FrancophonIA/ELRC3.0 huggingface dataset:
English: Immune-mediated colitis or diarrhoea, defined as requiring use of systemic corticosteroids and with no clear alternate etiology, occurred in patients receiving IMFINZI (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali zdravilo IMFINZI, sta se pojavila imunsko pogojeni kolitis ali driska, opredeljeno kot potreba po sistemskih kortikosteroidih in brez jasne druge etiologije (glejte poglavje 4.8).
English: Myositis
Slovenian: Imunogenost
English: Preparation of solution
Slovenian: Priprava raztopine
English: Initiate 1 to 4 mg/kg/day prednisone or equivalent followed by a taper
Slovenian: 3. ali 4. stopnja trajno prenehajte uporabljati od 1 do 4 mg/kg/dan prednizona ali ekvivalenta in nato postopoma zmanjšujte
English: Immune-mediated nephritis, defined as requiring use of systemic corticosteroids and with no clear alternate etiology, occurred in patients receiving IMFINZI (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali zdravilo IMFINZI, se je pojavil imunsko pogojeni nefritis, opredeljen kot potreba po sistemskih kortikosteroidih in brez jasne druge etiologije (glejte poglavje 4.8).
English: Grade 2
Slovenian: Preglednica 2.
English: Initiate 2 to 4 mg/kg/day prednisone or equivalent followed by a taper
Slovenian: 2. stopnja odložite uporabo odmerka uvedite 2 do 4 mg/kg/dan prednizona ali ekvivalenta in nato postopoma zmanjšujte
English: PFS
Slovenian: PC:
English: Withhold dose
Slovenian: Dajanje zdravila
English: Posology
Slovenian: Mesec
English: • underactive thyroid gland that can cause tiredness or weight gain
Slovenian: • premalo dejavna žleza ščitnica; posledici sta lahko utrujenost ali povečanje telesne mase
English: Severity
Slovenian: • driska
English: More information about the medicine can be found on the EMA website: ema.europa.eu/medicines/human/EPAR/lartruvo.
Slovenian: Več informacij o zdravilu je na voljo na spletni strani Evropske agencije za zdravila:ema.europa.eu/medicines/human/EPAR/lartruvo.
English: The review of Lartruvo was initiated on 31 January 2019 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Slovenian: Pregled zdravila Lartruvo se je pričel 31. januarja 2019 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
English: Regarding safety, the data did not show any new safety concerns.
Slovenian: Kar zadeva varnost, podatki niso pokazali nobenih novih varnostnih pomislekov.
English: In addition, the Agency is preparing a scientific publication on this first revocation of a conditional marketing authorisation.
Slovenian: Agencija bo poleg tega pripravila tudi znanstveno objavo o tej prvi ukinitvi pogojnega dovoljenja za promet.
English: 26 April 2019 EMA/237662/2019 Rev.11
Slovenian: 19. julij 2019 EMA/423345/2019
English: It was approved on condition that the company carried out a study to confirm its benefits.
Slovenian: Odobreno je bilo pod pogojem, da bo podjetje izvedlo študijo, s katero bo potrdilo njegove koristi.
English: The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.
Slovenian: Mnenje odbora CHMP je bilo predloženo Evropski komisiji, ki je 19. julija 2019 izdala končni pravno zavezujoči sklep, ki velja za vse države članice EU.
English: In January 2019, when preliminary results of the ANNOUNCE study became available, the Agency recommended that no new patients should start treatment with the medicine.
Slovenian: Januarja 2019, ko so bili objavljeni predhodni rezultati študije ANNOUNCE, jeagencija priporočila, da se s tem zdravilom ne sme začeti zdraviti novih bolnikov.
English: • For patients already on treatment with Lartruvo, doctors should consider the available treatment options.
Slovenian: • Pri bolnikih, ki se že zdravijo z zdravilom Lartruvo, morajo zdravniki razmisliti o drugih razpoložljivih možnostih zdravljenja.
English: Having now assessed the full data from the study, the Agency has concluded that the benefit of Lartruvo in combination with doxorubicin is not confirmed.
Slovenian: Ker je sedaj ocenila celotne podatke iz študije, je zaključila, da korist zdravila Lartruvo v kombinaciji z doksorubicinom ni potrjena.
