FrancophonIA/ELRC3.0 huggingface dataset:
English: The adverse drug reactions reported with idelalisib alone or in combination with anti-CD20 monoclonal antibodies (rituximab or ofatumumab) are provided in Table 2.
Danish: De bivirkninger, der blev rapporteret med idelalisib alene eller i kombination med anti-CD20 et monoklonalt antistof (rituximab eller ofatumumab) er opstillet i tabel 2.
English: Do not stop taking this medicine unless your doctor tells you to.
Danish: Du må ikke holde op med at tage dette lægemiddel, medmindre lægen fortæller dig det. Spørg lægen, hvis der er noget, du er i tvivl om.
English: If you miss a dose by more than 6 hours, wait and take the next dose at your usual time.
Danish: Hvis du har sprunget en dosis over, og det er mere end 6 timer siden, du skulle have taget dosen, skal du vente og tage den næste dosis til den sædvanlige tid.
English: In general, the SmPC for the other product must be consulted for the recommendations regarding co-administration with CYP3A4 inhibitors (see section 4.4).
Danish: Generelt henvises til produktresuméet for det andet præparat for anbefalinger vedrørende administration sammen med CYP3A4-hæmmere (se pkt.
English: Idelalisib is metabolised primarily via aldehyde oxidase, and to a lesser extent via CYP3A and glucuronidation (UGT1A4).
Danish: Idelalisib metaboliseres primært via aldehydoxidase, og i mindre grad via CYP3A og glukuronidation (UGT1A4).
English: Study 312-0119 was a Phase 3, randomised, open-label, multicentre, parallel-group study in 261 subjects with previously treated CLL who had measurable lymphadenopathy, required treatment, and experienced CLL progression < 24 months since the completion of the last prior therapy.
Danish: Studie 312-0119 var et fase 3, randomiseret, åbent multicenterstudie med parallelle grupper med 261 patienter med tidligere behandlet CLL, som havde målbar lymfadenopati, var behandlingskrævende og oplevede CLL-progression < 24 måneder siden, den sidste tidligere behandling var gennemført.
English: Organising pneumonia
Danish: Organiserende pneumoni
English: • amlodipine, diltiazem, felodipine, nicardipine, nifedipine, medicines used to treat high blood pressure and heart problems
Danish: • amlodipin, diltiazem, felodipin, nicardipin, nifedipin, lægemidler, der anvendes til at behandle højt blodtryk og hjerteproblemer
English: Idelalisib should not be co-administered with lovastatin or simvastatin.
Danish: Idelalisib bør ikke administreres sammen med lovastatin eller simvastatin.
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: Co-administration of multiple doses of idelalisib 150 mg twice daily to healthy subjects resulted in comparable exposures for rosuvastatin (AUC 90% CI: 87, 121) and digoxin (AUC 90% CI: 98, 111), suggesting no clinically relevant inhibition of BCRP, OATP1B1/1B3 or systemic P-gp by idelalisib.
Danish: BCRP-, OATP1B1-, OATP1B3- og P-gp-substrater Administration sammen med flere doser idelalisib 150 mg to gange dagligt hos raske personer førte til sammenlignelige eksponeringer over for rosuvastatin (AUC 90 % CI: 87; 121) og digoxin (AUC 90 % CI: 98; 111), hvilket ikke tyder på en klinisk relevant hæmning af BCRP, OATP1B1/1B3 eller systemisk P-gp af idelalisib.
English: Therefore, women of childbearing potential must use highly effective contraception while taking Zydelig and for 1 month after stopping treatment.
Danish: Derfor skal kvinder i den fertile alder anvende meget sikker kontraception, mens de tager Zydelig og i 1 måned efter behandlingsophør.
English: You should not breast-feed while taking Zydelig.
Danish: Du må ikke amme, når du tager Zydelig.
English: • amiodarone, bepridil, disopyramide, lidocaine, quinidine, medicines used to treat heart problems
Danish: • amiodaron, bepridil, disopyramid, lidocain, quinidin, lægemidler, der anvendes til at behandle hjerteproblemer
English: Co-administration of Zydelig with moderate or strong CYP3A inducers such as rifampicin, phenytoin, St. John's wort, or carbamazepine should be avoided as this may result in decreased efficacy (see section 4.4).
Danish: Administration af Zydelig sammen med moderate eller stærke CYP3A-inducere, såsom rifampicin, phenytoin, prikbladet perikon eller carbamazepin bør undgås, da det kan føre til nedsat virkning (se pkt.
