FrancophonIA/ELRC3.0 huggingface dataset:
English: In conclusion, the CHMP considers the benefit-risk balance of bacterial lysates based products for use in respiratory conditions unchanged in the prophylaxis setting with regard to their authorised subsets of recurrent RTIs, provided their efficacy and safety is further characterised by Q1 2026 through the conduct of phase IV double-blind, multicentre, RCTs in this indication, and provided the agreed changes to the product information are implemented.
Slovenian: Odbor CHMP je končno sklenil, da razmerje med tveganji in koristmi zdravil, ki temeljijo na bakterijskih lizatih, za uporabo pri profilaksi bolezni dihal ostaja nespremenjeno, kar zadeva njihove odobrene podskupine ponavljajočih se okužb dihal, pod pogojem, da se do prvega četrtletja leta 2026 nadalje opredelita njihova varnost in učinkovitost, in sicer z izvedbo dvojno slepih, multicentričnih randomiziranih kliničnih preskušanj IV. faze pri tej indikaciji, in pod pogojem, da se uvedejo dogovorjene spremembe informacij o zdravilu.
English: The SAG also considered that extrapolation of clinical effects in prophylaxis of upper and lower RTI to treatment of these infections, and vice versa was not scientifically justified, which was agreed by CHMP.
Slovenian: Skupina SAG je menila tudi, da ekstrapolacija kliničnih učinkov pri profilaksi okužb zgornjih in spodnjih dihal na zdravljenje teh okužb in obratno ni znanstveno utemeljena, s čimer se je strinjal tudi odbor CHMP.
English: A small doubleblind placebo-controlled RCT and some supportive studies with methodological limitations provide some evidence of efficacy of Ismigen in the prophylaxis of URTIs in adults.
Slovenian: Majhno, dvojno slepo, s placebom nadzorovano randomizirano klinično preskušanje in nekaj podpornih študij z metodološkimi omejitvami zagotavlja nekaj dokazov o učinkovitosti zdravila Ismigen pri profilaksi okužb zgornjih dihal pri odraslih.
English: A recent well-designed, double-blind, placebo-controlled, RCT in children failed to demonstrate any significant effect of Ribomunyl in the primary (i.e. number of URTI) and most secondary endpoints.
Slovenian: V nedavnem dobro zasnovanem, dvojno slepem, s placebom nadzorovanem, randomiziranem kliničnem preskušanju pri otrocih niso dokazali pomembnega učinka zdravila Ribomunyl pri primarnem (tj. številu okužb zgornjih dihal) in večini sekundarnih opazovanih dogodkov.
English: Favourable effects were reported from a small placebo controlled study and 8 observation uncontrolled studies, all suffering from serious methodological issues.
Slovenian: Iz majhne, s placebom nadzorovane študije in osmih opazovalnih, nenadzorovanih študij so poročali o ugodnih učinkih, pri čemer so imele vse študije hude metodološke pomanjkljivosti.
English: The CHMP considered the benefit-risk balance of the bacterial lysates unchanged in the prophylaxis setting with regard to their authorised subsets of recurrent RTIs.
Slovenian: Odbor CHMP je menil, da je razmerje med tveganji in koristmi bakterijskih lizatov pri profilaksi nespremenjeno, kar zadeva odobrene podskupine ponavljajočih se okužb dihal.
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for bacterial lysates based medicinal products for use in respiratory conditions.
Slovenian: Zato priporoča spremembo pogojev dovoljenj za promet z zdravili na osnovi bakterijskih lizatov za uporabo pri boleznih dihal.
English: Overall, one adverse drug reaction (ADR) with no evaluation of causality was reported for Respivax, which is strongly suggestive a serious under-reporting.
Slovenian: V celoti so pri zdravilu Respivax poročali o enem neželenem učinku, brez ovrednotenja vzročne povezave, kar močno kaže na zelo pomanjkljivo poročanje.
English: A fatal case of allergic drug induced fever was noted after re-exposure.
Slovenian: Po ponovni izpostavljenosti so opazili smrtni primer alergijske, z zdravilom sprožene zvišane telesne temperature.
English: No robust study was conducted in the prophylaxis of RTIs in children, however positive results were shown in a few small open studies.
Slovenian: Glede profilakse okužb dihal pri otrocih ni bila opravljena nobena zanesljiva študija, vendar je nekaj manjših odprtih študij pokazalo pozitivne rezultate.
English: The SAG AI was of the view that extrapolation of clinical effects of the medicinal products in prophylaxis of URTI to LRTI and vice versa is not scientifically justified because upper and lower RTI represent different disease entities.
