FrancophonIA/ELRC3.0 huggingface dataset:
English: Exposure-dependent QT prolongation was observed in an uncontrolled, open-label phase II study in previously treated patients with metastatic melanoma.
Danish: Der blev observeret eksponeringsafhængig QT-forlængelse i et ukontrolleret, open-label, fase II-studie hos tidligere behandlede patienter med metastatisk melanom.
English: Older patients (≥ 65 years) may be more likely to experience adverse reactions, including cuSCC, decreased appetite, and cardiac disorders.
Danish: år) oplever bivirkninger, inklusive cuSCC, nedsat appetit og hjertesygdomme.
English: Liver injury(1)(2) (g)
Danish: Leverskade(1)(2)(g)
English: Table 9: Overall response rate and progression-free survival in previously untreated patients with BRAF V600 mutation-positive melanoma vemurafenib dacarbazine p-value (x)
Danish: Tabel 9: Samlet responsrate og progressionsfri overlevelse hos tidligere ubehandlede patienter med BRAF-V600-mutationspositivt melanom vemurafenib dacarbazine p-værdi(x)
English: The population apparent volume of distribution for vemurafenib in metastatic melanoma patients is estimated to be 91 L (with 64.8% between patient variability).
Danish: Det tilsyneladende populationsfordelingsvolumen for vemurafenib hos patienter med metastatisk melanom er estimeret til at være 91 liter (med 64,8 % variabilitet mellem patienter).
English: 2nd occurrence of any grade 4 AE or persistence of any grade 4 AE after 1st dose reduction
Danish: 2. forekomst af enhver grad 4 bivirkning eller enhver vedvarende grad 4 bivirkning efter 1. dosisreduktion
English: What Zelboraf looks like and contents of the pack Zelboraf 240 mg film-coated tablets are pinkish white to orange white.
Danish: Zelboraf 240 mg filmovertrukne tabletter er lyserøde-hvide til orange-hvide.
English: Concomitant use of vemurafenib with agents metabolized by CYP1A2 with narrow therapeutic windows (e.g. agomelatine, alosetron, duloxetine, melatonin, ramelteon, tacrine, tizanidine, theophylline) is not recommended.
Danish: Samtidig anvendelse af vemurafenib med midler, som metaboliseres af CYP1A2, med smalt terapeutisk vindue (f.eks. agomelatin, alosetron, duloxetin, melatonin, ramelteon, tacrin, tizanidin, theophyllin) kan ikke anbefales.
English: Manufacturer Roche Pharma AG Emil-Barell-Strasse 1 D-79639
Danish: Fremstiller Roche Pharma AG Emil-Barel-Strasse D-79639
English: In this section, ADRs are based on results in 468 patients from a phase III randomised open label study in adult patients with BRAF V600 mutation-positive unresectable or stage IV melanoma, as well as a phase II single-arm study in patients with BRAF V600 mutation-positive stage IV melanoma who had previously failed at least one prior systemic therapy (see section 5.1).
Danish: I dette afsnit er bivirkningerne baseret på resultater fra 468 patienter fra et fase III, randomiseret, openlabel studie hos voksne patienter med BRAF-V600-mutationspositivt ikke-operabelt eller stadium IV melanom, samt fra et fase II, enkelt-arm studie hos patienter med BRAF-V600-mutationspositivt stadium IV melanom.
English: Severe dermatologic reactions have been reported in patients receiving vemurafenib, including rare cases of Stevens-Johnson syndrome and toxic epidermal necrolysis in the pivotal clinical trial.
Danish: Der er blevet rapporteret svære hudreaktioner, herunder sjældne tilfælde af Stevens-Johnsons syndrom og toksisk epidermal nekrolyse, i de pivotale kliniske studier hos patienter, som får vemurafenib.
English: ● Keep this leaflet.
Danish: · Gem indlægssedlen.
English: ● Medicines that are mainly eliminated by metabolising proteins called CYP1A2 (e.g caffeine, olanzapine, theophylline), CYP3A4 (e.g. some oral contraceptives) or called CYP2C8.
Danish: · Medicin som primært udskilles af metaboliseringsproteiner kaldet CYP1A2 (f.eks. caffein, olanzapin, theophyllin), CYP3A4 (f.eks. nogle orale (indtaget gennem munden) præventionsmidler) eller CYP2C8.
