FrancophonIA/ELRC3.0 huggingface dataset:
English: In the preclinical models tested so far, intact pRb was required for ribociclib activity.
Danish: I de prækliniske modeller, der hidtil er testet, var intakt pRb nødvendig for ribociclib-aktivitet.
English: It is used in combination with an aromatase inhibitor or fulvestrant, which are used as hormonal anticancer therapies.
Danish: Det bruges i kombination med en aromatasehæmmer eller fulvestrant, der anvendes som hormonelle behandlinger mod kræft.
English: Reproductive toxicity/Fertility
Danish: Reproduktionstoksicitet/fertilitet
English: Kisqali may increase or decrease your blood levels of some other medicines.
Danish: Kisqali kan muligvis hæve eller sænke niveauet af visse andre lægemidler i blodet.
English: Infections and infestations Infections
Danish: Infektioner og parasitære sygdomme Infektioner
English: Table 6 Adverse drug reactions observed in the three phase III clinical studies
Danish: Tabel 6 Bivirkninger observeret i de tre kliniske fase III-studier
English: Patients in MONALEESA-7 had not received prior endocrine treatment in the advanced breast cancer setting.
Danish: Patienterne i MONALEESA-7 havde ikke tidligere fået endokrin behandling mod fremskreden brystkræft.
English: It may change how Kisqali is processed in your body and may increase the amount of Kisqali in your bloodstream.
Danish: Det kan ændre, hvordan Kisqali omsættes i kroppen og kan øge mængden af Kisqali i blodbanen.
English: This analysis is limited by the small sample sizes for most of the dose cohorts with a majority of the data coming from the 600 mg dose cohort.
Danish: Denne analyse er begrænset af de små prøvestørrelser for de fleste af dosis-kohorterne, hvor størstedelen af data kom fra 600 mg dosis-kohorten.
English: ANC = absolute neutrophil count; LLN = lower limit of normal
Danish: ANC = absolut neutrofiltal, LLN = nedre grænse i normalområdet.
English: Patients were not allowed to cross over from placebo to Kisqali during the study or after disease progression.
Danish: Det var ikke muligt for patienterne at krydse over fra placebo til Kisqali under studiet eller efter sygdomsprogression.
English: Dysgeusia, dyspepsia
Danish: Dysgeusi, dyspepsi
English: In case of QTcF prolongation during treatment, more frequent ECG monitoring is recommended.
Danish: I tilfælde af, at QTcF-forlængelse opstår under behandlingen anbefales hyppigere EKG-monitorering.
English: Medicinal products that elevate gastric pH
Danish: Lægemidler, der hæver gastrisk pH
English: pravastatin or rosuvastatin.
Danish: pitavastatin, pravastatin eller rosuvastatin.
English: The primary efficacy results were supported by PFS results based on blinded independent central radiological assessment.
Danish: De primære effektresultater blev understøttet af PFS-resultater baseret på blindet, uafhængig central radiologisk vurdering.
English: Updated analysis (02 January 2017 cut-off) Kisqali plus letrozole
Danish: Opdateret analyse (skæringsdato 2. januar 2017) Kisqali plus letrozol
English: No overall differences in safety or effectiveness of Kisqali were observed between these patients and younger patients (see section 4.2).
Danish: Der blev ikke observeret nogen overordnede forskelle i Kisqalis sikkerhed eller effektivitet mellem disse patienter og yngre patienter (se pkt.
English: In the event of an overdose, symptoms such as nausea and vomiting may occur.
Danish: I tilfælde af overdosering kan der opstå symptomer som fx kvalme og opkastning.
English: Febrile neutropenia was reported in about 1.4% of patients exposed to Kisqali in the phase III studies.
Danish: Febril neutropeni blev rapporteret hos ca. 1,4 % af patienter, der blev eksponeret for Kisqali i fase III-studierne.
English: Monitoring during your treatment with Kisqali
Danish: Overvågning under din behandling med Kisqali
English: The cyclin D-CDK4/6 complex regulates cell cycle progression through phosphorylation of the retinoblastoma protein (pRb).
Danish: Cyclin D-CDK4-/6komplekset regulerer cellecyklusprogression gennem fosforylering af retinoblastomproteinet (pRb).
