natgillin/translations-raw huggingface dataset:
For patienter i placebo + R-gruppen inkluderer oversigten data op til den første idelalisib-dosis i et forlængelsesstudie. 
For subjects in the placebo + R group, the summary includes data up to the first dosing of idelalisib in an extension study.
Der blev ikke observeret nedsat leverfunktion eller kroniske transaminaseforhøjelser hos rotter eller hunde i studier, der varede 13 uger eller længere. 
No hepatic impairment or chronic transaminase elevations were observed in rats or dogs in studies of 13 weeks and longer duration.
Patienterne blev randomiseret i forholdet 1:1 til 8 cyklusser rituximab (første cyklus med 375 mg/m2 kropsoverfladeareal (BSA, body surface area), efterfølgende cyklusser med 500 mg/m2 BSA) i kombination med enten oralt placebo to gange dagligt eller med idelalisib 150 mg to gange dagligt indtil sygdomsprogression eller uacceptabel toksicitet. 
Subjects were randomised 1:1 to receive 8 cycles of rituximab (first cycle at 375 mg/m2 body surface area [BSA], subsequent cycles at 500 mg/m2 BSA) in combination with either an oral placebo twice daily or with idelalisib 150 mg taken twice daily until disease progression or unacceptable toxicity.
Alle patienter skal have deres blodtal monitoreret mindst hver 14. dag i de første 6 måneder af behandlingen med idelalisib og mindst én gang ugentligt hos patienter med et ANC på under 1.000 pr. mm3 (se pkt. 
Blood counts should be monitored in all patients at least every 2 weeks for the first 6 months of treatment with idelalisib, and at least weekly in patients while ANC is less than 1,000 per mm3 (see section 4.2).
Idelalisibs sikkerhed og virkning blev vurderet i et klinisk multicenterstudie med en enkelt arm (studie 101-09), som blev udført hos 125 patienter med indolent B-celle non-Hodgkin lymfom (iNHL, herunder: FL, n = 72; SLL, n = 28; lymfoplasmacytisk lymfom/Waldenströms makroglobulinæmi [LPL/WM], n = 10; og marginalzonelymfom [MZL], n = 15). 
The safety and efficacy of idelalisib were assessed in a single-arm, multicentre clinical study (study 101-09) conducted in 125 subjects with indolent B-cell non-Hodgkin lymphoma (iNHL, including: FL, n = 72; SLL, n = 28; lymphoplasmacytic lymphoma/Waldenström macroglobulinaemia [LPL/WM], n = 10; and marginal zone lymphoma [MZL], n = 15).
Samtidig behandling med idelalisib og CYP3A-substrater med alvorlige og/eller livstruende bivirkninger (f.eks. alfuzosin, amiodaron, cisaprid, pimozid, quinidin, ergotamin, dihydroergotamin, quetiapin, lovastatin, simvastatin, sildenafil, midazolam, triazolam) bør undgås, og der bør om muligt anvendes andre lægemidler, som er mindre følsomme over for CYP3A4-hæmning. 
Concomitant treatment of idelalisib with CYP3A substrates with serious and/or life-threatening adverse reactions (e.g., alfuzosin, amiodarone, cisapride, pimozide, quinidine, ergotamine, dihydroergotamine, quetiapine, lovastatin, simvastatin, sildenafil, midazolam, triazolam) should be avoided and alternative medicinal products that are less sensitive to CYP3A4 inhibition should be used if possible.
Virkning af idelalisib på andre lægemidlers farmakokinetik 
Effect of idelalisib on the pharmacokinetics of other medicinal products
Idelalisib AUC (ubundet), efter der tages hensyn til forskelle i proteinbinding, var ~80 % (1,8 gange) højere ved moderat og ~152 % (2,5 gange) højere ved svært nedsat leverfunktion, sammenlignet med matchede kontroller. 
The idelalisib AUC (unbound), after accounting for differences in protein binding, was ~80% (1.8-fold) higher in moderate and ~152% (2.5-fold) higher in severe impairment compared to matched controls.
Idelalisib var ikke kræftfremkaldende ved eksponeringer på op til 1,4/7,9 gange (begge køn) hos mus sammenlignet med eksponeringen hos patienter med hæmatologiske maligniteter, der fik den anbefalede dosis på 150 mg to gange dagligt. 