English: Blood tests may also show: • increased blood levels of liver enzymes
Danish: Blodprøver kan også vise: • forhøjet niveau af leverenzymer i blodet
English: Ergotamine, dihydroergotamine ↑ serum concentrations Idelalisib should not be co-administered with ergotamine or dihydroergotamine.
Danish: Ergotamin, dihydroergotamin ↑ serumkoncentrationer Idelalisib bør ikke administreres sammen med ergotamin eller dihydroergotamin.
English: Once values have returned to Grade 1 or below (ALT/AST ≤ 3 x ULN), treatment can be resumed at 100 mg twice daily.
Danish: Når værdierne er vendt tilbage til grad 1 eller derunder (ALAT/ASAT ≤ 3 x ULN), kan behandlingen genoptages med 100 mg to gange dagligt.
English: Caution should be exercised, including consideration of dose reduction, when co-administering tadalafil with idelalisib.
Danish: Der skal udvises forsigtighed, og dosisreduktion kan overvejes, når tadalafil administreres sammen med idelalisib.
English: Idelalisib is metabolised primarily via aldehyde oxidase, and to a lesser extent via CYP3A and UGT1A4.
Danish: Idelalisib metaboliseres primært via aldehydoxidase, og i mindre grad via CYP3A og UGT1A4.
English: Idelalisib induced lymphoid depletion in spleen, thymus, lymph nodes and gut-associated lymphoid tissue.
Danish: Idelalisib inducerede lymfoid depletion i milten, tymus, lymfeknuderne og tarmassocieret lymfoidt væv.
English: No dose adjustment is required for patients with mild, moderate, or severe renal impairment (see section 5.2).
Danish: Dosisjustering er ikke nødvendig for patienter med let-, moderat- eller svært nedsat nyrefunktion (se pkt.
English: A clinical drug interaction study found that co-administration of a single dose of 400 mg idelalisib with 400 mg once daily ketoconazole (a strong CYP3A, P-gp and BCRP inhibitor) resulted in a 26% increase in Cmax and a 79% increase in AUCinf of idelalisib.
Danish: Et klinisk lægemiddelinteraktionsstudie fandt at administration af en enkeltdosis 400 mg idelalisib sammen med 400 mg ketoconazol én gang daligt (en kraftig CYP3A-, P-gp- og BCRP-hæmmer) førte til en 26 % forhøjelse i Cmax og en 79 % forhøjelse i AUCinf for idelalisib.
English: ANALGESICS
Danish: ANALGETIKA
English: Study 312-0116 was a Phase 3, randomised, double-blind, placebo-controlled study in 220 subjects with previously treated CLL who required treatment but were not considered suitable for cytotoxic chemotherapy.
Danish: Studie 312-0116 var et fase 3 randomiseret, dobbeltblindet, placebokontrolleret studie med 220 patienter med tidligere behandlet CLL, som havde behov for behandling, men som ikke blev anset for at være egnede til cytotoksisk kemoterapi.
English: HMG CO-A REDUCTASE INHIBITORS
Danish: HMG-CO-A-REDUKTASEHÆMMERE
English: ANTI-HYPERTENSIVES
Danish: ANTIHYPERTENSIVA
English: Follicular lymphoma
Danish: Follikulært lymfom
English: The terminal elimination half-life of idelalisib was 8.2 (range: 1.9; 37.2) hours and the apparent clearance of idelalisib was 14.9 (range: 5.1; 63.8) L/h following idelalisib 150 mg twice daily oral administration.
Danish: Den terminale eliminationshalveringstid for idelalisib var 8,2 (interval: 1,9; 37,2) timer, og den tilsyneladende clearance af idelalisib var 14,9 (interval: 5,1; 63,8) l/t efter oral administration af idelalisib 150 mg to gange daglig.
English: DOR (months) median (95% CI) PFS (months) median (95% CI) OS (months) median (95% CI)
Danish: DOR (måneder) median (95 % CI) PFS (måneder) median (95 % CI) OS (måneder) median (95 % CI)
English: No dose adjustment is required when initiating treatment with Zydelig in patients with mild or moderate hepatic impairment, but an intensified monitoring of adverse reactions is recommended (see sections 4.4 and 5.2).
Danish: Dosisjustering er ikke nødvendig når behandlingen med Zydelig påbegyndes for patienter med leteller moderat nedsat leverfunktion, men det anbefales at intensivere overvågning for bivirkninger (se pkt.
