natgillin/translations-raw huggingface dataset:
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.
• ciclosporin, sirolimus, tacrolimus, lægemidler, der anvendes til at kontrollere din krops immunrespons efter en transplantation
• ciclosporin, sirolimus, tacrolimus, medicines used to control your body's immune response after a transplant
Hvis der forekommer en overdosering, skal patienten overvåges for tegn på toksicitet (se pkt.
If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8).
Behandlingen kan genoptages ved en lavere dosis, når værdierne er vendt tilbage til grad 1 eller derunder (ALAT/ASAT ≤ 3 x ULN).
Treatment may be resumed at a lower dose once values have returned to Grade 1 or below (ALT/AST ≤ 3 x ULN).
Hvis du har glemt at tage Zydelig
If you forget to take Zydelig
Zydelig påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
Zydelig has no or negligible influence on the ability to drive and use machines.
Patienterne fik 150 mg idelalisib oralt to gange dagligt, indtil bevis for sygdomsprogression eller uacceptabel toksicitet.
Subjects received 150 mg of idelalisib orally twice daily until evidence of disease progression or unacceptable toxicity.
Klinisk anbefaling ved administration sammen med idelalisib
Clinical recommendation upon co-administration with idelalisib
Lymofocytose**
Lymphocytosis**
Idelalisib hæmmede imidlertid ikke det normale værtsrespons mod Staphylococcus aureus, og det forstærkede ikke den myelosuppressive virkning af cyklophosphamid.
However, idelalisib did not inhibit the normal host response to Staphylococcus aureus and did not exacerbate the myelosuppressive effect of cyclophosphamide.
Almindelig * Omfatter opportunistiske infektioner samt bakterielle og virale infektioner såsom pneumoni, bronkitis og sepsis.
Common * Comprised of opportunistic infections as well as bacterial and viral infections such as pneumonia, bronchitis, and sepsis.
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]).
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]).
Sørg for ikke at springe en dosis med Zydelig over.
Take care to not miss a dose of Zydelig.
Behandlingsrelateret neutropeni af grad 3 eller 4, herunder febril neutropeni, er forekommet i patienter behandlet med idelalisib.
Treatment-emergent Grade 3 or 4 neutropenia, including febrile neutropenia, have occurred in patients treated with idelalisib.
Klinisk overvågning anbefales for telithromycin.
Clinical monitoring is recommended for telithromycin.
Dyreforsøg indikerer mulighed for skadelige virkninger af idelalisib på fertilitet og føtal udvikling (se pkt.
Animal studies indicate the potential for harmful effects of idelalisib on fertility and foetal development (see section 5.3).
Forhøjede levertransaminaser blev generelt observeret inden for de første 12 ugers behandling og var reversible ved dosisafbrydelse (se pkt.
Increases in liver transaminases were generally observed within the first 12 weeks of treatment, and were reversible with dose interruption (see section 4.2).
Kvinder i den fertile alder/kontraception
Women of childbearing potential / contraception
Stevens-Johnsons syndrom/toksisk epidermal nekrolyse
Stevens-Johnson syndrome/ toxic epidermal necrolysis
• rifabutin, et lægemiddel, der anvendes til at behandle bakterieinfektioner, herunder tuberkulose
• rifabutin, a medicine used to treat bacterial infections including tuberculosis
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.
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).
Afbryd Zydelig-dosering.
Interrupt Zydelig dosing.
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.
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.
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).
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).
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.
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.
Idelalisib både hæmmede og inducerede CYP2C8 in vitro, men det er ukendt, om dette kan overføres til en in vivo-virkning på CYP2C8-substrater.
In vitro, idelalisib both inhibited and induced CYP2C8, but it is not known whether this translates to an in vivo effect on CYP2C8 substrates.
Der er meget begrænset erfaring med behandling af patienter, hvis anamnese inkluderer inflammatorisk tarmsygdom.
There is very limited experience from the treatment of patients with a history of inflammatory bowel disease.
• cisaprid, et lægemiddel, der anvendes til at lindre visse maveproblemer
• cisapride, a medicine used to relieve certain stomach problems
Zydelig bør ikke anvendes under graviditeten og til kvinder i den fertile alder, som ikke anvender sikker kontraception.
