FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP also agreed that the MAHs should submit annual cumulative reviews of hypersensitivity case reports, all fatal cases and all pregnancy cases, together with usage data, using same data lock point, same exposure definition, same event definition and the severity classification according to Ring and Messmer classification.
Slovenian: CHMP se je prav tako strinjal, da morajo imetniki dovoljenj za promet z zdravili ob uporabi enakega zaključnega obdobja zbiranja podatkov, enake opredelitve izpostavljenosti, enake opredelitve dogodka in klasifikacije resnosti po definiciji Ring in Messmer skupaj s podatki o uporabi predložiti letne kumulativne preglede poročil o primerih preobčutljivosti, vseh smrtnih primerih in vseh primerih nosečnosti.
English: Iron sucrose
Slovenian: Železov saharat
English: There does not appear to be a consistent pattern or predictive dose or rate of infusion that relates to the chance of these events occurring and importantly the higher individual doses do not appear to be correlated with increased frequency or severity of events.
Slovenian: Zdi se, da ni doslednega vzorca ali predvidljivega odmerka oz. predvidljive hitrosti infundiranja, ki bi bili povezani z možnostjo pojava teh dogodkov, in kar je pomembneje, zdi se, da višji posamezni odmerki niso povezani s povečano pogostnostjo ali resnostjo dogodkov.
English: Only two MAH studies have been conducted with low molecular weight iron (III)-hydroxide dextran complex.
Slovenian: Imetnik dovoljenja za promet z zdravilom je izvedel smo dve študiji s kompleksom železovega (III)hidroksid dekstrana z nizko molekulsko maso.
English: The CHMP concluded that the benefit-risk balance of intravenous iron containing medicinal products is favourable as the benefits continue to outweigh the risks in the treatment of iron deficiency when the oral route is insufficient or poorly tolerated.
Slovenian: CHMP je zaključil, da je razmerje med tveganji in koristmi za intravenska zdravila, ki vsebujejo železo, ugodno, ker so koristi še vedno večje od z njimi povezanih tveganj pri zdravljenju pomanjkanja železa, kadar peroralno jemanje ni zadostno ali bolnik zdravilo slabo prenaša.
English: One pivotal and one supportive controlled studies were conducted in adults to assess the efficacy and safety of sodium ferric gluconate as first line treatment for iron deficiency anaemia in renal haemodialysis patients on supplemental recombinant human erythropoietin.
Slovenian: Za oceno učinkovitosti in varnosti natrijevega železovega glukonata kot prve izbire zdravljenja anemije zaradi pomanjkanja železa pri bolnikih na hemodializi, ki prejemajo dodatni rekombinantni humani eritropoetin, sta bili izvedeni ena ključna študija in ena kontrolirana podporna študija.
English: Finally educational material for prescribers as well for patients highlighting the risks and warnings of hypersensitivity reactions (by e.g. a checklist, to be implemented at national level) have been requested by the CHMP for submission within the risk management plan.
Slovenian: Nazadnje je CHMP pozval, da se v okviru načrta za obvladovanje tveganja predloži izobraževalno gradivo za zdravnike, ki predpisujejo zdravilo, ter tudi za bolnike, v katerem bodo izpostavljena tveganja in opozorila glede preobčutljivostnih reakcij (npr. kontrolni seznam, ki se izpolni na nacionalni ravni).
English: The Committee concluded that the benefit-risk balance of intravenous iron containing medicinal products in the iron deficiency situations where the oral iron is not sufficient or tolerated remains positive under normal conditions of use, subject to the restrictions, warnings, changes to the product information, additional pharmacovigilance activities and risk minimisation measures agreed.
Slovenian: je Odbor zaključil, da razmerje med tveganji in koristmi intravenskih zdravil, ki vsebujejo železo, v situacijah pomanjkanja železa, kadar peroralno železo ni zadostno ali ga bolnik ne prenaša, ostaja ugodno pri normalnih pogojih uporabe, če se upoštevajo sprejete omejitve, opozorila, spremembe informacij o zdravilu, dodatne dejavnosti farmakovigilance in ukrepi za zmanjšanje tveganja.
