FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon hepatitis, cholecystitis, cholestasis Skin and subcutaneous tissue disorders
Danish: Ikke almindelig hepatitis, cholestasis, cholecystitis Hud og subkutane væv
English: 4 If cytopaenia is related to leukaemia, consider dose escalation to 180 mg once daily.
Danish: 4 Hvis cytopeni er relateret til leukæmi, skal dosisoptrapning til 180 mg én gang dagligt, overvejes.
English: In the study in advanced phase CML and Ph+ ALL, the primary endpoint was MaHR.
Danish: I studiet med CML i fremskreden fase og Ph+ ALL var det primære endepunkt MaHR.
English: The rate of major molecular response (defined as BCR-ABL/control transcripts ≤ 0.1% by RQ-PCR in peripheral blood samples) prior to crossover was 29% for dasatinib and 12% for imatinib.
Danish: Hyppigheden af major molekylært respons (defineret som BCR-ABL/kontroltranskriptioner ≤ 0,1% ved RQ-PCR i perifert blod) inden crossover var 29% for dasatinib og 12% for imatinib.
English: Once constituted by your pharmacist or healthcare professional, the oral suspension should only be administered using the oral dosing syringe supplied with each pack.
Danish: Efter rekonstitution, som foretages af apotekspersonalet eller en sundhedsperson, må den orale suspension kun administreres ved brug af den orale doseringssprøjte, der medfølger i hver pakning.
English: The dose for the use of powder for oral suspension in adult patients with accelerated, myeloid or lymphoid blast phase (advanced phase) CML or Ph+ ALL has not been determined.
Danish: Dosis af pulver til oral suspension til voksne patienter med accelereret, myeloid eller lymfoid blastfase (fremskreden fase) CML eller Ph+ ALL er ikke fastlagt.
English: Prior imatinib (N = 46)b
Danish: Forudgående imatinib (N = 46)b
English: In the pivotal study, 106 paediatric patients received SPRYCEL in combination with chemotherapy on a continuous dosing regimen.
Danish: I det pivotale studie fik 106 pædiatriske patienter SPRYCEL i kombination med kemoterapi i et kontinuerligt dosisregime.
English: They were randomised (2:1) to either dasatinib (70 mg twice daily) or imatinib (400 mg twice daily).
Danish: Patienterne randomiseredes (2:1) til enten dasatinib (70 mg 2 gange dagligt) eller imatinib (400 mg 2 gange dagligt).
English: In a randomized trial in patients with newly diagnosed chronic phase CML, the median duration of therapy was approximately 60 months.
Danish: I et randomiseret studie med patienter med nydiagnosticeret CML i kronisk fase var medianbehandlingsvarigheden ca. 60 måneder.
English: In the Phase I paediatric study, after a minimum of 7 years of follow-up among the 17 patients with imatinib-resistant or intolerant CML-CP, the median duration of PFS was 53.6 months and the rate of OS was 82.4%.
Danish: Efter minimum 7 års opfølgning i det pædiatriske fase-I studie blandt 17 patienter med imatinib resistent eller intolerant CML-CP var medianvarigheden af progressionsfri overlevelse (PFS) 53,6 måneder og raten af OS var 82,4%.
English: The overall safety profile of SPRYCEL in the paediatric Ph+ CML-CP population was similar to that of the adult population, regardless of formulation, with the exception of no reported pericardial effusion, pleural effusion, pulmonary oedema, or pulmonary hypertension in the paediatric population.
Danish: Uanset formulering var den overordnede sikkerhedsprofil af SPRYCEL i den pædiatriske population med Ph+ CML-CP tilsvarende den i den voksne population, med undtagelse af, at der ikke blev rapporteret perikardieansamling, pleuraansamling, pulmonært ødem eller pulmonær hypertension i den pædiatriske population.
English: Median time to MMR after 60 months of follow-up was 9.3 months in the SPRYCEL group and 15.0 months in the imatinib group in patients with a MMR.
Danish: Mediantiden til MMR var efter 60 måneders opfølgning 9,3 måneder i SPRYCEL gruppen og 15,0 måneder i imatinib gruppen hos patienter med en MMR.
English: Dasatinib is a potent, subnanomolar inhibitor of the BCR-ABL kinase with potency at concentration of 0.6-0.8 nM.
