natgillin/translations-raw huggingface dataset:
Do not try to put the cap back on the syringe. 
Ne poskušajte pokrovčka nameščati nazaj na brizgo.
For single use only Read the package leaflet before use. 
Pred uporabo preberite priloženo navodilo!
Do not use this medicine if the solution in the pen is cloudy, discoloured or contains particles, or if any part of the pre-filled pen looks damaged. 
Ne uporabite tega zdravila, če je raztopina v peresniku motna, spremenjene barve ali vsebuje delce, ali če je kateri koli del napolnjenega injekcijskega peresnika videti poškodovan.
Method of Administration Subcutaneous use. 
Način uporabe subkutana uporaba
Ask your healthcare professional to show you the right way to use the pen before your first injection. 
Preden si prvič injicirate zdravilo, zdravnika prosite, naj vam pokaže, kako pravilno uporabljati peresnik.
Let the syringe warm up to room temperature for at least 30 minutes before using. 
Brizgo pred uporabo vsaj 30 minut pustite, da se ogreje na sobno temperaturo.
In the Kevzara monotherapy population, observations were consistent with the Kevzara + DMARDs population. 
Opažanja v populaciji, ki je prejemala monoterapijo z zdravilom Kevzara, so se skladala s tistimi v populaciji, ki je prejemala zdravilo Kevzara + DMARD.
Sucrose 
Okence
The single-use pre-filled syringe has a styrene-butadiene elastomer needle cap and is equipped with a white polystyrene plunger rod and a dark-orange polypropylene finger flange. 
Napolnjena injekcijska brizga 200 mg: Napolnjena injekcijska brizga za enkratno uporabo ima pokrovček igle iz stiren-butadienskega elastomera in je opremljena z belim polistirenskim čepom bata ter temnooranžno polipropilensko polipropilenskim držalom za prste.
kevzara 200 mg syringe 
kevzara 200 mg brizga
Decreases in neutrophil counts below 0.5 x 109/L occurred in 0.8% and 0.6% of patients in the 200 mg and 150 mg Kevzara+ DMARDs groups, respectively. 
Zmanjšanje števila nevtrofilcev pod 0,5 x 109/l se je pojavilo pri 0,8 % prejemnikov 200 mg zdravila Kevzara + DMARD in pri 0,6 % prejemnikov 150 mg zdravila Kevzara + DMARD.
What Kevzara is used for 
Za kaj uporabljamo zdravilo Kevzara
Tell your doctor, pharmacist, or nurse if you notice any of the following side effects: Very Common (may affect more than 1 in 10 people): 
Resen neželen učinek Zdravnika takoj obvestite, če menite, da imate okužbo (pojavi se lahko pri največ 1 od 10 oseb).
Treatment with Kevzara 200 mg and 150 mg + MTX inhibited the progression of structural damage by 91% and 68%, respectively, compared to placebo + MTX at Week 52. 
Po 52 tednih je zdravljenje z 200 mg oz. 150 mg zdravila Kevzara skupaj z metotreksatom je v primerjavi s placebom skupaj z metotreksatom zavrlo napredovanje strukturne okvare za 91 % (200 mg) oz. 68 % (150 mg).
Patients treated with Kevzara + MTX (47.6% in the 200 mg treatment group and 47.0% in the 150 mg treatment group) achieved a clinically relevant improvement in HAQ-DI (change from baseline of 
Prejemniki zdravila Kevzara + metotreksata (47,6 % v skupini z 200 mg in 47,0 % v skupini s
Active Comparator-controlled Study 
Študija, kontrolirana z zdravilno učinkovino
In the Kevzara + DMARDs long-term safety population and the Kevzara monotherapy population, the observations on neutrophil counts were consistent with those seen in the placebo-controlled population (see section 4.4). 
Kevzara + DMARD in v populaciji, ki je prejemala monoterapijo z zdravilom Kevzara, skladala s tistimi v populaciji, kontrolirani s placebom (glejte poglavje 4.4).
Do not freeze or heat the syringe. 
Brizge ne zamrzujte in ne segrevajte.
Positive responses in the neutralizing antibody (NAb) assay were detected in 1.0%, 1.6%, and 0.2% of patients on Kevzara 200 mg, Kevzara 150 mg, and placebo respectively. 
Izvid preskusa za nevtralizacijska protitelesa (NAb) je bil pozitiven pri 1,0 % prejemnikov 200 mg zdravila Kevzara, 1,6 % prejemnikov 150 mg zdravila Kevzara in 0,2 % prejemnikov placeba.