Slovenian: Skupina SAG AI je bila mnenja, da ekstrapolacija kliničnih učinkov zdravil pri profilaksi okužb zgornjih dihal na okužbe spodnjih dihal in obratno ni znanstveno utemeljena, saj okužbe zgornjih in spodnjih dihal predstavljajo drugačne bolezni.
English: Eight medicinal products containing six different combinations of bacterial strains' lysates currently hold marketing authorisations for use in respiratory conditions in EU MS.
Slovenian: Dovoljenje za promet z zdravilom v državah članicah EU za uporabo pri boleznih dihal ima trenutno osem zdravil, ki vsebujejo lizate šestih različnih kombinacij bakterijskih sevov.
English: Ribomunyl is indicated for the prophylaxis of RURTI in children above 2 or 6 years old depending on the presentation, and of recurrent surinfections in chronic bronchitis in adults.
Slovenian: Zdravilo Ribomunyl je indicirano za profilakso ponavljajočih se okužb zgornjih dihal pri otrocih, starejših od 2 ali 6 let, odvisno od oblike zdravila, in ponavljajočih se superinfekcij pri kroničnem bronhitisu pri odraslih.
English: Polyvaccinum nasal drops are indicated for the prophylaxis and treatment of RURTI in adults and children from 6 months old and suspension for injections are indicated for prophylactic and therapeutic use or adjunctive treatment in case of long-lasting, chronic and recurrent RTI in adults and children from 2 years of age.
Slovenian: Kapljice za nos Polyvaccinum so indicirane za profilakso in zdravljenje ponavljajočih se okužb zgornjih dihal pri odraslih in otrocih, starejših od 6 mesecev, suspenzija za injiciranje pa je indicirana za profilaktično in terapevtsko uporabo ali dopolnilno zdravljenje dolgotrajnih, kroničnih in ponavljajočih se okužb dihal pri odraslih in otrocih, starih 2 leti in več.
English: No robust study was conducted in the prophylaxis of RTIs children; however, a retrospective cohort study and two small RCT provide some limited evidence of efficacy.
Slovenian: Pri profilaksi okužb dihal pri otrocih ni bila opravljena nobena zanesljiva študija, omejene dokaze o učinkovitosti pa zagotavljajo retrospektivna kohortna študija in dve manjši randomizirani klinični preskušanji.
English: Broncho-vaxom is indicated in for the prevention and treatment of RRTI in adults and children.
Slovenian: Zdravilo Broncho-Vaxom je indicirano za preprečevanje in zdravljenje ponavljajočih se okužb dihal pri odraslih in otrocih.
English: Limited data provides some evidence of efficacy in the prophylaxis of respiratory infections to different extents depending on products and on age groups.
Slovenian: Omejeni podatki v različnem obsegu zagotavljajo nekaj dokazov o učinkovitosti pri profilaksi okužb dihal, odvisno od zdravila in starostne skupine.
English: Conflicting results were obtained from two double-blind, placebo-controlled RCT evaluating Ismigen in the prophylaxis of LRTI in adults.
Slovenian: Nasprotujoči si rezultati so bili pridobljeni iz dveh dvojno slepih, s placebom nadzorovanih randomiziranih kliničnih preskušanj, v katerih so vrednotili zdravilo Ismigen pri profilaksi okužb spodnjih dihal pri odraslih.
English: Buccalin is indicated for the prophylaxis of RRTI in adults and of bacterial RURTI in children older than 6 months or for the prophylaxis of bacterial RTI without age limits.
Slovenian: Zdravilo Buccalin je indicirano za profilakso ponavljajočih se okužb dihal pri odraslih in ponavljajočih se bakterijskih okužb zgornjih dihal pri otrocih, starejših od 6 mesecev, ali za profilakso bakterijskih okužb dihal brez starostne omejitve.
English: The minimal age group for which Luivac can be used (from 4 years of age) should be explicitly stated across all EU MS PIs.
Slovenian: V informacijah o zdravilu v vseh državah članicah EU mora biti navedena minimalna starostna skupina, pri kateri se sme uporabljati zdravilo Luivac (od starosti 4 let dalje).
English: Conflicting results were observed in all double-blind, placebo-controlled, RCT which were associated with methodological limitations.
Slovenian: Pri vseh dvojno slepih, s placebom nadzorovanih, randomiziranih kliničnih preskušanjih, ki so bila povezana z metodološkimi omejitvami, so opazili nasprotujoče si rezultate.
