FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, results from logistic regression analyses of data from patients in the phase 1 trial, suggest a relationship between systemic exposure (AUC) and occurrence of arterial thrombotic events.
Danish: Endvidere tyder resultater fra logistiske regressionsanalyser af data fra patienter i fase 1-forsøget på, at der er en forbindelse mellem systemisk eksponering (AUC) og forekomst af arterietrombosehændelser.
English: If dose reduction is undertaken, close monitoring of response is recommended.
Danish: Hvis dosis reduceres, anbefales nøje overvågning af respons.
English: Pancreatitis Recommended modifications for pancreatic adverse reactions are summarized in Table 2.
Danish: Pancreatitis Anbefalede modifikationer ved pancreatiske bivirkninger er opsummeret i tabel 2.
English: Ponatinib is highly bound (>99%) to plasma proteins in vitro.
Danish: Ponatinib bindes stærkt (> 99 %) til plasmaproteiner in vitro.
English: Most patients who ultimately reduced dose to 15 mg initially had their dose reduced to 30 mg for a period.
Danish: De fleste patienter, som ultimativt reducerede dosis til 15 mg, fik initialt reduceret deres dosis til 30 mg i en periode.
English: Seek medical attention immediately if you experience any of the following serious side effects.
Danish: Kontakt straks lægen, hvis du får nogen af følgende alvorlige bivirkninger.
English: BCR-ABL mutation detected at entry, n (%) None
Danish: BCR-ABL mutation konstateret ved indtræden, n (%) Ingen
English: Table 5 Demographics and disease characteristics
Danish: Tabel 5 Demografiske og sygdomsmæssige karakteristika
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 1 July 2013
Danish: Dato for første markedsføringstilladelse: 1. juli 2013
English: Isolated reports of unintentional overdose with Iclusig were reported in clinical trials.
Danish: Isolerede rapporter om utilsigtet overdosering med Iclusig blev rapporteret i kliniske forsøg.
English: All Patients (N=449)
Danish: Alle patienter (N=449)
English: The tablets should be swallowed whole.
Danish: Tabletterne skal sluges hele.
English: Patients with hepatic impairment may receive the recommended starting dose.
Danish: Patienter med nedsat leverfunktion kan få den anbefalede startdosis.
English: It is unknown whether ponatinib affects the effectiveness of systemic hormonal contraceptives.
Danish: Det er ukendt, om ponatinib påvirker effekten af systemiske hormonkontraceptiva.
English: Patients with severe or very severe hypertriglyceridemia should be appropriately managed to reduce the risk of pancreatitis.
Danish: Patienter med svær eller meget svær hypertriglyceridæmi bør gives relevant behandling for at reducere risikoen for pancreatitis.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Peroral anvendelse.
English: • Available data on the relationship between dose and risk of vascular occlusive events.
Danish: • Forhåndenværende data om forbindelsen mellem dosis og risiko for vaskulære okklusive bivirkninger.
English: For all patients, additional secondary efficacy endpoints included: confirmed MCyR, time to response, duration of response, progression free survival, and overall survival.
Danish: For alle patienters vedkommende var der inkluderet yderligere sekundære effektendepunkter: bekræftet MCyR, tid til respons, varighed af respons, progressionsfri overlevelse og generel overlevelse.
English: Dose interruption or reduction may be required.
Danish: Det kan være nødvendigt at afbryde eller reducere dosis.
English: If abnormal results from blood tests are received, a doctor should be contacted immediately.
Danish: Hvis resultaterne af blodprøver bliver unormale, skal en læge straks kontaktes.
English: Maintained MCyR
Danish: Opretholdt MCyR
English: Peak concentrations of ponatinib are observed approximately 4 hours after oral administration.
Danish: Ponatinibs maksimale koncentration observeres ca. 4 timer efter oral administration.
English: Recommendation for close monitoring of response if a dose reduction is undertaken.
Danish: Anbefaling om nøje overvågning af respons, hvis dosis reduceres.
English: OUTER CARTON AND BOTTLE LABEL
Danish: YDRE KARTON OG ETIKET TIL FLASKE
English: Frequency categories are very common (≥ 1/10), common (≥1/100 to < 1/10) and uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Danish: Hyppighed er inddelt i følgende kategorier: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1000); meget sjælden (< 1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The median dose intensity was 36 mg or, 80% of the expected 45 mg dose.
