FrancophonIA/ELRC3.0 huggingface dataset:
English: Special monitoring of adult Ph+ CML patients in chronic phase who have achieved a sustained deep molecular response
Danish: Særlig monitorering af voksne Ph+ CML-patienter i kronisk fase, som har opnået et vedvarende dybt molekylært respons
English: Contains lactose - see the package leaflet for further information.
Danish: Indeholder lactose - læs indlægssedlen inden brug.
English: No sudden deaths or episodes of torsade de pointes (transient or sustained) were observed.
Danish: Ingen pludselige dødsfald eller episoder med torsades de pointes (forbigående eller vedvarende) blev observeret.
English: Upper abdominal pain
Danish: Øvre abdominal smerte
English: Loss of major molecular response (MMR=BCR-ABL/ABL ≤0.1%IS) will trigger treatment re-initiation within 4 weeks of when loss of remission is known to have occurred.
Danish: Tab af major molekylært respons (MMR=BCR-ABL/ABL ≤0,1 % IS) skal medføre genoptagelse af behandlingen senest 4 uger efter tab af remission er blevet konstateret.
English: By 5 years
Danish: Ved 5 år
English: Frequency very common: Growth retardation has been documented in paediatric patients treated with nilotinib.
Danish: Frekvens meget almindelig: Der er blevet dokumenteret væksthæmning hos pædiatriske patienter behandlet med nilotinib.
English: Molecular relapse can occur during the treatment-free phase, and long-term outcome data are not yet available.
Danish: Der kan opstå molekylært tilbagefald i løbet af den behandlingsfri fase.
English: Pain, chills, feeling body temperature change (including feeling hot, feeling cold), malaise
Danish: Smerter, kulderystelse, følelse af temperaturændring i kroppen (inklusive hedeture, kuldefølelse) utilpashed
English: For a dose of 300 mg twice daily, 150 mg hard capsules are available.
Danish: Ved behov for en dosis på 300 mg 2 gange dagligt, findes hårde kapsler på 150 mg.
English: In a Phase III study in newly diagnosed CML patients, 6.9% and 7.2% of the patients treated with 400 mg nilotinib and 300 mg nilotinib twice daily, respectively, showed a Grade 3-4 elevation in blood glucose.
Danish: I et fase III-studie med patienter med nydiagnosticeret CML viste henholdsvis 6,9 % og 7,2 % af patienterne behandlet med 400 mg nilotinib eller med 300 mg nilotinib 2 gange dagligt grad 3-4 stigning i blodglucose.
English: What Tasigna is used for
Danish: Hvad du skal bruge Tasigna til
English: Cholestasis, hepatomegaly Skin and subcutaneous tissue disorders Common:
Danish: Kolestase, hepatomegali Hud og subkutane væv Almindelig:
English: For patients who lose MR4 (MR4=BCR-ABL/ABL ≤0.01%IS) but not MMR (MMR=BCR-ABL/ABL ≤0.1%IS) during the treatment-free phase, BCR-ABL transcript levels should be monitored every 2 weeks until BCR-ABL levels return to a range between MR4 and MR4.5.
Danish: For patienter, der ikke kan opretholde MR4 (MR4=BCR-ABL/ABL ≤0,01 % IS), men kan opretholde MMR (MMR=BCR-ABL/ABL ≤0,1 % IS) i løbet af den behandlingsfri fase, skal BCR-ABL-transskriptniveauer monitoreres hver anden uge indtil BCR-ABL niveauerne vender tilbage mellem MR4 og MR4.5.
English: The data described below reflect exposure to nilotinib in 279 adult patients from a randomised Phase III study in patients with newly diagnosed Ph+ CML in chronic phase treated with 300 mg of nilotinib twice daily.
Danish: De nedenfor beskrevne data afspejler eksponeringen for nilotinib hos totalt 279 voksne patienter fra et randomiseret fase III studie hos patienter med nydiagnosticeret Ph+CML i kronisk fase behandlet med 300 mg nilotinib 2 gange dagligt.