English: The majority of patients was male (61%), Caucasian (99%), and had stage M1c disease (61%).
Danish: Størstedelen af patienterne var mænd (61 %), kaukasiske (99 %) og med stadie
English: Dose adjustments for CYP3A4 substrates with narrow therapeutic window may be considered, if clinically indicated (see sections 4.4 and 4.6).
Danish: Dosis modifikationer for CYP3A4 substrater med smalt terapeutisk vindue kan overvejes, hvis det er klinisk relevant (se pkt.
English: Serum creatinine should be measured before initiation of treatment and monitored during treatment as clinically indicated (see sections 4.2 and 4.8).
Danish: Serumkreatinin måles før behandlingsstart og monitoreres under behandlingen som klinisk indiceret (se pkt.
English: Grade 4 1st occurrence of any grade 4 AE Discontinue permanently or interrupt vemurafenib treatment until grade 0 - 1.
Danish: Seponer permanent eller afbryd behandling med vemurafenib indtil grad 0-1.
English: ● Medicines that influence a protein called P-gp or BCRP (e.g. verapamil, cyclosporine, ritonavir, quinidine, itraconazole, gefitinib).
Danish: · Medicin, som påvirker et protein kaldet P-gp eller BCRP (f.eks. verapamil, ciclosporin, ritonavir, quinidin, itraconazol, gefitinib).
English: 3rd occurrence of any grade 2 or 3 AE or persistence after 2nd dose reduction
Danish: 3. forekomst af enhver grad 2 eller 3 bivirkning eller vedvarende bivirkning efter 2. dosisreduktion
English: Concomitant administration of strong inducers of P-gp, glucuronidation, and/or CYP3A4 (e.g. rifampicin, rifabutin, carbamazepine, phenytoin or St John's Wort [Hypericum perforatum]) may lead to suboptimal exposure to vemurafenib and should be avoided.
Danish: Samtidig administration af kraftige induktorer af P-gp, glukuronidering og/eller CYP3A4 (f.eks. rifampicin, rifabutin, carbamazepin, phenytoin eller perikon [Hypericum perforatum]) kan medføre en suboptimal eksponering af vemurafenib og bør undgås.
English: ● Medicines that stimulate the metabolising proteins called CYP3A4 or a metabolising process called glucuronidation (e.g. rifampicin, rifabutin, carbamazepine, phenytoin or St John's Wort)
Danish: · Medicin, som stimulerer metaboliseringsproteiner kaldet CYP3A4 eller en metaboliseringsproces kaldet glukuronidering (f.eks. rifampicin, rifabutin, carbamazepin, phenytoin eller perikon).
English: Diarrhoea, vomiting, nausea, constipation
Danish: Mave-tarm-kanalen Diarré, opkastning, kvalme, konstipation
English: During clinical trials with vemurafenib, grade 3 adverse reactions reported more frequently in females than males were rash, arthralgia and photosensitivity.
Danish: De grad 3 bivirkninger, som blev rapporteret hyppigere hos kvinder end mænd under de kliniske studier med vemurafenib, var udslæt, artralgi og lysfølsomhed.
English: Fatigue, pyrexia, oedema peripheral, asthenia
Danish: Træhed, pyreksi, perifert ødem, asteni
English: Table 5: Acute kidney injury cases in the phase III study Vemurafenib (%) Dacarbazine (%)
Danish: Tabel 4: Ændringer i kreatinin fra baseline i fase III-studiet Vemurafenib (%) Dacarbazin (%)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 240 mg of vemurafenib (as a co-precipitate of vemurafenib and hypromellose acetate succinate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 240 mg vemurafenib (som co-præcipitat af vemurafenib og hypromelloseacetatsuccinat).
English: How to take Zelboraf
Danish: Sådan skal du tage Zelboraf
English: 7th nerve paralysis, neuropathy peripheral
Danish: Lammelse af 7. nerve (nervus facialis),
English: Concomitant administration of strong inducers of CYP3A4, P-gp and glucuronidation (e.g. rifampicin, rifabutin, carbamazepine, phenytoin or St John's Wort [hypericin]) might lead to decreased exposure of vemurafenib and should be avoided when possible (see section 4.5).
