natgillin/translations-raw huggingface dataset:
In addition, neutrophil count monitoring is recommended. 
Poleg tega se priporoča spremljanje števila nevtrofilcev.
• The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for Zydelig (idelalisib). 
• Odbor PRAC je obravnaval postopek v skladu s členom 20 Uredbe (ES) št. 726/2004, ki je bil na podlagi farmakovigilančnih podatkov sprožen za zdravilo Zydelig (idelalizib).
The PRAC also reviewed all the other relevant data presented by the MAH and the views expressed by the oncology scientific advisory group. 
Odbor PRAC je prav tako pregledal vse druge pomembne podatke, predstavljene s strani imetnika dovoljenja za promet in stališča znanstvene svetovalne skupine za onkologijo.
The PRAC concluded that the same risk minimisation measures should be applied. 
Odbor PRAC je zaključil, da je treba uporabiti enake dejavnosti za zmanjševanje tveganja.
In case of very low ANC (<500/mm3), treatment should be interrupted and may be resumed, at a lower dose, once this has resolved. 
V primeru zelo nizkega ANC (< 500/mm3) je treba zdravljenje prekiniti in ga ponovno nadaljevati z nižjim odmerkom, ko se to razreši.
Patients' blood counts should also be monitored during the first 6 months of treatment, adapting the frequency to the absolute neutrophil count (ANC). 
Prav tako je treba pri bolnikih spremljati krvno sliko prvih 6 mesecev zdravljenja in prilagajati pogostnost glede na absolutno število nevtrofilcev (ANC).
The wording of the indication in first line CLL should be amended to reflect the above recommendation and it should be specified that this is linked to the limited data available in this setting. 
Besedilo indikacije prve izbire zdravljenja KLL se mora spremeniti, da odraža zgornja priporočila, in treba je določiti, da je to povezano z omejenimi podatki, ki so na voljo pri tej kombinaciji.
In addition, the data suggest that these results reflect the fact that the known toxicity of the treatment was not outweighed by its benefits due to the good prognosis and therefore low disease-related mortality of previously untreated CLL patients. 
Poleg tega podatki kažejo, da ti rezultati odražajo dejstvo, da znana toksičnost zdravljenja ni odtehtala njegovih koristi zaradi dobre prognoze in zato nizke umrljivosti, povezane z boleznijo bolnikov s KLL, ki še niso bili zdravljeni.
Whereas, 
Ni pa bilo nobene
Characteristics of patients in those studies are compatible with a good prognosis, including slow disease progression, hence leading as in study -0123 to an unmasking of the idelalisib toxicity. 
Značilnosti bolnikov v teh študijah so združljive z dobrimi prognozami, vključno s počasnim potekom bolezni, zato vodijo, kot v študiji -0123, do razkrivanja toksičnosti idelaliziba.
Idelalisib is known to cause very commonly infections and neutropenia and these risks are reflected in the product information. 
Za idelalizib je znano, da povzroča zelo pogoste okužbe in nevtropenijo in ta tveganja se odražajo v informacijah o zdravilu.
Further, these two studies included patients with earlier disease characteristics than the population for which idelalisib is authorised. 
Poleg tega so bili v ti dve študiji vključeni bolniki z značilnostmi prejšnje bolezni, kot populacija, za katero je odobren idelalizib.
These results highlight nonetheless the importance of ensuring that the risk of serious infection is adequately minimised in the authorised indications, in line with the measures employed in studies that demonstrated the positive benefit-risk balance of idelalisib. 
Ti rezultati kljub temu poudarjajo pomembnost zagotavljanja, da je tveganje za resno okužbo ustrezno zmanjšano v odobrenih indikacijah v skladu z ukrepi, uporabljenimi v študijah, ki so kazale pozitivno razmerje med koristmi in tveganji idelaliziba.
This review was initiated due to a reported increased risk of death and higher incidence of serious adverse events (SAE) among subjects receiving idelalisib compared to the control groups observed in three clinical trials (GS-US-312-0123, GS-US-313-0124, GS-US-313-01251). 
