FrancophonIA/ELRC3.0 huggingface dataset:
English: This means that it blocks some specific enzymes known as tyrosine kinases, which are involved in stimulating cells to divide.
Slovenian: To pomeni, da zavira določene encime, imenovane tirozin kinaze, ki sodelujejo pri spodbujanju delitve celic.
English: Data showed only a limited and variable improvement in the distance that patients could walk during the walk test.
Slovenian: Podatki so pokazali zgolj omejeno in spremenljivo izboljšanje razdalje, ki so jo bolniki lahko prehodili med preskusom.
English: Furthermore, imatinib-treated PAH patients had a higher risk of serious side effects, often leading to hospitalisation during early treatment, and long-term follow-up showed no significant improvement in terms of survival or delaying the worsening of symptoms.
Slovenian: Poleg tega je pri bolnikih s pljučno arterijsko hipertenzijo, ki so bili zdravljeni z imatinibom, obstajalo večje tveganje za resne neželene učinke, zaradi katerih je bila v zgodnji fazi zdravljenja pogosto potrebna hospitalizacija, dolgotrajno spremljanje pa ni pokazalo znatnega izboljšanja v smislu preživetja ali podaljšanja časa do poslabšanja simptomov.
English: The applicant presented data from one main study involving 202 patients with PAH.
Slovenian: Družba je predložila podatke iz ene glavne študije, ki je vključevala 202 bolnika s pljučno arterijsko hipertenzijo.
English: This withdrawal has no impact on the use of other imatinib containing medicines in cancer.
Slovenian: Umik vloge nima posledic za uporabo drugih zdravil proti raku, ki vsebujejo imatinib.
English: Treatment with Ruvise was only to be started in patients who do not show a rapid progression of their disease.
Slovenian: Zdravljenje z zdravilom Ruvise naj bi se uvedlo samo pri bolnikih brez znakov hitrega napredovanja bolezni.
English: On 17 January 2013 Novartis Europharm Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ruvise, for the treatment of pulmonary arterial hypertension.
Slovenian: Družba Novartis Europharm Ltd je dne 17. januarja 2013 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Ruvise, namenjenim zdravljenju pljučne arterijske hipertenzije.
English: What is Ruvise?
Slovenian: Kaj je zdravilo Ruvise?
English: Ruvise was expected to be used as an add-on treatment in adults with pulmonary arterial hypertension (PAH, high blood pressure in the arteries of the lungs) to improve exercise capacity (the ability to carry out physical activity).
Slovenian: Zdravilo Ruvise naj bi se uporabljajo kot dopolnilno zdravljenje pri odraslih s pljučno arterijsko hipertenzijo (PAH, tj. visokim krvnim tlakom v pljučnih arterijah) za izboljšanje telesne zmogljivosti (zmožnosti izvajanja telesnih dejavnosti).
English: Imatinib is a tyrosine-kinase inhibitor.
Slovenian: Imatinib je zaviralec tirozin kinaze.
English: Withdrawal of the marketing authorisation application for Ruvise (imatinib)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Ruvise (imatinib)
English: Ruvise is a medicine that contains the active substance imatinib.
Slovenian: Ruvise je zdravilo, ki vsebuje zdravilno učinkovino imatinib.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated two rounds of questions.
Slovenian: Družba je vlogo umaknila po tem, ko je CHMP ocenil njeno predloženo dokumentacijo in oblikoval dva sklopa vprašanj.
English: The Committee was concerned that a beneficial effect of imatinib in PAH had not been sufficiently demonstrated.
Slovenian: Odbor je bil zaskrbljen, da koristi imatiniba pri zdravljenju pljučne arterijske hipertenzije niso bile zadostno dokazane.
English: It was expected to be used in patients who still have symptoms despite being treated with at least two medicines specific for PAH.
Slovenian: Uporabljalo naj bi se pri bolnikih, ki imajo simptome bolezni, čeprav so že bili zdravljeni z najmanj dvema zdraviloma za pljučno arterijsko hipertenzijo.