Danish: Samtidig administration af kraftige CYP3A4 induktorer, P-gp og glukoronidering (f.eks. rifampicin, rifabutin, carbamazepin, phenytoin eller perikon [hypericin]) kan forårsage nedsat eksponering af vemurafenib og bør undgås, når det er muligt (se pkt.
English: Cutaneous Squamous Cell Carcinoma (cuSCC)
Danish: Kutant planocellulært karcinom (cuSCC)
English: ● Tell your doctor if you have kidney or liver problems.
Danish: Nyre- eller leverproblemer · Fortæl lægen, hvis du har nyre- eller leverproblemer.
English: Caution should be exercised when dosing vemurafenib concurrently with P-gp substrates (e.g. aliskiren, ambrisentan, colchicine, dabigatran etexilate, digoxin, everolimus, fexofenadine, lapatinib, maraviroc, nilotinib, posaconazole, ranolazine, sirolimus, sitagliptin, talinolol, topotecan) and dose reduction of the concomitant medicinal product may be considered, if clinically indicated.
Danish: Der bør udvises forsigtighed, hvis vemurafenib anvendes samtidig med P-gp-substrater (f.eks. aliskiren, ambrisentan, colchicin, dabigatran etexilat, digoxin, everolimus, fexofenadin, lapatinib, maraviroc, nilotinib, posaconazol, ranolazin, sirolimus, sitagliptin, talinolol, topotecan).
English: There are only limited data available in patients with severe renal impairment (see section 5.2).
Danish: Der er kun begrænsede data tilgængelige hos patienter med svær nedsat nyrefunktion (se pkt.
English: Pancreatitis has been reported in vemurafenib-treated subjects.
Danish: Pancreatitis er rapporteret hos patienter behandlet med vemurafenib.
English: On this basis, the efficacy of contraceptive pills metabolized by CYP3A4 used concomitantly with vemurafenib might be decreased.
Danish: Virkningen af p-piller, som metaboliseres af CYP3A4, og som anvendes samtidig med vemurafenib, kan nedsættes på grund af dette.
English: Concomitant use of vemurafenib with agents metabolized by CYP1A2 and CYP3A4 with narrow therapeutic windows is not recommended.
Danish: Samtidig anvendelse af vemurafenib med midler, som er metaboliseret af CYP1A2 og CYP3A4 med smalt terapeutisk vindue, kan ikke anbefales.
English: ● Weight loss
Danish: Nedsat leverfunktion
English: Patients should be closely monitored when re-starting vemurafenib after an episode of pancreatitis.
Danish: Efter et tilfælde af pancreatitis bør patienten monitoreres tæt, når behandling med vemurafenib genoptages.
English: Vemurafenib should be used with caution in combination with strong inhibitors of CYP3A4, glucuronidation and/or transport proteins (e.g. ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone, atazanavir).
Danish: Vemurafenib bør anvendes med forsigtighed i kombination med kraftige hæmmere af CYP3A4, glukuronidering og/eller transportproteiner (f.eks. ritonavir, saquinavir, telithromycin, ketoconazol, itraconazol, voriconazol, posaconazol, nefazodon, atazanavir).
English: February 01, 2012 data cut-off date (z) Progression-free survival Hazard Ratio (95% CI)
Danish: Hazard ratio (95% konfidensinterval) Antal hændelser (%) Median progressionsfri overlevelse (måneder) (95% konfidensinterval) Cut-off 1. februar 2012 (z)
English: ● The active substance is vemurafenib.
Danish: Zelboraf indeholder: · Aktivt stof: Vemurafenib.
English: Exercise caution and consider additional INR (international normalized ratio) monitoring when vemurafenib is used concomitantly with warfarin (see section 4.4).
Danish: Forsigtighed bør udvises og yderligere INR (international nomaliseret ratio) monitorering bør overvejes, når vemurafenib anvendes samtidig med warfarin (se pkt.
English: Number of deaths
Danish: Cut-off datoer Behandling Antal dødsfald
English: However, in repeat-dose toxicity studies, no histopathological findings were noted on reproductive organs in males and females in rats and dogs at doses up to 450 mg/kg/day (at exposures below the anticipated clinical exposure based on AUC comparison).
