natgillin/translations-raw huggingface dataset:
Artificial challenge studies were carried out using tiamulin inclusion rates in drinking water ranging from 60 to 250 ppm or estimated doses from 10 to 64.2 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 60 in 250 ppm oziroma ocenjeni odmerki od 10 do 64,2 mg tiamulinijevega hidrogenfumarata/kg telesne mase.
From these data the CVMP concluded 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 Chronic Respiratory Disease caused by M. gallisepticum. 
Na podlagi teh podatkov je odbor CVMP zaključil, 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 zaporedoma učinkovito pri zdravljenju in metafilaksi kronične respiratorne bolezni, ki jo povzroča M. gallisepticum.
Target species chickens, indications and posology 
Ciljna vrsta piščanci, indikacije in način odmerjanja
From these data the CVMP concluded that Denagard 45% at a dose of 20 mg tiamulin hydrogen fumarate (equivalent to 44.4 mg of product)/kg body weight for five consecutive days would be efficacious in the treatment and metaphylaxis of Enzootic Pneumonia caused by M. hyopneumoniae, including infections complicated by P. multocida. 
Na podlagi teh podatkov je odbor CVMP zaključil, da je zdravilo Denagard 45% v odmerku 20 mg tiamulinijevega hidrogenfumarata (kar ustreza 44,4 mg zdravila)/kg telesne mase v obdobju petih dni zaporedoma učinkovito pri zdravljenju in metafilaksi enzootske pljučnice, ki jo povzroča M. hyopneumoniae, vključno z okužbami, ki se zapletejo zaradi P. multocida.
Denagard 450 mg/g Granulat zum Eingeben über das Trinkwasser 
Denagard 450 mg/g Granulat zum Eingeben über das Trinkwasser tiamulinijev hidrogenfumarat
Denagard vet 450 mg/g rakeet 
Denagard vet 450 mg/g rakeet tiamulinijev hidrogenfumarat
DENAGARD 450 mg/g granule pro přípravu perorálního roztoku 
DENAGARD 450 mg/g granule pro přípravu perorálního roztoku tiamulinijev hidrogenfumarat
• Treatment of Pleuropneumonia caused by A. pleuropneumoniae susceptible to tiamulin. 
• Zdravljenje plevropnevmonije, ki jo povzroča A. pleuropneumoniae, občutljiv za tiamulin.
Meat and offal: 2 days (8.8 mg tiamulin hydrogen fumarate (equivalent to 19.6 mg of product)/kg body weight) 
Meso in organi: 2 dni (8,8 mg tiamulinijevega hidrogenfumarata (kar ustreza 19,6 mg zdravila)/kg telesne mase).
• Treatment and metaphylaxis of Enzootic Pneumonia caused by M. hyopneumoniae, including infections complicated by P. multocida susceptible to tiamulin. 
• Zdravljenje in metafilaksa enzootske pljučnice, ki jo povzroča M. hyopneumoniae, vključno z okužbami, ki se zapletejo zaradi bakterije P. multocida, občutljive za tiamulin.
Name of the veterinary medicinal product Denagard 450 mg/g granules for use in drinking water for pigs, chickens and turkeys Tiamulin hydrogen fumarate 
Denagard 450 mg/g zrnca za uporabo v pitni vodi za prašiče, piščance in purane tiamulinijev hidrogenfumarat
Meat and offal: 4 days (20 mg tiamulin hydrogen fumarate (equivalent to 44.4 mg of product)/kg body weight) 
Meso in organi: 4 dni (20 mg tiamulinijevega hidrogenfumarata (kar ustreza 44,4 mg zdravila)/kg telesne mase).
Similar findings were reported from other studies dating from 1997 - 2014 with MIC50 ranging from ≤0.015 µg/ml - 0.06 µg/ml, MIC90 ranging from 0.031 µg/ml - 0,125 µg/ml, and MIC ranges of 0.002-0.125 µg/ml. 
O podobnih izsledkih so poročali iz drugih študij, izvedenih v obdobju med letoma 1997 in 2014, pri čemer je bil razpon MIK50 med ≤ 0,015 µg/ml in 0,06 µg/ml, MIK90 v razponu med
Oral, administered in drinking water 
peroralna uporaba, dajanje v vodo za pitje
• Treatment of Porcine Colonic Spirochaetosis (colitis) caused by B. pilosicoli susceptible to tiamulin. 
