natgillin/translations-raw huggingface dataset:
The full EPAR for SomaKit TOC can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo SomaKit TOC je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The active substance in SomaKit TOC, edotreotide, attaches specifically to receptors called somatostatin receptors on the surface of cells. 
Zdravilna učinkovina v zdravilu SomaKit TOC, edotreotid, se veže zlasti na receptorje, imenovane somatostatinski receptorji, na površini celic.
Other information about SomaKit TOC 
Druge informacije o zdravilu SomaKit TOC
SomaKit TOC is a diagnostic medicine used in adult patients who are thought to have so-called welldifferentiated gastroenteropancreatic neuroendocrine tumours (GEP-NETs). 
SomaKit TOC je zdravilo, ki se uporablja za diagnostične namene pri odraslih bolnikih, pri katerih se domneva, da imajo tako imenovano dobro diferencirane gastroenteropankreatične nevroendokrine tumorje (GEP-NET).
What is SomaKit TOC and what is it used for? 
Kaj je zdravilo SomaKit TOC in za kaj se uporablja?
For practical information about using SomaKit TOC, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila SomaKit TOC naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
SomaKit TOC is available as a kit for preparing a solution for injection. 
Zdravilo SomaKit TOC je na voljo kot komplet za pripravo raztopine za injiciranje.
What are the risks associated with SomaKit TOC? 
Kakšna tveganja so povezana z zdravilom SomaKit TOC?
SomaKit TOC is used with a technique called positron emission tomography (PET scan) to obtain images that locate the cancers. 
Zdravilo SomaKit TOC se uporablja s tehniko, imenovano pozitronska emisijska tomografija (slikanje s PET), da se pridobijo slike za lokalizacijo raka.
What benefits of SomaKit TOC have been shown in studies? 
Kakšne koristi je zdravilo SomaKit TOC izkazalo v študijah?
SomaKit TOC contains the active substance edotreotide. 
Zdravilo SomaKit TOC vsebuje zdravilno učinkovino edotreotid.
Why is SomaKit TOC approved? 
Zakaj je bilo zdravilo SomaKit TOC odobreno?
It is not intended to provide practical advice on how to use SomaKit TOC. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The prepared medicine, radiolabelled with gallium (68Ga) chloride, attaches to these receptors on the GEP-NET cells. 
Pripravljeno zdravilo, radioaktivno označeno z (68Ga)galijevim kloridom, se veže na te receptorje na celicah dobro diferenciranih gastroenteropankreatičnih nevroendokrinih tumorjev.
Ga) chloride had a sensitivity and specificity of 100% and 89% respectively, and found a lesion detection rate of 75%. 
Rezultati nadaljnjih študij so pokazali, da ima edotreotid, označen z (68Ga)galijevim kloridom, občutljivost 100 % in specifičnost 89 %, stopnjo odkrivanja lezij pa 75 %.
The active substance in SomaKit TOC, edotreotide radiolabelled with gallium (68Ga) chloride, has a well established use in detecting GEP-NETs. 
Uporaba zdravilne učinkovine zdravila SomaKit TOC, edotreotida, radioaktivno označene z (68Ga)galijevim kloridom, je dobro uveljavljena pri odkrivanju dobro diferenciranih gastroenteropankreatičnih nevroendokrinih tumorjev.
How is SomaKit TOC used? 
Kako se zdravilo SomaKit TOC uporablja?
How does SomaKit TOC work? 
Kako zdravilo SomaKit TOC deluje?
Adopted at the 9-12 March 2015 PRAC 
Sprejeto na seji odbora PRAC med 9. in 12. marcem 2015
Having considered the available evidence in the literature and from individual case safety reports, the PRAC has agreed that the MAH(s) of aripiprazole-containing medicinal products should submit a variation within 2 months, to amend the product information as described below (new text underlined). 
Po proučitvi razpoložljivih dokazov iz literature in posameznih poročil o varnosti se je odbor PRAC strinjal, da mora(jo) imetnik(i) dovoljenj za promet z zdravili, ki vsebujejo aripiprazol, v dveh mesecih predložiti vlogo za spremembo informacij o zdravilu, kot je opisano spodaj (novo besedilo je podčrtano).
Aripiprazole - Aggression and related events (EPITT no 
Aripiprazol - nasilno vedenje in povezani dogodki (EPITT št.