English: Microcrystalline cellulose, hydroxypropyl cellulose (E463), croscarmellose sodium, sodium starch glycolate, magnesium stearate.
Danish: Microkrystallinsk cellulose, hydroxypropylcellulose (E463), croscarmellosenatrium, carboxymethylstivelsesnatrium, magnesiumstearat.
English: In rats, idelalisib has the potential to inhibit T-dependent antibody responses.
Danish: Hos rotter har idelalisib potentialet for at hæmme T-afhængigt antistofrespons.
English: CI: confidence interval; O: ofatumumab; N: number of subjects per group
Danish: CI: konfidensinterval; O: ofatumumab; N: antal patienter pr. gruppe
English: Study 312-0119 was a randomised, controlled, open-label study in which 173 subjects with previously treated CLL received idelalisib + ofatumumab.
Danish: Studie 312-0119 var et randomiseret, kontrolleret, åbent studie, hvor 173 patienter med tidligere behandlet CLL fik idelalisib + ofatumumab.
English: Treatment with Zydelig must be withheld in the event of Grade 3 or 4 rash.
Danish: Behandlingen med Zydelig skal pauseres i tilfælde af grad 3 eller 4 udslæt.
English: Maintain Zydelig dosing.
Danish: Fortsæt Zydelig-dosering.
English: • alfentanil, fentanyl, methadone, buprenorphine/naloxone, medicines used for pain relief
Danish: • alfentanil, fentanyl, metadon, buprenorfin/naloxon, lægemidler, der anvendes til smertelindring
English: Study 312-0116 was a randomised, double-blind, placebo-controlled study in which 110 subjects with previously treated CLL received idelalisib + rituximab.
Danish: Studie 312-0116 var et randomiseret, dobbeltblindt, placebokontrolleret studie, hvor 110 patienter med tidligere behandlet CLL fik idelalisib + rituximab.
English: If the event recurs, treatment with Zydelig must be withheld until the values return to Grade 1 or less, after which re-initiation at 100 mg twice daily may be considered at the discretion of the physician (see sections 4.4 and 4.8).
Danish: Hvis hændelsen vender tilbage, pauseres behandlingen med Zydelig indtil værdierne er vendt tilbage til grad 1 eller derunder, hvorefter en genstart med 100 mg to gange dagligt kan overvejes efter lægens skøn (se pkt.
English: The ORR was 96.9%, with 12 CRs (18.8%) and 50 PRs (78.1%), including 3 CRs and 6 PRs in subjects with a 17p deletion and/or TP53 mutation and 2 CRs and 34 PRs in subjects with unmutated IGHV.
Danish: ORR var 96,9 %, med 12 CR'er (18,8 %) og 50 PR'er (78,1 %), herunder 3 CR'er og 6 PR'er hos patienter med en 17p-deletion og/eller TP53-mutation, og 2 CR'er og 34 PR'er hos patienter med ikke muteret IGHV.
English: Medicinal product
Danish: Lægemiddel
English: Orange, oval-shaped, film-coated tablet of dimensions 9.7 mm by 6.0 mm, debossed on one side with “GSI” and “100” on the other side.
Danish: Orange, oval, filmovertrukken tablet med dimensionerne 9,7 mm x 6,0 mm, påtrykt ”GSI” på den ene side og ”100” på den anden side.
English: The first infusion of ofatumumab was administered at a dose of 300 mg and was continued at a dose of either 1,000 mg in the idelalisib + ofatumumab group or a dose of 2,000 mg in the ofatumumab only group, weekly for 7 doses, and then every 4 weeks for 4 doses.
Danish: Den første infusion af ofatumumab blev administreret med en dosis på 300 mg og efterfølgende infusioner med en dosis på enten 1.000 mg i gruppen med idelalisib + ofatumumab eller en dosis på 2.000 mg i gruppen kun med ofatumumab.
English: Hepatocellular injury
Danish: Hepatocellulær leverskade
English: Each film-coated tablet contains 100 mg of idelalisib.
Danish: Hver filmovertrukken tablet indeholder 100 mg idelalisib.
English: • buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem, medicines used to treat nervous system disorders
Danish: • buspiron, clorazepat, diazepam, estazolam, flurazepam, zolpidem, lægemidler, der anvendes til at behandle lidelser i nervesystemet
English: Idelalisib should not be co-administered with amiodarone or quinidine.
Danish: Idelalisib bør ikke administreres sammen med amiodaron eller kinidin.
English: If the event does not recur, the dose can be re-escalated to 150 mg twice daily at the discretion of the treating physician.