English: Kisqali may have minor influence on the ability to drive and use machines.
Danish: Kisqali kan i ubetydelig grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Ask your doctor or pharmacist if you are not sure if your medicine is one of the medicines listed above.
Danish: Spørg lægen eller apotekspersonalet, hvis du er i tvivl om dit lægemiddel er et af de ovennævnte lægemidler.
English: Binding of ribociclib to human plasma proteins in vitro was approximately 70% and was independent of concentration (10 to 10000 ng/ml).
Danish: Ribociclibs binding til humane plasmaproteiner in vitro var ca. 70 % og var uafhængig af koncentrationen (10 til 10.000 ng/ml).
English: A series of pre-specified subgroup PFS analyses was performed based on prognostic factors and baseline characteristics to investigate the internal consistency of treatment effect.
Danish: En række forud specificerede PFS-analyser af subgrupper blev foretaget på baggrund af prognostiske faktorer og baseline-karakteristika med henblik på at undersøge den interne overensstemmelse af behandlingseffekt.
English: Kisqali should be used together with 2.5 mg letrozole or another aromatase inhibitor or with 500 mg fulvestrant.
Danish: Kisqali skal anvendes sammen med 2,5 mg letrozol eller en anden aromatasehæmmer eller med 500 mg fulvestrant.
English: Updated analysis (30 November 2018 cut-off)
Danish: Opdateret analyse (30. november 2018 som skæringsdato)
English: Refer to the SmPC for the co-administered aromatase inhibitor, fulvestrant or LHRH agonist for dose modification guidelines and other relevant safety information in the event of toxicity.
Danish: Der henvises til SmPC'et for den samtidigt administrerede aromatasehæmmer, fulvestrant eller LHRH-agonist for vejledning vedrørende dosisjustering og anden relevant sikkerhedsinformation i tilfælde af toksicitet.
English: The analysis suggested that ribociclib causes concentration-dependent increases in the QTc interval.
Danish: Analysen tydede på, at ribociclib forårsager koncentrationsafhængige stigninger i QTc-intervallet.
English: The exposure to ribociclib was higher in milk than in plasma.
Danish: Eksponeringen for ribociclib var højere i mælk end i plasma.
English: Your doctor will discuss with you the potential risks of taking Kisqali during pregnancy.
Danish: Lægen vil tale med dig om de mulige risici, der er ved at tage Kisqali under graviditet.
English: Among the patients who had grade 2, 3 or 4 neutropenia, the median time to onset was 16 days, for those patients who had an event.
Danish: Blandt patienter, der havde grad 2, 3 eller 4 neutropeni, var mediantiden til fremkomst 16 dage for de patienter, som oplevede en hændelse.
English: The global health status/QoL data showed no relevant difference between the Kisqali plus letrozole arm and the placebo plus letrozole arm.
Danish: De samlede data vedrørende helbredsstatus/livskvalitet (QoL) viste ingen relevant forskel mellem Kisqali plus letrozol-armen og placebo plus letrozol-armen.
English: Hypocalcaemia, hypokalaemia, hypophosphataemia
Danish: Hypocalcæmi, hypokaliæmi, hypofosfatæmi
English: • Fever (pyrexia)
Danish: • Feber (pyreksi)
English: These kinases are activated upon binding to D-cyclins and play a crucial role in signalling pathways which lead to cell cycle progression and cellular proliferation.
Danish: Disse kinaser aktiveres, når de bindes til D-cycliner, og spiller en afgørende rolle i signaleringsveje, der fører til cellecyklusprogression og celleproliferation.
English: Do not take Kisqali: - if you are allergic to ribociclib, peanut, soya or any of the other ingredients of this medicine
Danish: Tag ikke Kisqali: - hvis du er allergisk over for ribociclib, peanuts, soja eller et af de øvrige indholdsstoffer i
English: • Everolimus, used for several types of cancer and tuberous sclerosis (also used to prevent the rejection of an organ transplant).
Danish: • Everolimus, der anvendes til behandling af flere former for kræft og tuberøs sklerose (anvendes også til at forebygge afstødning af et transplanteret organ).
