FrancophonIA/ELRC3.0 huggingface dataset:
English: • sildenafil, tadalafil, medicines used to treat impotence and pulmonary hypertension, a lung disease that makes breathing difficult
Danish: • sildenafil, tadalafil, lægemidler, der anvendes til at behandle impotens og pulmonal hypertension, en lungesygdom, der gør det vanskeligt at trække vejret
English: There is a potential risk that idelalisib, via its major metabolite, GS-563117, may cause photosensitivity in treated patients.
Danish: Der er en potentiel risiko for, at idelalisib, via den primære metabolit, GS-563117, kan forårsage fotosensitivitet hos behandlede patienter.
English: Clinical monitoring is recommended.
Danish: Klinisk overvågning anbefales.
English: Tell your doctor if you have an allergy to sunset yellow FCF (E110).
Danish: Fortæl det til lægen, hvis du har allergi over for sunset yellow FCF (E110).
English: • if you have redness and blistering of the skin
Danish: • hvis du har rødme og vabler på huden
English: Buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem
Danish: Buspiron, clorazepat, diazepam, estazolam, flurazepam, zolpidem
English: Contains sunset yellow FCF (E110), see leaflet for further information.
Danish: Indeholder sunset yellow FCF (E110), se indlægssedlen for yderligere information.
English: 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.
Danish: 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.
English: Unmutated IGHV
Danish: Ikke muteret IGHV
English: ANTI-CANCER AGENTS
Danish: MIDLER MOD CANCER
English: Pneumonitis and organising pneumonia
Danish: Pneumonitis og organiserende pneumoni
English: Idelalisib should not be co-administered with midazolam (oral) or triazolam.
Danish: Idelalisib bør ikke administreres sammen med midazolam (oral) eller triazolam.
English: 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.
Danish: 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.
English: What you need to know before you take Zydelig Do not take Zydelig
Danish: Det skal du vide, før du begynder at tage Zydelig Tag ikke Zydelig
English: Zydelig contains sunset yellow FCF (E110)
Danish: Zydelig indeholder sunset yellow FCF (E110)
English: Solid line: idelalisib + R (N = 110), dashed line: placebo + R (N = 110) R: rituximab; N: number of subjects per group
Danish: Fuldt optrukken linje: idelalisib + R (N = 110), stiplet linje: placebo + R (N = 110) R: rituximab; N: antal patienter i gruppen
English: Elderly No specific dose adjustment is required for elderly patients (aged ≥ 65 years) (see section 5.2).
Danish: Ældre Specifik dosisjustering er ikke nødvendig hos ældre patienter (i alderen ≥ 65 år) (se pkt.
English: 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.
Danish: 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.
English: ↑ serum concentrations Careful dose titration of the antidepressant and monitoring for antidepressant response is recommended.
Danish: ↑ serumkoncentrationer Nøje dosistitrering af det antidepressive middel og overvågning af det antidepressive respons anbefales.
English: No patients with severe hepatic impairment were included in clinical studies of idelalisib.
Danish: Der blev ikke inkluderet nogen patienter med svært nedsat leverfunktion i kliniske studier af idelalisib.
English: Bepridil, disopyramide, lidocaine
Danish: Bepridil, disopyramid, lidocain
English: 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.
Danish: Når idelalisib administreres sammen med andre lægemidler, henvises til produktresuméerne (SPC'er) for de andre præparater for anbefalinger angående administration sammen med CYP3A4-hæmmere.
English: Repeated dose toxicity
Danish: Gentagen dosistoksicitet
English: The Kaplan-Meier curve for PFS is provided in Figure 2.
Danish: Kaplan-Meier-kurven for PFS ses i figur 2.
English: The Kaplan-Meier curve for PFS is provided in Figure 1.
Danish: Kaplan-Meier-kurven for PFS ses i figur 1.
English: 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.
Danish: Hvis en patient glemmer en dosis i mere end 6 timer, skal patienten ikke tage den glemte dosis, og blot genoptage det normale doseringsskema.
English: The recommended dose is 150 mg by mouth twice a day.
Danish: Den anbefalede dosis er 150 mg, der tages gennem munden, to gange dagligt.
English: ↑ serum concentrations It is recommended that the international normalised ratio (INR) be monitored upon co-administration and following ceasing treatment with idelalisib.
Danish: ↑ serumkoncentrationer Monitorering af international normaliseret ratio (INR) anbefales ved administration sammen med og efter ophør af idelalisib-behandling.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: For patienter med evidens for CMV-viræmi og kliniske tegn på CMV-infektion skal midlertidig afbrydelse af idelalisib, indtil infektionen er ophørt, overvejes.
English: 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.
Danish: 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.
English: Response category*†
Danish: Responskategori*†
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: The recommended dose is 150 mg idelalisib twice daily.
Danish: Den anbefalede dosis er 150 mg idelalisib to gange dagligt.
English: 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).
Danish: Behandling med Zydelig skal seponeres permanent i tilfælde af moderat eller svær symptomatisk pneumonitis eller organiserende pneumoni (se pkt.