Danish: Hvis hændelsen ikke vender tilbage, kan dosis igen øges til 150 mg to gange dagligt efter den behandlende læges skøn.
English: Gastrointestinal disorders Diarrhoea/colitis
Danish: Mave-tarm-kanalen Diarré/colitis
English: Pink, oval-shaped, film-coated tablet of dimensions 10.0 mm by 6.8 mm, debossed on one side with “GSI” and “150” on the other side.
Danish: Lyserød, oval, filmovertrukken tablet med dimensionerne 10,0 mm x 6,8 mm, påtrykt ”GSI” på den ene side og ”150” på den anden side.
English: Idelalisib should not be co-administered with sildenafil.
Danish: Idelalisib bør ikke administreres sammen med sildenafil.
English: • colchicine, a medicine used to treat gout
Danish: • colchicin, et lægemiddel, der anvendes til at behandle podagra
English: ↑ serum concentrations Clinical monitoring of therapeutic effect and adverse reactions is recommended.
Danish: ↑ serumkoncentrationer Klinisk overvågning af terapeutisk virkning og bivirkninger anbefales.
English: Dose modification
Danish: Dosismodifikation
English: If you miss a dose by less than 6 hours, take the missed dose right away.
Danish: Hvis du har sprunget en dosis over, og det er mindre end 6 timer siden, du skulle have taget dosen, skal du straks tage den glemte dosis.
English: ↑ serum concentrations Therapeutic monitoring is recommended.
Danish: ↑ serumkoncentrationer Terapeutisk overvågning anbefales.
English: Each film-coated tablet contains 150 mg of idelalisib.
Danish: Hver filmovertrukken tablet indeholder 150 mg idelalisib.
English: Treatment with Zydelig must be withheld in the event of Grade 3 or 4 ALT/AST elevation and liver function monitored.
Danish: Behandlingen med Zydelig skal pauseres i tilfælde af grad 3 eller 4 forhøjelser i ALAT/ASAT, og leverfunktionen skal overvåges.
English: Idelalisib is a selective inhibitor of adenosine-5'-triphosphate (ATP) binding to the catalytic domain of PI3Kδ, resulting in inhibition of the phosphorylation of the key lipid second messenger phosphatidylinositol and prevention of Akt (protein kinase B) phosphorylation.
Danish: Idelalisib er en selektiv hæmmer af bindingen af adenosin-5'-triphosphat (ATP) til det katalytiske domæne af PI3Kδ, hvilket fører til en hæmning af fosforyleringen af phosphatidylinositol,
English: Idelalisib should not be co-administered with colchicine to patients with renal or hepatic impairment.
Danish: Idelalisib bør ikke administreres sammen med colchicin til patienter med nedsat nyre- eller leverfunktion.
English: The median age was 71 years (range: 47 to 92) with 78.2% of subjects over 65 years; 65.5% were male, and 90.0% were white; 64.1% had a Rai stage of III or IV, and 55.9% had Binet Stage C. Most subjects had adverse cytogenetic prognostic factors: 43.2% had a 17p chromosomal deletion and/or tumour protein 53 (TP53) mutation, and 83.6% had unmutated genes for the immunoglobulin heavy chain variable region (IGHV).
Danish: Medianalderen var 71 år (interval: 47 til 92), hvor 78,2 % af patienterne var over 65 år; 65,5 % var mænd og 90,0 % var hvide, 64,1 % have et Rai-stadie på III eller IV, og 55,9 % havde et Binet-stadie på C. De fleste patienter havde dårlige cytogenetiske prognostiske faktorer: 43,2 % havde en 17p kromosomdeletion og/eller tumorprotein 53 (TP53) mutation, og 83,6 % havde ikke muterede gener i den variable region af den tunge kæde af immunglobulinet (IGHV).
English: • itraconazole, ketoconazole, posaconazole, voriconazole, medicines used to treat fungal infections • boceprevir, telaprevir, medicines used to treat hepatitis C
Danish: • itraconazol, ketoconazol, posaconazol, voriconazol, lægemidler, der anvendes til at behandle svampeinfektioner
English: Hazard ratio (95% CI) P-value ORR* n (%) (95% CI) Odds ratio (95% CI) P-value LNR** n/N (%) (95% CI) Odds ratio (95% CI) P-value OS^ Median (months) (95% CI)
Danish: Hazard ratio (95 % CI) P-værdi ORR* n (%) (95 % CI) Odds ratio (95 % CI) P-værdi LNR** n/N (%) (95 % CI) Odds ratio (95 % CI) P-værdi OS^ Median (måneder) (95 % CI)
English: Clinical efficacy in chronic lymphocytic leukaemia
Danish: Klinisk virkning ved kronisk lymfatisk leukæmi
English: ↑ serum concentrations Idelalisib should not be co-administered with quetiapine or pimozide.