Idelalisib was not carcinogenic at exposures up to 1.4/7.9-fold (male/female) in mice compared to the exposure in patients with haematologic malignancies administered the recommended dose of 150 mg twice daily.
Patienterne fik idelalisib 150 mg to gange dagligt, og rituximab 375 mg/m2 BSA ugentligt for 8 doser. 
Subjects received idelalisib 150 mg twice daily and rituximab 375 mg/m2 BSA weekly for 8 doses.
ANC 1.000 til < 1.500/mm3 
ANC 1,000 to < 1,500/mm3
En generelt højere forekomst af infektioner (herunder infektioner af grad 3 og 4) blev observeret i idelalisib-armene sammenlignet med kontrolarmene i de kliniske studier med idelalisib. 
Higher frequencies of infections overall, including Grade 3 and 4 infections, were observed in the idelalisib arms compared to the control arms of idelalisib clinical studies.
↑ serumkoncentrationer Niveauerne af antikonvulsiva bør monitoreres. 
↑ serum concentrations Anticonvulsant drug levels should be monitored.
Fentanyl, alfentanil, metadon, buprenorfin/naloxon 
Fentanyl, alfentanil, methadone, buprenorphine/naloxone
Oralt budesonid 
Oral budesonide
ANC 500 til < 1.000/mm3 
ANC 500 to < 1,000/mm3
Efter en enkelt 150 mg oral dosis af [14C]-mærket idelalisib, blev hhv. ca. 78 % og 15 % udskilt i fæces og urin. 
Following a single 150 mg oral dose of [14C]-labelled idelalisib, approximately 78% and 15% was excreted in faeces and urine, respectively.
Brug af anden medicin sammen med Zydelig 
Other medicines and Zydelig
• sildenafil, tadalafil, lægemidler, der anvendes til at behandle impotens og pulmonal hypertension, en lungesygdom, der gør det vanskeligt at trække vejret 
• sildenafil, tadalafil, medicines used to treat impotence and pulmonary hypertension, a lung disease that makes breathing difficult
Der er en potentiel risiko for, at idelalisib, via den primære metabolit, GS-563117, kan forårsage fotosensitivitet hos behandlede patienter. 
There is a potential risk that idelalisib, via its major metabolite, GS-563117, may cause photosensitivity in treated patients.
Klinisk overvågning anbefales. 
Clinical monitoring is recommended.
Fortæl det til lægen, hvis du har allergi over for sunset yellow FCF (E110). 
Tell your doctor if you have an allergy to sunset yellow FCF (E110).
• hvis du har rødme og vabler på huden 
• if you have redness and blistering of the skin
Buspiron, clorazepat, diazepam, estazolam, flurazepam, zolpidem 
Buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem
Indeholder sunset yellow FCF (E110), se indlægssedlen for yderligere information. 
Contains sunset yellow FCF (E110), see leaflet for further information.
Substrater for inducerbare enzymer (f.eks. CYP2C9, CYP2C19, CYP2B6 og UGT) Idelalisib inducerede adskillige enzymer in vitro, og en risiko for nedsat eksponering og dermed reduceret virkning over for substrater af inducerbare enzymer, såsom CYP2C9, CYP2C19, CYP2B6 og UGT kan ikke udelukkes. 
Substrates of inducible enzymes (e.g., CYP2C9, CYP2C19, CYP2B6 and UGT) In vitro, idelalisib was an inducer of several enzymes, and a risk for decreased exposure and thereby decreased efficacy of substrates of inducible enzymes such as CYP2C9, CYP2C19, CYP2B6 and UGT cannot be excluded.
Ikke muteret IGHV 
Unmutated IGHV
MIDLER MOD CANCER 
ANTI-CANCER AGENTS
Pneumonitis og organiserende pneumoni 
Pneumonitis and organising pneumonia
Idelalisib bør ikke administreres sammen med midazolam (oral) eller triazolam. 
Idelalisib should not be co-administered with midazolam (oral) or triazolam.
Et studie af idelalisibs farmakokinetik og sikkerhed blev udført hos raske personer og hos patienter med moderat (Child-Pugh klasse B) eller svært (Child-Pugh klasse C) nedsat leverfunktion. 
A study of pharmacokinetics and safety of idelalisib was performed in healthy subjects and subjects with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment.
