FrancophonIA/ELRC3.0 huggingface dataset:
English: All subjects were refractory to rituximab and 124 of 125 subjects were refractory to at least one alkylating agent.
Danish: Alle patienterne var refraktære til rituximab, og 124 ud af 125 patienter var refraktære til mindst et alkylerende stof.
English: The film-coated tablet can be taken with or without food (see section 5.2).
Danish: Den filmovertrukne tablet kan tages med eller uden mad (se pkt.
English: Alternatively, switching to pravastatin, rosuvastatin, or pitavastatin may be considered.
Danish: Alternativt kan det overvejes at skifte til pravastatin, rosuvastatin eller pitavastatin.
English: ** Idelalisib-induced lymphocytosis should not be considered progressive disease in the absence of other clinical findings (see section 5.1).
Danish: ** Idelalisib-induceret lymfocytose skal ikke betragtes som progressiv sygdom ved fravær af andre kliniske fund (se afsnit 5.1).
English: Most frequently observed were infections in the respiratory system and septic events.
Danish: De hyppigst observerede infektioner var i luftvejene og septiske hændelser.
English: Each carton contains 1 bottle.
Danish: Hver karton indeholder 1 tabletbeholder.
English: Prophylaxis for PJP should therefore be administered to all patients throughout idelalisib treatment, and for a period of 2 to 6 months after discontinuation.
Danish: Profylaktisk behandling for PJP skal gives til alle patienter under hele behandlingen med idelalisib og i en periode på 2 til 6 måneder efter seponering.
English: ↑ serum concentrations Caution should be exercised and patients closely observed for bosentan-related toxicity.
Danish: ↑ serumkoncentrationer Der bør udvises forsigtighed, og patienterne bør observeres nøje for bosentanrelateret toksicitet.
English: Clinical monitoring is recommended for patients with CrCl < 90 mL/min.
Danish: Klinisk overvågning anbefales af patienter med CrCl < 90 ml/min.
English: Table 1: Interactions between idelalisib and other medicinal products that are CYP3A substrates
Danish: Tabel 1: Interaktioner mellem idelalisib og andre lægemidler, der er CYP3A-substrater Lægemiddel
English: At a dose 2.7 times the maximum recommended dose, idelalisib did not prolong the QT/QTc interval (i.e.,< 10 ms).
Danish: Ved en dosis 2,7 gange den maksimalt anbefalede dosis, forlængede idelalisib ikke QT/QTc-intervallet (dvs. < 10 ms).
English: Co-administration of idelalisib with CYP3A substrates may increase their systemic exposures and increase or prolong their therapeutic activity and adverse reactions.
Danish: Administration af idelalisib sammen med CYP3A-substrater kan øge deres systemiske eksponeringer og øge eller forlænge deres terapeutiske aktivitet og bivirkninger.
English: Overall iNHL cohort (N=125) n (%)
Danish: Overordnet iNHL-kohorte (N = 125) n (%)
English: Cases of pneumonitis and organising pneumonia (some with fatal outcome) have been reported with idelalisib.
Danish: Tilfælde af pneumonitis og organiserende pneumoni (nogle med dødelig udgang) er blevet rapporteret med idelalisib.
English: The following pack size is available: outer carton containing 1 plastic bottle of 60 film-coated tablets.
Danish: De følgende pakningsstørrelser er tilgængelige: ydre karton indeholdende 1 plastikbeholder med 60 filmovertrukne tabletter.
English: SEDATIVES/HYPNOTICS
Danish: SEDATIVA/HYPNOTIKA
English: Intensified monitoring of adverse reactions is recommended in patients with impaired hepatic function as exposure is expected to be increased in this population, in particular in patients with severe hepatic impairment.
Danish: Det anbefales at intensivere overvågning for bivirkninger hos patienter med nedsat leverfunktion, da eksponeringen forventes at være øget i denne population, især hos patienter med svært nedsat leverfunktion.
English: Only subjects that had both baseline and ≥ 1 evaluable post-baseline assessments were included in this analysis.
