FrancophonIA/ELRC3.0 huggingface dataset:
English: PVC-Aluminium /Aluminium blister sealed inside a wallet pack containing one capsule.
Danish: PVC-aluminiums-/aluminiumsblisterkort forseglet i en mappe, der indeholder én kapsel.
English: There are no data for the use of ixazomib in pregnant women.
Danish: Der er ingen data fra anvendelse af ixazomib til gravide kvinder.
English: Ixazomib is an oral, highly selective and reversible proteasome inhibitor.
Danish: Ixazomib er en oral, meget selektiv og reversibel proteasomhæmmer.
English: Fatigue and dizziness have been observed in clinical trials.
Danish: Der er observeret træthed og svimmelhed i kliniske studier.
English: Do not use this medicine if you notice any damage or signs of tampering to medicine packaging.
Danish: Brug ikke lægemidlet, hvis du bemærker eventuelle skader eller tegn på, at emballagen har været åbnet.
English: No dose adjustment of ixazomib is required for patients over 65 years of age.
Danish: Dosisjustering af ixazomib er ikke nødvendig for patienter over 65 år.
English: NINLARO is not recommended during pregnancy as it may harm your unborn baby.
Danish: NINLARO anbefales ikke under graviditet, da det kan skade dit ufødte barn.
English: Day 1 Days 2 to 7
Danish: Dag 1 Dag 2 til 7
English: 3 packs of 1 hard capsule.
Danish: 3 pakker af 1 hård kapsel.
English: The primary endpoint was progression-free survival (PFS) according to the 2011 International Myeloma Working Group (IMWG) Consensus Uniform Response Criteria as assessed by a blinded independent review committee (IRC) based on central laboratory results.
Danish: Det primære endepunkt var progressionsfri overlevelse (PFS) i henhold til de standardiserede responskriterier fra IMWG (International Myeloma Working Group) fra 2011 efter vurdering af et uafhængigt bedømmelsesudvalg (IRC) baseret på centrallaboratorie-resultater.
English: Take the next dose, as normal, when it is due.
Danish: Tag den næste dosis som planlagt, når det er tid.
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX50
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, andre antineoplastiske midler, ATC-kode: L01XX50
English: Ixazomib Cmax was decreased by 4% and AUC was increased by 11%.
Danish: Ixazomib-Cmax blev reduceret med 4%, og AUC blev øget med 11%.
English: Based on a population PK analysis, systemic clearance (CL) was approximately 1.86 L/hr with inter-individual variability of 44%.
Danish: Baseret på en populationsfarmakokinetisk analyse er den systemiske clearance (CL) ca. 1,86 l/time med en inter-individuel variation på 44%.
English: Ixazomib AUC increases in a dose proportional manner over a dose range of 0.2-10.6 mg.
Danish: Ixazomib-AUC øges proportionalt med dosis i et dosisområde på 0,2-10,6 mg.
English: Take each NINLARO capsule whole with water at the same time each week, at least one hour before or no sooner than two hours after any food.
Danish: Tag hver NINLARO-kapsel hel sammen med vand på samme tidspunkt hver uge, mindst én time før eller mindst to timer efter indtagelse af føde.
English: The Phase 3 study excluded patients who were refractory to lenalidomide or proteasome inhibitors and patients who received more than three prior therapies.
Danish: Fase 3-studiet udelukkede patienter, der var refraktære over for lenalidomid eller proteasomhæmmere, og patienter, der havde fået mere end tre tidligere behandlinger.
English: Treatment continued until disease progression or unacceptable toxicities.
Danish: Behandlingen fortsatte indtil sygdomsprogression eller uacceptabel toksicitet.
English: Twenty three percent of patients had light chain disease and 12% of patients had measurable disease by free light chain assay only.
Danish: 23% af patienterne havde light chain disease, og 12% havde kun målbar sygdom ved free light chain assay.
English: As NINLARO is given in combination with lenalidomide, you should adhere to the pregnancy prevention programme of lenalidomide because lenalidomide can be harmful to the unborn child.