English: There is no consistent pattern or predictive dose or administration relationship in relation with the occurrence of these events and importantly the higher individual doses do not appear to be correlated with increased frequency or severity of events.
Slovenian: Ni doslednega vzorca ali predvidljivega odmerka ali povezave pri odmerjanju v povezavi v zvezi s temi dogodki, še pomembneje pa je, da se zdi, da višji posamezni odmerki niso povezani s povečano pogostnostjo ali resnostjo dogodkov.
English: The CHMP reviewed all available data from pre-clinical and clinical studies, published literature and post-marketing experience on the hypersensitivity reactions of intravenous iron containing medicinal products.
Slovenian: CHMP je pregledal vse razpoložljive podatke iz predkliničnih in kliničnih študij, objavljene literature in izkušenj v obdobju trženja v zvezi s preobčutljivostnimi reakcijami intravenskih zdravil, ki vsebujejo železo.
English: No dose response or relationship to method of administration (undiluted bolus injection versus diluted infusion) was observed for hypersensitivity events.
Slovenian: Pri preobčutljivostnih dogodkih niso zabeležili nobenega odziva na odmerek oziroma povezave z načinom dajanja (nerazredčena bolusna injekcija v primerjavi z razredčeno infuzijo).
English: The Committee as consequence concluded that the benefit-risk balance of intravenous iron containing medicinal products in the iron deficiency situations where the oral iron is not sufficient or tolerated remains positive under normal conditions of use, subject to the restrictions, warnings, changes to the product information, additional pharmacovigilance activities and risk minimisation measures agreed.
Slovenian: Odbor je zaključil, da razmerje med tveganji in koristmi intravenskih zdravil, ki vsebujejo železo, v situacijah pomanjkanja železa, kadar peroralno železo ni zadostno ali ga bolnik ne prenaša, ostaja ugodno pri normalnih pogojih uporabe, če se upoštevajo sprejete omejitve, opozorila, spremembe informacij o zdravilu, dodatne dejavnosti farmakovigilance in ukrepi za zmanjšanje tveganja.
English: Three patients experienced ADRs of potential allergic nature in completed studies.
Slovenian: V zaključenih študijah so trije bolniki doživeli neželene reakcije potencialno alergijske narave.
English: Of these, 17 were considered serious, of which five within the immune system disorder, as mentioned above.
Slovenian: Pri železovem (III) izomaltozidu 1000 so zabeležili skupno 26 spontanih poročil, od katerih je bilo 17 ocenjenih kot resnih, od tega jih je pet spadalo med motnje imunskega sistema, kot je navedeno zgoraj.
English: Cumulative annual reporting of hypersensitivity reactions should be undertaken by all MAHs of these products.
Slovenian: Vsi imetniki dovoljenj za promet s temi zdravili morajo izdelati kumulativna letna poročila o preobčutljivostnih reakcijah.
English: In inflammatory bowel disease population, according to Khalil et al (2011), 6% of IBD patients experienced anaphylactoid reactions (Ring and Messmer grade I-II).
Slovenian: (2011) o anafilaktoidnih reakcijah poročali pri 6 % bolnikih z vnetno boleznijo črevesja (stopnja I−II po klasifikaciji Ring in Messmer).
English: The Committee reviewed all available data from pre-clinical, clinical studies, published literature, postmarketing experience on the safety of intravenous iron containing medicinal products with regards to hypersensitivity reactions.
Slovenian: Odbor je pregledal vse razpoložljive podatke iz predkliničnih in kliničnih študij, objavljene literature in izkušenj v obdobju trženja v zvezi z varnostjo intravenskih zdravil, ki vsebujejo železo, glede preobčutljivostnih reakcij.
English: Close monitoring for signs of hypersensitivity during and for at least 30 minutes after each administration of an intravenous iron product is also recommended.
