FrancophonIA/ELRC3.0 huggingface dataset:
English: Each film-coated tablet contains 100 mg of doravirine, 300 mg of lamivudine and 245 mg of tenofovir disoproxil.
Slovenian: Ena filmsko obložena tableta vsebuje100 mg doravirina, 300 mg lamivudina in 245 mg dizoproksiltenofovirata.
English: Doravirine
Slovenian: Doravirin
English:  doravirine
Slovenian:  doravirin
English: Severe acute exacerbations of hepatitis B (e.g., liver decompensated and liver failure) have been reported in patients who are co-infected with HIV-1 and HBV, and have discontinued lamivudine or tenofovir disoproxil, two of the components of Delstrigo.
Slovenian: Pri bolnikih, sočasno okuženih s HIV-1 in HBV, ki so prenehali uporabljati lamivudin ali dizoproksiltenofovirat (dve od sestavin zdravila Delstrigo), so poročali o hudem akutnem poslabšanju hepatitisa B (npr. jetrna dekompenzacija in odpoved jeter).
English: Antidiabetics metformin (1000 mg SD, doravirine 100 mg QD)
Slovenian: Antidiabetiki metformin (1000 mg enkratni odmerek, doravirin 100 mg 1x/dan)
English: Hepatitis C Antiviral Agents elbasvir + grazoprevir (50 mg elbasvir QD + 200 mg grazoprevir QD, doravirine 100 mg QD)
Slovenian: elbasvir + grazoprevir (50 mg elbasvirja 1x/dan + 200 mg grazoprevirja 1x/dan, doravirin 100 mg 1x/dan)
English: Placental transfer of lamivudine has been shown to occur in humans.
Slovenian: Ugotovljeno je, da lamivudin pri človeku prehaja skozi placento.
English: rifabutin (300 mg QD, doravirine 100 mg SD)
Slovenian: rifabutin (300 mg 1x/dan, doravirin 100 mg enkratni odmerek)
English: If Delstrigo is stopped your doctor may recommend that you resume hepatitis B treatment.
Slovenian: Če boste nehali jemati zdravilo Delstrigo, vam bo zdravnik morda svetoval, da znova začnete z zdravljenjem hepatitisa B. Morda bodo še 4 mesece po prenehanju zdravljenja potrebne preiskave krvi za preverjanje delovanja jeter.
English: No clinically relevant racial differences in the pharmacokinetics of doravirine have been identified based on a population pharmacokinetic analysis of doravirine in healthy and HIV-1-infected subjects.
Slovenian: Na podlagi populacijske farmakokinetične analize doravirina pri zdravih osebah in preiskovancih, okuženih s HIV-1, niso ugotovili klinično pomembnih rasnih razlik v farmakokinetiki doravirina.
English: Cases of osteomalacia associated with proximal renal tubulopathy, manifested as bone pain or pain in extremities and which may contribute to fractures, have been reported in association with the use of tenofovir disoproxil .
Slovenian: V povezavi z uporabo dizoproksiltenofovirata so poročali o primerih osteomalacije, povezane s proksimalno ledvično tubulopatijo, ki se je kazala s kostnimi bolečinami ali bolečinami v okončinah ter lahko pripomore k zlomom.
English: Statins atorvastatin (20 mg SD, doravirine 100 mg QD)
Slovenian: Statini atorvastatin (20 mg enkratni odmerek, doravirin 100 mg 1x/dan)
English: lamivudine AUC 0.94 (0.88, 1.00) Cmax 0.92 (0.81, 1.05)
Slovenian:  lamivudin AUC 0,94 (0,88; 1,00) Cmax 0,92 (0,81; 1,05)
English: No clinically relevant pharmacokinetic differences have been identified between men and women for doravirine, lamivudine, and tenofovir.
Slovenian: V farmakokinetiki doravirina, lamivudina in tenofovirja niso ugotovili klinično pomembnih razlik med moškimi in ženskami.
English: No dose adjustment of Delstrigo is required in adults with estimated creatinine clearance (CrCl) ≥ 50 mL/min.
Slovenian: Pri bolnikih z ocenjenim očistkom kreatinina (CrCl) ≥ 50 ml/min odmerka zdravila Delstrigo ni treba prilagoditi.
English: Delstrigo should be discontinued if estimated CrCl declines below 50 mL per minute (see section 4.4).