Danish: I studier af toksicitet efter gentagne doser blev der dog ikke bemærket histopatologiske fund i forplantningsorganerne hos hanog hunrotter og hunde ved doser på op til 450 mg/kg/døgn (ved eksponeringer under den forventede kliniske eksponering baseret på sammenligning af AUC).
English: In a clinical study, co-administration of a single dose 960 mg of vemurafenib with rifampicin, significantly decreased the plasma exposure of vemurafenib by approximately 40%.
Danish: I et klinisk studie faldt plasma-eksponeringen af vemurafenib signifikant med omkring 40 % ved administration af en enkelt dosis på 960 mg vemurafenib sammen med rifampicin.
English: acute tubular necrosis(1)(2) (h)
Danish: Akut interstitiel nefritis(1) (2) (h), akut tubulær nekrose(1) (2) (h)
English: Do not chew or crush the tablets.
Danish: Tabletterne må ikke tygges eller knuses.
English: PFS - overall Median (months)e
Danish: Progressionsfri overlevelse - total Median (måneder)e konfidensinterval)d
English: Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported in association with vemurafenib in the post-marketing setting (see section 4.8).
Danish: Efter markedsføring er en medikamentel reaktion med eosinofili og systemiske symptomer (DRESS) rapporteret i forbindelse med vemurafenib (se pkt.
English: December 30, 2010 data cut-off date (y) Overall Response Rate (95% CI)
Danish: Cut-off 30. december 2010 data (y)
English: ● Medicines that strongly inhibit the metabolising protein called CYP3A4 (e.g. ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone, atazanavir)
Danish: · Medicin, som hæmmer metaboliseringsprotein kaldet CYP3A4 (f.eks. ritonavir, saquinavir, telithromycin, ketoconazol, itraconazol, voriconazol, posaconazol, nefazodon, atazanavir).
English: Events should be managed with dose reduction with treatment interruption or with treatment discontinuation (see section 4.2).
Danish: Bivirkningerne skal håndteres med dosisreduktion ved midlertidig afbrydelse af behandlingen eller med permanent seponering af behandingen (se pkt.
English: Liver enzyme abnormalities reported in the phase III clinical study are expressed below as the proportion of patients who experienced a shift from baseline to a grade 3 or 4 liver enzyme abnormalities:
Danish: Stigning i leverenzymer (c) Leverenzymanormaliteter rapporteret i det kliniske fase III-studie er udtrykt nedenfor som den andel af patienter, som oplevede en ændring fra baseline til grad 3 eller 4 leverenzymanormaliteter: · Meget almindelig: GGT · Almindelig: ALAT, alkalisk fosfatase, bilirubin · Ikke almindelig: ASAT
English: The most common adverse drug reactions (ADR) of any grade (> 30%) reported with vemurafenib include arthralgia, fatigue, rash, photosensitivity reaction, alopecia, nausea diarrhea, headache,
Danish: De mest almindelige bivirkninger af alle grader (> 30 %) rapporteret ved behandling med vemurafenib inkluderer artralgi, træthed, udslæt, lysfølsomhedsreaktion, alopeci, kvalme, diarré, hovedpine, kløe, opkastning, hudpapillom og hyperkeratose.
English: In vitro studies suggest that CYP3A4 metabolism and glucuronidation are responsible for the metabolism of vemurafenib.
Danish: Virkning af samtidig brug af lægemidler på vemurafenib In vitro-studier indikerer, at CYP3A4-metabolisering og glukuronidering er ansvarlige for metabolisering af vemurafenib.
English: Zelboraf 240 mg film-coated tablets vemurafenib
Danish: Zelboraf 240 mg filmovertrukne tabletter Vemurafenib
English: Concomitant use of vemurafenib with agents metabolized by CYP3A4 with narrow therapeutic windows is not recommended.
Danish: Samtidig anvendelse af vemurafenib med midler, som metaboliseres af CYP3A4, med smalt terapeutisk vindue kan ikke anbefales.
English: Exposure-dependent QT prolongation was observed in an uncontrolled, open-label phase II study in previously treated patients with metastatic melanoma (see section 4.8).
Danish: Der blev observeret eksponeringsafhængig QT-forlængelse i et ukontrolleret, open-label, fase II-studie hos tidligere behandlede patienter med metastatisk melanom (se pkt.
