FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duaklir Genuair, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Duaklir Genuair in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: For practical information about using Duaklir Genuair, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Duaklir Genuair naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Side effects with Duaklir Genuair are similar to those with the individual components.
Slovenian: Neželeni učinki zdravila Duaklir Genuair so podobni tistim, ki jih opažajo pri posameznih učinkovinah.
English: However the improvement over formoterol alone was small and not considered clinically significant: FEV1 measured in the morning before the inhalation was 68 ml more with Duaklir Genuair than with formoterol alone.
Slovenian: Izboljšanje v primerjavi s formoterolom kot samostojnim zdravilom je bilo majhno in se ne šteje za klinično pomembnega: volumen FEV1, izmerjen zjutraj pred vdihavanjem, je bil pri uporabi zdravila Duaklir Genuair za 68 ml večji kot pri uporabi formoterola kot samostojnega zdravila.
English: Duaklir Genuair has been studied in 2 main studies involving over 3,400 patients with COPD, in which it was compared with aclidinium alone, formoterol alone and placebo (a dummy treatment).
Slovenian: Zdravilo Duaklir Genuair so proučevali v dveh glavnih študijah, v katerih je sodelovalo več kot 3 400 bolnikov s KOPB in v katerih so ga primerjali z aklidinijem kot samostojnim zdravilom, formoterolom kot samostojnim zdravilom in placebom (zdravilom brez zdravilne učinkovine).
English: Duaklir Genuair was also shown to increase the percentage of patients who had an improvement in breathlessness compared with placebo.
Slovenian: Prav tako je zdravilo Duaklir Genuair povečalo odstotek bolnikov, pri katerih so opazili zmanjšanje zasoplosti, v primerjavi s placebom.
English: Duaklir Genuair is available as an inhalation powder in a portable inhaler device.
Slovenian: Zdravilo Duaklir Genuair je na voljo v obliki praška za inhaliranje v prenosnem inhalatorju.
English: The CHMP noted that Duaklir Genuair was shown to significantly improve lung function in patients with COPD compared with placebo, although the improvement observed when Duaklir Genuair was compared with one of the components on its own, formoterol, was small.
Slovenian: Odbor CHMP je upošteval, da je zdravilo Duaklir Genuair znatno izboljšalo delovanje pljuč pri bolnikih s KOPB v primerjavi s placebom, čeprav je bilo izboljšanje, opaženo pri primerjavi zdravila Duaklir Genuair z eno od posamičnih učinkovin, tj. formoterolom, majhno.
English: For the full list of all side effects and restrictions with Duaklir Genuair, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Duaklir Genuair glejte navodilo za uporabo.
English: Duaklir Genuair contains two active substances: aclidinium bromide and formoterol fumarate dihydrate.
Slovenian: Zdravilo Duaklir Genuair vsebuje dve zdravilni učinkovini: aklidinijev bromid in formoterolijev fumarat dihidrat.
English: The two active substances in Duaklir Genuair, aclinidium bromide and formoterol fumarate dihydrate, work by keeping the airways open and allowing the patient to breathe more easily.
Slovenian: Zdravilni učinkovini v zdravilu Duaklir Genuair, aklidinijev bromid in formoterolijev fumarat dihidrat, delujeta tako, da pomagata ohranjati prehodnost dihalnih poti in tako bolniku olajšata dihanje.
English: Duaklir Genuair can only be obtained with a prescription.
Slovenian: Izdaja zdravila Duaklir Genuair je le na recept.
English: How is Duaklir Genuair used?
Slovenian: Kako se zdravilo Duaklir Genuair uporablja?
English: How does Duaklir Genuair work?
Slovenian: Kako zdravilo Duaklir Genuair deluje?
English: These products were approved in the European Union on 04 August 2000.
Slovenian: V Evropski uniji sta bili odobreni dne 4. avgusta 2000.
English: The PRAC reviewed the preliminary 3-year data.
Slovenian: PRAC je pregledal predhodne podatke iz obdobja 3 let.
English: Both registries were part of the risk management plan (RMP) of the respective products.