Slovenian: Priporočeno je tudi skrbno spremljanje bolnikov za znake preobčutljivosti med dajanjem intravenskega železa in vsaj še 30 minut po njem.
English: The Committee is of the opinion that the benefits of intravenous iron containing medicinal products continue to outweigh the risks in the treatment of iron deficiency situations when the oral route is insufficient or poorly tolerated.
Slovenian: • Odbor je menil, da je so koristi intravenskih zdravil, ki vsebujejo železo, še vedno večje od z njimi povezanih tveganj pri zdravljenju v situacijah pomanjkanja železa, kadar peroralno jemanje ni zadostno ali bolnik zdravilo slabo prenaša;
English: The Committee reviewed all available data from pre-clinical, clinical studies, pharmacoepidemiological studies, published literature, post-marketing experience on the safety of intravenous iron containing medicinal products with regards to hypersensitivity reactions.
Slovenian: • Odbor je pregledal vse razpoložljive podatke iz predkliničnih in kliničnih študij, farmakoepidemioloških študij, objavljene literature in izkušenj v obdobju trženja v zvezi varnostjo intravenskih zdravil, ki vsebujejo železo, glede preobčutljivostnih reakcij;
English: The frequency of hypersensitivity related events reported with iron sucrose in the analysed clinical trials (0.27%) was considerably less than the hypersensitivity event risk for the respective background populations (1.2
Slovenian: 6 resnih primerov so zabeležili kot 1 primer stopnje 1, 2 primera stopnje III in 3 primere stopnje IV. Pogostnost dogodkov, povezanih s preobčutljivostjo, o katerih so v analiziranih kliničnih preskušanjih (0,27 %) poročali pri železovem saharatu, je bila veliko manjša od tveganja za preobčutljivostni dogodek pri ustreznih populacijah v ozadju (1,2−16,8 %).
English: Sodium ferric gluconate
Slovenian: Natrijev železov glukonat
English: 19 March 2018 EMA/176752/2018
Slovenian: 19. marec 2018 EMA/219997/2018
English: Xofigo was authorised in the European Union in November 2013.
Slovenian: Zdravilo Xofigo je bilo v Evropski uniji odobreno novembra 2013.
English: The review of Xofigo has been initiated at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Slovenian: Pregled zdravila Xofigo se je začel na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
English: More information on Xofigo is available.
Slovenian: Več informacij o zdravilu Xofigo je na voljo.
English: • If you are being treated with this combination, your doctor will alter your treatment.
Slovenian: • Če se zdravite s to kombinacijo zdravil, bo zdravnik spremenil vaše zdravljenje.
English: • Further information will be made available once an ongoing review of the evidence is complete.
Slovenian: • Nadaljnje informacije bodo na voljo, ko bo zaključen pregled dokazov, ki še poteka.
English: The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
Slovenian: Končna faza postopka pregleda je pravno zavezujoč sklep, ki ga sprejme Evropska komisija in je veljaven v vseh državah članicah EU.
English: This was sent to the European Commission (EC), which issued a provisional legally binding decision on 19 March
Slovenian: Priporočila so posredovali Evropski komisiji, ki je 19. marca 2018 izdala začasen pravno zavezujoč sklep.
English: EMA will communicate further at the conclusion of the review.
Slovenian: Agencija EMA bo nadaljnja sporočila podala ob zaključku pregleda.
English: • If you are being treated with Xofigo and have any questions, you should contact your doctor.
Slovenian: • Če se zdravite z zdravilom Xofigo in imate kakršna koli vprašanja, se posvetujte z zdravnikom.
English: During the review, the PRAC made provisional recommendations to protect public health.
Slovenian: Medtem ko pregled poteka, je odbor PRAC pripravil začasna priporočila za zaščito javnega zdravja.
English: Fractures have also occurred more frequently with the Xofigo combination than the placebo combination (26% versus 8.1%).
Slovenian: Tudi zlomi so se pojavili pogosteje pri kombinaciji z zdravilom Xofigo (26 %) kot pri kombinaciji s placebom (8,1 %).