Danish: Da NINLARO anvendes i kombination med lenalidomid, skal du overholde programmet for forebyggelse af graviditet, der gælder for lenalidomid, fordi lenalidomid kan være skadeligt for det ufødte barn.
English: Ixazomib is for oral use.
Danish: Ixazomib er til oral anvendelse.
English: The mean AUC was 35% higher in Asian patients; however, there was overlap in the AUC of ixazomib across White and Asian patients.
Danish: Det gennemsnitlige AUC var 35% højere hos asiatiske patienter, men der var overlap i AUC for ixazomib på tværs af hvide og asiatiske patienter.
English: Twenty five percent of patients had a creatinine clearance of < 60 mL/min.
Danish: 25% af patienterne havde kreatininclearance på < 60 ml/min.
English: If you take more NINLARO than you should, talk to a doctor or go to a hospital straight away.
Danish: Hvis du har taget for meget NINLARO, skal du tale med en læge eller tage direkte på hospitalet.
English: Seventy seven percent of patients relapsed after prior therapies and 11% were refractory to prior therapies.
Danish: 77% af patienterne recidiverede efter tidligere behandlinger, og 11% var refraktære over for tidligere behandlinger.
English: If a patient vomits after taking a dose, the patient should not repeat the dose but should resume dosing at the time of the next scheduled dose.
Danish: Hvis en patient kaster op efter at have taget en dosis, skal patienten ikke tage en ny dosis, men genoptage doseringen på tidspunktet for den næste planlagte dosis.
English: NINLARO may affect your ability to drive or use machines.
Danish: NINLARO kan påvirke din evne til at køre motorkøretøj og betjene maskiner.
English: • nausea, vomiting and diarrhoea
Danish: • kvalme, opkastning og diarré
English: At the primary analysis (median follow up of 14.7 months and a median of 13 cycles), PFS was statistically significantly different between the treatment arms.
Danish: Ved den primære analyse (median opfølgning på 14,7 måneder og et mediant antal cyklusser på 13) var PFS statistisk signifikant forskellig mellem de to behandlingsarme.
English: Studies of fertility and early embryonic development and pre- and post-natal toxicology were not conducted with ixazomib, but evaluation of reproductive tissues was conducted in the general toxicity studies.
Danish: Der er ikke udført studier af fertilitet og tidlig fosterudvikling eller præ- og postnatal toksikologiske studier med ixazomib, men reproduktionsvæv blev evalueret i de generelle toksicitetsstudier.
English: Other possible side effects Tell your doctor or pharmacist if any of the side effects below become severe.
Danish: Andre bivirkninger Fortæl det til din læge eller apotekspersonalet, hvis nogen af nedenstående bivirkninger bliver svære.
English: There is no known specific antidote for ixazomib overdose.
Danish: Der er ingen kendt specifik antidot mod overdosering af ixazomib.
English: Following oral administration, a tissue distribution study in rats revealed that the brain and spinal cord were amongst the tissues with the lowest levels, suggesting that the penetration of ixazomib through the blood-brain barrier appears to be limited.
Danish: Efter oral indgivelse viste et studie af vævsfordelingen af ixazomib hos rotter, at hjernen og rygmarven var blandt de væv, der havde de laveste niveauer, hvilket tyder på, at penetrationen af ixazomib gennem blod-hjerne-barrieren synes at være begrænset.
English: PRES is a rare, reversible, neurological disorder which can present with seizure, hypertension, headache, altered consciousness, and visual disturbances.
Danish: PRES er en sjælden, reversibel neurologisk lidelse, som kan vise sig med krampeanfald, hypertension, hovedpine, ændret bevidsthedsniveau og synsforstyrrelser.
English: Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
Danish: Thalidomid er et aktivt stof, som er teratogent hos mennesker, og som forårsager alvorlige livstruende medfødte misdannelser.
English: Patients that changed therapies prior to disease progression were eligible for enrolment, as well as those with controlled cardiovascular conditions.
Danish: Patienter, der skiftede behandling før sygdomsprogression, var kvalificerede til at deltage, ligesom patienter med kontrolleret kardiovaskulær sygdom var det.
