FrancophonIA/ELRC3.0 huggingface dataset:
English: • cisapride, a medicine used to relieve certain stomach problems
Danish: • cisaprid, et lægemiddel, der anvendes til at lindre visse maveproblemer
English: Zydelig is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Zydelig bør ikke anvendes under graviditeten og til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: Breast-feeding It is not known whether idelalisib and its metabolites are excreted in human milk.
Danish: Amning Det er ukendt, om idelalisib/metabolitter udskilles i human mælk.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: If the benefits of resuming idelalisib are judged to outweigh the risks, consideration should be given to administering pre-emptive CMV therapy.
Danish: Hvis fordelene ved genoptagelse af idelalisib-behandling vurderes at opveje risiciene, skal forebyggende CMV-behandling overvejes.
English: Idelalisib in combination with rituximab
Danish: Idelalisib i kombination med rituximab
English: Study 101-08/99 enrolled 64 subjects with previously untreated CLL, including 5 subjects with small lymphocytic lymphoma (SLL).
Danish: Der indgik 64 patienter i studie 101-08/99 med tidligere ubehandlet CLL, herunder 5 patienter med småcellet lymfatisk lymfom (SLL).
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på tabletbeholderen og kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: 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).
Danish: Clarithromycin, telithromycin ↑ serumkoncentrationer Dosisjustering af clarithromycin er ikke nødvendig hos patienter med normal nyrefunktion eller let nedsat nyrefunktion (kreatininclearance [CrCl] 60-90 ml/min).
English: ↑ serum concentrations ↑ serum concentrations
Danish: ↑ serumkoncentrationer ↑ serumkoncentrationer
English: • 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.
Danish: • Anvend en meget sikker præventionsmetode for at undgå at blive gravid, mens du behandles med Zydelig, og i 1 måned efter din sidste behandling.
English: In patients who resumed idelalisib at a lower dose, 26% had recurrence of ALT/AST elevation.
Danish: Af patienter, som genoptog behandlingen med idelalisib ved en lavere dosis, oplevede 26 % recidiv af forhøjelserne i ALAT og ASAT.
English: ↑ serum concentrations Careful monitoring of the tolerance to these anti-cancer agents is recommended.
Danish: ↑ serumkoncentrationer Nøje overvågning af tolerancen over for disse midler mod cancer anbefales.
English: No mechanistic explanations for the development of resistance to treatment with idelalisib have been identified from clinical studies.
Danish: Der er ikke identificeret nogen mekanistiske forklaringer på udviklingen af resistens over for behandlingen med idelalisib i kliniske studier.
English: Serious and fatal infections have occurred with idelalisib, including opportunistic infections such as Pneumocystis jirovecii pneumonia (PJP) and cytomegalovirus (CMV).
Danish: Der er forekommet alvorlige og dødelige infektioner med idelalisib, herunder opportunistiske infektioner, som f.eks. pneumocystis jirovecii pneumoni (PJP) og cytomegalovirus (CMV).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/.
English: If the patient misses a dose of Zydelig within 6 hours of the time it is usually taken, the patient should take the missed dose as soon as possible and resume the normal dosing schedule.
Danish: Hvis patienten glemmer en dosis Zydelig inden for 6 timer fra det tidspunkt den normalt tages, skal patienten tage den glemte dosis snarest muligt og genoptage det normale doseringsskema.
English: Stevens-Johnson syndrome and toxic epidermal necrolysis Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) with fatal outcomes have been reported when idelalisib was administered concomitantly with other medicinal products associated with these syndromes.
Danish: Stevens-Johnsons syndrom og toksisk epidermal nekrolyse Tilfælde af Stevens-Johnsons syndrom (SJS) og toksisk epidermal nekrolyse (TEN) med dødelig udgang er blevet rapporteret, når idelalisib blev administreret samtidigt med andre lægemidler forbundet med disse syndromer.
English: In an embryo-foetal development study in rats, increased post-implantation loss, malformations (absence of caudal vertebrae and in some cases also of sacral vertebrae), skeletal variations and lower foetal body weights were observed.
Danish: I et embryoføtalt udviklingsstudie med rotter blev der observeret øget post-implantationstab, misdannelser (ingen kaudal vertebra og i nogle tilfælde også ingen sakral vertebra), variationer i skelettet og lavere legemsvægt af fosteret.
English: Of the 125 subjects enrolled, 80 (64%) were male, the median age was 64 years (range: 33 to 87), and 110 (89%) were white.
Danish: Ud af de 125 patienter, der indgik, var 80 (64 %) mænd, og medianalderen var 64 år (interval: 33 til 87 år), og 110 (89 %) var hvide.
English: The major metabolite, GS-563117, may enhance phototoxicity when cells are simultaneously exposed to UVA light.