Slovenian: Oba registra sta bila vključena v načrt za obvladovanje tveganja (RMP) zadevnih zdravil.
English: The Federal Institute for Vaccines and Biomedicines (Germany) informed the Commission on the findings on the 1st of March 2013.
Slovenian: Zvezni inštitut za cepiva in biološka zdravila (Nemčija) je dne 1. marca 2013 z ugotovitvami seznanil Komisijo.
English: EUHASS study
Slovenian: Študija EUHASS
English: • Observational studies
Slovenian: • Opazovalne študije
English: Updated results from the EUHASS registry were also provided.
Slovenian: Prav tako je predložil tudi najnovejše rezultate iz registra sistema EUHASS.
English: Nine of these changes had a potential impact on inhibitor formation.
Slovenian: Devet od teh sprememb bi lahko imelo vpliv na nastanek zaviralcev.
English: The amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are set out in Annexes I and III.
Slovenian: Spremembe zadevnih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo so opredeljene v Prilogah I in III.
English: Therefore, the European Commission (EC) initiated a procedure under Article 20 of Regulation (EC) No 726/2004 and requested the Agency to assess available data and its impact on the benefit-risk balance of the medicinal products concerned and to give its opinion as to whether the marketing authorisations should be maintained, varied, suspended or revoked.
Slovenian: Evropska komisija je nato sprožila postopek v skladu s členom 20 Uredbe (ES) št. 726/2004 in zahtevala, da agencija oceni razpoložljive podatke ter njihov vpliv na razmerje med tveganji in koristmi zadevnih zdravil ter poda mnenje o tem, ali naj se dovoljenja za promet z njima ohranijo, spremenijo, začasno umaknejo ali prekličejo.
English: RODIN/PedNet study
Slovenian: Študija RODIN/PedNet
English: - the EUHASS (European Haemophilia Safety Surveillance System) registry.
Slovenian: - register sistema EUHASS (evropski sistem za spremljanje varnosti zdravil za hemofilijo).
English: • Conclusions
Slovenian: • Zaključki
English: The results of the RODIN/PedNet study (S. C. Gouw et al., N. Engl.
Slovenian: Ko so rezultati študije RODIN/PedNet (S. C. Gouw in sod., N. Engl.
English: • Quality data
Slovenian: • Podatki o kakovosti
English: One patient was lost to follow up and one patient developed a low-titre inhibitor during post study follow-up.
Slovenian: Enega bolnika ni bilo mogoče spremljati, en bolnik pa je v obdobju spremljanja po študiji razvil nizek titer zaviralcev.
English: The PRAC noted that all parameters were within specification and that there is no correlation between changes and inhibitor events.
Slovenian: PRAC je ugotovil, da so bili vsi parametri znotraj določenih vrednosti in da med spremembami in dogodki v zvezi z zaviralci ni nobene povezave.
English: Overall, 9 out of 60 (15%) developed inhibitors.
Slovenian: Skupno so se zaviralci razvili pri 9 od 60 (15 %) bolnikov.
English: These studies were either sponsored or supported by the MAH.
Slovenian: Imetnik dovoljenj za promet je te študije bodisi sponzoriral ali podprl.
English: The PRAC noted that the Factor VIII gene mutation profile of these study population (in studies 200021EU and 100074US) reflects the typical distribution seen in patients with severe haemophilia A, indicating that there was no bias in patient recruitment.
Slovenian: PRAC je ugotovil, da profil mutacij v genu za faktor VIII pri populaciji v teh študijah (200021EU in 100074US) odraža običajno porazdelitev, ki jo je mogoče opaziti pri bolnikih s hudo hemofilijo A, kar kaže na to, da je bil izbor bolnikov objektiven.
English: The EUHASS study was established in 2008 as an adverse event reporting system for patients with inherited bleeding disorders, including Haemophilia A, in Europe.
Slovenian: Študijo EUHASS, ki je bila zasnovana kot sistem za poročanje o neželenih dogodkih pri bolnikih s prirojenimi motnjami strjevanja krvi, vključno s hemofilijo A, so začeli izvajati v Evropi leta 2008.