English: If ixazomib is used during pregnancy or if the patient becomes pregnant while taking ixazomib, the patient should be apprised of the potential hazard to the foetus.
Danish: Hvis ixazomib anvendes under graviditet, eller hvis patienten bliver gravid, mens hun tager ixazomib, skal patienten informeres om den potentielle risiko for fostret.
English: Ixazomib caused embryo-foetal toxicity in pregnant rats and rabbits only at maternally toxic doses and at exposures that were slightly higher than those observed in patients receiving the recommended dose.
Danish: Ixazomib forårsagede kun embryo-føtal toksicitet hos drægtige rotter og kaniner ved maternelt toksiske doser og ved eksponeringer, som var lidt højere end observeret hos patienter, der fik den anbefalede dosis.
English: As multiple myeloma is a heterogeneous disease, benefit may vary across subgroups in the Phase 3 study (C16010) (see Figure 2).
Danish: Da myelomatose er en heterogen sygdom, kan fordelene variere i de forskellige undergrupper i fase 3-studiet (se Figur 2).
English: Figure 1: Kaplan-Meier plot of progression-free survival in the intent-to-treat population
Danish: Figur 1: Kaplan-Meier kurver over progressionsfri overlevelse i ITT-populationen
English: Ixazomib citrate, a prodrug, is a substance that rapidly hydrolyses under physiological conditions to its biologically active form, ixazomib.
Danish: Ixazomibcitrat er et pro-drug, der under fysiologiske betingelser hurtigt hydrolyseres til dets biologisk aktive form, ixazomib.
English: Nineteen percent had high-risk cytogenetic abnormalities (del[17], t[4;14], t[14;16]) (N=137), 10% had del(17) (N=69) and 34% had 1q amplification (1q21) (N=247).
Danish: 19% havde højrisiko cytogenetiske abnormiteter (del[17], t[4;14], t[14;16]) N = 137), 10% havde del(17) (N = 69), og 34% havde 1q amplifikation (1q21) (N = 247).
English: Non-clinical safety pharmacology studies both in vitro (on hERG channels) and in vivo (in telemetered dogs following single oral administration) demonstrated no effects of ixazomib on cardiovascular or respiratory functions at AUC more than 8-fold higher than the clinical value.
Danish: Ikke-kliniske farmakologiske sikkerhedsstudier, både in vitro (på hERG-kanaler) og in vivo (på telemetriovervågede hunde efter en enkelt oral indgivelse) viste ingen indvirkning af ixazomib på kardiovaskulære og respiratoriske funktioner ved AUC på mere end 8 gange den kliniske værdi.
English: If the capsule breaks, clean up the powder, taking care that it does not cause dust in the air.
Danish: Hvis kapslen går i stykker, skal du tørre pulveret op og passe på, at det ikke hvirvles op i luften.
English: If you forget to take NINLARO
Danish: Hvis du glemmer at tage NINLARO
English: Gastrointestinal toxicities
Danish: Gastrointestinal toksicitet
English: Other Grade 3 or 4 non-haematological toxicities
Danish: Andre ikke-hæmatologiske toksiciteter Andre grad 3 eller 4 ikke-hæmatologiske toksiciteter
English: Treatment for multiple myeloma involves killing myeloma cells and reducing the symptoms of the disease.
Danish: Behandling af myelomatose skal slå myelomcellerne ihjel og reducere sygdommens symptomer.
English: Duration of Response§, months Median
Danish: Responsvarighed§, måneder Median
English: Additionally, tell a doctor immediately if you notice any of these following rare side effects which may affect up to 1 in 1,000 people:
Danish: Fortæl det også straks til en læge, hvis du bemærker nogen af følgende s jældne bivirkninger, som kan forekomme hos op til 1 ud af 1.000 personer:
English: Animal toxicology and/or pharmacology
Danish: Toksikologiske og/eller farmakologiske studier hos dyr
English: Metabolism by multiple CYP enzymes and non-CYP proteins is expected to be the major clearance mechanism for ixazomib.
