FrancophonIA/ELRC3.0 huggingface dataset:
English: From post-marketing experience, only 18 adverse reactions have been reported to Eudravigilance for Symbioflor 2, covering both the treatment of IBS and other functional gastrointestinal disorders despite significant exposure over several decades of marketing and the pharmacovigilance system put in place by the MAH since the early 2000.
Slovenian: Iz obdobja trženja so v zbirko Eudravigilance poročali samo o 18 neželenih učinkih zdravila Symbioflor 2, ki zajemajo zdravljenje sindroma razdražljivega črevesa in drugih funkcionalnih motenj prebavil, kljub precejšnji, večdesetletni izpostavljenosti in sistemu farmakovigilance, ki ga je vzpostavil imetnik dovoljenja za promet z zdravilom kmalu po letu 2000.
English: Although the results of Study S2 point at a possible efficacy of Symbioflor 2 in the treatment of IBS, a large unexplained heterogeneity was observed among centres in terms of treatment effect and response rate.
Slovenian: Čeprav rezultati Študije S2 nakazujejo na morebitno učinkovitost zdravila Symbioflor 2 pri zdravljenju sindroma razdražljivega črevesa, so med centri opazili veliko nepojasnjeno heterogenost glede učinka zdravljenja in stopnje odzivnosti.
English: “Functional gastrointestinal disorders” defines a heterogeneous group of individual diseases, ranging from functional oesophageal, gastric, intestinal, biliary, pancreatic to functional anorectal disorders, with a wide range of different underlying pathophysiologies and symptomatic entities that require different treatment modalities.
Slovenian: „Funkcionalne motnje prebavil“ so opredeljene kot heterogena skupina posameznih bolezni, od funkcionalnih ezofagealnih, želodčnih, črevesnih, žolčnih, pankreatičnih do funkcionalnih anorektalnih motenj, s širokim obsegom različnih osnovnih patofiziologij in simptomatskih stanj, ki zahtevajo različne načine zdravljenja.
English: In 2005, based on the evaluation of the available evidence at that time in the claimed indications ("functional gastrointestinal disorders'', "irritable bowel syndrome"), the application was refused by the German National Competent Authority on the ground that a positive benefit-risk had not been adequately established.
Slovenian: Leta 2005 je nemški pristojni nacionalni organ na podlagi ovrednotenja razpoložljivih dokazov v tistem času za zahtevane indikacije („funkcionalne motnje prebavil“, „sindrom razdražljivega črevesa“) zavrnil vlogo z utemeljitvijo, da pozitivno razmerje med tveganji in koristmi ni bilo dokazano v zadostni meri.
English: No adverse events were reported in the observational study conducted in children and adolescents.
Slovenian: Iz opazovalne študije pri otrocih in mladostnikih niso poročali o nobenih neželenih učinkih.
English: The CHMP agreed with the MAH's proposal to amend the product information to include the information of this review and concluded that, considering its long presence on the market with limited adverse drug reactions reporting, the safety profile of Symbioflor 2 is generally expected to be benign.
Slovenian: Odbor CHMP se je strinjal s predlogom imetnika dovoljenja za promet z zdravilom, da spremeni informacije o zdravilu in vanje vključi informacije tega pregleda, in zaključil, da se glede na dolgoletno prisotnost na trgu z omejenim poročanjem o neželenih učinkih na splošno pričakuje sorazmerno benigen varnostni profil zdravila Symbioflor 2.
English: The CHMP recommends amendments to the product information and in view of the limitations of the currently available efficacy data for Symbioflor2 in the treatment of irritable bowel syndrome (IBS), the CHMP is of the view that a post-authorisation efficacy study should be conducted.
Slovenian: Odbor CHMP priporoča spremembe informacij o zdravilu in v luči omejitev trenutno razpoložljivih podatkov o učinkovitosti zdravila Symbioflor 2 pri zdravljenju sindroma razdražljivega črevesa meni, da je treba opraviti študijo učinkovitosti po pridobitvi dovoljenja.
English: The CHMP therefore concluded that the possibility that significant bias had compromised the validity of the results of this study could not be ruled out.
Slovenian: Odbor CHMP je zato zaključil, da ni mogoče izključiti možnosti, da je veljavnost rezultatov te študije ogrožena zaradi pomembne pristranskosti.
English: • Regulation of the immune system, gastrointestinal disorders, irritable bowel syndrome (DE).
Slovenian: • uravnavanje imunskega sistema, prebavne motnje, sindrom razdražljivega črevesa (DE);
English: In the absence of relevant data submitted by the MAH and in view of the uncertainties about proof of efficacy in Study S2, the CHMP concluded that these results cannot be extrapolated from adults to children or to adolescents.