English: Table 5: Efficacy results from study 312-0119 Idelalisib + O N = 174
Danish: Tabel 5: Virkningsresultater fra studie 312-0119 Idelalisib + O N = 174
English: 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.
Danish: 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.
English: Infections (see section 4.4)
Danish: Infektioner (se pkt.
English: Idelalisib induces apoptosis and inhibits proliferation in cell lines derived from malignant B-cells and in primary tumour cells.
Danish: Idelalisib inducerer apoptose og hæmmer celledelingen i cellelinjer, der stammer fra maligne B-celler, og i primære tumorceller.
English: 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
Danish: 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
English: Solid line: idelalisib + O (N = 174), dashed line: ofatumumab (N = 87) O: ofatumumab; N: number of subjects per group
Danish: Fuldt optrukken linje: idelalisib + O (N = 174), stiplet linje: ofatumumab (N = 87) O: ofatumumab; N: antal patienter i gruppen
English: Electrocardiographic
Danish: Elektrokardiografisk
English: Particular caution must be used and dose reduction may be considered when prescribing sildenafil or tadalafil with idelalisib with increased monitoring for adverse events.
Danish: Der skal udvises særlig forsigtighed, og dosisreduktion kan overvejes, når sildenafil eller tadalafil ordineres sammen med idelalisib med øget overvågning for bivirkninger.
English: Blood tests may also show: • increased blood levels of fats
Danish: Blodprøver kan også vise: • øgede niveauer af fedt i blodet
English: Figure 1: Kaplan-Meier curve of PFS from study 312-0116 (intent-to-treat population)
Danish: Figur 1: Kaplan-Meier-kurve for PFS fra studie 312-0116 (intent-to-treat-population)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON LABEL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ETIKETTERING PÅ KARTON
English: 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).
Danish: Zydelig er indiceret som monoterapi til behandling af voksne patienter med follikulært lymfom (FL), som er refraktært over for to tidligere behandlingsregimer (se pkt.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Idelalisib exposure may be reduced when co-administered with CYP3A inducers such as rifampicin, phenytoin, St. John's wort (Hypericum perforatum), or carbamazepine.
Danish: Eksponeringen for idelalisib kan reduceres ved administration sammen med CYP3A-inducere, såsom rifampicin, phenytoin, prikbladet perikon (Hypericum perforatum) eller carbamazepin.
English: Figure 2: Kaplan-Meier curve of PFS from study 312-0119 (intent-to-treat population)
Danish: Figur 2: Kaplan-Meier-kurve for PFS fra studie 312-0119 (intent-to-treat-population)
English: • if you have swelling and blistering of the lining of the mouth, genitals, and/or eyes
Danish: • hvis du har hævelse og vabler i slimhinden i munden, kønsdelene og/eller øjnene
English: 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.
Danish: 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.
English: CYP3A/P-gp inhibitors
Danish: CYP3A/P-gp-hæmmere
English: 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).
Danish: 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).
English: ↑ serum concentrations
Danish: ↑ serumkoncentrationer
English: Table 2: Adverse drug reactions reported in clinical studies in subjects with haematologic malignancies receiving idelalisib
Danish: Tabel 2: Bivirkninger rapporteret i kliniske studier hos patienter med hæmatologisk malignitet, som fik idelalisib
English: Table 3: Efficacy results from study 312-0116 Idelalisib + R N = 110
Danish: Tabel 3: Virkningsresultater fra studie 312-0116 Idelalisib + R N = 110
English: • budesonide, fluticasone, medicines used to treat hayfever and asthma, and salmeterol, used to treat asthma
Danish: • budesonid, fluticason, lægemidler, der anvendes til at behandle høfeber og astma, og salmeterol, anvendes til at behandle astma
English: 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.
Danish: 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.
English: • carbamazepine, S-mephenytoin, phenytoin, medicines used to prevent seizures
Danish: • carbamazepin, S-mephenytoin, phenytoin, lægemidler, der anvendes til at forebygge krampeanfald
English: 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.
Danish: 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.
English: Follicular lymphoma (FL) is a cancer of a type of white blood cell called B-lymphocytes.
Danish: Follikulært lymfom (FL) er en kræftsygdom i en type hvide blodlegemer, som kaldes B-lymfocytter.
English: 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).
Danish: 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).
English: 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).
Danish: Der bør derfor udvises forsigtighed når Zydelig administreres til denne population, og det anbefales at intensivere overvågning for bivirkninger (se pkt.
English: 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.
Danish: 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.
English: Microcrystalline cellulose Hydroxypropyl cellulose (E463) Croscarmellose sodium Sodium starch glycolate Magnesium stearate
Danish: Mikrokrystallinsk cellulose Hydroxypropylcellulose (E463) Croscarmellosenatrium Carboxymethylstivelsesnatrium Magnesiumstearat
English: • Zydelig is indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):
Danish: • Zydelig i kombination med rituximab er indiceret til behandling af voksne patienter med kronisk lymfatisk leukæmi (CLL):
English: The primary and only circulating metabolite, GS-563117, is inactive against PI3Kδ.