Zydelig is not recommended during pregnancy and in women of childbearing potential not using contraception.
Amning Det er ukendt, om idelalisib/metabolitter udskilles i human mælk.
Breast-feeding It is not known whether idelalisib and its metabolites are excreted in human milk.
Idelalisib inducerede ikke mutationer i den mikrobielle mutagenese (Ames)-analyse, det var ikke klastogent i in vitro kromosomsaberrationsanalysen med humane perifere blodlymfocytter, og det var ikke genotoksisk i in vivo rotte mikronukleusstudiet.
Idelalisib did not induce mutations in the microbial mutagenesis (Ames) assay, was not clastogenic in the in vitro chromosome aberration assay using human peripheral blood lymphocytes, and was not genotoxic in the in vivo rat micronucleus study.
Blandt de 122 patienter med målbare lymfeknuder både ved baseline og efter baseline opnåede 71 patienter (58,2 %) en ≥ 50 % reduktion fra baseline i summen af produkterne for diametrene (SPD, sum of the products of the diameters) af indekslæsionerne.
Among the 122 subjects with measurable lymph nodes at both baseline and post-baseline, 71 subjects (58.2%) achieved a ≥ 50% decrease from baseline in the sum of the products of the diameters (SPD) of index lesions.
Hvis fordelene ved genoptagelse af idelalisib-behandling vurderes at opveje risiciene, skal forebyggende CMV-behandling overvejes.
If the benefits of resuming idelalisib are judged to outweigh the risks, consideration should be given to administering pre-emptive CMV therapy.
Idelalisib i kombination med rituximab
Idelalisib in combination with rituximab
Der indgik 64 patienter i studie 101-08/99 med tidligere ubehandlet CLL, herunder 5 patienter med småcellet lymfatisk lymfom (SLL).
Study 101-08/99 enrolled 64 subjects with previously untreated CLL, including 5 subjects with small lymphocytic lymphoma (SLL).
Brug ikke lægemidlet efter den udløbsdato, der står på tabletbeholderen og kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP.
Clarithromycin, telithromycin ↑ serumkoncentrationer Dosisjustering af clarithromycin er ikke nødvendig hos patienter med normal nyrefunktion eller let nedsat nyrefunktion (kreatininclearance [CrCl] 60-90 ml/min).
Clarithromycin, telithromycin ↑ serum concentrations No dose adjustment of clarithromycin is required for patients with normal renal function or mild renal impairment (creatinine clearance [CrCl] 60-90 mL/min).
↑ serumkoncentrationer ↑ serumkoncentrationer
↑ serum concentrations ↑ serum concentrations
• Anvend en meget sikker præventionsmetode for at undgå at blive gravid, mens du behandles med Zydelig, og i 1 måned efter din sidste behandling.
• Use a reliable method of contraception to avoid becoming pregnant while you are being treated with Zydelig, and for 1 month after your last treatment.
Af patienter, som genoptog behandlingen med idelalisib ved en lavere dosis, oplevede 26 % recidiv af forhøjelserne i ALAT og ASAT.
In patients who resumed idelalisib at a lower dose, 26% had recurrence of ALT/AST elevation.
↑ serumkoncentrationer Nøje overvågning af tolerancen over for disse midler mod cancer anbefales.
↑ serum concentrations Careful monitoring of the tolerance to these anti-cancer agents is recommended.
Der er ikke identificeret nogen mekanistiske forklaringer på udviklingen af resistens over for behandlingen med idelalisib i kliniske studier.
No mechanistic explanations for the development of resistance to treatment with idelalisib have been identified from clinical studies.
Der er forekommet alvorlige og dødelige infektioner med idelalisib, herunder opportunistiske infektioner, som f.eks. pneumocystis jirovecii pneumoni (PJP) og cytomegalovirus (CMV).
Serious and fatal infections have occurred with idelalisib, including opportunistic infections such as Pneumocystis jirovecii pneumonia (PJP) and cytomegalovirus (CMV).