Ta pregled je bil uveden zaradi poročanega povečanega tveganja za smrt in višjo pojavnost resnih neželenih učinkov pri preiskovancih, ki so prejemali idelalizib, v primerjavi s kontrolnimi skupinami, opazovanimi v treh kliničnih preskušanjih (GS-US-312-0123, GS-US-313-0124, GS-US-313-01251).
While CMV and PJP are important risks, in the studies they accounted for a relatively small proportion of the serious infections observed, therefore the PRAC considered that more general measures to minimise the risk of serious infections as implemented as part of the provisional measures were justified. 
Medtem ko sta okužbi s CMV in PJP pomembni tveganji, sta v študijah predstavljali relativno majhen delež opaženih resnih okužb, zato je odbor PRAC menil, da so utemeljeni bolj splošni ukrepi za zmanjšanje tveganja za resne okužbe, kot se izvajajo v okviru začasnih ukrepov.
These recommendations should be reflected in the product information together with a description of the infectious events and the MAH should conduct a study to assess healthcare practitioners' awareness to these risk minimisation measures. 
Priporočila morajo biti izražena v informacijah o zdravilu skupaj z opisom nalezljivih dogodkov, imetnik dovoljenja za promet pa mora opraviti študijo za ocenitev osveščenosti zdravstvenih delavcev glede teh dejavnosti za zmanjšanje tveganja.
Regular clinical and laboratory monitoring for cytomegalovirus infection is also recommended in patients with evidence of prior infection. 
Priporoča se tudi redno klinično in laboratorijsko spremljanje za okužbe s citomegalovirusom pri bolnikih z znaki predhodne okužbe.
If clinical signs of CMV infection appear, consideration should be given to interrupting idelalisib until the infection has resolved. 
Če se pojavijo klinični znaki okužbe s CMV, je treba premisliti o prekinitvi zdravljenja z idelalizibom, dokler se okužba ne pozdravi.
The unfavourable results of studies -0124 and -0125 reflect the use of the additional treatment related toxicity, which is not the same as that of the authorised use in monotherapy. 
Neugodni rezultati študij -0124 in -0125 odražajo toksičnost, povezano z uporabo dodatnega zdravljenja, ki ni enaka kot tista pri odobreni uporabi v monoterapiji.
The PRAC considered that further minimisation measures of the known risk of infection related to the use of idelalisib were necessary. 
Odbor PRAC je menil, da so bile potrebne nadaljnje dejavnosti za zmanjšanje znanega tveganja za okužbo, povezano z uporabo idelaliziba.
The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for Zydelig. 
Odbor posledično priporoča spremembo pogojev dovoljenja za promet z zdravilom Zydelig.
The trials evaluated treatment combinations with chemotherapy and immunotherapy which are currently not authorised for Zydelig (idelalisib) in populations with earlier disease characteristics than the currently approved indication. 
V preskušanjih so vrednotili kombinacije zdravljenj s kemoterapijo in imunoterapijo, ki trenutno za zdravilo Zydelig (idelalizib) niso odobrene za populacije z značilnostmi zgodnejše bolezni, kot je trenutno odobrena indikacija.
In the event of severe neutropenia, treatment should be interrupted and may be restarted at a lower dose upon resolution. 
V primeru hude nevtropenije je treba prekiniti zdravljenje, zdravljenje pa ponovno pričeti pri nižjem odmerku, ko se to razreši.
The CHMP recently adopted a positive opinion to also authorise the use of idelalisib in CLL in combination with another anti CD20 monoclonal antibody, ofatumumab. 
Odbor CHMP je pred kratkim sprejel pozitivno mnenje, da odobri uporabo idelaliziba pri KLL v kombinaciji z drugim monoklonskim protitelesom proti CD20, ofatumumabom.
• The PRAC noted that most of the serious adverse events reported in studies -0123, -0124 and -0125 were related to infections. 
• Odbor PRAC je ugotovil, da je bila večina resnih neželenih učinkov, o katerih so poročali v študijah -0123, -0124 in -0125, povezana z okužbami.