Danish: Kun patienter, der både havde baseline vurdering og ≥ 1 evaluerbare vurderinger efter baseline, blev inkluderet i denne analyse.
English: Caution should be exercised when administering Zydelig in patients with active hepatitis.
Danish: Der rådes til forsigtighed, når Zydelig administreres til patienter med aktiv hepatitis.
English: The median OS, including long-term follow-up for all FL subjects was 61.2 months.
Danish: Medianen for OS, herunder langvarig opfølgning for alle FL-patienter var 61,2 måneder.
English: • if you are allergic to idelalisib or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for idelalisib eller et af de øvrige indholdsstoffer i Zydelig (angivet i punkt 6).
English: Treatment with Zydelig should not be initiated in patients with any evidence of ongoing systemic bacterial, fungal, or viral infection.
Danish: Der bør ikke initieres behandling med Zydelig hos patienter med nogen form for evidens for aktuel systemisk bakterie-, svampe- eller virusinfektion.
English: • The active substance is idelalisib.
Danish: • Aktivt stof: idelalisib.
English: Idelalisib has not been studied in patients with chronic active hepatitis including viral hepatitis.
Danish: Idelalisib er ikke blevet undersøgt hos patienter med kronisk aktiv hepatitis, herunder viral hepatitis.
English: If Grade 2 or higher elevations in ALT and/or AST are observed, patients' ALT, AST, and total bilirubin must be monitored weekly until the values return to Grade 1 or below.
Danish: Hvis der observeres forhøjelser af grad 2 eller derover i ALAT og/eller ASAT, skal patienternes ALAT, ASAT og totalt bilirubin overvåges ugentligt, indtil de vender tilbage til grad 1 eller derunder.
English: Quetiapine, pimozide
Danish: Quetiapin, pimozid
English: If PML is suspected then appropriate diagnostic evaluations should be undertaken and treatment suspended until PML is excluded.
Danish: Hvis der er mistanke om PML, skal relevante diagnostiske vurderinger udføres, og behandlingen skal stilles i bero, indtil PLM er udelukket.
English: Caution is recommended when administering Zydelig in this population.
Danish: Der rådes til forsigtighed, når Zydelig administreres til denne population.
English: ANTI-PSYCHOTICS/NEUROLEPTICS
Danish: ANTIPSYKOTIKA/NEUROLEPTIKA
English: In FL Zydelig is used on its own in patients whose cancer has not responded to treatment with two previous cancer treatments.
Danish: Ved FL anvendes Zydelig alene hos patienter, hvis deres kræftsygdom ikke responderede på behandling med to tidligere kræftbehandlinger.
English: Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents, ATC code: L01XX47
Danish: Farmakoterapeutisk klassifikation: antineoplastiske stoffer, andre antineoplastiske stoffer, ATC-kode: L01XX47
English: ** LNR defined as the proportion of subjects who achieved a ≥ 50% decrease in the sum of products of the greatest perpendicular diameters of index lesions.
Danish: ** LNR defineret som andelen af patienter, som opnåede ≥ 50 % reduktion i summen af produkterne af de største vinkelrette diametre i indekslæsionerne.
English: Following oral administration of a single dose of idelalisib, peak plasma concentrations were observed 2 to 4 hours post-dose under fed conditions and after 0.5 to 1.5 hours under fasted conditions.
Danish: Efter oral administration af en enkeltdosis idelalisib, blev maksimale plasmakoncentrationer observeret 2 til 4 timer efter indtagelse under ikke-fastende betingelser og efter 0,5 til 1,5 timer under fastende betingelser.
English: The plasma exposures (Cmax and AUC) of idelalisib are approximately dose proportional between 50 mg and 100 mg and less than dose proportional above 100 mg.
Danish: Plasmaeksponeringerne (Cmax og AUC) for idelalisib er ca. dosisproportionale fra 50 mg til 100 mg, og mindre end dosisproportionale over 100 mg.
English: In studies up to 4 weeks in rats and dogs, hepatic necrosis was observed at 7 and 5 times the human exposure based on AUC, respectively.