Danish: Den primære metabolit, GS-563117, kan øge fototoksicitet, når cellerne samtidigt eksponeres over for UVA-lys.
English: Blistering can also involve the lining of the mouth, genitals, and/or eyes.
Danish: Vablerne kan også omfatte slimhinden i munden, kønsdelene og/eller øjnene.
English: Expected effect of idelalisib on drug levels
Danish: Forventet virkning af idelalisib på lægemiddelniveauer
English: The duration of post-treatment prophylaxis should be based on clinical judgment and may take into account a patient's risk factors such as concomitant corticosteroid treatment and prolonged neutropenia (see section 4.8).
Danish: Varigheden af profylakse efter behandling skal baseres på en klinisk vurdering, eventuelt under hensyntagen til patientens risikofaktorer såsom samtidig kortikosteroidbehandling og forlænget neutropeni (se pkt.
English: • as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies (see section 4.4).
Danish: • som førstevalgsbehandling hos patienter med 17p-deletion eller TP53-mutation, som ikke er egnede til at få andre behandlinger (se pkt.
English: A dose-related increase in pancreatic islet cell tumors was observed at low incidence in male rats at exposures up to 0.4-fold compared to the human exposure at the recommended dose; a similar finding was not observed in female rats at 0.62-fold exposure margin.
Danish: En dosisrelateret forøgelse af pankreatiske øcelletumorer blev observeret med lav hyppighed hos hanrotter ved eksponeringer op til 0,4 gange sammenlignet med den menneskelige eksponering ved den anbefalede dosis; lignende fund blev ikke konstateret hos hunrotter ved 0,62 gange eksponeringsmargin.
English: In patients presenting with serious lung events, idelalisib should be interrupted and the patient assessed for an explanatory aetiology.
Danish: Hos patienter, der får alvorlige lungehændelser, bør idelalisib afbrydes, og patienten vurderes for en forklarende ætiologi.
English: The onset of isolated lymphocytosis typically occurs during the first 2 weeks of idelalisib therapy and is often associated with reduction of lymphadenopathy.
Danish: Start af isoleret lymfocytose forekommer typisk i de første 2 uger af behandling med idelalisib og er ofte forbundet med reduceret lymfadenopati.
English: Potential interactions between idelalisib and co-administered medicinal products that are CYP3A substrates are listed in Table 1 (increase is indicated as “↑”).
Danish: Potentielle interaktioner mellem idelalisib ved administration sammen med lægemidler, der er CYP3A-substrater er opstillet i tabel 1 (en stigning er indikeret ved ”↑”).
English: Skin and subcutaneous tissue disorders Rash***
Danish: Hud og subkutane væv Udslæt***
English: Since a reduction in idelalisib plasma concentrations may result in decreased efficacy, co-administration of Zydelig with moderate or strong CYP3A inducers should be avoided (see section 4.5).
Danish: Da en reduktion af plasmakoncentrationen af idelalisib kan føre til nedsat virkning, bør det undgås at administrere Zydelig sammen med moderate eller stærke CYP3A-inducere (se pkt.
English: ^ Overall survival (OS) analysis includes data from subjects who received placebo + R on study 312-0116 and subsequently received idelalisib in an extension study, based on intent-to-treat analysis.
Danish: ^ Analysen af samlet overlevelse (OS, overall survival) inkluderer data fra patienter, der fik placebo + R i studie 312-0116 og efterfølgende fik idelalisib i et forlængelsesstudie, baseret på intent-to-treat-analyse.
English: Upon initiation of idelalisib, a temporary increase in lymphocyte counts (i.e., ≥ 50% increase from baseline and above absolute lymphocyte count of 5,000/mcL) has been observed.
Danish: Efter start af idelalisib er der blevet observeret en midlertidig stigning i antallet af lymfocytter (dvs. ≥ 50 % stigning fra baseline og over det absolutte lymfocyttal på 5.000/mikroliter).
English: Ketoconazole, itraconazole, posaconazole, voriconazole
Danish: Ketoconazol, itraconazol, posaconazol, voriconazol
English: Contents of the pack and other information What Zydelig contains
Danish: Pakningsstørrelser og yderligere oplysninger Zydelig indeholder:
English: • pimozide, a medicine used to treat abnormal thoughts or feelings
Danish: • pimozid, et lægemiddel, der anvendes til at behandle unormale tanker og følelser
English: Regular clinical and laboratory monitoring for CMV infection is recommended in patients with positive CMV serology at the start of treatment with idelalisib or with other evidence of a history of CMV infection.
Danish: Regelmæssig klinisk og laboratoriemæssig monitorering for CMV-infektion anbefales hos patienter med positiv CMV-serologi ved påbegyndelse af idelalisib eller med anden evidens for CMV-infektion i anamnesen.