Slovenian: Če se ocenjeni očistek kreatinina zmanjša pod 50 ml/min, je treba zdravilo Delstrigo prenehati uporabljati (glejte poglavje 4.4).
English: Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphataemia), has been reported with the use of tenofovir disoproxil, a component of Delstrigo.
Slovenian: Med uporabo dizoproksiltenofovirata, sestavine zdravila Delstrigo, so poročali o okvari ledvic, vključno s primeri akutne odpovedi ledvic in Fanconijevega sindroma (okvara ledvičnih tubulov s hudo hipofosfatemijo).
English: General disorders and administration site conditions Common fatigue, fever*
Slovenian: Splošne težave in spremembe na mestu aplikacije Pogosti utrujenost, zvišana telesna temperatura*
English: Doravirine has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Slovenian: Pri bolnikih s hudo okvaro jeter (Child-Pugh C) doravirin ni raziskan.
English: Documentation of pretreatment resistance genotyping was not required for patients who switched from a NNRTI-based regimen.
Slovenian: Pri bolnikih, ki so prešli iz sheme na osnovi NNRTI, podatki o genotipski odpornosti pred začetkom zdravljenja niso bili potrebni.
English: pantoprazole (40 mg QD, doravirine 100 mg SD)
Slovenian: pantoprazol (40 mg 1x/dan, doravirin 100 mg enkratni odmerek)
English:  ethinyl oestradiol AUC 0.98 (0.94, 1.03) Cmax 0.83 (0.80, 0.87)
Slovenian:  etinilestradiol AUC 0,98 (0,94; 1,03) Cmax 0,83 (0,80; 0,87)
English:  doravirine AUC 0.83 (0.76, 0.91) Cmax 0.88 (0.76, 1.01) C24 0.84 (0.77, 0.92)
Slovenian:  doravirin AUC 0,83 (0,76; 0,91) Cmax 0,88 (0,76; 1,01) C24 0,84 (0,77; 0,92)
English:  doravirine AUC 0.95 (0.80, 1.12) Cmax 0.80 (0.64, 1.01) C24 0.94 (0.78, 1.12)
Slovenian:  doravirin AUC 0,95 (0,80; 1,12) Cmax 0,80 (0,64; 1,01) C24 0,94 (0,78; 1,12)
English: + T'.
Slovenian: + več kot
English:  doravirine AUC 1.01 (0.92, 1.11) Cmax 0.86 (0.74, 1.01) C24 1.03 (0.94, 1.12)
Slovenian:  doravirin AUC 1,01 (0,92; 1,11) Cmax 0,86 (0,74; 1,01) C24 1,03 (0,94; 1,12)
English: Expected:  buprenorphine  naloxone
Slovenian: Pričakovano:  buprenorfin  nalokson
English:  S-methadone AUC 0.98 (0.90, 1.06) Cmax 0.97 (0.91, 1.04) C24 0.97 (0.86, 1.10)
Slovenian:  S-metadon AUC 0,98 (0,90; 1,06) Cmax 0,97 (0,91; 1,04) C24 0,97 (0,86; 1,10)
English:  doravirine AUC 0.91 (0.78, 1.06) Cmax 1.40 (1.21, 1.63) C24 0.90 (0.80, 1.01)
Slovenian:  doravirin AUC 0,91 (0,78; 1,06) Cmax 1,40 (1,21; 1,63) C24 0,90 (0,80; 1,01)
English: Cases of acute renal failure after initiation of high-dose or multiple NSAIDs have been reported in HIV-infected patients with risk factors for renal dysfunction who appeared stable on tenofovir disoproxil.
Slovenian: Pri bolnikih, okuženih s HIV, ki so imeli dejavnike tveganja za moteno delovanje ledvic in so se na dizoproksiltenofoviratu zdeli stabilni, so poročali o primerih akutne odpovedi ledvic po uvedbi velikih odmerkov ali več NSAID.
English: Expected: ↓ doravirine (Induction of CYP3A)
Slovenian: Pričakovano: ↓ doravirin (indukcija CYP3A)
English:  doravirine AUC 0.96 (0.87, 1.06) Cmax 0.97 (0.88, 1.07) C24 0.94 (0.83, 1.06)
Slovenian:  doravirin AUC 0,96 (0,87; 1,06) Cmax 0,97 (0,88; 1,07) C24 0,94 (0,83; 1,06)
English: Doravirine demonstrated antiviral activity against a broad panel of primary HIV-1 isolates (A, A1, AE, AG, B, BF, C, D, G, H) with EC50 values ranging from 1.2 nM to 10.0 nM.
