FrancophonIA/ELRC3.0 huggingface dataset:
English: Temporary dose reductions for intermediate degrees of cytopaenia and disease response should be implemented as needed.
Danish: Midlertidige dosisreduktioner for intermediære grader af cytopeni og sygdomsrespons kan implementeres efter behov.
English: Renal changes in monkeys treated for up to 9 months were limited to an increase in background kidney mineralisation.
Danish: Nyreforandringer hos aber behandlet i op til 9 måneder var begrænset til en stigning i baggrundsnyremineralisering.
English: One case was fatal and was associated with Common Toxicity Criteria (CTC) grade 4 thrombocytopaenia.
Danish: Et tilfælde var letalt og var forbundet med trombocytopeni Common Toxicity Criteria (CTC) grad 4.
English: Do not give this medicine to children younger than one year of age.
Danish: Giv ikke dette lægemiddel til børn under 1 år.
English: • Take SPRYCEL oral suspension on an empty or full stomach.
Danish: • Tag SPRYCEL oral suspension på tom eller fuld mave.
English: 2 Resume treatment at the original starting dose.
Danish: 2 Genoptag behandling med den oprindelige startdosis.
English: Physicians and other healthcare providers should counsel male patients of appropriate age about possible effects of SPRYCEL on fertility, and this counseling may include consideration of semen deposition.
Danish: Læger og andre sundhedspersoner bør rådgive mandlige patienter af passende alder om de mulige virkninger af SPRYCEL på fertilitet, og denne rådgivning kan inkludere overvejelser omkring deponering af sæd.
English: Most resistant patients (72%) had received > 600 mg imatinib.
Danish: De fleste resistente patienter (72%) havde fået > 600 mg imatinib.
English: The majority of the patients (53%) had received prior imatinib treatment for more than 3 years.
Danish: Størstedelen af patienterne (53%) var tidligere behandlet med imatinib igennem mere end 3 år.
English: Survival (%; Kaplan-Meier estimates) Progression-Free 1 year 2 year Overall 1 year 2 year
Danish: Overlevelse (%; Kaplan-Meier-estimater) Progressionsfri 1 år 2 år Samlet 1 år 2 år
English: Film-coating Hypromellose Titanium dioxide (E171) Macrogol 400
Danish: Filmovertræk Hypromellose Titandioxid (E171) Macrogol 400
English: Data was pooled across two studies and showed that dasatinib was rapidly absorbed.
Danish: Data fra to studier blev poolet og viste, at dasatinib absorberes hurtigt.
English: There were no mutations detected in newly diagnosed CML-CP patients at the end of treatment.
Danish: Ingen mutationer blev påvist i nydiagnosticerede CML-CP patienter ved behandlingens afslutning.
English: The highest overdose of 280 mg per day for one week was reported in two patients and both developed a significant decrease in platelet counts.
Danish: Den højeste overdosis på 280 mg per dag i en uge blev rapporteret hos to patienter, som begge udviklede et signifikant nedsat antal blodplader.
English: SPRYCEL tablets can be taken with or without a meal.
Danish: SPRYCEL tabletter kan tages med eller uden mad.
English: Common depression, insomnia
Danish: Almindelig depression, søvnløshed
English: if you experience bruising, bleeding, fever, fatigue and confusion when taking SPRYCEL, contact your doctor.
Danish: hvis du oplever blå mærker, blødning, feber, træthed og forvirring, når du tager SPRYCEL, skal du kontakte din læge.
English: Take the next scheduled dose at the regular time.
Danish: Tag næste planlagte dosis på det planlagte tidspunkt.
English: ALLOW TO AIR DRY AFTER EACH USE
Danish: LAD LUFTTØRRE EFTER HVER BRUG
English: SPRYCEL has minor influence on the ability to drive and use machines.
Danish: SPRYCEL påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: There were no discontinuations of SPRYCEL therapy due to these biochemical laboratory parameters.
Danish: Ingen af patienterne afbrød behandlingen med SPRYCEL på grund af disse biokemiske laboratorieparametre.
