natgillin/translations-raw huggingface dataset:
Anaphylactic-type adverse events have been reported most frequently in three of the 16 Member States where the product is authorised, Belgium, France and Italy. 
O anafilaktičnih neželenih dogodkih so najpogosteje poročali v treh od 16 držav članic, v katerih je bilo zdravilo odobreno, in sicer v Belgiji, Franciji in Italiji.
Following the initial placing on the market in France in 2009, the frequency of adverse events reported in relation to the amount of product sold was estimated to be approximately one affected animal for 860 animals treated (nine adverse event reports involving 69 affected animals, 18 of which died). 
Po začetku trženja v Franciji leta 2009 so ocenili, da se glede na količino prodanega zdravila neželeni dogodki, o katerih so poročali, pojavljajo pri približno eni prizadeti živali na 860 zdravljenih živali (devet poročil o neželenih dogodkih pri 69 prizadetih živalih, 18 od teh je poginilo).
A second study, also investigating the potential role of bovine respiratory syncytial virus vaccines as a predisposing factor, was ongoing and results are expected by the end of July 2011. 
Druga študija, v kateri prav tako preučujejo morebiten vpliv cepiv proti govejemu respiratornemu sincicijskemu virusu kot predispozicijskih dejavnikov, še poteka, rezultati pa naj bi bili na voljo do konca julija 2011.
The potential risk of such events following use of the product was considered to be not acceptable in comparison to the benefits provided. 
Možno tveganje za pojav takih dogodkov po uporabi zdravila je štelo za nesprejemljivo v primerjavi s koristmi tega zdravila.
The Committee considered the possible role of additional contributory factors in relation to the adverse events reported, such as quality (batch)related effects, animal related effects (e.g. breed, age sensitivity); interactions; and/or geographical factors. 
Odbor je upošteval morebitno vlogo drugih dejavnikov, ki bi lahko vplivali na pojav neželenih dogodkov, o katerih so poročali, na primer vplivi kakovosti (serije); učinki, povezani z živalmi (npr. pasma, starostna občutljivost); interakcije in/ali zemljepisni dejavniki.
The frequency of anaphylactic-type events reported following use of the product increased markedly since October 2010 in Belgium, France and Italy compared with other concerned Member States. 
Pogostnost anafilaktičnih dogodkov, o katerih so poročali po uporabi zdravila, se je od oktobra 2010 v primerjavi z drugimi zadevnimi državami članicami bistveno povečala v Belgiji, Franciji in Italiji.
Adverse events concerning anaphylactic-type reactions, some of which were fatal, have been reported in four EU Member States. 
O neželenih dogodkih v zvezi z anafilaktičnimi reakcijami, med katerimi so bili tudi primeri s smrtnim izidom, so poročali v štirih državah članicah EU.
In France, the incidence of anaphylactictype events reported was estimated to be 0.177% or 1 affected animal for 560 treated animals. 
V Franciji je bila pojavnost anafilaktičnih dogodkov, o katerih so poročali, ocenjena na 0,177 % ali 1 prizadeto žival na 560 zdravljenih živali.
Since October 2010, the number of reports resembling anaphylactic events, some of which were fatal, has increased, (from 12 to 24), most notably in four of the 16 European Union (EU) Member States where the product is authorised. 
Od oktobra 2010 se je povečalo število poročil (z 12 na 24) o anafilaktičnih dogodkih, med katerimi so bili tudi primeri s smrtnim izidom, predvsem v štirih od 16 držav članic Evropske unije (EU), v katerih je zdravilo odobreno.
The Committee for Medicinal Products for Veterinary Use (CVMP) considered that the pharmacovigilance data (adverse event reports) indicated that the frequency of reported events of anaphylactic-type reactions varied across the EU. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je menil, da farmakovigilančni podatki (poročila o neželenih dogodkih) kažejo, da se pogostost dogodkov z anafilaktičnimi reakcijami, o katerih so poročali v EU, razlikuje.
The marketing authorisation holder voluntarily stopped the sales of the product in March 2011, initially in France and subsequently in all other concerned EU Member States. 