Slovenian: Vrednost EC50 (50 % maksimalne efektivne koncentracije) doravirina proti divjemu tipu laboratorijskih sevov HIV-1, testirana v prisotnosti 100 % normalnega človeškega seruma z uporabo poročevalskih celic MT4-GFP, je bila 12,0 ± 4,4 nM. Doravirin je izkazal protivirusno aktivnost proti obsežni skupini primarnih izolatov HIV-1 (A, A1, AE, AG, B, BF, C, D, G, H) z vrednostjo EC50 od 1,2 do 10,0 nM. Protivirusna aktivnost doravirina ni bila antagonistična, če je bil uporabljen z lamivudinom in dizoproksiltenofoviratom.
English: In an in vivo mouse micronucleus assay, tenofovir disoproxil was negative when administered to male mice.
Slovenian: V mikrojedrnem preizkusu pri miših in vivo je bil pri mišjih samcih uporabljeni dizoproksiltenofovirat negativen.
English: If co-administration cannot be avoided, a 100 mg dose of doravirine should be taken daily, 12 h after the dose of doravirine/lamivudine/tenofovir disoproxil.
Slovenian: Če se sočasni uporabi ni mogoče izogniti, je treba vsak dan vzeti 100-mg odmerek doravirina 12 ur po odmerku kombinacije doravirin/lamivudin/ dizoproksiltenofovirat.
English: If co-administration cannot be avoided, a 100 mg dose of doravirine should be taken daily, approximately 12 h after the dose of doravirine/lamivudine/tenofovir disoproxil.
Slovenian: Če se sočasni uporabi ni mogoče izogniti, je treba vsak dan vzeti 100-mg odmerek doravirina približno 12 ur po odmerku kombinacije doravirin/lamivudin/ dizoproksiltenofovirat.
English: Treatment-naïve adult subjects
Slovenian: Še nezdravljeni odrasli preiskovanci
English: Co-administration of doravirine/lamivudine/tenofovir disproxil and medicinal products that are inhibitors of CYP3A may result in increased plasma concentrations of doravirine.
Slovenian: Sočasna uporaba kombinacije doravirin/lamivudin/dizoproksiltenofovirat in zdravil, ki zavirajo CYP3A, lahko poveča koncentracijo doravirina v plazmi, vendar pa med sočasno uporabo z zaviralci CYP3A odmerka doravirina ni treba prilagoditi.
English: Uncommon constipation, abdominal discomfort
Slovenian: Občasni astenija, splošno slabo počutje
English: Uncommon: may affect up to 1 in 100 people: • nightmares, depression, anxiety, irritability, confusion, suicidal thoughts
Slovenian: • nočne more, depresija, tesnoba (anksioznost), zmedenost, samomorilne misli
English: Geometric Mean Ratio (90 % CI)*
Slovenian: Vpliv na koncentracijo zdravila Razmerje geometričnih sredin (90 % IZ)*
English: Bone mineral density
Slovenian: Mineralna gostota kosti
English: HIV-1 RNA copies/mL
Slovenian: HIV-1 RNA kopij/ml študija DRIVE-FORWARD
English: Uncommon disturbance in attention, memory impairment, paraesthesia, hypertonia, poor quality sleep
Slovenian: Občasni motnje pozornosti, motnje spomina, parestezije,
English: • hair loss, rash
Slovenian: • izpadanje las, izpuščaj
English: Arthralgias and muscle pain or weakness have also been reported in cases of proximal renal tubulopathy.
Slovenian: Pri bolnikih s proksimalno ledvično tubulopatijo so poročali o artralgijah in bolečinah v mišicah ali šibkosti mišic.
English: No dose adjustment of doravirine/lamivudine/tenofovir disoproxil is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
Slovenian: Pri bolnikih z blago (Child-Pugh A) ali zmerno (Child-Pugh B) okvaro jeter odmerka kombinacije doravirin/lamivudin/dizoproksiltenofovirat ni treba prilagoditi.
English: Expected:  doravirine (Induction of CYP3A)
Slovenian: Pričakovano:  doravirin (indukcija CYP3A)
English: Therefore, caution is advised when doravirine/lamivudine/tenofovir disoproxil is administered to patients with severe hepatic impairment (see section 5.2).