English: In a healthy volunteer study with exposures that were comparable to the exposures observed in patients, the time-averaged mean placebo-subtracted QTcF change from baseline was 7 msec (CI ± 4 msec).
Danish: I et studie med raske frivillige forsøgspersoner med eksponeringer, som var sammenlignelige med de eksponeringer, der ses hos patienter, var den gennemsnitlige placebokorrigerede QTcF-ændring fra baseline 7 msek.
English: The exposure to nilotinib in healthy subjects was increased 3-fold when co-administered with the strong CYP3A4 inhibitor ketoconazole.
Danish: Eksponeringen for nilotinib hos raske forsøgspersoner 3-dobledes ved samtidig administration med den potente CYP3A4-hæmmer ketoconazol.
English: By 24 months
Danish: MMR ved 24 måneder
English: ≤0.01% IS), and maintained for one year - the last assessment being MR4.5 (BCR-ABL/ABL ≤0.0032% IS) - no more than two assessments falling between MR4.0 and MR4.5
Danish: ≤0,01 % IS) og opretholdt i et år - den sidste vurdering var MR4.5 (BCR-ABL/ABL ≤0,0032 % IS) - højst to vurderinger lå mellem MR4.0 og MR4.5 (0,0032 % IS < BCR-ABL/ABL ≤0,01 % IS).
English: Treatment must be resumed within 2 weeks at prior dose if ANC >1.5 x 10
Danish: Behandlingen skal genoptages inden 2 uger ved tidligere dosis, hvis ANC > 1,5 x 10
English: Outcomes were reported as recovered.
Danish: Det blev rapporteret, at patienterne kom sig.
English: Monitoring of BCR-ABL transcript levels must be performed with a quantitative diagnostic test validated to measure molecular response levels on the International Scale (IS) with a sensitivity of at least MR4.5 (BCR-ABL/ABL ≤0.0032% IS).
Danish: Monitorering af BCR-ABL-transskriptniveauer skal udføres med en kvantitativ diagnostisk test, som er valideret til at måle molekulær responsniveauer på den internationale skala (IS) med en sensitivitet på mindst MR4.5 (BCR-ABL/ABL ≤0,0032 % IS).
English: Posology for Philadelphia chromosome positive CML adult patients The recommended dose is 300 mg twice daily.
Danish: Dosering til voksne Philadelphiakromosom-positive CML-patienter Den anbefalede dosis er 300 mg 2 gange dagligt.
English: Best CCyR rate by 12 months (including patients who achieved CCyR at or before the 12 month time point as responders) was statistically higher for both nilotinib 300 mg and 400 mg twice daily compared to imatinib 400 mg once daily, see Table 9.
Danish: Bedste CCyR rate ved 12 måneder (inkluderer patienter, som opnåede CCyR på eller før den 12 måned, som respondenter) var statistisk højere for både nilotinib 300 mg og 400 mg 2 gange dagligt sammenlignet med imatinib 400 mg 1 gang dagligt, se tabel 9.
English: 190 of 215 patients (88.4%) entered the TFR phase after achieving a sustained deep molecular response during the consolidation phase, defined by the following criteria: - the 4 last quarterly assessments (taken every 12 weeks) were at least MR4.0 (BCR-ABL/ABL
Danish: 190 af 215 patienter (88,4 %) nåede fasen for TFR efter at have opnået et vedvarende dybt molekylært respons under konsolideringsfasen, som defineret ved følgende kriterier: - de 4 sidste kvartalsvise vurderinger (foretaget hver 12. uge) var mindst MR4.0 (BCR-ABL/ABL
English: Biochemistry parameters - Elevated creatinine - Elevated lipase - Elevated SGOT (AST) - Elevated SGPT (ALT) - Hypophosphataemia - Elevated bilirubin (total) - Elevated glucose - Elevated cholesterol (total) - Elevated triglycerides *Percentages with one decimal precision are used and rounded to integer for presentation in this table **Parameters not collected
Danish: Biokemiske parametre - Forhøjet kreatinin - Forhøjet lipase - Forhøjet ASAT - Forhøjet ALAT - Hypofosfatæmi - Forhøjet bilirubin (total) - Forhøjet glucose - Forhøjet kolesterol (total) - Forhøjede triglycerider *Procenter med en decimals præcision er anvendt og afrundet til hele tal til præsentation i denne tabel **Parametre ikke indsamlet
English: In a study in the CML paediatric population, growth retardation has been documented in patients treated with nilotinib (see section 4.8).
