FrancophonIA/ELRC3.0 huggingface dataset:
English: Intermittent claudication, peripheral arterial occulsive disease, arteriosclerosis
Danish: Claudicatio intermittens, perifer arteriel okklusiv sygdom, arteriosklerose
English: Herpes virus infection, oral candidiasis, subcutaneous abscess, anal abscess, tinea pedis, hepatitis B reactivation Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
Danish: Herpes virus infektion, oral candidiasis, subkutan absces, anal absces, tinea pedis, hepatitis B reaktivering Benigne, maligne og uspecificerede tumorer (inkl.
English: Some side effects are uncommon (may affect up to 1 in 100 people) - generally feeling unwell - painful and swollen joints (gout) - inability to achieve or maintain an erection - feeling body temperature change (including feeling hot, feeling cold) - sensitive teeth
Danish: Nogle bivirkninger er ikke almindelige (kan påvirke op til 1 ud af 100 patienter) - generel utilpashed - smerter og hævede led (gigt) - kan ikke opnå eller opretholde rejsning - følelse af, at kropstemperaturen ændrer sig (inklusive svedeture, kuldefølelse) - følsomme tænder
English: PVC/PVDC/Alu blisters.
Danish: PVC/PVDC/Alu- blister.
English: Close monitoring of growth in paediatric patients under nilotinib treatment is recommended (see section 4.4).
Danish: Der anbefales tæt monitorering af pædiatriske patienters vækst under behandling med nilotinib (se pkt.
English: Figure 3 Cumulative incidence of molecular response of ≤0.0032% (4.5 log reduction)
Danish: Figur 3 Kumulativ forekomst af molekulært respons på ≤0,0032 % (4,5 log-reduktion)
English: Diabetes mellitus, hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia, hyperglycaemia, decreased appetite, hypocalcaemia, hypokalaemia
Danish: Diabetes mellitus, hyperkolesterolæmi, hyperlipidæmi, hypertriglyceridæmi, hyperglykæmi, nedsat appetit, hypokalcæmi, hypokaliæmi
English: If so, you may sprinkle the content of each hard capsule in one teaspoon of apple sauce and take it immediately.
Danish: Hvis du ikke kan synke kapsler, kan du komme indholdet af en hård kapsel på én teske med æblemos, og derefter tage det straks.
English: Frequency rare: Cases of tumour lysis syndrome have been reported in patients treated with nilotinib.
Danish: Frekvens sjælden: Tilfælde af tumor lysis syndrom er blevet rapporteret hos patienter behandlet med nilotinib.
English: Bilirubin and hepatic transaminases levels should be tested monthly or as clinically indicated.
Danish: Bilirubin og levertransaminaseniveauer skal testes hver måned eller hvor det er klinisk relevant.
English: If clinically appropriate, re-escalation of the dose to 300 mg twice daily in adult patients or to 230 mg/m twice daily in paediatric patients should be considered.
Danish: Hvis det er klinisk passende, bør det overvejes at re-eskalere dosis til 300 mg 2 gange dagligt hos voksne patienter, eller 230 mg/m2 gange dagligt hos pædiatriske patienter.
English: A red imprint is stamped on each hard capsule (“NVR/TKI”).
Danish: De hårde kapsler er præget med rødt (”NVR/TKI”).
English: Elevated bilirubin and hepatic transaminases: For Grade 3-4 bilirubin and hepatic transaminase elevations in adult patients, doses should be reduced to 400 mg once daily or interrupted.
Danish: Forhøjede billirubin og levertransaminaserværdier: For grad 3-4 bilirubin- og levertransaminasestigninger hos voksne patienter, skal dosis reduceres til 400 mg 1 gang dagligt eller afbrydes.
English: Twenty-six (26) of these 55 deaths were related to CML (6 in the nilotinib 300 mg twice daily group, 4 in the nilotinib 400 mg twice daily group and 16 in the imatinib 400 mg once daily group).
Danish: 26 af disse 55 dødsfald var relateret til CML (6 i gruppen, der fik nilotinib 300 mg 2 gange dagligt, 4 i gruppen, der fik nilotinib 400 mg 2 gange dagligt, og 16 i gruppen, der fik imatinib 400 mg 1 gang dagligt).
English: Tasigna is used in adult and paediatric patients with newly diagnosed CML or in patients with CML who are no longer benefiting from previous treatment including imatinib.