English: Whilst most double-blind, placebo controlled, RCTs and supportive studies reported positive effects of Broncho-Vaxom these are not considered to provide robust evidence of efficacy in adults of children, in view of the methodological limitations noted.
Slovenian: Iz večine dvojno slepih, s placebom nadzorovanih randomiziranih kliničnih preskušanj in podpornih študij so poročali o pozitivnih učinkih zdravila Broncho-Vaxom, vendar zaradi opaženih metodoloških omejitev te ne zagotavljajo zanesljivih dokazov o učinkovitosti pri odraslih in otrocih.
English: Respivax is indicated for the prophylaxis and treatment of chronic and recurrent RTI in adults and children from 3 years of age.
Slovenian: Zdravilo Respivax je indicirano za profilakso in zdravljenje kroničnih in ponavljajočih se okužb dihal pri odraslih in otrocih, starih 3 leta in več.
English: However considering the lack of robust evidence, the conduct of phase IV placebo-controlled, double-blind, multicentre, RCTs according to agreed protocols in order to further characterise the efficacy and safety in their authorised indication(s) should be imposed on the MAs of these products.
Slovenian: Zaradi pomanjkanja zanesljivih dokazov pa je treba od imetnikov dovoljenj za promet z zdravilom za ta zdravila zahtevati, naj izvedejo s placebom nadzorovana, dvojno slepa, multicentrična randomizirana klinična preskušanja IV. faze po dogovorjenih protokolih, s čimer bodo nadalje opredelili učinkovitost in varnost pri odobrenih indikacijah.
English: The CHMP also noted that whilst some studies suggest that the positive effects observed were mainly related to URTIs, for the majority of studies it was not possible to differentiate between the effects related to the prophylaxis of URTIs and that related to the prophylaxis of LRTIs.
Slovenian: Odbor CHMP je opozoril tudi, da pri večini študij ni bilo mogoče razlikovati med učinki, povezanimi s profilakso okužb zgornjih dihal, in učinki, povezanimi s profilakso okužb spodnjih dihal, čeprav nekatere študije kažejo, da so opaženi pozitivni učinki večinoma povezani z okužbami zgornjih dihal.
English: Lantigen B is indicated for the prophylaxis and treatment of RURTI or bacterial URTI in adults and children, as prophylaxis of RRTI in adults and URTIs in children or for the prevention of RRTI in adults and children from 3 years of age.
Slovenian: Zdravilo Lantigen B je indicirano za profilakso in zdravljenje ponavljajočih se okužb zgornjih dihal ali bakterijskih okužb zgornjih dihal pri odraslih in otrocih, kot profilaksa za ponavljajoče se okužbe dihal pri odraslih in okužbe zgornjih dihal pri otrocih ali za preprečevanje ponavljajočih se okužb dihal pri odraslih in otrocih, starih 3 leta in več.
English: Ismigen is indicated in for the prophylaxis of RRTI in adults and in some MS for the treatment of acute, subacute recurrent or chronic RTI as well as in one MS in children from 3 years of age.
Slovenian: Zdravilo Ismigen je indicirano za profilakso ponavljajočih se okužb dihal pri odraslih in v nekaterih državah članicah za zdravljenje akutnih, subakutnih ponavljajočih se ali kroničnih okužb dihal ter v eni državi članici pri otrocih, starih 3 leta in več.
English: In one MS, the paediatric indication is restricted to recurrent upper RTI (RURTI).
Slovenian: V eni državi članici je pediatrična indikacija omejena na ponavljajoče se okužbe zgornjih dihal.
English: The prototypic URTI is the common cold. URTI occur commonly in both children and adults and is a major cause of mild morbidity.
Slovenian: Okužbe zgornjih dihal se pogosto pojavljajo pri otrocih in odraslih ter so glavni vzrok blage obolevnosti.
English: Favourable effects of Lantigen B in the prophylaxis of RTI were observed in adults and children in a number of old studies, with methodological limitations.
Slovenian: Pri odraslih in otrocih so v številnih starih študijah z metodološkimi omejitvami opazili ugodne učinke zdravila Lantigen B pri profilaksi okužb dihal.
English: Luivac is indicated for the prophylaxis of recurrent respiratory tract infections (RRTI) in adults and children from 4 years of age.
Slovenian: Zdravilo Luivac je indicirano za profilakso ponavljajočih se okužb dihal pri odraslih in otrocih, starih 4 leta in več.
English: Limited data provides some evidence of efficacy in the prophylaxis of recurrent respiratory infections to different extent depending on products and on age groups.