• Zdravljenje spirohetoze debelega črevesa (kolitisa) pri prašičih, ki jo povzroča B. pilosicoli, občutljiva za tiamulin.
Doses administered ranged from 8.8-20 mg tiamulin hydrogen fumarate/kg body weight for 5 days. 
Odmerki so bili v razponu med 8,8 in 20 mg tiamulinijevega hidrogenfumarata/kg telesne mase, dajali pa so jih v obdobju 5 dni.
Denagard 450 mg/g granulát na perorálny roztok 
Denagard 450 mg/g granulát na perorálny roztok tiamulinijev hidrogenfumarat
• Meat and offal: 2 days (when the administered dose is 8.8 mg tiamulin hydrogen fumarate (equivalent to 19.6 mg of product)/kg body weight) 
• Meso in organi: 2 dni (ob uporabi odmerka 8,8 mg tiamulinijevega hidrogenfumarata (kar ustreza 19,6 mg zdravila)/kg telesne mase)
Tiamutin 45% PigsChicken-Turkey 
Tiamutin 45% PigsChicken-Turkey tiamulinijev hidrogenfumarat
From these data the CVMP concluded that Denagard 45% at a dose of 20 mg tiamulin hydrogen fumarate (equivalent to 44.4 mg of product)/kg body weight for five consecutive days would be efficacious in the treatment Pleuropneumonia caused by A. pleuropneumoniae. 
Na podlagi teh podatkov je odbor CVMP zaključil, da je zdravilo Denagard 45% v odmerku 20 mg tiamulinijevega hidrogenfumarata (kar ustreza 44,4 mg zdravila)/kg telesne mase v obdobju petih dni zaporedoma učinkovito pri zdravljenju plevropnevmonije, ki jo povzroča A. pleuropneumoniae.
• Meat and offal: 4 days (when the administered dose is 20 mg tiamulin hydrogen fumarate (equivalent to 44.4 mg of product)/kg body weight) 
• Meso in organi: 4 dni (ob uporabi odmerka 20 mg tiamulinijevega hidrogenfumarata (kar ustreza 44,4 mg zdravila)/kg telesne mase)
Target species turkeys, indications and posology 
Ciljna vrsta purani, indikacije in način odmerjanja
Meat and offal: 2 days Eggs: 
Meso in organi: 2 dni.
Pigs - Treatment of Swine Dysentery caused by Brachyspira hyodysenteriae susceptible to tiamulin. 
Prašiči - Zdravljenje prašičje dizenterije, ki jo povzroča Brachyspira hyodysenteriae, občutljiva na tiamulin.
6.1 List of excipients 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi laktoza
The dosage is 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. 
Odmerek je 25 mg tiamulinijevega hidrogenfumarata (kar ustreza 55,6 mg zdravila)/kg telesne mase na dan od 3 do 5 dni zaporedoma.
• Treatment and metaphylaxis of Chronic Respiratory Disease caused by M. gallisepticum and Airsacculitis and Infectious Synovitis caused by M. synoviae susceptible to tiamulin. 
• Zdravljenje in metafilaksa kronične respiratorne bolezni, ki jo povzroča M. gallisepticum, ter vnetja zračnih vrečk in infekcijskega sinovitisa, ki ju povzroča M. synoviae, občutljiva za tiamulin.
PHARMACEUTICAL FORM Granules for use in drinking water White to pale yellow granules 
FARMACEVTSKA OBLIKA Zrnca za uporabo v pitni vodi.
Denagard 450 mg/g granulado oral para suínos, galinhas e perus 
Denagard 450 mg/g granulado oral para suínos, galinhas e perus tiamulinijev hidrogenfumarat
- Dosage: 25 mg tiamulin hydrogen fumarate (equivalent to 55.6 mg of product)/kg body weight administered daily for 3 to 5 consecutive days. 
- Odmerjanje: Dnevni odmerek 25 mg tiamulinijevega hidrogenfumarata (kar ustreza 55,6 mg zdravila)/kg telesne mase v obdobju 3 do 5 dni zaporedoma.
Pigs i) Treatment of Swine Dysentery caused by Brachyspira hyodysenteriae susceptible to tiamulin. 
Prašiči i) Zdravljenje prašičje dizenterije, ki jo povzroča Brachyspira hyodysenteriae, občutljiva na tiamulin.
The dosage is 20 mg tiamulin hydrogen fumarate (equivalent to 44.4 mg of product)/kg body weight administered daily for 5 consecutive days. 