Danish: Tasigna bruges til voksne og børn og unge patienter med nylig konstateret CML eller til patienter med CML, som ikke længere har gavn af tidligere behandling, herunder behandling med imatinib.
English: Drug eruption, skin pain
Danish: Medikamentelt udslæt, smerte i huden
English: The data described below reflect exposure to nilotinib in a total of 737 adult patients from a randomised Phase III study in patients with newly diagnosed Ph+ CML in chronic phase treated at the recommended dose of 300 mg twice daily (n=279) and from an open-label multicentre Phase II study in adult patients with imatinib-resistant or intolerant CML in chronic phase (n=321) and accelerated phase (n=137) treated at the recommended dose of 400 mg twice daily.
Danish: De nedenfor beskrevne data afspejler eksponeringen for nilotinib hos totalt 737 voksne patienter fra et randomiseret fase III studie hos patienter med nydiagnosticeret Ph+CML i kronisk fase behandlet med den anbefalede dosis på 300 mg 2 gange dagligt (n=279) og fra et open-label-, multicenter fase II studie hos imatinib-resistente eller intolerante voksne patienter med CML i kronisk fase (n=321) og accelererede fase (n=137) behandlet med den anbefalede dosis på 400 mg 2 gange dagligt.
English: Chest pain (including non-cardiac chest pain), pain, pyrexia, chest discomfort, malaise
Danish: Brystsmerter (inklusive ikke-kardielle brystsmerter), smerter, feber, ubehag i brystet, utilpashed
English: In addition, tell your doctor or pharmacist before taking Tasigna if you are taking any antacids, which are medicines against heartburn.
Danish: Før du tager Tasigna, skal du desuden fortælle din læge eller på apoteket, hvis du tager medicin mod for meget mavesyre, f.eks. medicin mod halsbrand.
English: Cardiac failure, myocardial infarction, coronary artery disease, cardiac murmur, pericardial effusion, cyanosis
Danish: Hjertesvigt, myokardieinfarkt, koronararteriesygdom, hjertemislyd, perikardiel effusion, cyanose
English: In a Phase III study in newly diagnosed CML patients, 1.1% of the patients treated with 400 mg nilotinib twice daily showed a Grade 3-4 elevation in total cholesterol; no Grade 3-4 elevations were however observed in the 300 mg twice daily dose group (see section 4.8).
Danish: I et fase III-studie med patienter med nydiagnosticeret CML viste 1,1 % af patienterne, behandlet med 400 mg nilotinib 2 gange dagligt, grad 3-4 stigning i total-kolesterol, hvorimod der ikke blev observeret grad 3-4 stigning i gruppen, der fik 300 mg 2 gange dagligt (se pkt.
English: If blood counts remain low, a dose reduction to 230 mg/m once daily may be required.
Danish: Hvis tallene fortsat er lave, kan en dosisreduktion til 230 mg/m
English: Monitoring of patients who have discontinued therapy Frequent monitoring of BCR-ABL transcript levels in patients eligible for treatment discontinuation must be performed with a quantitative diagnostic test validated to measure molecular response levels with a sensitivity of at least MR4.5 (BCR-ABL/ABL ≤0.0032% IS).
Danish: Monitorering af patienter, som har seponeret behandlingen Hyppig monitorering af BCR-ABL-transkriptniveauer hos patienter, som er egnede til seponering af behandlingen, skal foretages med en kvantitativ diagnostisk test, der er valideret til at måle molekylært respons med en følsomhed på mindst MR4.5 (BCR-ABL/ABL ≤0,0032 % IS).
English: By 2 years
Danish: Ved 2 år
English: Clinical studies in imatinib-resistant or intolerant CML in chronic phase and accelerated phase An open-label, uncontrolled, multicentre Phase II study was conducted to determine the efficacy of nilotinib in adult patients with imatinib resistant or intolerant CML with separate treatment arms for chronic and accelerated phase disease.
Danish: Kliniske studier med imatinib-resistente eller intolerante patienter med kronisk eller accelereret CML Der blev udført et open label-, ukontrolleret, multicenter-, fase II-forsøg for at fastslå nilotinibs virkning hos voksne patienter med imatinib-resistent eller -intolerant CML med separate behandlingsarme for kronisk og accelereret CML.
English: The rate of MMR at 12 months, was also statistically significantly higher for nilotinib 400 mg twice daily compared to imatinib 400 mg once daily (42.7% versus 22.3%, p<0.0001).