Danish: i studier op til 4 uger hos rotter og hunde blev levernekrose observeret ved hhv. 7 og 5 gange den humane eksponering, baseret på AUC.
English: Severe skin blistering conditions have been reported in some people who have received Zydelig while also receiving other medicines known to cause these potentially life-threatening conditions.
Danish: Svære tilfælde af hudvabler er blevet rapporteret hos nogle personer, som fik Zydelig samtidigt med andre lægemidler, der vides at forårsage disse eventuelt livstruende tilstande.
English: Cases of severe drug-related colitis occurred relatively late (months) after the start of therapy, sometimes with rapid aggravation, but resolved within a few weeks with dose interruption and additional symptomatic treatment (e.g., anti-inflammatory agents such as enteric budesonide).
Danish: Tilfælde af svær lægemiddelrelateret colitis forekom relativt sent (måneder) efter behandlingsstart, til tider med hurtig forværring, men gik væk i løbet af et par uger efter dosisafbrydelse og yderligere symptomatisk behandling (f.eks. anti-inflammatoriske stoffer, såsom enterisk budesonid).
English: (may affect up to 1 in 10 people) • inflammation of the lungs
Danish: (kan forekomme hos flere end 1 ud af 10 personer) • diarré/betændelse i tyktarmen
English: The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia.
Danish: Kombinationen kan føre til en øget risiko for kardiovaskulære uønskede hændelser forbundet med salmeterol, herunder QT-forlængelse, palpitationer og sinus-takykardi.
English: * ORR defined as the proportion of subjects who achieved a complete response (CR) or partial response (PR) and maintained their response for at least 8 weeks.
Danish: * ORR defineret som andelen af patienter, som opnåede fuldstændigt respons (CR, complete response) eller delvist respons (PR, partial response), og opretholdt deres respons i mindst 8 uger.
English: Amiodarone, quinidine
Danish: Amiodaron, kinidin
English: * ORR defined as the proportion of subjects who achieved a complete response (CR) or partial response (PR) based on the 2013 National Comprehensive Cancer Network (NCCN) response criteria and Cheson (2012).
Danish: * ORR defineret som andelen af patienter, som opnåede et fuldstændigt respons (CR, complete response) eller et delvist respons (PR, partial response) baseret på 2013 National Comprehensive Cancer Network (NCCN) responskriterier og Cheson (2012).
English: Zydelig is unlikely to affect your ability to drive or use machines.
Danish: Det er ikke sandsynligt, at Zydelig påvirker din evne til at føre motorkøretøj eller betjene maskiner.
English: Diarrhoea/colitis
Danish: Diarré/colitis
English: Idelalisib was taken until disease progression or unacceptable toxicity.
Danish: Idelalisib blev taget indtil sygdomsprogression eller uacceptabel toksicitet.
English: If either moderate or severe symptomatic pneumonitis or organising pneumonia is diagnosed, appropriate treatment should be initiated and idelalisib must be permanently discontinued.
Danish: Ved diagnosticering af enten moderat eller svær symptomatisk pneumonitis eller organiserende pneumoni, bør der indledes hensigtsmæssig behandling, og idelalisib skal seponeres permanent.
English: Women using hormonal contraceptives should add a barrier method as a second form of contraception since it is currently unknown whether idelalisib may reduce the effectiveness of hormonal contraceptives.
Danish: Kvinder, der bruger hormonel kontraception skal tilføje en barrieremetode, som ekstra kontraception da det aktuelt er ukendt, om idelalisib kan reducere effektiviteten af hormonel kontraception.
English: UNIQUE IDENTIFIER - 2D BARCODE 18.
Danish: UNIK IDENTIFIKATOR - 2D STREGKODE 18.
English: Women should avoid becoming pregnant while taking Zydelig, and for up to 1 month after ending treatment.
Danish: Kvinder bør undgå at blive gravide, mens de tager Zydelig og i op til en måned efter endt behandling.