Slovenian: Ni znano, ali se izpostavljenost doravirinu pri bolnikih s hudo okvaro jeter poveča, zato je v primeru uporabe kombinacije doravirin/lamivudin/dizoproksiltenofovirat pri bolnikih s hudo okvaro jeter potrebna previdnost (glejte poglavje 5.2).
English: Multiple dose rifampicin (600 mg QD, doravirine 100 mg SD)
Slovenian: Večkratni odmerki rifampicina (600 mg 1x/dan, doravirin 100 mg enkratni odmerek)
English: What Delstrigo is
Slovenian: Kaj je zdravilo Delstrigo
English: Lamivudine-resistant variants of HIV-1 have been selected in cell culture and in subjects treated with lamivudine.
Slovenian: V celičnih kulturah in pri preiskovancih, zdravljenih z lamivudinom, so se selekcionirale proti lamivudinu odporne različice HIV-1.
English: Single dose rifampicin (600 mg SD, doravirine 100 mg SD)
Slovenian: Enkratni odmerek rifampicina (600 mg enkratni odmerek, doravirin 100 mg enkratni odmerek)
English: norgestimate/ethinyl oestradiol
Slovenian: norgestimat/etinilestradiol
English: buprenorphine naloxone
Slovenian: buprenorfin nalokson
English: Because lamivudine is primarily eliminated by the kidneys through a combination of glomerular filtration and active tubular secretion (see section 5.2), co-administration of doravirine/lamivudine/tenofovir disoproxil with medicinal products that reduce renal function or compete for active tubular secretion may increase serum concentrations of lamivudine.
Slovenian: Zato lahko sočasna uporaba kombinacije doravirin/lamivudin/dizoproksiltenofovirat z zdravili, ki zmanjšajo delovanje ledvic ali tekmujejo za aktivno tubularno sekrecijo, poveča koncentracijo lamivudina v serumu.
English: Recommendation Concerning Co-administration with doravirine/lamivudine/tenofo vir disoproxil ledipasvir + sofosbuvir (90 mg ledipasvir SD + 400 mg sofosbuvir SD, doravirine 100 mg SD)
Slovenian: ledipasvir + sofosbuvir (90 mg ledipasvirja enkratni odmerek + 400 mg sofosbuvirja enkratni odmerek, doravirin 100 mg enkratni odmerek)
English: How to store Delstrigo
Slovenian: Shranjevanje zdravila Delstrigo
English: daclatasvir
Slovenian: daklatasvir
English: No clinically relevant differences in tenofovir pharmacokinetics were observed between subjects with hepatic impairment and healthy subjects.
Slovenian: Med preiskovanci z okvaro jeter in zdravimi preiskovanci niso ugotovili klinično pomembnih razlik v farmakokinetiki tenofovirja.
English: • 90 film-coated tablets (3 bottles of 30 film-coated tablets) Not all pack sizes may be marketed.
Slovenian: • 90 filmsko obloženih tablet (3 plastenke po 30 filmsko obloženih tablet).
English: Outer carton
Slovenian: Zunanja škatla
English: • lumacaftor
Slovenian: • lumakaftor.
English: Delstrigo tablets contains lactose
Slovenian: Izgled zdravila Delstrigo in vsebina pakiranja
English: There were no effects on fertility, mating performance or early embryonic development when doravirine was administered to rats at up to 7 times the exposure in humans at the RHD.
Slovenian: Med uporabo doravirina pri podganah v izpostavljenostih, ki so bile do 7-krat večje kot je izpostavljenost pri človeku med uporabo RHD, niso ugotovili vplivov na plodnost, sposobnost za parjenje ali zgodnji razvoj zarodka.
English: Do not run out of Delstrigo.
Slovenian: Pazite, da vam zdravila Delstrigo ne zmanjka.
English: omeprazole
Slovenian: omeprazol
English: HIV Antiviral Agents tenofovir disoproxil (300 mg QD, doravirine 100 mg SD)
Slovenian: dizoproksiltenofovirat (300 mg 1x/dan, doravirin 100 mg enkratni odmerek)
English: Expected:  doravirine (Inhibition of CYP3A)
Slovenian: Pričakovano:  doravirin (zavrtje CYP3A)
English: These include:
Slovenian: Mednje sodijo:
English: In addition, the European Commission requested the Agency to give its opinion, as to whether provisional measures were necessary to protect public health.