Det skal du vide, før du begynder at tage Zydelig Tag ikke Zydelig 
What you need to know before you take Zydelig Do not take Zydelig
Zydelig indeholder sunset yellow FCF (E110) 
Zydelig contains sunset yellow FCF (E110)
Fuldt optrukken linje: idelalisib + R (N = 110), stiplet linje: placebo + R (N = 110) R: rituximab; N: antal patienter i gruppen 
Solid line: idelalisib + R (N = 110), dashed line: placebo + R (N = 110) R: rituximab; N: number of subjects per group
Ældre Specifik dosisjustering er ikke nødvendig hos ældre patienter (i alderen ≥ 65 år) (se pkt. 
Elderly No specific dose adjustment is required for elderly patients (aged ≥ 65 years) (see section 5.2).
Af disse havde 5,7 %, som fik idelalisib + et anti-CD20 monoklonalt antistof (rituximab eller ofatumumab), og 1,5 %, der kun fik et anti-CD20 monoklonalt antistof (rituximab eller ofatumumab), udslæt af grad 3, og ingen patienter havde en grad 4-bivirkning. 
Of these, 5.7% who received idelalisib + an anti-CD20 monoclonal antibody (rituximab or ofatumumab) and 1.5% who received an anti-CD20 monoclonal antibody only (rituximab or ofatumumab) had rash of Grade 3, and no subjects had an adverse reaction of Grade 4.
↑ serumkoncentrationer Nøje dosistitrering af det antidepressive middel og overvågning af det antidepressive respons anbefales. 
↑ serum concentrations Careful dose titration of the antidepressant and monitoring for antidepressant response is recommended.
Der blev ikke inkluderet nogen patienter med svært nedsat leverfunktion i kliniske studier af idelalisib. 
No patients with severe hepatic impairment were included in clinical studies of idelalisib.
Bepridil, disopyramid, lidocain 
Bepridil, disopyramide, lidocaine
Når idelalisib administreres sammen med andre lægemidler, henvises til produktresuméerne (SPC'er) for de andre præparater for anbefalinger angående administration sammen med CYP3A4-hæmmere. 
When idelalisib is co-administered with other medicinal products, the Summary of Product Characteristics (SmPC) for the other product must be consulted for the recommendations regarding co-administration with CYP3A4 inhibitors.
Gentagen dosistoksicitet 
Repeated dose toxicity
Kaplan-Meier-kurven for PFS ses i figur 2. 
The Kaplan-Meier curve for PFS is provided in Figure 2.
Kaplan-Meier-kurven for PFS ses i figur 1. 
The Kaplan-Meier curve for PFS is provided in Figure 1.
Hvis en patient glemmer en dosis i mere end 6 timer, skal patienten ikke tage den glemte dosis, og blot genoptage det normale doseringsskema. 
If a patient misses a dose by more than 6 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Den anbefalede dosis er 150 mg, der tages gennem munden, to gange dagligt. 
The recommended dose is 150 mg by mouth twice a day.
↑ serumkoncentrationer Monitorering af international normaliseret ratio (INR) anbefales ved administration sammen med og efter ophør af idelalisib-behandling. 
↑ serum concentrations It is recommended that the international normalised ratio (INR) be monitored upon co-administration and following ceasing treatment with idelalisib.
Via hæmning af CXCR4 og CXCR5 kemokinreceptorernes signalering, der induceres af hhv. kemokinerne CXCL12 og CXCL13, hæmmer idelalisib cellemigration til oprindelsesstedet og retention af maligne B-celler i tumor-mikromiljøet, herunder lymfatisk væv og i knoglemarven. 
Through inhibition of chemokine receptors CXCR4 and CXCR5 signalling induced by the chemokines CXCL12 and CXCL13, respectively, idelalisib inhibits homing and retention of malignant B-cells in the tumour microenvironment including lymphoid tissues and the bone marrow.
Efter en enkelt 150 mg dosis var idelalisib AUC (totalt, dvs. bundet plus ubundet) ~60 % højere ved moderat og svært nedsat funktion, sammenlignet med matchede kontroller. 
Following a single 150 mg dose, idelalisib AUC (total, i.e., bound plus unbound) was ~60% higher in moderate and severe impairment compared to matched controls.
For patienter med evidens for CMV-viræmi og kliniske tegn på CMV-infektion skal midlertidig afbrydelse af idelalisib, indtil infektionen er ophørt, overvejes. 
