natgillin/translations-raw huggingface dataset:
Dosering til voksne Philadelphiakromosom-positive CML-patienter Den anbefalede dosis er 300 mg 2 gange dagligt. 
Posology for Philadelphia chromosome positive CML adult patients The recommended dose is 300 mg twice daily.
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. 
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.
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 
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
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 
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
Et studie udført på den pædiatriske CML population har dokumenteret væksthæmning hos patienter behandlet med nilotinib (se pkt. 
In a study in the CML paediatric population, growth retardation has been documented in patients treated with nilotinib (see section 4.8).
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. 
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.
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). 
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).
- 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. 
- Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
Hepatotoksicitet, toksisk hepatitis, icterus 
Hepatotoxicity, toxic hepatitis, jaundice
Hjælpestof, som behandleren skal være opmærksom på En hård kapsel indeholder 39,03 mg lactosemonohydrat. 
Excipient with known effect One hard capsule contains 39.03 mg lactose monohydrate.
28 hårde kapsler 40 hårde kapsler 
28 hard capsules 40 hard capsules
Ved 12 måneder Respons (95 % CI) Intet respons 
Response (95% CI) No response
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. 
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.
Seponering af behandling hos voksne Ph+ CML-patienter i kronisk fase, som har opnået et vedvarende dybt molekylært respons 
Treatment discontinuation in adult Ph+ CML patients in chronic phase who have achieved a sustained deep molecular response
Der er i sjældne tilfælde set pludselige dødsfald hos patienter, der tog Tasigna. 
Uncommon cases of sudden death have been reported in patients taking Tasigna.
Figur 2 Kumulativ forekomst af molekulært respons på ≤0,01 % (4-log-reduktion) 
Figure 2 Cumulative incidence of molecular response of ≤0.01% (4-log reduction)
Lipidprofilen skal bestemmes før behandlingsstart med nilotinib, vurderes ved måned 3 og 6 efter behandlingsstart og mindst 1 gang årligt ved kronisk behandling. 
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.
De hyppigste (≥10 %) ikke-hæmatologiske bivirkninger var udslæt, hovedpine, kvalme, træthed, alopeci, myalgi og øvre abdominalsmerte. 
The most frequent (≥10%) non-haematological adverse reactions were rash, pruritus, headache, nausea, fatigue, alopecia, myalgia and upper abdominal pain.
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. 
Daily systemic exposure to nilotinib with 400 mg twice-daily dosing at steady state was 35% higher than with 800 mg once-daily dosing.
Nydiagnosticeret CML-CP 300 mg 2 gange dagligt 
Newly diagnosed CML-CP 300 mg twice daily
Leukopeni, eosinofili, lymfopeni 
Leukopenia, eosinophilia, lymphopenia
Behandling skal genoptages inden 2 uger ved tidligere dosis, hvis ANC >1,0 x 10 
Treatment must be resumed within 2 weeks at prior dose if ANC >1.0 x 10
Meget almindelig Træthed 
Very common Fatigue Common
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. 
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.
De hyppigste (≥10 %) ikke-hæmatologiske lægemiddelrelaterede bivirkninger var udslæt, pruritus, kvalme, træthed, hovedpine, opkastning, myalgi, obstipation og diarré. 
The most frequent (≥10%) non-haematological drug-related adverse events were rash, pruritus, nausea, fatigue, headache, vomiting, myalgia, constipation and diarrhoea.
Fototoksicitetsstudier 
Phototoxicity studies
Hjælpestof, som behandleren skal være opmærksom på En hård kapsel indeholder 156,11 mg lactosemonohydrat. 
Excipient with known effect One hard capsule contains 156.11 mg lactose monohydrate.
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. 
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.
Denne dosis fås ved at tage to hårde kapsler på 200 mg 2 gange dagligt. 
This dose is achieved by taking two hard capsules of 200 mg twice a day.
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. 
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.
Bivirkninger indberettet hos voksne patienter i fase III studier med Tasigna med en hyppighed på mindre end 5 % er vist i tabel 4. 
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.