The PRAC has further agreed that the MAH for Abilify and Abilify Maintena should submit in the next PSUR (data lock point 16/07/2015), a cumulative review of aripiprazole overdose and the risk of aggression and related events. 
Odbor PRAC se je nadalje strinjal, da mora imetnik dovoljenj za zdravili Abilify in Abilify Maintena v naslednje redno posodobljeno poročilo o varnosti (PSUR) (presečni datum obdobja zbiranja podatkov je 16. 7. 2015) vključiti skupne podatke o prevelikih odmerjanjih aripiprazola ter tveganju za nasilno vedenje in povezane dogodke.
Summary of Product Characteristics: 
Povzetek glavnih značilnosti zdravila
The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known: Aggression 
Po sprostitvi peroralnega aripiprazola na trg so poročali o naslednjih neželenih učinkih, vendar njihova pogostost ni znana: nasilno vedenje
Frequency ‘not known': aggression 
Pogostost ni znana: nasilno vedenje
Psychiatric disorders 
Preglednica z neželenimi učinki: psihiatrične motnje
0.5 mg Capsule, hard 
0,5 mg Kapsula, trda
Xagrid 
Ovojnina
Invented name Strength Pharmaceutical Form Route of administration Packaging Package size 
Farmacevtska oblika Pot uporabe
Bottle (HDPE) 100 capsules 
100 kapsul
The European Commission granted a marketing authorisation valid throughout the European Union for Ifirmacombi on 4 March 2011. 
Evropska komisija je dovoljenje za promet z zdravilom Ifirmacombi, veljavno po vsej Evropski uniji, izdala 4. marca 2011.
This means that Ifirmacombi is similar to a ‘reference medicine' already authorised in the European Union (EU) called CoAprovel. 
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu CoAprovel.
What are the benefits and risks of Ifirmacombi? 
Kakšne so koristi in tveganja, povezani z zdravilom Ifirmacombi?
It is available as tablets (150 mg irbesartan and 12.5 mg hydrochlorothiazide; 300 mg irbesartan and 25 mg hydrochlorothiazide; 300 mg irbesartan and 12.5 mg hydrochlorothiazide). 
Na voljo je v obliki tablet (150 mg irbesartana in 12,5 mg hidrokolorotiazida; 300 mg irbesartana in 25 mg hidrokolorotiazida; 300 mg irbesartana in 12,5 mg hidroklorotiazida).
The full EPAR for Ifirmacombi can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ifirmacombi je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
For more information about treatment with Ifirmacombi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Ifirmacombi preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This is a summary of the European public assessment report (EPAR) for Ifirmacombi. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ifirmacombi.
Other information about Ifirmacombi 
Druge informacije o zdravilu Ifirmacombi
Because Ifirmacombi is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Ifirmacombi generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ifirmacombi. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Ifirmacombi, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Ifirmacombi is a ‘generic medicine'. 
Zdravilo Ifirmacombi je „generično zdravilo“.
Why has Ifirmacombi been approved? 
Zakaj je bilo zdravilo Ifirmacombi odobreno?
The dose of Ifirmacombi to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before. 
Odmerek zdravila Ifirmacombi, ki ga bolnik uporabi, je odvisen od odmerka irbesartana ali hidroklorotiazida, ki ga je bolnik jemal prej.
The Committee recommended that Ifirmacombi be given marketing authorisation. 
Priporočil je, da se za zdravilo Ifirmacombi izda dovoljenje za promet.
Ifirmacombi is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone. 
Zdravilo Ifirmacombi se uporablja pri odraslih bolnikih, ki imajo esencialno hipertenzijo (visok krvni tlak), ki je ni mogoče ustrezno uravnavati samo z irbesartanom ali hidroklorotiazidom.
The CHMP concluded that, in accordance with EU requirements, Ifirmacombi has been shown to have comparable quality and to be bioequivalent to CoAprovel. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Ifirmacombi primerljivo raven kakovosti kot zdravilo CoAprovel ter da mu je biološko enakovredno.
Because Ifirmacombi is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, CoAprovel. 
Ker je zdravilo Ifirmacombi generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu CoAprovel.
The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone. 
Kombinacija obeh zdravilnih učinkovin daje pri zniževanju krvnega tlaka boljše rezultate kot posamezni učinkovini, uporabljeni kot samostojni zdravili.