For patients with evidence of CMV viraemia and clinical signs of CMV infection, consideration should be given to interrupting idelalisib until the infection has resolved.
Patienterne blev randomiseret i forholdet 2:1 til at få idelalisib 150 mg to gange dagligt og 12 infusioner af ofatumumab i løbet af 24 uger, eller kun 12 infusioner med ofatumumab i løbet af 24 uger. 
Subjects were randomised 2:1 to receive idelalisib 150 mg twice daily and 12 infusions of ofatumumab over 24 weeks, or 12 infusions of ofatumumab only over 24 weeks.
Responskategori*† 
Response category*†
Fase 1- og fase 2-studierne vurderede sikkerheden af idelalisib hos i alt 536 patienter med hæmatologisk malignitet, herunder 400 patienter, som fik idelalisib (en hvilken som helst dosis) som enkeltstof, og 136 patienter, som fik idelalisib i kombination med et anti-CD20 monoklonalt antistof (rituximab eller ofatumumab). 
The Phase 1 and 2 studies assessed the safety of idelalisib in a total of 536 subjects with haematologic malignancies, including 400 subjects who received idelalisib (any dose) as a single agent and 136 subjects who received idelalisib in combination with an anti-CD20 monoclonal antibody (rituximab or ofatumumab).
I et fertilitetsstudie hos hanrotter blev der observeret reduktioner i vægten af epididymis og testikler, men uden bivirkninger på parrings- eller fertilitetsparametre, og ingen degeneration eller tab i spermatogenese blev observeret. 
In a rat male fertility study, decreases in epididymides and testes weight were observed but no adverse effects on mating or fertility parameters, and no degeneration or loss in spermatogenesis were observed.
Den anbefalede dosis er 150 mg idelalisib to gange dagligt. 
The recommended dose is 150 mg idelalisib twice daily.
Behandling med Zydelig skal seponeres permanent i tilfælde af moderat eller svær symptomatisk pneumonitis eller organiserende pneumoni (se pkt. 
Treatment with Zydelig must be permanently discontinued in the event of moderate or severe symptomatic pneumonitis or organising pneumonia (see sections 4.4 and 4.8).
Tabel 5: Virkningsresultater fra studie 312-0119 Idelalisib + O N = 174 
Table 5: Efficacy results from study 312-0119 Idelalisib + O N = 174
Efter en enkelt 150 mg dosis blev der ikke observeret nogen klinisk relevante ændringer i eksponering over for idelalisib eller GS-563117 hos patienter med svært nedsat nyrefunktion, sammenlignet med raske personer. 
Following a single 150 mg dose, no clinically relevant changes in exposures to idelalisib or GS-563117 were observed in subjects with severe renal impairment compared to healthy subjects.
Infektioner (se pkt. 
Infections (see section 4.4)
Idelalisib inducerer apoptose og hæmmer celledelingen i cellelinjer, der stammer fra maligne B-celler, og i primære tumorceller. 
Idelalisib induces apoptosis and inhibits proliferation in cell lines derived from malignant B-cells and in primary tumour cells.
NR: ikke nået * Respons bestemt af en uafhængig bedømmelseskomité (IRC), hvor ORR = fuldstændigt respons (CR) + delvist respons (PR) + mindre respons (MR) hos patienter med WM. † I den overordnede iNHL-kohorte havde 1 patient (0,6 %) med WM det bedste overordnede respons på MR 
CI: confidence interval; n: number of responding subjects NR: not reached * Response as determined by an independent review committee (IRC) where ORR = complete response (CR) + partial response (PR) + minor response (MR) in subjects with WM. † In the overall iNHL cohort, 1 subject (0.6%) with WM had the best overall response of MR
Fuldt optrukken linje: idelalisib + O (N = 174), stiplet linje: ofatumumab (N = 87) O: ofatumumab; N: antal patienter i gruppen 
Solid line: idelalisib + O (N = 174), dashed line: ofatumumab (N = 87) O: ofatumumab; N: number of subjects per group
Elektrokardiografisk 
Electrocardiographic
Der skal udvises særlig forsigtighed, og dosisreduktion kan overvejes, når sildenafil eller tadalafil ordineres sammen med idelalisib med øget overvågning for bivirkninger. 
Particular caution must be used and dose reduction may be considered when prescribing sildenafil or tadalafil with idelalisib with increased monitoring for adverse events.
