FrancophonIA/ELRC3.0 huggingface dataset:
English: Response rates are summarised in Table 9.
Danish: Responsrate er opsummeret i tabel 9.
English: • difficulty falling or staying asleep (insomnia)
Danish: • besvær med at falde i søvn eller blive ved med at sove (søvnløshed)
English: Panobinostat is a P-gp substrate.
Danish: Panobinostat er et P-gp-substrat.
English: Its fraction in the erythrocyte is 0.60 in vitro, independent of the concentration.
Danish: Fraktionen af det i erytrocytter er 0,60 in vitro uanset koncentration.
English: Panobinostat represented 6 to 9% of the drug-related exposure in plasma.
Danish: Panobinostat repræsenterede 6 til 9 % af den lægemiddelrelaterede eksponering i plasma.
English: Modification of the treatment dose and/or schedule may be required based on individual tolerability.
Danish: Det kan være nødvendigt at ændre behandlingsdosis og/eller -planen baseret på individuel tolerabilitet.
English: • dry mouth or changes to your sense of taste
Danish: • tør mund eller ændringer i din smagssans
English: 15.7% of patients were exposed to study treatment for ≥48 weeks.
Danish: 15,7 % af patienterne blev eksponeret for forsøgsbehandling i ≥48 uger.
English: One Farydak blister = 3 weeks = 1 cycle
Danish: En Farydak blisterpakning = 3 uger = 1 cyklus
English: Neutropenia was frequently reported on the basis of laboratory findings determined during the study (all grades: 75%).
Danish: Neutropeni Neutropeni blev indberettet hyppigt på baggrund af laboratorieresultater bestemt under forsøget (alle grader: 75 %).
English: Farydak is not to be used in children or adolescents under 18 years of age.
Danish: Farydak må ikke bruges til børn eller unge under 18 år.
English: Treatment discontinuation due to infections was reported in 5% of patients.
Danish: Behandlingsseponering som følge af infektioner blev indberettet hos 5 % af patienterne.
English: Day 10 Day 11 Day 12 Day 13 Day 14 Day 15 Day 16 Day 17 Day 18 Day 19 Day 20 Day 21
Danish: Dag 10 Dag 11 Dag 12 Dag 13 Dag 14 Dag 15 Dag 16 Dag 17 Dag 18 Dag 19 Dag 20 Dag 21
English: Your doctor will tell you exactly how many capsules of Farydak you need to take.
Danish: Din læge vil fortælle dig nøjagtigt, hvor mange kapsler med Farydak du skal tage.
English: Ask your doctor or pharmacist if you are not sure whether your medicine is one of the medicines listed above.
Danish: Spørg lægen eller apotekspersonalet, hvis du er usikker på, om din medicin er et af de lægemidler, der er nævnt ovenfor.
English: Overall survival (OS) was the key secondary endpoint.
Danish: Det vigtigste sekundære endepunkt var overall survival (OS).
English: STOP taking Farydak and seek medical help immediately if you experience any of the following:
Danish: STOP med at tage Farydak og søg straks lægehjælp, hvis du oplever noget af følgende:
English: In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from available data).
Danish: Derudover er den tilsvarende frekvenskategori for hver bivirkning baseret på følgende konvention (CIOMS III): meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Hard capsule 6 capsules 12 capsules 24 capsules
Danish: Hård kapsel 6 kapsler 12 kapsler 24 kapsler
English: Patients had to be exposed to an IMiD (lenalidomide or thalidomide).
Danish: Patienterne skulle være eksponeret for et IMiD (lenalidomid eller thalidomid).
English: If it is used during pregnancy or if the patient becomes pregnant while using it, the patient must be informed of the potential risk to the foetus.
Danish: Hvis det anvendes under graviditet, eller hvis patienten bliver gravid, mens hun tager det, skal patienten informeres om den potentielle risiko for fosteret.
English: Treatment was administered for a maximum of 16 cycles (see Tables 1 and 2).
Danish: Behandlingen blev administreret i højst 16 cyklusser (se tabel 1 og 2).
