vnos vode se pri pticah med zdravljenjem s tiamulinom lahko zmanjša.
• Enzootic Pneumonia caused by M hyopneumoniae, including infections complicated by Pasteurella multocida, or Pleuropneumonia caused by A. pleuropneumoniae: 20 mg tiamulin hydrogen fumarate (equivalent to 44.4 mg of product)/kg body weight administered daily for 5 consecutive days. 
• Enzootska pljučnica, ki jo povzroča M. hyopneumoniae, vključno z okužbami, ki se zapletejo zaradi bakterije Pasteurella multocida, in plevropneumonija, ki jo povzroča A. pleuropneumoniae: Dnevni odmerek 20 mg tiamulinijevega hidrogenfumarata (kar ustreza 44,4 mg zdravila)/kg telesne mase v pitni vodi za prašiče v obdobju 5 dni zaporedoma.
Denagard 45% is a veterinary medicinal product presented as granules for use in drinking water for pigs, chicken and turkeys containing 450 mg tiamulin hydrogen fumarate per gram product. 
Zdravilo Denagard 45% je zdravilo za uporabo v veterinarski medicini, na voljo v obliki zrnc za uporabo v pitni vodi za prašiče, piščance in purane, ki vsebuje 450 mg tiamulinijevega hidrogenfumarata na gram zdravila.
Denagard 45% and its associated names are veterinary medicinal products presented as granules for use in drinking water for pigs, chicken and turkeys containing 450 mg tiamulin hydrogen fumarate as an active substance per gram product. 
Zdravilo Denagard 45% in povezana imena so zdravila za uporabo v veterinarski medicini, na voljo v obliki zrnc za uporabo v pitni vodi za prašiče, piščance in purane, ki kot zdravilno učinkovino vsebujejo 450 mg tiamulinijevega hidrogenfumarata na gram zdravila.
In the field trials tiamulin was administered at inclusion rates of 125 - 250 ppm or daily doses from 12.7 to 59.7 mg tiamulin hydrogen fumarate/kg body weight for three days. 
V terenskih preskušanjih je bila uporabljena vsebnost tiamulina 125-250 ppm oziroma dnevni odmerki 12,7-59,7 mg tiamulinijevega hidrogenfumarata/kg telesne mase v obdobju treh dni.
In drinking water 
dajanje v vodo za pitje
Pregnancy and lactation: Can be used in pigs during pregnancy and lactation. 
Lahko se uporablja pri prašičih v obdobju brejosti in laktacije.
In turkeys serum levels of tiamulin hydrogen fumarate are lower with a 50 mg tiamulin hydrogen fumarate/kg body weight single dose giving a Cmax of 3.02 µg/ml in serum, and 25 mg/kg giving 1.46 µg/ml. 
Pri puranih so serumske koncentracije tiamulinijevega hidrogenfumarata po enkratnem odmerku 50 mg tiamulinijevega hidrogenfumarata/kg telesne mase manjše, in sicer je vrednost Cmax 3,02 µg/ml, po odmerku 25 mg/kg pa 1,46 µg/ml.
From these data the CVMP concluded that Denagard 45% at a dose of 40 mg tiamulin hydrogen fumarate (equivalent to 88.9 mg of product)/kg body weight for three to five consecutive days would be efficacious in the treatment and metaphylaxis of Infectious Sinusitis and Airsacculitis caused by Mycoplasma gallisepticum, Mycoplasma synoviae and Mycoplasma meleagridis susceptible to tiamulin. 
Na podlagi teh podatkov je odbor CVMP zaključil, da je zdravilo Denagard 45 % v odmerku 40 mg tiamulinijevega hidrogenfumarata (kar ustreza 88,9 mg zdravila)/kg telesne mase v obdobju treh do petih dni zaporedoma učinkovito pri zdravljenju in metafilaksi infeksijckskega sinusitisa in vnetja zračnih vrečk, ki ju povzročajo Mycoplasma gallisepticum, Mycoplasma synoviae in Mycoplasma meleagridis, občutljive za tiamulin.