Upper respiratory tract infection Urinary tract infection Nasopharyngitis Oral herpes 
Nazofaringitis Oralni herpes
Week 12 
Teden študije
In MOBILITY and TARGET, patients receiving Kevzara 200 mg + DMARDs every two weeks or Kevzara 150 mg + DMARDs every two weeks demonstrated greater improvement from baseline compared to placebo + DMARDs in physical component summary (PCS) and no worsening on the mental component summary (MCS) at Week 24. 
Kevzara + DMARD na dva tedna po 24 tednih v primerjavi z izhodiščem izboljšal bolj kot prejemnikom placeba + DMARD, povzetek mentalne komponente (MCS - mental component summary) pa se ni poslabšal.
Do not re-use the syringe. 
Peresnika nikoli ne uporabite ponovno.
Prior to initiating Kevzara, it is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines. 
Podatkov o sekundarnem prenosu okužbe z oseb, ki so prejele živa cepiva, na bolnike, zdravljene z zdravilom Kevzara, ni. Priporočljivo je, da pred zdravljenjem z zdravilom Kevzara vsi bolniki opravijo vsa cepljenja v skladu s trenutnimi smernicami za cepljenja.
KEVZARA 150 mg injection sarilumab 
KEVZARA 150 mg injekcija sarilumab s.c.
KEVZARA 200 mg q2w* + cDMARDs (N = 184) 
KEVZARA 200 mg na 2t* + kDMARD (N = 184)
The rates of serious infections were 4.3, 3.0, and 3.1 events per 100 patient-years, in the 200 mg, 150 mg Kevzara + DMARDs, and placebo + DMARDs groups, respectively. 
Deleži resnih okužb na 100 bolnik-let so bili 4,3 z 200 mg zdravila Kevzara + DMARD, 3,0 s 150 mg zdravila Kevzara + DMARD in 3,1 s placebom + DMARD.
In the Kevzara + DMARDs long-term safety population and the Kevzara monotherapy population, the rates of malignancies were consistent with the rate observed in the placebo-controlled population (see section 4.4). 
Deleži malignih bolezni so se v dolgoročni varnostni populaciji z zdravilom Kevzara + DMARD in v populaciji, ki je prejemala monoterapijo z zdravilom Kevzara, skladali z deležem v populaciji, kontrolirani s placebom (glejte poglavje 4.4).
Sarilumab had no effect on maintenance of pregnancy or on the neonates evaluated up to 1 month after birth in body weight measurements, in parameters of functional or morphological development including skeletal evaluations, in immunophenotyping of peripheral blood lymphocytes, and in microscopic evaluations. 
vključno z ocenami okostja, imunofenotipizacijo limfocitov v periferni krvi in z mikroskopskimi ocenami.
KEVZARA 150 mg q2w* + cDMARDs (N = 181) 
KEVZARA 150 mg na 2t* + kDMARD (N = 181)
How Kevzara works 
Kako deluje zdravilo Kevzara
There were no reports of gastrointestinal perforation in the Kevzara monotherapy population. 
V populaciji, ki je prejemala monoterapijo z zdravilom Kevzara, niso poročali o perforacijah prebavil.
Do not put the cap back on. Do not throw the used pens in household waste. 
Ne zavrzite uporabljenih peresnikov med gospodinjske odpadke.
• Once taken out the refrigerator, do not store Kevzara above 25 ºC. 
• Ko zdravilo Kevzara vzamete iz hladilnika, ga shranjujte na temperaturi do 25°C.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON with the Blue Box - MULTIPACK OF 6 (3 PACKS OF 2) PRE-FILLED SYRINGES 
ZUNANJA ŠKATLA s podatki za modro okence - SKUPNO PAKIRANJE S 6 (3 PAKIRANJA PO 2) NAPOLNJENIMI INJEKCIJSKIMI BRIZGAMI
Kevzara 200 mg q2w (N=184) 
Kevzara 200 mg na 2t (N = 184)
The parts of the Kevzara pre-filled syringe are shown in this picture. 
Ta slika prikazuje dele napolnjene injekcijske brizge zdravila Kevzara.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED PEN 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Injection sites (abdomen, thigh and upper arm) should be rotated with each injection. 
Mesto injiciranja je treba pri vsakem injiciranju krožno menjati (trebuh,
solution for injection 1 pre-filled syringe 
raztopina za injiciranje 1 napolnjena injekcijska brizga
• Do not freeze or heat the syringe. 
• Brizge ne zamrzujte in ne segrevajte.