English: In view of the serious side effects observed in some PAH patients, the CHMP considered that more data were needed to identify which patients were at particular risk.
Slovenian: Zaradi resnih neželenih učinkov, opaženih pri nekaterih bolnikih s pljučno arterijsko hipertenzijo, je CHMP menil, da so potrebni dodatni podatki za opredelitev bolnikov, pri katerih je tveganje večje.
English: In the study, patients were given either imatinib or placebo (a dummy treatment), added to two or more PAH medicines, for 24 weeks.
Slovenian: V študiji so bolniki 24 tednov prejemali bodisi imatinib bodisi placebo (zdravilo brez zdravilne učinkovine) kot dodatek k dvema ali več zdravilom za pljučno arterijsko hipertenzijo.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Ruvise could not be approved for the treatment of PAH.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil CHMP, je Odbor v času umika izrazil določene zadržke ter je začasno menil, da zdravila Ruvise ni mogoče odobriti za zdravljenje pljučne arterijske hipertenzije.
English: In its official letter, the company stated that its decision to withdraw the application was based on the fact that the additional data required to address CHMP's questions could not be made available within the regulatory timeframe.
Slovenian: Družba je v uradnem dopisu navedla, da se je za umik vloge odločila na podlagi dejstva, da v zakonsko predpisanem roku ni mogla zagotoviti dodatnih podatkov, ki bi jih potrebovala, da bi lahko ogovorila na vprašanja, ki jih je zastavil CHMP.
English: By blocking this action, Ruvise is expected to make it easier for the blood to flow through the arteries of the lungs, thereby lowering the high blood pressure in the lungs.
Slovenian: Zdravilo Ruvise naj bi z zaviranjem njihovega delovanja omogočilo lažji pretok krvi skozi pljučne arterije in s tem znižalo visok krvni tlak v pljučih.
English: How is Ruvise expected to work?
Slovenian: Kako naj bi zdravilo Ruvise delovalo?
English: What was Ruvise expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Ruvise uporabljalo?
English: In the blood vessel cells in the lungs, this action of the tyrosine kinases contributes to the narrowing of blood vessels leading to high blood pressure.
Slovenian: Tirozin kinaze s svojim delovanjem v krvnih celicah v pljučih prispevajo k zoženju krvnih žil, posledica pa je visok krvni tlak.
English: The company informed the CHMP that on-going PAH extension studies are continuing.
Slovenian: Družba je CHMP obvestila, da še naprej potekajo podaljšane študije pri bolnikih s pljučno arterijsko hipertenzijo.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Ruvise did not outweigh its risks in the PAH population.
Slovenian: Zato je CHMP v času umika menil, da koristi zdravila Ruvise ne odtehtajo z njim povezanih tveganj pri bolnikih s pljučno arterijsko hipertenzijo.
English: Invented name
Slovenian: Zaščiteno ime Jakost
English: MA (EU) Number Name
Slovenian: Številka (EU) dovoljenja za promet
English: Strength Pharmaceutical Form Route of Administration Immediate Packaging
Slovenian: Jakost Farmacevtska oblika
English: Invented name Strength Pharmaceutical Form Route of administration
Slovenian: Farmacevtska oblika Pot uporaba
English: The review of Zydelig has been initiated at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Slovenian: Pregled zdravila Zydelig se je pričel 11. marca 2016 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
English: 1 For more information see here.
Slovenian: 1 Več informacij je na voljo tukaj.
English: 18 March 2016 EMA/201814/2016
Slovenian: marec 2016 EMA/309645/2016
English: However, these studies did not use the medicine in the same way as currently authorised.
Slovenian: Vendar se zdravilo v teh študijah ni uporabljalo tako, kot je trenutno odobreno.
English: In the EU, Zydelig is authorised for the treatment of:
Slovenian: V EU je zdravilo Zydelig odobreno za zdravljenje:
English: EMA recommends new safety measures for Zydelig
Slovenian: EMA priporoča nove varnostne ukrepe za zdravilo Zydelig
English: It is only used in combination with rituximab.
