natgillin/translations-raw huggingface dataset:
Furthermore, in depth assessment is needed to firmly establish factors that may have driven death rates and it is too early to conclude that the risk is most apparent in the first 6 months. 
Potrebna je tudi poglobljena ocena, s katero bi trdno določili dejavnike, ki so morda dvignili stopnjo umrljivosti; še prezgodaj bi bilo namreč zaključiti, da je tveganje najočitnejše v prvih 6 mesecih.
• monitoring for respiratory signs and symptoms of throughout treatment and reporting of new respiratory symptoms; 
• spremljanje respiratornih znakov in simptomov ves čas zdravljenja in poročanje o novih respiratornih simptomih;
It is to be noted that the data currently available to the PRAC is very limited and does not enable the PRAC to give definite conclusions. 
Treba je poudariti, da so podatki, ki so trenutno na voljo odboru PRAC, zelo omejeni in mu ne omogočajo dokončnih zaključkov.
This recommendation is without prejudice to the final conclusions of the ongoing procedure under Article 20 of Regulation (EC) 726/2004. 
To priporočilo ne posega v končne zaključke potekajočega postopka v skladu s členom 20 Uredbe (ES) 726/2004.
These recommendations should be reflected in the product information and communicated to healthcare professionals via a dedicated letter. 
Ta priporočila se morajo odražati v informacijah o zdravilu, zdravstvenim delavcem pa jih je treba sporočiti s posebnim dopisom.
The current recommendation relates only to provisional measures recommended by the PRAC for idelalisib. 
Trenutno priporočilo se nanaša le na začasne ukrepe, ki jih je za idelalizib priporočil odbor PRAC.
These measures will be further reviewed as part of the ongoing Article 20. 
Ti ukrepi bodo nadalje revidirani kot del potekajočega postopka v skladu s členom 20.
The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for idelalisib. 
Odbor posledično priporoča spremembo pogojev dovoljenja za promet z idelalizibom.
As only very limited data is available, these measures are only temporary and are without prejudice to the ongoing review under Article 20. 
Ker so na voljo le omejeni podatki, so ti ukrepi samo začasni in ne posegajo v potekajoči pregled v skladu s členom 20.
• The PRAC considered the provisional measure under Article 20(3) of Regulation (EC) No 726/2004 in the framework of Article 20 of Regulation (EC) No 726/2004 procedure resulting from pharmacovigilance data for Zydelig (idelalisib). 
• Odbor PRAC je upošteval začasni ukrep v skladu s členom 20(3) Uredbe (ES) št. 726/2004 v okviru postopka v skladu s členom 20 Uredbe (ES) št. 726/2004, ki je bil na podlagi farmakovigilančnih podatkov predložen za zdravilo Zydelig (idelalizib).
• monitoring of absolute neutrophil counts (ANC) in all patients at least every two weeks for the first six months of treatment with idelalisib, and at least weekly in patients while ANC is less than 1,000 per mm3. 
• spremljanje absolutnega števila nevtrofilcev (ANC) pri vseh bolnikih vsaj enkrat na dva tedna prvih šest mesecev zdravljenja z idelalizibom in vsaj enkrat tedensko pri bolnikih, pri katerih je ANC manj kot 1 000 na mm3.
Further, if continuing with therapy, new risk minimisation (see below) should be implemented. 
V primeru nadaljevanja zdravljenja je treba uvesti nove ukrepe za zmanjševanje tveganja (glejte spodaj).
Notwithstanding this fact, the PRAC considered that the limited data available justified the recommendation of temporary measures to ensure that healthcare professionals and patients are aware of the risks and of the measures to mitigate those. 
Ne glede na to je odbor PRAC menil, da omejeni razpoložljivi podatki upravičujejo priporočilo za začasne ukrepe, s katerimi se zagotovi, da zdravstveni delavci in bolniki poznajo tveganja in ukrepe za njihovo ublažitev.
On 11 March 2016 the EC therefore triggered a procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of Zydelig (idelalisib) and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked. 
Zato je Evropska komisija 11. marca 2016 na podlagi farmakovigilančnih podatkov sprožila postopek v skladu s členom 20 Uredbe (ES) št. 726/2004 in odbor PRAC zaprosila, naj oceni vpliv zgornjih pomislekov na razmerje med tveganji in koristmi zdravila Zydelig (idelalizib) ter izda priporočilo o tem, ali naj se ustrezna dovoljenja za promet z zdravilom ohranijo, spremenijo, začasno umaknejo ali odvzamejo.