English: Response category*† CR
Danish: Responskategori*† CR
English: Patients with CMV viraemia without associated clinical signs of CMV infection should be carefully monitored.
Danish: Patienter med CMV-viræmi uden medfølgende kliniske tegn på CMV-infektion skal overvåges nøje.
English: Infections and infestations Infections (including Pneumocystis jirovecii pneumonia and CMV)*
Danish: Infektioner og parasitære sygdomme Infektioner (herunder Pneumocystis jirovecii pneumoni og CMV)*
English: • if you have a new or worsening cough
Danish: • hvis du har nyopstået eller forværret hoste
English: Of the 53 subjects who did not respond, 41 (32.8%) had stable disease, 10 (8.0%) had progressive disease, and 2 (1.6%) were not evaluable.
Danish: Af de 53 patienter, der ikke responderede, havde 41 (32,8 %) stabil sygdom, 10 (8,0 %) havde progressiv sygdom, og 2 (1,6 %) kunne ikke evalueres.
English: If any doubt exists, referral to a neurologist and appropriate diagnostic measures for PML including MRI scan preferably with contrast, cerebrospinal fluid (CSF) testing for JC viral DNA and repeat neurological assessments should be considered.
Danish: Hvis der er nogen tvivl, skal henvisning til en neurolog og relevante diagnostiske tiltag til PML, herunder MR-scanning helst med kontraststof, test af cerebrospinalvæske for JC viral DNA og gentagne neurologiske vurderinger overvejes.
English: ALT, AST, and total bilirubin must be monitored in all patients every 2 weeks for the first 3 months of treatment, then as clinically indicated.
Danish: ALAT, ASAT og totalt bilirubin skal overvåges hos alle patienter hver 2. uge i de første 3 måneder af behandlingen, og siden efter klinisk vurdering.
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 8 months following authorisation.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette lægemiddel inden for 8 måneder efter godkendelsen.
English: Evaluation of the potential for phototoxicity in the embryonic murine fibroblast cell line BALB/c 3T3 was inconclusive for idelalisib due to cytotoxicity in the in vitro assay.
Danish: Evaluering af potentialet for fototoksicitet i den embryoniske murine fibroblastcellelinje BALB/c 3T3 var inkonklusiv for idelalisib på grund af cytotoksicitet i in vitro-analysen.
English: Cases of progressive multifocal leukoencephalopathy (PML) have been reported following the use of idelalisib within the context of prior or concomitant immunosuppressive therapies that have been associated with PML.
Danish: Tilfælde af progressiv multifocal leukoencephalopati (PML) er blevet rapporteret efter brug af indelalisib i forbindelse med tidligere eller samtidige immunosuppressive behandlinger, der er blevet forbundet med PML.
English: Do not stop taking Zydelig
Danish: Du må ikke holde op med at tage Zydelig
English: Idelalisib can be administered without regard to food.
Danish: Idelalisib kan administreres uden hensyntagen til mad.
English: In follicular lymphoma, the B-lymphocytes multiply too quickly and live for too long, so there are too many of them in the lymph nodes.
Danish: Ved follikulært lymfom deler B-lymfocytterne sig for hurtigt og lever for længe, så der er for mange af dem i lymfeknuderne.
English: No human data on the effect of idelalisib on fertility are available.
Danish: Der er ingen humane data om idelalisibs virkning på fertiliteten.
English: The effect of idelalisib (150 mg and 400 mg) on the QT/QTc interval was evaluated in a placebo- and positive-controlled (moxifloxacin 400 mg) crossover study in 40 healthy subjects.
Danish: Idelalisibs virkning (150 mg og 400 mg) på QT/QTc-intervallet blev evalueret i et placebokontrolleret og positivt kontrolleret (moxifloxacin 400 mg) overkrydsningsstudie hos 40 raske personer.
English: This occurs in approximately two-thirds of patients with CLL treated with idelalisib monotherapy and one-fourth of patients with CLL treated with idelalisib combination therapy.