Imetnik dovoljenja za promet z zdravilom je marca 2011 prostovoljno zaustavil prodajo zdravila, najprej v Franciji in nato še v vseh drugih zadevnih državah članicah EU.
The underlying mechanism for the events observed and potential contributory factors are unknown at present and subject to ongoing research. 
Trenutno so osnovni mehanizem opaženih dogodkov in možni dejavniki, ki bi lahko nanje vplivali, neznani in se preučujejo v potekajočih raziskavah.
Belgium LABORATORIOS HIPRA, S.A. Avda. 
Madžarska LABORATORIOS HIPRA, S.A. Avda.
Whilst the animal health and welfare and economic and benefits of vaccination against bovine respiratory disease are acknowledged, HIPRABOVIS PNEUMOS Emulsion for injection for cattle is not an essential vaccine for cattle. 
Medtem ko so zdravje in dobrobit živali ter ekonomske in druge koristi cepiv proti goveji respiratorni bolezni dobro znani, pa zdravilo HIPRABOVIS PNEUMOS Emulzija za injiciranje za govedo ni osnovno cepivo za govedo.
Benefit-risk evaluation 
Ocena razmerja med koristmi in tveganji
It was noted that since March 2011 the marketing authorisation holder voluntarily stopped sales of the product in all concerned EU Member States where the product is authorised. 
Poudarjeno je bilo, da je imetnik dovoljenja za promet z zdravilom marca 2011 prostovoljno ustavil prodajo zdravila v vseh zadevnih državah članicah EU, v katerih je bilo zdravilo odobreno.
The underlying mechanism and potential contributory factors associated with the events have yet to be elucidated. 
Osnovni mehanizem in dejavnike, ki bi lahko vplivali na te dogodke, je treba še pojasniti.
It was considered that the conditions under which the study was conducted and the limited number of animals enrolled were insufficient to draw definitive conclusions to explain the increase in anaphylactic-type events observed in the field or to recommend measures to reduce the risk of such events. 
Ugotovljeno je bilo, da pogoji, pod katerimi je bila študija izvedena, in omejeno število vključenih živali ne zadostujejo za dokončne sklepe, ki bi pojasnili povečano število opaženih anafilaktičnih dogodkov na terenu ali na podlagi katerih bi se lahko priporočili ukrepi za zmanjšanje tveganja za take dogodke.
Between 1 April 2010 and 28 February 2011, the overall incidence of adverse events in the EU was estimated to be approximately 0.048% (or ‘rare') and the incidence of fatalities was estimated as approximately 0.0087% (or ‘very rare'). 
Med 1. aprilom 2010 in 28. februarjem 2011 je bila skupna pojavnost neželenih dogodkov v EU ocenjena na okoli 0,048 % (ali „redki“), pojavnost smrtnosti pa na okoli 0,0087 % (ali „zelo redka“).
The potential relation between the adverse events reported and possible endotoxin effects associated with the product was considered. 
Preučili so tudi možno povezavo med neželenimi dogodki, o katerih so poročali, in možnimi endotoksičnimi učinki, povezanimi z zdravilom.
The marketing authorisation holder should investigate the qualitative nature of the adverse events observed; investigate the potential factors that may explain the regional differences observed concerning the adverse events; and propose appropriate measures to mitigate the risk of occurrence of such adverse events to demonstrate a favourable benefit-risk balance for the product when used according to the recommendations of the summary of product characteristics. 
Imetnik dovoljenja za promet z zdravilom mora preučiti kakovost opaženih neželenih dogodkov, preučiti možne dejavnike, ki bi lahko pojasnili opažene regionalne razlike pri pojavljanju teh neželenih dogodkov, predlagati ustrezne ukrepe za zmanjšanje tveganja za pojav takih neželenih dogodkov ter dokazati ugodno razmerje med koristmi in tveganji zdravila pri uporabi v skladu s priporočili, navedenimi v povzetku glavnih značilnosti zdravila.