English: Farydak should be used with caution in patients who already have or who are at significant risk of developing QTc prolongation.
Danish: Farydak skal anvendes med forsigtighed hos patienter, der allerede har eller har betydelig risiko for at udvikle forlængelse af QTc.
English: The median number of prior therapies was 1.0.
Danish: Det mediane antal tidligere behandlinger var 1,0.
English: Patients achieved an ORR (≥PR (partial response)) of 34.5% and 52.7% (≥MR (minimal response)).
Danish: Patienterne opnåede en ORR (≥PR (partielt respons)) på 34,5 % og 52,7 % (≥ MR (minimalt respons)).
English: It is recommended that patients with clinical benefit continue the treatment for eight additional cycles.
Danish: Det anbefales, at patienter med klinisk gavnlig virkning, fortsætter behandlingen i yderligere otte cyklusser.
English: 95% CI [0.31; 0.72] Logrank p-value=0.0003
Danish: 95 % CI: [0,31; 0,72] Logrank p-værdi=0,0003
English: PVC/PCTFE/Alu blister containing 6 capsules.
Danish: PVC/PCTFE/Alu-blister med 6 kapsler.
English: Magnesium stearate Mannitol
Danish: Magnesiumstearat Mannitol
English: Contraception for women and men
Danish: Prævention til kvinder og mænd
English: Cycle:Day
Danish: Cyklus:Dag
English: Patients should be advised to contact their physician to discuss the use of any laxative product.
Danish: Patienterne skal rådes til at kontakte deres læge for at drøfte brugen af eventuelle laksantia.
English: Monitoring recommendations
Danish: Anbefalinger vedrørende monitorering
English: Farydak blocks the growth of cancerous plasma cells and reduces the number of cancer cells.
Danish: Farydak blokerer kræftplasmacellernes vækst og nedsætter antallet af kræftceller.
English: o Patient information leaflet o A patient compliance card
Danish: o Indlægsseddel o Et patient compliance-kort
English: Prior to launch of Farydak in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Før lancering af Farydak i hvert medlemsland, skal indehaveren af markedsføringstilladelsen være enige om indholdet og formatet af uddannelsesprogrammet, inklusive kommunikationsmedier, distribution af behandlingsmetoder og enhver anden karakter af programmet med de nationale kompetente myndigheder.
English: Caucasians comprised 65.0% of the study population, Asians 30.2% and blacks 2.9%.
Danish: Kaukasider udgjorde 65,0 % af forsøgspopulationen, asiater 30,2 % og sorte 2,9 %.
English: This could potentially lead to slightly decreased exposure to sensitive CYP3A4 substrates.
Danish: Dette kan potentielt føre til let nedsat eksponering af sensitive CYP3A4 substrater.
English: If a dose is missed, it can be taken up to 12 hours after the specified dose time.
Danish: Hvis en dosis springes over, kan den tages op til 12 timer efter det angivne doseringstidspunkt.
English: Discontinuation due to adverse events, regardless of causality, was observed in 36.2% of patients.
Danish: Seponering som følge af bivirkninger uanset causalitet blev observeret hos 36,2 % af patienterne.
English: If vomiting occurs the patient should not take an additional dose, but should take the next usual prescribed dose.
Danish: Hvis der forekommer opkastning, må patienten ikke tage en yderligere dosis, men skal tage den næste ordinerede dosis som sædvanligt.
English: Most newly occurring severe neutropenia was grade 3 (28%), with considerably fewer cases of grade 4 (6.6%).
Danish: De fleste tilfælde af nyopstået neutropeni var af grad 3 (28 %), med væsentligt færre tilfælde af grad 4 (6,6 %).
English: Patients were heavily pre-treated and had received multiple prior regimens (median: 4; range: 2-11).
Danish: Patienterne havde modtaget massiv forudgående behandling og havde fået flere forudgående regimer (median: 4; spredning: 2-11).
English: Farydak metabolism is through both non-CYP and CYP mediated routes.