Danish: Dette sker hos cirka to tredjedele af patienter med CLL, som behandles med idelalisib monoterapi, og en fjerdedel af patienter med CLL behandlet med idelalisib kombinationsterapi.
English: Rash was generally mild to moderate and resulted in discontinuation of treatment in 2.1% of subjects.
Danish: Udslæt var generelt let til moderat og førte til seponering hos 2,1 % af patienterne.
English: There are no or limited amount of data from the use of idelalisib in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af idelalisib til gravide kvinder.
English: Treatment with Zydelig must be withheld in the event of suspected pneumonitis.
Danish: Behandlingen med Zydelig skal pauseres i tilfælde af formodet pneumonitis.
English: A risk for P-gp inhibition in the gastrointestinal tract, that could result in increased exposure of sensitive substrates for intestinal P-gp such as dabigatran etexilate, cannot be excluded.
Danish: En risiko for P-gp-hæmning i mave-tarm-kanalen, der kunne føre til øget eksponering af følsomme substrater over for intestinalt P-gp, såsom dabigatranetexilat, kan ikke udelukkes.
English: • ciclosporin, sirolimus, tacrolimus, medicines used to control your body's immune response after a transplant
Danish: • ciclosporin, sirolimus, tacrolimus, lægemidler, der anvendes til at kontrollere din krops immunrespons efter en transplantation
English: If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8).
Danish: Hvis der forekommer en overdosering, skal patienten overvåges for tegn på toksicitet (se pkt.
English: Treatment may be resumed at a lower dose once values have returned to Grade 1 or below (ALT/AST ≤ 3 x ULN).
Danish: Behandlingen kan genoptages ved en lavere dosis, når værdierne er vendt tilbage til grad 1 eller derunder (ALAT/ASAT ≤ 3 x ULN).
English: If you forget to take Zydelig
Danish: Hvis du har glemt at tage Zydelig
English: Zydelig has no or negligible influence on the ability to drive and use machines.
Danish: Zydelig påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Subjects received 150 mg of idelalisib orally twice daily until evidence of disease progression or unacceptable toxicity.
Danish: Patienterne fik 150 mg idelalisib oralt to gange dagligt, indtil bevis for sygdomsprogression eller uacceptabel toksicitet.
English: Clinical recommendation upon co-administration with idelalisib
Danish: Klinisk anbefaling ved administration sammen med idelalisib
English: Lymphocytosis**
Danish: Lymofocytose**
English: However, idelalisib did not inhibit the normal host response to Staphylococcus aureus and did not exacerbate the myelosuppressive effect of cyclophosphamide.
Danish: Idelalisib hæmmede imidlertid ikke det normale værtsrespons mod Staphylococcus aureus, og det forstærkede ikke den myelosuppressive virkning af cyklophosphamid.
English: Common * Comprised of opportunistic infections as well as bacterial and viral infections such as pneumonia, bronchitis, and sepsis.
Danish: Almindelig * Omfatter opportunistiske infektioner samt bakterielle og virale infektioner såsom pneumoni, bronkitis og sepsis.
English: The primary endpoint was the ORR defined as the proportion of subjects who achieved a CR or PR (based on the Revised Response Criteria for Malignant Lymphoma [Cheson]), and, for subjects with Waldenström macroglobulinaemia, a minor response (MR) (based on the Response Assessment for Waldenström macroglobulinaemia [Owen]).
Danish: Det primære endepunkt var ORR defineret som andelen af patienter, der opnåede et CR eller PR (baseret på de reviderede responskriterier for malignt lymfom [Cheson]), og for patienter med Waldenströms makroglobulinæmi, et mindre respons (MR) (baseret på responsvurderingen for Waldenströms makroglobulinæmi [Owen]).
English: Take care to not miss a dose of Zydelig.
Danish: Sørg for ikke at springe en dosis med Zydelig over.
English: Treatment-emergent Grade 3 or 4 neutropenia, including febrile neutropenia, have occurred in patients treated with idelalisib.
Danish: Behandlingsrelateret neutropeni af grad 3 eller 4, herunder febril neutropeni, er forekommet i patienter behandlet med idelalisib.