Learning how to use the pre-filled pen 
Učenje uporabe napolnjenega injekcijskega peresnika
• Initiating treatment with Kevzara is not recommended in patients with a platelet count below 150 x103/µL. 
• Uvedba zdravljenja z zdravilom Kevzara ni priporočljiva pri bolnikih z majhnim številom trombocitov, tj. številom trombocitov pod 150 x 103/µl.
Let the pen warm up to room temperature for at least 60 minutes before using. 
Peresnik pred uporabo vsaj 60 minut pustite, da se ogreje na sobno temperaturo.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PACK OF 1 PRE-FILLED SYRINGE 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - PAKIRANJE Z 1 NAPOLNJENO INJEKCIJSKO BRIZGO
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON without Blue Box - 2 PRE-FILLED SYRINGES (MULTIPACK PRESENTATION) 
NOTRANJA ŠKATLA brez podatkov za modro okence - 2 NAPOLNJENA INJEKCIJSKA PERESNIKA (SKUPNO PAKIRANJE)
Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see section 5.1). 
Zdravilo Kevzara je mogoče uporabljati kot samostojno zdravljenje (v monoterapiji), če bolnik ne prenaša metotreksata ali zdravljenje z metotreksatom zanj ni primerno
≥0.3 units) at Week 52 compared to 26.1% in the placebo + MTX treatment group. 
150 mg) so po 52 tednih dosegli klinično pomembno izboljšanje HAQ-DI (spremembo ≥ 0,3 enote v primerjavi z izhodiščem); v skupini s placebom + metotreksatom je bil ta delež 26,1 %.
Decreases in neutrophil counts below 1 x 109/L occurred in 6.4% and 3.6% of patients in the 200 mg and 150 mg Kevzara + DMARDs group, respectively, compared to no patients in the placebo + DMARDs group. 
Število nevtrofilcev se je zmanjšalo pod 1 x 109/l pri 6,4 % prejemnikov 200 mg zdravila Kevzara + DMARD, pri 3,6 % prejemnikov 150 mg zdravila Kevzara + DMARD in pri nobenem prejemniku placeba + DMARD.
Always keep the container out of the sight and reach of children. 
Vsebnik vedno shranjujte nedosegljiv otrokom!
KEVZARA 200 mg injection sarilumab 
KEVZARA 200 mg injekcija sarilumab subkutana uporaba
Put your used syringe and the cap into a puncture-resistant container right away after use. 
Uporabljeno brizgo in pokrovček takoj po uporabi odvrzite v vsebnik za ostre odpadke.
• slowing down damage to joints 
• upočasni okvaro sklepov,
Decreases in platelet counts below 100 x 103/µL occurred in 1.2% and 0.6% of patients on 200 mg and 150 mg Kevzara + DMARDs, respectively, compared to no patients on placebo + DMARDs. 
Število trombocitov se je zmanjšalo pod 100 x 103/µl pri 1,2 % prejemnikov 200 mg zdravila Kevzara + DMARD, pri 0,6 % prejemnikov 150 mg zdravila Kevzara + DMARD in pri nobenem prejemniku placeba + DMARD.
Kevzara is available as 150 mg or 200 mg pre-filled syringes. 
Zdravilo Kevzara je na voljo v napolnjenih injekcijskih brizgah s 150 mg ali 200 mg.
• Multipack containing 6 (3 packs of 2) pre-filled pens 
• Skupno pakiranje s 6 (3 pakiranja po 2) napolnjenimi injekcijskimi peresniki
Placebo + cDMA RDs* N = 181 
Placebo + DMARD (N=181)
• 1 pre-filled syringe 
• 1 napolnjena injekcijska brizga
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PACK OF 2 PRE-FILLED SYRINGES 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - PAKIRANJE Z 2 NAPOLNJENIMA INJEKCIJSKIMA BRIZGAMA
Infections and Infestations 
Infekcijske in parazitske bolezni Pogosti
In the placebo-controlled population, 0.2% of the patients treated with Kevzara 200 mg q2w + DMARD reported serious adverse events of hypersensitivity reactions, and none from Kevzara 150 mg q2w + DMARD group. 
0,2 % bolnikov, zdravljenih z zdravilom Kevzara na 2 tedna + DMARD, in nobeden od bolnikov, zdravljenih z zdravilom Kevzara 150 mg na 2 tedna + DMARD.
MOBILITY MTX Inadequate Responders 
MOBILITY Bolniki, ki se niso ustrezno odzvali na metotreksat
Laboratory parameters Neutrophil count Treatment with Kevzara was associated with a higher incidence of decrease in ANC. 