Similarly, in studies -0124 and -0125 idelalisib was not used as monotherapy as currently authorised but in combination with rituximab or rituximab and bendamustine, respectively. 
Podobno v študijah -0124 in -0125 idelalizib ni bil uporabljen kot monoterapija, kot je trenutno odobreno, ampak v kombinaciji z rituksimabom oziroma rituksimabom in bendamustinom.
The CHMP therefore concluded that it is not needed to include this statement in the SmPC. 
Odbor CHMP je zato zaključil, da tega stavka ni potrebno vključiti v povzetek glavnih značilnosti zdravila.
• The PRAC noted that studies -0123, -0124 and -0125 involved patient groups and treatment combinations different from those of the authorised indications of Zydelig. 
• Odbor PRAC je ugotovil, da so študije -0123, -0124 in -0125 vključevale skupine bolnikov in kombinacije zdravljenj, ki so se razlikovale od tistih, ki so odobrene indikacije zdravila Zydelig.
In addition as no controlled study was conducted in this indication, in view of the importance of the risk of serious infections, the MAH should conduct a post-authorisation safety study to collect additional safety data in those patients. 
Ker pa za to indikacijo ni bila izvedena kontrolirana študija, mora imetnik dovoljenja za promet glede na pomembnost tveganja za resne okužbe izvesti študijo po pridobitvi dovoljenja za promet, da zbere dodatne podatke o varnosti teh bolnikov.
Nonetheless, considering the seriousness of those events, and following the SAG advice, the PRAC recommended that patients with evidence of prior CMV infection should undergo regular clinical and laboratory monitoring and patients with CMV viremia should be carefully monitored. 
Kljub temu je odbor PRAC, ob upoštevanju resnosti teh dogodkov in po upoštevanju nasvetov znanstvene svetovalne skupine, priporočil, da je treba pri bolnikih z znaki predhodne okužbe s CMV redno izvajati klinično in laboratorijsko spremljanje in redno spremljati bolnike s CMV v krvi.
Therefore while the relevance of these results are also limited for the authorised use in patients refractory to two prior lines of follicular lymphoma treatment, where idelalisib has been demonstrated to be effective and no other effective treatment options exist, they highlight the importance of minimising the risk of serious infection. 
Ker pa je pomen teh rezultatov omejen tudi za pooblaščeno uporabo pri bolnikih s folikularnim limfomom, neodzivnih na dve predhodni obliki zdravljenja, kjer se je idelalizib pokazal za učinkovitega, in ker ne obstajajo nobene druge učinkovite možnosti, poudarjajo pomembnost zmanjševanja tveganja za resno okužbo.
No low-risk population or risk-free period could be identified and the risk may persist after end of therapy, therefore, taking into account current guidelines on PJP prophylaxis and in line with the advice from experts consulted during the review (scientific advisory group [SAG]), the PRAC recommended that PJP prophylaxis should be administered to all patients throughout idelalisib treatment and prolonged afterward for up to 6 months based on clinical judgement. 
Ker ni bilo mogoče opredeliti populacije z majhnim tveganjem ali obdobje brez tveganja in ker se lahko tveganje ohrani po koncu zdravljenja, je odbor PRAC, ob upoštevanju sedanjih smernic o profilaktičnem zdravljenju za pljučnico, ki jo povzroča PJP, in v skladu s posvetom s strokovnjaki med pregledom (znanstvena svetovalna skupina [SAG]), priporočil, da je treba skozi celotno zdravljenje z idelalizibom vsem bolnikom dajati profilaktično zdravljenje za pljučnico, ki jo povzroča PJP, in ga na osnovi klinične presoje podaljšati do 6 mesecev po zdravljenju.
• The PRAC reviewed the preliminary data provided by the marketing authorisation holder on the interim results of studies GS-US-312-0123, GS-US-313-0124, GS-US-313-0125 that suggested an increased risk of death and serious infection with idelalisib. 