Danish: Farydak metaboliseres både gennem ikke-CYP- og CYP-medierede veje.
English: These are to: - check how well your liver is working (by measuring your blood levels of bilirubin and transaminase, which are substances made by the liver).
Danish: Dette gøres for at: - undersøge hvor godt din lever fungerer (ved at måle blodets indhold af bilirubin og transaminase, som er stoffer, der dannes i leveren).
English: The absolute oral bioavailability of panobinostat was approximately 21%.
Danish: Panobinostats absolutte orale biotilgængelighed var ca. 21 %.
English: If you have to vomit after you swallow the Farydak capsules, do not take any more capsules until your next scheduled dose.
Danish: Hvis du skal kaste op, efter at du har taget Farydak, må du ikke tage flere kapsler, før din næste planlagte dosis.
English: ECOG performance status was 0-1 in 93% of patients.
Danish: ECOG-performancestatus var 0-1 hos 93 % af patienterne.
English: If you accidentally take more capsules than you should, or if someone else accidentally takes your medicine, talk to a doctor or go to a hospital straight away.
Danish: Hvis du ved et uheld har taget flere kapsler end du skulle, eller hvis nogen ved et uheld har taget din medicin, skal du/I straks kontakte en læge eller tage på hospitalet.
English: A total of 53.0% of patients were male.
Danish: I alt 53,0 % af patienterne var mænd.
English: Limited experience with overdose has been reported during clinical studies.
Danish: Der er indberettet begrænsede erfaringer med overdosering i kliniske forsøg.
English: More than one third (35.8%) of the patients were relapsed and refractory to prior treatment.
Danish: Over en tredjedel (35,8 %) af patienterne var recidive og behandlingsrefraktære over for den forudgående behandling.
English: • with long QT syndrome.
Danish: • langt QT syndrom.
English: Since food did not alter overall bioavailability (AUC), panobinostat can be administered regardless of food in cancer patients.
Danish: Da mad ikke ændrede den samlede biotilgængelighed (AUC), kan panobinostat administreres uden hensyntagen til mad hos cancerpatienter.
English: Apparent panobinostat renal clearance (CLR/F) was found to range from 2.4 to 5.5 l/h.
Danish: Panobinostats tilsyneladende renale clearance (CLR/F) blev målt til mellem 2,4 og 5,5 l/h.
English: The median time to response was 1.4 months and the median duration of response was 6.0 months.
Danish: Den mediane tid til respons var 1,4 måneder, og responsets mediane varighed var 6,0 måneder.
English: Panobinostat is moderately (approximately 90%) bound to human plasma proteins.
Danish: Panobinostat bindes i moderat grad (ca. 90 %) til humane plasmaproteiner.
English: Five patients (1.3%) died of events associated with haemorrhage.
Danish: Fem patienter (1,3%) døde af tilfælde forbundet med hæmoragi.
English: Farydak should be administered orally once daily on scheduled days only, at the same time each day.
Danish: Farydak skal administreres oralt én gang dagligt og kun på de planlagte dage på samme tidspunkt hver dag.
English: The majority of patients had received prior transplant (63.6%).
Danish: Størstedelen af patienterne havde tidligere fået foretaget stamcelletransplantation (63,6 %).
English: Farydak treatment should not be initiated in patients with active infections.
Danish: Behandling med Farydak bør ikke indledes hos patienter med aktive infektioner.
English: QTc prolongation
Danish: QTc-forlængelse
English: Carcinogenicity studies have not been performed with panobinostat.
Danish: Der er ikke udført karcinogenitetsstudier med panobinostat.
English: Your heart rate will also be checked using a machine that measures the electrical activity of the heart (called an ECG).
Danish: Din hjertefrekvens vil også blive undersøgt med et apparat, der måler hjertets elektriske aktivitet (EKG).
English: Keep taking Farydak for as long as your doctor tells you.
Danish: Fortsæt med at tage Farydak, så længe din læge siger, at du skal gøre det.
English: - check the amounts of certain cells of your blood (white blood cells, red blood cells, platelets).
