natgillin/translations-raw huggingface dataset:
Zydelig kan anvendes til behandling af to forskellige kræftsygdomme hos voksne: 
Zydelig may be used for the treatment of two different cancers in adults:
I mange tilfælde blev patogenet ikke identificeret, dog var konventionelle og opportunistiske patogener, herunder PJP og CMV, blandt de identificerede. 
In many instances the pathogen was not identified; however, both conventional and opportunistic pathogens, including PJP and CMV, were among those identified.
Idelalisib anses ikke for at have en bred immunosuppressiv aktivitet. 
Idelalisib is not considered to have broad immunosuppressive activity.
Zydelig er et lægemiddel mod kræft, som indeholder det aktive stof idelalisib. 
Zydelig is a cancer medicine that contains the active substance idelalisib.
• midazolam, triazolam, når det tages gennem munden, til at hjælpe dig med at sove og/eller lindre angst 
• midazolam, triazolam, when taken by mouth to help you sleep and/or relieve anxiety
Patienterne skal instrueres i at sluge tabletten hel. 
Patients should be instructed to swallow the tablet whole.
Patienterne havde en median Cumulative Illness Rating Scale (CIRS) score på 8. 
Subjects had a median Cumulative Illness Rating Scale (CIRS) score of 8.
Hvis du i øjeblikket ammer, skal du kontakte lægen, før du starter behandlingen. 
If you are currently breast-feeding, talk to your doctor before starting treatment.
Kontakt lægen, før du tager Zydelig. 
Talk to your doctor before taking Zydelig.
Hvis du ved et uheld tager mere end den anbefalede dosis Zydelig, kan du have en øget risiko for bivirkninger med dette lægemiddel (se punkt 4, Bivirkninger). 
If you accidentally take more than the recommended dose of Zydelig, you may be at increased risk of side effects with this medicine (see section 4, Possible side effects).
ENDOTELIN-RECEPTORANTAGONISTER 
ENDOTHELIN RECEPTOR ANTAGONISTS
Andre bivirkninger Meget almindelige bivirkninger 
Other side effects Very common side effects
Du skal især fortælle det til lægen, hvis du tager nogle af de følgende lægemidler: 
In particular, tell your doctor if you are taking any of the following:
Ved denne sygdom deler lymfocytterne sig for hurtigt og lever for længe, så der cirkulerer for mange af dem i blodet. 
In this disease, the lymphocytes multiply too quickly and live for too long, so that there are too many of them circulating in the blood.
Idelalisibs potentielle karcinogenicitet blev evalueret i et 26-ugers transgent RasH2 musestudie og et 2-årigt rottestudie. 
The carcinogenicity potential of idelalisib was evaluated in a 26-week transgenic RasH2 mouse study and a 2-year rat study.
INHALERET BETA-AGONIST 
INHALED BETA AGONIST
Behandling med Zydelig bør udføres af en læge med erfaring i anvendelsen af anticancerbehandling. 
Treatment with Zydelig should be conducted by a physician experienced in the use of anti-cancer therapies.
Næsten alle (95,9 %) patienter havde tidligere fået anti-CD20 monoklonale antistoffer. 
Nearly all (95.9%) subjects had received prior anti-CD20 monoclonal antibodies.
Fertiliteten hos hunner blev ikke påvirker hos rotter. 
Female fertility was not affected in rats.
Medianen for OS, herunder langvarig opfølgning for alle 125 patienter, var 48,6 måneder. 
The median OS, including long-term follow-up for all 125 subjects, was 48.6 months.
Det virker ved at blokere virkningerne af et enzym, som er involveret i multiplikationen og overlevelsen af visse hvide blodlegemer, som kaldes lymfocytter. 
It works by blocking the effects of an enzyme involved in multiplication and survival of certain white blood cells called lymphocytes.
Pædiatrisk population Zydeligs sikkerhed og virkning hos børn under 18 år er ikke klarlagt. 
The safety and efficacy of Zydelig in children under the age of 18 years have not been established.
In vitro var CYP3A4-hæmningen irreversibel, og det forventes derfor at tage flere dage at vende tilbage til normal enzymaktivitet efter administrationen af idelalisib stoppes. 
In vitro, the CYP3A4 inhibition was irreversible, and return to normal enzyme activity is therefore expected to take several days after stopping idelalisib administration.
Det er ukendt, om det aktive stof i Zydelig udskilles i human mælk. 
It is not known whether the active substance in Zydelig passes into human milk.