• Odbor PRAC je pregledal preliminarne podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom, o vmesnih rezultatih študij GS-US-312-0123, GS-US-313-0124, GS-US-313-0125, ki kažejo na povečano tveganje za smrt in resne okužbe pri idelalizibu.
CMV infections were also notably reported in the idelalisib treatment arms, however, in controlled studies where idelalisib was administered in combination with rituximab or ofatumumab and not bendamustine, the reported rate was low. 
O okužbah s CMV so prav tako poročali v krakih zdravljenja z idelalizibom, vendar je bila v nadzorovanih študijah, kjer je bil dajan idelalizib v kombinaciji z rituksimabom ali ofatumumabom in ne bendamustinom, poročana stopnja nizka.
While these risks were considered acceptable due to the demonstrated beneficial effect observed in the studies that supported the initial marketing authorisation and later extension of indication, these three new studies indicate that in patients with early disease (CLL or 
Medtem ko so bila ta tveganja ocenjena kot sprejemljiva zaradi dokazano blagodejnega vpliva, opaženega v študijah, predloženih v podporo prvemu dovoljenju za promet z zdravilom in kasnejše razširitve indikacije, te tri nove študije kažejo, da pri bolnikih v zgodnjem stadiju bolezni (KLL ali iNHL) koristi ne odtehtajo tveganj (predvsem za resne okužbe).
If the benefits of resuming idelalisib are judged to outweigh the risks of CMV, consideration should be given to administering pre-emptive CMV therapy. 
Če se oceni, da so koristi ponovnega začetka zdravljenja z idelalizibom večje od tveganja za okužbo s CMV, je treba premisliti o dajanju preventivnega zdravljenja za CMV.
This text was considered not to be contributory as adequate information on the benefit-risk balance of idelalisib in these patients is already included in other sections of the product information. 
Menil je, da to besedilo ne prispeva ustreznih informacij glede razmerja med koristjo in tveganjem idelaliziba pri teh bolnikih, ki so že vključene v druga poglavja informacij o zdravilu.
The PRAC considered the new interim safety data and very limited efficacy data from three studies (-0123,0124, -0125), that have been terminated, evaluating the addition of idelalisib to standard therapies in first line CLL and relapsed indolent non-Hodgkin lymphoma (iNHL)/small lymphocytic lymphoma (SLL) as well as the results of all other relevant trials including those that supported the above listed indications. 
Odbor PRAC je proučil nove začasne podatke o varnosti in zelo omejene podatke o učinkovitosti iz treh zaključenih študij (-0123, -0124, -0125), v katerih so vrednotili dodajanje idelaliziba standardnim terapijam pri prvi izbiri zdravljenja KLL in ponovljenem indolentnem ne-Hodgkinovem limfomu (iNHL)/limfomu malih limfocitov (SLL), ter tudi rezultate vseh drugih ustreznih preskušanj, vključno s tistimi, ki so podprli zgoraj navedene indikacije.
In particular, PRAC recommended that treatment should not be initiated in patients with evidence of ongoing systemic infection, that patients should be monitored for respiratory signs and symptoms throughout treatment and advised to report new respiratory symptoms promptly. 
Odbor PRAC je priporočil, da se zdravljenje ne sme uvesti pri bolnikih z znaki potekajoče sistemske okužbe, da je treba pri bolnikih ves čas zdravljenja spremljati respiratorne znake in simptome in jih opozoriti, da nemudoma poročajo o novih respiratornih simptomih.
The PRAC considered that the benefit-risk balance in this indication remained positive provided the risk minimisation measures are implemented. 
Odbor PRAC je menil, da je razmerje med tveganji in koristmi pri tej indikaciji še naprej pozitivno, pod pogojem, da se izvajajo dejavnosti za zmanjševanje tveganja.
To this effect, the PRAC recommended that treatment with idelalisib should not be initiated in patients with evidence of systemic infections, that patients should be monitored for respiratory symptoms and that they should be administered Pneumocystis jirovecii pneumonia prophylaxis throughout and after idelalisib treatment. 