English: • MAH sponsored and supported clinical trials
Slovenian: • Klinična preskušanja, ki jih je sponzoriral in podprl imetnik dovoljenj za promet z zdraviloma
English: No update of the RMP was considered necessary by the PRAC.
Slovenian: Posodobitev načrta za obvladovanje tveganja po mnenju odbora PRAC ni potrebna.
English: Annex IV Scientific conclusions and grounds for variation to the terms of the marketing authorisations
Slovenian: Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravilom
English: In this study, the incidence of inhibitor development ranged from 28.2% to 37.7% for all FVIII products.
Slovenian: Incidenca nastanka zaviralcev v študiji je bila od 28,2 do 37,7 % pri vseh zdravilih, ki vsebujejo faktor VIII.
English: In addition, upon request from the PRAC, the MAH provided analyses of the overall results on the observed inhibitor incidence in the light of the study design and patient selection.
Slovenian: Poleg tega je imetnik dovoljenj za promet z zdraviloma na zahtevo odbora PRAC zagotovil analize vseh podatkov o opaženi incidenci zaviralcev ob upoštevanju zasnove študije in izbora bolnikov.
English: As a consequence, the marketing authorisation holder (MAH) for Kogenate Bayer and Helixate NexGen supported two EU registries:
Slovenian: Imetnik dovoljenj za promet z zdraviloma Kogenate Bayer in Helixate NexGen je zato podprl dva registra v EU:
English: These two interventional studies were carried out as prospective, uncontrolled trials, for treatment of bleeding episodes in 37 PUPs and 23 MTPs with residual FVIII:C < 2 IU/dl.
Slovenian: Obe intervencijski študiji so izvedli kot prospektivni nenadzorovani preskušanji za zdravljenje krvavitev pri 37 predhodno nezdravljenih bolnikih in 23 minimalno zdravljenih bolnikih s preostalim faktorjem VIII: C < 2 i.e./dl.
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 for Kogenate Bayer and Helixate NexGen.
Slovenian: • PRAC je obravnaval postopek v skladu s členom 20 Uredbe (ES) št. 726/2004 za zdravili Kogenate Bayer in Helixate NexGen ;
English: Haemophilia centres in Western Europe and major haemophilia centres in North America enrolled a total of 60 PUPs/MTPs without pre-existing inhibitors in two studies (200021EU and 100074US).
Slovenian: Centri za hemofilijo v Zahodni Evropi in večji centri za hemofilijo v Severni Ameriki so izvedli dve študiji s skupno 60 predhodno nezdravljenimi in minimalno zdravljenimi bolniki brez obstoječih zaviralcev (200021EU in 100074US).
English: The PRAC was of the view that the available data are consistent with the general experience that most inhibitors develop within the first 20 EDs and that the overall data does not provide evidence that factor VIII products differ from each other in terms of inhibitor development in PUPs.
Slovenian: PRAC je menil, da razpoložljivi podatki potrjujejo splošne izkušnje, da se zaviralci v glavnem razvijejo v prvih 20 dneh izpostavljenosti, in da podatki na splošno ne dokazujejo, da bi se zdravila s faktorjem VIII med seboj razlikovala glede nastajanja zaviralcev pri predhodno nezdravljenih bolnikih.
English: Following the provisions under Article 20 of Regulation (EC) No 726/2004, the CHMP, having considered the PRAC recommendation dated 5 December 2013, is of the opinion that the marketing authorisations for Kogenate Bayer and Helixate NexGen should be varied as recommended by the PRAC.
Slovenian: V skladu z določbami iz člena 20 Uredbe (ES) št. 726/2004 je CHMP po preučitvi priporočila odbora PRAC z dne 5. decembra 2013, podal mnenje, da je treba dovoljenja za promet z zdraviloma Kogenate Bayer in Helixate NexGen spremeniti v skladu s priporočili odbora PRAC.
