natgillin/translations-raw huggingface dataset:
The parent compound is widely distributed in the tissues with the highest concentrations found in the lungs, bile, intestinal mucosa, spleen, kidney and liver. 
Prvotna spojina se v tkivih dobro porazdeli, z najvišjimi koncentracijami najdenimi v pljučih, žolču, mukozi črevesa, vranici, ledvicah in jetrih.
4.25 mg/kg bodyweight 
4,25 mg/kg telesne mase
• Treatment of porcine proliferative enteropathy caused by Lawsonia intracellularis in herds where there is a diagnosis based on clinical history, post-mortem findings and clinical pathology results. 
• Zdravljenje prašičje proliferativne enteropatije, ki jo povzroča Lawsonia intracellularis v čredah, kjer je diagnoza postavljena na podlagi klinične anamneze, ugotovitev avtopsij in rezultatov klinične patologije.
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” 
POSEBNA NAVODILA ZA SHRANJEVANJE Zdravilo shranjujte izven dosega in pogleda otrok.
In vivo studies have shown tylvalosin to be present in higher concentrations in the mucous lining of the respiratory and gut tissues compared to the plasma. 
In vivo raziskave so pokazale, da je tilvalozin v primerjavi s plazmo prisoten v višjih koncentracijah v sluznični plasti tkiv dihal in črevesja.
EU/2/04/044/009 - 40 g EU/2/04/044/010 - 160 g EU/2/04/044/017 - 400 g 
EU/2/04/044/010 - 160 g EU/2/04/044/010 - 400 g
Therapeutic classification 
KLINIČNI PODATKI
The veterinary medicinal product should be added to a volume of water that the birds will consume in one day. 
Zdravilo dodajte količini vode, ki jo bodo ptice lahko zaužile v enem dnevu.
2.125 mg/kg bodyweight/day 
2,125 mg/kg telesne mase/dan
No signs of intolerance have been observed in poultry species at up to 150 mg tylvalosin per kg bodyweight per day for 5 days. 
Pri perutnini, zdravljeni z do 150 mg tilvalozina na kg telesne mase na dan, do največ 5 dni, niso opazili znamenj preobčutljivosti.
In order to achieve a correct dose, the preparation of a concentrated (stock) solution might be required (e.g. to treat a total of 2,500 kg total pig weight, only 50% of the prepared stock solution prepared from the 40 g sachet should be used). 
Za doseganje tarčnega odmerka bo morda potrebno pripraviti koncentrirano raztopino (npr. za zdravljenje prašičev s skupno telesno maso 2500 kg uporabite le 50 % koncentrirane raztopine, pripravljene iz 40-gramske vrečke).
4.25 mg/kg bodyweight/day 
4,25 mg/kg telesne mase/dan
Marker residue 
Marker ostanek Živalska vrsta
телефон: +44 (0) 20 8447 8899 
Tel: +358 (0)20 144 3360
Aivlosin 42.5 mg/g oral powder for pigs Tylvalosin (as tylvalosin tartrate) 
Aivlosin 42,5 mg/g peroralni prašek za prašiče tilvalozin (v obliki tilvalozinijevega tartrata)
• Treatment and metaphylaxis of swine dysentery, caused by Brachyspira hyodysenteriae in herds where the disease has been diagnosed. 
• Zdravljenje metafilaksa dizenterije pri prašičih, ki jo povzroča Brachyspira hyodysenteriae, v čredah, kjer je bila diagnosticirana bolezen.
Batch {number} 
“EXP”.
When preparing a stock solution, the maximum concentration should be 40 g per 1,500 ml or 400 g of product per 15 litres and it is necessary to mix the solution for 10 minutes. 
Kadar pripravljate koncentrirano raztopino, naj bo najvišja koncentracija 40 g na 1500 ml ali 400 g izdelka na 15 litrov, nato morate raztopino mešati 10 minut.
Treatment of respiratory disease associated with Mycoplasma gallisepticum in pheasants. 
Za zdravljenje bolezni dihal, povezanih z Mycoplasma gallisepticum:
In mice, a slight reduction in the foetal bodyweight was seen at doses causing maternal toxicity. 
Pri odmerkih, ki povzročajo toksične učinke na mater, je bila pri miših opažena manjša izguba fetalne telesne mase.