Slovenian: V odsotnosti ustreznih podatkov, ki bi jih predložil imetnik dovoljenja za promet z zdravilom, in v luči negotovosti o dokazu učinkovitosti v Študiji S2 je odbor CHMP zaključil, da teh rezultatov ni mogoče ekstrapolirati z odraslih na otroke in mladostnike.
English: • The CHMP was of the opinion that, although the results of Study S2 seemed to suggest possible efficacy of Symbioflor 2 in IBS in adult patients, the possibility that significant bias had been introduced compromising the validity of the results could not be ruled out.
Slovenian: • odbor CHMP je menil, da čeprav kaže, da rezultati Študije S2 nakazujejo na morebitno učinkovitost zdravila Symbioflor 2 pri sindromu razdražljivega črevesa pri odraslih, ni mogoče izključiti možnosti pomembne pristranskosti, ki ogroža veljavnost rezultatov.
English: The CHMP acknowledged the MAH's proposal to delete this indication as, in the absence of any data to support the treatment of functional gastrointestinal disorders, a positive benefit-risk balance of Symbioflor 2 could not be established;
Slovenian: Odbor CHMP je sprejel predlog imetnika dovoljenja za promet z zdravilom, da izbriše to indikacijo, saj v odsotnosti podatkov v podporo zdravljenju funkcionalnih motenj prebavil pozitivnega razmerja med tveganji in koristmi zdravila Symbioflor 2 ni mogoče ugotoviti;
English: Overall, the evaluations presented by the MAH indicated that the decrease in symptom score was more important in the Symbioflor 2 than in the placebo arm.
Slovenian: Skupaj so ocene, ki jih je predstavil imetnik dovoljenja za promet z zdravilom, pokazale, da je bilo zmanjšanje simptomov pomembnejše v skupini, ki je jemala zdravilo Symbioflor 2, kot v skupini, ki je jemala placebo.
English: In the absence of relevant data submitted by the MAH to support the paediatric use and in view of the uncertainties about the benefit-risk in Study S2 conducted in adult patients only, the CHMP concluded that extrapolation of the results from adults to children or adolescents was not justified.
Slovenian: V odsotnosti ustreznih predloženih podatkov, ki bi jih predložil imetnik dovoljenja za promet z zdravilom, v podporo pediatrični uporabi in zaradi negotovosti glede razmerja med tveganji in koristmi v Študiji S2, izvedeni samo pri odraslih bolnikih, je odbor CHMP zaključil, da ekstrapolacija rezultatov z odraslih na otroke ali mladostnike ni utemeljena.
English: In this regards, the SmPC is amended to reflect that efficacy in children has not been established;
Slovenian: V tem smislu se popravi povzetek glavnih značilnosti zdravila tako, da navaja, da učinkovitost pri otrocih ni bila ugotovljena;
English: • Functional disturbances of the gastrointestinal tract and irritable bowel syndrome (Colon irritable) (AT).
Slovenian: • funkcionalne motnje prebavil in sindrom razdražljivega črevesa (iritabilni kolon) (AT);
English: In summary, in the absence of valid statistical evaluation and given the risk of bias and the paucity of elements contributing to support the robustness and the strength of the results (the evidence being based on a single pivotal trial), the CHMP was not able to confidently draw a conclusion with regards to the efficacy of Symbioflor 2 in IBS or a sub-type of IBS.
Slovenian: Če povzamemo, v odsotnosti veljavnega statističnega ovrednotenja in glede na tveganje za pristranskost in pomanjkanje elementov, ki bi prispevali k podpori robustnosti in moči rezultatov (ker dokazi temeljijo na enem samem ključnem preskušanju), odbor CHMP ni mogel oblikovati zanesljivega sklepa o učinkovitosti zdravila Symbioflor 2 pri sindromu razdražljivega črevesa ali podtipu sindroma razdražljivega črevesa.
English: In the clinical development program, there were respectively 50 adverse drug reactions reported in the Symbioflor 2 group, and 44 in the placebo group for Study S2 in 79 patients.
Slovenian: V programu kliničnega razvoja so iz Študije S2 pri 79 bolnikih poročali o 50 neželenih učinkih v skupini, ki je prejemala zdravilo Symbioflor 2, in o 44 neželenih učinkih v skupini, ki je prejemala placebo.