Although it was not clear whether such events represented ‘true' anaphylactic reactions or resulted from similar clinical signs due to anaphylactoid or endotoxin-related events, the term ‘anaphylactic-type' is used hereafter to describe the adverse events reported. 
Čeprav ni bilo jasno, ali taki dogodki predstavljajo „dejansko“ anafilaktično reakcijo ali pa so posledica podobnih kliničnih znakov zaradi dogodkov, povezanih z anafilaktoidi ali endotoksini, se v nadaljevanju za opisovanje neželenih dogodkov, o katerih so poročali, uporablja izraz „anafilaktični“.
The marketing authorisations in Spain and Italy were suspended by the national competent authorities on 11 and 20 April 2011, respectively. 
Nacionalni pristojni organ v Španiji je dovoljenje za promet začasno umaknil 11. aprila 2011, v Italiji pa 20. aprila 2011.
A laboratory trial is currently ongoing, however further investigations will be required to determine the underlying cause(s) of the anaphylactic-type events reported. 
Trenutno poteka laboratorijsko preskušanje, vendar bodo potrebne nadaljnje raziskave za določitev osnovnih vzrokov za pojav anafilaktičnih dogodkov, o katerih so poročali.
Scientific conclusions and grounds for suspension of the marketing authorisation(s) 
Znanstveni zaključki in podlaga za začasni umik dovoljenj za promet z zdravilom
After evaluation of the adverse events, the French competent authority considered that the benefit-risk balance for the product was unfavourable and suspended the marketing authorisation in France as a precautionary measure until the cause of the adverse events could be identified and corrective measures implemented. 
Po oceni neželenih dogodkov je francoski pristojni organ sklenil, da je razmerje med koristmi in tveganji zdravila neugodno in kot previdnosti ukrep začasno umaknil dovoljenje za promet z zdravilom v Franciji, dokler se ne pojasni vzrok neželenih učinkov in sprejmejo ustrezni popravni ukrepi.
The data evaluated indicate an association between vaccination of cattle with HIPRABOVIS PNEUMOS Emulsion for injection for cattle and the occurrence of anaphylactic-type events, which has increased recently in some EU Member States. 
Ovrednoteni podatki kažejo na povezavo med cepljenjem goveda z zdravilom HIPRABOVIS PNEUMOS Emulzija za injiciranje za govedo in pojavnostjo anafilaktičnih dogodkov, ki se je nedavno v nekaterih državah članicah EU povečala.
The emphasis placed by the marketing authorisation holder on investigation of the role of bovine respiratory syncytial virus infection or vaccination was considered to be pursued to the exclusion of other possible risk factors which may contribute to the adverse events. 
Poudarek, ki ga je imetnik dovoljenja za promet z zdravilom namenil preučevanju vloge okužb z govejim respiratornim sincicijskim virusom ali cepiv, naj bi bil namenjen izključitvi drugih možnih dejavnikov tveganja, ki bi lahko vplivali na neželene dogodke.
Although it was considered that it may be useful to revise the SPC text in future to more accurately reflect the frequency and severity of adverse events reported, such a change was not considered to be an adequate measure to address the issue concerning anaphylactic-type events. 
Čeprav so menili, da bi bila v prihodnosti koristna sprememba besedila povzetka glavnih značilnosti zdravila, tako da bi natančneje odražalo pogostost in resnost neželenih dogodkov, o katerih so poročali, pa so za take spremembe menili, da niso zadosten ukrep za reševanje težav v zvezi z anafilaktičnimi dogodki.
There are valid alternative therapeutic and management tools available on the EU market to control the diseases caused by Mannheimia haemolytica and Histophilus somni. 
Na tržišču EU so na voljo odobrena nadomestna terapevtska sredstva in orodja za obvladovanje bolezni, ki jih povzročata Mannheimia haemolytica in Histophilus somni.
Between 1 April 2010 and 28 February 2011, the overall EU incidence for adverse events reported following use of the product was estimated to be 0.048% (or ‘rare') between 1 April 2010 and 28 February 2011 and the incidence of fatalities was 0.0087% (or ‘very rare'). 