Ifirmacombi may be added to other treatments for hypertension. 
Zdravilo Ifirmacombi je mogoče uvesti sočasno z drugimi načini zdravljenja hipertenzije.
Ifirmacombi is a medicine that contains two active substances, irbesartan and hydrochlorothiazide. 
Ifirmacombi je zdravilo, ki vsebuje dve zdravilni učinkovini, irbesartan in hidroklorotiazid.
What is Ifirmacombi? 
Kaj je zdravilo Ifirmacombi?
What is Ifirmacombi used for? 
Za kaj se zdravilo Ifirmacombi uporablja?
How has Ifirmacombi been studied? 
Kako je bilo zdravilo Ifirmacombi raziskano?
Ifirmacombi contains two active substances, irbesartan and hydrochlorothiazide. 
Zdravilo Ifirmacombi vsebuje dve zdravilni učinkovini, irbesartan in hidroklorotiazid.
Therefore, the CHMP's view was that, as for CoAprovel, the benefit outweighs the identified risk. 
Zato je menil, da koristi zdravila Ifirmacombi, tako kot pri zdravilu CoAprovel, odtehtajo znana tveganja.
How is Ifirmacombi used? 
Kako se zdravilo Ifirmacombi uporablja?
How does Ifirmacombi work? 
Kako zdravilo Ifirmacombi deluje?
The company will also carry out studies to further characterise this risk. 
Družba bo izvedla tudi študije za dodatno opredelitev tega tveganja.
The European Commission granted a marketing authorisation valid throughout the European Union for Rienso on 15 June 2012. 
Evropska komisija je dovoljenje za promet z zdravilom Rienso, veljavno po vsej Evropski uniji, izdala 15. junija 2012.
The full EPAR for Rienso can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila Rienso je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Depending on the severity of the anaemia and the patient's body weight, a second infusion may be given two to eight days after the first dose. 
Glede na resnost anemije in bolnikovo telesno maso lahko ta dva do osem dni po prvem odmerku prejme drugo infuzijo.
The main measure of effectiveness was how much haemoglobin levels (measured in grams per decilitre, g/dl) rose after five weeks. 
Glavno merilo učinkovitosti je bila rast ravni hemoglobina (izmerjenih v gramih na deciliter, g/dl) po petih tednih.
This is a summary of the European public assessment report (EPAR) for Rienso. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Rienso.
What measures are being taken to ensure the safe and effective use of Rienso? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Rienso?
In studies with Rienso, side effects were seen in 7.9% of patients taking the medicine, of which 0.2% were considered serious. 
V študijah zdravila Rienso so pri 7,9 % bolnikov opazili neželene učinke, od katerih jih je bilo 0,2 % ocenjenih kot resnih.
Serious cases of hypersensitivity (allergic reaction) or hypotension were uncommon and were seen in 0.2% of patients. 
Pojavi resnih preobčutljivostnih (alergijskih) reakcij ali hipotenzije so bili redki in opaženi pri 0,2 % bolnikov.
In all three studies, patients taking Rienso had higher average increases in haemoglobin: 1.2 g/dl versus 0.5 g/dl; 0.8 g/dl versus 0.2 g/dl; and 1.0 g/dl versus 0.5 g/dl. 
1,2 g/dl v primerjavi z 0,5 g/dl; 0,8 g/dl v primerjavi z 0,2 g/dl in 1,0 g/dl v primerjavi z 0,5 g/dl.
The CHMP decided that Rienso's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Rienso večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Other information about Rienso 
Druge informacije o zdravilu Rienso
For more information about treatment with Rienso, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Rienso preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Rienso is given as an infusion into a vein lasting at least 15 minutes. 
Zdravilo Rienso se daje kot infuzija v veno v trajanju vsaj 15 minut.
The increase in haemoglobin seen in the main studies was considered by the CHMP to be a valuable improvement and comparable to what is obtained with standard intravenous iron preparations. 
Odbor je dvig ravni hemoglobina, opažen v glavnih študijah, ocenil kot pomembno izboljšanje, ki je primerljivo z rezultati, doseženimi z običajnimi intravenskimi železovimi pripravki.
With the iron stores replenished, the body can produce more haemoglobin, which will help correct the anaemia. 
Ko se zaloge železa obnovijo, lahko telo tvori več hemoglobina, kar pomaga odpraviti anemijo.