English: • Acknowledging the limitations of the established efficacy profile of Symbioflor 2, the CHMP requested the MAH to conduct a well-designed and adequately powered multi-centre, double blind, randomised, placebo controlled post approval efficacy study allowing for relevant subpopulation analyses to confirm the efficacy of Symbioflor 2 in the treatment of IBS in general versus subtypes of the disease such as IBS C and IBS D, gender, disease severity and address the sustainability of efficacy to confirm the efficacy of Symbioflor 2 in IBS;
Slovenian: • S priznavanjem omejitev ugotovljenega varnostnega profila zdravila Symbioflor 2 je odbor CHMP zahteval, da imetnik dovoljenja za promet z zdravilom opravi dobro zasnovano multicentrično, dvojno slepo, randomizirano, s placebom nadzorovano študijo učinkovitosti po odobritvi z zadostno statistično močjo, ki bo omogočila primerne analize podpopulacij za potrditev učinkovitosti zdravila Symbioflor 2 pri zdravljenju sindroma razdražljivega črevesa na splošno v primerjavi s podtipi bolezni, kot so sindrom razdražljivega črevesa C in D, spol, resnost bolezni, ter preučila trajnost učinkovitosti za potrditev učinkovitosti zdravila Symbioflor 2 pri sindromu razdražljivega črevesa;
English: Furthermore, the CHMP requested that the MAH conduct a well-designed and adequately powered multi-centre, double blind, randomised, placebo controlled post approval efficacy study allowing for relevant subpopulation analyses to assess the efficacy of Symbioflor 2 in the treatment of IBS in general versus subtypes of the disease such as IBS C and IBS D, gender, disease severity and address the sustainability of efficacy to confirm the efficacy of Symbioflor 2 in IBS.
Slovenian: Nadalje je odbor CHMP zahteval, da imetnik dovoljenja za promet z zdravilom opravi dobro zasnovano multicentrično, dvojno slepo, randomizirano, s placebom nadzorovano študijo učinkovitosti po odobritvi z zadostno statistično močjo, ki bo omogočila primerne analize podpopulacij za oceno učinkovitosti zdravila Symbioflor 2 pri zdravljenju sindroma razdražljivega črevesa na splošno v primerjavi s podtipi bolezni, kot so sindrom razdražljivega črevesa C in D, spol, resnost bolezni, ter preučila trajnost učinkovitosti za potrditev učinkovitosti zdravila Symbioflor 2 pri sindromu razdražljivega črevesa.
English: In addition, in the absence of valid statistical evaluations and given the paucity of elements contributing to support the robustness and the strength of the results, the CHMP was, neither able to draw reliable conclusions with regards to the efficacy of Symbioflor 2, nor to establish whether Symbioflor 2 is efficacious in IBS in general or any sub-type of IBS.
Slovenian: Poleg tega v odsotnosti veljavnega statističnega ovrednotenja in glede na pomanjkanje elementov, ki bi prispevali k podpori robustnosti in moči rezultatov, odbor CHMP ni mogel ne oblikovati zanesljivega sklepa o učinkovitosti zdravila Symbioflor 2 niti ugotoviti, ali je zdravilo Symbioflor 2 učinkovito pri zdravljenju sindroma razdražljivega črevesa na splošno ali pri katerem od njegovih podtipov.
English: Two reports in support of the claimed indication in the treatment of irritable bowel syndrome (IBS) were submitted in the context of this referral procedure:
Slovenian: V okviru tega napotitvenega postopka sta bili v podporo predloženi indikaciji za zdravljenje sindroma razdražljivega črevesa predloženi dve poročili:
English: Indication in the treatment of functional gastrointestinal disorders
Slovenian: Indikacija za zdravljenje funkcionalnih motenj prebavil
English: • The CHMP also noted that results of the observational study in children older than 4 years with IBS suggested a possible efficacy of Symbioflor 2.
Slovenian: • odbor CHMP je ugotovil tudi, da rezultati opazovalne študije pri otrocih, starejših od 4 let, s sindromom razdražljivega črevesa, kažejo na morebitno učinkovitost zdravila Symbioflor 2.
English: The SmPC was amended to reflect that efficacy in children has not been established.
Slovenian: Povzetek glavnih značilnosti zdravila je bil popravljen tako, da navaja, da učinkovitost pri otrocih ni bila ugotovljena.
English: The CHMP also noted that results of the observational study in children older than 4 years with IBS suggested a possible efficacy of Symbioflor 2.
Slovenian: Odbor CHMP je ugotovil tudi, da rezultati opazovalne študije pri otrocih, starejših od štirih let, s sindromom razdražljivega črevesa, kažejo na morebitno učinkovitost zdravila Symbioflor 2.
