natgillin/translations-raw huggingface dataset:
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.
2000, Study report [NP07760] 3 Bouter K. 7-day treatment of acute infectious rhinopharyngitis with fusafungine (1.0 mg x 4 daily): a double-blind placebo-controlled parallel-group study.
2000, Poročilo o študiji [NP07760] 3 Bouter K. 7-day treatment of acute infectious rhinopharyngitis with fusafungine (1.0 mg x 4 daily): a double-blind placebo-controlled parallel-group study.
The PRAC considered that the use of fusafungine for oromucosal and nasal use is associated with serious adverse allergic reactions sometimes fatal.
Odbor PRAC je presodil, da sta oromukozna in nazalna uporaba fuzafungina povezani z resnimi, včasih smrtnimi neželenimi alergijskimi učinki.
During the assessment, the PRAC also noted that the MAH stated that available data no longer support tonsillitis and laryngitis indications; the MAH also confirmed that all the available data have been provided and that they will not be able to provide any further data to demonstrate the clinical safety and benefit of fusafungine in the management of diseases of the upper respiratory airways.
Imetnik dovoljenja za promet z zdravili je potrdil tudi, da so bili predloženi vsi razpoložljivi podatki in da za dokaz klinične varnosti in koristi fuzafungina pri zdravljenju bolezni zgornjih dihal ne bo mogel zagotoviti nobenih dodatnih podatkov.
The author's conclusion that the outcomes achieved by fusafungine are not relevant in clinical practice is supported by the PRAC.
Odbor PRAC podpira avtorjev zaključek, da izidi, doseženi s fuzafunginom, v klinični praksi niso pomembni.
The MAH provided: - 5 clinical studies in adults including 3 pivotal studies in acute rhinopharyngitis (Chabolle, 19991, Eccles 20002 and Bouter, 20023) and 2 supportive randomized, double-blind, placebo controlled studies in rhinosinusitis (Cuénant 19884, Mösges 2002) and, - one study in children (a double-blind, placebo-controlled, randomized, in 515 children, aged 8-12 years, with acute rhinopharyngitis, Januszewicz 2002).
- pet kliničnih študij pri odraslih, ki so obsegale tri osrednje študije pri akutnem rinofaringitisu (Chabolle, 19991, Eccles, 20002, in Bouter, 20023) in dve podporni, dvojno slepi, s placebom nadzorovani študiji pri rinosinuzitisu (Cuénant, 19884, Mösges, 2002), ter
• The PRAC noted that serious, life-threatening hypersensitivity (including allergic) reactions have been reported with fusafungine for oromucosal and nasal use, including fatal cases, with short time to onset (even at first dose).
• odbor PRAC je ugotovil, da so pri fuzafunginu za oromukozno in nazalno uporabo poročali o življenjsko nevarnih preobčutljivostnih (tudi alergijskih) reakcijah, vključno s smrtnimi primeri, s kratkim časom do pojava (celo pri prvem odmerku);
The PRAC reviewed all the available data submitted with regards to the clinical efficacy and safety of fusafungine-containing products.
Odbor PRAC je pregledal vse razpoložljive podatke, predložene v zvezi s klinično učinkovitostjo in varnostjo zdravil, ki vsebujejo fuzafungin.
The PRAC considered all the available data submitted with regards to the mechanism of action of fusafungine.
Odbor PRAC je upošteval vse razpoložljive podatke o mehanizmu delovanja fuzafungina, ki so bili predloženi.
Further risk minimisation measures such as additional amendments to the product information (further restriction of the indication and contra-indications, limitation of treatment duration, addition of the wording ‘do not inhale' in special warning and precautions for use, limitation of excipients), communication material (Direct Health Care Professional communication) and restriction to prescription only were therefore also considered during the discussions.
V razpravah so bili tako obravnavani tudi dodatni ukrepi za zmanjševanje tveganja, kot so dodatne spremembe informacij o zdravilu (nadaljnja omejitev indikacij in dodatne kontraindikacije, omejitev trajanja zdravljenja, dodane besede „ne vdihujte“ v posebnem opozorilu in previdnostnih ukrepih za uporabo, omejitev pomožnih snovi), komunikacijsko gradivo (neposredno obvestilo za zdravstvene delavce) in omejitev izdaje zdravil samo na recept.
• rash - 4.7% (2.1%),
• izpuščaj - 4,7 % (2,1 %),
Further risk minimisation measures, as proposed by the MAH, such as additional amendments to the product information (further restriction of the indication and additional contra-indications, limitation of treatment duration, addition of the wording ‘do not inhale' in special warning and precautions for use, limitation of excipients), communication material (Direct Health Care Professional communication) and restriction to prescription only were also considered during the discussions.