For M. synoviae MICs ranged from 0.05 to 0.5 µg/ml with MIC50s of 0.1 µg/ml and a MIC90 of 0.25 µg/ml. 
MIK za M. synoviae so bile v razponu med 0,05 in 0,5 µg/ml z MIK50 0,1 µg/ml in MIK90 0,25 µg/ml.
The artificial infection studies were carried out using tiamulin inclusion rates in drinking water ranging from 60 to 250 ppm or estimated daily doses from 15.4 to 64.2 mg tiamulin hydrogen fumarate/kg body weight. 
Študiji z umetno okužbo sta bili opravljeni z uporabo vsebnosti tiamulina v pitni vodi med 60 in 250 ppm oziroma z ocenjenimi dnevnimi odmerki od 15,4 do 64,2 mg tiamulinijevega hidrogenfumarata/kg telesne mase.
The indication treatment of Porcine Proliferative Enteropathy (ileitis) caused by L. intracellularis was supported by in vitro susceptibility data, artificial infection studies and a field trial. 
Indikacijo zdravljenja prašičje proliferativne enteropatije (ileitisa), ki jo povzroča L. intracellularis, podpirajo podatki o občutljivosti in vitro, študije z umetno okužbo in terensko preskušanje.
Guidance for preparing product solutions: 
Navodila za pripravo raztopine zdravila:
Following a single oral dose of 10 mg and 25 mg tiamulin hydrogen fumarate/kg body weight the Cmax was 1.03 µg/ml and 1.82 µg/ml in serum respectively by microbiological assay and the Tmax was 2 hours for both. 
Po enkratnem peroralnem odmerku 10 mg in 25 mg tiamulinijevega hidrogenfumarata/kg telesne mase sta bili vrednosti Cmax, določeni z mikrobiološkim testom, 1,03 µg/ml oziroma 1,82 µg/ml, čas tmax pa je bil v obeh primerih 2 uri.
ii) For the treatment of Porcine Colonic Spirochaetosis (colitis) caused by Brachyspira pilosicoli. 
ii) Za zdravljenje spirohetoze debelega črevesa (kolitisa) pri prašičih, ki jo povzroča Brachyspira pilosicoli.
Consequently, a withdrawal period in eggs of zero days is accepted. 
Zato je sprejeta karenca za jajca nič dni.
Tiamulin at inclusion rates of 100 ppm (equivalent to 5 mg tiamulin hydrogen fumarate/kg body weight) and doses of 8 mg tiamulin hydrogen fumarate/kg body weight was administered for five to ten days. 
Tiamulin so dajali pet do deset dni z vsebnostjo 100 ppm (kar ustreza 5 mg tiamulinijevega hidrogenfumarata/kg telesne mase) in odmerkom 8 mg tiamulinijevega hidrogenfumarata/kg telesne mase.
iMIC50 was 0.125 µg/ml, iMIC90 0.125 µg/ml with an iMIC range of 0.125-0.5 µg/ml. 
iMIK50 je bila 0,125 µg/ml, iMIK90 0,125 µg/ml z razponom iMIK med 0,125 in 0,5 µg/ml.
• Swine Dysentery caused by B hyodysenteriae or Porcine Colonic Spirochaetosis (colitis) caused by B.pilosicoli: 8.8 mg tiamulin hydrogen fumarate (equivalent to 19.6 mg of product)/kg body weight administered daily in the drinking water of pigs for 3 to 5 consecutive days depending on the severity of the infection and/or the duration of the disease. 
• Prašičja dizenterija, ki jo povzroča B. hyodysenteriae,in spirohetoza debelega črevesa (ileitis) pri prašičih, ki jo povzroča B. pilosicoli: Dnevni odmerek 8,8 mg tiamulinijevega hidrogenfumarata (kar ustreza 19,6 mg zdravila)/kg telesne mase v pitni vodi za prašiče v obdobju 3 do 5 dni zaporedoma, odvisno od resnosti okužbe in/ali trajanja bolezni.
