FrancophonIA/ELRC3.0 huggingface dataset:
English: However based on the evidence of allergic reactions reported in children 12-17 years old as well as in adult population, the Italian National Competent Authority (NCA) considered that the above-mentioned major safety concerns will not be fully controlled in clinical practice despite the risk minimisation measures in place.
Slovenian: Na podlagi podatkov o alergijskih reakcijah pri otrocih, starih od 12 do 17 let, ter pri odrasli populaciji pa je italijanski pristojni nacionalni organ presodil, da zadevni varnostni pomisleki v klinični praksi kljub ukrepom za zmanjševanje tveganja ne bodo v celoti pod nadzorom.
English: In addition, concerns have also been raised with regards to the role of the excipients in the occurrence of allergic reactions.
Slovenian: Poleg tega se je pojavila zaskrbljenost o vlogi pomožnih snovi pri pojavu alergijskih reakcij.
English: 2002, Study report [NP08516] 4 Cuénant G. Intérêt de Locabiotal Pressurisé dans les rhinosinusites.
Slovenian: 2002, Poročilo o študiji [NP08516] 4 Cuénant G. Intérêt de Locabiotal Pressurisé dans les rhinosinusites.
English: Valid Marketing Authorisations of fusafungine-containing medicinal products for oral use for oromucosal and nasal use currently available in 19 Member States (see Annex I).
Slovenian: Veljavna dovoljenja za promet z zdravili, ki vsebujejo fuzafungin, za peroralno uporabo ter za oromukozno in nazalno uporabo so trenutno na voljo v 19 državah članicah (glejte Prilogo I).
English: With regards to the allergic reactions, a total of 717 non-serious and serious cases have been spontaneously reported in patients exposed to fusafungine since the launch of the product (from 1963 up to 31 August 2015).
Slovenian: V zvezi z alergijskimi reakcijami so pri bolnikih, izpostavljenih fuzafunginu, od začetka trženja zdravila (od leta 1963 do 31. avgusta 2015) poročali o skupaj 717 manj resnih in resnih primerih.
English: Fusafungine is a depsipeptide antibacterial produced by Fusarium lateritium strain 437.
Slovenian: Fuzafungin je depsipeptidni antibiotik, ki ga tvori sev 437 glive Fusarium lateritium.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from Pharmacovigilance data, for fusafungine-containing products for oromucosal and nasal use (see Annex I).
Slovenian: • odbor PRAC je upošteval postopek v skladu s členom 31 Direktive 2001/83/ES, ki je bila na podlagi farmakovigilančnih podatkov predložena za zdravila, ki vsebujejo fuzafungin, za oromukozno in nazalno uporabo (glejte Prilogo I);
English: The MAH was asked to provide a cumulative review of all case reports, both serious and non-serious, along with causality assessment for serious cases and stratification by age as well as analyses on age and sex of patient, indication of use, duration and dose, time to onset, outcome, seriousness, concomitant medications and illnesses, relevant medical history or any other factors.
Slovenian: Imetnik dovoljenja za promet z zdravili je bil naprošen, da predloži kumulativni pregled vseh poročil, resnih in manj resnih, skupaj z oceno vzročnosti med resnimi primeri in starostno stratifikacijo ter analizami po starosti in spolu bolnikov, indikaciji, trajanju in odmerku, času do pojava, izidu, resnosti, uporabi sočasnih zdravil in sočasnih boleznih, ustrezni medicinski anamnezi in drugih dejavnikih.
English: Moreover, the available efficacy data showed only limited efficacy in support of the claimed indications of local fusafungine in rhinopharyngitis which does not translate in evidence of a benefit for patients in the current context of the therapeutic clinical practice.
Slovenian: Še več, razpoložljivi podatki o učinkovitosti so pokazali le omejeno učinkovitost v podporo predloženi indikaciji lokalnega fuzafungina pri rinofaringitisu, kar v trenutnem okviru terapevtske klinične prakse ne dokazuje koristi za bolnike.
English: The in vitro and in vivo data can be generally regarded as supportive of anti-inflammatory effect of fusafungine although the mechanism of action of antiinflammatory activity of fusafungine is complex and remains unknown.