Slovenian: Uporablja se samo v kombinaciji z rituksimabom;
English: Patients who are already on treatment will have their treatment reviewed by their doctor.
Slovenian: Pri bolnikih, ki se že zdravijo, bo zdravnik njihovo zdravljenje pregledal.
English: To ensure that the medicine is used as safely as possible changes have been made to the way the medicine is used:
Slovenian: Da bi zagotovili čim varnejšo uporabo zdravila, se je način njegove uporabe spremenil:
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 sprejetje pravno zavezujoče odločbe s strani Evropske komisije, ki stopi v veljavo v vseh državah članicah EU.
English: While the review is ongoing the PRAC has made a set of provisional recommendations to protect public health.
Slovenian: Medtem ko pregled poteka, je odbor PRAC pripravil vrsto začasnih priporočil za zaščito javnega zdravja.
English: Measures include close monitoring and use of antibiotics to prevent pneumonia
Slovenian: Ukrepi vključujejo skrbno spremljanje in uporabo antibiotikov za preprečevanje pljučnice
English: Healthcare professionals will be informed in writing about the precautionary measures to be taken.
Slovenian: Zdravstveni delavci so bili pisno obveščeni o previdnostnih ukrepih, ki jih morajo izvajati.
English: Once the review is concluded, EMA will communicate further and provide guidance to patients and healthcare professionals.
Slovenian: Po koncu pregleda bo EMA sporočila še več informacij ter bolnikom in zdravstvenim delavcem posredovala navodila.
English: If you are taking Zydelig and have any questions or concerns speak to your doctor or pharmacist.
Slovenian: Če jemljete zdravilo Zydelig in imate kakršna koli vprašanja ali pomisleke, se pogovorite z zdravnikom ali farmacevtom.
English: Once the PRAC review is concluded any further recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt a final opinion.
Slovenian: Ko bo odbor PRAC zaključil pregled, bodo vsa nadaljnja priporočila posredovana Odboru za zdravila za uporabo v humani medicini (CHMP), odgovornemu za vprašanja glede zdravil za uporabo v humani medicini, ki bo sprejel končno mnenje.
English: These are provisional recommendations which the PRAC has issued, as a precaution, to protect patients while the medicine is being reviewed.
Slovenian: To so začasna priporočila, ki jih je odbor PRAC izdal kot previdnostni ukrep za zaščito bolnikov v času pregleda zdravila.
English: Regular clinical and laboratory monitoring for cytomegalovirus infection is also recommended.
Slovenian: Priporoča se tudi redno klinično in laboratorijsko spremljanje za okužbe s citomegalovirusom.
English: Patients should also be monitored for infection and have regular blood tests for white cell counts because low counts can increase their risk of infection.
Slovenian: Bolnike je treba tudi spremljati zaradi okužbe in pri njih redno opravljati krvne preiskave za določitev števila belih krvnih celic, saj zmanjšano število lahko poveča tveganje za okužbo.
English: In case of neutropenia your doctor may stop your treatment with Zydelig.
Slovenian: V primeru nevtropenije bo zdravnik morda vaše zdravljenje z zdravilom Zydelig prekinil.
English: • Patients should be informed about the risk of serious infections with Zydelig.
Slovenian: • Bolnike je treba obvestiti, da pri zdravljenju z zdravilom Zydeliog obstaja tveganje za resne okužbe.
English: • You should not stop Zydelig before speaking to your doctor.
Slovenian: • Zdravila Zydelig ne prenehajte jemati, dokler se ne posvetujete z zdravnikom.
English: More information on the approved uses of Zydelig can be found here.
Slovenian: Več informacij o odobreni uporabi zdravila Zydelig je na voljo tukaj.
English: Other excess deaths related mainly to respiratory events.
Slovenian: Drugi smrtni primeri, ki so presegali običajno umrljivost, so bili v glavnem povezani z dogodki na dihalih.
English: • Further information on the review of Zydelig will be provided as necessary and once the review is concluded.