Blodprøver kan også vise: • øgede niveauer af fedt i blodet 
Blood tests may also show: • increased blood levels of fats
Figur 1: Kaplan-Meier-kurve for PFS fra studie 312-0116 (intent-to-treat-population) 
Figure 1: Kaplan-Meier curve of PFS from study 312-0116 (intent-to-treat population)
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ETIKETTERING PÅ KARTON 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON LABEL
Zydelig er indiceret som monoterapi til behandling af voksne patienter med follikulært lymfom (FL), som er refraktært over for to tidligere behandlingsregimer (se pkt. 
Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment (see section 4.4).
Populationsfarmakokinetiske analyser indikerede, at alder ikke havde nogen klinisk relevant virkning på eksponeringerne over for idelalisib eller GS-563117, herunder ældre patienter (65 år og derover), sammenlignet med yngre patienter. 
Population pharmacokinetic analyses indicated that age had no clinically relevant effect on the exposures to idelalisib or GS-563117, including elderly subjects (65 years of age and older), compared to younger subjects.
Idelalisib hæmmer phosphatidylinositol 3-kinase p110δ (PI3Kδ), som er hyperaktiv ved B-cellemaligniteter, og som er afgørende for en række signalerings-pathways, der stimulerer celledeling, overlevelse, cellemigration til oprindelsesstedet og retention af maligne celler i det lymfoide væv og knoglemarven. 
Idelalisib inhibits phosphatidylinositol 3-kinase p110δ (PI3Kδ), which is hyperactive in B-cell malignancies and is central to multiple signalling pathways that drive proliferation, survival, homing, and retention of malignant cells in lymphoid tissues and bone marrow.
Eksponeringen for idelalisib kan reduceres ved administration sammen med CYP3A-inducere, såsom rifampicin, phenytoin, prikbladet perikon (Hypericum perforatum) eller carbamazepin. 
Idelalisib exposure may be reduced when co-administered with CYP3A inducers such as rifampicin, phenytoin, St. John's wort (Hypericum perforatum), or carbamazepine.
Figur 2: Kaplan-Meier-kurve for PFS fra studie 312-0119 (intent-to-treat-population) 
Figure 2: Kaplan-Meier curve of PFS from study 312-0119 (intent-to-treat population)
• hvis du har hævelse og vabler i slimhinden i munden, kønsdelene og/eller øjnene 
• if you have swelling and blistering of the lining of the mouth, genitals, and/or eyes
Efter administration af 150 mg idelalisib to gange dagligt, var gennemsnittet (intervallet) Cmax og AUC ved steady-state hhv. 1.953 (272; 3.905) ng/ml og 10.439 (2.349; 29.315) ng•t/ml for idelalisib og 4.039 (669; 10.897) ng/ml og 39.744 (6.002; 119.770) ng•t/ml for GS-563117. 
Following 150 mg twice daily administration of idelalisib, average (range) Cmax and AUC at steady-state were 1,953 (272; 3,905) ng/mL and 10,439 (2,349; 29,315) ng•h/mL for idelalisib and 4,039 (669; 10,897) ng/mL and 39,744 (6,002; 119,770) ng•h/mL for GS-563117, respectively.
CYP3A/P-gp-hæmmere 
CYP3A/P-gp inhibitors
Et studie af idelalisibs farmakokinetik og sikkerhed blev udført hos raske personer samt patienter med svært nedsat nyrefunktion (estimeret CrCl på 15 til 29 ml/min). 
A study of pharmacokinetics and safety of idelalisib was performed in healthy subjects and subjects with severe renal impairment (estimated CrCl 15 to 29 mL/min).
↑ serumkoncentrationer 
↑ serum concentrations
Tabel 2: Bivirkninger rapporteret i kliniske studier hos patienter med hæmatologisk malignitet, som fik idelalisib 
Table 2: Adverse drug reactions reported in clinical studies in subjects with haematologic malignancies receiving idelalisib
Tabel 3: Virkningsresultater fra studie 312-0116 Idelalisib + R N = 110 
Table 3: Efficacy results from study 312-0116 Idelalisib + R N = 110
• budesonid, fluticason, lægemidler, der anvendes til at behandle høfeber og astma, og salmeterol, anvendes til at behandle astma 
• budesonide, fluticasone, medicines used to treat hayfever and asthma, and salmeterol, used to treat asthma
GS-563117 er ikke en hæmmer af de metaboliserende enzymer CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 eller UGT1A1, eller af transporterne P-gp, BCRP, OATP1B1, OATP1B3, OAT1, OAT3 eller OCT2. 