The PRAC therefore proposed risk minimisation measures, including amendments to the product information and a communication to healthcare professionals. 
Odbor PRAC je zato predlagal ukrepe za zmanjševanje tveganja, vključno s spremembami informacij o zdravilu in sporočilom za zdravstvene delavce.
• prophylaxis for Pneumocystis jirovecii pneumonia (PJP) to all patients throughout treatment; 
• profilaktično zdravljenje pljučnice, ki jo povzroča Pneumocystis jirovecii, pri vseh bolnikih ves čas zdravljenja;
In addition, given the higher risk for infection, advice on dose reduction or treatment interruption in the event of severe neutropenia was also proposed. 
Poleg tega so zaradi visokega tveganja za okužbo predlagali tudi, da se v primeru hude nevtropenije zmanjša odmerek ali prekine zdravljenje.
Idelalisib treatment should be discontinued in patients with evidence of infection or viraemia; 
Zdravljenje z idelalizibom je treba prekiniti pri bolnikih z znaki okužbe ali viremije;
The reason why patients in the earlier stages of disease might be at increased risk of death and serious infection with idelalisib is not clear, although it is likely that there is an interaction between benefit-risk balance in differing populations and their level of disease-related mortality. 
Razlog, zakaj naj bi bilo pri bolnikihv zgodnejšem stadiju bolezni pri idelalizibu tveganje za smrt in resne okužbe večje, ni jasen, čeprav je mogoče, da obstaja medsebojni odnos med razmerjem med tveganji in koristmi pri različnih populacijah in njihovo stopnjo z boleznijo povezane umrljivosti.
Interim results of these studies have shown an increased risk of death and serious adverse events in the idelalisib treatment arms compared to placebo. 
Vmesni rezultati teh študij so pokazali povečano tveganje za smrt in resne neželene učinke v skupinah zdravljenja z idelalizibom v primerjavi s placebom.
Further measures to minimise the risk of infection should also be carried forward to clinical practice, including those used in studies supporting the initial marketing authorisation application with favourable results. 
Dodatne ukrepe za zmanjševanje tveganja za okužbo je treba prenesti tudi v klinično prakso, vključno z ukrepi, uporabljenimi v študijah, ki podpirajo osnovno vlogo za pridobitev dovoljenja za promet z zdravilom in so imele ugodne rezultate.
Therefore, provisional measures are recommended but these are without prejudice of the outcome of the ongoing review under Article 20 procedure. 
Zato se začasni ukrepi priporočajo, vendar ne posegajo v izid potekajočega pregleda v okviru postopka v skladu s členom 20.
Also, post-marketing reports of adverse events in EudraVigilance indicate that infections (including sepsis and pneumocystis) account for a large proportion of reported cases, including fatal cases. 
Poročila o neželenih učinkih iz sistema EudraVigilance iz obdobja po tem, ko je bilo zdravilo dano v promet, kažejo, da okužbe (vključno s sepso in pnevmocistozo) predstavljajo velik delež poročanih primerov, vključno s smrtnimi.
Similarly, studies -0124 and -0125 are not consistent with the FL indication because idelalisib was combined with rituximab or rituximab and bendamustine, respectively, which are not authorised combinations. 
Podobno tudi študiji -0124 in -0125 nista v skladu z indikacijo za FL, saj so idelalizib dajali v kombinaciji z rituksimabom oziroma rituksimabom in bendamustinom, kar nista odobreni kombinaciji.
These temporary measures may be revised in light of the data that will become available and will be assessed in the ongoing Article 20 procedure, as the precise factors for the differences in safety outcomes between the three new studies (0123, -0124 and -0125) and those observed in studies supporting the initial marketing authorisation and proposed extension of indication for use in CLL in combination with ofatumumab. 
Ti začasni ukrepi se lahko revidirajo v luči podatkov, ki bodo na voljo v prihodnosti in bodo ocenjeni v potekajočem postopku v skladu s členom 20, kot so konkretni dejavniki, ki so prispevali k razlikam med varnostnimi izidi treh novih študij (0123, -0124 in -0125) in izidi, opaženimi v študijah, ki podpirajo prvotno dovoljenje za promet z zdravilom in predlagano razširitev terapevtske indikacije na uporabo pri KLL v kombinaciji z ofatumumabom.
• regular clinical and laboratory screening for cytomegalovirus (CMV) infection. 