Med 1. aprilom 2010 in 28. februarjem 2011 je bila skupna pojavnost neželenih dogodkov, o katerih so poročali po uporabi zdravila, ocenjena na 0,048 % (ali „redki“), pojavnost smrtnosti v tem obdobju pa je bila 0,0087 % (ali „zelo redka“).
The principal risks associated with the product relate to the potential for anaphylactic-type events in treated animals, some of which have been fatal. 
Glavno tveganje, povezano z uporabo zdravila, je pojav anafilaktičnih dogodkov pri zdravljenih živalih, med katerimi so tudi primeri s smrtnim izidom.
• the underlying cause of the adverse events observed has yet to be determined and consequently no specific measures could be recommended to ensure that the product is not associated with an unacceptable risk of anaphylactic-type events, some of which were fatal, under the authorised conditions of use; 
• Osnovni vzrok opaženih neželenih dogodkov še ni bil ugotovljen in zato pri odobrenih pogojih uporabe ni bilo mogoče priporočiti nobenih posebnih ukrepov, ki bi zagotovili, da zdravilo ni povezano s nesprejemljivim tveganjem za anafilaktične dogodke, med katerimi so tudi primeri s smrtnim izidom.
As the underlying cause(s) has not yet been determined, appropriate corrective measures to minimise the risk of such adverse events could not be identified. 
Ker osnovni vzroki še niso bili ugotovljeni, ni bilo mogoče določiti ustreznih popravnih ukrepov za zmanjšanje tveganja za pojav teh neželenih dogodkov.
These reports raised concern over a potential association with the use of HIPRABOVIS PNEUMOS Emulsion for injection for cattle. 
Ta poročila so sprožila zadržke glede možne povezave z uporabo zdravila HIPRABOVIS PNEUMOS Emulzija za injiciranje za govedo.
The vaccine is expected to benefit herd health and welfare by reducing the clinical signs and lung lesions caused by Mannheimia haemolytica serotype A1 and Histophilus somni in cattle. 
Cepivo naj bi koristilo zdravju in dobremu počutju črede z zmanjševanjem kliničnih znakov in pljučnih lezij, ki jih pri govedu povzročata Mannheimia haemolytica serotip A1 in Histophilus somni.
One clinical trial investigated the potential role of bovine respiratory syncytial virus vaccines as a potential predisposing factor to the adverse events after use of HIPRABOVIS PNEUMOS Emulsion for injection for cattle. 
V enem kliničnem preskušanju so preučevali morebiten vpliv cepiv proti govejemu respiratornemu sincicijskemu virusu kot potencialnih predispozicijskih dejavnikov za neželene dogodke po uporabi zdravila HIPRABOVIS PNEUMOS Emulzija za injiciranje za govedo.
HIPRABOVIS PNEUMOS Emulsion for injection for cattle is the only vaccine currently authorised in the EU with the combination of active components, Mannheimia haemolytica and Histophilus somni. 
Zdravilo HIPRABOVIS PNEUMOS Emulzija za injiciranje za govedo je trenutno edino odobreno cepivo v EU, ki vsebuje kombinacijo zdravilnih učinkovin Mannheimia haemolytica in Histophilus somni.
Following the evaluation of the data presented by the marketing authorisation holder, it was considered that there was insufficient information to identify the underlying mechanism for anaphylactic-type events following administration of HIPRABOVIS PNEUMOS Emulsion for injection for cattle, or potential factors that may contribute to such events. 
Po oceni podatkov, ki jih je predstavil imetnik dovoljenja za promet z zdravilom, je bilo ugotovljeno, da ni zadostnih informacij za določitev osnovnega mehanizma za anafilaktične dogodke po uporabi zdravila HIPRABOVIS PNEUMOS Emulzija za injiciranje za govedo ali drugih potencialnih dejavnikov, ki bi lahko vplivali na take dogodke.
