natgillin/translations-raw huggingface dataset:
Of the 5 fatal cases related to allergic reaction, causality with fusafungine has been assessed both by MAH and the PRAC as “likely" in 3 cases and “unlikely” in 2 cases. 
Od 5 smrtnih primerov, povezanih z alergijsko reakcijo, sta vzročno povezanost s fuzafunginom kot „verjetno“ ocenila imetnik dovoljenja za promet z zdravili in tudi odbor PRAC v treh primerih, kot „malo verjetno“ pa v dveh primerih.
This was based on a recent Cochrane review (Reveiz, et al, 2015) which concluded that the outcomes achieved by fusafungine was not relevant in clinical practice, and that antibiotics appeared to have no benefits in the treatments of acute laryngitis in adults that may not outweigh the risk of adverse effects and negative consequences for antibiotic resistance patterns. 
Utemeljeni so bili na nedavnem Cochranovem pregledu (Reveiz idr., 2015), ki je zaključil, da izidi pri uporabi fuzafungina v klinični praksi niso bili pomembni in da pri zdravljenju akutnega laringitisa pri odraslih antibiotiki niso izkazali nobenih koristi, ki bi odtehtale tveganje za neželene učinke in negativne posledice na vzorce odpornosti za antibiotike.
In light of the new available information, a Type II variation, to update the product information on this risk, was submitted by the MAH in September 2014 in the Member States. 
Ob upoštevanju novih informacij je imetnik dovoljenja za promet z zdravili septembra 2014 v državah članicah predložil spremembo tipa II za vključitev tega tveganja v informacije o zdravilu.
Based on the post-marketing experience, the main safety concern with fusafungine is serious allergic reactions. 
Sodeč po izkušnjah iz obdobja trženja so glavni varnostni pomislek pri fuzafunginu resne alergijske reakcije.
In addition, the mechanism of action of fusafungine is unclear, and while the MAH argues that it is predominantly related to an anti-inflammatory activity, the compound has bacteriostatic activity and has been classified as an antibiotic compound (e.g. in the SmPC, the Pharmacotherapeutic group is listed as Respiratory System, Throat preparations/ Antibiotics, ATC code: R02A B03). 
Poleg tega je mehanizem delovanja fuzafungina nejasen, in čeprav imetnik dovoljenja za promet z zdravili trdi, da gre predvsem za protivnetno delovanje, ima spojina tudi bakteriostatično delovanje in je bila uvrščena med antibiotične spojine (npr. v povzetku glavnih značilnosti zdravila je farmakoterapevtska skupina navedena kot Pripravki za dihala, žrelo/antibiotiki, oznaka ATC: R02A B03).
In addition, although there is insufficient evidence to conclude on potential risk of inducing bacterial resistance, the risk of cross-resistance cannot be excluded. 
Poleg tega kljub nezadostnim dokazom o možnih tveganjih za bakterijsko odpornost ni mogoče izključiti tveganja za navzkrižno odpornost;
Overall, the number of serious allergic reactions including the fatal cases is not acceptable to the PRAC in the context a mild disease of self-limited nature, usually of a viral aetiology. 
V celoti gledano število resnih alergijskih reakcij, vključno s smrtnimi primeri, za odbor PRAC v okviru blage bolezni, ki izzveni sama in je običajno virusne etiologije, ni sprejemljivo.
No further studies adequate to demonstrate the efficacy of fusafungine in its current indications could be identified. 
Opredeliti ni bilo mogoče nobene dodatne študije, ki bi dokazala učinkovitost fuzafungina pri trenutnih indikacijah.
• The PRAC reviewed the totality of the data submitted in support of the safety and efficacy of fusafungine-containing products for oromucosal and nasal use including submissions from the marketing authorisation holders and views expressed by experts such as the CHMP Scientific Advisory Group (SAG) in Anti-Infectives and the Paediatric Committee (PDCO). 