• redno klinično in laboratorijsko presejalno testiranje na okužbe s citomegalovirusom (CMV).
However, in light of the emerging safety data, the European Commission (EC) considered that the findings from the clinical trials and all available safety data related to idelalisib should be reviewed in order to assess their potential impact on the benefit-risk balance of Zydelig in the approved indications and relevant ongoing variations. 
Glede na nove podatke o varnosti je Evropska komisija (EK) menila, da je treba pregledati izsledke kliničnih preskušanj in vse razpoložljive podatke o varnosti, povezane z idelalizibom, da bi ocenili njihov morebiten vpliv na razmerje med tveganji in koristmi zdravila Zydelig pri odobrenih indikacijah in ustreznih potekajočih postopkih za spremembo.
Whilst the matter is being further reviewed, the PRAC recommended as a provisional measure an update of the posology and warnings to take due account that treatment should not be initiated in patients with systemic infections, patients should be monitored for respiratory symptoms and be administered Pneumocystis jirovecii pneumonia prophylaxis. 
Čeprav se zadeva še nadalje preučuje, je odbor PRAC kot začasni ukrep priporočil, da se odmerjanje in opozorila posodobijo tako, da upoštevajo dejstvo, da se zdravljenje ne sme uvesti pri bolnikih s sistemskimi okužbami, da je treba bolnike spremljati v zvezi z respiratornimi simptomi in da morajo prejemati profilaktično zdravljenje proti pljučnici, ki jo povzroča Pneumocystis jirovecii.
The PRAC also considered available safety data from clinical trials submitted in support of the initial marketing authorisation and extensions of indication and Eudravigilance data in relation to the overall risk of treatment with idelalisib. 
Odbor PRAC je preučil tudi razpoložljive podatke o varnosti iz kliničnih preskušanj, predložene v podporo prvotnemu dovoljenju za promet z zdravilom in razširitvam terapevtske indikacije, ter podatke iz sistema Eudravigilance v povezavi s celotnim tveganjem zdravljenja z idelalizibom.
The trials evaluated combinations with chemotherapy and immunotherapy which are currently not authorised for Zydelig (idelalisib), or authorised combination of Zydelig and immunotherapy but in a population with earlier disease characteristics than the currently approved indication. 
V preskušanjih so vrednotili kombinacije s kemoterapijo in imunoterapijo, ki trenutno za zdravilo Zydelig (idelalizib) niso odobrene, ali odobreno kombinacijo zdravila Zydelig in imunoterapije, vendar v populaciji z značilnostmi zgodnejše bolezni, kot je trenutno odobrena indikacija.
The PRAC took into account the data submitted by the marketing authorisation holder (MAH). 
Odbor PRAC je upošteval podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom.
Therefore, the PRAC recommended that idelalisib should not be initiated in patients with any evidence of ongoing systemic bacterial, fungal, or viral infection. 
Zato je odbor PRAC priporočil, da se idelalizib ne sme uvesti pri bolnikih z znaki potekajoče sistemske bakterijske, glivne ali virusne okužbe.
• The PRAC noted that the use of idelalisib in studies -0123, -0124 and -0125 was in different conditions than those currently authorised, and at earlier stages of the diseases. 
• Odbor PRAC je ugotovil, da se je idelalizib v študijah -0123, -0124 in -0125 uporabljal drugače, kot je trenutno odobreno, in v zgodnejših stadijih bolezni.
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 zdravljenje prve izbire v prisotnosti delecije 17p ali mutacije TP53 pri bolnikih, pri katerih kemoimunoterapija ni primerna.
For CLL patients with 17p deletion or TP53 mutation already on idelalisib therapy as first line, clinicians should carefully consider individual benefit-risk balance and decide whether to continue treatment. 
Pri bolnikih s KLL z delecijo 17p ali mutacijo TP53, ki se že zdravijo z idelalizibom kot zdravljenjem prve izbire, morajo zdravniki skrbno pretehtati razmerje med tveganji in koristmi pri posameznem bolniku ter se odločiti, ali naj nadaljujejo z zdravljenjem.
In view of the above, the Committee considers that the benefit-risk balance of Zydelig remains favourable subject to the agreed provisional amendments to the product information and other risk minimisation measures. 
Z upoštevanjem zgoraj navedenega odbor meni, da je razmerje med tveganji in koristmi zdravila Zydelig še naprej ugodno, pod pogojem, da se upoštevajo dogovorjene začasne spremembe informacij o zdravilu in drugi ukrepi za zmanjševanje tveganja.