Whilst acknowledging the inherent limitations of the pharmacovigilance data and the limited size of the clinical study conducted by the marketing authorisation holder, having evaluated the data available, the CVMP concluded that the above-mentioned findings provide evidence to suggest an association between the anaphylactic-type events observed and administration of HIPRABOVIS PNEUMOS Emulsion for injection for cattle. 
Ob upoštevanju omejitev farmakovigilančnih podatkov in omejene velikosti klinične študije, ki jo je izvedel imetnik dovoljenja za promet z zdravilom, je CVMP po oceni razpoložljivih podatkov sklenil, da navedene ugotovitve zagotavljajo dokaz, ki kaže na povezavo med opaženimi anafilaktičnimi dogodki in uporabo zdravila HIPRABOVIS PNEUMOS Emulzija za injiciranje za govedo.
• anaphylactic-type adverse events, some of which were fatal, reported after the use of HIPRABOVIS PNEUMOS Emulsion for injection for cattle indicates an association with the product; 
• Anafilaktični neželeni dogodki, med katerimi so bili tudi primeri s smrtnim izidom in o katerih so poročali po uporabi zdravila HIPRABOVIS PNEUMOS Emulzija za injiciranje za govedo, kažejo na povezavo z zdravilom.
HIPRABOVIS PNEUMOS Emulsion for injection for cattle is an inactivated vaccine for reduction of the clinical signs and lung lesions caused by Mannheimia haemolytica serotype A1 and Histophilus somni in calves from 2 months of age. 
Zdravilo HIPRABOVIS PNEUMOS Emulzija za injiciranje za govedo je inaktivirano cepivo za zmanjšanje kliničnih znakov in pljučnih lezij, ki jih povzročata Mannheimia haemolytica serotip A1 in Histophilus somni, pri teletih od starosti dveh mesecev.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF HIPRABOVIS PNEUMOS EMULSION FOR INJECTION FOR CATTLE AND ASSOCIATED NAMES 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA HIPRABOVIS PNEUMOS EMULZIJA ZA INJICIRANJE ZA GOVEDO IN POVEZANIH IMEN
It was recommended that further investigation of all potential contributory factors be explored further by the marketing authorisation holder. 
Priporočeno je bilo, da imetnik dovoljenja za promet z zdravilom podrobneje preuči tudi vse ostale dejavnike, ki bi lahko imeli vpliv.
Grounds for suspension of the marketing authorisations 
Podlaga za začasen umik dovoljenj za promet z zdravilom
The Committee considered the measures proposed by the marketing authorisation holder to mitigate the risk of anaphylactic-type events following use of the product. 
Odbor je preučil ukrepe, ki jih je predlagal imetnik dovoljenja za promet z zdravilom za zmanjšanje tveganja za pojav anafilaktičnih dogodkov po uporabi zdravila.
The Committee reviewed the ongoing and planned studies supported by the marketing authorisation holder to investigate the potential relation between HIPRABOVIS PNEUMOS Emulsion for injection for cattle and anaphylactic-type adverse events. 
Odbor je pregledal potekajoče in načrtovane študije, ki jih podpira imetnik dovoljenja za promet z zdravilom, ker želi s temi študijami raziskati možno povezavo med zdravilom HIPRABOVIS PNEUMOS Emulzija za injiciranje za govedo in anafilaktičnimi neželenimi dogodki.
• the CVMP concluded that the benefit-risk balance for HIPRABOVIS PNEUMOS Emulsion for injection for cattle is unfavourable under the authorised conditions of use; therefore, in accordance with Article 83 (1)(a) of Directive 2001/82/EC, the CVMP recommends the suspension of the marketing authorisations for the veterinary medicinal products referred to in Annex I of the CVMP Opinion. 
Zato CVMP v skladu s členom 83(1)(a) Direktive 2001/82/ES priporoča začasni umik dovoljenj za promet z veterinarskimi zdravili, navedenimi v Prilogi I mnenja CVMP.