English: In vitro data indicate a potential risk for interaction with CYP2C8 substrates, such as glitazones.
Danish: In vitro data indikerer en mulig risiko for interaktioner med CYP2C8-substrater såsom glitazoner.
English: Crossover to the alternative treatment arm was allowed if patients showed evidence of disease progression or intolerance that could not be managed by dose modification.
Danish: Crossover til alternativ behandling var tilladt, hvis patienten viste tegn på sygdomsprogression eller intolerans, som ikke kunne håndteres med dosismodifikation.
English: Film-coated tablets should not be dispersed as the exposure in patients receiving a dispersed tablet is lower than in those swallowing a whole tablet.
Danish: Filmovertrukne tabletter bør ikke opløses, da eksponeringen i patienter der får dispergible tabletter er lavere end hos de, der synker en hel tablet.
English: When this rate was based on the 85 patients with evaluable Ig/TCR assessments, the estimate was 89.4%.
Danish: Da raten var baseret på 85 patienter med evaulerbare Ig/TCR-vurderinger, var estimatet 89,4%.
English: Do not take dispersed tablets.
Danish: Tag ikke opløste tabletter.
English: Your doctor will decide the right formulation and dose based on your weight, any side effects and response to treatment.
Danish: Din læge vil fastsætte den rigtige formulering og dosis baseret på din vægt, eventuelle bivirkninger og respons på behandlingen.
English: Hypokalaemia or hypomagnesaemia should be corrected prior to dasatinib administration.
Danish: Hypokaliæmi eller hypomagnesiæmi skal korrigeres inden administration af dasatinib.
English: Your doctor will discuss with you the potential risk of taking SPRYCEL during pregnancy.
Danish: Lægen vil informere dig om risikoen ved at tage SPRYCEL under graviditet.
English: There are arrows to show the next tablet to be taken according to your treatment schedule.
Danish: Pilene viser, hvilken tablet der skal tages næste gang i dit behandlingsprogram.
English: Step 2: Immediately invert the bottle and shake vigorously for no less than 60 seconds to obtain a uniform suspension.
Danish: Trin 2: Vend straks flasken på hovedet og ryst den kraftigt i mindst 60 sekunder for at opnå en ensartet suspension.
English: Remove child-resistant closure and foil seal.
Danish: Fjern den børnesikrede lukning og folieforseglingen.
English: No clinically relevant age-related pharmacokinetic differences have been observed in these patients.
Danish: Der er ikke observeret klinisk relevante, aldersrelaterede, farmakokinetiske forskelle hos disse patienter.
English: The primary efficacy endpoint was 3-year event-free survival (EFS), which was 65.5% (55.5, 73.7).
Danish: Det primære effektendepunkt var hændelsesfri overlevelse (EFS) efter 3 år, som var 65,5% (55,5; 73,7).
English: Cytogenetic response within 12 months cCCyRa p< 0.007*
Danish: Cytogenetisk respons inden for 12 måneder cCCyRa p< 0,007*
English: In this population of patients who received 100 mg once daily, MCyR was achieved in 77% and CCyR in 67%.
Danish: Hos denne patientpopulation, som fik 100 mg én gang dagligt, blev MCyR opnået hos 77% og CCyR hos 67%.
English: Follow up should be performed according to standard practice guidelines.
Danish: Opfølgning skal udføres i henhold til almindeligt gældende retningslinjer.
English: It binds to both the inactive and active conformations of the BCR-ABL enzyme.
Danish: Det bindes både til inaktive og aktive konformationer af BCR-ABL-enzymet.
English: Mix the SPRYCEL oral suspension in the closed bottle by shaking for 30 seconds.
Danish: Bland SPRYCEL oral suspension i den lukkede flaske ved at omryste i 30 sekunder.
English: Results described below are based on a minimum of 2 years and 7 years follow-up after the start of dasatinib therapy.
Danish: Nedenstående resultater er baseret på mindst 2 år og 7 års opfølgning efter behandlingsstart med dasatinib.