MMR ved 12 måneder 
By 12 months
Forstyrrelser i elektrolytbalancen (herunder hypomagnesæmi, hyperkaliæmi, hypokaliæmi, hyponatriæmi, hypokalcæmi, hyperkalcæmi, hyperfosfatæmi), diabetes mellitus, hyperglykæmi, hyperkolesterolæmi, hyperlipidæmi, hypertriglyceridæmi 
Electrolyte imbalance (including hypomagnesaemia, hyperkalaemia, hypokalaemia, hyponatraemia, hypocalcaemia, hypercalcaemia, hyperphosphataemia), diabetes mellitus, hyperglycaemia, hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia
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). 
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).
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). 
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).
Substanser, der kan mindske serumkoncentrationerne af nilotinib 
Substances that may decrease nilotinib serum concentrations
Hyperurikæmi, hypoglykæmi Psykiske forstyrrelser Almindelig: 
Hyperuricaemia, hypoglycaemia Psychiatric disorders Common:
Meget almindelig: Hypofosfatæmi (herunder nedsat fosfor i blodet) Almindelig: 
Hypophosphataemia (including blood phosphorus decreased)
Voksne patienter med nydiagnosticeret kronisk fase CML ved 300 mg 2 gange dagligt 
Adult patients with newly diagnosed chronic phase CML at 300 mg twice daily
ÆSKE MED MULTIPAKNING (FOLDER) (INKLUSIVE BLÅ BOKS) ÆSKE MED MULTIPAKNING (KARTON) (INKLUSIVE BLÅ BOKS) 
CARTON OF MULTIPACK (WALLET) (INCLUDING BLUE BOX) CARTON OF MULTIPACK (CARTON) (INCLUDING BLUE BOX)
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. 
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).
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. 
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.
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. 
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.
Leukopeni, eosinofili, febril neutropeni, pancytopeni, lymfopeni 
Leukopenia, eosinophilia, febrile neutropenia, pancytopenia, lymphopenia
Kumulativ forekomst af MR4,5 (BCR-ABL ≤0,0032% på den internationale skala), % 
Cumulative incidence of MR4.5 (BCR-ABL ≤0.0032% on the international scale), %
Nydiagnosticeret CML-CP 300 mg 2 gange dagligt n=279 
Newly diagnosed CML-CP 300 mg twice daily n=279
ÆSKE MED MULTIPAKNING (INKLUSIVE BLÅ BOKS) 
CARTON OF MULTIPACK (INCLUDING BLUE BOX)
PA/Alu/PVC/Alu-blistere 
PA/Alu/PVC/Alu blisters
Nilotinib metaboliseres primært af CYP3A4, og CYP2C8 spiller muligvis en mindre rolle. 
Nilotinib is primarily metabolised by CYP3A4, with possible minor contribution from CYP2C8.
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, 
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).
Imatinib-resistente eller intolerante CML-CP and CML-AP 400 mg 2 gange dagligt n=279 
Imatinib-resistant or intolerant CML-CP and CML-AP 400 mg twice daily n=279
Erytem, hyperhidrose, kontusion, akne, dermatitis (inklusive allergisk, eksfoliativ og akneiform), natlige svedeture, eksem 
Erythema, hyperhidrosis, contusion, acne, dermatitis (including allergic, exfoliative and acneiform), night sweats, eczema
Meget almindelig Hovedpine Mave-tarm-kanalen Meget almindelig Kvalme Meget almindelig Øvre abdominalsmerter Almindelig 
Very common Nausea Very common Abdominal pain upper
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. 
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.
Forhøjet laktatdehydrogenase i blodet, nedsat glucose i blodet, forhøjet urea i blodet 
Blood lactate dehydrogenase increased, blood glucose decreased, blood urea increased
Behandlingsfremkaldt hæmatologisk toksicitet inkluderer myelosuppression: trombocytopeni (31 %), neutropeni (17 %) og anæmi (14 %). 
Treatment-emergent haematological toxicities include myelosuppression: thrombocytopenia (31%), neutropenia (17%) and anaemia (14%).
- hurtig vægtstigning, hævelse af hænder, ankler, fødder eller ansigt (tegn på vandophobning) - smerter eller ubehag i brystet, højt blodtryk, uregelmæssig hjerterytme (hurtig eller langsom), 
- 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),
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). 
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).