Danish: Et studie udført på den pædiatriske CML population har dokumenteret væksthæmning hos patienter behandlet med nilotinib (se pkt.
English: The median actual dose intensity was 593 mg/day for nilotinib 300 mg twice daily, 772 mg/day for nilotinib 400 mg twice daily and 400 mg/day for imatinib 400 mg once daily.
Danish: Gennemsnitsdosis var hhv. 593 mg/dag for nilotinib 300 mg 2 gange dagligt, 772 mg/dag for nilotinib 400 mg 2 gange dagligt og 400 mg/dag for imatinib 400 mg 1 gang dagligt.
English: These side effects are very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people) or have been reported with frequency not known (cannot be estimated from the available data).
Danish: Disse bivirkninger er meget almindelige (kan påvirke mere end 1 ud af 10 patienter), almindelige (kan påvirke op til 1 ud af 10 patienter), ikke almindelige (kan påvirke op til 1 ud af 100 patienter) eller er rapporteret med hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: - Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
Danish: - Brug ikke lægemidlet, hvis du bemærker, at emballagen er beskadiget eller viser tegn på, at nogen har forsøgt at åbne den. - Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: Hepatotoxicity, toxic hepatitis, jaundice
Danish: Hepatotoksicitet, toksisk hepatitis, icterus
English: Excipient with known effect One hard capsule contains 39.03 mg lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på En hård kapsel indeholder 39,03 mg lactosemonohydrat.
English: 28 hard capsules 40 hard capsules
Danish: 28 hårde kapsler 40 hårde kapsler
English: Response (95% CI) No response
Danish: Ved 12 måneder Respons (95 % CI) Intet respons
English: Biochemistry parameters - Elevated creatinine - Elevated lipase - Elevated SGOT (AST) - Elevated SGPT (ALT) - Hypophosphataemia - Elevated bilirubin (total) - Elevated glucose - Elevated cholesterol (total) - Elevated triglycerides *Percentages with one decimal precision are used and rounded to integer for presentation in this table.
Danish: Biokemiske parameter - Forhøjet kreatinin - Forhøjet lipase - Forhøjet ASAT - Forhøjet ALAT - Hypofosfatæmi - Forhøjet bilirubin (total) - Forhøjet glucose - Forhøjet kolesterol (total) - Forhøjede triglycerider *Procenter med en decimals præcision er anvendt og afrundet til hele tal til præsentation i denne tabel.
English: Treatment discontinuation in adult Ph+ CML patients in chronic phase who have achieved a sustained deep molecular response
Danish: Seponering af behandling hos voksne Ph+ CML-patienter i kronisk fase, som har opnået et vedvarende dybt molekylært respons
English: Uncommon cases of sudden death have been reported in patients taking Tasigna.
Danish: Der er i sjældne tilfælde set pludselige dødsfald hos patienter, der tog Tasigna.
English: Figure 2 Cumulative incidence of molecular response of ≤0.01% (4-log reduction)
Danish: Figur 2 Kumulativ forekomst af molekulært respons på ≤0,01 % (4-log-reduktion)
English: Lipid profiles should be determined prior to initiating nilotinib therapy, assessed at month 3 and 6 after initiating therapy and at least yearly during chronic therapy.