In the absence of an identified underlying cause for the adverse events observed at the time, the changes proposed to the summary of product characteristics (SPC) and product literature were, on the whole, not considered sufficient to minimise the risk of anaphylactic-type events following administration of HIPRABOVIS PNEUMOS Emulsion for injection for cattle under authorised conditions of use. 
Ker takrat še ni bil ugotovljen osnovni vzrok za pojav opaženih neželenih dogodkov, je veljalo, da predlagane spremembe povzetka glavnih značilnosti zdravila in literature o zdravilu pri odobrenih pogojih uporabe ne zadostujejo v celoti za zmanjšanje tveganja za anafilaktične dogodke po uporabi zdravila HIPRABOVIS PNEUMOS Emulzija za injiciranje za govedo.
The CVMP concluded that the overall benefit-risk balance of the product is unfavourable under the authorised conditions of use. 
CVMP je sklenil, da pri odobrenih pogojih uporabe skupno razmerje med koristmi in tveganji tega zdravila ni ugodno.
Fortekor Plus is given twice daily approximately one hour before feeding. 
Zdravilo Fortekor Plus se daje dvakrat na dan, približno eno uro pred hranjenjem.
The European Commission granted a marketing authorisation valid throughout the European Union for Fortekor Plus on 8 September 2015. 
Evropska komisija je dovoljenje za promet z zdravilom Fortekor Plus, veljavno po vsej Evropski uniji, izdala 8. septembra 2015.
The full EPAR for Fortekor Plus can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila Fortekor Plus je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Fortekor Plus. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Fortekor Plus.
Other information about Fortekor Plus 
Druge informacije o zdravilu Fortekor Plus
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) decided that Fortekor Plus' benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Fortekor Plus večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Congestive heart failure is a condition where the heart cannot pump enough blood around the body. 
Kongestivno srčno popuščanje je stanje, pri katerem srce ne more črpati dovolj krvi po telesu.
The most common side effects with pimobendan (which may affect more than 1 in 10,000 dogs) are an increase in heart rate and vomiting. 
Najpogostejši neželeni učinki pimobendana (ki lahko prizadenejo več kot 1 psa od 10 000) so povišanje srčnega utripa in bruhanje.
The dose is adjusted according to bodyweight. 
Odmerek je treba prilagoditi v skladu s telesno maso.
This allows the blood pressure to drop, reducing the load on the heart. 
S tem se zniža krvni tlak in zmanjša obremenitev srca.
What are the risks associated with Fortekor Plus? 
Kakšna tveganja so povezana z zdravilom Fortekor Plus?
It is not intended to provide practical advice on how to use Fortekor Plus. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Why is Fortekor Plus approved? 
Zakaj je bilo zdravilo Fortekor Plus odobreno?
Fortekor Plus is available as tablets (pimobendan 1.25 mg/benazepril hydrochloride 2.5 mg and pimobendan 5 mg/benazepril hydrochloride 10 mg) and can only be obtained with a prescription. 
Zdravilo Fortekor Plus je na voljo v obliki tablet (pimobendan 1,25 mg/benazeprilijev klorid 2,5 mg in pimobendan 5 mg/benazeprilijev klorid 10 mg) in se izdaja le na recept.
It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. 
Pojasnjuje, kako je agencija ocenila to zdravilo za uporabo v veterinarski medicini, na podlagi česar je priporočila njegovo odobritev v Evropski uniji (EU) in pogoje njegove uporabe.
What is Fortekor Plus and what is it used for? 
Kaj je zdravilo Fortekor Plus in za kaj se uporablja?
Pregnant women should take special care to avoid accidentally swallowing Fortekor Plus because angiotensin converting enzyme (ACE) inhibitors have been found to affect the unborn child during pregnancy. 
Nosečnice morajo biti posebej previdne, da preprečijo nenamerno zaužitje zdravila Fortekor Plus, saj je bilo ugotovljeno, da zaviralci angiotenzinske konvertaze (ACE) vplivajo na nerojenega otroka med nosečnostjo.
What benefits of Fortekor Plus have been shown in studies? 
Kakšne koristi je zdravilo Fortekor Plus izkazalo v študijah?