Slovenian: Omejeni podatki v različnem obsegu zagotavljajo nekaj dokazov o učinkovitosti pri profilaksi ponavljajočih se okužb dihal, odvisno od zdravila in starostne skupine, vendar o učinkovitosti pri tej indikaciji ni mogoče izpeljati dokončnega zaključka;
English: A meta-analysis reporting a favourable effect had also a number of limitations and the MAH plans to revise it. No study evaluating the effect of Lantigen B in the treatment of RTIs was identified.
Slovenian: Tudi metaanaliza, iz katere so poročali o ugodnem učinku, je imela številne omejitve in imetnik dovoljenja za promet z zdravilom jo namerava popraviti.
English: The main measure of effectiveness was the number of patients who had responded to treatment at the end of the treatment course.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, ki so se ob koncu zdravljenja nanj odzvali.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ecalta on 20 September 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Ecalta, veljavno po vsej Evropski uniji, izdala 20. septembra 2007.
English: Both medicines were given by infusion, for between 14 and 42 days.
Slovenian: Obe zdravili so bolnikom dajali v obliki infuzije v obdobju od 14 do 42 dni.
English: What measures are being taken to ensure the safe and effective use of Ecalta?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ecalta?
English: The full EPAR for Ecalta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ecalta je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: ‘Invasive' means that the fungus has spread into the bloodstream.
Slovenian: „Invazivna“ pomeni, da se je glivica razširila v krvni obtok.
English: Ecalta is given as an initial dose of 200 mg on day one, followed by 100 mg each day from day two.
Slovenian: Zdravilo Ecalta se daje v začetnem odmerku 200 mg na prvi dan, ki mu sledijo odmerki po 100 mg vsak dan od drugega dne naprej.
English: A response was defined as a significant or complete improvement of symptoms, with no need for further antifungal treatment and no Candida found in the specimens taken from the patient.
Slovenian: Odziv je bil opredeljen kot pomembno ali popolno izboljšanje simptomov brez potrebe po nadaljnjem protiglivičnem zdravljenju in z odsotnostjo Candide v vzorcih, odvzetih pri bolnikih.
English: In the analysis of patients with neutropenia, around 57% of patients (26 out of 46) had responded to treatment.
Slovenian: V analizi bolnikov z nevtropenijo so ugotovili, da se je na zdravljenje odzvalo okoli 57 % (26 od 46) bolnikov.
English: Other information about Ecalta
Slovenian: Druge informacije o zdravilu Ecalta
English: This is a summary of the European public assessment report (EPAR) for Ecalta.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ecalta.
English: The Committee recommended that Ecalta be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Ecalta izda dovoljenje za promet.
English: Fungal cells treated with Ecalta have incomplete or defective cell walls, making them fragile and unable to grow.
Slovenian: Celice glivic, izpostavljene zdravilu Ecalta, imajo nepopolne ali okvarjene celične stene, zaradi česar so krhke in ne morejo rasti.
English: An analysis of other studies evaluated the effects Ecalta in 46 patients with neutropenia.
Slovenian: Z analizo drugih študij so ocenjevali učinke zdravila Ecalta pri 46 bolnikih z nevtropenijo.
English: What benefit has Ecalta shown during the studies?
Slovenian: Kakšne koristi je zdravilo Ecalta izkazalo med študijami?
English: Ecalta should only be given by infusion, at a maximum rate of 1.1 mg per minute to avoid side effects: this corresponds to about three hours for the initial infusion, and one and a half hours for the subsequent infusions.
Slovenian: Zdravilo Ecalta se lahko daje samo v obliki infuzije z največjo hitrostjo injiciranja 1,1 mg na minuto, da bi tako preprečili stranske učinke: časovno to ustreza približno trem uram za začetno infuzijo ter poldrugi uri za nadaljnje infuzije.
English: At the end of the treatment course, 76% of the patients receiving Ecalta had responded to treatment (96 out of 127), compared with 60% of the patients receiving fluconazole (71 out of 118).
Slovenian: Ob koncu zdravljenja se je nanj odzvalo 76 % (96 od 127) bolnikov, ki so prejemali zdravilo Ecalta, v primerjavi s 60 % (71 od 118) bolnikov, ki so prejemali flukonazol.
English: A risk management plan has been developed to ensure that Ecalta is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Ecalta je bil pripravljen načrt obvladovanja tveganj.
English: It contains the active substance anidulafungin.
Slovenian: Vsebuje zdravilno učinkovino anidulafungin.
English: It is not intended to provide practical advice on how to use Ecalta.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom treatment should continue for at least two weeks after the last day that fungus is found in the patient's blood.