Slovenian: • Več informacij o pregledu zdravila Zydelig bo na voljo po potrebi in po zaključku pregleda.
English: The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines.
Slovenian: Pregled opravlja Odbor za oceno tveganja na področju farmakovigilance (PRAC), ki je odgovoren za presojo varnostnih vprašanj o zdravilih za uporabo v humani medicini.
English: Doctors should reevaluate each patient taking Zydelig first-line for CLL, and only continue treatment if the benefits outweigh the risks.
Slovenian: Zdravniki morajo ponovno oceniti vsakega bolnika, ki prejema zdravilo Zydelig kot zdravilo prve izbira za KLL, zdravljenje pa se sme nadaljevati le, če so koristi večje od tveganj.
English: • a type of non-Hodgkin lymphoma called follicular lymphoma where it is used on its own.
Slovenian: • vrste ne-Hodgkinovega limfoma, imenovane folikularni limfom, kjer se uporablja samostojno.
English: • Studies in non-Hodgkin lymphoma included patients with disease characteristics different from those covered by the currently approved indication and investigated a combination of medicines not currently approved.
Slovenian: • Študije pri ne-Hodgkinovem limfomu so vključevale bolnike z značilnostmi bolezni, ki so bile drugačne od značilnosti, zajetih v trenutno odobreno indikacijo, v študijah pa so preučevali kombinacijo zdravil, ki trenutno ni odobrena.
English: EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is issuing provisional advice for doctors and patients using the cancer medicine Zydelig (idelalisib) to ensure that it continues to be used as safely as possible.
Slovenian: Odbor za oceno tveganja na področju farmakovigilance (PRAC) agencije EMA je 17. marca 2016 izdal začasni nasvet za zdravnike in bolnike, ki uporabljajo zdravilo Zydelig (idelalizib) za zdravljenje raka, da bi še naprej zagotavljali njegovo čim varnejšo uporabo.
English: In case the patient has moderate or severe neutropenia treatment with Zydelig may have to be interrupted, in line with the updated summary of product characteristics (SmPC).
Slovenian: Če ima bolnik zmerno ali hudo nevtropenijo, bo zdravljenje z zdravilom Zydelig skladno s posodobljenim povzetkom glavnih značilnosti zdravila morda treba prekiniti.
English: • If you are taking Zydelig, you will receive antibiotics to prevent a particular type of lung infection (Pneumocystis jirovecii pneumonia) and be monitored for signs of infections.
Slovenian: • Če jemljete zdravilo Zydelig, boste prejeli antibiotike za preprečevanje določene vrste pljučne okužbe (pljučnice, ki jo povzroča Pneumocystis jirovecii) in spremljali vas bodo zaradi znakov okužbe.
English: The PRAC recommends that all patients treated with Zydelig should receive antibiotics to prevent a particular type of lung infection (Pneumocystis jirovecii pneumonia).
Slovenian: Odbor PRAC je priporočil, naj vsi bolniki, ki se zdravijo z zdravilom Zydelig, prejemajo antibiotike za preprečevanje določene vrste pljučne okužbe (pljučnice, ki jo povzroča Pneumocystis jirovecii).
English: • Further details on these provisional measures will be provided in writing to healthcare professionals and the product information will be updated accordingly.
Slovenian: • Zdravstveni delavci so v pisni obliki prejeli več podrobnosti o začasnih ukrepih, v skladu s tem pa so bile posodobljene tudi informacije o zdravilu.
English: Zydelig is currently authorised in the EU to treat two types of blood cancers called chronic lymphocytic leukaemia (CLL) and follicular lymphoma (one of a group of cancers called nonHodgkin lymphoma).
Slovenian: Zdravilo Zydelig je trenutno odobreno v EU za zdravljenje dveh vrst krvnega raka, imenovanih kronična limfocitna levkemija (KLL) in folikularni limfom (eden iz skupine rakov, imenovane ne-Hodgkinov limfom).
English: • Your doctor will order regular blood tests to minimise the risk of infections or neutropenia (low white blood cell count which may make you more likely to develop an infection).