Danish: Lipidprofilen skal bestemmes før behandlingsstart med nilotinib, vurderes ved måned 3 og 6 efter behandlingsstart og mindst 1 gang årligt ved kronisk behandling.
English: The most frequent (≥10%) non-haematological adverse reactions were rash, pruritus, headache, nausea, fatigue, alopecia, myalgia and upper abdominal pain.
Danish: De hyppigste (≥10 %) ikke-hæmatologiske bivirkninger var udslæt, hovedpine, kvalme, træthed, alopeci, myalgi og øvre abdominalsmerte.
English: Daily systemic exposure to nilotinib with 400 mg twice-daily dosing at steady state was 35% higher than with 800 mg once-daily dosing.
Danish: Den daglige systemiske eksponering for nilotinib med 400 mg 2 gange dagligt ved steady state var 35 % højere end med 800 mg 1 gang dagligt.
English: Newly diagnosed CML-CP 300 mg twice daily
Danish: Nydiagnosticeret CML-CP 300 mg 2 gange dagligt
English: Leukopenia, eosinophilia, lymphopenia
Danish: Leukopeni, eosinofili, lymfopeni
English: Treatment must be resumed within 2 weeks at prior dose if ANC >1.0 x 10
Danish: Behandling skal genoptages inden 2 uger ved tidligere dosis, hvis ANC >1,0 x 10
English: Very common Fatigue Common
Danish: Meget almindelig Træthed
English: Median age was 47 years in both nilotinib arms and 46 years in the imatinib arm, with 12.8%, 10.0% and 12.4% of patients were ≥65 years of age in the nilotinib 300 mg twice daily, nilotinib 400 mg twice daily and imatinib 400 mg once daily treatment arms, respectively.
Danish: Gennemsnitlig alder var 47 år i begge nilotinib-arme og 46 år i imatinib-armen; med 12,8 %, 10,0 % og 12,4 % af patienterne værende ≥65 år i hhv. behandlingsarmene for nilotinib 300 mg 2 gange dagligt, nilotinib 400 mg 2 gange dagligt og imatinib 400 mg 1 gang dagligt.
English: The most frequent (≥10%) non-haematological drug-related adverse events were rash, pruritus, nausea, fatigue, headache, vomiting, myalgia, constipation and diarrhoea.
Danish: De hyppigste (≥10 %) ikke-hæmatologiske lægemiddelrelaterede bivirkninger var udslæt, pruritus, kvalme, træthed, hovedpine, opkastning, myalgi, obstipation og diarré.
English: Phototoxicity studies
Danish: Fototoksicitetsstudier
English: Excipient with known effect One hard capsule contains 156.11 mg lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på En hård kapsel indeholder 156,11 mg lactosemonohydrat.
English: Progression to accelerated phase or blast crisis on treatment was observed in a total of 17 patients: 2 patients on nilotinib 300 mg twice daily, 3 patients on nilotinib 400 mg twice daily and 12 patients on imatinib 400 mg once daily.
Danish: Progression til accelereret fase eller blastkrise i behandling blev observeret hos totalt 17 patienter: 2 patienter på nilotinib 300 mg 2 gange dagligt, 3 patienter på nilotinib 400 mg 2 gange dagligt og 12 patienter på imatinib 400 mg 1 gang dagligt.
English: This dose is achieved by taking two hard capsules of 200 mg twice a day.
Danish: Denne dosis fås ved at tage to hårde kapsler på 200 mg 2 gange dagligt.
English: In the same study as above, administration of an antacid (aluminium hydroxide/magnesium hydroxide/simethicone) 2 hours before or after a single 400 mg dose of nilotinib also did not alter nilotinib pharmacokinetics.
Danish: I det samme studie som nænvt ovenfor var der ingen ændringer i nilotinibs farmakokinetik ved administrationen af et antacidum (aluminiumhydroxid/magnesiumhydroxid/simethicon) 2 timer før eller efter en enkelt 400 mg dosis af nilotinib.
English: Adverse reactions that were reported in adult patients in the Tasigna Phase III study at a frequency of less than 5% are shown in Table 4.