V zvezi s tem je odbor PRAC priporočil, da se zdravljenje z idelalizibom ne sme uvesti pri bolnikih z znaki sistemskih okužb, da je treba bolnike opazovati zaradi respiratornih simptomov in da jim je treba dajati profilaktično zdravljenje proti pljučnici, ki jo povzroča Pneumocystis jirovecii, skozi celotno zdravljenje z idelalizibom in po njem.
The PRAC considered that these measures should be applied for the use of idelalisib in combination with ofatumumab in CLL patients. 
Odbor PRAC je menil, da bi te ukrepe bilo treba izvajati pri uporabi idelaliziba v kombinaciji z ofatumumabom pri bolnikih s KLL.
The benefit-risk balance of idelalisib in combination with rituximab in treatment naïve and relapsed/refractory CLL is therefore considered to remain positive provided the recommended risk minimisation measures are applied. 
Zato se šteje, da razmerje med tveganji in koristmi idelaliziba v kombinaciji z rituksimabom pri zdravljenju še nezdravljene in relapsne/refraktorne KLL, ostane pozitivno, pod pogojem, da se upoštevajo priporočene dejavnosti za zmanjšanje tveganja.
However as patients with 17p deletion or TP53 mutation have a poor prognosis, the extrapolation of the positive results observed in relapsed/refractory subjects with 17p deletion or TP53 mutation that supported the initial granting of the indication in patients unsuitable for chemoimmunotherapy is not questioned. 
Ker pa imajo bolniki z delecijo 17p ali mutacijo TP53 slabo prognozo, ni vprašljiva ekstrapolacija pozitivnih rezultatov pri relapsnih/refraktornih preiskovancih z delecijo 17p ali mutacijo TP53, ki je podpirala začetno pridobitev indikacije pri bolnikih, neprimernih za kemoimunoterapijo.
In particular an increased incidence of PJP, carrying a high risk of morbidity and mortality, was observed in the idelalisib treatment arms compared to controls in all the studies, and appeared to be significantly lower in patients administered PJP prophylaxis. 
Povečana incidenca pljučnice, ki jo povzroča Pneumocystis jirovecii (PJP) in predstavlja veliko tveganje za obolevnost in umrljivost, je bila ugotovljena v veji zdravljenja z idelalizibom v primerjavi s kontrolno skupino v vseh študijah in se je zdela znatno nižja pri bolnikih, ki so prejemali profilaktično zdravljenje za pljučnico, ki jo povzroča PJP.
The results of study -0123 are considered of limited relevance to the benefit-risk balance of idelalisib in the authorised CLL indication, due to the added toxicity of bendamustine. 
Rezultati študije -0123 se štejejo za manj pomembne za razmerje med koristjo in tveganjem idelaliziba v odobreni indikaciji za KLL zaradi dodane toksičnosti bendamustina.
The PRAC noted that in study -0123, idelalisib was administered in combination with rituximab and bendamustine (an unauthorised combination) in previously untreated CLL patients with and without 17p deletion/TP53 mutation, which is not the same population as the one in the current CLL indication in first line. 
Odbor PRAC je ugotovil, da so idelalizib v študiji -0123 dajali v kombinaciji z rituksimabom in bendamustinom (neodobreno kombinacijo) pri predhodno nezdravljenih bolnikih s KLL z in brez delecije 17p/mutacije TP53, kar ni enaka populacija kot tista v trenutni indikaciji KLL prve izbire.
On 10 March 2016, the European Commission was informed that an increased risk of death and higher incidence of serious adverse events (SAE) among subjects receiving idelalisib compared to the control groups had been observed in three clinical trials by the independent safety data monitoring group. 
10. marca 2016 je neodvisna skupina za spremljanje podatkov o varnosti Evropsko komisijo obvestila, da so v treh kliničnih preskušanjih opazili povečano tveganje za smrt in višjo pojavnost resnih neželenih učinkov pri preiskovancih, ki so prejemali idelalizib, v primerjavi s kontrolnimi skupinami.