English: - the RODIN (Research of Determinants of Inhibitor development)/PedNet registry; and
Slovenian: - register študije RODIN (raziskava dejavnikov nastanka zaviralcev)/PedNet in
English: Overall summary of the scientific evaluation of Kogenate Bayer and Helixate NexGen
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil Kogenate Bayer in Helixate NexGen (glejte Prilogo A)
English: In 2006, an EMA expert meeting1 on FVIII products and inhibitor development concluded that there was a need to collect comparable clinical data on the immunogenicity of recombinant and plasmaderived FVIII products as a long-term objective.
Slovenian: Leta 2006 so izvedenci Evropske agencije za zdravila na sestanku1, na katerem so obravnavali zdravila, ki vsebujejo faktor VIII, in nastanek zaviralcev, zaključili, da mora biti dolgoročni cilj, da se zberejo primerljivi klinični podatki o imunogenosti rekombinantnih zdravil in zdravil iz plazme, ki vsebujejo faktor VIII.
English: According to the MAH, since the Marketing Authorisations, 42 changes in the manufacturing process of KOGENATE Bayer have been introduced.
Slovenian: Imetnik dovoljenj za promet je trdil, da je od odobritve dovoljenja za promet v postopek izdelave zdravila Kogenate Bayer vpeljal 42 sprememb.
English: The CHMP considered the below PRAC recommendation dated 5 December 2013 with regards to the procedure under Article 20 of Regulation (EC) No 726/2004 for Kogenate Bayer and Helixate NexGen.
Slovenian: CHMP je preučil spodnje priporočilo odbora PRAC z dne 5. decembra 2013 v zvezi s postopkom po členu 20 Uredbe (ES) št. 726/2004 za zdravili Kogenate Bayer in Helixate NexGen.
English: In support of the above mentioned clinical data, the MAH provided information with regards to the manufacturing process (i.e. growth condition, purification) of Kogenate Bayer /Helixate Nexgen and discussed any change which took place since the studies 200021EU and 100074US.
Slovenian: Imetnik dovoljenj za promet z zdraviloma je v podporo zgoraj omenjenim kliničnim podatkom predložil podatke v zvezi s postopkom izdelave zdravil Kogenate Bayer in Helixate NexGen (npr. pogoji za tvorjenje, prečiščevanje) in pojasnil vse spremembe od izvedbe študij 200021EU in 100074US.
English: Finally in support of the above mentioned clinical data, the MAH provided quality data with regards to the manufacturing process for Kogenate Bayer and Helixate Nexgen.
Slovenian: Poleg tega je imetnik dovoljenj za promet z zdraviloma v podporo zgoraj omenjenim kliničnim podatkom predložil še podatke o kakovosti v zvezi s postopkom izdelave zdravil Kogenate Bayer in Helixate NexGen.
English: • The PRAC noted that the efficacy of Kogenate Bayer/Helixate NexGen is not questioned and, on the basis of the available data, concluded that the current results do not confirm an increased risk of developing antibodies against Kogenate Bayer and Helixate NexGen when compared with other factor VIII products in PUPs with the bleeding disorder haemophilia A.
Slovenian: • PRAC je ugotovil, da učinkovitost zdravil Kogenate Bayer in Helixate NexGen ni vprašljiva, in na podlagi razpoložljivih podatkov zaključil, da trenutni rezultati ne potrjujejo povečanega tveganja za nastanek protiteles proti zdraviloma Kogenate Bayer in Helixate NexGen v primerjavi z drugimi zdravili, ki vsebujejo faktor VIII, pri predhodno nezdravljenih bolnikih s hemofilijo A;
English: In one observational study, the incidence of inhibitor development in previously untreated patients with severe haemophilia A was 64/183 (37.7%) with Helixate NexGen (followed up to 75 exposure days).
Slovenian: V eni opazovalni študiji je bila incidenca nastanka zaviralcev pri predhodno nezdravljenih bolnikih s hudo hemofilijo A, ki so prejemali zdravilo Helixate NexGen, 64/183 (37,7 %) (spremljali so jih do 75 dni izpostavljenosti).
English: However, the data presented by the MAH indicate that there are no significant changes in the posttranslational modifications, aggregation profile, specific activity or excipients since MA of Kogenate Bayer that might have increased the risk for inhibitor development over time.