Danish: Den mediane dosis var 36 mg eller 80 % af den forventede dosis på 45 mg.
English: Total safety population N=449
Danish: Total sikkerhedspopulation N=449
English: Compared to patients < 65 years, older patients are more likely to experience adverse reactions.
Danish: I sammenligning med patienter < 65 år er det mere sandsynligt, at ældre patienter vil opleve bivirkninger.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Patient characteristics at entry
Danish: Patientkarakteristika ved indtræden
English: The tablets can be taken with or without food.
Danish: Tabletterne kan tages sammen med eller uden mad.
English: Therefore, caution should be recommended when driving or operating machines.
Danish: Det anbefales derfor at være forsigtig, når der føres motorkøretøj eller betjenes maskiner.
English: * of 427 patients reporting prior TKI therapy with dasatinib or nilotinib
Danish: * ud af 427 patienter der rapporterede tidligere TKI-behandling med dasatinib eller nilotinib
English: In the event of an overdose of Iclusig, the patient should be observed and appropriate supportive treatment given.
Danish: I tilfælde af en overdosis af Iclusig skal patienten observeres, og relevant understøttende behandling gives.
English: Most of these events occurred at the dose at which the patient achieved MCyR; fewer events occurred after dose reduction.
Danish: De fleste af disse hændelser forekom med den dosis, hvor patienten opnåede MCyR; færre hændelser forekom efter dosisreduktion.
English: Iclusig may be taken with or without food.
Danish: Iclusig kan tages sammen med eller uden mad.
English: Of the 449 patients in the clinical study of Iclusig, 155 (35%) were ≥ 65 years of age.
Danish: Ud af de 449 patienter i det kliniske studie med Iclusig var 155 (35 %) ≥ 65 år.
English: The blood/plasma ratio of ponatinib is 0.96.
Danish: Ponatinibs blod/plasma-forhold er 0,96.
English: (95% CI)
Danish: (95 % KI)
English: • The active substance is ponatinib.
Danish: • Aktivt stof: ponatinib.
English: All patients received 45 mg Iclusig once daily.
Danish: Alle patienter fik 45 mg Iclusig én gang dagligt.
English: • the number of blood platelets is reduced.
Danish: • antallet af blodplader reduceres
English: Swallow the tablets whole, with a glass of water.
Danish: Tabletterne sluges hele med et glas vand.
English: Myelosuppression was reported in patients with normal baseline laboratory values as well as in patients with pre-existing laboratory abnormalities.
Danish: Myelosuppression blev rapporteret hos patienter med normale baseline-laboratorieværdier såvel som hos patienter med forud eksisterende laboratorieanomalier.
English: Iclusig film-coated tablets are white, round and rounded on the upper and lower side.
Danish: Iclusig filmovertrukne tabletter er hvide, runde og afrundede på over- og undersiden.
English: Iclusig is associated with pancreatitis.
Danish: Iclusig er forbundet med pancreatitis.
English: Iclusig with food and drink Avoid grapefruit products such as grapefruit juice.
Danish: Undgå grapefrugtprodukter som f.eks. grapefrugtjuice.
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal derefter fremsende PSUR'er i overensstemmelse med kravene på listen over EU-referencedatoer (EURD-list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske web-portal for lægemidler.
English: The educational programme is aimed at providing information that helps identify patients eligible for therapy, understand how ponatinib should be used safely, the risks for patients and the important adverse reactions for which monitoring and dose adjustment are recommended.
Danish: Uddannelsesprogrammet har til formål at give information, som hjælper med at identificere patienter, der er egnede til behandling, og med at forstå, hvordan ponatinib anvendes sikkert, samt oplyse om risiciene for patienten og de vigtige bivirkninger, for hvilke der anbefales overvågning og dosisjustering.
English: In patients with CML and Ph+ ALL, changes in the DNA trigger a signal that tells the body to produce abnormal white blood cells.
Danish: Hos patienter med CML og Ph+ ALL udløser en ændring i DNA et signal, der fortæller kroppen, at den skal danne unormale hvide blodlegemer.
English: Hypertension may contribute to risk of arterial thrombotic events.
Danish: Hypertension kan øge risikoen for arterielle trombotiske hændelser.