Slovenian: Podatke in vitro in in vivo lahko v splošnem obravnavamo, kot da podpirajo protivnetno učinkovanje fuzafungina, čeprav je mehanizem protivnetnega delovanja fuzafungina zapleten in ostaja nerazjasnjen.
English: Hypersensitivity including anaphylactic reactions with short time to onset can be considered as a risk related to the use of fusafungine.
Slovenian: Preobčutljivost, vključno z anafilaktičnimi reakcijami s kratkim časom do pojava, se lahko obravnava kot tveganje, povezano z uporabo fuzafungina.
English: • The PRAC considered that the available efficacy data, including data which became available since the initial marketing authorisation, and concluded that the evidence for beneficial effects of fusafungine in all approved indications is weak and such effects are not clinically meaningful.
Slovenian: • odbor PRAC je preučil razpoložljive podatke o učinkovitosti, vključno s podatki, ki so postali razpoložljivi od izdaje prvotnega dovoljenja za promet, in zaključil, da so dokazi o koristnih učinkih fuzafungina pri vseh odobrenih indikacijah šibki in da taki učinki klinično niso pomembni;
English: The current risk minimisations measures (restriction of the indication to acute rhinopharyngitis and additional contra-indication) are considered insufficient to mitigate the risk of serious hypersensitivity reactions.
Slovenian: Trenutni ukrepi za zmanjševanje tveganja (omejitev indikacij na akutni rinofaringitis in dodatne kontraindikacije) ne zadostujejo za zmanjšanje tveganja resnih preobčutljivostnih reakcij.
English: Furthermore, the PRAC is of the opinion that the quality of the clinical evidence is very low for all other indications.
Slovenian: Odbor PRAC je menil, da je kakovost kliničnih dokazov pri vseh drugih indikacijah zelo slaba.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Based on the post-marketing experience, the main safety concern with fusafungine is serious allergic reactions.
Slovenian: Sodeč po izkušnjah iz obdobja trženja so glavni varnostni pomislek pri fuzafunginu resne alergijske reakcije.
English: 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).
Slovenian: 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).
English: In addition, although there is insufficient evidence to conclude on potential risk of inducing bacterial resistance, the risk of cross-resistance cannot be excluded.
Slovenian: Poleg tega kljub nezadostnim dokazom o možnih tveganjih za bakterijsko odpornost ni mogoče izključiti tveganja za navzkrižno odpornost;
English: 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.
Slovenian: 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.
English: No further studies adequate to demonstrate the efficacy of fusafungine in its current indications could be identified.
Slovenian: Opredeliti ni bilo mogoče nobene dodatne študije, ki bi dokazala učinkovitost fuzafungina pri trenutnih indikacijah.
English: • 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).
Slovenian: • 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);
English: 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.
Slovenian: 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.
English: 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.
Slovenian: V kliničnih študijah (Chabolles, Eccles in Bouter), izvedenih pri odraslih, so bile predložene neskladne številke o pogostnosti preobčutljivostnih reakcij.
English: The SAG agreed that notwithstanding some evidence supports the antibiotic and anti-inflammatory effects of fusafungine, the evidence from clinical trials was weak.
Slovenian: Znanstvena svetovalna skupina se je strinjala, da so kljub nekaterim dokazom, ki podpirajo antibiotične in protivnetne učinke fuzafungina, dokazi iz kliničnih preizkušanj šibki.
English: The PRAC requested the MAH to analyse the cases with fatal outcome in detail together with their causality assessment and stratification by age.
Slovenian: 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.
English: In addition to the data from clinical trials, the PRAC reviewed data from spontaneous reports provided by the MAH.
Slovenian: Poleg podatkov iz kliničnih preizkušanj je odbor PRAC pregledal podatke iz spontanih poročil, ki jih je predložil imetnik dovoljenja za promet z zdravili.
English: With regards to paediatric data, the advice of the Paediatric Committee (PDCO) was requested by the PRAC.
Slovenian: V zvezi s pediatričnimi podatki se je odbor PRAC za nasvet obrnil na Odbor za pediatrijo (PDCO).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The PRAC therefore concluded that revocation, rather than suspension, was justified.