Slovenian: Vendar pa podatki, ki jih je predložil imetnik dovoljenja za promet z zdravilom, kažejo, da od odobritve dovoljenja za promet z zdravilom Kogenate Bayer ni prišlo do večjih sprememb v posttranslacijskih modifikacijah, profilu strjevanja, specifični aktivnosti ali pomožnih snoveh, ki bi lahko povečale tveganje za to, da se sčasoma razvijejo zaviralci.
English: Post-hoc analysis of the RODIN study showed that PUPs with severe haemophilia A given Kogenate Bayer were more likely to develop inhibitor than those given another recombinant antihaemophilic factor VIII (adjusted hazard ratio, 1.60; 95%-CI: 1.08 -2.37).
Slovenian: Analiza študije RODIN post hoc je pokazala, da so se zaviralci pogosteje razvili pri predhodno nezdravljenih bolnikih s hudo hemofilijo A, ki so prejemali zdravilo Kogenate Bayer, kot pri tistih, ki so prejemali drug rekombinantni koagulacijski faktor VIII (prilagojeno razmerje tveganja, 1,60; 95-odstotni interval zaupanja: 1,08-2,37).
English: In this context, the PRAC noted that Kogenate Bayer and Helixate Nexgen is potency labelled based on an one-stage clotting assay, in accordance with the approved quality documentation for the product, and not the chromogenic assay as per the European Pharmacopeia.
Slovenian: V zvezi s tem je PRAC ugotovil, da je bila jakost zdravil Kogenate Bayer in Helixate NexGen opredeljena na podlagi enostopenjskega koagulacijskega preskusa, skladno z odobreno dokumentacijo o kakovosti za zdravilo, in ne na podlagi preskusa s kromogenim substratom po evropski farmakopeji.
English: • The PRAC considered though that the frequency for inhibitor development in PUPs should be amended from “common” to “very common” in the section 4.8 of the SmPC and also recommended that the product information should be updated to reflect the most recent results from the RODIN study.
Slovenian: • kljub temu pa je menil, da je treba v poglavju 4.8 povzetka glavnih značilnosti zdravila pogostnost nastanka zaviralcev pri predhodno nezdravljenih bolnikih spremeniti iz „pogosto“ v „zelo pogosto“, in priporočil tudi posodobitev informacij o zdravilu, tako da se vključijo najnovejši rezultati iz študije RODIN.
English: J. Med. 368, 231 (2013)) were made available and seemed to suggest that Kogenate Bayer/Helixate NexGen were associated with an increased risk of inhibitor development in previously untreated patients (PUPs) when compared to another recombinant antihaemophilic factor VIII, after adjustment for confounding factors.
Slovenian: J. Med. 368, 231 (2013)) postali na voljo, je kazalo, da sta bili po prilagoditvi glede na sočasne dejavnike zdravili Kogenate Bayer in Helixate NexGen povezani s povečanim tveganjem za nastanek zaviralcev v primerjavi z drugim rekombinantnim koagulacijskim faktorjem VIII pri predhodno nezdravljenih bolnikih.
English: The MAH will continue to support the RODIN/PedNet registry as well as the EUHASS registry, as per current obligations defined in the RMP, to further investigate individual risk factors for inhibitor development and risk mitigation in PUPs.
Slovenian: Imetnik dovoljenj za promet z zdraviloma bo še naprej podpiral register študije RODIN/PedNet in register sistema EUHASS v skladu z veljavnimi obveznostmi, opredeljenimi v RMP, da se nadalje raziščejo posamezni dejavniki tveganja za nastanek zaviralcev in zmanjšanje tveganja pri predhodno nezdravljenih bolnikih.
English: In addition, the PRAC noted an update from the on-going EUHASS data, and results showed an inhibitor incidence for Kogenate Bayer and Helixate Nexgen comparable to other products: whereas no adjustment for known risk factors for inhibitor development could be performed due to the study design, the PRAC noted that the 95 % CIs of the point estimates of PUP inhibitor incidence were overlapping substantially between different products.