English: • There are no new safety concerns with the medicine.
Slovenian: • V zvezi z zdravilom ni nobenih novih varnostnih pomislekov.
English: • However, that study showed that Lartruvo with doxorubicin is no better than doxorubicin alone at prolonging patients' lives.
Slovenian: • Vendar je ta študija pokazala, da zdravilo Lartruvo v kombinaciji z doksorubicinom ni nič boljše od samega doksorubicina pri podaljševanju življenja bolnikov.
English: • The phase 3 study ANNOUNCE of Lartruvo in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma did not confirm the clinical benefit of Lartruvo.
Slovenian: • III. faza študije ANNOUNCE z zdravilom Lartruvo v kombinaciji z doksorubicinom pri bolnikih z napredovalim ali metastatskim sarkomom mehkih tkiv ni potrdila kliničnih koristi tega zdravila.
English: The medicine was therefore granted a conditional marketing authorisation on condition that the company provided additional data from the ANNOUNCE study.
Slovenian: Zdravilo je zato pridobilo pogojno dovoljenje za promet pod pogojem, da podjetje predloži dodatne podatke iz študije ANNOUNCE.
English: Lartruvo is a cancer medicine that was authorised in the EU on 9 November 2016 to treat adults with advanced soft tissue sarcoma, a type of cancer that affects tissues of the body such as muscles, blood vessels and fat tissue.
Slovenian: Lartruvo je zdravilo za zdravljenje raka, ki je bilo odobreno 9. novembra 2016 za zdravljenje odraslih z napredovalim sarkomom mehkih tkiv, tj. vrste raka, ki prizadene mehka tkiva v telesu, kot so mišice, krvne žile in maščobno tkivo.
English: • If you are already being treated with Lartruvo, your doctor will consider the most appropriate treatment for you.
Slovenian: • Če se že zdravite s tem zdravilom, bo vaš zdravnik pretehtal najustreznejše zdravljenje za vas.
English: • The study did not meet its primary objective to prolong survival in the overall population (stratified hazard ratio [HR]: 1.05; median 20.4 for Lartruvo plus doxorubicin versus 19.8 months for placebo plus doxorubicin) or in the leiomyosarcoma sub-population (HR: 0.95; median 21.6 months for Lartruvo plus doxorubicin versus 21.9 months for placebo plus doxorubicin).
Slovenian: • Študija ni izpolnila svojega osnovnega cilja, tj. podaljšanja preživetja v splošni populaciji (stratificirano razmerje tveganja [HR]: 1,05; mediana 20,4 meseca pri jemanju zdravila Lartruvo v kombinaciji z doksorubicinom v primerjavi z 19,8 meseca pri jemanju placeba v kombinaciji z doksorubicinom) ali v podpopulaciji z leiomiosarkomom (HR: 0,95); mediana 21,6 meseca pri jemanju zdravila Lartruvo v kombinaciji z doksorubicinom v primerjavi z 21,9 meseca pri jemanju placeba v kombinaciji z doksorubicinom).
English: • Additionally, no benefit was shown in terms of prolonging progression-free survival in the overall population (HR: 1.23; median 5.4 months for Lartruvo plus doxorubicin versus 6.8 months for placebo plus doxorubicin), which was one of the secondary objectives of the study.
Slovenian: • Poleg tega niso bile ugotovljene nobene koristi z vidika podaljšanja preživetja brez napredovanja bolezni v splošni populaciji (HR: 1,23; mediana 5,4 meseca pri jemanju zdravila Lartruvo v kombinaciji z doksorubicinom v primerjavi s 6,8 meseca pri jemanju placeba v kombinaciji z doksorubicinom), kar je bil eden od sekundarnih ciljev študije.
English: Lartruvo was for use together with doxorubicin (another cancer medicine) in patients who could not undergo surgery or radiotherapy (treatment with radiation) and who had not been previously treated with doxorubicin.
Slovenian: Zdravilo Lartruvo se je uporabljalo skupaj z doksorubicinom (drugim zdravilom za zdravljenje raka) pri bolnikih, pri katerih ni bilo mogoče opraviti kirurškega posega ali jih ni bilo mogoče zdraviti z radioterapijo (zdravljenjem z obsevanjem) in ki se predhodno še niso zdravili z doksorubicinom.