• odbor PRAC je pregledal vse podatke, ki so bili predloženi v podporo varnosti in učinkovitosti zdravil, ki vsebujejo fuzafungin, za oromukozno in nazalno uporabo, vključno s predloženimi podatki imetnikov dovoljenja za promet z zdravilom in stališči strokovnjakov, kot sta znanstvena svetovalna skupina CHMP za zdravila proti okužbam in Odbor za pediatrijo (PDCO);
In order to minimize the risk of allergic reactions, the MAH proposed the several risk minimisation measures (RMMs) within the above mentioned variation including an extension of the existing contraindication in children (by restricting the age limit from less than 30 months to less than 12 years of age) and the introduction of a contraindication regarding the use in patients with allergic tendencies and bronchospasm. 
Da bi se zmanjšalo tveganje za alergijske reakcije, je imetnik dovoljenja za promet z zdravili v okviru zadevne spremembe predlagal več ukrepov za zmanjševanje tveganja, vključno z razširitvijo obstoječih kontraindikacij pri otrocih (z omejitvijo starostne meje z manj kot 30 mesecev na manj kot 12 let) in uvedbo kontraindikacije pri bolnikih z nagnjenostjo k alergijam in bronhospazmom.
In the clinical studies (Chabolles, Eccles and Bouter) conducted in adults, non-consistent figures were provided regarding frequency of hypersensitivity reactions, none of the events were serious. 
V kliničnih študijah (Chabolles, Eccles in Bouter), izvedenih pri odraslih, so bile predložene neskladne številke o pogostnosti preobčutljivostnih reakcij.
The SAG agreed that notwithstanding some evidence supports the antibiotic and anti-inflammatory effects of fusafungine, the evidence from clinical trials was weak. 
Znanstvena svetovalna skupina se je strinjala, da so kljub nekaterim dokazom, ki podpirajo antibiotične in protivnetne učinke fuzafungina, dokazi iz kliničnih preizkušanj šibki.
The PRAC requested the MAH to analyse the cases with fatal outcome in detail together with their causality assessment and stratification by age. 
Odbor PRAC je zahteval, da imetnik dovoljenja za promet z zdravili podrobno analizira primere s smrtnim izidom skupaj z oceno njihove vzročnosti in starostno stratifikacijo.
In addition to the data from clinical trials, the PRAC reviewed data from spontaneous reports provided by the MAH. 
Poleg podatkov iz kliničnih preizkušanj je odbor PRAC pregledal podatke iz spontanih poročil, ki jih je predložil imetnik dovoljenja za promet z zdravili.
With regards to paediatric data, the advice of the Paediatric Committee (PDCO) was requested by the PRAC. 
V zvezi s pediatričnimi podatki se je odbor PRAC za nasvet obrnil na Odbor za pediatrijo (PDCO).
This was also based on the fact that, in the current state of knowledge, the studies available in support of the efficacy data for fusafungine may not completely fulfil requirements to demonstrate efficacy in particular with regards to infections sustained by Streptococcus pyogenes or Streptococcus viridans. 
To je temeljilo tudi na dejstvu, da po trenutnem vedenju študije, ki so podpirale učinkovitost fuzafungina, morda niso v celoti izpolnile pogojev za dokaz učinkovitosti, zlasti kar zadeva okužbe z bakterijskima vrstama Streptococcus pyogenes in Streptococcus viridans.
With regards to the antimicrobial activity, the MAH submitted several studies presenting the Minimum Inhibitory Concentration (MIC) data for fusafungine for a wide range of clinical isolates (bacterial species and fungi), claiming that there was no significant change in the observed MICs after fusafungine exposure. 
V zvezi s protimikrobnim delovanjem je imetnik dovoljenja za promet z zdravili predložil več študij, v katerih so bili podani podatki o minimalni inhibicijski koncentraciji (MIK) fuzafungina pri širokem spektru kliničnih izolatov (bakterijske vrste in glive), pri čemer je trdil, da po izpostavitvi fuzafunginu ni bilo bistvene spremembe ugotovljenih vrednosti MIK.
The PRAC therefore concluded that revocation, rather than suspension, was justified. 
Zato je zaključil, da je bila upravičena razveljavitev in ne začasni umik dovoljenja za promet z zdravilom,
The MAH submitted in vitro data regarding the anti-inflammatory activity of fusafungine suggesting that the mechanism of action of anti-inflammatory activity of fusafungine is complex (such as inhibition of release of ICAM-1, IL-1β, IL-6, IL-8, and TNF-α by human alveolar macrophages). 