450 mg/g Oral granules Swine, chickens (broilers, rearing of broilers, layers / breeders), turkeys (for fattening and breeding) 
450 mg/g peroralna zrnca prašiči, piščanci (brojlerji, brojlerji za rejo, nesnice/vzrejne živali), purani (ta pitanje in vzrejo)
Animals should not receive products containing monensin, salinomycin or narasin during or at least 7 days before or after treatment with tiamulin. 
Živali med zdravljenjem s tiamulinom ali vsaj 7 dni pred njim oziroma 7 dni po njem ne smejo prejemati zdravil, ki vsebujejo monenzin, salinomicin ali narazin.
EXP {month/year} 
Datum izteka roka uporabnosti zdravila EXP: {mesec/leto}
The Netherlands Elanco Europe Ltd. Lilly House, Priestley Road Basingstoke, Hampshire RG24 9NL 
Nizozemska Elanco Europe Ltd. Lilly House, Priestley Road Basingstoke, Hampshire RG24 9NL
Lactose 
Karenca
Following a 50 mg tiamulin hydrogen fumarate/kg body weight single dose the Cmax was 4.02 µg/ml in serum by microbiological assay and after a 25 mg/kg dose it was 1.86 µg/ml. 
Po enkratnem odmerku 50 mg tiamulinijevega hidrogenfumarata/kg telesne mase je bila vrednost Cmax v serumu, določena z mikrobiološkim testom, 4,02 µg/ml, po odmerku 25 mg/kg pa 1,86 µg/ml.
Denagard 45% granulat dla świń, kur i indyków 
Denagard 45% granulat dla świń, kur i indyków tiamulinijev hidrogenfumarat
DENAGARD 45%, κοκκία για πόσιμο διάλυμα 
DENAGARD 45%, κοκκία για πόσιμο διάλυμα tiamulinijev hidrogenfumarat
The presence of the disease in the flock must be established before the product is used. 
Pred uporabo zdravila je treba ugotoviti prisotnost bolezni v jati.
• Treatment and metaphylaxis of Infectious Sinusitis and Airsacculitis caused by M. gallisepticum, M. synoviae and M. meleagridis susceptible to tiamulin. 
• Zdravljenje in metafilaksa infekcijskega sinusitisa in vnetja zračnih vrečk, ki ju povzročajo M. gallisepticum, M. synoviae in M. meleagridis, občutljive za tiamulin.
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. 
Skupine ptic so žrtvovali po 0 urah, 8 urah, 1 dnevu, 2 dneh, 3 dneh in 5 dneh po ukinitvi zdravljenja.
• Treatment of Swine Dysentery caused by B. hyodysenteriae susceptible to tiamulin. 
• Zdravljenje prašičje dizenterije, ki jo povzroča B. hyodysenteriae, občutljiva za tiamulin.
For M. synoviae MICs ranged from 0.004 to 0.5 µg/ml with a MIC50 of 0,125 µg/ml and a MIC90 of 0.25 µg/ml. 
MIK za M. synoviae so bile v razponu med 0,004 in 0,5 µg/ml z MIK50 0,125 µg/ml in MIK90 0,25 µg/ml.
In chicken a GLP-compliant residue depletion study in laying hens was conducted. 
Pri kokoših nesnicah so opravili študijo izločanja ostankov, skladno z dobro laboratorijsko prakso.
Slovak Republic Elanco Europe Ltd. Lilly House, Priestley Road Basingstoke, Hampshire RG24 9NL 
Portugalska Elanco Europe Ltd. Lilly House, Priestley Road Basingstoke, Hampshire RG24 9NL
• Treatment of Porcine Proliferative Enteropathy (ileitis) caused by L. intracellularis susceptible to tiamulin. 
• Zdravljenje prašičje proliferativne enteropatije (ileitisa), ki jo povzroča L. intracellularis, občutljiva za tiamulin.