English: However, E255K and F317L were also detected prior to treatment.
Danish: E255K og F317L blev dog også detekteret før behandlingens start.
English: Contact your doctor immediately if you notice any of the above.
Danish: Kontakt straks lægen, hvis du får en eller flere af ovenstående bivirkninger.
English: Patients who are able to swallow tablets and who desire to switch from SPRYCEL powder for oral suspension to SPRYCEL tablets or patients who are not able to swallow tablets and who desire to switch from tablets to oral suspension, may do so, provided that the correct dosing recommendations for the dosage form are followed.
Danish: Patienter, der er i stand til at synke tabletter og som gerne vil skifte fra SPRYCEL pulver til oral suspension til SPRYCEL tabletter, eller patienter, der ikke er i stand til at synke tabletter, og som gerne vil skifte fra tabletter til oral suspension, kan frit gøre det, såfremt de korrekte doseringsanbefalinger for doseringsformen følges.
English: Dose modifications were allowed for improving activity or management of toxicity (see section 4.2).
Danish: Dosismodifikationer var tilladt med henblik på at forbedre aktivitet eller behandling af toksicitet (se pkt.
English: There is insufficient/limited information on the excretion of dasatinib in human or animal breast milk.
Danish: Der er utilstrækkelig/begrænset information vedrørende udskillelse af dasatinib i human modermælk og brystmælk hos dyr.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE Navn og adresse på den fremstiller(e), der er ansvarlig(e) for batchfrigivelse
English: The frequency of grade 3 and 4 haematological abnormalities is presented in Table 8.
Danish: Hyppigheden af hæmatologiske abnormiteter grad 3 og 4 angives i Tabel 8.
English: Similar rates of mutation were observed in both the treatment arms.
Danish: Samme mutationsfrekvens blev observeret for begge behandlingsarme.
English: Other secondary endpoints included duration of MCyR, PFS, and overall survival.
Danish: Andre sekundære endepunkter omfattede varighed af MCyR, PFS samt samlet overlevelse.
English: How long to take SPRYCEL
Danish: Hvor længe skal du tage SPRYCEL
English: Time-to MMR
Danish: Tid-til MMR
English: In people with ALL, white cells called lymphocytes multiply too quickly and live too long.
Danish: Hos mennesker med ALL deler de hvide blodlegemer, der kaldes lymfocytter, sig for hurtigt og lever for længe.
English: Additionally, 34 (47%) received diuretics, 23 (32%) received corticosteroids, and 20 (27%) received both corticosteroids and diuretics.
Danish: Derudover fik 34 (47%) behandling med diuretika, 23 (32%) fik kortikosteroider og 20 (27%) fik både kortikosteroider og diuretika.
English: Mean Tmax was observed between 0.5 and 6 hours and mean half-life ranged from 2 to 5 hours across all dose levels and age groups.
Danish: Gennemsnitlig Tmax blev observeret mellem 0,5 og 6 timer og den gennemsnitlige halveringstid strakte sig fra 2 til 5 timer hen over alle dosisniveauer og aldersgrupper.
English: SPRYCEL is not to be used during pregnancy unless clearly necessary.
Danish: SPRYCEL må ikke bruges under graviditet, medmindre det er klart nødvendigt.
English: Dasatinib is rapidly absorbed in patients following oral administration, with peak concentrations between 0.5-3 hours.
Danish: Dasatinib absorberes hurtigt hos patienter efter oral administration, med maksimal koncentration efter 0,5 til 3 timer.
English: Efficacy of SPRYCEL was consistently demonstrated across different subgroups, including age, gender, and baseline Hasford score.
Danish: Virkningen af SPRYCEL blev konsistent vist i forskellige undergrupper som f.eks. alder, køn og baseline-Hasford-score.
English: a Numbers in bold font are the results of primary endpoints.
Danish: a Tal angivet i fed er resultater af de primære endepunkter.
English: In general, there was no association of decreased calcium with clinical symptoms.