Det er aktuelt ukendt, om idelalisib kan reducere effektiviteten af hormonel kontraception, og derfor skal kvinder, der bruger hormonel kontraception, tilføje en barrieremetode, som ekstra kontraception. 
It is currently unknown whether idelalisib may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method as a second form of contraception.
Klinisk overvågning anbefales, og en lavere startdosis af atorvastatin kan overvejes. 
Clinical monitoring is recommended and a lower starting dose of atorvastatin may be considered.
Klinisk overvågning anbefales for øgede tegn/symptomer på kortikosteroidvirkninger. 
Clinical monitoring is recommended for increased signs/symptoms of corticosteroid effects.
↑ serumkoncentrationer Dosisreduktion af colchicin kan være nødvendig. 
↑ serum concentrations Dose reductions of colchicine may be required.
Der er ikke planlagt yderligere undersøgelser af dette emne i de igangværende studier af B-celle-malignitet. 
Further investigation of this topic in current B-cell malignancy studies is not planned.
Virkningsresultaterne er opsummeret i tabel 3 og 4. 
Efficacy results are summarised in Tables 3 and 4.
Uændret idelalisib udgjorde 23 % af den totale radioaktivitet, der blev genfundet i urinen i løbet af 48 timer, og 12 % af den totale radioaktivitet, der blev genfundet i fæces i løbet af 144 timer. 
Unchanged idelalisib accounted for 23% of total radioactivity recovered in urine over 48 hours and 12% of total radioactivity recovered in faeces over 144 hours.
Baseret på fund hos dyr kan idelalisib forårsage fosterskade. 
Based on findings in animals, idelalisib may cause foetal harm.
Patienterne havde en median CIRS-score på 4. 
Subjects had a median CIRS score of 4.
Fortæl det straks til lægen: 
Tell your doctor right away:
Virkningsresultater er opsummeret i tabel 7. 
Efficacy results are summarised in Table 7.
FL undergruppe (N = 72) n (%) 
FL subset (N=72) n (%)
Monitorering af koncentrationen af sedativa/hypnotika anbefales, og dosisreduktion kan overvejes. 
Concentration monitoring of sedatives/hypnotics is recommended and dose reduction may be considered.
Din læge vil kontrollere dine blodtal før eller under behandling med Zydelig og i sjældne tilfælde vil lægen give dig et andet lægemiddel. 
Your doctor will check your blood counts before or during treatment with Zydelig and in rare cases they may need to give you another medicine.
Degeneration af de seminiferuse tubuli i testiklerne blev observeret i 2 til 13 ugers studier med gentagne doser hos hunde og rotter, men ikke i studier, der varede 26 uger eller længere. 
Degeneration of the seminiferous tubules in the testes was observed in 2- to 13-week repeated dose studies in dogs and rats, but not in studies of 26 weeks and longer duration.
Denne observerede lymfocytose er en farmakodynamisk virkning og skal ikke betragtes som progressiv sygdom ved fravær af andre kliniske fund. 
This observed lymphocytosis is a pharmacodynamic effect and should not be considered progressive disease in the absence of other clinical findings.
Zydelig kan forårsage svær diarré. 
Zydelig can cause severe diarrhoea.
Tabel 7: Oversigt over virkning i studie 101-09 (IRC-vurdering) Karakteristik 
Table 7: Summary of efficacy in Study 101-09 (IRC assessment) Characteristic
Ved CLL anvendes Zydelig sammen med et andet lægemiddel (rituximab) hos patienter med visse højrisiko-faktorer og hos patienter, hvor kræften er vendt tilbage efter mindst én tidligere behandling. 
In CLL Zydelig treatment is used in combination with another medicine (rituximab) in patients who have certain high-risk factors or in patients whose cancer has come back after at least one previous treatment.
Næsten alle PJP-infektioner, herunder tilfælde med dødelig udgang, opstod uden PJP-profylakse. 
Nearly all PJP infections, including fatal cases, occurred in the absence of PJP prophylaxis.
Alle patienterne var refraktære til rituximab, og 124 ud af 125 patienter var refraktære til mindst et alkylerende stof. 
All subjects were refractory to rituximab and 124 of 125 subjects were refractory to at least one alkylating agent.
Den filmovertrukne tablet kan tages med eller uden mad (se pkt. 
The film-coated tablet can be taken with or without food (see section 5.2).
Alternativt kan det overvejes at skifte til pravastatin, rosuvastatin eller pitavastatin. 