English: The absolute bioavailability of ribociclib is not known.
Danish: Den absolutte biotilgængelighed af ribociclib kendes ikke.
English: Stopping your treatment with Kisqali may cause your condition to get worse.
Danish: Stop af behandling med Kisqali kan forværre din tilstand.
English: Patients with measurable disease
Danish: Patienter med målbar sygdom
English: Treatment of pre- and perimenopausal women with the approved Kisqali combinations should also include an LHRH agonist in accordance with local clinical practice.
Danish: Behandling af præ- eller perimenopausale kvinder med de godkendte kombinationer med Kisqali skal også omfatte en LHRH-agonist i overensstemmelse med lokal klinisk praksis.
English: Log-rank p-value = 0.00973
Danish: Log-rank p-værdi = 0,00973
English: Enter weekdays starting with the 1st day of treatment.
Danish: Start med første behandlingsdag.
English: General supportive care should be initiated in all cases of overdosage as necessary.
Danish: I alle tilfælde af overdosering bør der iværksættes generel understøttende behandling efter behov.
English: Kisqali contains soya lecithin If you are allergic to peanut or soya, do not use this medicine.
Danish: Kisqali indeholder sojalecithin Hvis du er allergisk over for peanuts eller soja, skal du ikke tage dette lægemiddel.
English: Progression free survival a
Danish: Progressionsfri overlevelse a
English: 44.2% patients were older than 65 years, including 69 patients older than 75 years.
Danish: 44,2 % af patienterne var ældre end 65 år, herunder 69 patienter ældre end 75 år.
English: Table 11 MONALEESA-7 - Efficacy results (OS)
Danish: Tabel 11 MONALEESA-7 - Effektresultater (OS)
English: In rats, reduced foetal weights accompanied by skeletal changes considered to be transitory and/or related to the lower foetal weights were noted.
Danish: I rotter blev der bemærket reduceret fostervægt ledsaget af skeletale forandringer, som blev anset for at være forbigående og/eller relateret til lavere fostervægt.
English: 54.7% of patients receiving ribociclib plus letrozole were estimated to be progression-free at 24 months compared with 35.9% in the placebo plus letrozole arm.
Danish: 54,7 % af patienter, der fik ribociclib plus letrozol, blev estimeret at være progressionsfrie ved 24 måneder sammenlignet med 35,9 % i placebo plus letrozol-armen.
English: Appropriate monitoring of serum electrolytes (including potassium, calcium, phosphorus and magnesium) should be performed before initiating treatment, at the beginning of the first 6 cycles and then as clinically indicated.
Danish: Der skal foretages relevant monitorering af serumelektrolytter (herunder kalium, calcium, fosfor og magnesium) før opstart af behandling, i starten af de første 6 serier og herefter ved klinisk behov.
English: Demographics and baseline disease characteristics were balanced and comparable between study arms.
Danish: Demografi og sygdomskarakteristika ved baseline var ligeligt fordelt og sammenlignelige mellem forsøgsarme.
English: Of all patients who received Kisqali in studies MONALEESA-2 and MONALEESA-3, representative proportions of patients were ≥65 years and ≥75 years of age (see section 5.1).
Danish: Ud af alle patienter, der fik Kisqali i studierne MONALEESA-2 og MONALEESA-3, var repræsentative andele af patienterne ≥65 år og ≥75 år (se pkt.
English: If any of the following apply to you, tell your doctor or pharmacist before taking Kisqali:
Danish: Hvis noget af følgende gælder for dig, skal du fortælle det til lægen eller apotekspersonalet, før du tager Kisqali:
English: Do not change the Kisqali dose or schedule without talking to your doctor.
Danish: Du må ikke ændre dosen af Kisqali eller de planlagte doseringstidspunkter/-dage uden at have talt med lægen.
English: Food effect
Danish: Effekt af fødevarer
English: PVC/PCTFE (polyvinylchloride/polychlorotrifluoroethylene) or PA/alu/PVC (polyamide/aluminium/polyvinylchloride) blisters containing 14 or 21 film-coated tablets.