English: The analysis of the dose intensity-safety relationship in the phase 2 trial concluded that after adjusting for covariates, the overall dose intensity is significantly associated with an increased risk of vascular occlusion, with an odds ratio of approximately 1.6 for each 15 mg increase.
Danish: Analyse af dosisstørrelses-sikkerhedsforholdet i fase 2-forsøget konkluderede, at efter justering for kovariater er den generelle dosisstørrelse i signifikant grad forbundet med en øget risiko for vaskulær okklusion med en odds ratio på ca. 1,6 for hver 15 mg stigning.
English: Other covariates that show a statistically significant association with the occurrence of vascular occlusive events in this analysis are medical history of ischemia and age.
Danish: Andre kovariater, som viser en statistisk signifikant forbindelse med forekomst af vaskulære okklusive hændelser i denne analyse, er iskæmi i anamnesen og alder.
English: INFORMATION IN BRAILLE Outer Carton:
Danish: INFORMATION I BRAILLE-SKRIFT Ydre karton:
English: • checks of the serum protein known as lipase A serum protein called lipase will be checked every 2 weeks for the first 2 months, then periodically.
Danish: • kontrol af serumproteinet, som kaldes lipase Et serumprotein, den såkaldte serumlipase, vil blive kontrolleret hver 2. uge i de første 2 måneder og derefter jævnligt.
English: The carboxylic acid and the N-desmethyl metabolite comprise 58% and 2% of the circulating levels of ponatinib, respectively.
Danish: Carboxylsyren og N-desmethylmetabolitten udgør hhv. 58 % og 2 % af de cirkulerende niveauer af ponatinib.
English: Patients should not crush or dissolve the tablets.
Danish: Patienterne må ikke knuse eller opløse tabletterne.
English: Single doses of 165 mg and an estimated 540 mg in two patients did not result in any clinically significant adverse reactions.
Danish: Enkelte doser på 165 mg og estimeret 540 mg hos to patienter medførte ikke nogle klinisk signifikante bivirkninger.
English: Bottles are packed within a cardboard box.
Danish: Flaskerne er pakket i en papæske.
English: • metabolic disorders caused by the break-down products of dying cancer cells
Danish: • stofskiftelidelser forårsaget af nedbrydningsprodukter fra døende kræftceller
English: • a severe side effect occurs, not affecting the blood
Danish: • der opstår en alvorlig bivirkning, som påvirker blodet
English: A complete blood count should be performed every 2 weeks for the first 3 months and then monthly or as clinically indicated.
Danish: Der bør tages fuldstændigt blodbillede hver 2. uge i de første 3 måneder og herefter hver måned, eller som klinisk indiceret.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use are described below.
Danish: Bivirkninger er ikke observeret i kliniske studier, men set hos dyr ved eksponeringsniveauer, som ligner kliniske eksponeringsniveauer og muligvis er relevante for den kliniske anvendelse, og disse er beskrevet nedenfor.
English: Treatment was interrupted, the events resolved, and Iclusig was restarted at 45 mg, once daily.
Danish: Behandlingen blev afbrudt, bivirkningerne forsvandt, og Iclusig blev startet igen med 45 mg én gang dagligt.
English: Most haemorrhagic events, but not all, occurred in patients with grade 3/4 thrombocytopenia.
Danish: De fleste hæmoragiske hændelser, men ikke alle, forekom hos patienter med grad 3/4 trombocytopeni.
English: Ponatinib is metabolized by CYP3A4.
Danish: Ponatinib metaboliseres af CYP3A4.
English: At the time of updated reporting with minimum follow-up for all ongoing patients of 27 months, the median durations of MCyR and MMR had not yet been reached.
Danish: På tidspunktet for den opdaterede rapportering med minimumopfølgning på 27 måneder for alle igangværende patienter var de mediane varigheder af MCyR og MMR endnu ikke nået.
English: You should take special care when driving and using machines as patients taking Iclusig may experience visual disturbance, dizziness, sleepiness, and tiredness.
Danish: Du bør udvise særlig forsigtighed, når du kører bil og betjener maskiner, da patienter, der tager Iclusig, kan opleve synsforstyrrelser, svimmelhed, søvnighed og træthed.
English: The risk of vascular occlusive events is likely to be dose-related.
Danish: Risikoen for vaskulære okklusive hændelser er sandsynligvis dosisrelateret.