Slovenian: • Zdravnik vas bo poslal na redne krvne preiskave, da bi se tveganje za okužbe in nevtropenijo (nizko število belih krvnih celic, zaradi česar ste bolj dovzetni za razvoj okužbe) čim bolj zmanjšalo.
English: Most deaths related to infections such as Pneumocystis jirovecii pneumonia and cytomegalovirus infections.
Slovenian: Večina smrtnih primerov je bila povezana z okužbami, kot je pljučnica, ki jo povzroča Pneumocystis jirovecii, in okužbami s citomegalovirusom.
English: • All patients should receive prophylaxis for P. jirovecii pneumonia during Zydelig treatment and should be monitored for respiratory signs and symptoms.
Slovenian: • Vsi bolniki morajo med zdravljenjem z zdravilom Zydelig prejemati profilaktično zdravljenje za pljučnico, ki jo povzroča P. jirovecii, spremljati pa jih je treba zaradi pojava znakov in simptomov na dihalih.
English: • No new patients with chronic lymphocytic leukaemia (CLL) will be started on Zydelig if they have not received previous treatment for their cancer.
Slovenian: • Novi bolniki s kronično limfocitno levkemijo (KLL) se ne bodo začeli zdraviti z zdravilom Zydelig, če zdravil za zdravljenje raka predhodno še niso prejemali.
English: The clinical trials, which have now been stopped, involved patients with CLL and indolent non-Hodgkin lymphoma.
Slovenian: Klinična preskušanja, ki so jih že prekinili, so vključevala bolnike s KLL in indolentnim neHodgkinovim limfomom.
English: • Further information on Zydelig will be provided as necessary.
Slovenian: • Več podatkov o zdravilu Zydelig bo na voljo po potrebi.
English: Zydelig should not be started in patients with a generalised infection.
Slovenian: Zdravilo Zydelig se ne sme uvesti pri bolnikih z generalizirano okužbo.
English: • Zydelig can continue to be used in combination, only with rituximab, in CLL patients who have received at least one prior therapy, and as monotherapy in patients with follicular lymphoma that is refractory to two lines of treatment.
Slovenian: • Zdravilo Zydelig se lahko še naprej uporablja v kombinaciji, samo z rituksimabom, pri bolnikih s KLL, ki so prejemali vsaj eno predhodno zdravljenje, in kot monoterapija pri bolnikih s folikularnim limfomom, neodzivnim na dve obliki zdravljenja.
English: Zydelig must not be started in patients with any evidence of ongoing systemic infection.
Slovenian: Zdravilo Zydelig se ne sme uvesti pri bolnikih s kakršnimi koli znaki potekajoče sistemske okužbe.
English: The review started after a higher rate of serious adverse events was seen in three clinical trials among patients receiving Zydelig compared with placebo (a dummy treatment).1 The adverse events included deaths related to infections such as pneumonia.
Slovenian: Pregled se je začel, ko so v treh kliničnih preskušanjih pri bolnikih, ki so prejemali zdravilo Zydelig, opazili povečano pogostnost resnih neželenih učinkov v primerjavi s placebom (zdravilom brez zdravilne učinkovine).1 Neželeni učinki so vključevali smrtne primere, povezane z okužbami, kot je pljučnica.
English: It should also not be started in previously untreated patients with CLL whose cancer cells have certain genetic mutations (17p deletion or TP53 mutation).
Slovenian: Prav tako se ne sme uvesti pri predhodno nezdravljenih bolnikih s KLL, pri katerih rakave celice vsebujejo določeno gensko mutacijo (delecijo 17p ali mutacijo TP53).
English: These will now be forwarded to the European Commission (EC), which will issue a provisional legally binding decision applicable in all EU Members States.
Slovenian: Priporočila so bila predložena Evropski komisiji, ki je 23. marca 2016 izdala začasno pravno zavezujočo odločbo, ki velja za vse države članice EU.
English: • As a precaution and while a thorough review is ongoing, Zydelig should not be started as first-line treatment in patients with CLL who have the 17p deletion or TP53 mutation.