Danish: Dasatinib er en potent, subnanomolær hæmmer af BCR-ABL-kinase med effekt ved en koncentration på 0,6-0,8 nM.
English: Excipients: contains sucrose, sodium, sodium benzoate, benzoic acid, benzyl alcohol and sulphur dioxide (E220).
Danish: Hjælpestoffer: indeholder saccharose, natrium, natriumbenzoat, benzoesyre, benzylalkohol og svovldioxid (E220).
English: After 60 months of follow-up, median time to cCCyR was 3.1 months in the SPRYCEL group and 5.8 months in the imatinib group in patients with a confirmed CCyR.
Danish: Efter 60 måneders opfølgning var mediantiden til cCCyR 3,1 måneder i SPRYCEL gruppen og 5,8 måneder i imatinib gruppen hos patienter med en bekræftet CCyR.
English: If SPRYCEL is not tolerated after dose reduction, either discontinue the strong CYP3A4 inhibitor or interrupt SPRYCEL until the inhibitor is discontinued.
Danish: Hvis SPRYCEL ikke tåles efter dosisreduktion, skal enten den potente CYP3A4-hæmmer seponeres, eller behandlingen med SPRYCEL afbrydes, indtil hæmmeren seponeres.
English: If you have accidentally taken too much SPRYCEL, talk to your doctor immediately.
Danish: Hvis du ved en fejl har taget for meget SPRYCEL, skal du straks kontakte lægen.
English: Rare leukocytoclastic vasculitis, skin fibrosis
Danish: Sjælden leukocytoklastisk vaskulitis, hudfibrose
English: Patients aged 65 years and older are more likely than younger patients to experience pleural effusion, dyspnoea, cough, pericardial effusion and congestive heart failure, and should be monitored closely.
Danish: Hos patienter over 65 år er der større sandsynlighed end hos yngre patienter for at opleve pleuraeffusion, dyspnø, hoste, perikardieeffusion og kongestiv hjertesvigt, og disse patienter bør derfor monitoreres omhyggeligt.
English: By 1 year 5%, p<.2394
Danish: Ved år 1 5%, p<0,2394
English: An open-label, single-arm, multicentre study was conducted in patients resistant or intolerant to imatinib (i.e. patients who experienced significant toxicity during treatment with imatinib that precluded further treatment).
Danish: Et åbent, enkeltarms-, multicenter-studie med patienter med resistens eller intolerans over for imatinib (dvs. patienter som oplevede signifikant toksicitet under behandling med imatinib hvor fortsat behandling var udelukket).
English: The 140 mg once daily regimen showed a comparable efficacy profile to the 70 mg twice daily regimen but a more favourable safety profile.
Danish: Behandlingen med 140 mg én gang dagligt viste en virkningsprofil, der svarede til behandling med 70 mg to gange dagligt, men med en mere gunstig sikkerhedsprofil.
English: If SPRYCEL must be administered with a strong CYP3A4 inhibitor, consider a dose decrease to:
Danish: Hvis SPRYCEL skal administreres med en potent CYP3A4-hæmmer, skal der overvejes en dosisreduktion til:
English: In patients with CML with resistance or intolerance to prior imatinib therapy, cytopaenias (thrombocytopaenia, neutropaenia, and anaemia) were a consistent finding.
Danish: Hos patienter med CML med resistens eller intolerans over for tidligere imatinib behandling var cytopenier (trombocytopeni, neutropeni og anæmi) et vedvarende fund.
English: The median duration of therapy in the 100 mg once daily group was 37 months (range 1-91 months).
Danish: Den mediane behandlingsvarighed i behandlingsgruppen med 100 mg én gang dagligt var 37 måneder (1-91 måneder).
English: SPRYCEL 10 mg/mL powder for oral suspension
Danish: SPRYCEL 10 mg/ml pulver til oral suspension
English: These non-clinical studies show that dasatinib can overcome imatinib resistance resulting from BCR-ABL overexpression, BCR-ABL kinase domain mutations, activation of alternate signalling pathways involving the SRC family kinases (LYN, HCK), and multidrug resistance gene overexpression.