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom odvisno od bolnikovega odziva.
English: Ecalta is available with or without a solvent.
Slovenian: Na voljo je z vehiklom ali brez njega.
English: However, the Committee noted that Ecalta has been studied mainly in patients with candidaemia (Candida in the blood) and only in a limited number of patients with neutropenia (low white blood cell counts) or deep tissue infections or abscesses.
Slovenian: Vendar pa je opozoril, da je bilo zdravilo Ecalta proučevano predvsem pri bolnikih s kandidemijo (Candido v krvi) in le pri omejenem številu bolnikov z nevtropenijo (nizko ravnjo belih krvnih celic) ali okužbami globokih tkiv oziroma abscesi.
English: Ecalta has been studied in one main study involving 261 patients with invasive candidiasis and who did not have neutropenia (low white blood cell counts).
Slovenian: Zdravilo Ecalta so proučevali v eni glavni študiji, ki je vključevala 261 bolnikov z invazivno kandidazo, ki pa niso imeli nevtropenije (nizke ravni belih krvničk).
English: It works by interfering with the production of a component of the fungal cell wall called 1,3 β D glucan, which is necessary for the fungus to continue living and growing.
Slovenian: Deluje tako, da zavira tvorbo 1,3-β-D-glukana, ene od sestavin celične stene glivice, ki je nujna, da bi glivica lahko živela in rasla.
English: Ecalta was compared with fluconazole (another antifungal medicine).
Slovenian: Zdravilo Ecalta so primerjali s flukonazolom (drugim protiglivičnim zdravilom).
English: What is the risk associated with Ecalta?
Slovenian: Kakšna tveganja so povezana z zdravilom Ecalta?
English: Treatment with Ecalta should be started by a doctor who has experience in the management of invasive fungal infections.
Slovenian: Zdravljenje z zdravilom Ecalta mora uvesti zdravnik z izkušnjami z zdravljenjem invazivnih glivičnih okužb.
English: For practical information about using Ecalta, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Ecalta naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The most common side effects with Ecalta (seen in more than 1 patient in 10) are diarrhoea, nausea (feeling sick) and hypokalaemia (low blood potassium levels).
Slovenian: Najpogostejši neželeni učinki zdravila Ecalta (opaženi pri 1 bolniku od 10) so driska, navzeja (slabost) in hipokaliemija (nizke ravni kalija v krvi).
English: Ecalta must not be used in people who are hypersensitive (allergic) to anidulafungin or any of the other ingredients, or to any other medicines in the echinocandin class.
Slovenian: Zdravila Ecalta ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) anidulafungin ali katero koli drugo sestavino zdravila oziroma na katero koli zdravilo iz razreda ehinokandinov.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ecalta, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: For more information about treatment with Ecalta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Ecalta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that Ecalta's benefits are greater than its risks for the treatment of invasive candidiasis in adult patients.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Ecalta pri zdravljenju invazivne kandidoze pri odraslih bolnikih, večje od z njim povezanih tveganj.
English: The list of fungi against which Ecalta is active can be found in the summary of product characteristics (also part of the EPAR).
Slovenian: Za seznam glivic, proti katerim deluje zdravilo Ecalta, glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: Why has Ecalta been approved?
Slovenian: Zakaj je bilo zdravilo Ecalta odobreno?
English: For the full list of all side effects reported with Ecalta, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ecalta, glejte navodilo za uporabo.
English: Ecalta is used to treat adult patients with invasive candidiasis (a fungal infection caused by a yeast called Candida).
Slovenian: Zdravilo Ecalta se uporablja za zdravljenje invazivne kandidoze (glivične okužbe, ki jo povzroča kvasovka, imenovana Candida) pri odraslih.
English: The active substance in Ecalta, anidulafungin, is an antifungal medicine, which belongs to the group ‘echinocandins'.
Slovenian: Zdravilna učinkovina zdravila Ecalta, anidulafungin, je protiglivično zdravilo, ki spada v skupino ehinokandinov.
English: Ecalta was more effective than fluconazole in treating invasive candidiasis in non-neutropenic patients.
Slovenian: Zdravilo Ecalta je bilo pri zdravljenju invazivne kandidoze učinkovitejše od flukonazola pri bolnikih brez nevtropenije.
English: Ecalta is a powder that is made up into a solution for infusion (drip) into a vein.
Slovenian: Zdravilo Ecalta je prašek za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: The duration of treatment depends on how the patient responds.
Slovenian: Trajanje zdravljenja je
English: What is Ecalta used for?
Slovenian: Za kaj se zdravilo Ecalta uporablja?