FrancophonIA/ELRC3.0 huggingface dataset:
English: Strong CYP3A inhibitors should not be started in patients who have already received a reduced dose of panobinostat due to adverse events.
Danish: Stærke CYP3A-hæmmere skal ikke opstartes hos patienter, der allerede modtager en nedsat dosis panobinostat på grund af bivirkninger.
English: Mild, moderate and severe renal impairment based on baseline urinary creatinine clearance did not increase the panobinostat plasma exposure in mild, moderate and severe groups.
Danish: Mild, moderat og svær nyreinsufficiens baseret på urinkreatininclearance ved baseline øgede ikke plasmaeksponeringen for panobinostat i grupperne mild, moderat og svær.
English: Out of the pre-specified subgroup of patients with prior treatment with bortezomib and an immunomodulatory agent (N=193), 76% of patients had received at least two prior regimens.
Danish: Ud fra den præspecificerede undergruppe af patienter, med forudgående behandling med bortezomib og en immunmodulator (N=193), har 76 % af patienterne modtaget mindst 2 behandlingsregimer forinden.
English: No pharmacokinetic data are available for patients with severe hepatic impairment.
Danish: Der foreligger ingen data om farmakokinetik hos patienter med svær leverinsufficiens.
English: Approximately 40% of panobinostat is metabolised through CYP3A4.
Danish: Ca. 40 % af panobinostat metaboliseres gennem CYP3A4.
English: For patients experiencing severe adverse drug reactions other than thrombocytopenia, gastrointestinal toxicity, neutropenia or QTc prolongation, the recommendation is the following:
Danish: For patienter, der oplever andre svære bivirkninger end trombocytopeni, gastrointestinal toksicitet, neutropeni eller QTc-forlængelse, er anbefalingen følgende:
English: Prostatic atrophy accompanied by reduced secretory granules, testicular degeneration, oligospermia and increased epididymal debris were observed in dogs at exposures corresponding to 0.41-0.69 of the human clinical AUC and not fully reversible after a 4 week recovery period.
Danish: Prostataatrofi ledsaget af nedsat sekretionsgranulat, testikulær degeneration, oligospermi og øget epididymis debris blev observeret hos hunde ved eksponering svarende til 0,41-0,69 af det humane kliniske AUC og var ikke fuldstændigt reversibelt efter en 4 ugers restitutionsperiode.
English: Due to the potential risk of death or malformation to the foetus, Farydak should not be taken during:
Danish: På grund af den potentielle risiko for død eller misdannelser af fosteret, bør Farydak ikke tages under:
English: • increased blood level of the waste product creatinine
Danish: • forhøjet mængde af affaldsproduktet kreatinin i blodet
English: Patients should be advised to contact their physician if severe gastrointestinal toxicity occurs and dose adjustment or discontinuation may be required (see section 4.4).
Danish: Patienter skal rådes til at kontakte deres læge, hvis der opstår svær gastrointestinal toksicitet, og dosisjustering eller seponering kan være nødvendigt (se pkt.
English: The median time to onset for grade 3 and 4 thrombocytopenia was one month and the median time to recovery was 12 days.
Danish: Mediantiden til start for grad 3 og 4 trombocytopeni var en måned, og mediantiden til bedring var 12 dage.
English: In particular tell your doctor or pharmacist if you are taking any of the following medicines: - medicines used to treat infections, including fungal infections (such as ketoconazole,
Danish: Du skal især fortælle det til din læge eller apotekspersonalet, hvis du tager et eller flere af følgende lægemidler: - medicin til behandling af infektioner, herunder svampeinfektioner (fx ketoconazol, itraconazol,
English: 1 dose omitted
Danish: 1 dosis udeladt
English: Never take a missed dose of Farydak on one of the “off” days when no Farydak dose is planned.
Danish: Du må aldrig tage en glemt dosis Farydak på en af de dage, hvor du ifølge planen ikke skal tage Farydak.
English: If you are a sexually active man, you should use condoms during treatment with Farydak.
Danish: Hvis du er en seksuelt aktiv mand, skal du bruge kondomer under behandlingen med Farydak.