Danish: Bivirkninger indberettet hos voksne patienter i fase III studier med Tasigna med en hyppighed på mindre end 5 % er vist i tabel 4.
English: By 12 months
Danish: MMR ved 12 måneder
English: Electrolyte imbalance (including hypomagnesaemia, hyperkalaemia, hypokalaemia, hyponatraemia, hypocalcaemia, hypercalcaemia, hyperphosphataemia), diabetes mellitus, hyperglycaemia, hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia
Danish: Forstyrrelser i elektrolytbalancen (herunder hypomagnesæmi, hyperkaliæmi, hypokaliæmi, hyponatriæmi, hypokalcæmi, hyperkalcæmi, hyperfosfatæmi), diabetes mellitus, hyperglykæmi, hyperkolesterolæmi, hyperlipidæmi, hypertriglyceridæmi
English: Alopecia, muscle spasms, decreased appetite, arthralgia, abdominal pain, bone pain, peripheral oedema, asthenia, upper abdominal pain, dry skin, erythema and pain in extremity were observed less commonly (<10% and ≥5%) and have been of mild to moderate severity (Grade 1 or 2).
Danish: Alopeci, muskelspasmer, nedsat appetit, artralgi, abdominalsmerter, knoglesmerter, perifere ødemer, asteni, øvre abdominalsmerter, tør hud, erytem og smerter i ekstremiteter blev observeret mindre almindeligt (<10 % og ≥5 %) og var milde til moderate (grad 1 eller 2).
English: There were slightly more male than female patients (56.0%, 62.3% and 55.8%, in the nilotinib 300 mg twice daily, 400 mg twice daily and imatinib 400 mg once daily arm, respectively).
Danish: Der var en lille overvægt af kvindelige patienter (56,0 %, 62,3 % og 55,8 %, i hhv. nilotinib 300 mg 2 gange dagligt, 400 mg 2 gange dagligt and imatinib 400 mg 1 gang dagligt).
English: Substances that may decrease nilotinib serum concentrations
Danish: Substanser, der kan mindske serumkoncentrationerne af nilotinib
English: Hyperuricaemia, hypoglycaemia Psychiatric disorders Common:
Danish: Hyperurikæmi, hypoglykæmi Psykiske forstyrrelser Almindelig:
English: Hypophosphataemia (including blood phosphorus decreased)
Danish: Meget almindelig: Hypofosfatæmi (herunder nedsat fosfor i blodet) Almindelig:
English: Adult patients with newly diagnosed chronic phase CML at 300 mg twice daily
Danish: Voksne patienter med nydiagnosticeret kronisk fase CML ved 300 mg 2 gange dagligt
English: CARTON OF MULTIPACK (WALLET) (INCLUDING BLUE BOX) CARTON OF MULTIPACK (CARTON) (INCLUDING BLUE BOX)
Danish: ÆSKE MED MULTIPAKNING (FOLDER) (INKLUSIVE BLÅ BOKS) ÆSKE MED MULTIPAKNING (KARTON) (INKLUSIVE BLÅ BOKS)
English: It is recommended that the lipid profiles be determined before initiating treatment with nilotinib, assessed at month 3 and 6 after initiating therapy and at least yearly during chronic therapy (see section 4.2).
Danish: Det anbefales, at lipidprofilen bestemmes før behandlingsstart med nilotinib, vurderes ved måned 3 og 6 efter behandlingsstart og mindst 1 gang årligt ved kronisk behandling (se pkt.
English: Adverse reactions that were reported in adult patients in the Tasigna clinical studies which serve as a basis for the approved indications at a frequency of less than 5% are shown in Table 4.
Danish: Bivirkninger indberettet hos voksne patienter i kliniske studier af Tasigna, som ligger til grund for de godkendte indikationer, med en hyppighed på mindre end 5 % er vist i Tabel 4.