Danish: Generelt var fald i calcium ikke forbundet med kliniske symptomer.
English: Patients achieving early molecular response had a lower risk of transformation, higher rate of progression-free survival (PFS) and higher rate of overall survival (OS), as shown in Table 10.
Danish: Hos patienter, der opnåede tidlig molekylært respons, var der en lavere risiko for transformation, en højere progressionsfri overlevelsesrate (PFS) og en højere samlet overlevelsesrate (OS) som vist i Tabel 10.
English: There may be a vacuum pulling the plunger back into barrel.
Danish: Der kan være opstået et vakuum, der trækker stemplet tilbage i cylinderen.
English: Histamine-2 antagonists and proton pump inhibitors
Danish: Histamin-2-antagonister og protonpumpe-hæmmere
English: No specific dose recommendation is necessary in elderly.
Danish: Specifikke dosisanbefalinger for ældre er ikke nødvendige.
English: This dose represents 30% lower exposure compared to the recommended dose (see section 5.2).
Danish: Denne dosis repræsenterer 30% lavere eksponering sammenlignet med den anbefalede dosis (se pkt.
English: Durability of response and estimated survival rates provide additional evidence of dasatinib clinical benefit.
Danish: Varigheden af respons og de estimerede overlevelsesrater har givet yderligere evidens for dasatinibs kliniske effekt.
English: The powder for oral suspension consists of powder blend with the active substance plus excipients, contained within a bottle for constitution.
Danish: Pulveret til oral suspension består af pulverblanding med det aktive stof plus hjælpestoffer indeholdt i en flaske til rekonstitution.
English: ANC: absolute neutrophil count
Danish: ANC: absolut neutrofiltal
English: The minimal residual disease (MRD) negativity rate assessed by Ig/TCR rearrangement was 71.7% by the end of consolidation in all treated patients.
Danish: Raten for MRD-negativitet (minimal restsygdom) vurderet vha. Ig/TCR var 71,7% ved afslutningen af konsolideringen for alle behandlede patienter.
English: Remind the patient or caregiver to shake the bottle vigorously prior to each use.
Danish: Mind patienten eller omsorgspersonen om, at flasken skal rystes kraftigt inden hver brug.
English: Dosing for children and adolescents is on the basis of body weight (see Table 1).
Danish: Dosering til børn og unge er baseret på legemsvægt (se Tabel 1).
English: Discard any unused suspension 60 days after constitution.
Danish: Ubrugt suspension skal bortskaffes 60 dage efter rekonstitution.
English: At the request of the European Medicines Agency, 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: En opdateret RMP skal fremsendes: på anmodning fra Det Europæiske Lægemiddelagentur når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: • 1 SPRYCEL oral suspension bottle containing a white to yellow opaque suspension.
Danish: • 1 flaske med SPRYCEL oral suspension indeholdende en hvid til gul uigennemsigtig suspension.
English: Swallow the tablets whole.
Danish: Synk tabletterne hele.
English: The MRD negativity rates at the end of induction and consolidation as measured by flow cytometry were 66.0% and 84.0%, respectively.
Danish: Raterne for MRD-negativitet ved afslutningen af induktionen og konsolideringen målt vha. flowcytometri var henholdsvis 66,0% og 84,0%.
English: If possible, an alternative concomitant medication with no or minimal enzyme inhibition potential should be selected.
Danish: Om muligt skal der vælges et andet samtidigt lægemiddel uden eller med minimalt potentiale for enzymhæmning.
English: SPRYCEL with food and drink Do not take SPRYCEL with grapefruit or grapefruit juice.
Danish: Brug af SPRYCEL sammen med mad og drikke Du må ikke tage SPRYCEL sammen med grapefrugt eller grapefrugtjuice.
English: Take special care when driving or using machines in case you experience side effects such as dizziness and blurred vision.
Danish: Vær særligt forsigtig når du kører bil eller bruger maskiner, da du kan opleve bivirkninger som for eksempel svimmelhed og sløret syn.