Although the potential impact of these new safety findings in the current authorised indications is presently unknown, the PRAC recommended provisional amendments of the indication of idelalisib and considered that as a precautionary measure, idelalisib should not be initiated as a first line treatment in CLL patients with 17p deletion or TP53 mutation. 
Čeprav morebitni vpliv teh novih izsledkov o varnosti za trenutno odobrene indikacije še ni znan, je odbor PRAC priporočil začasne spremembe indikacije za idelalizib in menil, da se kot previdnostni ukrep idelalizib ne sme uvesti kot zdravljenje prve izbire pri bolnikih s KLL z delecijo 17p ali mutacijo TP53.
Based on the inhibitory effects of idelalisib on the PI3K pathway, it is possible that the increased risk of serious infection observed in studies 0123, -0124 and -0125 could be relevant to the authorised indications. 
Na podlagi zaviralnih učinkov idelaliziba na pot PI3K je mogoče, da je povečano tveganje za resne okužbe, opaženo v študijah 0123, -0124 in -0125, pomembno tudi za odobrene indikacije.
Regular clinical and laboratory screening for cytomegalovirus should also be performed. 
Treba je izvajati tudi redno klinično in laboratorijsko presejalno testiranje okužbe s citomegalovirusom.
• The PRAC reviewed the very limited and preliminary data provided by the marketing authorisation holder on the interim results of study 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 zelo omejene in preliminarne podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom, o vmesnih rezultatih študij GS-US-312-0123, GS-US-3130124, GS-US-313-0125, ki kažejo na povečano tveganje za smrt in resne okužbe pri idelalizibu.
• 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.
The PRAC considered the very limited new safety data from three studies (GS-US-312-0123, GSUS-313-0124, GS-US-313-0125), now terminated, evaluating the addition of idelalisib to standard therapies in first line CLL and relapsed indolent non-Hodgkin lymphoma (iNHL)/small lymphocytic lymphoma (SLL). 
Odbor PRAC je preučil zelo omejene nove podatke o varnosti iz treh študij (GS-US-312-0123, GS-US313-0124, GS-US-313-0125), ki so se že zaključile in v katerih so vrednotili dodatek idelaliziba standardnim terapijam pri prvi izbiri zdravljenja KLL in ponovljenem indolentnem ne-Hodgkinovem limfomu (iNHL)/limfomu malih limfocitov (SLL).
The PRAC noted that in study -0123, idelalisib was administered in combination with bendamustine and rituximab (which is not an authorised combination) and CLL patients were previously untreated, which is not consistent with the current CLL indication. 
Odbor PRAC je ugotovil, da so idelalizib v študiji -0123 dajali v kombinaciji z bendamustinom in rituksimabom (kar ni odobrena kombinacija), bolniki s KLL pa predhodno še niso prejeli zdravljenja, kar ni v skladu s trenutno indikacijo za KLL.
Idelalisib is also indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment. 
Idelalizib je indiciran tudi kot monoterapija za zdravljenje odraslih bolnikov s folikularnim limfomom (FL), neodzivnim na dve predhodni obliki zdravljenja.
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.
A table to guide physicians was proposed for the posology section. 
Za poglavje o odmerjanju je bila predlagana preglednica kot smernica za zdravnike.
The impact of the new safety findings in the currently authorised indications and extension of indication for use in CLL in combination with ofatumumab cannot be evaluated with certainty at present in view of the limited data available. 
Ker so na voljo samo omejeni podatki, vpliva novih izsledkov o varnosti pri trenutno odobrenih indikacijah in razširitvi terapevtske indikacije za uporabo pri KLL v kombinaciji z ofatumumabom trenutno ni mogoče z gotovostjo ovrednotiti.
The MAH suggested that in studies -0123, -0124 and -0125 lines of therapy (i.e. increased risk in earlier stages of disease) and concomitant medication (such as bendamustine) may have increased the risk of infection. 
Imetnik dovoljenja za promet z zdravilom je domneval, da je povečano tveganje za okužbo v študijah -0123,0124 in -0125 morda posledica oblik zdravljenja (tj. povečano tveganje v zgodnejših stadijih bolezni) in sočasnega zdravila (kot je bendamustin).
As a temporary measure, the PRAC recommended that idelalisib should not be initiated as a first line treatment in CLL patients with 17p deletion or TP53 mutation. 