O protivnetnem delovanju fuzafungina je predložil podatke in vitro, po katerih je mehanizem protivnetnega delovanja fuzafungina zapleten (npr. inhibicija sproščanja ICAM-1, IL1β, IL-6, IL-8 in TNF-α iz človeških alveolarnih makrofagov).
The PRAC considered also the views expressed by experts such as the CHMP Scientific Advisory Group (SAG) in Anti-Infectives and the Paediatric Committee (PDCO). 
Obravnaval je tudi stališča, ki so jih izrazili strokovnjaki, kot sta znanstvena svetovalna skupina CHMP za zdravila proti okužbam in Odbor za pediatrijo (PDCO).
While the anti-bacterial effect of fusafungine is presented by the MAH as beneficial to the antiinflammatory effect, the PRAC is of the view that anti-bacterial effect can be regarded as a potential risk because it cannot be excluded that the medicine might induce antimicrobial resistance and interfere with the throat microbiota. 
Medtem ko je imetnik dovoljenja za promet z zdravili protibakterijski učinek fuzafungina predstavil kot koristen za protivnetni učinek, je odbor PRAC menil, da je protibakterijski učinek mogoče obravnavati kot možno tveganje, saj ni mogoče izključiti, da bi zdravilo lahko izzvalo protimikrobno odpornost in vplivalo na mikroorganizme v žrelu.
• Furthermore, the PRAC could not identify any potential measure or condition, the fulfilment of which would demonstrate a positive benefit/risk balance for fusafungine in any of the current indications. 
• odbor PRAC poleg tega ni mogel prepoznati nobenega morebitnega ukrepa ali stanja, s katerim bi dokazal pozitivno razmerje med tveganji in koristmi fuzafungina pri kateri koli od trenutnih indikacij.
The PRAC noted that no established susceptibility interpretive criteria (clinical breakpoints) for fusafungine were determined by EUCAST (European Committee for Antibacterial Susceptibility Testing) in Europe or CLSI (Clinical and Laboratory Standards Institution) in the US. 
Odbor PRAC je ugotovil, da EUCAST (Evropski odbor za preverjanje protimikrobne občutljivosti) v Evropi in CLSI (Inštitut za klinične in laboratorijske standarde) v ZDA za fuzafungin nista določila nobenih uveljavljenih razlagalnih meril preobčutljivosti (kliničnih mejnih vrednosti).
The PRAC, having due regard to the therapeutic effect of the above medicinal products, concluded that the benefit-risk balance of fusafungine for oromucosal and nasal use is not favourable as pursuant to Article 116 of Directive 2001/83/EC due to safety concerns in relation to serious, potentially fatal, hypersensitivity reactions, in the context of limited clinical efficacy for a self-limiting condition. 
Odbor PRAC je ob upoštevanju terapevtskega učinka navedenih zdravil v skladu s členom 116 Direktive 2001/83/ES zaključil, da razmerje med tveganji in koristmi fuzafungina za oromukozno in nazalno uporabo zaradi varnostnih pomislekov v zvezi z resnimi, morebitno smrtnimi preobčutljivostnimi reakcijami v okviru omejene klinične učinkovitosti pri bolezni, ki izzveni sama, ni ugodno.
The PRAC acknowledged that specific information on the efficacy of fusafungine in documented infections sustained by streptococcus pyogenes or viridans could not be provided. 
Odbor PRAC je potrdil, da določene informacije o učinkovitosti fuzafungina pri dokumentiranih okužbah z bakterijama Streptococcus pyogenes in viridans niso bile predložene.
• dyspnoea - 16.4% of hypersensitivity ADRs (15.0 % with regard to serious ADRs), 
• dispneja - 16,4 % preobčutljivostnih neželenih učinkov zdravila (15,0 % pri resnih neželenih učinkih zdravila),
The PDCO questioned the place of this product in the treatment armamentarium of viral upper respiratory illnesses and concluded that information on limited beneficial effect in the literature, did not point towards a different clinical interest of fusafungine across the various paediatric age sub-groups. 