Zdravljenje z zdravilom Kevzara je bilo povezano z večjo pojavnostjo zmanjšanja AŠN.
NA§ 
NP§
DAS28-CRP remission (< 2.6) ACR20‡ ACR50 
24. teden Remisija DAS28CRP (< 2,6) ACR20‡
KEVZARA 150 mg q2w* + MTX (N = 400) 
KEVZARA 150 mg na 2t* + MTX (N = 400)
KEVZARA 200 mg q2w* + MTX (N = 399) 
KEVZARA 200 mg na 2t* + MTX (N = 399)
Solution for injection 2 pre-filled syringes. 
raztopina za injiciranje 2 napolnjeni injekcijski brizgi.
Use the syringe within 14 days after taking it out of the refrigerator or insulated bag. 
Brizgo uporabite v 14 dneh potem, ko ste jo vzeli iz hladilnika ali izolacijske vrečke.
Put your used pen and the cap into a puncture-resistant container right away after use. 
Uporabljen peresnik in pokrovček takoj po uporabi dajte v vsebnik za ostre odpadke.
Do not remove the needle cap until just before you are ready to inject. 
Ne odstranite pokrovčka igle, dokler niste že povsem pripravljeni za injiciranje.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PACK OF 1 PRE-FILLED PEN 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - PAKIRANJE Z 1 NAPOLNJENIM INJEKCIJSKIM PERESNIKOM
EU/1/17/1196/004 6 pre-filled syringes (3 packs of 2) 
EU/1/17/1196/004 6 napolnjenih injekcijkih brizg (3 pakiranja po 2)
• Use the syringe within 14 days after taking it out of the refrigerator or the insulated bag. 
• Brizgo uporabite v 14 dneh potem, ko ste jo vzeli iz hladilnika ali izolacijske vrečke.
kevzara 150 mg pen 
kevzara 150 mg peresnik
Both doses of Kevzara + MTX were superior to placebo + MTX in the change from baseline in mTSS at 24 and 52 weeks (see Table 5). 
Kar zadeva spremembo mTSS po 24 in 52 tednih v primerjavi z izhodiščem, sta bila oba odmerka zdravila Kevzara skupaj z metotreksatom superiorna placebu skupaj z metotreksatom (glejte preglednico 5).
In the Kevzara +DMARDs long-term safety population, the rates of infections and serious infection were 57.3 and 3.4 events per 100-patient years, respectively. 
100 bolnik-let 57,3 in resnih okužb 3,4.
In the placebo-controlled population, 4.0%, 5.6%, and 2.0% of patients treated with Kevzara 200 mg + DMARDs, Kevzara 150 mg + DMARDs and placebo + DMARDs respectively, exhibited a positive response in the anti-drug antibody (ADA) assay. 
V populaciji, kontrolirani s placebom, je bil izvid preskusa za protitelesa proti zdravilu pozitiven pri: 4,0 % prejemnikov 200 mg zdravila Kevzara + DMARD ter 5,6 % prejemnikov 150 mg zdravila Kevzara + DMARD in 2,0 % prejemnikov placeba + DMARD.
Do not try to put the cap back on a pen. 
Ne poskušajte pokrovčka nameščati nazaj na peresnik.
Reduction of dose from 200 mg once every 2 weeks to 150 mg once every 2 weeks is recommended for management of neutropenia, thrombocytopenia, and liver enzyme elevations. 
Za obvladovanje nevtropenije, trombocitopenije in zvišanj jetrnih encimov je priporočljivo zmanjšanje odmerka z 200 mg enkrat na 2 tedna na 150 mg enkrat na 2 tedna.
Do not remove the cap until you are ready to inject. 
Ne odstranite pokrovčka, dokler niste že povsem pripravljeni za injiciranje.
Kevzara 200 mg q2w* + MTX (N = 399) 
KEVZARA 200 mg + MTX (N=399)
If it has been 3 days or less since the missed dose: 
Če ste izpustili odmerek zdravila Kevzara Če so od izpuščenega odmerka minili 3 dnevi ali manj:
After use, put the syringe into a puncture-resistant container. 
Po uporabi dajte brizgo v vsebnik za ostre odpadke (tj. proti prebadanju odporen vsebnik).