English: Once the PRAC review is concluded, its recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for evaluating medicines for human use, which will adopt a final opinion.
Slovenian: Ko bo odbor PRAC zaključil pregled, bodo njegova priporočila posredovana Odboru za zdravila za uporabo v humani medicini (CHMP), ki je odgovoren za ovrednotenje zdravil za uporabo v humani medicini in bo sprejel končno mnenje.
English: In view of the seriousness of the events reported, the PRAC took action by introducing a contraindication as a temporary measure to protect patients' safety while an in-depth review of the benefits and risks of Xofigo is ongoing.
Slovenian: Glede na resnost dogodkov, o katerih so poročali, je odbor PRAC ukrepal, tako da je uvedel kontraindikacijo kot začasni ukrep za zaščito varnosti bolnikov, medtem ko temeljit pregled koristi in tveganj zdravila Xofigo še poteka.
English: These are temporary measures until the ongoing in-depth review of the benefits and risks of Xofigo is complete.
Slovenian: To so začasni ukrepi, dokler ne bo zaključen temeljit pregled koristi in tveganj zdravila Xofigo, ki še poteka.
English: Ongoing clinical study shows increased risk of death and fractures with the combination
Slovenian: Klinična študija, ki še poteka, kaže na povečano tveganje za umrljivost in zlome, povezano s to kombinacijo
English: Patients have completed the Xofigo part of the study, and the combination is no longer being used; all the patients involved are being monitored closely.
Slovenian: Bolniki so zaključili del študije z zdravilom Xofigo in kombinacija s tem zdravilom se ne uporablja več, vse udeležene bolnike pa zdaj skrbno spremljajo.
English: It is authorised for use when medical or surgical castration (stopping the production of male hormones in the body using medicines or surgery) does not work, and when the cancer has spread to the bones and is causing symptoms such as pain but is not known to have spread to other internal organs.
Slovenian: Odobreno je za uporabo, kadar kastracija z zdravili ali kirurška kastracija (prekinitev proizvodnje moških hormonov v telesu z zdravili ali operacijo) ni učinkovita ter kadar se je rak razširil na kosti in povzroča simptome, kot je bolečina, vendar ni znano, da bi se razširil na druge notranje organe.
English: Xofigo is used to treat men with cancer of the prostate (a gland of the male reproductive system).
Slovenian: Zdravilo Xofigo se uporablja pri moških za zdravljenje raka prostate (žleze moškega reproduktivnega sistema).
English: In this study 34.7% of patients treated with Xofigo, Zytiga and prednisone/prednisolone have died so far, compared with 28.2% of patients given placebo, Zytiga and prednisone/prednisolone.
Slovenian: V tej študiji je do zdaj umrlo 34,7 % bolnikov, ki so se zdravili s kombinacijo zdravil Xofigo in Zytiga ter prednizona/prednizolona, v primerjavi z 28,2 % bolnikov, ki so prejemali placebo, zdravilo Zytiga in prednizon/prednizolon.
English: EMA's Pharmacovigilance Risk Assessment Committee (PRAC) had reviewed the preliminary data from an ongoing clinical study in metastatic prostate cancer patients.
Slovenian: Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC) agencije EMA je pregledal predhodne podatke klinične študije, ki še poteka in vključuje bolnike z metastatskim rakom prostate.
English: On 8 March 2018, the European Medicines Agency (EMA) recommended contraindicating the use of the prostate cancer medicine Xofigo (radium-223 dichloride) with Zytiga (abiraterone acetate) and prednisone/prednisolone, due to an increased risk of death and fractures with this combination.
Slovenian: Dne 8. marca 2018 je Evropska agencija za zdravila (EMA) priporočila, da se kontraindicira uporaba zdravila Xofigo za zdravljenje raka prostate ([223Ra]radijev klorid) v kombinaciji z zdravilom Zytiga (abirateron acetat) in prednizonom/prednizolonom, in sicer zaradi povečanega tveganja za umrljivost in zlome, povezanega s to kombinacijo.