Alternatively, switching to pravastatin, rosuvastatin, or pitavastatin may be considered.
** Idelalisib-induceret lymfocytose skal ikke betragtes som progressiv sygdom ved fravær af andre kliniske fund (se afsnit 5.1). 
** Idelalisib-induced lymphocytosis should not be considered progressive disease in the absence of other clinical findings (see section 5.1).
De hyppigst observerede infektioner var i luftvejene og septiske hændelser. 
Most frequently observed were infections in the respiratory system and septic events.
Hver karton indeholder 1 tabletbeholder. 
Each carton contains 1 bottle.
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. 
Prophylaxis for PJP should therefore be administered to all patients throughout idelalisib treatment, and for a period of 2 to 6 months after discontinuation.
↑ serumkoncentrationer Der bør udvises forsigtighed, og patienterne bør observeres nøje for bosentanrelateret toksicitet. 
↑ serum concentrations Caution should be exercised and patients closely observed for bosentan-related toxicity.
Klinisk overvågning anbefales af patienter med CrCl < 90 ml/min. 
Clinical monitoring is recommended for patients with CrCl < 90 mL/min.
Tabel 1: Interaktioner mellem idelalisib og andre lægemidler, der er CYP3A-substrater Lægemiddel 
Table 1: Interactions between idelalisib and other medicinal products that are CYP3A substrates
Ved en dosis 2,7 gange den maksimalt anbefalede dosis, forlængede idelalisib ikke QT/QTc-intervallet (dvs. < 10 ms). 
At a dose 2.7 times the maximum recommended dose, idelalisib did not prolong the QT/QTc interval (i.e.,< 10 ms).
Administration af idelalisib sammen med CYP3A-substrater kan øge deres systemiske eksponeringer og øge eller forlænge deres terapeutiske aktivitet og bivirkninger. 
Co-administration of idelalisib with CYP3A substrates may increase their systemic exposures and increase or prolong their therapeutic activity and adverse reactions.
Overordnet iNHL-kohorte (N = 125) n (%) 
Overall iNHL cohort (N=125) n (%)
Tilfælde af pneumonitis og organiserende pneumoni (nogle med dødelig udgang) er blevet rapporteret med idelalisib. 
Cases of pneumonitis and organising pneumonia (some with fatal outcome) have been reported with idelalisib.
De følgende pakningsstørrelser er tilgængelige: ydre karton indeholdende 1 plastikbeholder med 60 filmovertrukne tabletter. 
The following pack size is available: outer carton containing 1 plastic bottle of 60 film-coated tablets.
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. 
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.
Kun patienter, der både havde baseline vurdering og ≥ 1 evaluerbare vurderinger efter baseline, blev inkluderet i denne analyse. 
Only subjects that had both baseline and ≥ 1 evaluable post-baseline assessments were included in this analysis.
Der rådes til forsigtighed, når Zydelig administreres til patienter med aktiv hepatitis. 
Caution should be exercised when administering Zydelig in patients with active hepatitis.
Medianen for OS, herunder langvarig opfølgning for alle FL-patienter var 61,2 måneder. 
The median OS, including long-term follow-up for all FL subjects was 61.2 months.
• hvis du er allergisk over for idelalisib eller et af de øvrige indholdsstoffer i Zydelig (angivet i punkt 6). 
• if you are allergic to idelalisib or any of the other ingredients of this medicine (listed in section 6).
Der bør ikke initieres behandling med Zydelig hos patienter med nogen form for evidens for aktuel systemisk bakterie-, svampe- eller virusinfektion. 
Treatment with Zydelig should not be initiated in patients with any evidence of ongoing systemic bacterial, fungal, or viral infection.
• Aktivt stof: idelalisib. 
• The active substance is idelalisib.
Idelalisib er ikke blevet undersøgt hos patienter med kronisk aktiv hepatitis, herunder viral hepatitis. 
Idelalisib has not been studied in patients with chronic active hepatitis including viral hepatitis.
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. 
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.
Quetiapin, pimozid 
Quetiapine, pimozide
Hvis der er mistanke om PML, skal relevante diagnostiske vurderinger udføres, og behandlingen skal stilles i bero, indtil PLM er udelukket. 
If PML is suspected then appropriate diagnostic evaluations should be undertaken and treatment suspended until PML is excluded.
Der rådes til forsigtighed, når Zydelig administreres til denne population. 
Caution is recommended when administering Zydelig in this population.