English: Clinical monitoring is recommended for telithromycin.
Danish: Klinisk overvågning anbefales for telithromycin.
English: Animal studies indicate the potential for harmful effects of idelalisib on fertility and foetal development (see section 5.3).
Danish: Dyreforsøg indikerer mulighed for skadelige virkninger af idelalisib på fertilitet og føtal udvikling (se pkt.
English: Increases in liver transaminases were generally observed within the first 12 weeks of treatment, and were reversible with dose interruption (see section 4.2).
Danish: Forhøjede levertransaminaser blev generelt observeret inden for de første 12 ugers behandling og var reversible ved dosisafbrydelse (se pkt.
English: Women of childbearing potential / contraception
Danish: Kvinder i den fertile alder/kontraception
English: Stevens-Johnson syndrome/ toxic epidermal necrolysis
Danish: Stevens-Johnsons syndrom/toksisk epidermal nekrolyse
English: • rifabutin, a medicine used to treat bacterial infections including tuberculosis
Danish: • rifabutin, et lægemiddel, der anvendes til at behandle bakterieinfektioner, herunder tuberkulose
English: The European Medicines Agency has deferred the obligation to submit the results of studies with idelalisib in one or more subsets of the paediatric population in the treatment of mature B-cell neoplasms (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med idelalisib i en eller flere undergrupper af den pædiatriske population ved behandling af modne B-celle-neoplasmer (se pkt.
English: Interrupt Zydelig dosing.
Danish: Afbryd Zydelig-dosering.
English: Relative to fasting conditions, administration of an early capsule formulation of idelalisib with a highfat meal resulted in no change in Cmax and a 36% increase in mean AUCinf.
Danish: I forhold til fastende betingelser førte administration af en tidlig kapselformulering af idelalisib sammen med et måltid med højt fedtindhold ikke til nogen ændring i Cmax og til en 36 % forhøjelse i gennemsnitlig AUCinf.
English: The median DOR for all subjects was 12.5 months (12.5 months for SLL subjects, and 11.8 months for FL, 20.4 months for LPL/WM and 18.4 months for MZL subjects).
Danish: Medianen for DOR for alle patienter var 12,5 måneder (12,5 måneder for patienter med SLL og 11,8 måneder for patienter med FL, 20,4 måneder for LPL/WM og 18,4 måneder for MZL).
English: Compared with rituximab + placebo, treatment with idelalisib + rituximab resulted in statistically significant and clinically meaningful improvements in physical well-being, social well-being, functional well-being, as well as in the leukaemia-specific subscales of the Functional Assessment of Cancer Therapy: Leukaemia (FACT-LEU) instruments, and in statistically significant and clinically meaningful improvements in anxiety, depression and usual activities as measured by the EuroQoL Five-Dimensions (EQ-5D) instrument.
Danish: Sammenlignet med behandling med rituximab + placebo førte behandling med idelalisib + rituximab til statistisk signifikante og klinisk meningsfulde forbedringer i det fysiske velbehag, socialt velbehag, funktionelt velbehag samt i de leukæmi-specifikke underskalaer fra Functional Assessment of Cancer Therapy: Leukaemia (FACT-LEU)-instrumenterne, og til statistisk signifikante og klinisk meningsfulde forbedringer i angst, depression og sædvanlige aktiviteter, målt ved hjælp af EuroQoL Five-Dimensions (EQ-5D)-instrumentet.
English: In vitro, idelalisib both inhibited and induced CYP2C8, but it is not known whether this translates to an in vivo effect on CYP2C8 substrates.
Danish: Idelalisib både hæmmede og inducerede CYP2C8 in vitro, men det er ukendt, om dette kan overføres til en in vivo-virkning på CYP2C8-substrater.
English: There is very limited experience from the treatment of patients with a history of inflammatory bowel disease.
Danish: Der er meget begrænset erfaring med behandling af patienter, hvis anamnese inkluderer inflammatorisk tarmsygdom.