Danish: Disse ikke-kliniske studier har vist, at dasatinib kan overvinde imatinibresistens, der stammer fra BCR-ABL overekspression, BCR-ABL kinasedomænemutationer, aktivering af andre signalveje, der involverer kinaser i SRC-kinasefamilien (LYN, HCK), og overekspression af gener relateret til multimedicinresistens.
English: The overall mean terminal half-life of dasatinib is approximately 5-6 hours in patients.
Danish: Den overordnede gennemsnitlige halveringstid af dasatinib er cirka 5-6 timer hos patienter.
English: • Do not take the syringe apart in order to avoid damaging it.
Danish: • For at undgå at beskadige sprøjten må den ikke skilles ad.
English: For the recommended paediatric dosage, SPRYCEL oral suspension contains 1.17 grams sucrose per 40 mg dasatinib and 4.37 grams sucrose per 150 mg dasatinib.
Danish: Den anbefalede pædiatriske dosis SPRYCEL oral suspension indeholder 1,17 g saccharose pr. 40 mg dasatinib og 4,37 g saccharose pr. 150 mg dasatinib.
English: Infections and infestations Very common infection (including bacterial, viral, fungal, non-specified)
Danish: Meget almindelig infektion (inklusive bakteriel, viral, mykotisk, ikke-specifik)
English: Six percent of dasatinib-treated patients discontinued treatment due to drug-related pleural effusion.
Danish: Seks procent af de dasatinib behandlede patienter fik seponeret behandlingen på grund af lægemiddelrelateret pleuraeffusion.
English: Each film-coated tablet contains 20 mg, 50 mg, 70 mg, 80 mg, 100 mg or 140 mg dasatinib (as monohydrate).
Danish: Hver filmovertrukken tablet indeholder 20 mg, 50 mg, 70 mg, 80 mg, 100 mg eller 140 mg dasatinib (som monohydrat).
English: i Gravitational oedema, localised oedema, oedema peripheral.
Danish: i Deklivt ødem, lokaliseret ødem, perifert ødem.
English: Table 8: CTC grades 3/4 haematological laboratory abnormalities in clinical studies in patients with resistance or intolerance to prior imatinib therapya
Danish: Tabel 8: Hæmatologiske laboratorieabnormiteter af CTC-grad 3/4 i kliniske studier med patienter med resistens eller intolerans over for tidligere behandling med imatiniba
English: Allow a washout period of approximately 1 week after the inhibitor is stopped before the SPRYCEL dose is increased.
Danish: Sørg for en udvaskningsperiode på cirka 1 uge efter hæmmeren er seponeret, før dosis af SPRYCEL øges.
English: SPRYCEL oral suspension may be mixed with milk, yogurt, apple juice, or applesauce.
Danish: SPRYCEL oral suspension kan blandes med mælk, yoghurt, æblejuice eller æblemos.
English: Concomitant use of dasatinib and a CYP3A4 substrate may increase exposure to the CYP3A4 substrate.
Danish: Samtidig brug af dasatinib og et CYP3A4-substrat kan øge eksponeringen af CYP3A4-substratet.
English: Uncommon hypersensitivity (including erythema nodosum) Rare anaphylactic shock Endocrine disorders Uncommon hypothyroidism
Danish: Ikke almindelig overfølsomhed (inklusive erythema nodosum) Sjælden anafylaktisk shock Det endokrine system
English: Contains 0.29 g of sucrose per mL of oral suspension.
Danish: Indeholder 0,29 g saccharose pr. ml oral suspension.
English: In a study in healthy subjects, a single 100 mg dose of dasatinib increased AUC and Cmax exposure to simvastatin, a known CYP3A4 substrate, by 20 and 37% respectively.
Danish: I et studie med raske frivillige øgede en enkeltdosis på 100 mg dasatinib AUC og Cmax af simvastatin, der er et kendt CYP3A4-substrat, med henholdsvis 20 og 37%.
English: The median time to first occurrence of grade ≥ 3 dasatinib-related pleural effusion was 175 weeks (range: 114 to 274 weeks).
Danish: Mediantiden til første forekomst af grad ≥ 3 dasatinib relateret pleuraeffusion var 175 uger (114-274 uger).
English: There is no dose recommendation for SPRYCEL with children under 1 year of age.
Danish: Der foreligger ingen dosisanbefalinger for SPRYCEL til børn under 1 år.