Danish: Metabolisering via flere CYP-enzymer og ikke-CYP-proteiner forventes at være den vigtigste clearancemekanisme for ixazomib.
English: A randomised, double-blind, placebo-controlled Phase 3 study was conducted in China (N=115) with a similar study design and eligibility criteria.
Danish: Et randomiseret, dobbeltblindet, placebokontrolleret fase 3-studie blev gennemførtudført i Kina (N = 115) med samme studiedesign og egnethedskriterier.
English: Ixazomib was positive in an in vitro clastogenicity test in human peripheral blood lymphocytes.
Danish: Ixazomib var positiv i en in vitro klastogenicitetstest i humane perifere blodlymfocytter.
English: Unchanged ixazomib accounted for < 3.5% of the administered dose recovered in urine.
Danish: Uomdannet ixazomib udgjorde < 3,5% af den indgivne dosis, der blev genfundet i urinen.
English: Therefore, the weight of evidence indicates that ixazomib is not considered to present a genotoxic risk.
Danish: Evidensen vurderes følgelig at indikere, at ixazomib ikke repræsenterer en genotoksisk risiko.
English: Posterior reversible encephalopathy syndrome (PRES) has occurred in patients receiving ixazomib.
Danish: Posteriort reversibelt encefalopati-syndrom (PRES) er forekommet hos patienter, der fik ixazomib.
English: = intake of medicinal product
Danish:  = Indtagelse af lægemidlet
English: • Platelet count should be ≥ 75,000/mm3
Danish: • Trombocyttal skal være ≥ 75.000/mm3
English: There were no effects due to ixazomib treatment on male or female reproductive organs in studies up to 6-months duration in rats and up to 9-months duration in dogs.
Danish: Ixazomibbehandling havde ingen indvirkning på hanlige eller hunlige forplantningsorganer i studier af op til 6 måneders varighed hos rotter og af op til 9 måneders varighed hos hunde.
English: Ixazomib is not expected to produce drug-drug interactions via CYP inhibition or induction.
Danish: Ixazomib forventes ikke at forårsage lægemiddelinteraktioner via CYP-hæmning eller -induktion.
English: The safety and efficacy of ixazomib in children below 18 years of age have not been established.
Danish: Ixazomibs sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Women should avoid becoming pregnant while being treated with ixazomib.
Danish: Kvinder skal undgå at blive gravide, mens de er i behandling med ixazomib.
English: Approximately 2-fold accumulation in AUC was observed with weekly oral dosing on Day 15.
Danish: Ved ugentlig oral dosering blev der dag 15 observeret ca. 2-fold akkumulering i AUC.
English: Ixazomib should be taken at approximately the same time on days 1, 8, and 15 of each treatment cycle at least 1 hour before or at least 2 hours after food (see section 5.2).
Danish: Ixazomib skal tages på omtrent samme tidspunkt dag 1, 8 og 15 i hver behandlingscyklus og mindst 1 time før eller 2 timer efter indtagelse af føde (se pkt.
English: Quality of life as assessed by global health scores (EORTC QLQ-C30 and MY-20) was maintained during treatment and was similar in both treatment regimens in the Phase 3 study (C16010).
Danish: Livskvaliteten, vurderet på grundlag af score for overordnet helbredsstatus (EORTC QLQ-C30 og MY-20), blev bevaret under behandlingen og var sammenlignelig i de to grupper i fase 3-studiet (C16010).
English: Do not drive or operate machines if you have these side effects.
Danish: Undgå at køre motorkøretøj og betjene maskiner, hvis du får disse bivirkninger.
English: Tell your doctor or pharmacist straight away if you notice any of these following very common serious side effects which may affect more than 1 in 10 people:
Danish: Fortæl det straks til din læge eller på apoteket, hvis du får nogen af følgende alvorlige meget almindelige bivirkninger, som kan forekomme hos flere end 1 ud af 10 personer:
English: Ixazomib Lenalidomide
Danish: Ixazomib Lenalidomid
English: These are structures inside the cell that digest proteins and are important for cell survival.
Danish: Proteasomer er strukturer inde i cellen, der nedbryder proteiner, og er vigtige for cellens overlevelse.