Odmerek je 20 mg tiamulinijevega hidrogenfumarata (kar ustreza 44,4 mg zdravila)/kg telesne mase na dan 5 dni zaporedoma.
Treatment and metaphylaxis of Infectious Sinusitis and Airsacculitis caused by Mycoplasma gallisepticum, Mycoplasma synoviae and Mycoplasma meleagridis susceptible to tiamulin. 
Zdravljenje in metafilaksa infekcijskega sinusitisa in vnetja zračnih vrečk, ki ju povzročajo Mycoplasma gallisepticum, Mycoplasma synoviae in Mycoplasma meleagridis, občutljive za tiamulin.
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. 
Podatke o ostankih v jetrih so obdelali z logistično linearno regresijo z računskim programom WT1.4.
Treatment of Swine Dysentery caused by Brachyspira hyodysenteriae susceptible to tiamulin. 
Zdravljenje prašičje dizenterije, ki jo povzroča Brachyspira hyodysenteriae, občutljiva za tiamulin.
DENAGARD 45 %, vandenyje tirpios granulės 
DENAGARD 45 %, vandenyje tirpios granulės tiamulinijev hidrogenfumarat
Animal species 
zdravljenih živali
The dosage is 8.8 mg tiamulin hydrogen fumarate (equivalent to 19.6 mg of product)/kg body weight daily administered 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. 
Odmerek je 8,8 mg tiamulinijevega hidrogenfumarata (kar ustreza 19,6 mg zdravila)/kg telesne mase na dan, ki se daje prašičem v vodo za pitje od 3 do 5 dni zaporedoma, odvisno od resnosti okužbe in/ali trajanja bolezni.
NAME OF THE VETERINARY MEDICINAL PRODUCT Denagard 450 mg/g granules for use in drinking water for pigs, chickens and turkeys 
Denagard 450 mg/g zrnca za uporabo v pitni vodi za prašiče, piščance in purane
The dosage is 40 mg tiamulin hydrogen fumarate (equivalent to 88.9 mg of product)/kg body weight daily administered for the period of 3 to 5 consecutive days. 
Odmerek je 40 mg tiamulinijevega hidrogenfumarata (kar ustreza 88,9 mg zdravila)/kg telesne mase na dan od 3 do 5 dni zaporedoma.
- Dosage: 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. 
- Odmerjanje: 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.
The dosage is 8.8 mg tiamulin hydrogen fumarate (equivalent to 19.6 mg of product)/kg body weight daily administered in the drinking water of pigs for 5 consecutive days. 
Odmerek je 8,8 mg tiamulinijevega hidrogenfumarata (kar ustreza 19,6 mg zdravila)/kg telesne mase na dan, ki se daje prašičem v vodo za pitje 5 dni zaporedoma.
Tiamutin 45% ChickenTurkey 
Tiamutin 45% ChickenTurkey tiamulinijev hidrogenfumarat
From these data the CVMP concluded that Denagard 45% at a dose of 8.8 mg tiamulin hydrogen fumarate (equivalent to 19.6 mg of product)/kg body weight for five consecutive days would be efficacious in the treatment of Porcine Proliferative Enteropathy (ileitis) caused by L. intracellularis. 
Na podlagi teh podatkov je odbor CVMP zaključil, da je zdravilo Denagard 45% v odmerku 8,8 mg tiamulinijevega hidrogenfumarata (kar ustreza 19,6 mg zdravila)/kg telesne mase v obdobju petih dni zaporedoma učinkovito pri zdravljenju prašičje proliferativne enteropatije (ileitisa), ki jo povzroča L. intracellularis.
450 mg/g Powder for use in drinking water 
450 mg/g zrnca za uporabo v pitni vodi prašiči peroralna uporaba
For the treatment and metaphylaxis of Chronic Respiratory Disease caused by Mycoplasma gallisepticum and Airsacculitis and Infectious Synovitis caused by Mycoplasma synoviae. 
Za zdravljenje in metafilakso kronične bolezni dihal, ki jo povzroča Mycoplasma gallisepticum, ter vnetja zračnih vreč in infekcijskega sinovitisa, ki ju povzroča Mycoplasma synoviae.
- Dosage: 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 5 consecutive days. 