Danish: MMR raten ved 12 måneder var også statistisk signifikant højere for nilotinib 400 mg 2 gange dagligt sammenlignet med imantinib 400 mg 1 gang dagligt (42,7 % vs. 22,3 %, p<0,0001).
English: Constipation, dry skin, asthenia, muscle spasms, diarrhoea, arthralgia, abdominal pain, vomiting and peripheral oedema were observed less commonly (<10% and ≥5%), were of mild to moderate severity, manageable and generally did not require dose reduction.
Danish: Obstipation, tør hud, asteni, muskelspasmer, diarré, artralgi, abdominalsmerter, opkastning og perifert ødem blev observeret mindre hyppigt (<10 % og ≥5 %), var lette til moderate, håndterbare og krævede ikke dosisreduktion.
English: In the Phase II study in imatinib-resistant and intolerant CML patients in chronic and accelerated phase receiving 400 mg nilotinib twice daily, the change from baseline in mean time-averaged QTcF interval at steady state was 5 and 8 msec, respectively.
Danish: I fase II-studiet med imatinib-resistente og intolerante patienter med kronisk og accelereret CML, som behandledes med 400 mg imatinib 2 gange dagligt, var den gennemsnitlige ændring fra baseline i QTcF-intervallet ved steady state hhv. 5 og 8 msek.
English: Patients were randomised 1:1:1 to receive either nilotinib 300 mg twice daily (n=282), nilotinib 400 mg twice daily (n=281) or imatinib 400 mg once daily (n=283).
Danish: Patienterne blev randomiseret 1:1:1 til at modtage enten nilotinib 300 mg 2 gange dagligt (n=282), nilotinib 400 mg dagligt (n=281) eller imatinib 400 mg 1 gang dagligt (n=283).
English: Appropriate therapy should be prescribed to manage cardiovascular risk factors (see section 4.2 for instructions on managing non-haematological toxicities).
Danish: 4.2 for vejledning om håndtering af ikke-hæmatologisk toksicitet).
English: Localised oedema
Danish: Lokaliseret ødem
English: Musculoskeletal chest pain, musculoskeletal pain, back pain, flank pain, neck pain, muscular weakness
Danish: Muskuloskeletale brystsmerter, muskuloskeletale smerter, rygsmerter, smerter i siden, smerter i nakken, muskelsvaghed
English: Pancreatitis, abdominal discomfort, abdominal distension, dysgeusia, flatulence
Danish: Pankreatitis, abdominalt ubehag, abdominal udspiling, dysgeusi, flatulens
English: Treatment-emergent haematological toxicities include myelosuppression: thrombocytopenia (18%), neutropenia (15%) and anaemia (8%).
Danish: Behandlingsfremkaldt hæmatologisk toksicitet omfatter myelosuppression: trombocytopeni (18 %), neutropeni (15 %) og anæmi (8 %).
English: Patients who re-initiate nilotinib therapy should have their BCR-ABL transcript levels monitored monthly until previous major molecular response or MR4 level is re-established and every 12 weeks thereafter (see section 4.4).
Danish: For patienter, som genoptager behandling med nilotinib, skal BCR-ABL-transkriptniveauerne monitoreres månedligt, indtil det tidligere molekylære respons eller MR4 reetableres, og herefter hver 12. uge (se pkt.
English: Abdominal pain
Danish: Abdominal smerter
English: Hyperparathyroidism secondary, thyroiditis Metabolism and nutrition disorders Very common:
Danish: Sekundær hyperparathyroidisme, thyroiditis Metabolisme og ernæring
English: Capsule content Lactose monohydrate Crospovidone Type A Poloxamer 188
Danish: Indhold i kapsel Lactosemonohydrat Crospovidon Type A Poloxamer 188
English: Nilotinib should be used with caution in patients who have or may develop prolongation of the QT interval, including those patients taking anti-arrhythmic medicinal products such as amiodarone, disopyramide, procainamide, quinidine and sotalol or other medicinal products that may lead to QT prolongation such as chloroquine, halofantrine, clarithromycin, haloperidol, methadone and moxifloxacin (see section 4.4).
Danish: patienter, der tager antiarytmiske lægemidler som amiodaron, disopyramid, procainamid, quinidin og sotalol eller andre lægemidler, der kan føre til QT-forlængelse, f.eks. chloroquin, halofantrin, clarithromycin, haloperidol, methadon og moxifloxacin (se pkt.