English: The medicine was therefore granted a marketing authorisation on condition that the company provided additional data from the ANNOUNCE study in order to confirm the benefits and safety of the medicine.
Slovenian: Zdravilo je zato pridobilo pogojno dovoljenje za promet pod pogojem, da podjetje predloži dodatne podatke iz študije ANNOUNCE, s katero bi potrdilo koristi in varnost zdravila.
English: • The marketing authorisation of Lartruvo will therefore be withdrawn and no new patients will be treated with the medicine.
Slovenian: • Dovoljenje za promet z zdravilom Lartruvo bo zato umaknjeno, s tem zdravilom pa se ne bodo zdravili nobeni novi bolniki.
English: • Lartruvo was approved to treat a rare type of cancer called soft tissue sarcoma.
Slovenian: • Zdravilo Lartruvo je bilo odobreno za zdravljenje redke vrste raka, imenovanega sarkom mehkih tkiv.
English: EMA recommends withdrawal of marketing authorisation for cancer medicine Lartruvo
Slovenian: EMA priporoča umik dovoljenja za promet z zdravilom
English: At the time of its approval, data on the effects of Lartruvo were limited because of the small number of patients included in the main study which supported its authorisation.
Slovenian: V času odobritve zdravila Lartruvo so bili podatki o njegovih učinkih omejeni zaradi majhnega števila bolnikov, vključenih v glavno študijo, ki je bila podlaga za njegovo odobritev.
English: Lartruvo was to be given in combination with doxorubicin for up to 8 cycles of treatment, followed by Lartruvo alone in patients whose disease has not got worse.
Slovenian: Zdravilo Lartruvo naj bi se dajalo v kombinaciji z doksorubicinom največ osem ciklov zdravljenja, čemur naj bi sledilo samostojno zdravljenje z zdravilom Lartruvo pri bolnikih, pri katerih se bolezen ni poslabšala.
English: • No new safety concerns were identified during the study.
Slovenian: • Med študijo niso bili ugotovljeni nobeni novi pomisleki glede varnosti zdravila.
English: The Agency is therefore recommending that the marketing authorisation of the medicine be revoked.
Slovenian: Zato je priporočila ukinitev dovoljenja za promet s tem zdravilom.
English: Lartruvo was granted a ‘conditional approval'.
Slovenian: Zdravilo Lartruvo je pridobilo pogojno dovoljenje za promet.
English: • As a consequence, the marketing authorisation of Lartruvo will be revoked and no new patients will be able to receive Lartruvo.
Slovenian: • Zato bo dovoljenje za promet z zdravilom Lartruvo ukinjeno, tega zdravila pa ne bodo mogli prejemati novi bolniki.
English: Lartruvo was authorised in November 2016 to treat advanced soft tissue sarcoma, a condition for which there is paucity of suitable medicines.
Slovenian: Zdravilo Lartruvo je bilo novembra 2016 odobreno za zdravljenje napredovalega sarkoma mehkih tkiv, tj. obolenja, za katerega je na voljo izredno malo zdravil.
English: EMA has completed its assessment of the results of the ANNOUNCE study2 and concluded that Lartruvo (olaratumab) with doxorubicin does not prolong the lives of patients with soft tissue cancer more than doxorubicin alone.
Slovenian: Evropska agencija za zdravila (EMA) je 26. aprila 20198 zaključila svojo oceno rezultatov študije ANNOUNCE1 in ugotovila, da zdravilo Lartruvo (olaratumab) v kombinaciji z doksorubicinom nič bolj ne podaljšuje življenja bolnikov z rakom mehkih tkiv kot samostojno jemanje doksorubicina.
English: Once the European Commission has issued its decision, the Agency will publish on its website the assessment report, with details of the data assessed and the reasons for the revocation.
Slovenian: Poročilo o oceni s podrobnostmi o ocenjenih podatkih in razlogih za ukinitev dovoljenja je na voljo na spletni strani agencije EMA.