- Odmerjanje: Dnevni odmerek 8,8 mg tiamulinijevega hidrogenfumarata (kar ustreza 19,6 mg zdravila)/kg telesne mase v pitni vodi za prašiče v obdobju 5 dni zaporedoma.
- Dosage: 40 mg tiamulin hydrogen fumarate (equivalent to 88.9 mg of product)/kg body weight administered daily for 3 to 5 consecutive days. 
- Odmerjanje: Dnevni odmerek 40 mg tiamulinijevega hidrogenfumarata (kar ustreza 88,9 mg zdravila)/kg telesne mase v obdobju 3 do 5 dni zaporedoma.
Treatment of Porcine Proliferative Enteropathy (ileitis) caused by Lawsonia intracellularis susceptible to tiamulin. 
Zdravljenje prašičje proliferativne enteropatije (ileitisa), ki jo povzroča Lawsonia intracellularis, občutljiva za tiamulin.
Treatment and metaphylaxis of Enzootic Pneumonia caused by Mycoplasma hyopneumoniae, including infections complicated by Pasteurella multocida susceptible to tiamulin. 
Zdravljenje in metafilaksa enzootske pljučnice, ki jo povzroča Mycoplasma hyopneumoniae, vključno z okužbami, ki se zapletejo zaradi bakterije Pasteurella multocida, občutljive na tiamulin.
ii) Treatment of Porcine Colonic Spirochaetosis (colitis) caused by Brachyspira pilosicoli susceptible to tiamulin. 
ii) Zdravljenje spirohetoze debelega črevesa (kolitisa) pri prašičih, ki jo povzroča Brachyspira pilosicoli, občutljiva na tiamulin.
iii) Treatment of Porcine Proliferative Enteropathy (ileitis) caused by Lawsonia intracellularis susceptible to tiamulin. 
iii) Zdravljenje proliferativne enteropatije (ileitisa) pri prašičih, ki jo povzroča Lawsonia intracellularis, občutljiva na tiamulin.
From these data the CVMP concluded that Denagard 45% at a dose of 8.8 mg tiamulin hydrogen fumarate (equivalent to 19.6 mg of product)/kg body weight for three to five consecutive days would be efficacious in the treatment of Swine Dysentery caused by B. hyodysenteriae. 
Na podlagi teh podatkov je odbor CVMP zaključil, da je zdravilo Denagard 45% v odmerku 8,8 mg tiamulinijevega hidrogenfumarata (kar ustreza 19,6 mg zdravila)/kg telesne mase v obdobju treh do petih dni zaporedoma učinkovito pri zdravljenju prašičje dizenterije, ki jo povzroča B. hyodysenteriae.
Pigs, chickens, turkeys 
meleagridis, pri piščancih in puranih.
Denagard 450 mg/g Granulado Oral 
Denagard 450 mg/g Granulado Oral tiamulinijev hidrogenfumarat
In European isolates tiamulin was highly active against M. hyopneumoniae, with MIC50 of 0.016 µg/ml, MIC90 of 0.062 µg/ml, and a MIC range of 0.002-0.125 µg/ml (MycoPath I project, 2014). 
0,016 µg/ml, MIK90 0,062 µg/ml in razponom MIK med 0,002 in 0,125 µg/ml (projekt MycoPath I, 2014).
Denagard 45% Granulat Tiamulin hydrogen fumarate 
Denagard 45% Granulat tiamulinijev hidrogenfumarat
Denagard 45% WSG Tiamulin hydrogen fumarate 
Denagard 45% WSG tiamulinijev hidrogenfumarat
From these data the CVMP concluded that Denagard 45% at a dose of 8.8 mg tiamulin hydrogen fumarate (equivalent to 19.6 mg of product)/kg body weight for three to five consecutive days would be efficacious in the treatment of Porcine Colonic Spirochaetosis (colitis) caused by B. pilosicoli. 
Na podlagi teh podatkov je odbor CVMP zaključil, da je zdravilo Denagard 45% v odmerku 8,8 mg tiamulinijevega hidrogenfumarata (kar ustreza 19,6 mg zdravila)/kg telesne mase v obdobju treh do petih dni zaporedoma učinkovito pri zdravljenju spirohetoze debelega črevesa (kolitisa) pri prašičih, ki jo povzroča B. pilosicoli.
- Treatment of Pleuropneumonia caused by Actinobacillus pleuropneumoniae susceptible to tiamulin. 
- Zdravljenje plevropnevmonije, ki jo povzroča Actinobacillus pleuropneumoniae, občutljiv na tiamulin.