English: Tasigna is also available in multipacks of: - 112 (4 wallets of 28) hard capsules.
Danish: Tasigna er også tilgængeligt i multipakninger indeholdende: - 112 (4 foldere med 28) hårde kapsler.
English: Hearing impaired, ear pain, tinnitus
Danish: Nedsat hørelse, smerter i ørerne, tinnitus.
English: Cerebrovascular accident, brain oedema, optic neuritis, lethargy, dysaesthesia, restless legs syndrome
Danish: Cerebrovaskulære hændelser, hjerneødem, optisk neuritis, letargi, dysæstesi, restless legs syndrom
English: The MMR rate at 12 months was statistically significantly higher for nilotinib 300 mg twice daily compared to imatinib 400 mg once daily (44.3% versus 22.3%, p<0.0001).
Danish: MMR-rate ved 12 måneder var statistisk signifikant højere for nilotinib 300 mg 2 gange dagligt sammenlignet med imantinib 400 mg 1 gang dagligt (44,3 % vs. 22,3 %, p<,0001).
English: Sepsis, subcutaneous abscess, anal abscess, furuncle, tinea pedis, hepatitis B reactivation Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
Danish: Sepsis, subkutan absces, anal absces, furunkel, tinea pedis, hepatitis B reaktivering Benigne, maligne og uspecificerede tumorer (inkl.
English: Face oedema, gravitational oedema, influenza-like illness, chills, feeling body temperature change (including feeling hot, feeling cold)
Danish: Ansigtsødem, gravitationsødem, influenzalignende sygdom, kulderystelse, følelse af temperaturændring i kroppen (inklusive hedeture, kuldefølelse)
English: Uncommon cases (0.1 to 1%) of sudden deaths have been reported in patients with imatinib-resistant or intolerant CML in chronic phase or accelerated phase with a past medical history of cardiac disease or significant cardiac risk factors.
Danish: Usædvanlige tilfælde (0,1 til 1 %) af pludselige dødsfald er blevet rapporteret hos hos imatinib-resistente og intolerante patienter med kronisk og accelereret CML med tidligere hjertesygdom eller signifikante kardielle risikofaktorer.
English: Concomitant use of nilotinib with medicinal products that are potent inducers of CYP3A4 (e.g., phenytoin, rifampicin, carbamazepine, phenobarbital and St. John's Wort) is likely to reduce exposure to nilotinib to a clinically relevant extent.
Danish: Samtidig anvendelse af nilotinib med lægemidler, som er potente inducere af CYP3A4 (f.eks. phenytoin, rifampicin, carbamazepin, phenobarbital og perikon) kan sandsynligvis mindske eksponeringen for nilotinib i klinisk relevant udstrækning.
English: Tasigna is used in adult and paediatric patients with newly diagnosed CML.
Danish: Tasigna bruges til voksne og børn og unge patienter med nydiagnosticeret CML.
English: Of CP patients without a baseline CHR, 70% achieved a CHR, median time to CHR was 1 month and median duration of CHR was 32.8 months.
Danish: Den mediane tid til CHR var 1 måned, og den mediane varighed af CHR var 32,8 måneder.
English: Angina pectoris, arrhythmia (including atroventricular block, cardiac flutter, extrasystoles, tachycardia, atrial fibrillation, bradycardia), palpitations, electrocardiogram QT prolonged
Danish: Angina pectoris, arytmi (inklusiv atrioventrikulært blok, hjerteflimren, ekstrasystoler, takykardi, atriefibrillation, bradykardi), palpitationer, QT-forlængelse på EKG
English: Cytogenetic Response (%) Major (95%CI) Complete Partial
Danish: Cytogenetisk respons (%)
English: Colloidal anhydrous silica Magnesium stearate
Danish: Silica, kolloid vandfri Magnesiumstearat
English: Dizziness, peripheral neuropathy, hypoaesthesia, paraesthesia
Danish: Svimmelhed, perifær neuropati, hypæstesi, paræstesi
English: Including clonal evolution as a criterion for progression, a total of 25 patients progressed to accelerated phase or blast crisis on treatment by the cut-off date (3 in the nilotinib 300 mg twice daily group, 5 in the nilotinib 400 mg twice daily group and 17 in the imatinib 400 mg once daily group).