Slovenian: Poleg tega je PRAC upošteval tudi najnovejše podatke iz še potekajoče študije EUHASS, rezultati pa so pokazali, da je incidenca zaviralcev pri uporabi zdravil Kogenate Bayer in Helixate NexGen podobna kot pri drugih zdravilih: ker zasnova študije ni dopuščala prilagoditve glede na znane dejavnike tveganja za nastanek zaviralcev, je PRAC upošteval, da so se 95-odstotni intervali zaupanja točkovnih ocen incidence zaviralcev pri predhodno nezdravljenih bolnikih pri različnih zdravilih večinoma prekrivali.
English: The objective of the RODIN/Pednet study was to examine the inhibitor development in PUPs with severe haemophilia A given recombinant or plasma-derived FVIII products.
Slovenian: Cilj študije RODIN/PedNet je bil raziskati nastanek zaviralcev pri predhodno nezdravljenih bolnikih s hudo hemofilijo A, ki so jim dajali rekombinantna zdravila ali zdravila iz plazme, ki vsebujejo faktor VIII.
English: The MAH also submitted data from four interventional clinical trials and six observational studies, which investigated the safety and efficacy of Kogenate Bayer/Helixate NexGen in haemophilia A patients, including studies 200021EU and 100074US in PUPs and minimally treated patients (MTPs).
Slovenian: Imetnik dovoljenj za promet z zdraviloma je predložil tudi podatke iz štirih intervencijskih kliničnih preskušanj in šestih opazovalnih študij, v katerih so proučevali varnost in učinkovitost zdravil Kogenate Bayer in Helixate NexGen pri bolnikih s hemofilijo A, vključno s študijama 200021EU in 100074US pri http://www.ema.europa.eu/docs/en_GB/document_library/Report/2009/11/WC500015512.pdf predhodno nezdravljenih bolnikih in minimalno zdravljenih bolnikih.
English: In view of the above, the PRAC agreed that the current evidence does not confirm an increased risk of developing antibodies against Kogenate Bayer and Helixate NexGen when compared with other factor VIII products in PUPs with the bleeding disorder haemophilia A. However the PRAC considered that the frequency for inhibitor development in PUPs should be amended from “common” to “very common” in the section 4.8 of the SmPC and also recommended that the product information should be updated with results from the RODIN study as part of the routine risk minimisation activities.
Slovenian: Ob upoštevanju navedenega se je PRAC strinjal, da trenutni podatki ne potrjujejo povečanega tveganja za nastanek protiteles proti zdraviloma Kogenate Bayer in Helixate NexGen v primerjavi z drugimi zdravili, ki vsebujejo faktor VIII, pri predhodno nezdravljenih bolnikih z motnjo strjevanja krvi, hemofilijo A. Kljub temu pa je menil, da je treba v poglavju 4.8 povzetka glavnih značilnosti zdravila pogostnost nastanka zaviralcev pri predhodno nezdravljenih bolnikih spremeniti iz „pogosto“ v „zelo pogosto“, in priporočil tudi, da se v okviru rednih dejavnosti za zmanjševanje tveganja posodobijo informacije o zdravilu, tako da se vključijo rezultati iz študije RODIN.
English: • The PRAC considered the publication of the results of the RODIN/PedNet study, the preliminary findings from the European Haemophilia Safety Surveillance System (EUHASS) registry and all available data submitted from clinical trials, observational studies, published literature and quality data for Kogenate Bayer and Helixate NexGen with regards to its potential risk of inhibitor development in previously untreated patients (PUPs).
Slovenian: • PRAC je preučil objavljene rezultate študije RODIN/PedNet, predhodne ugotovitve iz registra evropskega sistema za spremljanje varnosti zdravil za hemofilijo (EUHASS) in vse razpoložljive predložene podatke iz kliničnih preskušanj, opazovalnih študij in objavljene literature ter podatke o kakovosti zdravil Kogenate Bayer in Helixate NexGen, povezane z možnim tveganjem za nastanek zaviralcev pri predhodno nezdravljenih bolnikih;