Treatment and metaphylaxis of Chronic Respiratory Disease caused by Mycoplasma gallisepticum and Airsacculitis and Infectious Synovitis caused by Mycoplasma synoviae susceptible to tiamulin. 
Zdravljenje in metafilaksa kronične bolezni dihal, ki jo povzroča Mycoplasma gallisepticum, ter vnetja zračnih vreč in infekcijskega sinovitisa, ki ju povzroča Mycoplasma synoviae, občutljiva na tiamulin.
Treatment of Pleuropneumonia caused by Actinobacillus pleuropneumoniae susceptible to tiamulin. 
Zdravljenje plevropnevmonije, ki jo povzroča Actinobacillus pleuropneumoniae, občutljiv za tiamulin.
v) Treatment of Pleuropneumonia caused by Actinobacillus pleuropneumoniae susceptible to tiamulin. 
v) Zdravljenje plevropnevmonije, ki jo povzroča Actinobacillus pleuropneumoniae, občutljiv na tiamulin.
- Treatment of Porcine Colonic Spirochaetosis (colitis) caused by Brachyspira pilosicoli susceptible to tiamulin. 
- Zdravljenje spirohetoze debelega črevesa (kolitisa), ki jo povzroča Brachyspira pilosicoli, občutljiva na tiamulin.
- Treatment of Porcine Proliferative Enteropathy (ileitis) caused by Lawsonia intracellularis susceptible to tiamulin. 
- Zdravljenje proliferativne enteropatije (ileitisa), ki jo povzroča Lawsonia intracellularis, občutljiva na tiamulin.
iv) For the treatment and metaphylaxis of Enzootic Pneumonia caused by Mycoplasma hyopneumoniae, including infections complicated by Pasteurella multocida susceptible to tiamulin. 
iv) Za zdravljenje in metafilakso enzootske pljučnice, ki jo povzroča Mycoplasma hyopneumoniae, in njenih zapletov, ki jih povzroča Pasteurella multocida, občutljiva na tiamulin.
450 mg/g Granules for use in drinking water 
450 mg/g zrnca prašiči peroralna uporaba za dajanje v vodo za pitje
Mean body weight (kg) of animals to be treated 
povprečna telesna masa (kg)
Treatment of Porcine Colonic Spirochaetosis (colitis) caused by Brachyspira pilosicoli susceptible to tiamulin. 
Zdravljenje spirohetoze debelega črevesa (kolitisa) pri prašičih, ki jo povzroča Brachyspira pilosicoli, občutljiva za tiamulin.
iv) Treatment and metaphylaxis of Enzootic Pneumonia caused by Mycoplasma hyopneumoniae, including infections complicated by Pasteurella multocida susceptible to tiamulin. 
iv) Zdravljenje in metafilaksa enzootske pljučnice, ki jo povzroča Mycoplasma hyopneumoniae, in njenih zapletov, ki jih povzroča Pasteurella multocida, občutljiva na tiamulin.
Nine older artificial infection studies and three old field studies were presented to support the indication ‘treatment and metaphylaxis of Chronic Respiratory Disease caused by M. gallisepticum'. 
V podporo indikaciji „zdravljenje in metafilaksa kronične respiratorne bolezni, ki jo povzroča M. gallisepticum“ so predložili devet starejših študij z umetno okužbo in tri stare terenske študije.
DENAGARD 45% Tiamulin hydrogen fumarate 
DENAGARD 45% tiamulinijev hidrogenfumarat
Benefit assessment 
Učinkovina Jakost
- Dosage: 20 mg tiamulin hydrogen fumarate (equivalent to 44.4 mg of product)/kg body weight administered daily for 5 consecutive days. 
- Odmerjanje: 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.
4.9 Amounts to be administered and administration route 
4.9 Odmerjanje in pot uporabe Navodila za pripravo raztopine zdravila:
Special precautions for use in animals 
Ime zdravila za uporabo v veterinarski medicini
QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Tiamulin hydrogen fumarate 
Učinkovina: tiamulinijev hidrogenfumarat
The frequency of adverse reactions is defined using the following convention: - 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). 
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali)
v) For the treatment of Pleuropneumonia caused by Actinobacillus pleuropneumoniae susceptible to tiamulin. 
v) Za zdravljenje plevropnevmonije, ki jo povzroča Actinobacillus pleuropneumoniae, občutljiv na tiamulin.