The 40 g sachet is sufficient to treat a total of 5,000 kg of pigs (e.g. 250 pigs with an average bodyweight of 20 kg). 
40-gramska vrečka zadošča za zdravljenje prašičev s skupno maso 5000 kg (npr. 250 prašičev s povprečno telesno maso 20 kg).
The dose is 2.125 mg tylvalosin per kg bodyweight per day in-feed for 7 consecutive days. 
Odmerek je 2,125 mg tilvalozina na kg telesne mase na dan s krmo, 7 zaporednih dni.
In addition to medical treatment, good management and hygiene practices should be established on the farm in order to reduce the risk of infection and to control the potential development of resistance. 
Kot dodatek zdravljenju uvedite na kmetiji dobro prakso upravljanja in dobro higiensko prakso, da boste zmanjšali nevarnost infekcije in obvladali morebitni razvoj rezistence.
Tylvalosin tartrate is rapidly absorbed after oral administration of the veterinary medicinal product. 
Tilvalozinijev tartrat se po peroralnem dajanju zdravila hitro absorbira.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Active substance: 
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN Učinkovina:
METHOD AND ROUTE OF ADMINISTRATION 
NAČIN IN POT(I) UPORABE
No adverse effects on egg production, egg fertility, hatchability and chick viability were observed in broiler breeder stock administered 75 mg tylvalosin/kg bodyweight per day for 28 consecutive days. 
Pri plemenskih jatah kokoši, ki so prejemale 75 mg tilvalozina/kg telesne mase na dan, 28 zaporednih dni, niso opazili negativnih učinkov na proizvodnjo, oplojenost in valilnost jajc ter sposobnost preživetja piščancev.
Tylvalosin (as tylvalosin tartrate) 
tilvalozin (kot tilvalozinijev tartrat)
Panchris Feeds (Veterinary) Ltd Industrial Area Aradippou, 7100, LarnacaPOB 40261, 6302, Larnaca, 
Panchris Feeds (Veterinary) Ltd Industrial Area Aradippou, 7100, Larnaca POB 40261, 6302, Larnaca, Τηλ: + 357 24813333
Edifίcio 1- Escritόrio 2K 
Belphar LDA Sintra Business Park No 7, Edifίcio 1- Escritόrio 2K
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT Active substance: 
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGEIH SESTAVIN Zdravilna učinkovina tilvalozin
Chickens/Turkeys 
Kokoši/purani
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Granules for use in drinking water for pigs - 400 g sachet 
Zrnca za uporabo v pitni vodi za prašiče - 40 g vrečka
Do not use this veterinary medicinal product after the expiry date which is stated on the label after “EXP”. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini po “EXP”.
Determine the combined bodyweight (in kg) of all the turkeys to be treated. 
Ugotovite skupno telesno maso (v kg) vseh puranov, ki jih boste zdravili.
The 400 g sachet is sufficient to treat a total of 50,000 kg of pigs (e.g. 1000 pigs with an average body weight of 50 kg). 
400-gramska vrečka zadošča za zdravljenje prašičev s skupno maso 50000 kg (npr. 1000 prašičev s povprečno telesno maso 50 kg).
The 160 g sachet is sufficient to treat a total of 20,000 kg of pigs (e.g. 400 pigs with an average bodyweight of 50 kg). 
160-gramska vrečka zadošča za zdravljenje prašičev s skupno maso 20000 kg (npr. 400 prašičev s povprečno telesno maso 50 kg).
One aluminium foil/polyester laminated bag containing 5 or 20 kg. Not all pack sizes may be marketed. 
Ena vreča iz aluminijeve folije, laminirane s poliestrom, vsebuje 5 ali 20 kg.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi laktoza monohidrat 6.2 Glavne inkompatibilnosti
Use of the product deviating from the instructions may increase the risk of development and selection of resistant bacteria and decrease the effectiveness of treatment with other macrolides due to the potential for cross-resistance. 
Če izdelka ne uporabljate v skladu z navodili, lahko zvečate možnost, da bo prišlo do razvoja in selekcije rezistentnih bakterij, s tem pa do zmanjšane učinkovitosti zdravljenja z drugimi makrolidnimi antibiotiki zaradi možnosti navzkrižne rezistence.
Use of the veterinary medicinal product deviating from the instructions may increase the risk of development and selection of resistant bacteria and decrease the effectiveness of treatment with other macrolides due to the potential for cross-resistance. 