Odbor PDCO je podvomil o ustreznosti umestitve zdravila med zdravila za zdravljenje bolezni zgornjih dihal in zaključil, da podatki o omejenih kliničnih koristih v literaturi niso nakazali drugačnega kliničnega pomena fuzafungina v različnih pediatričnih starostnih podskupinah.
In addition, the PRAC also noted uncertainties relating to the putative mechanisms of action of the antibacterial and anti-inflammatory effects and the occurrence of antimicrobial resistance cannot be excluded. 
Poleg tega je odbor PRAC ugotovil tudi nejasnosti pri domnevnih mehanizmih delovanja protibakterijskih in protivnetnih učinkov, pri čemer ni mogoče izključiti pojava protimikrobne odpornosti.
In line with the PDCO position, the PRAC concluded that the efficacy data of fusafungine-containing medicinal products for oromucosal and nasal use in the paediatric population is limited. 
V skladu s stališčem odbora PDCO je odbor PRAC zaključil, da so podatki o učinkovitosti zdravil, ki vsebujejo fuzafungin, za oromukozno in nazalno uporabo pri pediatrični populaciji omejeni.
basis of the studies submitted, at day 4 of treatment, there is about a 1.8 times higher chance that the adult patient in fusafungine group will improve from baseline (symptomatic relief) compared to patient in placebo group. 
Sodeč po predloženih študijah je na 4. dan zdravljenja verjetnost, da bo odrasel bolnik iz skupine, zdravljene s fuzafunginom, dosegel izboljšanje (simptomatsko lajšanje), 1,8-krat večja kot pri bolniku iz skupine, zdravljene s placebom.
Its bacteriostatic properties were presented as an additional activity by the MAH. 
Njegove bakteriostatične lastnosti je imetnik dovoljenja za promet z zdravili predstavil kot dodatno delovanje.
The PRAC noted that there have been 6 fatal cases reported post-marketing since the first MA of fusafungine. 
Odbor PRAC je ugotovil, da so v obdobju trženja od izdaje prvega dovoljenja za promet za fuzafungin poročali o šestih smrtnih primerih.
Overall, based on data from spontaneous reports and safety information available from other sources, the PRAC considers that fusafungine use is associated with serious cases of allergic reactions, potentially with short time to onset, which may be fatal. 
V celoti gledano je odbor PRAC na podlagi podatkov iz spontanih poročil in varnostnih informacij iz drugih virov presodil, da je uporaba fuzafungina povezana z resnimi primeri alergijskih reakcij, ki so lahko smrtne, z morebitno kratkim časom do njihovega pojava.
The MAH discussed fusafungine primarily as an antibiotic. 
Imetnik dovoljenja za promet z zdravili je fuzafungin obravnaval predvsem kot antibiotik.
Later in the procedure, the MAH re-defined fusafungine as a primarily anti-inflammatory medicine for symptomatic relief of acute (and predominantly viral) rhinopharyngitis. 
Pozneje v postopku je imetnik dovoljenja za promet z zdravili fuzafungin opredelil kot predvsem protivnetno zdravilo za simptomatsko lajšanje akutnega (in predvsem virusnega) rinofaringitisa.
The PRAC could not identify any potential measure or condition, the fulfilment of which would demonstrate a positive benefit risk balance for fusafungine in any of the current indications. 
Odbor PRAC ni mogel prepoznati nobenega morebitnega ukrepa ali stanja, s katerim bi dokazal pozitivno razmerje med tveganji in koristmi fuzafungina pri kateri koli od trenutnih indikacij.
Whilst acknowledging that patients with a medical history of allergy are at higher risk of developing allergic reaction, the PRAC also considered that serious allergic reactions including life-threatening even fatal ones also occurred in patients with no medical history of allergy. 
Ob upoštevanju, da alergijske reakcije bolj ogrožajo bolnike z alergijo v anamnezi, je odbor PRAC upošteval tudi, da so se resne alergijske reakcije, vključno z življenjsko nevarnimi in celo smrtnimi, pojavile tudi pri bolnikih, kadar alergije v anamnezi ni bilo.
The PRAC therefore concluded that the benefit-risk balance of fusafungine-containing medicinal products for oromucosal and nasal use is not favourable. 
Odbor PRAC je zato zaključil, da razmerje med tveganji in koristmi zdravil, ki vsebujejo fuzafungin, za oromukozno in nazalno uporabo ni ugodno.