English: Ninety-seven of the 130 paediatric patients with CML-CP were treated with SPRYCEL tablets 60 mg/m2 once daily (maximum dose of 100 mg once daily for patients with high
Danish: Syvoghalvfems af de 130 pædiatriske patienter med CML-CP blev behandlet med SPRYCEL tabletter 60 mg/m2 en gang dagligt (maximumdosis på 100 mg en gang dagligt for patienter med højt BSA).
English: Very common side effects (may affect more than 1 in 10 people) Infections (including bacterial, viral and fungal) Heart and lungs: shortness of breath
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer) Infektioner (både infektioner forårsaget af bakterier og af virus samt svampeinfektioner) Hjerte og lunger: åndenød
English: Each pack also contains a low-density polyethylene press-in-bottle adapter (PIBA) and a 12-mL oral dosing syringe (polypropylene syringe barrel with high-density polyethylene syringe plunger rod) in a sealed plastic bag.
Danish: Hver pakning indeholder også en lavdensitets-polyethylenadapter til flasken, som kan presses i (PIBA), og en 12-ml doseringssprøjte (polypropylen sprøjtecylinder med et højdensitetspolyethylenstempel) i en forseglet plastikpose.
English: Advise patients who are or may become pregnant of the potential risk to the foetus from dasatinib and the excipient benzyl alcohol, which may accumulate over time and cause metabolic acidosis.
Danish: Rådgiv gravide patienter og patienter der kan blive gravide om de potentielle risici for fosteret ved dasitinib og hjælpestoffet benzylalkohol, som kan akkumuleres over tid og kan forårsage metabolisk acidose.
English: The use of latex or nitrile gloves is recommended when handling any powder that is inadvertently spilled from the bottle, for appropriate disposal in order to minimise the risk of dermal exposure.
Danish: Det anbefales at bruge latex- eller nitrilhandsker til håndtering og passende bortskaffelse af pulver, der utilsigtet spildes fra flasken, for at minimere risikoen for hudeksponering.
English: In clinical studies in adult CML and Ph+ ALL patients, dose escalation to 140 mg once daily (chronic phase CML) or 180 mg once daily (advanced phase CML or Ph+ ALL) was allowed in patients who did not achieve a haematologic or cytogenetic response at the recommended starting dose.
Danish: I kliniske studier med voksne CML- og Ph+ ALL-patienter var dosiseskalering til 140 mg én gang dagligt (CML i kronisk fase) eller 180 mg én gang dagligt (fremskreden CML eller Ph+ ALL) tilladt hos patienter, som ikke opnåede hæmatologisk eller cytogenetisk respons ved den anbefalede startdosis.
English: If you have any questions about how SPRYCEL works or why this medicine has been prescribed for you, ask your doctor.
Danish: Spørg lægen, hvis du har spørgsmål om, hvordan SPRYCEL virker, eller hvorfor du har fået ordineret denne medicin.
English: Rare epiphyses delayed fusion,h growth retardationh
Danish: Sjælden forsinket epifysefusion,h væksthæmningh
English: The following dose escalations shown in Table 2 are recommended in paediatric patients with Ph+ CML-CP who do not achieve a haematologic, cytogenetic and molecular response at the recommended time points, per current treatment guidelines, and who tolerate the treatment.
Danish: Følgende dosiseskaleringer, vist i Tabel 2, anbefales til pædiatriske patienter med Ph+ CML-CP, som ikke opnår et hæmatologisk, cytogenetisk og molekylært respons på de anbefalede tidspunkter, ifølge gældende behandlingsvejledninger, og som tåler behandlingen.
English: Musculoskeletal and connective tissue: delayed fusion of the rounded ends that form joints (epiphyses); slower or delayed growth
Danish: Knogler, led, muskler og bindevæv: forsinket sammenvoksning af de afrundede ender, der udgør led (epifyser); langsommere eller forsinket vækst.
English: Miscellaneous adverse reactions such as pleural effusion, ascites, pulmonary oedema and pericardial effusion with or without superficial oedema may be collectively described as “fluid retention”.
Danish: Diverse bivirkninger som f.eks. pleuraeffusion, ascites, lungeødem og perikardie-effusion med eller uden superficielt ødem kan samlet set betegnes som ”væskeretention”.