English: With the patient in an upright position, place the tip of the syringe into the mouth between the side of the mouth and the tongue.
Danish: Mens patienten står op placeres spidsen af sprøjten i munden mellem tungen og siden af munden.
English: At the maximum daily dose of 16 mL oral suspension, this is equivalent to 1.7% of the WHO recommended maximum daily dietary intake of 2 g sodium for an adult.
Danish: Ved den maksimale dosis på 16 ml SPRYCEL oral suspension svarer dette til 1,7% af den WHO-anbefalede maksimale daglige indtagelse på 2 g natrium for en voksen.
English: Your doctor will decide the right dose based on age and weight.
Danish: Din læge vil fastsætte den rigtige dosis baseret på alder og vægt.
English: Make sure the second bottle is shaken before use.
Danish: Sørg for at omryste den anden flaske før brug.
English: Hazard ratio (HR) within 12 months (99.99% CI)
Danish: Hazard ratio (HR) inden for 12 måneder (99,99% CI)
English: Dasatinib PK showed dose proportionality with a dose-related increase in exposure observed in paediatric patients.
Danish: PK for dasatinib viste dosisproportionalitet med en dosisrelateret stigning i eksponering observeret hos pædiatriske patienter.
English: Add 77.0 mL of purified water all at once to the bottle and close tightly with closure.
Danish: Tilsæt 77,0 ml renset vand til flasken på én gang og luk flasken tæt med låget.
English: Patients with mild, moderate or severe hepatic impairment may receive the recommended starting dose.
Danish: Patienter med let, moderat eller alvorligt nedsat leverfunktion kan få den anbefalede startdosis.
English: In addition to imatinib, 35% of patients had received prior cytotoxic chemotherapy, 65% had received prior interferon, and 10% had received a prior stem cell transplant.
Danish: Ud over imatinib, havde 35% af patienterne tidligere modtaget cytotoksisk kemoterapi, 65% havde tidligere modtaget interferon, og 10% havde tidligere modtaget stamcelletransplantation.
English: These are blisters showing the days of the week.
Danish: Dette er blisterkort, hvor ugedagene er angivet.
English: It can be taken with or without a meal and should be taken consistently either in the morning or in the evening (see section 5.2).
Danish: Det kan tages med eller uden mad og bør tages konsekvent enten om morgenen eller om aftenen (se pkt.
English: White to off-white powder.
Danish: Hvidt til næsten hvidt pulver.
English: 6.6 Special precautions for disposal and other handling The film-coated tablets consist of a core tablet, surrounded by a film-coating to prevent exposure of healthcare professionals to the active substance.
Danish: 6.6 Regler for bortskaffelse og anden håndtering De filmovertrukne tabletter består af en kernetablet, omgivet af filmovertræk for at undgå, at sundhedspersonalet udsættes for det aktive stof.
English: These are cumulative rates representing minimum follow up for the timeframe specified.
Danish: Disse er kumulative rater, der repræsenterer den tidligste opfølgning i den nævnte periode.
English: n/a Duration of MaHR (%; Kaplan-Meier estimates) 1 year n/a
Danish: n/a Varighed af MaHR (%; Kaplan-Meier estimates) 1 år n/a
English: A bioequivalence study evaluating the powder for oral suspension to the reference tablet formulation in 77 adult patients showed that the exposure for the powder for oral suspension was 19% less than that of reference tablets.
Danish: Et bioækvivalensstudie, der evaluerede pulveret til oral suspension i forhold til referencetabletformuleringen hos 77 voksne patienter, viste at eksponeringen for pulveret til oral suspension var 19% lavere end for referencetabletten.
English: The diagnostic approach should follow standard practice guidelines.
Danish: Diagnosticeringen bør følge almindeligt gældende retningslinjer.
English: The tablets may come in packs with calendar blisters.
Danish: Tabletterne kan være pakket i pakninger med kalenderblisterkort.
English: SPRYCEL film-coated tablets and SPRYCEL powder for oral suspension are not bioequivalent.