Če se pri uporabi zdravila za uporabo v veterinarski medicini ne ravnate po navodilih lahko zvečate tveganje razvoja in selekcije rezistentnih bakterij in zmanjšate učinkovitost zdravljenja z drugimi makrolidnimi antibiotiki zaradi možne navzkrižne odpornosti.
This is followed by a second treatment with 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days at the period of risk, i.e. at times of management stress such as administration of vaccines (typically when birds are 2-3 weeks old). 
Temu sledi drugo zdravljenje s 25 mg tilvalozina na kg telesne mase na dan v vodi za pitje 3 zaporedne dni v obdobju tveganja, t.j.
For treatment and metaphylaxis of swine enzootic pneumonia The dose is 2.125 mg tylvalosin per kg bodyweight per day in-feed for 7 consecutive days. 
Za zdravljenje in metafilakso enzootske pljučnice pri prašičih Odmerek je 2,125 mg tilvalozina na kg telesne mase na dan s krmo, 7 zaporednih dni.
2.125 mg/kg bodyweight 
2,125 mg/kg telesne mase
Tylvalosin is widely distributed in tissues with the highest concentrations found in the respiratory tissues, bile, intestinal mucosa, spleen, kidney and liver. 
Tilvalozin se porazdeli po različnih tkivih, najvišje koncentracije pa so prisotne v tkivih dihal, žolču, sluznici črevesja, vranici, ledvicah in jetrih.
For treatment and metaphylaxis of swine enzootic pneumonia The dose is 2.125 mg tylvalosin per kg bodyweight per day for 7 consecutive days. 
Za zdravljenje in metafilakso enzootske pljučnice pri prašičih Odmerek je 2,125 mg tilvalozina na kg telesne mase na dan, 7 zaporednih dni.
A horizontal ribbon mixer should be used to incorporate the veterinary medicinal product into feeding stuff. 
Za vmešanje zdravila za uporabo v veterinarski medicini v krmo priporočamo uporabo horizontalnega polžnega mešalnika.
Treatment and metaphylaxis of swine enzootic pneumonia 
Zdravljenje in metafilaksa enzootske pljučnice pri prašičih
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Granules for use in drinking water for chickens and turkeys - 400 g sachet 
Zrnca za uporabo v pitni vodi za kokoši in purane (40 g vrečka)
Name and address of the manufacturer responsible for batch release 
Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serij Cod Beck Blenders Limited
Shelf life after incorporation into meal or pelleted feed: 1 month. 
Rok uporabnosti po vmešanju v krmo ali v peletirano krmo: 1 mesec Odprto zdravilo uporabite takoj.
As an adjunct to medication, good management and hygiene practices should be introduced in order to reduce the risk of infection and to control the build-up of resistance. 
Kot dodatek zdravljenju, bi morali uvesti dobro gospodarjenje in higienske navade, da bi tako zmanjšali tveganje infekcije in za nadzor morebitne krepitve rezistence.
Ecuphar GmbH Brandteichstrasse 20, 17489 Greifswald, Deutschland, E-mail: info@ecuphar.de Tel: +49 (0)38348 3584 0 
Deutschland, E-mail: info@ecuphar.de Tel: +49 (0)38348 3584 0
One sachet of 40 g is sufficient to treat a total of 1,000 kg of turkeys (e.g. 10,000 birds with an average bodyweight of 100 g). 
Ena 40-gramska vrečica zadostuje za zdravljenje skupno 1000 puranov (npr. 10.000 ptic s povprečno telesno maso 100 g).
Shelf life after first opening of the immediate packaging: 4 weeks. 
Rok uporabnosti po prvem odpiranju stične ovojnine: 4 tedne.
NB: A level scoop of the product should be measured As an adjunct to medication, good management and hygiene practices should be introduced in order to reduce the risk of infection and to control the potential build-up of resistance. 
Dnevna količina krme (kg) x koncentracija predmešanice (mg/g) Kot dodatek zdravljenju, bi morali uvesti dobro gospodarjenje in higienske prakse, da bi tako zmanjšali tveganje infekcije in za nadzor morebitne krepitve rezistence.
When preparing a stock solution, the maximum concentration should be 40 g of product per 1,500 ml and it is necessary to mix the solution for 10 minutes. 