Danish: Blistere af PVC/PCTFE (polyvinylchlorid/polychlorotrifluoroethylen) eller PA/alu/PVC (polyamid/aluminium/polyvinylchlorid), der indeholdende 14 eller 21 filmovertrukne tabletter.
English: Each film-coated tablet contains 0.344 mg soya lecithin.
Danish: Hver filmovertrukket tablet indeholder 0,344 mg sojalecithin.
English: Grade 4* (ANC <500/mm
Danish: Grad 4* (ANC <500/mm
English: Do not take a tablet that is broken, cracked or otherwise damaged.
Danish: Tag ikke en tablet, der er knækket, revnet eller på anden måde beskadiget.
English: Initiate appropriate medical therapy and monitor as clinically indicated.
Danish: Indled passende medicinsk behandling og monitorér efter klinisk behov.
English: Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Danish: Inden for hver systemorganklasse er bivirkningerne ordnet efter hyppighed med den hyppigste bivirkning først.
English: 46.7% of patients were of age 65 years and older, including 13.8% patients of age 75 years and older.
Danish: 46,7 % af patienterne var 65 år og ældre, herunder 13,8 % patienter på 75 år og ældre.
English: If the patient vomits after taking the dose or misses a dose, an additional dose should not be taken that day.
Danish: Hvis patienten kaster op efter at have taget dosen eller glemmer dosen, må der ikke tages en ny dosis den pågældende dag.
English: Infections: urinary tract infections, respiratory tract infections, gastroenteritis, sepsis (<1%).
Danish: Infektioner: urinvejsinfektioner, luftvejsinfektioner, gastroenteritis, sepsis (<1 %).
English: Combined elevations in AST and/or ALT together with total bilirubin increase, in the absence of cholestasis
Danish: Kombinerede stigninger i ASATog/eller ALATniveauet sammen med stigning i totalbilirubinniveauet, ved fravær af cholestase
English: Caution should be used in patients with severe renal impairment with close monitoring for signs of toxicity.
Danish: Der skal udvises forsigtighed hos patienter med svært nedsat nyrefunktion med tæt monitorering for tegn på toksicitet.
English: Patients enrolled in this study had a median age of 44 years (range 25 to 58) and 27.7% of patients were younger than 40 years old.
Danish: Patienterne, der var inkluderet i dette studie, havde en medianalder på 44 år (interval: 25 til 58), og 27,7 % af patienterne var yngre end 40 år.
English: Erythema, dry skin, vitiligo
Danish: Erytem, tør hud, vitiligo
English: Data on differences in pharmacokinetics due to race are too limited to draw conclusions.
Danish: Mængden af data vedrørende racens indflydelse på ændring i farmakokinetik er for begrænset til at drage konklusioner.
English: Cmax and AUClast for LEQ803 (a prominent metabolite of ribociclib accounting for less than 10% of parent exposure) decreased by 96% and 98%, respectively.
Danish: Cmax og AUClast for LEQ803 (en fremtrædende metabolit af ribociclib, der tegner for mindre end 10 % af den samlede eksponering) blev reduceret med henholdsvis 96 % og 98 %.
English: Adverse drug reactions from the phase III clinical studies (Table 6) are listed by MedDRA system organ class.
Danish: Bivirkningerne fra de kliniske fase III-studier (tabel 6) er angivet i henhold til MedDRAsystemorganklasse.
English: Tables 2, 3, 4 and 5 summarise recommendations for dose interruption, reduction or discontinuation of Kisqali in the management of specific ADRs.
Danish: I tabel 2, 3, 4 og 5 er der en oversigt over anbefalinger til afbrydelse, dosisreduktion eller seponering af Kisqali ved håndtering af specifikke bivirkninger.
English: Kisqali tablets should be swallowed whole (tablets should not be chewed, crushed or split before swallowing).
Danish: Kisqali-tabletterne skal synkes hele (tabletterne må ikke tygges, knuses eller deles, før de synkes).
English: Kisqali contains the active substance ribociclib, which belongs to a group of medicines called cyclin-dependent kinase (CDK) inhibitors.
Danish: Kisqali indeholder det aktive stof ribociclib, der tilhører en gruppe af lægemidler, som kaldes cyclinafhængige kinase (CDK)-hæmmere.