English: The frequency of pancreatitis is greater in the first 2 months of use.
Danish: Pancreatitis opstår hyppigere i de første 2 måneder, lægemidlet anvendes.
English: Myelosuppression was generally reversible and usually managed by withholding Iclusig temporarily or reducing the dose (see section 4.2).
Danish: Myelosuppression var som regel reversibel og kunne oftest håndteres ved midlertidigt at seponere Iclusig eller reducere dosis (se pkt.
English: During Iclusig treatment, blood pressure should be monitored and managed at each clinic visit and hypertension should be treated to normal.
Danish: Under behandling med Iclusig skal blodtrykket overvåges og håndteres ved hvert besøg på klinikken, og hypertension skal behandles til normaltilstand.
English: • Instructions on management of adverse events based on monitoring and dose modifications or treatment withdrawal.
Danish: • Vejledning i håndtering af bivirkninger baseret på overvågning og dosismodifikation eller seponering.
English: Keep the canister in the bottle.
Danish: Lad dåsen blive i flasken.
English: Very common insomnia
Danish: Meget almindelig søvnløshed
English: Therefore, clinical medicinal product interactions are unlikely to occur as a result of ponatinib-mediated inhibition of substrates for these transporters.
Danish: Derfor er det usandsynligt, at der vil være kliniske lægemiddelinteraktioner som følge af ponatinib-medieret hæmning af substrater for disse transportører.
English: Ponatinib did not adversely affect important developmental parameters in the juvenile toxicity study.
Danish: Ponatinib påvirkede ikke vigtige udviklingsparametre i toksicitetsstudiet med unge dyr.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milespæl
English: If you forget to take Iclusig
Danish: Hvis du har glemt at tage Iclusig
English: Age Median, years (range) Gender, n (%) Male Race, n (%) Asian Black/African American White Other ECOG Performance Status, n (%) ECOG=0 or 1 Disease History Median time from diagnosis to first dose, years (range) Resistant to Prior TKI Therapy*, n (%) Prior TKI therapy- number of regimens, n (%)
Danish: Alder Median, år (interval) Køn, n (%) Mand Race, n (%) Asiatisk Sort/afrikansk-amerikansk Hvid Andet ECOG Performance Status n (%) ECOG=0 eller 1 Anamnese Median tid fra diagnose til første dosis, år (interval) Resistent over for tidligere TKI behandling*, n (%) Tidligere TKI behandling- antal regimer, n (%)
English: • carbamazepine: a medicine to treat epilepsy, euphoric/depressive stages and certain pain conditions.
Danish: • carbamazepin: et lægemiddel, der bruges til at behandle epilepsi, euforiske/depressive stadier og visse smertetilstande
English: • night sweats, increased sweating
Danish: • nattesved, øget svedafsondring
English: 6.6 Special precautions for disposal and other handling Disposal:
Danish: 6.6 Regler for bortskaffelse og anden håndtering Bortskaffelse:
English: If you stop taking Iclusig
Danish: Hvis du holder op med at tage Iclusig
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe opstilles bivirkninger efter, hvor alvorlige de er.
English: Grade 3 or 4 asymptomatic elevation of lipase/amylase (> 2.0 x IULN*) only
Danish: Kun grad 3 eller 4 asymptomatisk forhøjelse af lipase/amylase (> 2,0 x IULN*)
English: Discontinue Iclusig *IULN = institution upper limit of normal
Danish: Pausér Iclusig *IULN = laboratoriets øvre normalgrænse
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu
English: • uncomfortable pressure, fullness, squeezing or pain in the centre of the chest (Angina pectoris)
Danish: • ubehagelig trykken, følelse af opfyldning, klemmen eller smerte midt i brystet (angina pectoris)
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen og enhver efterfølgende opdatering af RMP.
English: • the number of white blood cells called neutrophils is reduced.
Danish: • antallet af hvide blodlegemer, de såkaldte neutrofiler, reduceres
English: • nerve disorder in the arms and/or legs (often causes numbness and pain in the hands and feet)
Danish: • nervelidelser i arme og/eller ben (som ofte forårsager følelsesløshed og smerter i hænder og fødder)
English: An integrated population pharmacokinetic analysis completed for ponatinib suggests that age may be predictive of variability for ponatinib apparent oral clearance (CL/F).