Danish: Ved inklusion af klonal evolution som et kriterie for progression progredierede i alt 25 patienter til accelereret fase eller blastkrise i behandling ved cut-off datoen (3 i gruppen, der fik nilotinib 300 mg 2 gange dagligt, 5 i gruppen, der fik nilotinib 400 mg 2 gange dagligt, og 17 i gruppen, der fik imatinib 400 mg 1 gang dagligt).
English: Angina pectoris, arrhythmia (including atroventricular block, tachycardia, atrial fibrillation, ventricular extrasystoles, bradycardia), electrocardiogram QT prolonged, palpitations, myocardial infarction
Danish: Angina pectoris, arytmi (inklusive atrioventrikulært blok, takykardi, atriefibrillation, ventrikulære ekstrasystoler, bradykardi) QT-forlængelse på EKG, palpitationer, myokardieinfarkt
English: By 4 years
Danish: Ved 4 år
English: If signs of severe fluid retention appear during treatment with nilotinib, the aetiology should be evaluated and patients treated accordingly (see section 4.2 for instructions on managing non-haematological toxicities).
Danish: Hvis der forekommer tegn på svær væskeretention under behandling med nilotinib, bør ætiologien evalueres og patienten behandles i overensstemmelse hermed (se pkt.
English: A total of 55 patients died during treatment or during the follow-up after discontinuation of treatment (21 in the nilotinib 300 mg twice daily group, 11 in the nilotinib 400 mg twice daily group and 23 in the imatinib 400 mg once daily group).
Danish: I alt 55 patienter døde under behandlingen eller under followup efter behandlingsophør (21 i gruppen, der fik nilotinib 300 mg 2 gange dagligt, 11 i gruppen, der fik nilotinib 400 mg 2 gange dagligt, og 23 i gruppen, der fik imatinib 400 mg 1 gang dagligt).
English: Adult patients with imatinib-resistant or intolerant CML in accelerated phase at 400 mg twice daily
Danish: Voksne patienter med imatinib-resistente eller intolerante patienter med accelereret CML ved 400 mg 2 gange dagligt
English: In the 26-week Tg.rasH2 mouse carcinogenicity study, in which nilotinib was administered at 30, 100 and 300 mg/kg/day, skin papillomas/carcinomas were detected at 300 mg/kg, representing approximately 30 to 40 times (based on AUC) the human exposure at the maximum approved dose of 800 mg/day (administered as 400 mg twice daily).
Danish: I et 26-ugers Tg.rasH2-karcinogenitetsstudie med mus, hvor nilotinib blev administreret i doser på 30, 100 og 300 mg/kg/dag, blev der observeret hudpapillom/karcinom ved doser på 300 mg/kg.
English: In healthy subjects receiving esomeprazole at 40 mg once daily for 5 days, gastric pH was markedly increased, but nilotinib absorption was only decreased modestly (27% decrease in Cmax and 34% decrease in AUC0-∞).
Danish: Nilotinibs opløselighed er pH-afhængig med lavere opløselighed ved højere pH. Gastrisk pH var markant øget, men absorptionen af nilotinib var kun let nedsat (27 % nedsættelse af Cmax og 34 % nedsættelse af AUC0-∞) i raske frivillige, der fik esomeprazol på 40 mg 1 gang dagligt i 5 dage.
English: Serum lipase levels should be tested monthly or as clinically indicated (see section 4.4).
Danish: Serumlipaseniveauerne skal testes hver måned eller hvor det er klinisk relevant (se pkt.
English: QTcF of >500 msec was observed in <1% of these patients.
Danish: Der blev observeret QTcF >500 msek.
English: Separate treatment arms were also included in the Phase II study to investigate Tasigna in a group of CP and AP patients who had been extensively pre-treated with multiple therapies including a tyrosine kinase inhibitor agent in addition to imatinib.
Danish: Der var også inkluderet separate behandlingsarme i fase II-studiet for at undersøge Tasigna på en gruppe CP- og AP-patienter, som havde fået ekstensiv tidligere behandling, inkl.
English: 9/l and/or platelets >75 x 10 9/l.
Danish: 9/l og/eller trombocytter > 75 x 10 9/l.
English: Black iron oxide (E172) Propylene glycol Ammonium hydroxide
Danish: Jernoxid, sort (E 172) Propylenglycol Ammoniumhydroxid
English: Discontinuation of nilotinib therapy should be initiated by a physician experienced in the treatment of patients with CML (see sections 4.4 and 5.1).
Danish: Seponering af behandling med nilotinib skal iværksættes af en læge, som har erfaring med behandling af patienter med CML (se pkt.