English: Blood urea increased, glomerular filtration rate decreased, blood alkaline phosphatase increased, electrocardiogram QT prolonged, blood creatinine increased a, SGPT alanine transaminase (ALT) increased a, SGOT aspartate transaminase (AST) increased a a Frequency is based on laboratory values
Danish: Blodurea forhøjet, glomerulær filtrationsrate nedsat, blod-alkalisk fosfatase forhøjet, QT forlænget på elektrokardiogram, blodkreatinin forhøjet a, SGPT-alaninaminotransaminase (ALAT) forhøjet a, SGOTaspartataminotransaminase (ASAT) forhøjet a a Hyppigheden er baseret på laboratorieværdier
English: - If it is more than 12 hours since you should have taken the medicine, skip the missed dose.
Danish: - Hvis det er mere end 12 timer siden, du skulle have taget medicinen, skal du springe den glemte dosis over.
English: Due to the potential risk of death or malformation to the foetus, you should use the following methods of contraception while taking Farydak:
Danish: På grund af den potentielle risiko for død eller misdannelser af fosteret, bør du bruge følgende præventionsmetoder, mens du tager Farydak:
English: - if you are allergic to panobinostat or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for panobinostat eller et af de øvrige indholdsstoffer i dette lægemiddel
English: Chills, malaise
Danish: Kulderystelser, malaise
English: Consider dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 in subsequent cycles based on patient tolerability.
Danish: Overvej dosiseskalering til 1,0 mg/m2 eller yderligere dosisreduktion til 0,5 mg/m2 i efterfølgende cyklusser baseret på patient-tolerabilitet.
English: HDACs catalyse the removal of acetyl groups from the lysine residues of histones and some non-histone proteins.
Danish: HDAC´er katalyserer fjernelse af acetylgrupper fra lysinresterne af histoner og nogle ikke-histonproteiner.
English: If this is unavoidable, patients should be closely monitored and further dose reduction or discontinuation may be considered as clinically indicated (see section 4.5).
Danish: Hvis dette er uundgåeligt, skal patienter nøje monitoreres, og det bør overvejes at foretage yderligere dosisreduktion eller behandlingsophør, hvis det er klinisk indiceret (se pkt.
English: If continuous treatment with a strong CYP3A4 inhibitor is required, a dose escalation from 10 mg to 15 mg panobinostat may be considered based on patient tolerability.
Danish: Hvis det er nødvendigt med fortsat behandling med stærke CYP3A4-hæmmere, skal det overvejes at foretage dosiseskalering fra 10 mg til 15 mg panobinostat, baseret på patient-tolerabilitet.
English: Plasma exposure of panobinostat in patients aged 65 years or younger was similar to those older than 65 years in the pooling of single-agent panobinostat studies between the dose range of 10 mg and 80 mg.
Danish: Plasmaeksponeringen for panobinostat hos patienter på 65 år eller derunder var omtrent den samme som hos patienter på over 65 år ved pooling af forsøg med panobinostat som enkeltmiddel i dosisområdet 10 mg til 80 mg.
English: QTcF should be <480 msec prior to initiation of treatment with Farydak.
Danish: QTcF bør være <480 msek., før behandling med Farydak initieres.
English: • CTC grade 2 toxicity recurrence or CTC grades 3 and 4 - omit the dose until recovery to CTC
Danish: • Recidiv af CTC grad 2 toksicitet eller CTC grad 3 eller 4 - udelad dosis indtil forbedring til
English: Women using hormonal contraceptives should additionally use a barrier method of contraception.
Danish: Kvinder, der anvender hormonelle kontraceptiva skal derudover anvende en kontraceptiv barrieremetode.
English: Farydak 20 mg hard capsules panobinostat This medicine is subject to additional monitoring.
Danish: Farydak 20 mg hårde kapsler panobinostat Dette lægemiddel er underlagt supplerende overvågning.
English: Patients should be instructed to avoid star fruit, grapefruit, grapefruit juice, pomegranates and pomegranate juice, as these are known to inhibit cytochrome P450 3A enzymes and may increase the bioavailability of panobinostat.