English: Hepatobiliary toxicity
Danish: Hepatobiliær toksicitet
English: • Dry eyes
Danish: • Tørre øjne
English: A more mature update of overall survival data (30 November 2018 cut-off) is provided in Table 11 and Figures 4 and 5.
Danish: Opdaterede data for samlet overlevelse (30. november 2018 som skæringsdato) er vist i Tabel 11 og Figur 4 og 5.
English: Data in subjects with ESRD are limited (n=3) but indicate a similar or somewhat larger increase in ribociclib exposure compared to subjects with severe renal impairment.
Danish: Data fra forsøgspersoner med ESRD er begrænsede (n=3), men tyder på en lignende eller lidt højere stigning i ribociclib-eksponering sammenlignet med forsøgspersoner med svært nedsat nyrefunktion.
English: Patients with prior (neo)adjuvant therapy with anastrozole or letrozole must have completed this therapy at least 12 months before study randomisation.
Danish: Patienter, der havde fået (neo)adjuverende behandling med anastrozol eller letrozol, skulle have afsluttet denne behandling mindst 12 måneder før studierandomisering.
English: Updated results for overall response and clinical benefit rates are displayed in Table 8.
Danish: Opdaterede resultater for samlede responsrater og rater for klinisk fordel er vist i tabel 8.
English: Kisqali Dose
Danish: Kisqali Dosis
English: * Excluding neutropenia, hepatotoxicity and QT interval prolongation.
Danish: *Med undtagelse af neutropeni, hepatotoksicitet og forlænget QT-interval.
English: Log rank p-value = 4.10*10^(-7)
Danish: Log rank p-værdi = 4,10*10^(-7)
English: ** Grading according to CTCAE Version 4.03 (CTCAE = Common Terminology Criteria for Adverse Events)
Danish: ** Sværhedsgrad i henhold til CTCAE version 4.03 (CTCAE = Common Terminology Criteria for Adverse Events).
English: Patients who are hypersensitive to peanut or soya should not take Kisqali (see section 4.3).
Danish: Patienter, der er allergiske over for peanuts eller soja, bør ikke tage Kisqali (se pkt.
English: 20.7% of patients had bone-only disease and 59.0% of patients had visceral disease.
Danish: 20,7 % af patienterne havde knoglesygdom alene, og 59,0 % af patienterne havde visceral sygdom.
English: Baseline grade <2:
Danish: Sværhedsgrad ved baseline <2:
English: • Tamoxifen, another medicine for the treatment of breast cancer.
Danish: • Tamoxifen, som er et andet lægemiddel til behandling af brystkræft.
English: Elderly No dose adjustment is required in patients over 65 years of age (see section 5.2).
Danish: Ældre Dosisjustering er ikke nødvendig hos patienter over 65 år (se pkt.
English: These effects can be linked to a direct anti-proliferative effects on the testicular germ cells resulting in atrophy of the seminiferous tubules.
Danish: Disse påvirkninger kan sammenkædes med en direkte antiproliferativ virkning på de testikulære kimceller, der resulterer i atrofi af sædkanalerne.
English: Compared to the fasted state, oral administration of a single 600 mg dose of ribociclib film-coated tablets with a high-fat, high-calorie meal had no effect on the rate and extent of absorption of ribociclib.
Danish: Sammenlignet med fastende tilstand havde oral administration af en enkelt 600 mg dosis ribociclib filmovertrukne tabletter sammen med et fedtholdigt og kalorierigt måltid ingen indvirkning på hastigheden og graden af absorption af ribociclib.
English: • Abnormal kidney blood test result (high level of creatinine in the blood)
Danish: • Unormale blodprøveresultater for nyretal (højt niveau af kreatinin i blodet)
English: Ribociclib was equally distributed between red blood cells and plasma with a mean in vivo blood-to-plasma ratio of 1.04.
Danish: Ribociclib blev jævnt fordelt mellem røde blodlegemer og plasma med et gennemsnitligt forhold mellem blod og plasma in vivo på 1,04.
English: Do not take this medicine if you notice any damage to the packaging or if there are any signs of tampering.