Danish: Den primære og eneste cirkulerende metabolit, GS-563117, er inaktiv over for PI3Kδ.
English: Monitor ANC at least weekly until ANC ≥ 500/mm3, then may resume Zydelig dosing at 100 mg twice daily.
Danish: Monitorér ANC mindst én gang ugentligt, indtil ANC ≥ 500/mm3, hvorefter Zydeligdoseringen kan genoptages med 100 mg to gange dagligt.
English: Chronic lymphocytic leukaemia (CLL) is a cancer of a type of white blood cell called B-lymphocytes.
Danish: Kronisk lymfatisk leukæmi (CLL) er en kræftsygdom i en type hvide blodlegemer, som kaldes B-lymfocytter.
English: Film-coated tablets 60 film-coated tablets
Danish: Filmovertrukne tabletter 60 filmovertrukne tabletter
English: Breast-feeding should be discontinued during treatment with Zydelig.
Danish: Amning skal ophøre under behandling med Zydelig.
English: ↑ serum concentrations Increased monitoring for rifabutinassociated adverse reactions including neutropenia and uveitis is recommended.
Danish: ↑ serumkoncentrationer Øget overvågning for rifabutinassocierede bivirkninger, herunder neutropeni og uveitis, anbefales.
English: • quetiapine, a medicine used to treat schizophrenia, bipolar disorder and major depressive disorder
Danish: • quetiapin, et lægemiddel, der anvendes til at behandle skizofreni, bipolær lidelse og svær depressiv lidelse
English: *** Includes the preferred terms dermatitis exfoliative generalised, drug eruption, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular, papule, skin plaque, and exfoliative rash.
Danish: *** Omfatter de foretrukne termer generaliseret eksfoliativ dermatitis, lægemiddeludslæt, udslæt, erytematøst udslæt, generaliseret udslæt, makuløst udslæt, makulopapuløst udslæt, papuløst udslæt, pruritisk udslæt, pustuløst udslæt, vesikulært udslæt, papler, plaques og eksfoliativt udslæt.
English: Its primary metabolite is GS-563117, which is not pharmacologically active.
Danish: Den primære metabolit er GS-563117, som ikke er farmakologisk aktiv.
English: Paediatric population The pharmacokinetics of idelalisib in paediatric subjects has not been established (see section 4.2).
Danish: Pædiatrisk population Idelalisibs farmakokinetik hos pædiatriske patienter er ikke klarlagt (se pkt.
English: • redness and blistering of the skin • swelling and blistering of the lining of the mouth, genitals, and/or eyes
Danish: • rødme og vabler på huden • hævelse og vabler i slimhinden i munden, kønsdelene og/eller øjnene
English: ANC should be monitored at least weekly until ANC is ≥ 500 per mm3 when treatment can be resumed at 100 mg twice daily (see section 4.4).
Danish: ANC bør monitoreres mindst én gang ugentligt, indtil ANC er ≥ 500 pr. mm3, hvorefter behandlingen kan genoptages med 100 mg to gange dagligt (se pkt.
English: • dihydroergotamine, ergotamine, medicines used to treat migraine headache
Danish: • dihydroergotamin, ergotamin, lægemidler, der anvendes til at behandle migræne-hovedpine
English: Once pneumonitis has resolved and if re-treatment is appropriate, resumption of treatment at 100 mg twice daily can be considered.
Danish: Efter restitution af pneumonitis og hvis forsættelse af behandlingen er hensigtsmæssigt, kan det overvejes at genstarte behandlingen med 100 mg to gange dagligt.
English: Women of childbearing potential must use highly effective contraception while taking idelalisib and for 1 month after stopping treatment (see section 4.6).
Danish: Kvinder i den fertile alder skal anvende meget sikker kontraception, mens de tager idelalisib og i 1 måned efter behandlingsophør (se pkt.
English: • diarrhoea/inflammation of the large intestine
Danish: • diarré/betændelse i tyktarmen
English: Rash typically resolved with treatment (e.g., topical and/or oral steroids, diphenhydramine) and dose interruption for severe cases (see section 5.3, phototoxicity).
Danish: Udslættet gik typisk væk ved behandling (f.eks. topikale og/eller orale steroider, diphenhydramin) og ved dosisafbrydelse i svære tilfælde (se pkt.
English: Effect of other medicinal products on idelalisib pharmacokinetics
Danish: Virkning af andre lægemidler på idelalisibs farmakokinetik
English: A clinical drug interaction study found that co-administration of a single dose of 150 mg idelalisib with rifampicin (a strong CYP3A inducer) resulted in a ~75% reduction in idelalisib AUCinf.
Danish: Et klinisk lægemiddelinteraktionsstudie fandt at administration af en enkeltdosis 150 mg idelalisib sammen med rifampicin (en kraftig CYP3A-inducer) førte til en ~75 % reduktion i idelalisib AUCinf.
English: Respiratory, thoracic and mediastinal disorders Pneumonitis
Danish: Luftveje, thorax og mediastinum Pneumonitis