Danish: Patienterne skal instrueres i at undgå carambol (stjernefrugt), grapefrugt, grapefrugtjuice, granatæbler og granatæblejuice, da disse vides at hæmme CYP3A-enzymer og kan øge biotilgængeligheden af panobinostat.
English: Modification of bortezomib starting dose
Danish: Ændring af startdosis af bortezomib
English: Permanently discontinue
Danish: Seponér permanent
English: • decreased appetite or weight loss
Danish: • nedsat appetit eller vægttab
English: Pneumonia fungal, hepatitis B, aspergillosis
Danish: Ikke almindelig Mykotisk pneumoni, hepatitis B, aspergillosis
English: Prophylactic anti-emetics (e.g. prochlorperazine) may be considered at the discretion of the physician and in accordance with local medical practice.
Danish: Profylaktiske antiemetika (f.eks. prochlorperazin) kan overvejes ifølge lægens skøn og i overensstemmelse med lokal lægelig praksis.
English: You should also do this for six months after you have stopped taking Farydak.
Danish: Det skal du også gøre i seks måneder, efter at du er holdt op med at tage Farydak.
English: In clinical studies in multiple myeloma, the exposure of panobinostat was decreased by approximately 20% by the concomitant use of dexamethasone, which is a dose-dependent mild/moderate CYP3A4 inducer.
Danish: I kliniske forsøg med myelomatose blev eksponeringen for panobinostat nedsat med ca. 20 % af samtidig brug af dexamethason, som er en dosisafhængig mild/moderat CYP3A4-inducer.
English: Tabulated list of adverse drug reactions from clinical studies
Danish: Tabuleret liste af lægemiddelbivirkninger fra kliniske forsøg.
English: Based on non-clinical findings, male fertility may be compromised by treatment with Farydak (see section 5.3).
Danish: Ud fra ikke-kliniske fund kan hanlig fertilitet kompromitteres af behandling med Farydak (se pkt.
English: Potential contributing factors may include prior history of chemotherapy, stem cell transplant, the nature of the disease and neutropenia or lymphopenia associated with Farydak treatment.
Danish: Potentielle bidragende faktorer kan omfatte tidligere kemoterapi i anamnesen, stamcelletransplantation, sygdommens beskaffenhed og neutropeni eller lymfopeni i forbindelse med Farydak-behandlingen.
English: In the event of grade 3 or 4 neutropenia, physicians should consider the use of growth factors (e.g.
Danish: I tilfælde af grad 3 eller 4 neutropeni skal lægerne overveje at anvende vækstfaktorer (f.eks. G-CSF) i overensstemmelse med lokale retningslinjer.
English: The thyroid changes including hormones in dogs (decrease triodothyronine (T3)) and rats (decrease in triodothyronine (T3), tetraiodothyronine (T4) (males) and thyroid stimulating hormone (TSH)) were observed at exposures corresponding to 0.07-2.2 of the human AUC observed clinically.
Danish: Der blev observeret thyroid-ændringer inklusive hormoner hos hunde (nedsat triodothyronin (T3)) og rotter (nedsat triodothyronin (T3), tetraiodothyronin (T4) (hanner) og thyroidstimulerende hormon (TSH)) ved eksponering svarende til 0,07-2,2 af det humane klinisk observerede AUC.
English: When Farydak is co-administered with sensitive CYP2D6 substrates (e.g. atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine and pimozide), dose titrate individual CYP2D6 substrates based on tolerability and frequently monitor patients for adverse reactions.
Danish: Når Farydak er administreret samtidig med sensitive CYP2D6-substrater (f.eks. atomoxetin, dextromethorphan, metoprolol, nebivolol, perphenazin og pimozid), skal der foretages individuel dosistitrering af CYP2D6-substrater baseret på tolerabilitet og patienten skal hyppigt monitoreres for bivirkninger.
English: Reduce bortezomib dose to 0.7 mg/m2 in the first treatment cycle.
Danish: Nedsæt bortezomibdosis til 0,7 mg/m2 i den første behandlingscyklus.
English: Hepatic dysfunction, primarily mild transient elevations in aminotransferases and total bilirubin, has been reported in patients during treatment with panobinostat.