Danish: En integreret farmakokinetisk populationsanalyse udført med ponatinib tyder på, at alder kan være prædiktiv for variabilitet af ponatinibs åbenbare orale clearance (CL/F).
English: Table 10 shows these data for patients who achieved MCyR and MMR at 45 mg; similar data are available for patients who achieved MCyR and MMR at 30 mg.
Danish: Tabel 10 viser disse data for patienter, som opnåede MCyR og MMR med 45 mg; lignende data foreligger for patienter, som opnåede MCyR og MMR med 30 mg.
English: For every BCR-ABL mutation detected in more than one CP-CML patient at entry, a MCyR was achieved following treatment with Iclusig.
Danish: For hver BCR-ABL-mutation konstateret hos flere end én CP-CML-patient ved indtræden blev der opnået et MCyR efter behandling med Iclusig.
English: Formal studies of ponatinib with anti-clotting medicinal products have not been conducted.
Danish: Der er ikke udført formelle studier af ponatinib sammen med antikoagulerende lægemidler.
English: The Marketing Authorisation Holder shall ensure that in each Member State where ICLUSIG is marketed all physicians who are expected to prescribe ICLUSIG are provided with the Healthcare Professional
Danish: Indehaveren af markedsføringstilladelse skal sikre, at alle læger, der forventes at ordinere ICLUSIG, i hver enkelt medlemsstat, hvor ICLUSIG markedsføres, får udleveret en informationspakke til læger.
English: There is insufficient data available to make formal recommendations on dose reduction (in the absence of an adverse event) in patients with chronic phase (CP) CML patients who have achieved Major Cytogenetic Response.
Danish: Der foreligger ikke tilstrækkelige data til at give formelle anbefalinger om dosisreduktion (ved fravær af en bivirkning) hos patienter med CML i kronisk fase, der har opnået major cytogenisk respons.
English: In a patient suspected of developing an arterial or venous occlusive event, Iclusig should be immediately interrupted.
Danish: Hvis det mistænkes, at en patient er ved at udvikle en arteriel eller venøs okklusiv hændelse, skal Iclusig omgående seponeres.
English: • dabigatran: a medicine to prevent the formation of blood clots.
Danish: • dabigatran: et lægemiddel, der bruges til at forebygge dannelse af blodpropper
English: Grade 4 pancreatitis
Danish: Grad 4 pancreatitis
English: Overall (N=62)
Danish: Generelt (N=62)
English: Iclusig is used to treat adults with the following leukaemia types who are no longer benefiting from treatment with other medicines, or have a certain genetic difference known as a T315I mutation:
Danish: Iclusig anvendes til at behandle voksne med følgende typer leukæmi, som ikke længere har gavn af behandling med andre lægemidler eller som har en vis genetisk forskel (kendt som en T315I-mutation):
English: Serial ECGs in triplicate were collected at baseline and at steady state to evaluate the effect of ponatinib on QT intervals.
Danish: Der blev taget tre gentagne ekg'er ved baseline og ved steady state for at evaluere ponatinibs effekt på QT-intervaller.
English: Discontinuation due to myelosuppression was infrequent (thrombocytopenia 4.5%, neutropenia and anaemia <1% each).
Danish: Seponering på grund af myelosuppression var sjælden (trombocytopeni 4,5 %, neutropeni og anæmi <1 % hver).
English: In vitro studies suggested that ponatinib is either not a substrate or is a weak substrate for both P-gp and breast cancer resistance protein BCRP.
Danish: In vitro-studier tyder på, at ponatinib enten ikke er et substrat eller er et svagt substrat for både P-gp og brystcancerresistens-proteinet BCRP.
English: • Recommendation to consider discontinuing ponatinib if a complete haematologic response has not occurred by 3 months (90 days).
Danish: • Anbefaling om at overveje seponering af ponatinib, hvis komplet hæmatologisk respons ikke er opnået efter 3 måneder (90 dage).
English: Preliminary data from the phase 2 trial are available on the maintenance of response (MCyR and MMR) in all CP-CML patients who underwent dose reduction for any reason.
Danish: Der foreligger foreløbige data fra fase 2-forsøget om opretholdelse af respons (MCyR og MMR) hos alle CP-CML-patienter, hvor dosis af en eller anden grund blev reduceret.