English: For patients taking SPRYCEL 60 mg or 40 mg daily, consider interrupting the dose of SPRYCEL until the CYP3A4 inhibitor is discontinued, or switching to a lower dose with the powder for oral suspension formulation.
Danish: For patienter, der tager SPRYCEL 60 mg eller 40 mg dagligt, skal det overvejes at seponere SPRYCEL dosen, indtil CYP3A4-hæmmeren er seponeret, eller at skifte til en lavere dosis med formuleringen pulver til oral suspension.
English: Myeloid blast phase (n= 74)c
Danish: Myeloid blastfase (n= 74)c
English: If cytopaenia persists for more than 3 weeks, check if cytopaenia is related to leukaemia (marrow aspirate or biopsy).
Danish: Hvis cytopeni bliver ved i mere end 3 uger, check da om cytopeni er relateret til leukæmien (knoglemarvsaspirat eller -biopsi)
English: Median duration of treatment for all patients at 7 years of follow-up was 29.8 months (range < 1-92.9 months).
Danish: Medianbehandlingsvarigheden for alle patienter ved en opfølgningsperiode på 7 år var ca. 29,8 måneder (1-92,9 måneder).
English: Dose increase or reduction is recommended based on individual patient response and tolerability.
Danish: Det anbefales at basere øgning eller reduktion af dosis på den enkelte patients respons og tolerance.
English: Grade 3 or 4 gastrointestinal haemorrhage occurred in 6% of patients with advanced phase CML and generally required treatment interruptions and transfusions.
Danish: Der opstod gastrointestinal blødning grad 3 eller 4 hos 6% af patienterne med CML i fremskreden fase, hvilket almindeligvis krævede behandlingsafbrydelser og transfusioner.
English: A low-fat meal 30 minutes prior to dasatinib resulted in a 21% increase in the mean AUC of dasatinib.
Danish: Et fedtfattigt måltid 30 minutter inden dasatinib resulterede i en stigning i gennemsnitligt AUC for dasatinib på 21%.
English: For patients taking SPRYCEL 60 mg or 40 mg daily, consider interrupting the dose of SPRYCEL until the CYP3A4 inhibitor is discontinued, or switching to a lower dose with the powder for oral suspension formulation (see Summary of Product Characteristics for SPRYCEL powder for oral suspension).
Danish: For patienter, der tager SPRYCEL 60 mg eller 40 mg dagligt, skal det overvejes at seponere SPRYCEL dosen, indtil CYP3A4-hæmmeren er seponeret, eller at skifte til en lavere dosis med formuleringen pulver til oral suspension (se produktresuméet for SPRYCEL pulver til oral suspension).
English: Dosing for children with chronic phase CML or Ph+ ALL is on the basis of body weight.
Danish: Dosering til børn med CML eller Ph+ ALL i kronisk fase er baseret på legemsvægt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One bottle of powder for oral suspension contains 990 mg of dasatinib (as monohydrate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Én flaske med pulver til oral suspension indeholder 990 mg dasatinib (som monohydrat).
English: Warnings and precautions Talk to your doctor or pharmacist before using SPRYCEL if you are taking medicines to thin the blood or prevent clots (see "Other medicines and SPRYCEL") if you have a liver or heart problem, or used to have one if you start having difficulty breathing, chest pain, or a cough when taking SPRYCEL: this may be a sign of fluid retention in the lungs or chest (which can be more common in patients aged 65 years and older), or due to changes in the blood vessels supplying the lungs if you have ever had or might now have a hepatitis B infection.
Danish: Kontakt lægen eller apotekspersonalet, før du tager SPRYCEL hvis du tager blodfortyndende medicin eller medicin, der forebygger blodpropper (se ”Brug af anden medicin sammen med SPRYCEL”) hvis du har eller tidligere har haft lever- eller hjerteproblemer hvis du får åndedrætsbesvær, brystsmerter eller hoste, mens du tager SPRYCEL: dette kan være et tegn på ophobning af væske i lungerne eller brystet (som kan være mere almindeligt hos patienter over 65 år) eller skyldes ændringer i de blodårer, der forsyner lungerne med blod hvis du nogensinde har været eller måske er smittet med hepatitis B-virus.