Danish: ↑ serumkoncentrationer Idelalisib bør ikke administreres sammen med quetiapin eller pimozid.
English: The film-coated tablets are orange, oval-shaped tablets, debossed on one side with “GSI” and “100” on the other side.
Danish: De filmovertrukne tabletter er orange, ovale tabletter, påtrykt ”GSI” på den ene side og ”100” på den anden side.
English: Zydelig contains sunset yellow FCF which may cause allergic reactions.
Danish: Zydelig (100 mg filmovertrukne tabletter) indeholder sunset yellow FCF, hvilket kan medføre allergiske reaktioner.
English: Zydelig contains the azo colouring agent sunset yellow FCF (E110), which may cause allergic reactions.
Danish: Hjælpestoffer Zydelig indeholder azo-farvestoffet sunset yellow FCF (E110), som kan medføre allergiske reaktioner.
English: The primary metabolite of idelalisib, GS-563117, is a strong CYP3A4 inhibitor.
Danish: Idelalisibs primære metabolit, GS-563117, er en kraftig CYP3A4-hæmmer.
English: Stevens-Johnson syndrome and toxic epidermal necrolysis (see section 4.4) Rarely, cases of SJS and TEN have occurred when idelalisib was administered concomitantly with other medicinal products associated with these syndromes (bendamustine, rituximab, allopurinol, and amoxicillin).
Danish: 4.4) Sjældne tilfælde af SJS og TEN er forekommet, når idelalisib blev administreret samtidigt med andre lægemidler forbundet med disse syndromer (bendamustin, rituximab, allopurinol og amoxicillin).
English: Once diarrhoea/colitis has returned to Grade 1 or below, treatment can be resumed at 100 mg twice daily.
Danish: Når diarréen/colitisen er vendt tilbage til grad 1 eller derunder, kan behandlingen genoptages med 100 mg to gange dagligt.
English: Elevated liver transaminases
Danish: Lever og galdeveje Forhøjet transaminase
English: The median age was 68 years (range: 61 to 74) with 64.0% of subjects over 65 years; 71.3% were male, and 84.3% were white; 63.6% had a Rai stage of III or IV, and 58.2% had Binet Stage C. Most subjects had adverse cytogenetic prognostic factors: 39.5% had a 17p chromosomal deletion and/or TP53 mutation, and 78.5% had unmutated genes for IGHV.
Danish: Medianalderen var 68 år (interval 61-74), hvor 64,0 % af patienterne var over 65 år, 71,3 % var mænd, og 84,3 % var hvide, 63,6 % have Rai-stadie III eller IV, og 58,2 % havde Binet-stadie C. De fleste patienter havde prognostisk dårlige cytogenetiske faktorer: 39,5 % havde 17p-kromosomdeletion og/eller TP53-mutation, og 78,5 % havde ikke-muterede gener for IGHV.
English: Table 4: Summary of PFS and response rates in pre-specified subgroups from study 312-0116 Idelalisib + R
Danish: Tabel 4: Oversigt over PFS og responsrater i præspecificerede undergrupper fra studie Idelalisib + R
English: The film-coated tablets are pink, oval-shaped tablets, debossed on one side with “GSI” and “150” on the other side.
Danish: De filmovertrukne tabletter er lyserøde, ovale tabletter, påtrykt ”GSI” på den ene side og ”150” på den anden side.
English: Idelalisib in combination with ofatumumab
Danish: Idelalisib i kombination med ofatumumab
English: If diarrhoea/colitis does not recur, the dose can be re-escalated to 150 mg twice daily at the discretion of the treating physician (see section 4.8).
Danish: Hvis diarréen/colitisen ikke vender tilbage, kan dosis igen øges til 150 mg to gange dagligt efter den behandlende læges skøn (se pkt.
English: CI: confidence interval; R: rituximab; N: number of subjects per group; NR: not reached
Danish: CI: konfidensinterval; R: rituximab; N: antal patienter pr. gruppe; NR: ikke nået (not reached)
English: How to take Zydelig
Danish: Sådan skal du tage Zydelig
English: The primary metabolite of idelalisib, GS-563117, is a strong CYP3A inhibitor.