English: Grade 1 or Grade 2 (tolerable)
Danish: Grad 2 (uacceptabel) eller grad 3
English: ● Film-coating: iron oxide red, macrogol 3350, polyvinyl alcohol, talc and titanium dioxide.
Danish: · øvrige indholdsstoffer: · Tabletkerne: Kolloid vandfri silica, croscarmellosenatrium, hydroxypropylcellulose og magnesiumstearat · Filmovertræk: Rød jernoxid, macrogol 3350, polyvinylalkohol, talcum og titandioxid.
English: Serious hypersensitivity reactions, including anaphylaxis have been reported in association with vemurafenib.
Danish: Der er blevet rapporteret alvorlige overfølsomhedsreaktioner, inklusive anafylaksi, i forbindelse med vemurafenib.
English: Dermatologic reactions (f)
Danish: Hudreaktioner (f)
English: A single-arm, multicentre study (N = 146) of vemurafenib was conducted in adult patients with histologically confirmed metastatic melanoma harbouring the BRAF V600 mutation (according to the cobas 4800 BRAF V600 Mutation Test) and with brain metastases.
Danish: Et multicenterstudie (n = 146) med vemurafenib med en enkelt arm blev udført hos voksne patienter med histologisk bekræftet metastatisk melanom, som havde BRAF V600 mutation (iht.
English: Dose reduction and/or additional drug level monitoring for P-gp substrate medicinal products with narrow therapeutic index (NTI) (e.g. digoxin, dabigatran etexilate, aliskiren) may be considered if these medicinal products are used concomitantly with vemurafenib (see section 4.5).
Danish: Dosisnedsættelse og/eller supplerende monitorering af lægemiddelkoncentrationen skal overvejes for lægemidler, som er P-pg substrater, og som har et smalt terapeutisk vindue (såsom digoxin, dabigatran etexilat, aliskiren), hvis disse lægemidler gives samtidig med vemurafenib (se pkt.
English: Each film-coated tablet contains 240 milligrams (mg) of vemurafenib (as a co-precipitate of vemurafenib and hypromellose acetate succinate).
Danish: Hver filmovertrukket tablet indeholder 240 mg vemurafenib (som copræcipitat af vemurafenib og hypromelloseacetatsuccinat).
English: Renal elimination does not appear to be of importance for vemurafenib elimiation, whereas biliary excretion of unchanged compound may be an important route of elimination.. Vemurafenib is a substrate and inhibitor of P-gp in vitro.
Danish: Udskillelse via nyrerne ser ikke ud til at være vigtig for eliminationen af vemurafenib imens udskillelse af uomdannet stof via galden kan være en vigtig eliminationsvej.
English: Chronic myelomonocytic leukaemia(2)(4),
Danish: Kronisk myelomonocytær leukæmi(2)(4), pankreatisk adenokarcinom5
English: Non-Cutaneous Squamous Cell Carcinoma (non-cuSCC) Cases of non-cuSCC have been reported in clinical trials where patients received vemurafenib.
Danish: Der er rapporteret tilfælde af non-cuSCC i kliniske studier, hvor patienter fik vemurafenib.
English: Consider additional drug level monitoring for P-gp substrate medicinal products with a narrow therapeutic index (NTI) (e.g. digoxin, dabigatran etexilate, aliskiren) (see section 4.4).
Danish: Supplerende monitorering af lægemiddelkoncentrationen skal overvejes for lægemidler, som er P-pgsubstrater, og som har et smalt terapeutisk vindue (såsom digoxin, dabigatran etexilat, aliskiren) (se pkt.
English: Maintain vemurafenib at a dose of 960 mg twice daily.
Danish: Grad 1 eller grad 2 (acceptabel) Fasthold vemurafenib-dosis på 960 mg to gange dagligt.
English: Limited data are available in patients with renal impairment.
Danish: Begrænsede data er tilgængelige for patienter med nedsat nyrefunktion.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 240 mg of vemurafenib (as a co-precipitate of vemurafenib and hypromellose acetate succinate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 240 mg vemurafenib (som co-præcipitat af vemurafenib og hypromelloseacetatsuccinat).
English: Vemurafenib should be used with caution in patients with severe renal impairment and patients should be closely monitored.
Danish: Vemurafenib bør anvendes med forsigtighed hos patienter med svært nedsat nyrefunktion.