English: Take the medicine pack with you.
Danish: Medbring emballagen til lægemidlet.
English: The most commonly reported reaction was peripheral sensory neuropathy (16% and 12% in the ixazomib and placebo regimen, respectively).
Danish: Den hyppigst rapporterede bivirkning var perifer sensorisk neuropati (16% og 12% i henholdsvis ixazomib- og placebogruppen).
English:  Daily  Daily  Daily Dexamethasone 
Danish:  Dagligt  Dagligt  Dagligt Dexamethason 
English: If you are a woman of childbearing potential or a man who can father a child, you must use effective contraception during and for 90 days after treatment.
Danish: Hvis du er en kvinde i den fødedygtige alder eller en mand, der kan blive far til et barn, skal du benytte sikker prævention under behandlingen og i mindst 90 dage efter, behandlingen er afsluttet.
English: Less than 1% of patients in both regimens had a platelet count ≤ 5,000/mm3 during treatment.
Danish: I begge grupper havde under 1% af patienterne trombocyttal ≤ 5.000/mm3 under behandlingen.
English: • Absolute neutrophil count should be ≥ 1,000/mm3
Danish: • Det absolutte neutrofiltal skal være ≥ 1.000/mm3
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR WALLET
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER TIL MAPPE
English: Ninety three percent of patients had an ECOG performance status of 0-1 and 12% had baseline ISS stage III disease (N=90).
Danish: 93% af patienterne havde ECOG-performancestatus 0-1, og 12% havde ISS-stadie III ved baseline (N = 90).
English: Many of the patients enrolled in the study had advanced disease with Durie-Salmon Stage III (69%) at initial diagnosis and a treatment history of receiving at least 2 prior therapies (60%) and being thalidomide refractory (63%).
Danish: Mange af de patienter, der var inkluderet i forsøget, havde fremskreden sygdom med Durie-Salmon stadie III (69%) ved den initialt stillede diagnose og en behandlingshistorik med mindst to foregående behandlinger (60%) samt status som thalidomidrefraktær (63%).
English: • changes in vision, changes in mental status, or seizures (posterior reversible encephalopathy syndrome)
Danish: • synsforstyrrelser, ændringer i mental tilstand eller krampeanfald (posteriort reversibelt encefalopati-syndrom)
English: Day 8 Days 9 to 14
Danish: Dag 8 Dag 9 til 14
English: Do not use this medicine after the expiry date which is stated on the blister, wallet and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisteren, blistermappen og pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Serious adverse reactions reported in ≥ 2% of patients included thrombocytopenia (2%) and diarrhoea (2%).
Danish: Alvorlige bivirkninger er rapporteret hos ≥ 2% af patienterne og omfattede trombocytopeni (2%) og diarré (2%).
English: Ixazomib is not dialyzable and, therefore, can be administered without regard to the timing of dialysis (see section 5.2).
Danish: ixazomib er ikke dialyserbart og kan derfor gives uden hensyntagen til tidsplanen for dialyse (se pkt.
English: Because myeloma cells produce a lot of proteins, blocking the action of proteasomes can kill the cancerous cells.
Danish: Da myelomceller danner mange proteiner, kan blokering af proteasomers virkning slå kræftcellerne ihjel.
English: The majority of target organ findings demonstrated partial to full recovery following discontinuation of treatment, with the exception of neuronal findings in the lumbar dorsal root ganglion and dorsal column.
Danish: De fleste fund for målorganerne viste delvis til fuld restitution efter seponering med undtagelse af neuronale fund i den lumbale dorsale rodganglie og rygsøjlen.
English: In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines: carbamazepine, phenytoin, rifampicin and St. John's wort (Hypericum perforatum).
Danish: Husk især at fortælle lægen, apotekspersonalet eller sygeplejersken, hvis du tager et af følgende lægemidler: carbamazepin, phenytoin, rifampicin og perikon (Hypericum perforatum).