Danish: Leverdysfunktion, primært milde forbigående forhøjelser af aminotransferaser og totalbilirubin er blevet indberettet hos patienter under behandling med panobinostat.
English: Septic shock, urinary tract infection, viral infection, oral herpes, Clostridium difficile colitis, otitis media, cellulitis, sepsis, gastroenteritis, lower respiratory tract infection, candidiasis
Danish: Septisk shock, urinvejsinfektion, virusinfektion, oral herpes, Clostridium difficile-colitis, otitis media, cellulitis, sepsis, gastroenteritis, nedre luftvejsinfektion, candidiasis
English: Medicines used to treat tuberculosis, such as rifabutin or rifampicin.
Danish: Medicin til behandling af tuberkulose, som fx rifambutin eller rifampicin.
English: CTC grade 3 or 4 thrombocytopenia occurred in 256 patients, with a median onset time of one month.
Danish: Trombocytopeni i CTC-grad 3 eller 4 forekom hos 256 patienter med en median debuttid på en måned.
English: Treatment of tumour cells with panobinostat resulted in a dose-dependent increase in acetylation of histones H3 and H4 both in vitro and in xenograft animal pre-clinical models, demonstrating target inhibition.
Danish: Behandling af tumorceller med panobinostat medførte en dosisafhængig stigning i acetyleringen af histonerne H3 og H4 både in vitro og i prækliniske dyre-xenograftmodeller, hvilket viser en hæmning af målet.
English: The European Medicines Agency has waived the obligation to submit the results of studies within all subsets of the paediatric population in multiple myeloma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Farydak i alle undergrupper af den pædiatriske population med myelomatose (se pkt.
English: A clinical study in cancer patients with impaired hepatic function showed that plasma exposure of panobinostat increased by 43% (1.4-fold) and 105% (2-fold) in patients with mild and moderate hepatic impairment, respectively.
Danish: Et klinisk forsøg med patienter med nedsat leverfunktion viste, at plasmaeksponeringen for panobinostat steg med 43 % (1,4 gange) og 105 % (2 gange) hos patienter med henholdsvis mild og moderat nedsat leverfunktion.
English: - if you notice any signs of a heart problem.
Danish: - hvis du bemærker et eller flere tegn på et hjerteproblem.
English: Concomitant administration of medicinal products that are known to cause QTc prolongation should be used with caution (see section 4.5).
Danish: Samtidig administration af lægemidler, der vides at forårsage QTc-forlængelse, skal anvendes med forsigtighed (se pkt.
English: Resume at the same dose
Danish: Genoptag med samme dosis
English: You should not eat star fruit, pomegranate or grapefruit or drink pomegranate or grapefruit juice during your treatment with Farydak, as they may increase the amount of the medicine that passes into your blood.
Danish: Brug af Farydak sammen med mad og drikke Du må ikke spise carambole (stjernefrugt), granatæble eller grapefrugt eller drikke granatæble eller grapefrugtjuice under behandlingen med Farydak, da det kan øge den mængde lægemiddel, der optages i blodet.
English: Modification of panobinostat starting dose
Danish: Ændring af startdosis af panobinostat
English: If you have any questions about how Farydak works or why you have been given it, ask your doctor or pharmacist.
Danish: Hvis du har spørgsmål til, hvordan Farydak virker, eller hvorfor du skal tage det, skal du spørge lægen eller apotekspersonalet.
English: Contents of the pack and other information What Farydak contains
Danish: Pakningsstørrelser og yderligere oplysninger Farydak indeholder:
English: The panobinostat fraction metabolised through CYP3A4 is approximately 40%.
Danish: Panobinostat-fraktionen, der metaboliseres gennem CYP3A4 er ca. 40 %.
English: What you need to know before you take Farydak Do not take Farydak:
Danish: Det skal du vide, før du begynder at tage Farydak Tag ikke Farydak:
English: - Do not chew or crush the capsules.
Danish: - Kapslerne må ikke tygges eller knuses.
English: If you are pregnant, think you might be pregnant or plan to become pregnant, ask your doctor for advice.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager Farydak.