Danish: Idelalisibs primære metabolit, GS-563117, er en kraftig CYP3A-hæmmer.
English: PFS median (months) (95% CI) Hazard ratio (95% CI) ORR (95% CI)
Danish: Median PFS (måneder) (95 % CI) Hazard ratio (95 % CI) ORR (95 % CI)
English: Each tablet contains 0.1 mg sunset yellow FCF (E110) (see section 4.4).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 0,1 mg sunset yellow FCF (E110) (se pkt.
English: PFS median (months) (95% CI)
Danish: PFS median (måneder) (95 % CI)
English: Clinical efficacy in follicular lymphoma
Danish: Klinisk virkning ved follikulært lymfom
English: Polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E553B), sunset yellow FCF (E110) (see Section 2, What you need to know before you take Zydelig).
Danish: Polyvinylalkohol (E1203), macrogol 3350 (E1521), titandioxid (E171), talcum (E553B), sunset yellow FCF (E110) (se afsnit 2, Det skal du vide, før du begynder at tage Zydelig).
English: ↑ serum concentrations Clinical monitoring is recommended.
Danish: ↑ serumkoncentrationer Klinisk overvågning anbefales.
English: ↑ serum concentrations Idelalisib should not be co-administered with cisapride.
Danish: ↑ serumkoncentrationer Idelalisib bør ikke administreres sammen med cisaprid.
English: PFS Median (months) (95% CI) Hazard ratio (95% CI) P-value ORR* n (%) (95% CI) Odds ratio (95% CI) P-value LNR** n/N (%) (95% CI) Odds ratio (95% CI) P-value OS Median (months) (95% CI)
Danish: Median PFS (måneder) (95 % CI) Hazard ratio (95 % CI) P-værdi ORR* n (%) (95 % CI) Oddsratio (95 % CI) P-værdi LNR** n/N (%) (95 % CI) Oddsratio (95 % CI) P-værdi Median OS (måneder) (95 % CI)
English: Zydelig 150 mg film-coated tablets
Danish: Zydelig 150 mg filmovertrukne tabletter
English: ↑ serum concentrations Idelalisib should not be co-administered with alfuzosin.
Danish: ↑ serumkoncentrationer Idelalisib bør ikke administreres sammen med alfuzosin.
English: • dasatinib, nilotinib, paclitaxel, vinblastine, vincristine, medicines used to treat cancer • oral or implanted hormonal contraceptives, used to prevent pregnancy
Danish: • dasatinib, nilotinib, paclitaxel, vinblastin, vincristin, lægemidler, der anvendes til at behandle kræft
English: Package leaflet: Information for the patient Zydelig 150 mg film-coated tablets idelalisib
Danish: Indlægsseddel: Information til patienten Zydelig 150 mg filmovertrukne tabletter idelalisib
English: Zydelig 100 mg film-coated tablets
Danish: Zydelig 100 mg filmovertrukne tabletter
English: If you take more Zydelig than you should
Danish: Hvis du har taget for meget Zydelig
English: PHOSPHODIESTERASE INHIBITORS
Danish: FOSFODIESTERASEHÆMMERE
English: Package leaflet: Information for the patient Zydelig 100 mg film-coated tablets idelalisib
Danish: Indlægsseddel: Information til patienten Zydelig 100 mg filmovertrukne tabletter idelalisib
English: Zydelig 100 mg film-coated tablets idelalisib
Danish: Zydelig 100 mg filmovertrukne tabletter idelalisib
English: Inhaled/nasal corticosteroids: Budesonide, fluticasone
Danish: Inhalerede/nasale kortikosteroider:
English: • inflammation of the lungs
Danish: • lungebetændelse
English: CI: confidence interval; R: rituximab; n: number of responding subjects; N: number of subjects per group; NR: not reached.
Danish: CI: konfidensinterval; R: rituximab; n: antal patienter, der responderer; N: antal patienter i gruppen; NR: ikke nået (not reached).
English: Zydelig 150 mg film-coated tablets idelalisib
Danish: Zydelig 150 mg filmovertrukne tabletter idelalisib
English: ANTICOAGULANTS
Danish: ANTIKOAGULANTIA
English: CI: confidence interval; O: ofatumumab; n: number of responding subjects; N: number of subjects per group; NR: not reached.
Danish: CI: konfidensinterval; O: ofatumumab; n: antal patienter, der responderer; N: antal patienter i gruppen; NR: ikke nået (not reached).