Kadar pripravljate koncentrirano raztopino, naj bo najvišja koncentracija 40 g zdravila na 1500 ml, nato morate raztopino mešati 10 minut.
The dose is 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days at 1 day old. 
Odmerek znaša 25 mg tilvalozina na kg telesne mase na dan v vodi za pitje 3 zaporedne dni od 1. dne starosti.
One sachet of 400 g is sufficient to treat a total of 10,000 kg of turkeys (e.g. 10,000 birds with an average bodyweight of 1 kg). 
Ena 400-gramska vrečica zadostuje za zdravljenje skupno 10.000 puranov (npr. 10.000 ptic s povprečno telesno maso 1 kg).
4.7 Use during pregnancy, lactation or lay 
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Varnost zdravila v obdobju nesnosti ni bila ugotovljena.
For treatment of porcine proliferative enteropathy (ileitis) The dose is 4.25 mg tylvalosin per kg bodyweight per day for 10 consecutive days. 
Za zdravljenje prašičje proliferativne enteropatije (ileitis) Odmerek je 4,25 mg tilvalozina na kg telesne mase na dan, 10 zaporednih dni.
PACKAGE LEAFLET: Aivlosin 625 mg/g granules for use in drinking water for chickens and turkeys 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Aivlosin 625 mg/g zrnca za uporabo v pitni vodi za kokoši in purane
Personal protective equipment consisting of impervious gloves and a half-mask respirator conforming to European Standard EN 149 or a non-disposable respirator conforming to European Standard EN 140, with a filter conforming to European Standard EN 143 should be worn when mixing the product. 
Pri mešanju zdravila nosite osebno zaščitno opremo, ki sestoji iz rokavic in dihalne polmaske skladno z evropskim standardom EN 149 ali dihalne maske skladne z evropskim standardom EN 140 s filtrom skladnim z evropskim standardom EN 143.
Maternal toxicity in rodents has been observed at doses of 400 mg tylvalosin per kg bodyweight and above. 
Pri odmerkih 400 mg tilvalozina na kg telesne mase in več so bili pri glodalcih zabeleženi toksični učinki na mater.
Good management and hygiene practices should be introduced to reduce the risk of re-infection. 
Za zmanjšanje tveganja za ponovno okužbo bi morali uvesti dobre prakse upravljanja in higienske prakse.
EU/2/04/044/001 - 20 kg EU/2/04/044/002 - 5 kg 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/04/044/001 - 20 kg EU/2/04/044/002 - 5 kg
PACKAGE LEAFLET: Aivlosin 625 mg/g granules for use in drinking water for pigs 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Aivlosin 625 mg/g zrnca za uporabo v pitni vodi za prašiče
Shelf life after first opening of the immediate packaging: 5 weeks. 
Rok uporabnosti po prvem odpiranju stične ovojnine: 5 tednov.
Use of the veterinary medicinal product deviating from the instructions in the SPC may increase the risk of development and selection of resistant bacteria and decrease the effectiveness of treatment with other macrolides due to the potential for cross-resistance. 
Če se pri uporabi zdravila za uporabo v veterinarski medicini ne ravnate po navodilih, navedenih v povzetku glavnih značilnosti zdravila, lahko zvečate tveganje razvoja in selekcije rezistentnih bakterij in zmanjšate učinkovitost zdravljenja z drugimi makrolidnimi antibiotiki zaradi možne navzkrižne odpornosti.
Good management and hygiene practices should be followed to reduce the risk of re-infection. 
Ravnajte se po dobri praksi organizacije dela in dobri higienski praksi, da boste zmanjšali nevarnost ponovne okužbe.
Tylvalosin has activity against pathogenic organisms isolated from a range of animal species-mainly Gram-positive organisms and mycoplasma but also some Gram-negative organisms, including Lawsonia intracellularis. 
predvsem proti gram pozitivnim mikroorganizmov in mikoplazmam, pa tudi proti nekaterim gram negativnim mikroorganizmom, vključno z Lawsonia intracellularis.
For treatment and metaphylaxis of swine enzootic pneumonia: 
Za zdravljenje in metafilaksa enzootske pljučnice pri prašičih
160 g sachet: do not store above 25 °C. 
160 g vrečka: Ne shranjujte pri temperaturi nad 25 °C.