English: Increases in total serum cholesterol levels have been reported with nilotinib therapy (see section 4.4).
Danish: Der er blevet rapporteret stigning i serumkoncentrationen af total-kolesterol i forbindelse med behandling med nilotinib (se pkt.
English: Bilirubin and hepatic transaminase levels should be monitored during treatment (see sections 4.2 and
Danish: Bilirubin og levertransaminaseniveauer bør overvåges under behandling (se pkt.
English: Increases in blood glucose levels have been reported with nilotinib therapy (see section 4.4).
Danish: Der er rapporteret stigning i blodglucose i forbindelse med behandling med nilotinib (se pkt.
English: Based on Kaplan-Meier estimates, the proportions of patients who were maintaining response for 72 months among patients who achieved CCyR were 99.1% (95% CI: 97.9-100%) in the nilotinib 300 mg twice daily group, 98.7% (95% CI: 97.1-100%) in the nilotinib 400 mg twice daily group and 97.0% (95% CI: 94.7-99.4%) in the imatinib 400 mg once daily group.
Danish: Baseret på Kaplan-Meier-estimater var andelen af patienter, der opretholdt responset i 72 måneder, blandt patienter, der opnåede CCyR, 99,1 % (95 % CI: 97,9-100 %) i gruppen, der fik nilotinib 300 mg to gange dagligt, 98,7 % (95 % CI: 97,1-100 %) i gruppen, der fik nilotinib 400 mg 2 gange dagligt, og 97,0 % (95 % CI: 94,7-99,4 %) i gruppen, der fik imatinib 400 mg 1 gang dagligt.
English: Cerebrovascular accident, basilar artery stenosis, syncope, tremor, lethargy, dysaesthesia, restless legs syndrome, hyperaesthesia
Danish: Cerebrovaskulære hændelser, basilar arteriestenose, synkope, tremor, letargi, dysæstesi, restless legs syndrom, hyperæstesi
English: By 6 years
Danish: Ved 6 år
English: 120 hard capsules
Danish: 120 hårde kapsler
English: A black imprint is stamped on each hard capsule (“NVR/BCR”).
Danish: De hårde kapsler er præget med sort (”NVR/BCR”).
English: Ischaemic stroke, cerebral infarction, migraine, paraestheisa
Danish: Iskæmisk apopleksi, cerebralt infarkt, migræne, paræstesi
English: Uncommon cases (0.1 to 1%) of sudden deaths have been reported in Tasigna clinical trials and/or compassionate use programs in patients with imatinib-resistant or intolerant CML in chronic phase or accelerated phase with a past medical history of cardiac disease or significant cardiac risk factors (see section 4.4).
Danish: Der er rapporteret om usædvanlige tilfælde (0,1 til 1 %) af pludselige dødsfald for Tasigna i kliniske forsøg og/eller i ”compassionate use”-programmer hos imatinib-resistente eller intolerante patienter med kronisk eller accelereret CML, der havde anamnese med tidligere hjertesygdom eller signifikante kardielle risikofaktorer (se pkt.
English: Endocrine disorders Uncommon:
Danish: Hypersensitivitet Det endokrine system Ikke almindelig:
English: 149 to 517 mg/m2/day), and the median relative dose intensity was 94.7% (range: 32 to 112%).
Danish: I den samlede CML-patientpopulation var den gennemsnitlige faktiske dosisintensitet 435,5 mg/m2/dag (område: 149 til 517 mg/m2/dag), og den gennemsnitlige relative dosisintensitet var 94,7 % (område: 32 til 112 %).
English: Face oedema, localised oedema
Danish: Ansigtsødem, lokaliseret ødem
English: Thereafter, if the prior dose was 230 mg/m twice daily, treatment can be resumed at 230 mg/m once daily.
Danish: Såfremt den tidligere dosis var 230 mg/m 2 gange dagligt, kan behandlingen genoptages med 230 mg/m
English: Capsule content
Danish: Indhold i kapsel
English: The KM estimated MR4.0 and MR4.5 rates at 48 weeks of re-initiation were 100.0% (95% CI: not estimated) and 94.8% (95% CI: 85.1, 99.0), respectively.
Danish: De estimerede KM MMR- og MR4.5-rater 48 uger efter genoptagelse var 100.0 % (95 % CI: ikke estimeret) og 94,8 % (95 % CI: 85,1; 99,0).