Slovenian: Poleg tega je Evropska komisija agencijo zaprosila za mnenje, ali so potrebni začasni ukrepi za zaščito javnega zdravja.
English: 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.
Slovenian: 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.
English: • monitoring for respiratory signs and symptoms of throughout treatment and reporting of new respiratory symptoms;
Slovenian: • spremljanje respiratornih znakov in simptomov ves čas zdravljenja in poročanje o novih respiratornih simptomih;
English: 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.
Slovenian: Treba je poudariti, da so podatki, ki so trenutno na voljo odboru PRAC, zelo omejeni in mu ne omogočajo dokončnih zaključkov.
English: This recommendation is without prejudice to the final conclusions of the ongoing procedure under Article 20 of Regulation (EC) 726/2004.
Slovenian: To priporočilo ne posega v končne zaključke potekajočega postopka v skladu s členom 20 Uredbe (ES) 726/2004.
English: These recommendations should be reflected in the product information and communicated to healthcare professionals via a dedicated letter.
Slovenian: Ta priporočila se morajo odražati v informacijah o zdravilu, zdravstvenim delavcem pa jih je treba sporočiti s posebnim dopisom.
English: The current recommendation relates only to provisional measures recommended by the PRAC for idelalisib.
Slovenian: Trenutno priporočilo se nanaša le na začasne ukrepe, ki jih je za idelalizib priporočil odbor PRAC.
English: These measures will be further reviewed as part of the ongoing Article 20.
Slovenian: Ti ukrepi bodo nadalje revidirani kot del potekajočega postopka v skladu s členom 20.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for idelalisib.
Slovenian: Odbor posledično priporoča spremembo pogojev dovoljenja za promet z idelalizibom.
English: As only very limited data is available, these measures are only temporary and are without prejudice to the ongoing review under Article 20.
Slovenian: Ker so na voljo le omejeni podatki, so ti ukrepi samo začasni in ne posegajo v potekajoči pregled v skladu s členom 20.
English: • 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).
Slovenian: • 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).
English: • 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.
Slovenian: • 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.
English: Further, if continuing with therapy, new risk minimisation (see below) should be implemented.
Slovenian: V primeru nadaljevanja zdravljenja je treba uvesti nove ukrepe za zmanjševanje tveganja (glejte spodaj).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The PRAC therefore proposed risk minimisation measures, including amendments to the product information and a communication to healthcare professionals.
Slovenian: Odbor PRAC je zato predlagal ukrepe za zmanjševanje tveganja, vključno s spremembami informacij o zdravilu in sporočilom za zdravstvene delavce.
English: • prophylaxis for Pneumocystis jirovecii pneumonia (PJP) to all patients throughout treatment;
Slovenian: • profilaktično zdravljenje pljučnice, ki jo povzroča Pneumocystis jirovecii, pri vseh bolnikih ves čas zdravljenja;
English: In addition, given the higher risk for infection, advice on dose reduction or treatment interruption in the event of severe neutropenia was also proposed.
Slovenian: Poleg tega so zaradi visokega tveganja za okužbo predlagali tudi, da se v primeru hude nevtropenije zmanjša odmerek ali prekine zdravljenje.
English: Idelalisib treatment should be discontinued in patients with evidence of infection or viraemia;
Slovenian: Zdravljenje z idelalizibom je treba prekiniti pri bolnikih z znaki okužbe ali viremije;
English: 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.
Slovenian: 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.
English: Interim results of these studies have shown an increased risk of death and serious adverse events in the idelalisib treatment arms compared to placebo.
Slovenian: Vmesni rezultati teh študij so pokazali povečano tveganje za smrt in resne neželene učinke v skupinah zdravljenja z idelalizibom v primerjavi s placebom.
English: 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.
Slovenian: 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.
English: Therefore, provisional measures are recommended but these are without prejudice of the outcome of the ongoing review under Article 20 procedure.
Slovenian: Zato se začasni ukrepi priporočajo, vendar ne posegajo v izid potekajočega pregleda v okviru postopka v skladu s členom 20.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • regular clinical and laboratory screening for cytomegalovirus (CMV) infection.
Slovenian: • redno klinično in laboratorijsko presejalno testiranje na okužbe s citomegalovirusom (CMV).