Slovenian: • Kot previdnostni ukrep in v času temeljitega pregleda se zdravilo Zydelig ne sme uvesti kot zdravilo prve izbire pri bolnikih s KLL, ki imajo delecijo 17p ali mutacijo TP53.
English: • chronic lymphocytic leukaemia in patients who have received previous treatment as well as in previously untreated patients who have certain genetic mutations (17p deletion or TP53 mutation) in their cancer cells.
Slovenian: • kronične limfocitne levkemije pri bolnikih, ki so predhodno že prejemali zdravljenje, in pri predhodno nezdravljenih bolnikih z določenimi genskimi mutacijami (delecijo 17p ali mutacijo TP53) v rakavih celicah.
English: • Patients should also have regular checks of their blood counts to detect neutropenia.
Slovenian: • Redno je treba preverjati krvno sliko za odkrivanje nevtropenije.
English: There have been reports of serious side effects in clinical studies with the cancer medicine Zydelig.
Slovenian: Iz kliničnih študij z zdravilom Zydelig za zdravljenje raka so poročali o resnih neželenih učinkih.
English: You should contact your doctor straight away if you develop fever, cough or difficulty breathing.
Slovenian: Če se pojavijo povišana telesna temperatura, kašelj ali težave z dihanjem, se takoj posvetujte z zdravnikom.
English: • Increased rates of serious adverse effects including deaths were seen in 3 clinical trials in the treatment arm evaluating the addition of Zydelig to standard therapy in first-line CLL and relapsed indolent non-Hodgkin lymphoma.
Slovenian: • V treh kliničnih preskušanjih, v katerih so vrednotili dodatek zdravila Zydelig k standardnemu zdravljenju pri prvi izbiri zdravljenja KLL in ponovljenem indolentnem ne-Hodgkinovem limfomu, so v terapevtski veji opazili povečano pogostnost resnih neželenih učinkov, vključno s smrtnimi primeri.
English: The clinical trial in CLL involved patients who had not received previous treatment, some of whom had the 17p deletion or TP53 mutation; however, it also investigated a combination of medicines which is currently not approved.
Slovenian: V klinično preskušanje pri KLL so bili vključeni bolniki, ki se predhodno niso zdravili, in med njimi so bili tudi bolniki z delecijo 17p ali mutacijo TP53.
English: No meeting in August
Slovenian: V avgustu ni sestanka
English: 3 Final accounts 2004.
Slovenian: 3 Zaključni račun 2004.
English: NATIONAL COMPETENT AUTHORITIES NATIONAL COMPETENT AUTHORITIES 3,500 EUROPEAN EXPERTS 3,500 EUROPEAN EXPERTS
Slovenian: NACIONALNI PRISTOJNI ORGANI NATIONAL COMPETENT AUTHORITIES 3500 EVROPSKIH STROKOVNJAKOV 3,500 EUROPEAN EXPERTS
English: A need for this type of meeting may emerge, for example, in the event of a pandemic-influenza outbreak.
Slovenian: Potreba po takem sestanku se na primer lahko pojavi pri izbruhu pandemije gripe.
English: The priorities and key objectives for 2006 can be summarised as follows:
Slovenian: Prednostne naloge in ključne cilje za leto 2006 je mogoče povzeti na naslednji način:
English: 18 Staff insurances
Slovenian: 18 Zavarovanje osebja
English: London E14 4HB UK
Slovenian: London E14 4HB Združeno kraljestvo
English: • by writing to:
Slovenian: • pisno na:
English: The Agency will be able to organise meetings within 24 hours, on any day of the week.
Slovenian: Agencija bo sestanke lahko organizirala v 24 urah, vse dni v tednu.
English: 301 Evaluations 302 Translation 303 Studies and consultants 304 Publications 305 Community programmes
Slovenian: 300 Sestanki 301 Ocenjevanje 302 Prevajanje 303 Študije in svetovalci 304 Objavljanje 305 Programi Skupnosti