English: The average nilotinib trough and peak concentrations over 12 months were approximately 15.7% and 14.8% higher following 400 mg twice daily dosing compared to 300 mg twice daily.
Danish: Den gennemsnitlige dal- og peakkoncentration af nilotinib over 12 måneder var ca. 15,7 % og 14,8 % højere efter en 400 mg 2 gange daglig dosering set i forhold til en 300 mg 2 gange daglig dosering.
English: Leukopenia, eosinophilia, febrile neutropenia, pancytopenia, lymphopenia
Danish: Leukopeni, eosinofili, febril neutropeni, pancytopeni, lymfopeni
English: Cumulative incidence of MR4.5 (BCR-ABL ≤0.0032% on the international scale), %
Danish: Kumulativ forekomst af MR4,5 (BCR-ABL ≤0,0032% på den internationale skala), %
English: Newly diagnosed CML-CP 300 mg twice daily n=279
Danish: Nydiagnosticeret CML-CP 300 mg 2 gange dagligt n=279
English: CARTON OF MULTIPACK (INCLUDING BLUE BOX)
Danish: ÆSKE MED MULTIPAKNING (INKLUSIVE BLÅ BOKS)
English: PA/Alu/PVC/Alu blisters
Danish: PA/Alu/PVC/Alu-blistere
English: Nilotinib is primarily metabolised by CYP3A4, with possible minor contribution from CYP2C8.
Danish: Nilotinib metaboliseres primært af CYP3A4, og CYP2C8 spiller muligvis en mindre rolle.
English: A total of 69 paediatric patients (from 2 to <18 years of age) with either newly diagnosed Ph+ CML in chronic phase (n=25) or imatinib/dasatinib resistant or imatinib-intolerant Ph+ CML in chronic phase (n=44) received nilotinib treatment at a dose of 230 mg/m twice daily, rounded to the nearest 50 mg dose (to a maximum single dose of 400 mg).
Danish: I alt 69 pædiatriske patienter (fra 2 til < 18 år) med enten nydiagnosticeret Ph+ CML i kronisk fase (n = 25) eller imatinib/dasatinib-resistent eller imatinib-intolerant Ph+ CML i kronisk fase (n = 44) modtog nilotinibbehandling med en dosis på 230 mg/m2 gange dagligt,
English: Imatinib-resistant or intolerant CML-CP and CML-AP 400 mg twice daily n=279
Danish: Imatinib-resistente eller intolerante CML-CP and CML-AP 400 mg 2 gange dagligt n=279
English: Erythema, hyperhidrosis, contusion, acne, dermatitis (including allergic, exfoliative and acneiform), night sweats, eczema
Danish: Erytem, hyperhidrose, kontusion, akne, dermatitis (inklusive allergisk, eksfoliativ og akneiform), natlige svedeture, eksem
English: Very common Nausea Very common Abdominal pain upper
Danish: Meget almindelig Hovedpine Mave-tarm-kanalen Meget almindelig Kvalme Meget almindelig Øvre abdominalsmerter Almindelig
English: The rates of MMR at 3, 6, 9 and 12 months were 8.9%, 33.0%, 43.3% and 44.3% for nilotinib 300 mg twice daily, 5.0%, 29.5%, 38.1% and 42.7% for nilotinib 400 mg twice daily and 0.7%, 12.0%, 18.0% and 22.3% for imatinib 400 mg once daily.
Danish: Raten for MMR ved 3, 6, 9 og 12 måneder var hhv. 8,9 %, 33,0 %, 43,3 % and 44,3 % for nilotinib 300 mg 2 gange dagligt, 5,0 %, 29,5 %, 381 % og 42,7 % for nilotinib 400 mg 2 gange dagligt, og 0,7 %, 12,0 %, 18,0 % and 22,3 % for imatinib 400 mg 1 gang dagligt.