English: Most cases were cutaneous in nature but some cases involving visceral organs had fatal outcomes (see sections 4.5 and 4.8).
Danish: Nogle tilfælde, hvor indre organer var involveret, havde dødelig udgang (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Zelboraf 240 mg tablets vemurafenib
Danish: LÆGEMIDLETS NAVN Zelboraf 240 mg tabletter vemurafenib
English: ● Decreased white blood cells (neutropenia).
Danish: · Ændringer i resultater fra levertests (stigning i GGT) · Nedsat antal hvide blodlegemer (neutropeni).
English: ● Progression of a type of pre-existing cancers with RAS mutations (Chronic Myelomonocytic
Danish: Sjældne (kan påvirke op til 1 ud af 1.000 behandlede): · Forværring af allerede eksisterende typer kræft med RAS-mutationer (kronisk myelomonocytær leukæmi, adenokarcinom i bugspytkirtlen).
English: - Cohort 1 with previously untreated patients (N = 90): Patients who had not received previous treatment for brain metastases; prior systemic therapy for metastatic melanoma was allowed, excluding BRAF inhibitors and MEK inhibitors.
Danish: - Kohort 1 med ikke-tidligere behandlede patienter (n = 90): Patienter, som ikke tidligere havde fået behandling for hjernemetastaser.
English: Posology adjustments
Danish: Dosisjusteringer
English: Liver injury, including cases of severe liver injury, has been reported with vemurafenib (see section 4.8).
Danish: Der er rapporteret tilfælde af leverskade, inklusive tilfælde af svære leverskader, ved behandling med vemurafenib (se pkt.
English: Photosensitivity reaction, actinic keratosis, rash, rash maculo-papular, pruritus, hyperkeratosis, erythema, palmarplantar erythrodysaesthesia syndrome, alopecia, dry skin, sunburn
Danish: Hud og subkutane væv Lysfølsomhedsreaktion, aktinisk keratose, udslæt, makulo-papuløst udslæt, kløe, hyperkeratose, erytem, palmoplantar erytrodysæstesisyndrom, alopeci, tør hud, solskoldning
English: In patients who develop cuSCC, it is recommended to continue the treatment without dose adjustment.
Danish: Det anbefales at fortsætte behandling uden dosisjustering hos patienter, som udvikler cuSCC.
English: All percentages are expressed as cases out of total patients exposed to each medicinal product.
Danish: Tilfælde af akutte nyreskader* Tilfælde af akutte nyreskader i forbindelse med dehydrering Dosis modificeret på grund af akut nyreskade Alle procenter er angivet som tilfælde hos det totale antal patienter, som har været eksponeret for hvert lægemiddel.
English: In the phase II and phase III clinical trials, eligible patients were identified using a real-time polymerase chain reaction assay (the cobas 4800 BRAF V600 Mutation Test).
Danish: Før anvendelse af vemurafenib skal patienter have en BRAF-V600-mutationspositiv tumorstatus bekræftet ved en valideret test. I de kliniske fase II- og fase III-studier blev egnede patienter identificeret ved brug af real-time polymerase-kædereaktionssassay (cobas 4800 BRAF-V600mutationstest).
English: Cases of renal toxicity have been reported with vemurafenib ranging from creatinine elevations to acute interstitial nephritis and acute tubular necrosis, some observed in the setting of dehydration events.
Danish: Der har været rapporteret tilfælde af nyretoksicitet med vemurafenib, spændende fra kreatininstigning til akut interstitiel nefritis og akut tubulær nekrose.
English: Malta (See Ireland)
Danish: Malta (ara Renju Unit)
English: Arthritis,
Danish: Artritis
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udsted af en begrænset lægegruppe (se bilag I: Produktresumé; pkt.
English: Laboratory abnormalities should be managed with dose reduction, treatment interruption or with treatment discontinuation (see sections 4.2 and 4.8).
Danish: Abnorme analyseresultater bør håndteres med dosisreduktion, afbrydelse af behandling eller med seponering af behandling (se pkt.
English: Median (months) (95% CI)d
Danish: Median (måneder)e konfidensinterval)d
English: Limited data are available in patients with hepatic impairment.
Danish: Begrænsede data er tilgængelige for patienter med nedsat leverfunktion.
English: (t)
Danish: (z)