Kot začasni ukrep je odbor PRAC priporočil, da se idelalizib pri bolnikih s KLL z delecijo 17p ali mutacijo TP53 ne sme uvesti kot zdravljenje prve izbire.
However, the committee recommended that idelalisib could be used for continuing treatment in those patients who had already initiated the medicine as first line treatment based on individual benefit-risk balance assessment and with the addition of new risk minimisation measures. 
Vendar pa je priporočil, da se na podlagi posamične ocene razmerja med tveganji in koristmi ter z dodatnimi novimi ukrepi za zmanjševanje tveganja idelalizib lahko uporablja za nadaljevanje zdravljenja pri tistih bolnikih, ki so se že začeli zdraviti s tem zdravilom kot zdravljenjem prve izbire.
Annex IV Conditions of the marketing authorisations 
Priloga IV Pogoji dovoljenj za promet z zdravili
Updates on the registry will be submitted to national competent authorities with periodic safety update reports (PSURs). 
Posodobitve registra bodo predložene pristojnim nacionalnim organom skupaj s periodičnimi poročili o varnosti (PSUR).
Marketing authorisation holders of aprotinin containing medicinal products shall submit to the national competent authorities, further to the issuing of the Commission Decision and prior to relaunch of the medicinal product to the European market, an update of the risk management plan (RMP) referring to the agreed products' safety concerns as described in the assessment report of the referral procedure and their risk minimisation which includes a direct healthcare professional communication. 
Imetniki dovoljenj za promet z zdravili, ki vsebujejo aprotinin, morajo pristojnim nacionalnim organom predložiti, in sicer po izdaji sklepa Odbora in pred začetkom ponovnega trženja zdravila na evropskem trgu, posodobitev načrta za obvladovanje tveganj (RMP), ki se nanaša na pomisleke v zvezi z varnostjo zdravil, opisane v poročilu o oceni napotitvenega postopka, in na zmanjševanje tveganj, ki vključuje neposredno komunikacijo z zdravstvenimi delavci.
The MAH shall take due account of the draft protocol and comments received during assessment. 
Imetnik dovoljenja za promet bo upošteval osnutek protokola in pripombe, prejete med ocenjevanjem.
This RMP shall follow the EU RMP template and shall include the measures to assess the effectiveness of the risk minimisation. 
Ta načrt za obvladovanje tveganj mora ustrezati predlogi EU RMP in vključevati ukrepe za oceno učinkovitosti zmanjševanja tveganja.
The registry shall record utilisation information on patients at cardiac surgery centres exposed to aprotinin in participating countries. 
V registru se bodo zbirale informacije o uporabi pri bolnikih, izpostavljenih aprotininu, v centrih za srčno kirurgijo v sodelujočih državah.
The registry's protocol shall be submitted to the national competent authorities within 2 months of Commission Decision. 
V dveh mesecih od sklepa Odbora bo pristojnim nacionalnim organom predložil protokol registra.
National Competent Authorities shall ensure that the following conditions are fulfilled by the MAHs of aprotinin containing medicinal products: 
Pristojni nacionalni organi morajo zagotoviti, da imetniki dovoljenj za promet z zdravili, ki vsebujejo aprotinin, izpolnijo naslednje pogoje:
Marketing authorisation holders shall conduct a registry, in order to monitor the pattern of use of aprotinin. 
Imetniki dovoljenj za promet z zdravili bodo vodili register, namenjen spremljanju vzorca uporabe aprotinina.
It shall thus be set up in advance of placing the product on the market. 
To je treba opraviti pred začetkom trženja zdravil.
A restricted distribution of aprotinin with the above mentioned registry, with aprotinin available only to centres that perform cardiac surgery on cardio-pulmonary bypass and that commit to participate in the registry. 
Omejena distribucija aprotinina z zgoraj-omenjenim registrom, tako da bo aprotinin na voljo samo v zdravstvenih centrih, ki izvajajo operacije srca z vstavitvijo obvoda koronarne arterije in ki sodelujejo pri registru.
None. 
Nobenih.
This summary was last updated in February 2016. 
Povzetek je bil nazadnje posodobljen februarja 2016.
This will help to protect against the disease. 
To bo pripomoglo k obrambi pred boleznijo.
The full EPAR for Letifend can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila Letifend je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Letifend. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Letifend.
It is not intended to provide practical advice on how to use Letifend. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.