Det anbefales at vurdere glucoseniveauet før behandlingsstart med Tasigna og at monitorere blodglucose under behandlingen i henhold til klinisk praksis (se pkt. 
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).
Intrakraniel blødning, iskæmisk apopleksi, transitorisk iskæmisk attak, cerebralt infarkt, migræne, bevidstløshed (herunder synkope), tremor, opmærksomhedsforstyrrelser, hyperæstesi 
Intracranial haemorrhage, ischaemic stroke, transient ischaemic attack, cerebral infarction, migraine, loss of consciousness (including syncope), tremor, disturbance in attention, hyperaesthesia
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. 
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.
Denne dosis opnås ved at tage to hårde kapsler på 150 mg 2 gange dagligt. 
This dose is achieved by taking two hard capsules of 150 mg twice a day.
Natlige svedeture, eksem, urticaria, hyperhidrose, kontusion, akne, dermatitis (inklusive allergisk, eksfoliativ og akneiform) 
Night sweats, eczema, urticaria, hyperhidrosis, contusion, acne, dermatitis (including allergic, exfoliative and acneiform)
Claudicatio intermittens, perifer arteriel okklusiv sygdom, arteriosklerose 
Intermittent claudication, peripheral arterial occulsive disease, arteriosclerosis
Herpes virus infektion, oral candidiasis, subkutan absces, anal absces, tinea pedis, hepatitis B reaktivering Benigne, maligne og uspecificerede tumorer (inkl. 
Herpes virus infection, oral candidiasis, subcutaneous abscess, anal abscess, tinea pedis, hepatitis B reactivation Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
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 
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
PVC/PVDC/Alu- blister. 
PVC/PVDC/Alu blisters.
Der anbefales tæt monitorering af pædiatriske patienters vækst under behandling med nilotinib (se pkt. 
Close monitoring of growth in paediatric patients under nilotinib treatment is recommended (see section 4.4).
Figur 3 Kumulativ forekomst af molekulært respons på ≤0,0032 % (4,5 log-reduktion) 
Figure 3 Cumulative incidence of molecular response of ≤0.0032% (4.5 log reduction)
Diabetes mellitus, hyperkolesterolæmi, hyperlipidæmi, hypertriglyceridæmi, hyperglykæmi, nedsat appetit, hypokalcæmi, hypokaliæmi 
Diabetes mellitus, hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia, hyperglycaemia, decreased appetite, hypocalcaemia, hypokalaemia
Hvis du ikke kan synke kapsler, kan du komme indholdet af en hård kapsel på én teske med æblemos, og derefter tage det straks. 
If so, you may sprinkle the content of each hard capsule in one teaspoon of apple sauce and take it immediately.
Frekvens sjælden: Tilfælde af tumor lysis syndrom er blevet rapporteret hos patienter behandlet med nilotinib. 
Frequency rare: Cases of tumour lysis syndrome have been reported in patients treated with nilotinib.
Bilirubin og levertransaminaseniveauer skal testes hver måned eller hvor det er klinisk relevant. 
Bilirubin and hepatic transaminases levels should be tested monthly or as clinically indicated.
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. 
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.
De hårde kapsler er præget med rødt (”NVR/TKI”). 
A red imprint is stamped on each hard capsule (“NVR/TKI”).
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. 
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.
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). 
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).
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. 
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.
Medikamentelt udslæt, smerte i huden 
Drug eruption, skin pain
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. 
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.
Brystsmerter (inklusive ikke-kardielle brystsmerter), smerter, feber, ubehag i brystet, utilpashed 
Chest pain (including non-cardiac chest pain), pain, pyrexia, chest discomfort, malaise
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. 
In addition, tell your doctor or pharmacist before taking Tasigna if you are taking any antacids, which are medicines against heartburn.
Hjertesvigt, myokardieinfarkt, koronararteriesygdom, hjertemislyd, perikardiel effusion, cyanose 
Cardiac failure, myocardial infarction, coronary artery disease, cardiac murmur, pericardial effusion, cyanosis
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. 
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).
Hvis tallene fortsat er lave, kan en dosisreduktion til 230 mg/m 
If blood counts remain low, a dose reduction to 230 mg/m once daily may be required.