• bronchospasm - 3.9% (8.1%), 
• bronhospazem - 3,9 % (8,1 %),
The advice of the CHMP Scientific Advisory Group (SAG) in Anti-Infectives was requested by the PRAC. 
Odbor PRAC se je za nasvet obrnil na znanstveno svetovalno skupino (SAG) CHMP za zdravila proti okužbam.
b. the risk-benefit balance is not favourable. 
a. zdravilo škodljivo in da b. razmerje med tveganji in koristmi ni ugodno.
When treating upper respiratory tract infections, the aetiology of which is mainly viral, with antibiotics, the risk for selecting antimicrobial resistance cannot be excluded. 
Pri zdravljenju okužb zgornjih dihal, katerih etiologija je predvsem virusna, z antibiotiki tveganja za nastanek protimikrobne odpornosti s selekcijo ni mogoče izključiti.
The PRAC considered that the risk minimisations measures proposed and discussed during the assessment were not sufficient to reduce the risk. 
Presodil je, da med oceno predlagani in obravnavani ukrepi za zmanjševanje tveganja tega ne bi zadostno zmanjšali.
In addition, in the Cochrane review by Reveiz et al. (2015), fusafungine or fusafungine plus clarithromycin in acute laryngitis in adults were more effective than no treatment only at day five, but no differences were found at days 8 and 28. 
(2015)) fuzafungin ali fuzafungin s klaritromicinom pri akutnem laringitisu pri odraslih učinkovitejši od nejemanja zdravil le peti dan, na 8. in 28. dan pa razlika ni bila ugotovljena.
Based on the safety data from post marketing data, the PRAC is of the view that the risk minimisation measures proposed by the MAH would not be able to adequately reduce the risks of serious adverse reactions considering that the severity of hypersensitivity reactions cannot be predicted. 
Na podlagi varnostnih podatkov iz podatkov v obdobju trženja je odbor PRAC menil, da ukrepi za zmanjševanje tveganja, kot jih je predlagal imetnik dovoljenja za promet z zdravili, ob upoštevanju dejstva, da resnosti preobčutljivostnih reakcij ni mogoče napovedati, ne bi zadostno zmanjšali tveganja za resne neželene reakcije.
• cough - 10.6% (3.1%), 
• kašelj - 10,6 % (3,1 %),
Based on the above data, the uncertainties relating to the mechanisms of action of the antiinflammatory and antibacterial effects were noted by the PRAC. 
Na podlagi zgornjih podatkov je odbor PRAC izpostavil, da v zvezi z mehanizmi protivnetnega in protibakterijskega učinkovanja obstajajo nejasnosti.
The MAH submitted studies regarding rhinopharyngitis, rhinosinusitis, pharyngitis, laryngitis, status after tonsillectomy and URTI in general. 
Imetnik dovoljenja za promet z zdravili je predložil študije o rinofaringitisu, rinosinuzitisu, faringitisu, laringitisu, stanju po tonzilektomiji in okužbah zgornjih dihal na splošno.
• The PRAC considered that the risk minimisations measures discussed during the assessment, including further restriction of the indication and additional contra-indications, limitation of treatment duration, addition of special warning and precautions for use, limitation of excipients, Direct Health Care Professional communication and restriction to prescription only, would not sufficiently reduce the risk of serious hypersensitivity (including allergic) reactions. 
• odbor PRAC je presodil, da ukrepi za zmanjševanje tveganja, obravnavani med oceno, vključno z dodatno omejitvijo indikacij in dodatnimi kontraindikacijami, omejitvijo trajanja zdravljenja, vključitvijo posebnih opozoril in previdnostnih ukrepov za uporabo, omejitvijo pomožnih snovi, neposrednim obvestilom za zdravstvene delavce in omejitvijo izdaje zdravil samo na recept, tveganja za resne preobčutljivostne (tudi alergijske) reakcije ne bi zadostno zmanjšali;
• The PRAC is of the view, after having reviewed the available data that fusafungine, in the context of a mild disease of self-limited nature, is associated with an increased risk of serious hypersensitivity (including allergic) adverse reactions including anaphylactic reactions which can be life threatening and fatal. 