English: Data were not controlled and did thus not account for the contribution of spontaneous fluctuations of IBS symptoms or for a placebo response in the assessment of the benefit-risk of Symbioflor 2.
Slovenian: Podatki niso bili nadzorovani, zato pri ocenjevanju razmerja med tveganji in koristmi zdravila Symbioflor 2 ne upoštevajo spontanega nihanja simptomov sindroma razdražljivega črevesa ali odziva na zdravljenju s placebom.
English: The CHMP was of the opinion that a significant number of adverse events would have been expected to be reported in this study due to the underlying disease regardless of the safety profile of Symbioflor 2.
Slovenian: Odbor CHMP je menil, da bi bilo zaradi osnovne bolezni, ne glede na varnostni profil zdravila Symbioflor 2, v tej študiji pričakovati pomembno število neželenih učinkov.
English: However, the CHMP concluded that there were no new elements to motivate a change in the established benefit risk balance since the initial marketing authorisation for Symbioflor 2 in adult patients for the treatment of IBS;
Slovenian: Vendar pa je odbor CHMP zaključil, da od časa prvega dovoljenja za promet z zdravilom za zdravilo Symbioflor 2 pri odraslih bolnikih za zdravljenje sindroma razdražljivega črevesa ni bilo novih elementov, zaradi katerih bi bila potrebna sprememba uveljavljenega razmerja med tveganji in koristmi;
English: The best dose to use in these patients has not been determined.
Slovenian: Najboljši odmerek za te bolnike še ni bil določen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Iscover on 15 July 1998.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Iscover veljavno po vsej Evropski uniji, odobrila dne 15. julija 1998.
English: The full EPAR for Iscover 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 Iscover je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Iscover clopidogrel
Slovenian: Iscover klopidogrel
English: Iscover is converted into its active form in the body.
Slovenian: Zdravilo Iscover se v svojo aktivno obliko pretvori v telesu.
English: For genetic reasons, some patients may not be able to convert Iscover as effectively as others, which could reduce their response to the medicine.
Slovenian: Zaradi genetskih razlogov nekateri bolniki zdravila Iscover morda ne morejo tako učinkovito pretvarjati, kar lahko zmanjša njihov odziv na zdravilo.
English: Iscover is used to prevent problems caused by blood clots in adults who have:
Slovenian: Zdravilo Iscover se uporablja za preprečevanje težav, ki jih povzročajo krvni strdki pri odraslih, ki:
English: For more information about treatment with Iscover, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Iscover preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: This is a summary of the European public assessment report (EPAR) for Iscover.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Iscover.
English: The CHMP decided that Iscover's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Iscover večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: Iscover can be started between a few days and 35 days after the attack;
Slovenian: Zdravilo Iscover se lahko začne dajati od nekaj dni po napadu do 35 dni po njem;
English: In other words, about 10 patients in 1,000 will avoid having a new ischaemic event two years after starting Iscover instead of aspirin.
Slovenian: Z drugimi besedami, približno 10 bolnikov od 1 000 se bo izognilo novemu ishemičnemu napadu v dveh letih po pričetku prejemanja zdravila Iscover namesto aspirina.
English: The standard dose of Iscover is one 75-mg tablet once a day.
Slovenian: Priporočeni odmerek zdravila Iscover je ena 75-miligramska tableta enkrat dnevno.
English: This showed that Iscover reduces the risk of an event.
Slovenian: To je dokaz, da zdravilo Iscover znižuje tveganje za pojav dogodka.
English: In CAPRIE, there were 939 events in the Iscover group, and 1,020 in the aspirin group.
Slovenian: V študiji CAPRIE je bilo v skupini, ki je prejemala zdravilo Iscover, 939 dogodkov, v skupini, zdravljeni z aspirinom, pa 1 020.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Iscover.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Iscover, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Iscover was more effective than aspirin at preventing new ischaemic events.
Slovenian: Zdravilo Iscover je bilo pri preprečevanju novih ishemičnih dogodkov učinkovitejše od aspirina.
English: What benefit has Iscover shown during the studies?
Slovenian: Kakšne koristi je zdravilo Iscover izkazalo med študijami?
English: Iscover should not be used in people who may be hypersensitive (allergic) to clopidogrel or any of the other ingredients.
Slovenian: Zdravila Iscover ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) klopidogrel ali katero koli drugo sestavino zdravila.
English: This means that fewer patients will have new ischaemic events if they receive Iscover than if they receive aspirin.
Slovenian: To pomeni, da bo manj bolnikov doživelo nov ishemični napad, če bodo jemali zdravilo Iscover, kot pa če bodo jemali aspirin.