English: 18 October 2019
Slovenian: 18. oktober 2019
English: Further information on Translarna's current uses can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/translarna.
Slovenian: Več informacij o trenutnih uporabah zdravila Translarna je na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/translarna.
English: Does this refusal affect patients in clinical trials?
Slovenian: Ali ta zavrnitev vpliva na bolnike v kliničnih preskušanjih?
English: What change had the company applied for?
Slovenian: Za katero spremembo je podjetje zaprosilo?
English: It had issued its initial opinion on 27 June 2019.
Slovenian: Agencija je po zaključku ponovne presoje svoje mnenje izdala 17. oktobra 2019.Svoje prvotno mnenje je izdala 27. junija 2019.
English: The refusal was confirmed after re-examination.
Slovenian: Ta zavrnitev je bila po ponovni presoji potrjena.
English: If you are in a clinical trial and need more information about your treatment, speak with your clinical trial doctor.
Slovenian: Če ste vključeni v klinično preskušanje in potrebujete več informacij o zdravljenju, se obrnite na zdravnika, ki sodeluje v kliničnem preskušanju.
English: What were the main reasons for refusing the change to the marketing authorisation?
Slovenian: Kateri so bili glavni razlogi za zavrnitev vloge za spremembo dovoljenja za promet?
English: Re-examination confirms refusal
Slovenian: Zavrnitev po ponovni presoji potrjena
English: The company informed the Agency that there are no consequences for patients who are receiving Translarna in clinical trials.
Slovenian: Podjetje je obvestilo agencijo, da umik nima nobenih posledic za bolnike, ki zdravilo Translarna prejemajo v kliničnih preskušanjih.
English: Refusal of a change to the marketing authorisation for Translarna (ataluren)
Slovenian: Zavrnitev vloge za spremembo dovoljenja za promet z zdravilom Translarna (ataluren)
English: Although the main objective of the study was to assess the long-term safety of Translarna, the study also investigated the effectiveness of treatment in patients unable to walk, measuring changes in lung function.
Slovenian: Čeprav je bil glavni cilj študije oceniti dolgoročno varnost zdravila Translarna, so preučevali tudi učinkovitost zdravljenja pri bolnikih, ki ne morejo hoditi, in sicer z merjenjem sprememb v delovanju pljuč.
English: The additional data from the study could also not confirm the benefit of Translarna in patients no longer able to walk because there were problems with the way data from the CINRG database, which was used to indirectly compare the effects of Translarna, were selected and analysed.
Slovenian: Z dodatnimi podatki iz študije prav tako niso mogli dokazati koristi zdravila Translarna pri bolnikih, ki ne morejo več hoditi, saj so bile težave pri izboru in analizi podatkov iz zbirke podatkov CINRG, ki so jih uporabili za posredno primerjavo učinkov zdravila Translarna.
English: The company then compared the results with historical data from patients with Duchenne muscular dystrophy recorded in the database of the CINRG (Cooperative International Neuromuscular Research Group).
Slovenian: Podjetje je nato primerjalo rezultate s starimi podatki pri bolnikih z Duchennovo mišično distrofijo iz zbirke podatkov CINRG (kooperativne mednarodne skupine za živčno-mišične raziskave).
English: Therefore, the Agency was of the opinion that the balance of benefits and risks of Translarna in patients unable to walk could not be established and recommended refusing the change to the marketing authorisation.
Slovenian: Zato je agencija menila, da razmerja med koristmi in tveganji zdravila Translarna pri bolnikih, ki ne morejo več hoditi, ni mogoče določiti, in je priporočila zavrnitev vloge za spremembo dovoljenja za promet z zdravilom.
English: This is because patients unable to walk are at a more advanced stage of the disease and have reduced muscle mass and therefore the benefits of treatment may be different.
Slovenian: Bolezen pri bolnikih, ki ne morejo hoditi, je namreč v bolj napredovalem stadiju, bolniki pa imajo manjšo mišično maso, zato so koristi zdravljenja lahko drugačne.
English: The fact that Translarna is handled by the body in a similar way in patients who can walk and those who cannot was not enough to confirm the effectiveness of Translarna in these patients.