Slovenian: Zato je zaključil, da je bila upravičena razveljavitev in ne začasni umik dovoljenja za promet z zdravilom,
English: 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).
Slovenian: 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).
English: 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).
Slovenian: Obravnaval je tudi stališča, ki so jih izrazili strokovnjaki, kot sta znanstvena svetovalna skupina CHMP za zdravila proti okužbam in Odbor za pediatrijo (PDCO).
English: 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.
Slovenian: 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.
English: • angioedema - 3.8% (7.7%).
Slovenian: • angioedem - 3,8 % (7,7 %).
English: • 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.
Slovenian: • 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.
English: 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.
Slovenian: 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).
English: 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.
Slovenian: 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.
English: The PRAC acknowledged that specific information on the efficacy of fusafungine in documented infections sustained by streptococcus pyogenes or viridans could not be provided.
Slovenian: Odbor PRAC je potrdil, da določene informacije o učinkovitosti fuzafungina pri dokumentiranih okužbah z bakterijama Streptococcus pyogenes in viridans niso bile predložene.
English: • dyspnoea - 16.4% of hypersensitivity ADRs (15.0 % with regard to serious ADRs),
Slovenian: • dispneja - 16,4 % preobčutljivostnih neželenih učinkov zdravila (15,0 % pri resnih neželenih učinkih zdravila),
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Poleg tega je odbor PRAC ugotovil tudi nejasnosti pri domnevnih mehanizmih delovanja protibakterijskih in protivnetnih učinkov, pri čemer ni mogoče izključiti pojava protimikrobne odpornosti.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Its bacteriostatic properties were presented as an additional activity by the MAH.
Slovenian: Njegove bakteriostatične lastnosti je imetnik dovoljenja za promet z zdravili predstavil kot dodatno delovanje.
English: The PRAC noted that there have been 6 fatal cases reported post-marketing since the first MA of fusafungine.
Slovenian: Odbor PRAC je ugotovil, da so v obdobju trženja od izdaje prvega dovoljenja za promet za fuzafungin poročali o šestih smrtnih primerih.
English: 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.
Slovenian: 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.
English: The MAH discussed fusafungine primarily as an antibiotic.
Slovenian: Imetnik dovoljenja za promet z zdravili je fuzafungin obravnaval predvsem kot antibiotik.
English: Later in the procedure, the MAH re-defined fusafungine as a primarily anti-inflammatory medicine for symptomatic relief of acute (and predominantly viral) rhinopharyngitis.
Slovenian: Pozneje v postopku je imetnik dovoljenja za promet z zdravili fuzafungin opredelil kot predvsem protivnetno zdravilo za simptomatsko lajšanje akutnega (in predvsem virusnega) rinofaringitisa.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The PRAC therefore concluded that the benefit-risk balance of fusafungine-containing medicinal products for oromucosal and nasal use is not favourable.
Slovenian: Odbor PRAC je zato zaključil, da razmerje med tveganji in koristmi zdravil, ki vsebujejo fuzafungin, za oromukozno in nazalno uporabo ni ugodno.
English: • bronchospasm - 3.9% (8.1%),
Slovenian: • bronhospazem - 3,9 % (8,1 %),
English: The advice of the CHMP Scientific Advisory Group (SAG) in Anti-Infectives was requested by the PRAC.
Slovenian: Odbor PRAC se je za nasvet obrnil na znanstveno svetovalno skupino (SAG) CHMP za zdravila proti okužbam.
English: b. the risk-benefit balance is not favourable.
Slovenian: a. zdravilo škodljivo in da b. razmerje med tveganji in koristmi ni ugodno.
English: When treating upper respiratory tract infections, the aetiology of which is mainly viral, with antibiotics, the risk for selecting antimicrobial resistance cannot be excluded.
Slovenian: Pri zdravljenju okužb zgornjih dihal, katerih etiologija je predvsem virusna, z antibiotiki tveganja za nastanek protimikrobne odpornosti s selekcijo ni mogoče izključiti.
English: The PRAC considered that the risk minimisations measures proposed and discussed during the assessment were not sufficient to reduce the risk.
Slovenian: Presodil je, da med oceno predlagani in obravnavani ukrepi za zmanjševanje tveganja tega ne bi zadostno zmanjšali.