• odbora PRAC je po pregledu razpoložljivih podatkov menil, da je fuzafungin v okviru blage bolezni, ki izzveni sama, povezan z večjim tveganjem za resne preobčutljivostne (tudi alergijske) neželene reakcije, vključno z anafilaktičnimi reakcijami, ki so lahko življenjsko nevarne in smrtne.
To include all possibly relevant cases, the MAH used the combined search of “Identified Risk Events Anaphylactic reaction hypersensitivity” for its data collection and analysis. 
Za vključitev vseh morebitno pomembnih primerov je imetnik dovoljenja za promet z zdravili pri zbiranju in analizi podatkov uporabil kombinirano iskanje „Prepoznana tveganja za preobčutljivost z anafilaktično reakcijo“.
The distribution of ADRs as follows: 
Porazdelitev neželenih učinkov zdravila je naslednja:
Overall, based on the above and the views expressed by the experts of the CHMP SAG in AntiInfectives, the PRAC considered that the available efficacy data, including data which became available since the initial marketing authorisation, showed only limited efficacy of local fusafungine in its approved indications which does not translate into evidence of a benefit for patients in the current context of the therapeutic strategy and knowledge acquired in diseases in the upper respiratory airways. 
V splošnem je odbor PRAC na podlagi navedenega in stališč, ki so jih izrazili strokovnjaki iz znanstvene svetovalne skupine CHMP za zdravila proti okužbam, menil, da so razpoložljivi podatki o učinkovitosti, vključno s podatki, ki so postali razpoložljivi od izdaje prvotnega dovoljenja za promet, pokazali le omejeno učinkovitost lokalnega fuzafungina pri odobrenih indikacijah, česar ni
2002, Study report [NP08516] 8 Grouin J.M, 2003, Treatment of acute infectious rhinopharyngitis with fusafungine (1.0 mg x 4 daily): a pooled analysis of three double blind placebo-controlled parallel group studies. 
2002, Poročilo o študiji [NP08516] 8 Grouin J.M, 2003, Treatment of acute infectious rhinopharyngitis with fusafungine (1.0 mg x 4 daily): a pooled analysis of three double blind placebo-controlled parallel group studies.
Its efficacy was presented by the MAH derived from its bacteriostatic properties. 
Po mnenju imetnika dovoljenja za promet z zdravili njegova učinkovitost izvira iz bakteriostatičnih lastnosti.
In the context of signal detection activities, the Marketing Authorization Holder (MAH) of fusafunginecontaining medicinal products for oromucosal and nasal use noted an increased reporting rate of all adverse drug reactions (ADRs) including allergic reactions. 
V okviru dejavnosti zaznavanja signalov je imetnik dovoljenja za promet z zdravili, ki vsebujejo fuzafungin, za oromukozno in nazalno uporabo ugotovil naraščajočo stopnjo poročanja o vseh neželenih učinkih zdravila, vključno z alergijskimi reakcijami.
The PRAC considered that the use of fusafungine-containing medicinal products for oromucosal and nasal use is associated with serious hypersensitivity (including allergic) reactions including fatal cases, with short time to onset. 
Odbor PRAC je presodil, da je uporaba zdravil, ki vsebujejo fuzafungin, za oromukozno in nazalno uporabo povezana z resnimi preobčutljivostnimi (tudi alergijskimi) reakcijami, vključno s smrtnimi primeri, s kratkim časom do pojava.
The PRAC was of the view that the risk minimisation measures proposed by the MAH will not sufficiently reduce the risks of serious adverse reactions. 
Stališče odbora PRAC je bilo, da ukrepi za zmanjševanje tveganja, ki jih je predlagal imetnik dovoljenja za promet z zdravili, ne zadostujejo za zadostno zmanjšanje tveganja za resne neželene reakcije.
The PRAC is of the opinion that when treating upper respiratory tract infections, the aetiology of which is mainly viral, with antibiotics the risk for selecting antimicrobial resistance cannot be excluded. 
Menil je tudi, da pri zdravljenju okužb zgornjih dihal, katerih etiologija je v glavnem virusna, z antibiotiki tveganja za nastanek protimikrobne odpornosti s selekcijo ni mogoče izključiti.