ANTIPSYKOTIKA/NEUROLEPTIKA 
ANTI-PSYCHOTICS/NEUROLEPTICS
Ved FL anvendes Zydelig alene hos patienter, hvis deres kræftsygdom ikke responderede på behandling med to tidligere kræftbehandlinger. 
In FL Zydelig is used on its own in patients whose cancer has not responded to treatment with two previous cancer treatments.
Farmakoterapeutisk klassifikation: antineoplastiske stoffer, andre antineoplastiske stoffer, ATC-kode: L01XX47 
Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents, ATC code: L01XX47
** LNR defineret som andelen af patienter, som opnåede ≥ 50 % reduktion i summen af produkterne af de største vinkelrette diametre i indekslæsionerne. 
** 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.
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. 
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.
Plasmaeksponeringerne (Cmax og AUC) for idelalisib er ca. dosisproportionale fra 50 mg til 100 mg, og mindre end dosisproportionale over 100 mg. 
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.
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. 
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.
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. 
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.
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). 
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).
(kan forekomme hos flere end 1 ud af 10 personer) • diarré/betændelse i tyktarmen 
(may affect up to 1 in 10 people) • inflammation of the lungs
Kombinationen kan føre til en øget risiko for kardiovaskulære uønskede hændelser forbundet med salmeterol, herunder QT-forlængelse, palpitationer og sinus-takykardi. 
The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia.
* 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. 
* 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.
Amiodaron, kinidin 
Amiodarone, quinidine
* 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). 
* 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).
Det er ikke sandsynligt, at Zydelig påvirker din evne til at føre motorkøretøj eller betjene maskiner. 
Zydelig is unlikely to affect your ability to drive or use machines.
Diarré/colitis 
Diarrhoea/colitis
Idelalisib blev taget indtil sygdomsprogression eller uacceptabel toksicitet. 
Idelalisib was taken until disease progression or unacceptable toxicity.
Ved diagnosticering af enten moderat eller svær symptomatisk pneumonitis eller organiserende pneumoni, bør der indledes hensigtsmæssig behandling, og idelalisib skal seponeres permanent. 
If either moderate or severe symptomatic pneumonitis or organising pneumonia is diagnosed, appropriate treatment should be initiated and idelalisib must be permanently discontinued.
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. 
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.
UNIK IDENTIFIKATOR - 2D STREGKODE 18. 
UNIQUE IDENTIFIER - 2D BARCODE 18.
Kvinder bør undgå at blive gravide, mens de tager Zydelig og i op til en måned efter endt behandling. 
Women should avoid becoming pregnant while taking Zydelig, and for up to 1 month after ending treatment.
Responskategori*† CR 
Response category*† CR
Patienter med CMV-viræmi uden medfølgende kliniske tegn på CMV-infektion skal overvåges nøje. 
Patients with CMV viraemia without associated clinical signs of CMV infection should be carefully monitored.
Infektioner og parasitære sygdomme Infektioner (herunder Pneumocystis jirovecii pneumoni og CMV)* 
Infections and infestations Infections (including Pneumocystis jirovecii pneumonia and CMV)*
• hvis du har nyopstået eller forværret hoste 
• if you have a new or worsening cough
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. 
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.
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. 
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.
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. 
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.
Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette lægemiddel inden for 8 måneder efter godkendelsen. 
The marketing authorisation holder shall submit the first periodic safety update report for this product within 8 months following authorisation.
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. 
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.
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. 
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.
Du må ikke holde op med at tage Zydelig 
Do not stop taking Zydelig
Idelalisib kan administreres uden hensyntagen til mad. 
Idelalisib can be administered without regard to food.
Ved follikulært lymfom deler B-lymfocytterne sig for hurtigt og lever for længe, så der er for mange af dem i lymfeknuderne. 
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.
Der er ingen humane data om idelalisibs virkning på fertiliteten. 
No human data on the effect of idelalisib on fertility are available.
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. 
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.
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. 
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.
Udslæt var generelt let til moderat og førte til seponering hos 2,1 % af patienterne. 
Rash was generally mild to moderate and resulted in discontinuation of treatment in 2.1% of subjects.
Der er ingen eller utilstrækkelige data fra anvendelse af idelalisib til gravide kvinder. 
There are no or limited amount of data from the use of idelalisib in pregnant women.
Behandlingen med Zydelig skal pauseres i tilfælde af formodet pneumonitis. 
Treatment with Zydelig must be withheld in the event of suspected pneumonitis.
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. 
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.