English: Most patients with thrombocytopenia did not experience haemorrhage.
Danish: De fleste patienter med trombocytopeni oplevede ikke hæmoragi.
English: Abnormal values should be corrected as clinically indicated (see section 4.4).
Danish: Abnorme værdier bør korrigeres som klinisk indiceret (se pkt.
English: Paediatric population Panobinostat was not evaluated in multiple myeloma patients under 18 years of age.
Danish: Pædiatrisk population Panobinostat er ikke blevet evalueret hos patienter under 18 år med myelomatose.
English: No data is available that can be used to exclude the risk that panobinostat could be a weak inducer of the enzyme CYP3A4 in the gastrointestinal tract.
Danish: Der er ingen tilgængelige data, der kan bruges til at udelukke risikoen for, at panobinostat kan være en mild inducer af enzym CYP3A4 i mavetarmkanalen.
English: Decrease in blood cell count
Danish: Fald i blodcelletal
English: - medicines used to treat nausea and vomiting such as dolasetron, granisetron, ondansetron or tropisetron; these may also have an unwanted effect on the heart (QT prolongation).
Danish: - medicin til behandling af kvalme og opkastning, som fx dolasetron, granisetron, ondansetron eller tropisetron, da de også kan have en uønsket virkning på hjertet (QT-forlængelse).
English: The frequency category reflects the combination of all the medicinal products i.e. panobinostat + bortezomib + dexamethasone.
Danish: Frekvenskategorien afspejler kombinationen af alle lægemidlerne, dvs. panobinostat + bortezomib + dexamethason.
English: Panobinostat has a terminal elimination half-life of approximately 37 hours based on final parameters estimate in the population PK analysis.
Danish: Panobinostat har en halveringstid på ca. 37 timer baseret på endelige parameterestimater i den farmakokinetiske populationsanalyse.
English: It is recommended to monitor patients over 65 years of age more frequently, especially for thrombocytopenia and gastrointestinal toxicity (see sections 4.4 and
Danish: Det anbefales at monitorere patienter over 65 år hyppigere, særlig for trombocytopeni og gastrointestinal toksicitet (se pkt.
English: The recommended starting dose of panobinostat is 20 mg, taken orally once a day, on days 1, 3, 5, 8, 10 and 12 of a 21-day cycle.
Danish: Den anbefalede startdosis panobinostat er 20 mg indtaget oralt én gang dagligt på dag 1, 3, 5, 8, 10 og 12 i en 21-dages cyklus.
English: Patients with neutropenia are prone to infection, mostly upper respiratory tract infection or pneumonia.
Danish: Patienter med neutropeni er modtagelige over for infektioner og for det meste infektion i de øvre luftveje eller pneumoni.
English: Plasma exposure of panobinostat is not altered in cancer patients with mild to severe renal impairment.
Danish: Plasmaeksponeringen for panobinostat er ikke forandret hos cancerpatienter med mild til svær nyreinsufficiens.
English: quinidine, propafenone or sotalol.
Danish: procainamid, quinidin, propafenon og sotalol.
English: You must also use this for three months after you have stopped taking Farydak.
Danish: Det skal du også gøre i tre måneder efter, at du er holdt op med at tage Farydak.
English: In addition any abnormal serum potassium, magnesium or phosphorus values should be corrected prior to initiation of Farydak therapy (see section 4.4).
Danish: Desuden skal eventuelle abnorme kalium-, magnesium- eller fosforværdier korrigeres forud for initiering af behandling med Farydak (se pkt.
English: Panobinostat may increase the QTc interval (see section 4.4).
Danish: Panobinostat kan øge QTc-intervallet (se pkt.
English: The safety data of panobinostat have been assessed from a total of 451 patients with multiple myeloma treated with panobinostat in combination with bortezomib and dexamethasone and from a total of 278 patients treated with panobinostat as a single agent.
Danish: Sikkerhedsdata for panobinostat er blevet vurderet fra i alt 451 patienter med myelomatose, der blev behandlet med panobinostat i kombination med bortezomib og dexamethason, og fra i alt 278 patienter, der blev behandlet med panobinostat som enkeltmiddel.