GS-563117 is not an inhibitor of the metabolising enzymes CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or UGT1A1, or of the transporters P-gp, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, or OCT2.
• carbamazepin, S-mephenytoin, phenytoin, lægemidler, der anvendes til at forebygge krampeanfald 
• carbamazepine, S-mephenytoin, phenytoin, medicines used to prevent seizures
In vitro-data indikerede, at idelalisib ikke er en hæmmer af de metaboliserende enzymer CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A eller UGT1A1, eller af transporterne OAT1, OAT3 eller OCT2. 
In vitro data indicated that idelalisib is not an inhibitor of the metabolising enzymes CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A, or UGT1A1, or of the transporters OAT1, OAT3, or OCT2.
Follikulært lymfom (FL) er en kræftsygdom i en type hvide blodlegemer, som kaldes B-lymfocytter. 
Follicular lymphoma (FL) is a cancer of a type of white blood cell called B-lymphocytes.
i studie 312-0116/0117 og 312-0119 forekom udslæt (rapporteret som generaliseret eksfoliativ dermatitis, lægemiddeludslæt, udslæt, erytematøst udslæt, generaliseret udslæt, makuløst udslæt, makulopapuløst udslæt, papuløst udslæt, pruritisk udslæt, pustuløst udslæt, vesikulært udslæt, papler og plaques) hos 31,1 % af de patienter, der fik idelalisib + et anti-CD20 monoklonalt antistof (rituximab eller ofatumumab), og hos 8,2 % af de patienter, der kun fik et anti-CD20 monoklonalt antistof (rituximab eller ofatumumab). 
In studies 312-0116/0117 and 312-0119, rash (reported as dermatitis exfoliative generalised, drug eruption, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular, papule and skin plaque) occurred in 31.1% of subjects who received idelalisib + an anti-CD20 monoclonal antibody (rituximab or ofatumumab) and 8.2% who received an anti-CD20 monoclonal antibody only (rituximab or ofatumumab).
Der bør derfor udvises forsigtighed når Zydelig administreres til denne population, og det anbefales at intensivere overvågning for bivirkninger (se pkt. 
Therefore, caution is recommended when administering Zydelig in this population and an intensified monitoring of adverse reactions is recommended (see sections 4.4 and 5.2).
Et klinisk lægemiddelinteraktionsstudie fandt at administration af idelalisib sammen med midazolam (et følsomt CYP3A-substrat) førte til en ~140 % forhøjelse i Cmax og en ~440 % forhøjelse i AUCinf for midazolam på grund af CYP3A-hæmning af GS-563117. 
A clinical drug interaction study found that co-administration of idelalisib with midazolam (a sensitive CYP3A substrate) resulted in a ~140% increase in Cmax and a ~440% increase in AUCinf of midazolam due to the CYP3A inhibition by GS-563117.
Mikrokrystallinsk cellulose Hydroxypropylcellulose (E463) Croscarmellosenatrium Carboxymethylstivelsesnatrium Magnesiumstearat 
Microcrystalline cellulose Hydroxypropyl cellulose (E463) Croscarmellose sodium Sodium starch glycolate Magnesium stearate
• Zydelig i kombination med rituximab er indiceret til behandling af voksne patienter med kronisk lymfatisk leukæmi (CLL): 
• Zydelig is indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):
Den primære og eneste cirkulerende metabolit, GS-563117, er inaktiv over for PI3Kδ. 
The primary and only circulating metabolite, GS-563117, is inactive against PI3Kδ.
Monitorér ANC mindst én gang ugentligt, indtil ANC ≥ 500/mm3, hvorefter Zydeligdoseringen kan genoptages med 100 mg to gange dagligt. 
Monitor ANC at least weekly until ANC ≥ 500/mm3, then may resume Zydelig dosing at 100 mg twice daily.
Kronisk lymfatisk leukæmi (CLL) er en kræftsygdom i en type hvide blodlegemer, som kaldes B-lymfocytter. 
Chronic lymphocytic leukaemia (CLL) is a cancer of a type of white blood cell called B-lymphocytes.
Filmovertrukne tabletter 60 filmovertrukne tabletter 
Film-coated tablets 60 film-coated tablets