Aivlosin 625 mg/g granules for use in drinking water for pigs Tylvalosin (as tylvalosin tartrate) 
Aivlosin 625 mg/g zrnca za uporabo v pitni vodi za prašiče tilvalozin (v obliki tilvalozinijevega tartrata)
Number of scoops 
Število žlic
For treatment and metaphylaxis of swine dysentery The dose is 4.25 mg tylvalosin per kg bodyweight per day for 10 consecutive days. 
Za zdravljenje in metafilakso dizenterije pri prašičih Odmerek je 4,25 mg tilvalozina na kg telesne mase na dan, 10 zaporednih dni.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Granules for use in drinking water for pheasants - 400 g sachet 
Zrnca za uporabo v pitni vodi za fazane- 40 g vrečka
Personal protective equipment consisting of impervious gloves and a half-mask respirator conforming to European Standard EN 149 or a nondisposable respirator conforming to European Standard EN 140, with a filter conforming to European Standard EN 143 should be worn when mixing the product. 
ki sestoji iz rokavic in dihalne polmaske skladno z evropskim standardom EN 149 ali dihalne maske skladne z evropskim standardom EN 140 s filtrom skladnim z evropskim standardom EN 143.
400 g sachet: do not store above 25 °C. 
400 g vrečka: Ne shranjujte pri temperaturi nad 25 °C.
The presence of the disease in the herd should be established before metaphylaxis. 
Preden začnete z metafilakso, morate potrditi prisotnost bolezni v čredi.
A horizontal ribbon mixer should be used to incorporate the product into the feeding stuff. 
Za vmešanje zdravila v krmo priporočamo uporabo horizontalnega polžnega mešalnika.
The dose is 5 mg tylvalosin per kg bodyweight per day in drinking water for 5 consecutive days. 
Odmerek je 5 mg tilvalozina na kg telesne mase na dan v vodi za pitje, 5 zaporednih dni.
Aivlosin 625 mg/g granules for use in drinking water for chickens/turkeys Tylvalosin (as tylvalosin tartrate) 
Aivlosin 625 mg/g zrnca za uporabo v pitni vodi za kokoši / purane tilvalozin (kot tilvalozinijev tartrat)
Macrolides are metabolites or derivatives of metabolites of soil organisms obtained by fermentation. 
Makrolidi so s pomočjo fermentacije pridobljeni presnovki ali derivati presnovkov zemeljskih organizmov.
Acute cases and severely diseased pigs with reduced food and water intake should be treated with a suitable injectable product. 
Akutne primere in hudo bolne prašiče, ki manj pijejo in jedo, je potrebno zdraviti z ustreznim zdravilom za injiciranje.
PACKAGE LEAFLET: Aivlosin 625 mg/g granules for use in drinking water for pheasants 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Aivlosin 625 mg/g zrnca za uporabo v pitni vodi za fazane
Tylvalosin as tartrate 
Tilvalozin v obliki tartrata
In severely diseased pigs, if water intake is reduced, pigs should be treated with a suitable injectable veterinary medicinal product. 
Hudo bolne prašiče, ki manj pijejo, je potrebno zdraviti z ustreznim zdravilom za injiciranje.
For treatment and metaphylaxis of swine dysentery The dose is 4.25 mg tylvalosin per kg bodyweight per day in-feed for 10 consecutive days. 
Za zdravljenje in metafilakso dizenetrije pri prašičih Odmerek znaša 4,25 mg tilvalozina na kg telesne mase na dan s krmo, 10 zaporednih dni.
Phone: 0046 767 834 910 Fax: 0045 7550 8080 Email: Scan@salfarm.com www.salfarm.com 
Phone: 0046 767 834 910 Fax: 0045 7550 8080
The dose is 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days. 
Odmerek znaša 25 mg tilvalozina na kg telesne mase na dan v vodi za pitje 3 zaporedne dni.
A beige granular powder. 
Bež zrnat prašek.
Do not store above 25 ºC. 
POSEBNA NAVODILA ZA SHRANJEVANJE Ne shranjujte pri temperaturi nad 25 ºC.
Lay: 
Nesnost:
40 g sachet: do not store above 25 °C. 
40 g vrečka: Ne shranjujte pri temperaturi nad 25 °C.
No signs of intolerance have been observed in pigs at up to 100 mg tylvalosin per kg bodyweight per day for 5 days. 