V razpravah so bili obravnavani tudi dodatni ukrepi za zmanjševanje tveganja, kot jih je predlagal imetnik dovoljenja za promet z zdravili, npr. dodatne spremembe informacij o zdravilu (nadaljnja omejitev indikacij in dodatne kontraindikacije, omejitev trajanja zdravljenja, dodane besede „ne vdihujte“ v posebnem opozorilu in previdnostnih ukrepih za uporabo, omejitev pomožnih snovi), komunikacijsko gradivo (neposredno obvestilo za zdravstvene delavce) in omejitev izdaje zdravil samo na recept.
Fusafungine , used in the form of a spray, is indicated in the local antibacterial and anti-inflammatory treatment of diseases in the upper respiratory airways (sinusitis, rhinitis, rhinopharyngitis, angina, laryngitis), inhaled in usual doses of 500 micrograms every 4 hours into each nostril or via the mouth.
Fuzafungin, ki se uporablja v obliki pršila, je indiciran za lokalno protibakterijsko in protivnetno zdravljenje bolezni zgornjih dihal (sinuzitis, rinitis, rinofaringitis, angina, laringitis).
The PRAC reviewed all the available data submitted with regards to the clinical efficacy of fusafunginecontaining products.
Odbor PRAC je pregledal vse razpoložljive podatke, predložene v zvezi s klinično učinkovitostjo zdravil, ki vsebujejo fuzafungin.
The PRAC reviewed all the available data submitted with regards to the clinical safety of fusafunginecontaining products.
Odbor PRAC je pregledal vse razpoložljive podatke, predložene v zvezi s klinično varnostjo zdravil, ki vsebujejo fuzafungin.
Fusafungine is currently indicated in the local antibacterial and anti-inflammatory treatment of diseases in the upper respiratory airways (sinusitis, rhinitis, rhinopharyngitis, angina, laryngitis), inhaled in usual doses of 500 micrograms every 4 hours into each nostril or via the mouth.
Fuzafungin je trenutno indiciran za lokalno protibakterijsko in protivnetno zdravljenje bolezni zgornjih dihal (sinuzitis, rinitis, rinofaringitis, angina, laringitis).
7 Bouter K. 7-day treatment of acute infectious rhinopharyngitis with fusafungine (1.0 mg x 4 daily): a double-blind placebo-controlled parallel-group study.
2000, Poročilo o študiji [NP07760] 7 Bouter K. 7-day treatment of acute infectious rhinopharyngitis with fusafungine (1.0 mg x 4 daily): a double-blind placebo-controlled parallel-group study.
a. the medicinal product is harmful, and,
Imetnik dovoljenja za promet z zdravili je zagotovil:
Fusafungine was shown to be superior to placebo in the acute rhinopharyngitis indication regarding evolution of nasal symptom score after 4 days of treatment in adults in three pivotal studies Chabolle, 19995, Eccles 20006 and Bouter, 20027) and the pooled analysis of them (Grouin 20038).
V treh osrednjih študijah (Chabolle, 19995, Eccles, 20006, in Bouter, 20027) ter v njihovi zbirni analizi (Grouin, 20038) se je po štirih dneh zdravljenja pri odraslih pokazalo, da pri akutnem rinofaringitisu fuzafungin nosne simptome lajša učinkoviteje od placeba.
*** fluorescent focus units
*** fluorescentna fokusna enota.
Reassortant influenza virus* (live attenuated) of the following strains**: A/California/7/2009 (H1N1)pdm09-like strain (A/California/7/2009, MEDI 228029) 10
Novi virus gripe* (živ oslabljen) naslednjih sevov**: A/California/7/2009 (H1N1)pdm09-podoben sev (A/California/7/2009, MEDI 228029)
10 sprayers
10 pršilnikov
Nasal use sprayer (glass/PE) 0.2ml
Nazalna uporaba pršilnik (steklo/PE)
Nasal spray,
Pršilo za nos,
FFU*** ................................................................................................................................................per 0.2 ml dose
FFE*** ............................................................................................................................................................. na 0,2 ml odmerek
The frequency of these reactions is considered not known (cannot be estimated from the available data).
Pogostnost teh učinkov ni znana (ni je mogoče oceniti iz razpoložljivih podatkov).
Adopted at the 4-8 July 2016 PRAC
Sprejeto na seji odbora PRAC med 4. in 8. julijem 2016
Tell your doctor before taking this medicine, if:
Pred začetkom jemanja tega zdravila zdravnika obvestite, če:
• You are due to have a specific blood test (Chromogranin A)
• ste naročeni na specifično preiskavo krvi (kromogranin A)
Tablets should be taken before meals or during meals, depending on gastrointestinal tolerance.