Danish: - undersøge mængden af bestemte celler i dit blod (hvide blodlegemer, røde blodlegemer,
English: In the phase III clinical study 162 out of 387 patients were aged 65 years or over.
Danish: I det kliniske fase III-forsøg var 162 ud af 387 patienter 65 år gamle eller ældre.
English: Demographics and baseline disease characteristics were balanced and comparable between the study arms.
Danish: Demografi og sygdomskarakteristika ved baseline var afbalancerede og sammenlignelige mellem forsøgsarmene.
English: - Based on the recommendation of your doctor, the dose of Farydak is either 20 mg or 15 mg or
Danish: - Baseret på anbefalinger fra din læge, vil Farydak-dosis være enten 20 mg eller 15 mg eller
English: Platelet counts should be monitored at least twice a week until ≥50 x 109/l.
Danish: Trombocyttal bør monitoreres mindst to gange ugentligt indtil ≥50 x 109/l.
English: After oral administration, panobinostat pharmacokinetics appear to be linear in the dose range 10-30 mg, but AUC increases less than proportionally with dose at higher doses.
Danish: Efter oral administration synes panobinostats farmakokinetik at være lineær i dosisområdet 10-30 mg, men AUC stiger mindre end proportionalt med dosis ved højere doser.
English: Avoid panobinostat use in patients who are taking CYP2D6 substrates with a narrow therapeutic index (including, but not limited to, pimozide).
Danish: Undgå brug af panobinostat hos patienter, der tager CYP2D6 substrater med et snævert terapeutisk indeks (inklusive, men ikke begrænset til pimozid).
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX42
Danish: Farmakoterapeutisk klassifikation: Andre antineoplastiske midler, ATC-kode: L01XX42
English: Only 0.3% of the patients were discontinued from the treatment due to neutropenia.
Danish: Kun 0,3 % af patienterne fik seponeret behandlingen på grund af neutropeni.
English: Microcrystalline cellulose Pregelatinised starch (maize)
Danish: Mikrokrystallinsk cellulose Prægelatiniseret stivelse (majs)
English: Additional analysis suggests that the risk of QTc prolongation does not increase over time (see section 4.2).
Danish: Yderligere analyse tyder på, at risikoen for QTc-forlængelse ikke øges over tid (se pkt.
English: If your partner is able to become pregnant she should also use a highly effective method of contraception during your treatment and for six months after.
Danish: Hvis din partner er i stand til at blive gravid, skal hun også bruge en yderst effektiv præventionsmetode under behandlingen og i seks måneder derefter.
English: Unchanged panobinostat accounted for <2.5% of the dose in urine and <3.5% of the dose in faeces.
Danish: Uændret panobinostat udgjorde <2,5 % af dosis i urinen og <3,5 % af dosis i fæces.
English: The primary endpoint was progression free survival (PFS) as per modified European Bone Marrow Transplant Group (mEBMT) criteria and as assessed by the investigator.
Danish: Det primære endepunkt var progressionsfri overlevelse (PFS) ifølge kriterierne fra European Bone Marrow Transplant Group (mEBMT) og ifølge investigators vurdering.
English: • being unable to control the flow of urine because of loss of or weak bladder control
Danish: • manglende evne til at holde på vandet på grund af tab af eller svag blærekontrol
English: There are no clinical studies on the use of Farydak in pregnant patients.
Danish: Der foreligger ingen kliniske studier af brug af Farydak hos gravide kvinder.
English: The median age was 63 years, range 28-84; 42.1% of patients were older than 65 years.
Danish: Medianalderen var 63 år, spredning 28-84; 42,1 % af patienterne var ældre end 65 år.
English: Blood and lymphatic system disorders a
Danish: Blod og lymfesystem a
English: Take the pack and this leaflet with you.
Danish: Tag pakningen og denne indlægsseddel med.
English: Then continue taking the medicine as normal.
Danish: Fortsæt derefter med at tage medicinen, som du plejer.
English: This is a long-term treatment with 16 cycles (48 weeks).