English: Iscover can be started between seven days and six months after the stroke;
Slovenian: Zdravilo Iscover se lahko začne jemati od sedem dni po napadu do šest mesecev po njem;
English: In acute coronary syndrome and atrial fibrillation, Iscover is used together with aspirin, the dose of which should not be higher than 100 mg.
Slovenian: Pri akutnem koronarnem sindromu in atrijski fibrilaciji se zdravilo Iscover uporablja skupaj z aspirinom, katerega odmerek ne sme biti višji od 100 mg.
English: The most common side effects with Iscover (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising and bleeding where the skin is punctured.
Slovenian: Najpogostejši neželeni učinki zdravila Iscover (opaženi pri 1 do 10 bolnikih izmed 100) so hematomi (kopičenje krvi pod kožo), epistaksa (krvavitve iz nosu), gastrointestinalna hemoragija (krvavitve v želodcu ali črevesju), driska, bolečine v trebuhu, dispepsija (zgaga), podplutbe in krvavitve na mestu predrte kože.
English: What is the risk associated with Iscover?
Slovenian: Kakšna tveganja so povezana z zdravilom Iscover?
English: Iscover is a medicine that contains the active substance clopidogrel.
Slovenian: Iscover je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
English: Other information about Iscover
Slovenian: Druge informacije o zdravilu Iscover:
English: For the full list of all side effects reported with Iscover, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Iscover, glejte navodilo za uporabo.
English: In the study in atrial fibrillation patients, Iscover taken together with aspirin reduced the risk of new events by 11% compared with placebo taken with aspirin, with the largest reduction (28%) seen for stroke.
Slovenian: V študiji atrijske fibrilacije so bolniki zdravilo Iscover jemali skupaj z aspirinom, kar je zmanjšalo tveganje za nove dogodke za 11 % v primerjavi s placebom, jemanim skupaj z aspirinom, kjer je bilo največje zmanjšanje opaženo glede kapi (28 %).
English: Iscover as an anticoagulant has been compared with aspirin in a study called CAPRIE including around 19,000 patients who had recently had a heart attack or an ischaemic stroke, or who had established peripheral artery disease.
Slovenian: Zdravilo Iscover kot antikoagulant so primerjali z aspirinom v študiji CAPRIE, v katero je bilo vključenih okoli 19 000 bolnikov, ki so nedavno doživeli srčni napad ali ishemično kap ali pri katerih je bilo ugotovljeno periferno arterijsko obolenje.
English: In the studies of acute coronary syndrome, all of the patients also took aspirin and the main measure of effectiveness was the number of patients who experienced an ‘event' such as a blocked artery, another heart attack or death during the study.
Slovenian: V študijah akutnega koronarnega sindroma so vsi bolniki jemali aspirin, glavno merilo učinkovitosti pa je bilo število bolnikov z „dogodkom“, kot je zamašena arterija, ponovni srčni napad ali smrt med samo študijo.
English: In ST segment elevation myocardial infarction, fewer patients on Iscover had events than patients on placebo (262 against 377 in the CLARITY study, and 2,121 against 2,310 in the COMMIT study).
Slovenian: Pri miokardnem infarktu z dvigom spojnice ST je bilo število bolnikov, pri katerih so se pojavili dogodki, manjše med bolniki, ki so jemali zdravilo Iscover, kot med bolniki, ki so prejemali placebo (262 v primerjavi s 377 v študiji CLARITY ter 2 121 v primerjavi z 2 310 v študiji COMMIT).
English: Why has Iscover been approved?
Slovenian: Zakaj je bilo zdravilo Iscover odobreno?
English: Iscover has also been compared with placebo in two studies involving patients with ST segment elevation: CLARITY, which involved over 3,000 patients and lasted for up to eight days; and COMMIT, which involved almost 46,000 patients and in which the patients received Iscover with or without metoprolol (another medicine used for heart problems or high blood pressure) for up to four weeks.
Slovenian: Zdravilo Iscover so primerjali tudi s placebom v dveh študijah z bolniki z dvigom spojnice ST: študija CLARITY je vključevala 3 000 bolnikov in je trajala do osem dni, študija COMMIT pa je vključevala skoraj 46 000 bolnikov, ki so do štiri tedne prejemali zdravilo Iscover z metoprololom (drugim zdravilom za težave s srcem ali visok krvni tlak) ali brez njega.
English: The active substance in Iscover, clopidogrel, is an inhibitor of platelet aggregation.
Slovenian: Zdravilna učinkovina v zdravilu Iscover, klopidogrel, je zaviralec agregacije trombocitov.