English: Chronic hepatitis
Danish: Kronisk hepatitis
English: The analyses of PFS, overall response rate (ORR) and lymph node response rate (LNR) were based on evaluation by an independent review committee (IRC).
Danish: Analyserne af PFS, samlet responsrate (ORR, overall response rate) og lymfeknude responsrate (LNR, lymph node response rate) var baseret på evaluering af en uafhængig bedømmelseskomité (IRC, independent review committee).
English: (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to
Danish: Hyppighederne er defineret som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til
English: If SJS or TEN is suspected, idelalisib should be immediately interrupted and the patient treated accordingly.
Danish: Ved formodning om SJS eller TEN, bør idelalisib straks seponeres, og patienten bør behandles i overensstemmelse hermed.
English: Tyrosine kinase inhibitors such as dasatinib and nilotinib, also vincristine and vinblastine
Danish: Tyrosinkinasehæmmere, såsom dasatinib og nilotinib, også vincristin og vinblastin
English: Treatment with Zydelig must be withheld in the event of a Grade 3 or 4 aminotransferase elevation (alanine aminotransferase [ALT]/aspartate aminotransferase [AST] > 5 x upper limit of normal [ULN]).
Danish: Behandlingen med Zydelig skal pauseres i tilfælde af en grad 3 eller 4 aminotransferaseforhøjelse (alaninaminotransferase [ALAT]/aspartataminotransferase [ASAT] > 5 x øvre normalgrænse [ULN]).
English: You must also use a barrier method of contraception such as condoms or the “coil” while taking Zydelig and for 1 month after your last treatment.
Danish: Du skal også anvende en barrieremetode til prævention, såsom kondomer eller spiral, mens du tager Zydelig, og i 1 måned efter din sidste behandling.
English: • if you have shortness of breath or difficulty breathing
Danish: • hvis du er stakåndet eller har vejrtrækningsbesvær
English: Zydelig can cause lung inflammation.
Danish: Zydelig kan forårsage lungebetændelse.
English: Treatment with Zydelig should be withheld in patients while absolute neutrophil count (ANC) is below 500 per mm3.
Danish: Behandlingen med Zydelig skal pauseres hos patienter, så længe patientens absolutte neutrofiltal (ANC) er under 500 pr. mm3.
English: Thus, idelalisib has the potential to interact with medicinal products that are metabolised by CYP3A, which may lead to increased serum concentrations of the other product (see section 4.5).
Danish: Derfor har idelalisib potentialet til at påvirke andre lægemidler, der metaboliseres af CYP3A, som kan føre til øgede serumkoncentrationer af det andet produkt (se pkt.
English: Population pharmacokinetic analyses indicated that gender and race had no clinically relevant effect on the exposures to idelalisib or GS-563117.
Danish: Populationsfarmakokinetiske analyser indikerede, at køn og race ikke havde nogen klinisk relevant virkning på eksponeringerne over for idelalisib eller GS-563117.
English: There is insufficient data to make dose recommendations for patients with severe hepatic impairment.
Danish: Der er utilstrækkelige data til at give dosisanbefalinger for patienter med svært nedsat leverfunktion.
English: Idelalisib and GS-563117 are substrates of P-gp and BCRP.
Danish: Idelalisib og GS-563117 er substrater af P-gp og BCRP.
English: • who have received at least one prior therapy (see section 4.4), or
Danish: • som har fået mindst en tidligere behandling (se pkt.
English: Reaction
Danish: Reaktion
English: Caution is advised if Zydelig is used together with narrow therapeutic index drugs that are substrates of these enzymes (warfarin, phenytoin, S-mephenytoin).
Danish: Der rådes til forsigtighed, hvis Zydelig anvendes sammen med lægemidler med et snævert terapeutisk indeks, der er substrater for disse enzymer (warfarin, phenytoin, S-mephenytoin).
English: No initial dose adjustment of idelalisib is considered necessary when administered with CYP3A/P-gp inhibitors, but an intensified monitoring of adverse reactions is recommended.
Danish: En indledende dosisjustering af idelalisib anses ikke for at være nødvendig ved administration sammen med CYP3A/P-gp-hæmmere, men det anbefales at intensivere overvågning for bivirkninger.
English: Macrolide antibiotics
Danish: Makrolid-antibiotika
English: ↑ serum concentrations Careful monitoring of adverse reactions (e.g., respiratory depression, sedation) is recommended.
Danish: ↑ serumkoncentrationer Nøje overvågning af bivirkninger (f.eks. respirationsdepression, sedation) anbefales.
English: Serum transaminase elevations correlated with hepatic necrosis in dogs, but were not observed in rats.