Slovenian: Dejstvo, da se zdravilo Translarna pri bolnikih, ki lahko hodijo, in bolnikih, ki ne morejo hoditi, presnavlja podobno, ne zadošča za potrditev učinkovitosti zdravila Translarna pri teh bolnikih.
English: The company provided data to show that the body handles the medicine in a similar way in patients who are able to walk and those who cannot.
Slovenian: Podjetje je predložilo podatke, ki dokazujejo, da se zdravilo presnavlja podobno pri bolnikih, ki lahko hodijo, in bolnikih, ki ne morejo hoditi.
English: In addition, the company presented the results of a study involving 94 patients with nonsense mutation Duchenne muscular dystrophy, 44 of whom were no longer able to walk.
Slovenian: Poleg tega je podjetje predložilo rezultate študije, ki je vključevala 94 bolnikov z Duchennovo mišično distrofijo z nesmiselno mutacijo, od katerih jih 44 ne more več hoditi.
English: There are no consequences for the use of Translarna in its authorised indication.
Slovenian: Zavrnitev vloge nima nobenih posledic za uporabo zdravila Translarna pri odobreni indikaciji.
English: Patients with Duchenne muscular dystrophy lack normal dystrophin, a protein found in muscles.
Slovenian: Bolnikom z Duchennovo mišično distrofijo primanjkuje normalnega distrofina, tj. beljakovine, ki je prisotna v mišicah.
English: Translarna has been authorised in the EU since July 2014.
Slovenian: Zdravilo Translarna je v EU odobreno od julija 2014.Vsebuje učinkovino ataluren in je na voljo v obliki zrnc, ki se jemljejo peroralno.
English: The company that had applied for the change to Translarna's authorisation is PTC Therapeutics International Limited.
Slovenian: Za spremembo dovoljenja za promet z zdravilom Translarna je zaprosilo podjetje PTC Therapeutics International Limited.
English: Translarna is for use in patients whose disease is due to the presence of certain defects (called nonsense mutations) in the dystrophin gene that prematurely stop the production of dystrophin, leading to a shortened dystrophin protein that does not function properly.
Slovenian: Duchennovo mišično distrofijo lahko povzročijo številne genetske anomalije.Zdravilo Translarna je namenjeno za uporabo pri bolnikih, pri katerih je bolezen posledica prisotnosti določenih okvar (imenovanih nesmiselne mutacije) gena za distrofin, ki predčasno zaustavijo tvorbo distrofina, zaradi česar nastane skrajšana oblika beljakovine distrofin, ki ne deluje pravilno.
English: Translarna is a medicine used to treat patients aged 2 years and older with Duchenne muscular dystrophy who are able to walk.
Slovenian: Translarna je zdravilo, ki se uporablja za zdravljenje bolnikov z Duchennovo mišično distrofijo, ki so starejši od dveh let in lahko hodijo.
English: The company applied for an extension of indication to add the treatment of patients with Duchenne muscular dystrophy who can no longer walk.
Slovenian: Podjetje je zaprosilo za razširitev indikacije, v katero naj bi bilo vključeno zdravljenje bolnikov z Duchennovo mišično distrofijo, ki ne morejo več hoditi.
English: What is happening with Translarna for the treatment of patients with Duchenne muscular dystrophy who are able to walk?
Slovenian: Kaj to pomeni za nadaljnjo uporabo zdravila Translarna za zdravljenje bolnikov z Duchennovo mišično distrofijo, ki lahko hodijo?
English: After re-examining its initial opinion, the European Medicines Agency has confirmed its recommendation to refuse a change to the marketing authorisation for the medicine Translarna (ataluren).
Slovenian: Evropska agencija za zdravila je po ponovni presoji prvotnega mnenja potrdila svoje priporočilo za zavrnitev vloge za spremembo dovoljenja za promet z zdravilom Translarna (ataluren).Sprememba zadeva razširitev indikacije, v katero naj bi bilo vključeno zdravljenje bolnikov z Duchennovo mišično distrofijo, ki ne morejo več hoditi.
English: Translarna is used in the small group of patients whose disease is caused by a specific genetic defect (called a ‘nonsense mutation') in the dystrophin gene.