English: Prophylactic anti-emetics should be administered at the discretion of the physician and in accordance with local medical practice (see section 4.4).
Danish: Profylaktiske antiemetika bør administreres efter lægens skøn og i overensstemmelse med lokal lægelig praksis (se pkt.
English: Talk to your doctor or pharmacist before taking Farydak: - if you have liver problems or have ever had liver disease.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Farydak: - hvis du har problemer med leveren eller nogensinde har haft en leversygdom.
English: Adverse reactions observed were consistent with the safety profile, with events primarily involving haematological and gastrointestinal disorders such as thrombocytopenia, pancytopenia, diarrhoea, nausea, vomiting and anorexia.
Danish: De observerede bivirkninger stemte overens med sikkerhedsprofilen, idet hændelserne primært drejede sig om hæmatologiske og gastrointestinale lidelser, såsom trombocytopeni, pancytopeni, diarré, kvalme, opkastning og anoreksi.
English: If you use a hormonal contraceptive you must also use a barrier method of contraception (such as condom or diaphragm) in addition.
Danish: Hvis du bruger prævention, der indeholder hormoner, skal du derudover også bruge en barrieremetode (som fx kondom eller spiral).
English: Very common Cough, dyspnoea Common
Danish: Meget almindelig Hoste, dyspnø Almindelig
English: Gastrointestinal toxicity
Danish: Gastrointestinal toksicitet
English: Grade 3-4 events more frequently observed in patients included the following (percentages presented for patients <65 years, 65-75 years and ≥75 years of age, respectively): thrombocytopenia (60%, 74%, and 91%), anaemia (16%, 17% and 29%), diarrhoea (21%, 27% and 47%), and fatigue (18%, 28% and 47%).
Danish: Hændelser af grad 3-4, som hyppigst blev observeret hos patienterne, var følgende (procentdele angivet for patienter på henholdsvis <65 år, 65-75 år og ≥75 år): trombocytopeni (60 %, 74 % og 91 %), anæmi (16 %, 17 % og 29 %), diarré (21 %, 27 % og 47 %) og træthed (18 %, 28 % og 47 %).
English: Censoring Times PAN+BTZ+Dex (n/N=44/73) PBO+BTZ+Dex (n/N=54/74)
Danish: Censurerede tider PAN+BTZ+Dex (n/N=44/73) PBO+BTZ+Dex (n/N=54/74)
English: ECG
Danish: EKG
English: Given panobinostat's cytostatic/cytotoxic mode of action, the potential risk to the foetus is high.
Danish: I betragtning af panobinostats cytostatiske/cytotoksiske virkning er den potentielle risiko for fosteret høj.
English: Table 5 Recommended dose modifications for neutropenia Neutropenia grade on day of treatment
Danish: Tabel 5 Anbefalede dosisjusteringer for neutropeni Graden af neutropeni på behandlingsdagen
English: Kaplan Meier medians PAN+BTZ+Dex: 12.48 months PBO+BTZ+Dex: 4.70 months
Danish: Kaplan Meier medianer PAN+BTZ+Dex: 12,48 måneder PBO+BTZ+Dex: 4,70 måneder
English: The most common adverse events (AEs) leading to treatment discontinuation were diarrhoea (4.5%), asthenia and fatigue (2.9% each) and pneumonia (1.3%).
Danish: De mest almindelige uønskede hændelser (bivirkninger), der medførte seponering af behandlingen, var diarré (4,5 %), asteni og træthed (begge 2,9 %) og pneumoni (1,3 %).
English: Regardless of events chronology, syncope was reported in 9% of patients with ST-T depression and 7.2% of patients with T wave change and 4.9% of patients with neither of these ECG abnormalities.
Danish: Uanset rækkefølgen af tilfældene, blev synkope rapporteret hos 9% af patienter med nedsat ST-T og 7,2% af patienter med T-bølge ændringer og 4,9% af patienter uden nogle af disse EKG-afvigelser.
English: If you forget to take Farydak
Danish: Hvis du har glemt at tage Farydak