Danish: Tag ikke lægemidlet, hvis pakningen er beskadiget, eller hvis der er tegn på, at den har været åbnet.
English: You should not take Kisqali on days 22 to 28 of the cycle.
Danish: Du skal ikke tage Kisqali på dag 22 til 28 i serien.
English: Substances that may have plasma concentrations altered by Kisqali
Danish: Stoffer, hvis plasmakoncentration kan blive ændret af Kisqali
English: • Shortness of breath, difficulty breathing
Danish: • Åndenød, vejrtrækningsbesvær
English: Based on findings in animals, ribociclib can cause foetal harm when administered to a pregnant woman (see section 5.3).
Danish: På baggrund af fund i dyr kan ribociclib forårsage fosterskade, når det administreres til en gravid kvinde (se pkt.
English: 0.593 (0.480 to 0.732)
Danish: 0,593 (0,480 til 0,732)
English: The median follow-up time at the time of primary PFS analysis was 19.2 months.
Danish: Medianopfølgningstiden på tidspunktet for den primære PFS-analyse var 19,2 måneder.
English: Serial, triplicate ECGs were collected following a single dose and at steady state to evaluate the effect of ribociclib on the QTc interval in patients with advanced cancer.
Danish: Serier af tredobbelte EKG-optagelser blev foretaget efter en enkelt dosis og ved steady state for at vurdere indvirkningen af ribociclib på QTc-intervallet hos patienter med fremskreden kræft.
English: You should therefore be cautious when driving or using machines during your treatment with Kisqali.
Danish: Derfor skal du være forsigtig med at føre motorkøretøj eller betjene maskiner under din behandling med Kisqali.
English: A more mature update of efficacy data (02 January 2017 cut-off) is provided in Tables 7 and 8.
Danish: Mere opdaterede effektdata (skæringsdato den 2. januar 2017) fremgår af tabel 7 og 8.
English: The median follow-up time at the time of primary PFS analysis was 20.4 months.
Danish: Medianopfølgningstiden på tidspunktet for den primære PFS-analyse var 20,4 måneder.
English: No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh class A).
Danish: Dosisjustering er ikke nødvendig hos patienter med let nedsat leverfunktion (Child-Pugh klasse A).
English: In the phase III clinical studies, 83.2% (89/107) of grade 3 or 4 ALT or AST elevation events occurred within the first 6 months of treatment.
Danish: I de kliniske fase III-studier forekom der 83,2 % (89/107) hændelser med forhøjet ALAT- eller ASATniveau af grad 3 eller 4 inden for de første 6 måneders behandling.
English: • If you have or have had heart disorders or heart rhythm disorders, such as an irregular heartbeat, including a condition called prolonged QT syndrome (QT interval prolongation) or low levels of potassium, magnesium, calcium or phosphorus in your blood.
Danish: • Hvis du har eller har haft hjerteproblemer eller hjerterytmeforstyrrelser, fx uregelmæssige hjerteslag, herunder en tilstand, der kaldes langt QT-syndrom (forlænget QT-interval), eller lavt niveau af kalium, magnesium, calcium eller fosfor i blodet.
English: Kisqali is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Kisqali anbefales ikke under graviditet og hos fertile kvinder, der ikke anvender prævention.
English: Blood creatinine increased, electrocardiogram QT prolonged
Danish: Forhøjet niveau af blodkreatinin, forlænget QT-interval på elektrokardiogram
English: Women who have not reached menopause will also be treated with a medicine called a luteinising hormone releasing hormone (LHRH) agonist.
Danish: Kvinder, der endnu ikke er kommet i overgangsalderen, vil også blive behandlet med et lægemiddel, der kaldes en luteiniserende hormon-frigivende hormon (LHRH)-agonist.
English: In rabbits, there were adverse effects on embryo-foetal development as evidenced by increased incidences of foetal abnormalities (malformations and external, visceral and skeletal variants) and foetal growth (lower foetal weights).
Danish: I kaniner var der skadelige virkninger på den embryoføtale udvikling, hvilket kunne ses ved øgede forekomster af fosteranomalier (misdannelser og eksterne, viscerale og skeletale forandringer), og den føtale vækst (lavere fostervægt).