Danish: Dette er en langtidsbehandling med 16 cyklusser (48 uger).
English: Panobinostat is rapidly and almost completely absorbed with Tmax reached within 2 hours of oral administration in patients with advanced cancer.
Danish: Panobinostat absorberes hurtigt og næsten fuldstændigt, og Tmax opnås inden for 2 timer efter oral administration hos patienter med fremskreden cancer.
English: The recommended dose of bortezomib is 1.3 mg/m2 given as an injection.
Danish: Den anbefalede dosis bortezomib er 1,3 mg/m2 givet som injektion.
English: More than 1 dose omitted
Danish: Mere end 1 dosis udeladt
English: Electrocardiographic changes
Danish: Elektrokardiografiske forandringer
English: The total duration of treatment is up to 16 cycles (48 weeks).
Danish: Behandlingens samlede varighed er op til 16 cyklusser (48 uger).
English: Time (months)
Danish: Tid (måneder)
English: The following pack sizes are available: blister packs containing 6, 12 or 24 capsules.
Danish: Følgende pakningsstørrelser markedsføres: Blisterpakninger med 6, 12 eller 24 kapsler.
English: Relapsed or refractory multiple myeloma patients are at risk of infections.
Danish: Patienter med recidiverende eller behandlingsrefraktær myelomatose har risiko for infektion.
English: • reduced level of calcium in the blood, sometimes leading to cramps
Danish: • nedsat mængde kalcium i blodet, som sommetider kan give krampe
English: Figure 1 Median platelet counts over time (Study D2308, Safety set, cycles 1-8)
Danish: Figur 1 Median trombocyttal over tid (Studie D2308, sikkerhed, cyklus 1-8)
English: Physicians and patients should be aware of the increased risk of infection with panobinostat.
Danish: Læger og patienter skal være opmærksomme på den øgede infektionsrisiko med panobinostat.
English: The recommended dose of dexamethasone is 20 mg taken orally on a full stomach.
Danish: Den anbefalede dosis dexamethason er 20 mg taget oralt på fuld mave.
English: - if you have a bacterial, viral or fungal infection.
Danish: - hvis du har en bakterie-, virus- eller svampeinfektion.
English: While many patients developed neutropenia, febrile neutropenia only occurred in a fraction of treated patients (1.0%, both for CTC all grades and for grades 3 and 4).
Danish: Mens mange patienter udviklede neutropeni, forekom febril neutropeni kun hos en brøkdel af de behandlede patienter (1,0 %, både for alle CTC-grader og for grad 3 og 4).
English: If results of liver function tests show abnormalities according to the NCI-CTEP classification, dose adjustments for patients with mild and moderate hepatic impairment are recommended and the patient should be followed until values return to normal or pre-treatment levels.
Danish: Hvis resultaterne af leverfunktionstest viser abnormiteter ifølge NCI-CTEP-klassificeringen, anbefales det at justere dosis for patienter med mild og moderat nedsat leverfunktion, og patienten skal følges, indtil værdierne vender tilbage til de normale eller til niveauerne før behandling.
English: • Patient information pack
Danish: • Patient-informationspakke
English: Farydak should not be taken during pregnancy, unless the potential benefit to the mother is greater than the potential risk to the baby.
Danish: Farydak må ikke tages under graviditet, medmindre den mulige fordel for moren er større end den mulige risiko for barnet.
English: Liver function should be monitored prior to treatment and regularly during treatment.
Danish: Leverfunktionen bør monitoreres før behandlingen og regelmæssigt under behandlingen.
English: The effects of panobinostat on labour and post-natal growth and maturation were not evaluated in animal studies.
Danish: Panobinostats virkninger på fødslen og den postnatale udvikling og modning er ikke blevet evalueret i dyreforsøg.
English: • The patient compliance card shall contain instructions on the following key messages: o How to become familiar with the compliance card: this section provides a general overview of the compliance card and its purpose.
Danish: • Patient compliance-kort skal indeholde inskruktioner med følgende hovedbudskaber: o Hvordan man bliver fortrolig med compliance-kortet: dette afsnit giver et generelt overblik over compliance-kortet og dets formål.