A risk management plan has been developed to ensure that Rienso is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Rienso je bil pripravljen načrt obvladovanja tveganj.
What benefit has Rienso shown during the studies? 
Kakšne koristi je zdravilo Rienso izkazalo med študijami?
The doctor should ensure that the patient is observed for adverse reactions for at least 30 minutes following the infusion. 
Zaradi neželenih učinkov mora zdravnik zagotoviti, da se bolnika opazuje še vsaj 30 minut po vsakem infundiranju.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Rienso. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Patients should have their blood and iron levels tested after at least one month following treatment. 
Vsaj en mesec po zdravljenju je treba pri bolnikih opraviti preiskave krvi in ravni železa.
Iron deficiency is a common cause of anaemia in patients with long-term kidney disease and is itself caused by many factors including the poor absorption of dietary iron from food. 
Pomanjkanje železa je običajen vzrok za anemijo pri bolnikih z dolgotrajnim obolenjem ledvic, povzročijo pa ga številni dejavniki, med drugim slaba absorpcija železa iz živil.
The most frequently reported side effects were symptoms affecting the gut (diarrhoea, constipation, nausea and vomiting), headache, dizziness and hypotension (low blood pressure), all occurring in less than 2.5% of patients. 
Najpogosteje zabeleženi neželeni učinki so simptomi, povezani s črevesjem (driska, zaprtje, slabost in bruhanje), glavobol, omotica in hipotenzija (nizek krvni tlak).
Rienso is used to treat anaemia (low levels of red blood cells or haemoglobin) caused by a deficiency of iron in patients with chronic kidney disease (long-term, progressive decrease in the ability of the kidneys to work properly). 
Zdravilo Rienso se uporablja za zdravljenje anemije (nizke ravni rdečih krvničk ali hemoglobina), ki ga povzroča pomanjkanje železa pri bolnikih s kroničnim obolenjem ledvic (dolgotrajnim, postopnim zmanjšanjem sposobnosti pravilnega delovanja ledvic).
Rienso should only be given when healthcare professionals trained to manage anaphylactic (severe allergic) reactions and full resuscitation facilities are available. 
Zdravilo Rienso se daje samo ob navzočnosti zdravstvenih delavcev, izkušenih v obravnavi anafilaktičnih (hudih alergijskih) reakcij, in kadar je na voljo popolna oprema za oživljanje.
Rienso must not be used in people with a history of drug allergy, including allergy to ferumoxytol or any other iron preparation. 
Zdravila Rienso ne smejo uporabljati osebe z anamnezo alergije na zdravilo, vključno z alergijo na ferumoksitol ali kateri koli drug železov pripravek.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rienso, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
It must not be used in patients with evidence of excess iron in the body or in patients whose anaemia is not caused by iron deficiency. 
Ne sme se uporabiti pri ljudeh, ki izkazujejo presežek železa v krvi ali katerih anemija ni posledica pomanjkanja železa.
To maintain normal haemoglobin levels, patients may be re-treated with Rienso if they are confirmed to be lacking iron. 
Za vzdrževanje običajnih ravni hemoglobina se lahko zdravljenje z zdravilom Rienso ponovi, če se pri bolniku ugotovi ponovno pomanjkanje železa.
What is the risk associated with Rienso? 
Kakšna tveganja so povezana z zdravilom Rienso?
In addition, the company that market Rienso will provide educational material to patients and doctors expected to use Rienso, with information on the risk of allergic reactions. 
Poleg tega bo družba, ki trži zdravilo Rienso, bolnikom in zdravnikom, ki naj bi uporabljali to zdravilo, priskrbela izobraževalno gradivo, v katerem bodo pojasnjena tveganja za pojav alergijskih reakcij.
For the full list of all side effects reported with Rienso, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Rienso, glejte navodilo za uporabo.
Why has Rienso been approved? 
Zakaj je bilo zdravilo Rienso odobreno?
Rienso is an iron preparation that contains the active substance ferumoxytol. 
Zdravilo Rienso je železov pripravek, ki vsebuje zdravilno učinkovino ferumoksitol.
The active substance in Rienso, ferumoxytol, is an iron-containing compound. 
Zdravilna učinkovina v zdravilu Rienso, ferumoksitol, je spojina, ki vsebuje železo.