English: NINLARO  Lenalidomide
Danish: NINLARO  Lenalidomid
English: In the 9-month study (10 cycles) in dogs orally administered with a dosing schedule mimicking the clinical regimen (28-day cycle), microscopic neuronal effects were generally minimal in nature and only observed at 0.2 mg/kg (4 mg/m2).
Danish: I 9-måneders studiet (10 cyklusser), hvor hunde fik lægemidlet oralt efter et doseringsskema, der efterlignede det kliniske regime (28-dages cyklus), var de mikroskopiske neuronale fund generelt minimale og blev kun observeret ved 0,2 mg/kg (4 mg/m2).
English: Blood and lymphatic system disorders Thrombocytopenia*
Danish: Blod og lymfesystem Trombocytopeni*
English: Ask your pharmacist how to throw away medicines you no longer use.
Danish: Spørg apoteketspersonalet, hvordan du skal bortskaffe medicinrester.
English: Very common side effects may affect more than 1 in 10 people:
Danish: Meget almindelige bivirkninger, som kan forekomme hos flere end 1 ud af 10 personer:
English: Outside of the Phase 3 study, the following serious adverse reactions were rarely reported: acute febrile neutrophilic dermatosis (Sweet's syndrome), Stevens-Johnson syndrome, transverse myelitis, posterior reversible encephalopathy syndrome, tumour lysis syndrome and thrombotic thrombocytopenic purpura.
Danish: Uden for fase 3-studiet blev følgende alvorlige bivirkninger rapporteret sjældent: akut febril neutrofil dermatose (Sweets syndrom), Stevens-Johnsons syndrom, transversel myelitis, posteriort reversibelt encefalopati-syndrom, tumorlysesyndrom og trombotisk trombocytopenisk purpura.
English: Ixazomib is not a substrate of BCRP, MRP2 or hepatic OATPs.
Danish: Ixazomib er ikke substrat for BCRP, MRP2 eller hepatiske OATP'er.
English: The combination of ixazomib and lenalidomide demonstrated synergistic cytotoxic effects in multiple myeloma cell lines.
Danish: Kombinationen af ixazomib og lenalidomid udviste synergistiske cytotoksiske virkninger i myelomatosecellelinjer.
English: Antiviral prophylaxis should be considered in patients being treated with ixazomib to decrease the risk of herpes zoster reactivation.
Danish: Antiviral profylakse skal overvejes hos patienter, der behandles med ixazomib, for at reducere risikoen for reaktivering af herpes zoster.
English: Patients received one to three prior therapies (median of 1) including prior treatment with bortezomib (69%), carfilzomib (<1%), thalidomide (45%), lenalidomide (12%), melphalan (81%).
Danish: Patienterne havde gennemgået et til tre tidligere behandlingsregimer (median på 1), herunder med bortezomib (69%), carfilzomib (< 1%), thalidomid (45%), lenalidomid (12%) og melphalan (81%).
English: • low levels of potassium in the blood (hypokalaemia)
Danish: • nedsat indhold af kalium i blodet (hypokaliæmi).
English: A planned interim analysis for overall survival (OS) at a median follow up of 23 months was conducted with 35% of the required number of deaths for final OS analysis in the ITT population; there were 81 deaths in the ixazomib regimen and 90 deaths in the placebo regimen.
Danish: En planlagt interim-analyse af samlet overlevelse (OS) efter en median opfølgning på 23 måneder blev udført med 35% af det krævede antal dødsfald til den endelige OS-analyse i ITT-populationen: der var 81 dødsfald i ixazomib-gruppen og 90 dødsfald i placebogruppen.
English: Its active substance ixazomib works by blocking the action of proteasomes.
Danish: Det aktive stof ixazomib virker ved at blokere proteasomers virkning.
English: When ixazomib is administered together with dexamethasone, which is known to be a weak to moderate inducer of CYP3A4 as well as other enzymes and transporters, the risk for reduced efficacy of oral contraceptives needs to be considered.
Danish: Når ixazomib anvendes i kombination med dexamethason, en svag til moderat induktor af CYP3A4 og andre enzymer og transportører, skal risikoen for reduceret effektivitet af orale kontraceptiva tages i betragtning.