EU/1/17/1196/002 6 pre-filled syringes (3 packs of 2) 
EU/1/17/1196/002 6 napolnjenih injekcijkih brizg (3 pakiranja po 2)
solution for injection 2 pre-filled syringes 
raztopina za injiciranje 2 napolnjena injekcijska peresnika
Each pre-filled syringe contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml). 
En napolnjeni injekcijski peresnik vsebuje 200 mg sarilumaba v 1,14 ml raztopine (175 mg/ml).
Placebo + MTX (N = 
Placebo + kDMA
If you use more Kevzara than you should 
Če ste uporabili večji odmerek zdravila Kevzara, kot bi smeli Če ste uporabili večji odmerek zdravila Kevzara, kot bi smeli, se posvetujte z zdravnikom,
In the Kevzara + DMARDs long-term safety population and the Kevzara monotherapy population, the observations on platelet counts were consistent with those seen in the placebo-controlled population. 
DMARD in v populaciji, ki je prejemala monoterapijo z zdravilom Kevzara, skladala s tistimi v populaciji, kontrolirani s placebom.
Each pre-filled syringe contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml). 
En napolnjeni injekcijski peresnik vsebuje 150 mg sarilumaba v 1,14 ml raztopine (131,6 mg/ml).
There were no bleeding events associated with decreases in platelet count. 
Zmanjšanje števila trombocitov ni bilo povezano s krvavitvami.
• a group of medicines called “Janus kinase (JAK) inhibitors” (used for diseases like rheumatoid arthritis and cancer) 
(uporabljajo se za bolezni, kot sta revmatoidni artritis in rak),
Treatment with Kevzara should be withheld if a patient develops a serious infection or an opportunistic infection. 
Zdravljenje z zdravilom Kevzara ni priporočljivo za bolnike z aktivno boleznijo jeter ali okvaro jeter
Do not re-use the pen. 
Ne nameščajte pokrovčka nazaj na peresnik.
Metabolism and Nutrition Disorders 
Presnovne in prehranske motnje Pogosti
Kevzara 150 mg solution for injection in a pre-filled syringe sarilumab 
Kevzara 150 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku sarilumab
KEVZARA 150 mg solution for injection in pre-filled syringe sarilumab 
KEVZARA 150 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku sarilumab
Kevzara 200 mg solution for injection in a pre-filled syringe sarilumab 
KEVZARA 200 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku sarilumab
EU/1/17/1196/008 6 pre-filled pens (3 packs of 2) 
EU/1/17/1196/008 6 napolnjenih injekcijskih peresnikov (3 pakiranja po 2)
Tender Joints Swollen Joints Pain VAS† 
Rumeni pokrovček igle
Water for injections 
Okužba zgornjih dihal
The syringe components are pre-assembled into a single-use pre-filled pen with a yellow needle cover and dark-orange cap. 
Napolnjen injekcijski peresnik 200 mg: Sestavni deli brizge so predsestavljeni v napolnjen injekcijski peresnik za enkratno uporabo z rumenim pokrovčkom igle in temnooranžnim pokrovčkom.
Each single-dose pre-filled syringe contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml). 
Ena napolnjen injekcijski peresnik z enim odmerkom vsebuje 200 mg sarilumaba v 1,14 ml raztopine (175 mg/ml).
Arginine 
Igla
14 July 2014 
14. julij 2014
The opinion was converted into a Decision by the European Commission on 14 July 2014. 
Mnenje je bilo spremenjeno v sklep Evropske komisije dne 14. julija 2014.
International non-proprietary name (INN): fipronil 
Mednarodno nelastniško ime (INN): fipronil
notified the Agency of their intention to request a re-examination of the CVMP opinion of 11 December 2013. 
agencijo EMA obvestila, da namerava zaprositi za ponovni pregled mnenja odbora CVMP z dne 11. decembra 2013.
The Committee appointed D. Murphy as rapporteur and J. Bureš as co-rapporteur. 
Odbor je za poročevalca imenoval D. Murphyja, za soporočevalca pa J. Bureša.
The re-examination procedure started on 11 February 2014. 
Postopek ponovnega pregleda se je začel 11. februarja 2014.
were involved ( Austria, Belgium, Denmark, Greece, Ireland, Italy, the Netherlands, Spain, the Slovak Republic and the United Kingdom). 
Referenčna država članica za postopek z medsebojnim priznavanjem je bila Češka republika, vključenih pa je bilo deset zadevnih držav članic (Avstrija, Belgija, Danska, Grčija, Irska, Italija, Nizozemska, Španija, Slovaška in Združeno kraljestvo).
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the condition to lift the suspension of the marketing authorisations in Annex III. 