Rienso was shown to be superior to iron taken by mouth in treating iron deficiency anaemia in patients with chronic kidney disease. 
Zdravilo Rienso se je izkazalo za boljše v primerjavi s peroralnimi železovimi pripravki za zdravljenje anemije, ki je posledica pomanjkanja železa pri bolnikih s kroničnim ledvičnim obolenjem.
Rienso was more effective at increasing haemoglobin levels than the iron treatment taken by mouth. 
Zdravilo Rienso je bilo pri zviševanju ravni hemoglobina učinkovitejše od peroralnih zdravil.
Three main studies involving 838 chronic kidney disease patients with iron deficiency anaemia have been carried out to compare Rienso with an iron treatment taken by mouth. 
Za primerjavo zdravila Rienso z drugo vrsto peroralnega zdravljenja so bile opravljene tri glavne študije, v katerih je sodelovalo 838 bolnikov s kroničnim ledvičnim obolenjem z anemijo zaradi pomanjkanja železa.
What is Rienso used for? 
Za kaj se zdravilo Rienso uporablja?
What is Rienso? 
Kaj je zdravilo Rienso?
How has Rienso been studied? 
Kako je bilo zdravilo Rienso raziskano?
How does Rienso work? 
Kako zdravilo Rienso deluje?
When injected into the blood, it is taken up by cells in the liver, spleen and the bone marrow, at which point the iron is released from the compound and replaces the body's depleted iron stores. 
Ko se ferumoksitol injicira v kri, se veže na celice v jetrih, vranici in kostnem mozgu.
How is Rienso used? 
Kako se zdravilo Rienso uporablja?
The final opinion was converted into a Decision by the European Commission on 26 March 2010. 
Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 26. marca 2010.
The Rapporteur and Co-Rapporteur appointed were: Dr A. Holm and Dr B. Kolar, respectively. 
Poročevalec in soporočevalec sta bila: dr. A. Holm oziroma dr. B. Kolar.
The Decentralised Procedure FR/V/195/01/DC started on 29 February 2008. 
Decentralizirani postopek FR/V/195/01/DC se je začel 29. februarja 2008.
The application was submitted in the framework of Article 32 of Directive 2001/82/EC, where the Reference Member State was France and the Concerned Member States were Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Spain and United Kingdom. 
Vloga je bila predložena v skladu s členom 32 Direktive 2001/82/ES, kakor je bila spremenjena, pri čemer je bila Francija referenčna država članica, Avstrija, Belgija, Bolgarija, Ciper, Češka republika, Danska, Estonija, Nemčija, Grčija, Madžarska, Irska, Italija, Latvija, Litva, Luksemburg, Malta, Nizozemska, Poljska, Portugalska, Romunija, Slovaška, Španija in Združeno kraljestvo pa zadevne države članice.
Oral explanations were given on 8 December 2009. 
Ustna pojasnila so bila podana 8. decembra 2009.
The referral procedure started on 12 May 2009. 
Napotitveni postopek se je začel 12. maja 2009.
Written explanations were provided by the Applicant on 18 August 2009. 
Pisna pojasnila je predlagatelj predložil 18. avgusta 2009.
Toltrazuril is a triazinon derivative administered orally to piglets for the prevention of clinical signs of coccidiosis in neonatal piglets on farms with a confirmed history of coccidiosis caused by Isospora suis. 
Toltrazuril je derivat triazinona, ki se daje peroralno pujskom, za preprečevanje kliničnih znakov poporodne kokcidioze pri pujskih na kmetijah, na katerih je bila v preteklosti že potrjena kokcidioza, ki jo povzroča Isospora suis.
On 6 May 2009 France, referred the matter to the Agency under Article 33(4) of Directive 2001/82/EC, due to concerns, raised by Germany, Spain, Portugal, Poland and the United Kingdom, that the marketing authorisation of CEVAZURIL 50 mg/ml oral suspension for piglets may present a potential serious risk to the environment. 
Francija je 6. maja 2009 v skladu s členom 33(4) Direktive 2001/82/ES zadevo napotila na agencijo EMA zaradi zadržkov, ki so jih izpostavile Nemčija, Španija, Portugalska, Poljska in Združeno kraljestvo, in sicer, da utegne dovoljenje za promet z zdravilom CEVAZURIL 50 mg/ml peroralna suspenzija za pujske predstavljati možno resno tveganje za okolje.