English: • If QT prolongation is unresolved within 7 days, treatment should be discontinued.
Danish: • Hvis QT-forlængelsen ikke bedres i løbet af 7 dage, skal behandlingen seponeres.
English: Panobinostat shows more cytotoxicity towards tumour cells compared to normal cells.
Danish: Panobinostat viser mere cytotoksisitet over for tumorceller sammenlignet med normale celler.
English: The median PFS (95% CI) was 12.0 months (10.3, 12.9) and 8.1 months (7.6, 9.2), respectively.
Danish: Median PFS (95 % CI) var henholdsvis 12,0 måneder (10,3; 12,9) og 8,1 måneder (7,6; 9,2).
English: Efficacy results are summarised in Table 8 and the Kaplan-Meier curves for PFS are provided in Figure 2.
Danish: Effektresultaterne er opsummeret i tabel 8 og Kaplan-Meier graferne for PFS er vist i figur 2.
English: Amongst the patients who died of haemorrhage, one patient had thrombocytopenia grade 4, three patients had thrombocytopenia grade 3 and 1 patient had thrombocytopenia grade 1.
Danish: Blandt de patienter, der døde af hæmoragi, havde en patient trombocytopeni grad 4, tre patienter havde trombocytopeni grad 3 og 1 patient havde trombocytopeni grad 1.
English: If a dose reduction is required, the dose of panobinostat should be reduced by decrements of 5 mg (i.e. from 20 mg to 15 mg or from 15 mg to 10 mg).
Danish: Hvis dosisreduktion er nødvendigt, bør panobinostat nedsættes trinvis med 5 mg (dvs. fra 20 mg til 15 mg eller fra 15 mg til 10 mg).
English: An increase in early resorptions was observed in female rats (doses ≥30 mg/kg).
Danish: Der blev observeret en stigning i tidlig resorption hos hunrotter (dosis ≥ 30 mg/kg).
English: The incidence of deaths not related to study indication was 8.8% in patients ≥65 years of age compared to 5.4% in patients <65 years of age.
Danish: Forekomsten af dødsfald uden sammenhæng med forsøgets indikation var 8,8 % hos patienter ≥65 år sammenlignet med 5,4 % hos patienter <65 år.
English: Repeated dose toxicity studies
Danish: Toksicitetsstudier med gentagne doser
English: Thrombocytopenia rarely leads to treatment discontinuation (1.6% of patients).
Danish: Trombocytopeni medfører sjældent behandlingsseponering (1,6 % af patienterne).
English: Oxidative metabolism of panobinostat played a less prominent role, with approximately 40% of the dose eliminated by this pathway.
Danish: Oxidativ metabolisme af panobinostat spillede en mindre fremtrædende rolle, idet ca. 40 % af dosis blev elimineret via denne signalvej.
English: Farydak is used to treat adult patients with a rare type of blood cancer called multiple myeloma.
Danish: Farydak bruges til at behandle voksne patienter med en sjælden type blodkræft, som hedder myelomatose.
English: Discontinuation of treatment may be considered if neutropenia does not improve despite the dose modifications and/or despite the addition of granulocyte colony stimulating factor therapy according to local medical practice and treatment guidelines, and/or in the event of severe secondary infections.
Danish: Seponering af behandlingen kan overvejes, hvis neutropenien ikke bedres trods dosisjusteringerne og/eller trods tilføjelse af behandling med granulocyt-kolonistimulerende faktor i overensstemmelse med lokal lægelig praksis og lokale behandlingsretningslinjer og/eller i tilfælde af svære sekundære infektioner.
English: The parent substance is deemed to be responsible for the overall pharmacological activity of panobinostat.
Danish: Moderstoffet menes at være ansvarlig for den overordnede farmakologiske aktivitet af panobinostat.
English: Farydak may have a minor influence on the ability to drive and use machines.
Danish: Farydak kan have en minimal påvirkning på evnen til at køre bil eller betjene maskiner.