Seznam zadevnih imen zdravila je v Prilogi I. Znanstveni zaključki so podani v Prilogi II, skupaj s pogojem za preklic začasnega umika dovoljenj za promet z zdravili v Prilogi III.
The referral procedure started on 15 May 2013. 
Napotitveni postopek se je začel 15. maja 2013.
The mutual recognition procedures, CZ/V/0116/001/MR concerning the presentation for cats and CZ/V/0116/002-005/MR concerning the four presentations for dogs, started on 25 October 2012. 
Postopka z medsebojnim priznavanjem, tj. CZ/V/0116/001/MR za različico za mačke in CZ/V/0116/002-005/MR za štiri različice za pse, sta se začela 25. oktobra 2012.
On 20 December 2013, Vet-Agro Trading Sp. z o.o. 
Dne 20. decembra 2013 je družba Vet-Agro Trading Sp. z o.o.
The presentations for dogs have been nationally authorised in the Czech Republic since December 2011, and the presentation for cats has also been nationally authorised in the Czech Republic since May 2012. 
V Češki republiki so različice za pse nacionalno odobrene od decembra 2011, različice za mačke pa od maja 2012.
Potential serious risks to animal health were identified during the mutual recognition procedure by Ireland regarding the efficacy and target animal safety of the products. 
Med postopkom z medsebojnim priznavanjem je Irska ugotovila morebitna resna tveganja za zdravje živali v zvezi z učinkovitostjo in varnostjo zdravila pri ciljnih živalskih vrstah.
Fiprex is available in five different presentations, one for cats and four for different sizes of dogs. 
Na voljo je pet različic zdravila, od tega ena za mačke ter štiri za pse različnih velikosti.
On 29 April 2013, the reference Member State, the Czech Republic, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC. 
Referenčna država članica, Češka republika, je 29. aprila 2013 obvestila Evropsko agencijo za zdravila, da skupina CMD(v) ni dosegla soglasja in zadevo napotila na CVMP skladno s členom 33(4) Direktive 2001/82/ES.
During its meeting of 14-16 January 2014 the CVMP appointed R. Breathnach as rapporteur and B. Zemann as the co-rapporteur for the re-examination procedure. 
Na zasedanju odbora CVMP, ki je potekalo od 14. do 16. januarja 2014, so za poročevalca v postopku ponovnega pregleda mnenja imenovali R. Breathnacha, za soporočevalca pa B. Zemanna.
Based on the evaluation of the available data, the CVMP concluded that Fiprex does not pose a risk in terms of target animal safety. 
Odbor CVMP je na podlagi ocene razpoložljivih podatkov zaključil, da zdravilo Fiprex ne pomeni tveganja z vidika varnosti za ciljne živalske vrste.
Day 60 of the CMDv referral procedure was on 18 April 2013. 
60. dan napotitvenega postopka na skupino CMD(v) je bil 18. april 2013.
The legal basis of the marketing authorisations granted by the Czech Republic was Article 13a of Directive 2001/82/EC i.e. citing well-established use. 
Pravna podlaga za dovoljenja za promet z zdravili, odobrena v Češki republiki, je bil člen 13a Direktive 2001/82/ES, kar pomeni, da so se sklicevali na dobro uveljavljeno uporabo.
Regarding efficacy, the CVMP concluded that the data provided for Fiprex could not adequately justify the proposed duration of efficacy and consequently it is not possible to establish a positive benefit-risk balance for the product. 
Kar zadeva učinkovitost, je odbor CVMP zaključil, da s podatki, ki so bili predloženi za zdravilo Fiprex, ni mogoče zadovoljivo utemeljiti predlaganega trajanja učinkovitosti in dokazati, da je razmerje med tveganji in koristmi pozitivno.
The CVMP therefore adopted by majority a negative opinion recommending the refusal of the granting of the marketing authorisations and the suspension of the existing marketing authorisations for the aforementioned veterinary medicinal products. 
Odbor CVMP je zato z večino sprejel negativno mnenje ter priporočil zavrnitev vlog za pridobitev dovoljenja za promet z zdravilom in začasni umik obstoječih dovoljenj za promet z zdravilom za zgoraj navedena zdravila za uporabo v veterinarski medicini.
Written explanations were provided by the marketing authorisation holder on 10 September 2013 and 21 October 2013. 
Imetnik dovoljenja za promet z zdravilom je 10. septembra 2013 in 21. oktobra 2013 predložil pisna pojasnila ter 10. decembra 2013 še ustna pojasnila.