English: Xofigo is currently authorised for use in men whose prostate cancer has spread to the bones and is causing symptoms.
Slovenian: Zdravilo Xofigo je trenutno odobreno za uporabo pri moških, pri katerih se je rak prostate razširil na kosti in povzroča simptome.
English: • The safety and efficacy of Xofigo in combination with second generation androgen receptor antagonists such as Xtandi (enzalutamide) have not been established.
Slovenian: • Varnost in učinkovitost zdravila Xofigo v kombinaciji z drugo generacijo antagonistov androgenskih receptorjev, kot je zdravilo Xtandi (enzalutamid), nista bili dokazani.
English: Healthcare professionals in the EU must not use a combination of Xofigo with the anti-androgen Zytiga and prednisone/prednisolone, and should stop this combination in men currently treated with it and review the treatment for these patients.
Slovenian: Zdravstveni delavci v EU ne smejo uporabljati kombinacije zdravila Xofigo z zdravilom Zytiga za antiandrogeno zdravljenje in prednizonom/prednizolonom ter morajo zaključiti uporabo te kombinacije pri moških, ki se trenutno zdravijo z njo, in ponovno proučiti zdravljenje za te bolnike.
English: Healthcare professionals are also warned that the safety and efficacy of Xofigo in combination with a class of medicines called second generation androgen receptor antagonists, such as Xtandi (enzalutamide), have not been established.
Slovenian: Zdravstveni delavci so tudi prejeli opozorilo, da varnost in učinkovitost zdravila Xofigo v kombinaciji z razredom zdravil, ki se imenujejo druga generacija antagonistov androgenskih receptorjev, kot je zdravilo Xtandi (enzalutamid), nista bili dokazani.
English: The ongoing clinical study includes metastatic prostate cancer patients who have not previously received chemotherapy and who have no symptoms or only mild symptoms, such as pain.
Slovenian: Klinična študija, ki še poteka, vključuje bolnike z metastatskim rakom prostate, ki predhodno niso prejemali kemoterapije in nimajo nobenih simptomov ali pa imajo samo blage simptome, kot je bolečina.
English: • Doctors are being advised that the medicine for prostate cancer Xofigo must not be used with the prostate cancer medicine Zytiga and prednisone/prednisolone because there is evidence that the combination may be harmful to patients due to a possible increased risk of fractures and death.
Slovenian: • Zdravnikom je bilo svetovano, da se zdravilo Xofigo za zdravljenje raka prostate ne sme uporabljati skupaj z zdravilom Zytiga za zdravljenje raka prostate in prednizonom/prednizolonom, saj obstajajo dokazi, da je kombinacija škodljiva za bolnike zaradi možnega povečanega tveganja za zlome in umrljivost.
English: • Xofigo must not be used with the anti-androgen Zytiga (abiraterone acetate) and prednisone/prednisolone because of possible increased risk of fractures and mortality.
Slovenian: • Zdravilo Xofigo se ne sme uporabljati skupaj z zdravilom Zytiga za antiandrogeno zdravljenje (abirateron acetat) in prednizonom/prednizolonom, in sicer zaradi povečanega tveganja za zlome in umrljivost.
English: The ongoing study of Xofigo in combination with Zytiga and prednisone/prednisolone included patients with castration-resistant prostate cancer that has spread mainly to the bones, who have no symptoms or only mild symptoms and who have not been treated with chemotherapy.
Slovenian: Študija zdravila Xofigo v kombinaciji z zdravilom Zytiga in prednizonom/prednizolonom, ki še poteka, vključuje bolnike z rakom prostate, pri katerih kastracija ni učinkovita in se je rak razširil predvsem na kosti, ki nimajo simptomov ali imajo blage simptome in ki niso bili zdravljeni s kemoterapijo.