Date on which the label was last approved To be completed nationally. 
Datum zadnje odobritve stične ovojnine
Pigs, chickens (broilers, laying and breeding hens), turkeys 
zrnca prašiči, piščanci, purani dajanje v vodo za pitje
Airsacculitis and Infectious Synovitis caused by Mycoplasma synoviae susceptible to tiamulin. 
Mycoplasma gallisepticum, Mycoplasma synoviae in Mycoplasma meleagridis, občutljive na tiamulin.
Further information on Leucogen can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. 
Nadaljnje informacije o zdravilu Leucogen so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The European Medicines Agency decided that Leucogen's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je odločila, da so koristi zdravila Leucogen večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Leucogen received a marketing authorisation valid throughout the EU for Leucogen on 17 June 2009. 
Zdravilo Leucogen je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 17. junija 2009.
Other information about Leucogen 
Druge informacije o zdravilu Leucogen
Leucogen is a vaccine. 
Zdravilo Leucogen je cepivo.
The vaccine is used to prevent the disease signs and persistent viraemia (the presence of FeLV in the blood). 
Cepivo se uporablja za preprečevanje znakov bolezni in preprečevanje trajne viremije (prisotnosti virusa FeLV v krvi).
Why is Leucogen authorised in the EU? 
Zakaj je zdravilo Leucogen odobreno v EU?
For the full list of restrictions and all side effects reported with Leucogen, see the package leaflet. 
Za celoten seznam omejitev in neželenih učinkov, o katerih so poročali pri uporabi zdravila Leucogen, glejte navodilo za uporabo.
The most common side effects with Leucogen (which may affect up to 1 in 10 cats) are a moderate and short-lived local reaction (<2 cm) after the first injection which resolves without treatment within 3 to 4 weeks, raised body temperature (lasting 1 to 4 days), apathy (listlessness) and digestive disturbances. 
Najpogostejši neželeni učinki zdravila Leucogen (ki lahko prizadenejo največ 1 mačko od 10) so zmerna in kratkotrajna lokalna reakcija (< 2 cm) po prvi injekciji, ki izzveni v treh ali štirih tednih brez zdravljenja, povišana telesna temperatura (ki traja od enega do štirih dni), apatija (ravnodušnost) in prebavne motnje.
What benefits of Leucogen have been shown in studies? 
Kakšne koristi je zdravilo Leucogen izkazalo v študijah?
What is Leucogen and what is it used for? 
Kaj je zdravilo Leucogen in za kaj se uporablja?
An overview of Leucogen and why it is authorised in the EU 
Pregled zdravila Leucogen in zakaj je odobreno v EU
What are the risks associated with Leucogen? 
Kakšna tveganja so povezana z zdravilom Leucogen?
Leucogen must not be used in pregnant cats. 
Zdravilo Leucogen se ne sme uporabljati pri brejih mačkah.
Feline leukaemia is an infectious disease of cats which affects the immune system and is caused by the feline leukaemia virus (FeLV). 
Mačja levkemija je nalezljiva bolezen mačk, ki prizadene imunski sistem in jo povzroča virus mačje levkemije (FeLV).
In cases where the kitten may have antibodies passed from the mother, a third injection can be given from 15 weeks of age. 
Če je mlada mačka od matere prejela protitelesa, lahko tretjo injekcijo prejme od 15 tednov starosti dalje.
Leucogen is available as a suspension for injection and can only be obtained with a prescription. 
Zdravilo Leucogen je na voljo v obliki suspenzije za injiciranje, predpisovanje in izdaja zdravila pa je le na recept.
Leucogen contains small amounts of a protein from the outer layer of the virus called ‘envelope p45 protein'. 
Zdravilo Leucogen vsebuje majhno količino beljakovine zunanje ovojnice virusa, imenovano „beljakovina ovojnice p45“.
Following the first booster vaccination protection lasts 3 years. 
Po prvem obnovitvenem cepljenju traja zaščita tri leta.
When a cat is given the vaccine the cat's immune system recognises the protein as ‘foreign' and makes antibodies against it. 
Ko mačka prejme cepivo, imunski sistem prepozna beljakovino kot tujek in proti njej tvori protitelesa.
Protection starts 3 weeks after the primary course of vaccination and lasts one year. 
Zaščita je učinkovita tri tedne po prvem sklopu cepljenja in traja eno leto.