English: Blood lactate dehydrogenase increased, blood glucose decreased, blood urea increased
Danish: Forhøjet laktatdehydrogenase i blodet, nedsat glucose i blodet, forhøjet urea i blodet
English: Treatment-emergent haematological toxicities include myelosuppression: thrombocytopenia (31%), neutropenia (17%) and anaemia (14%).
Danish: Behandlingsfremkaldt hæmatologisk toksicitet inkluderer myelosuppression: trombocytopeni (31 %), neutropeni (17 %) og anæmi (14 %).
English: - rapid weight gain, swelling of hands, ankles, feet or face (signs of water retention) - chest pain or discomfort, high or low blood pressure, irregular heart rhythm (fast or slow),
Danish: - hurtig vægtstigning, hævelse af hænder, ankler, fødder eller ansigt (tegn på vandophobning) - smerter eller ubehag i brystet, højt blodtryk, uregelmæssig hjerterytme (hurtig eller langsom),
English: Based on the Kaplan-Meier analysis of time to first MMR the probability of achieving MMR at different time points was higher for both nilotinib at 300 mg and 400 mg twice daily compared to imatinib 400 mg once daily (HR=2.17 and stratified log-rank p<0.0001 between nilotinib 300 mg twice daily and imatinib 400 mg once daily, HR=1.88 and stratified log-rank p<0.0001 between nilotinib 400 mg twice daily and imatinib 400 mg once daily).
Danish: Baseret på Kaplan-Meier analysen af tiden til første MMR var sandsynligheden for at opnå MMR på forskellig tid højere for både nilotinib 300 mg og 400 mg 2 gange dagligt sammenlignet med imatinib 400 mg 1 gang dagligt (HR=2,17 og stratificeret log-rank p<0,0001 mellem nilotinib 300 mg 2 gange dagligt and imatinib 400 mg 1 gang dagligt, HR=1,88 og stratificeret log-rank p<0,0001 mellem nilotinib 400 mg 2 gange dagligt og imatinib 400 mg 1 gang dagligt).
English: It is recommended that the glucose levels be assessed before initiating treatment with Tasigna and monitored during treatment, as clinically indicated (see section 4.2).
Danish: Det anbefales at vurdere glucoseniveauet før behandlingsstart med Tasigna og at monitorere blodglucose under behandlingen i henhold til klinisk praksis (se pkt.
English: Intracranial haemorrhage, ischaemic stroke, transient ischaemic attack, cerebral infarction, migraine, loss of consciousness (including syncope), tremor, disturbance in attention, hyperaesthesia
Danish: Intrakraniel blødning, iskæmisk apopleksi, transitorisk iskæmisk attak, cerebralt infarkt, migræne, bevidstløshed (herunder synkope), tremor, opmærksomhedsforstyrrelser, hyperæstesi
English: Patients with confirmed loss of MR4 (MR4= BCR-ABL/ABL ≤0.01%IS) during the treatment-free phase (two consecutive measures separated by at least 4 weeks showing loss of MR4) or loss of major molecular response (MMR=BCR-ABL/ABL ≤0.1%IS) must re-initiate treatment within 4 weeks of when loss of remission is known to have occurred.
Danish: Patienter med bekræftet tab af MR4 (MR4=BCR-ABL/ABL ≤0,01 % IS) i den behandlingsfri fase (to konsekutive målinger med mindst 4 ugers mellemrum, der viser tab af MR4) eller tab af major molekylært respons (MMR=BCR-ABL/ABL ≤0,1 % IS) skal genoptage behandlingen senest 4 uger efter tab af remission er blevet konstateret.
English: This dose is achieved by taking two hard capsules of 150 mg twice a day.
Danish: Denne dosis opnås ved at tage to hårde kapsler på 150 mg 2 gange dagligt.
English: Night sweats, eczema, urticaria, hyperhidrosis, contusion, acne, dermatitis (including allergic, exfoliative and acneiform)
Danish: Natlige svedeture, eksem, urticaria, hyperhidrose, kontusion, akne, dermatitis (inklusive allergisk, eksfoliativ og akneiform)