Tablete je treba zaužiti pred ali med obrokom, odvisno od gastrointestinalne tolerance.
If you cannot follow this instruction or have difficulty swallowing, please contact your doctor.
Če tega navodila ne morete upoštevati ali imate težave pri požiranju, se obrnite na zdravnika.
To avoid this interference, [Product name] treatment should be stopped for at least 5 days before CgA measurements (see section 5.1).
Da bi to preprečili, je treba vsaj pet dni pred meritvami CgA prekiniti zdravljenje z zdravilom [ime zdravila] (glejte poglavje 5.1).
Ferrous sulfate - Mouth ulceration (EPITT no 18623)
Železov(II) sulfat - razjede v ustih (št. EPITT 18623)
3 - How to take [Product name] Swallow the tablet whole with water.
3 - Kako jemati zdravilo [ime zdravila] Tableto pogoltnite celo z vodo.
Proton pump inhibitors (PPIs): dexlansoprazole; esomeprazole; lansoprazole; omeprazole; pantoprazole; rabeprazole - Elevated circulating levels of Chromogranin A (EPITT no 18614)
Zaviralci protonske črpalke: dekslansoprazol, esomeprazol, lansoprazol, omeprazol, pantoprazol, rabeprazol - zvišane ravni kromogranina A v obtoku (št. EPITT 18614)
Post-marketing: The following ADRs have been reported during post-marketing surveillance.
Iz obdobja trženja: V okviru nadzora v obdobju trženja poročajo o naslednjih neželenih učinkih.
Not known (frequency cannot be estimated from the available data) Mouth ulceration (in case of incorrect use, when tablets are chewed, sucked or left in the mouth) Elderly patients and patients with difficulty swallowing may also be at risk of ulceration of the throat, oesophagus (the tube that connects your mouth with your stomach) or bronchus (the major air passages of the lungs) if the tablet enters the airways.
Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) Razjede v ustih (v primeru nepravilne uporabe, tj. kadar bolnik tablete žveči, sesa ali zadržuje v ustih) Pri starejših bolnikih in bolnikih, ki imajo težave s požiranjem, obstaja tudi tveganje za razjede grla, požiralnika ali sapnic (glavnih dihalnih poti v pljučih), če tableta pride v dihala.
Elderly patients and patients with deglutition disorders may also be at risk of oesophageal lesions or of bronchial necrosis, in case of false route.
Pri starejših bolnikih in bolnikih z motnjami požiranja obstaja tudi tveganje za razjede požiralnika ali bronhialno nekrozo, kadar je pot uporabe napačna.
Do not suck, chew or keep the tablet in your mouth.
Tablete ne sesajte, žvečite ali zadržujte v ustih.
The tablets should not be sucked, chewed or kept in the mouth, but swallowed whole with water.
Tablet se ne sme sesati, žvečiti ali zadrževati v ustih, pač pa jih je treba pogoltniti cele z vodo.
Due to the risk of mouth ulceration and tooth discolouration, tablets should not be sucked, chewed or kept in the mouth but swallowed whole with water.
Zaradi tveganja za razjede v ustih in obarvanje zob se tablet ne sme sesati, žvečiti ali zadrževati v ustih, pač pa jih je treba pogoltniti cele z vodo.
Gastrointestinal disorders: mouth ulceration* * in the context of incorrect administration, when the tablets are chewed, sucked or kept in mouth.
* pri nepravilnem dajanju, torej kadar bolnik tablete žveči, sesa ali zadržuje v ustih.
The application was withdrawn before ‘day 120'.
Vloga je bila umaknjena pred „120.
This was then compared with results reported in the scientific literature.
To so nato primerjali z rezultati, o katerih so poročali v znanstveni literaturi.
The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Dopis, s katerim družba Agencijo obvešča o umiku vloge, je na voljo pod zavihkom „All documents“ (Vsi dokumenti).
This means that Epostim was intended to be similar to a biological medicine that is already authorised in the European Union (also known as the ‘reference medicine') and contains the same active substance.
To pomeni, da naj bi bilo zdravilo Epostim podobno biološkemu zdravilu, ki je že odobreno v Evropski uniji (znano tudi kot „referenčno zdravilo“) in vsebuje isto zdravilno učinkovino.
The effects of Epostim were first tested in experimental models before being studied in humans.
Učinki zdravila Epostim so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Epostim was expected to be used in the following situations:
Zdravilo Epostim naj bi se uporabljalo v naslednjih primerih:
The company informed the CHMP that here are no consequences for patients currently in clinical trials using Epostim.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Epostim.