Pri prašičih, zdravljenih z največ 100 mg tilvalozina na kg telesne mase na dan, 5 dni, niso opazili znamenj preobčutljivosti.
The safety of Aivlosin during pregnancy and lactation has not been established in pigs. 
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Varnost zdravila v obdobju brejosti in laktacije pri prašičih ni bila ugotovljena.
Pheasants. 
Rp-Vet.
Chickens and Turkeys EU/2/04/044/019 
ŠTEVILKA(E) DOVOLJENJ(A) OLJENJ ZA PROMET EU/2/04/044/013
Chickens 
KARENCA
For treatment of respiratory disease associated with Mycoplasma gallisepticum: The dose is 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days. 
Kadar se uporablja kot pomoč pri zmanjševanju razvoja kliničnih znakov in smrtnosti (kjer je verjetna infekcija in ovo z Mycoplasma gallisepticum): Odmerek znaša 25 mg tilvalozina na kg telesne mase na dan v vodi za pitje 3 zaporedne dni od 1. dne starosti.
Aivlosin 625 mg/g granules for use in drinking water for pheasants Tylvalosin (as tylvalosin tartrate) 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Aivlosin 625 mg/g zrnca za uporabo v pitni vodi za fazane tilvalozin (kot tilvalozinijev tartrat)
NB: A level scoop of the product should be measured. 
Opomba: Za odmerjanje izdelka uporabljajte zravnane žlice.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM ECO Animal Health Europe Limited
Personal protective equipment consisting of impervious gloves and a half-mask respirator conforming to European Standard EN 149 
Pri mešanju zdravila nosite osebno zaščitno opremo, ki sestoji iz rokavic in dihalne polmaske skladno z evropskim standardom EN 149 ali dihalne maske skladne z evropskim standardom EN 140 s filtrom skladnim z evropskim standardom
MARKETING AUTHORISATION NUMBERS 
Najvišje dovoljene količine ostankov
Other information about Eporatio: 
Druge informacije o zdravilu Eporatio:
The European Commission granted a marketing authorisation valid throughout the European Union for Eporatio to ratiopharm GmbH on 29 October 2009. 
Evropska komisija je dovoljenje za promet z zdravilom Eporatio, veljavno po vsej Evropski uniji, odobrila družbi ratiopharm GmbH dne 29. oktobra 2009.
The effects of Eporatio were first tested in experimental models before being studied in humans. 
Učinki zdravila Eporatio so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The Committee recommended that Eporatio be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Eporatio odobri dovoljenje za promet.
What benefit has Eporatio shown during the studies? 
Kakšne koristi je zdravilo Eporatio izkazalo med študijami?
Eporatio should not be used in people who may be hypersensitive (allergic) to epoetin theta, to any other epoetins or substances derived from them, or to any of the other ingredients of Eporatio. 
Zdravila Eporatio ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) epoetin theta, na katere koli druge epoetine ali iz njih izpeljane snovi ali na katero koli drugo sestavino zdravila Eporatio.
The most common side effects with Eporatio (seen in between 1 and 10 patients in 100) are shunt thrombosis (clots that can form in blood vessels of patients on dialysis, a blood clearance technique), headache, hypertension (high blood pressure), hypertensive crisis (sudden, dangerously high blood pressure), skin reactions, arthralgia (joint pain) and influenza (flu)-like illness. 
Najpogostejši neželeni učinki zdravila Eporatio (opaženi pri 1 do 10 bolnikih izmed 100) so tromboza spoja (strdki, ki lahko nastanejo v krvnih žilah pri bolnikih na dializi, tj. tehnika čiščenja krvi), glavobol, hipertenzija (visok krvni tlak), hipertenzivna kriza (nenaden, nevarno visok krvni tlak), kožne reakcije, artralgija (bolečine v sklepih) in gripi podobna bolezen.
In the four renal failure studies, patients were given either Eporatio (under the skin or into a vein) or epoetin beta (another erythropoietin-like medicine used for anaemia). 
V štirih študijah ledvične odpovedi so bolnikom dali zdravilo Eporatio (pod kožo ali v veno) ali pa epoetin beta (drugo eritropoetinu podobno zdravilo, uporabljeno pri anemiji).
What is the risk associated with Eporatio? 
Kakšna tveganja so povezana z zdravilom Eporatio?