Slovenian: Duchennova mišična distrofija je genetska bolezen, ki postopoma povzroči šibkost in prenehanje delovanja mišic.Zdravilo Translarna se uporablja pri majhni skupini bolnikov, pri katerih je bolezen posledica posebne genetske okvare (imenovane „nesmiselna mutacija“) gena za distrofin.
English: This will be done by a nurse or doctor.
Slovenian: To bosta opravila medicinska sestra ali zdravnik.
English: Reduce the dose by 20%.
Slovenian: Odmerek zmanjšajte za 20 %.
English: (See section 4.4)
Slovenian: (Glejte poglavje 4.4.)
English: This is extremely important as using more than one medicine at the same time can strengthen or weaken their effect.
Slovenian: To je zelo pomembno, saj uporaba več zdravil hkrati lahko okrepi ali oslabi njihov učinek.
English: This is determined by your height and weight.
Slovenian: Ta se določi na podlagi vaše teže in višine.
English: Avoid contact with eyes and skin.
Slovenian: Preprečite stik s kožo in očmi.
English: These are used to treat cancer.
Slovenian: Uporabljajo se za zdravljenje raka.
English: The results of blood tests and your medical condition will also be taken into account.
Slovenian: Upoštevali bodo tudi rezultate krvnih preiskav in vaše zdravstveno stanje.
English: A risk to the newborn/infants cannot be excluded.
Slovenian: Tveganja za dojenega novorojenca/otroka ne moremo izključiti.
English: Delay treatment until recovery to grade 1.
Slovenian: Počakajte z zdravljenjem do okrevanja do 1. stopnje.
English: Date of latest renewal: 06 June 2019
Slovenian: Datum zadnjega podaljšanja: 06. junij 2019
English: The infusion may need to be slowed down or stopped.
Slovenian: Infundiranje bo morda treba upočasniti ali prekiniti.
English: Tell your doctor if you think you have any of the following reactions
Slovenian: Povejte zdravniku, če mislite, da imate katero koli izmed naslednjih reakcij:
English: The safety of intrathecal use has not been established.
Slovenian: Varnost intratekalne uporabe ni bila dokazana.
English: This effect has not been evaluated in humans.
Slovenian: Ta učinek pri človeku ni bil ocenjen.
English: This will take approximately one hour unless otherwise stated.
Slovenian: Kako dolgo traja infundiranje Infundiranje traja približno eno uro, razen če ni navedeno drugače.
English: No local tolerance study was conducted.
Slovenian: Študij lokalne tolerance niso izvedli.
English: Detailed instructions for users
Slovenian: Podrobna navodila za uporabnike
English: Caution should be exercised when treating such patients.
Slovenian: Pri zdravljenju teh bolnikov je potrebna previdnost.
English: Infections have been associated with hospitalisation, septic shock, and death.
Slovenian: Okužbe so bile povezane s hospitalizacijo, septičnim šokom in smrtjo.
English: The dose modifications should be considered (see section 4.2).
Slovenian: Treba je pretehtati možnost spreminjanja odmerka (glejte poglavje 4.2).
English: Tell the person giving you the infusion immediately if you feel pain or if the injection site gets red.
Slovenian: Osebi, ki vam daje infuzijo, takoj povejte, če čutite bolečino ali če mesto injiciranja postane rdeče.
English: Please note:
Slovenian: Pomnite:
English: Do not give this medicine to children under the age of 18 years because there is no information about Pixuvri treatment in children and adolescents.
Slovenian: Tega zdravila ne smete dajati otrokom, mlajšim od 18 let, ker informacij o zdravljenju z zdravilom Pixuvri pri otrocih in mladostnikih ni.
English: Recombinant hematopoietic growth factors may be used according to institutional or European Society for Medical Oncology (ESMO) guidelines.
Slovenian: Uporabijo se lahko rekombinantni hematopoetski rastni faktorji skladno z bolnišničnimi smernicami ali smernicami Evropskega društva za medicinsko onkologijo (European Society for Medical Oncology, ESMO).
English: Women and men must use effective contraception during and up to 6 months after treatment.
Slovenian: Ženske in moški morajo uporabljati učinkovito kontracepcijo med zdravljenjem in do 6 mesecev po njem.