English: SPRYCEL should not be used during pregnancy unless the clinical condition of the woman requires treatment with dasatinib (see section 4.6).
Danish: SPRYCEL bør ikke anvendes under graviditeten, medmindre kvindens kliniske tilstand kræver behandling med dasatinib (se pkt.
English: SPRYCEL will only be prescribed by a doctor with experience in treating leukaemia.
Danish: SPRYCEL ordineres udelukkende af læger, der har erfaring med behandling af leukæmi.
English: Dasatinib is associated with fluid retention.
Danish: Dasatinib er forbundet med væskeretention.
English: Table 15: Efficacy of SPRYCEL in paediatric patients with CML-CP Cumulative response over time by minimum follow-up period 3 months
Danish: Tabel 15: Effekt af SPRYCEL hos pædiatriske patienter med CML-CP Kumulativt respons over tid efter minimum opfølgningsperiode 3 måneder
English: Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.
Danish: Ph+ akut lymfoblastær leukæmi (ALL) og CML i lymfoid blastfase med resistens eller intolerans over for tidligere behandling.
English: No clinical studies were conducted with SPRYCEL in patients with decreased renal function (the study in patients with newly diagnosed chronic phase CML excluded patients with serum creatinine concentration > 3 times the upper limit of the normal range, and studies in patients with chronic phase CML with resistance or intolerance to prior imatinib therapy excluded patients with serum creatinine concentration > 1.5 times the upper limit of the normal range).
Danish: Der er ikke gennemført kliniske studier med SPRYCEL hos patienter med nedsat nyrefunktion (patienter med en serumkreatinin-koncentration > 3 gange den øvre normalgrænse blev ekskluderet fra studiet med patienter med nyligt diagnosticeret CML i kronisk fase, og patienter med en serumkreatinin-koncentration > 1,5 gange den øvre normalgrænse blev ekskluderet i studier med patienter med CML i kronisk fase med resistens eller intolerans over for tidligere behandling med imatinib).
English: However, SPRYCEL should be used with caution in patients with hepatic impairment (see section 5.2).
Danish: Dog bør SPRYCEL anvendes med forsigtighed hos patienter med leverinsufficiens (se pkt.
English: 30 to less than 45
Danish: 30 til under 45
English: What you need to know before you take SPRYCEL
Danish: Det skal du vide, før du begynder at tage SPRYCEL
English: With a minimum of 12 months follow-up, 85% of patients randomised to the SPRYCEL group and 81% of patients randomised to the imatinib group were still receiving first-line treatment.
Danish: Efter mindst 12 måneders opfølgning fik 85% af de patienter, der var randomiseret til SPRYCEL gruppen, og 81% af de patienter, der var randomiseret til imatinib gruppen, stadig førstelinjebehandling.
English: Decreased appetite Fatigue a In the pivotal study, among 106 total patients, 24 patients received the powder for oral suspension at least once, 8 of whom received the powder for oral suspension formulation exclusively.
Danish: Hovedpine Nedsat appetit Træthed a I det pivotale studie fik 24 patienter ud af et samlet antal på 106 patienter pulveret til oral suspension mindst én gang, og 8 af dem fik udelukkende pulveret til oral suspension.
English: In paediatric patients with Ph+ ALL treated with dasatinib in combination with chemotherapy, CBCs should be performed prior to the start of each block of chemotherapy and as clinically indicated.
Danish: Hos pædiatriske patienter med Ph+ ALL behandlet med dasatinib i kombination med kemoterapi skal der tages CBC før påbegyndelse af hver kemoterapiserie og som klinisk indiceret.
English: Haematopoietic growth factor has been used in patients with resistant myelosuppression.
Danish: Hos patienter med resistent myelosuppression er hæmatopoietisk vækstfaktor blevet anvendt.
English: In the Phase II paediatric study, 1 newly diagnosed patient and 2 imatinib-resistant or intolerant patients progressed to blast phase CML.
Danish: I det fase-II pædiatriske studie, progredierede 1 nydiagnosticeret patient og 2 imatinib resistente eller intolerante patienter til blastfase CML.
English: c CA180-035 study results in recommended starting dose of 140 mg once daily.
Danish: c CA180-035 studieresultater ved anbefalet startdosis på 140 mg én gang dagligt.