English: Titration pack: 12 tablets
Slovenian: Velikost pakiranja titracijsko pakiranje: 12 tablet
English: Route of administration
Slovenian: dovoljenja za promet
English: The reference member state (RMS) is France and 8 concerned member states (CMS) are involved: Austria, Germany, Hungary, the Netherlands, Poland, Romania, Spain and the United Kingdom.
Slovenian: Referenčna država članica je Francija, vključenih pa je 8 zadevnih držav članic: Avstrija, Nemčija, Madžarska, Nizozemska, Poljska, Romunija, Španija in Združeno kraljestvo.
English: It is not possible to conclude at present whether these findings could be extrapolated to altrenogest.
Slovenian: Trenutno ni mogoče skleniti, ali se lahko te ugotovitve ekstrapolirajo na altrenogest.
English: This procedure will allow an assessment of all available data and harmonised outcome in relation to all products concerned.
Slovenian: Ta postopek bo omogočil oceno vseh razpoložljivih podatkov in usklajen izid za vsa zadevna zdravila.
English: The modelling of the surface water concentrations is principally accepted.
Slovenian: Oblikovanje koncentracij v površinskih vodah je primarno sprejemljivo.
English: The warnings in the product literature remain appropriate at present in absence of new findings.
Slovenian: Opozorila v literaturi o zdravilu so trenutno ustrezna, saj ni novih ugotovitev.
English: Efficacy was not assessed in this referral procedure.
Slovenian: V tem napotitvenem postopku učinkovitost ni bila ocenjena.
English: The environmental risk assessment will be reviewed within the Article 35 referral.
Slovenian: Ocena okoljskega tveganja bo pregledana v sklopu napotitvenega postopka iz člena 35.
English: The efficacy of Suifertil has been demonstrated according to current rules during the decentralised procedure.
Slovenian: Učinkovitost zdravila Suifertil so dokazali med decentraliziranim postopkom v skladu s trenutnimi pravili.
English: For the DT50 water the conservative approach of 1000 days was used.
Slovenian: Pri vrednosti DT50 voda so uporabili konservativni pristop s 1000 dnevi.
English: This indicates potential adverse effects of steroid hormones in the environment.
Slovenian: To kaže na morebitne neželene učinke steroidnih hormonov na okolje.
English: The use of QSAR is very limited and only refers to metabolism, which is considered acceptable.
Slovenian: Uporaba razmerja QSAR je zelo omejena in se nanaša samo na presnovo, kar je sprejemljivo.
English: No further risk mitigation measures were considered than the ones proposed in the decentralised procedure.
Slovenian: Obravnavali niso nobenih dodatnih ukrepov za zmanjševanje tveganja, razen ukrepov, ki so bili predlagani pri decentraliziranem postopku.
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila za uporabo v veterinarski medicini, živalskih vrst, poti uporabe zdravila, predlagateljev dovoljenja za promet z zdravilom v državah članicah
English: Effect data with altrenogest are not available in the public domain.
Slovenian: Podatki o učinku altrenogesta niso javno dostopni.
English: For DT50 soil a conservative approach of 10 days was used, based on reported half-lives of different hormones.
Slovenian: Za vrednost DT50 tla so uporabili konservativni pristop z 10 dnevi, ki je temeljil na poročanih razpolovnih časih različnih hormonov.
English: Quality, target animal safety, user safety and residues were not assessed in this referral procedure, as no concern was notified by the reference Member State.
Slovenian: V tem napotitvenem postopku niso ocenjevali kakovosti, varnosti za ciljne živali, varnosti za uporabnika in ostankov, saj referenčna država članica ni priglasila nobenega pomisleka.
English: Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from France.
Slovenian: Na podlagi predloženih podatkov je odbor glede pomislekov, izpostavljenih v uradnem obvestilu, prejetem iz Francije, podal naslednje zaključke.
English: In parallel of the QSAR calculation, the applicant has considered the worst case where altrenogest is not metabolised at all.
Slovenian: Vzporedno z izračunom QSAR je predlagatelj predpostavil najslabši mogoči scenarij, pri katerem se altrenogest sploh ne presnovi.