Danish: SPRYCEL filmovertrukne tabletter og SPRYCEL pulver til oral suspension er ikke bioækvivalente.
English: Patients should be tested for HBV infection before initiating treatment with SPRYCEL.
Danish: Patienten bør testes for HBV-infektion før initiering af behandling med SPRYCEL.
English: Use the oral syringe included in the package.
Danish: Brug den orale sprøjte der medfølger i pakningen.
English: 1 bottle of 33 g powder 1 bottle adapter 1 oral syringe
Danish: 1 flaske med 33 g pulver 1 adapter til flasken 1 oral sprøjte
English: HDPE bottle with a polypropylene child-resistant closure.
Danish: HDPE-flaske med børnesikret polypropylenlåg.
English: Body Weight (kg)a
Danish: Legemsvægt (kg)a
English: Adverse reactions reported in these two paediatric studies at a frequency of 10% in patients on a continuous dosing regimen are shown in Table 7.
Danish: Bivirkninger rapporteret i disse to pædiatriske studier med en hyppighed på 10% hos patienter i et kontinuerligt dosisregime, fremgår af Tabel 7.
English: Since the renal clearance of dasatinib and its metabolites is < 4%, a decrease in total body clearance is not expected in patients with renal insufficiency.
Danish: Da dasatinib og dets metabolitter har en nyre-clearance < 4%, forventes total-clearance ikke at falde hos patienter med nyreinsufficiens.
English: What you need to know before you take SPRYCEL 3.
Danish: Det skal du vide, før du begynder at tage SPRYCEL 3.
English: With a minimum of 24 months follow-up, 21 of the 240 patients who had achieved a MCyR had progressed and the median duration of MCyR had not been reached.
Danish: Med en minimumsopfølgning på 24 måneder har kun 21 ud af de 240 patienter, som opnåede et MCyR, progredieret, og MCyRs medianvarighed er ikke bestemt.
English: SPRYCEL contains sulphur dioxide (E220) May rarely cause severe hypersensitivity reactions and bronchospasm.
Danish: SPRYCEL indeholder svovldioxid (E220) Kan i sjældne tilfælde medføre svære overfølsomhedsreaktioner og vejrtrækningsproblemer.
English: A total of 519 patients were randomised to a treatment group: 259 to SPRYCEL and 260 to imatinib.
Danish: 519 patienter blev randomiseret til en behandlingsgruppe: 259 til SPRYCEL og 260 til imatinib.
English: However, the occurrence of cytopaenias was also clearly dependent on the stage of the disease.
Danish: Forekomst af cytopenier afhang også tydeligt af sygdommens stadie.
English: These include patients with hypokalaemia or hypomagnesaemia, patients with congenital long QT syndrome, patients taking anti-arrhythmic medicinal products or other medicinal products which lead to QT prolongation, and cumulative high dose anthracycline therapy.
Danish: Dette inkluderer patienter med hypokaliæmi eller hypomagnesiæmi, patienter med kongenit langt QT-syndrom, patienter der tager antiarytmika eller andre lægemidler, som medfører QTforlængelse samt kumulative høje doser af anthracyclin.
English: It could not be determined whether these mucocutaneous adverse reactions were directly related to SPRYCEL or to concomitant medicinal product.
Danish: Det var ikke muligt at afgøre, hvorvidt disse mucokutane bivirkninger var direkte relateret til SPRYCEL eller til samtidig behandling med andre lægemidler.
English: A statistically significantly greater proportion of patients in the SPRYCEL group achieved a cCCyR compared with patients in the imatinib group within the first 12 months of treatment.
Danish: En statistisk signifikant større del af patienterne i SPRYCEL gruppen opnåede cCCyR sammenlignet med patienterne i imatinib gruppen inden for de første 12 måneder af behandlingen.
English: Do not take SPRYCEL if you are allergic to dasatinib or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke SPRYCEL hvis du er allergisk over for dasatinib eller et af de øvrige indholdsstoffer i SPRYCEL (angivet i afsnit 6).