There was however no indication that treatment-naïve CLL patients constitute a population more at risk of developing idelalisib-related adverse events compared to relapsed/refractory patients. 
indikacije, da bolniki s KLL, ki še niso bili zdravljeni, predstavljajo populacijo s povečanim tveganjem za razvoj neželenih učinkov, povezanih z jemanjem idelaliziba v primerjavi z relapsnimi/refraktornimi bolniki.
In view of the above, the PRAC concluded that the benefit-risk balance of Zydelig is favourable subject to changes to the product information, as described above. 
Z upoštevanjem zgoraj navedenega je odbor PRAC zaključil, da je razmerje med tveganji in koristmi zdravila Zydelig ugodno, pod pogojem, da se upoštevajo zgoraj opisane spremembe informacij o zdravilu.
The PRAC considered the results of these studies of limited relevance for the benefit-risk balance of idelalisib in its authorised indications and ongoing extension of indication in combination with ofatumumab for the treatment of CLL. 
Odbor PRAC je menil, da so rezultati teh študij manj pomembni za razmerje med tveganji in koristmi idelaliziba v njegovih odobrenih indikacijah in potekajoči razširitvi indikacij v kombinaciji z ofatumumabom za zdravljenje KLL.
Zydelig (idelalisib) is a centrally authorised product and is currently indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or as first line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. 
Zydelig (idelalizib) je centralno odobreno zdravilo in je trenutno indicirano v kombinaciji z rituksimabom za zdravljenje odraslih bolnikov s kronično limfocitno levkemijo (KLL), ki so pred tem prejeli vsaj eno zdravljenje, ali kot zdravilo prve izbire v prisotnosti delecije 17p ali mutacije TP53 pri bolnikih, pri katerih kemoimunoterapija ni primerna.
Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Zydelig (idelalisib). 
Zato priporoča spremembo pogojev dovoljenja za promet z zdravilom Zydelig (idelalizib).
The PRAC concluded that the benefit-risk balance in the authorised indications remained positive, provided that first line treatment with idelalisib is only used in patients with 17p deletion or TP53 mutation that are not eligible for any other therapies and that changes are implemented in the product information to minimise the risk of serious infections. 
Odbor PRAC je zaključil, da je razmerje med tveganji in koristmi v odobrenih indikacijah še naprej pozitivno, če se zdravljenje prve izbire z idelalizibom uporablja samo pri bolnikih z delecijo 17p ali mutacijo TP53, ki niso primerni za kakršno koli drugo zdravljenje, in da se informacije o zdravilu popravijo, da se zmanjša tveganje za resno okužbo.
For the same reasons, the relevance of the results of study -0123 is considered limited for the benefit-risk balance of idelalisib in combination with ofatumumab in the same types of CLL 
Iz istega razloga se rezultati študije -0123 štejejo za manj pomembne za razmerje med koristjo in tveganjem idelaliziba v kombinaciji z ofatumumabom pri bolnikih z enakimi vrstami KLL.
The CHMP discussed the statement proposed to be added in section 4.4 of the SmPC that limited efficacy and safety data explain why idelalisib is to be used as a first line treatment only in those patients with the 17p deletion or TP53 mutation who are not eligible for any other therapies. 
Odbor CHMP je razpravljal o stavku, predlaganem, da se ga doda v poglavje 4.4 povzetka glavnih značilnosti zdravila, ki je omejeval učinkovitost in podatke o varnosti in pojasnjeval, zakaj je treba idelalizib uporabljati kot zdravljenje prve izbire samo pri tistih bolnikih z delecijo 17p ali mutacijo TP53, ki niso primerni za drugo zdravljenje.
The CHMP, as a consequence, considers that the benefit-risk balance of Zydelig (idelalisib) remains favourable subject to the amendments to the product information. 
Odbor CHMP posledično meni, da je razmerje med tveganji in koristmi zdravila Zydelig (idelalizib) še naprej ugodno, pod pogojem, da se upoštevajo zgoraj opisane spremembe informacij o zdravilu.