Danish: Forhøjelser i serumtransaminase korrelerede med levernekrose hos hunde, men blev ikke observeret hos rotter.
English: Caution is advised if Zydelig is used together with narrow therapeutic index drugs that are substrates of CYP2C8 (paclitaxel).
Danish: Der rådes til forsigtighed, hvis Zydelig anvendes sammen med lægemidler med et snævert terapeutisk indeks, der er substrater for CYP2C8 (paclitaxel).
English: High density polyethylene (HDPE) bottle, capped with a polypropylene child-resistant closure, containing 60 film-coated tablets and a polyester coil.
Danish: Højdensitets-polyethylen (HDPE)-tabletbeholder med et børnesikret lukke af polypropylen, der indeholder 60 filmovertrukne tabletter og en vatspiral af polyester.
English: • Zydelig may make the contraceptive “pill” and implanted hormonal contraceptives work less well.
Danish: • Zydelig kan få p-piller og implanterede hormonelle præventionsmidler til at være mindre effektive.
English: In addition, 86 subjects from this study who were randomised to receive placebo + rituximab went on to receive idelalisib as a single agent in an extension study (study 312-0117).
Danish: Desuden fik 86 patienter fra dette studie, som blev randomiseret til placebo + rituximab, efterfølgende idelalisib som enkeltstof i et forlængelsesstudie (studie 312-0117).
English: Treatment with Zydelig must be withheld in the event of Grade 3 or 4 diarrhoea/colitis.
Danish: Behandlingen med Zydelig skal pauseres i tilfælde af grad 3 eller 4 diarré/colitis.
English: There have also been reports of hepatocellular injury including hepatic failure.
Danish: Der er desuden blevet rapporteret hepatocellulær leverskade, herunder leversvigt.
English: Blood and lymphatic system disorders Neutropenia
Danish: Blod og lymfesystem Neutropeni
English: There have been cases of PJP after stopping idelalisib treatment.
Danish: Der er set tilfælde af PJP efter seponering af idelalisib.
English: Amlodipine, diltiazem, felodipine, nifedipine, nicardipine
Danish: Amlodipin, diltiazem, felodipin, nifedipin, nicardipin
English: • clarithromycin, telithromycin, medicines used to treat bacterial infections
Danish: • clarithromycin, telithromycin, lægemidler, der anvendes til at behandle bakterieinfektioner
English: Elevations in ALT and AST of Grade 3 and 4 (> 5 x ULN) have been observed in clinical studies of idelalisib.
Danish: Der er blevet observeret forhøjelser af ALAT og ASAT af grad 3 og 4 (> 5 x ULN) i kliniske studier med idelalisib.
English: For subjects in the placebo + R group, the summary includes data up to the first dosing of idelalisib in an extension study.
Danish: For patienter i placebo + R-gruppen inkluderer oversigten data op til den første idelalisib-dosis i et forlængelsesstudie.
English: No hepatic impairment or chronic transaminase elevations were observed in rats or dogs in studies of 13 weeks and longer duration.
Danish: Der blev ikke observeret nedsat leverfunktion eller kroniske transaminaseforhøjelser hos rotter eller hunde i studier, der varede 13 uger eller længere.
English: 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.
Danish: 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.
English: 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).
Danish: 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.
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: Effect of idelalisib on the pharmacokinetics of other medicinal products
Danish: Virkning af idelalisib på andre lægemidlers farmakokinetik
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Subjects received idelalisib 150 mg twice daily and rituximab 375 mg/m2 BSA weekly for 8 doses.
Danish: Patienterne fik idelalisib 150 mg to gange dagligt, og rituximab 375 mg/m2 BSA ugentligt for 8 doser.
English: ANC 1,000 to < 1,500/mm3
Danish: ANC 1.000 til < 1.500/mm3
English: 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.
Danish: 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.
English: ↑ serum concentrations Anticonvulsant drug levels should be monitored.
Danish: ↑ serumkoncentrationer Niveauerne af antikonvulsiva bør monitoreres.
English: Fentanyl, alfentanil, methadone, buprenorphine/naloxone
Danish: Fentanyl, alfentanil, metadon, buprenorfin/naloxon
English: Oral budesonide
Danish: Oralt budesonid
English: ANC 500 to < 1,000/mm3
Danish: ANC 500 til < 1.000/mm3
English: Following a single 150 mg oral dose of [14C]-labelled idelalisib, approximately 78% and 15% was excreted in faeces and urine, respectively.
Danish: Efter en enkelt 150 mg oral dosis af [14C]-mærket idelalisib, blev hhv. ca. 78 % og 15 % udskilt i fæces og urin.
English: Other medicines and Zydelig
Danish: Brug af anden medicin sammen med Zydelig