natgillin/translations-raw huggingface dataset:
PA/Alu/PVC/Alu [i folder] 28 hårde kapsler
PA/Alu/PVC/Alu [in wallet] 28 hard capsules
Hvis den tidligere dosis var 300 mg 2 gange dagligt hos voksne patienter, eller 230 mg/m2 gange dagligt i pædiatriske patienter, kan behandlingen genoptages ved 400 mg 1 gang dagligt hos voksne patienter, og 230 mg/m
If the prior dose was 300 mg twice daily in adult patients or 230 mg/m twice daily in paediatric patients, dosing may be resumed at 400 mg once daily in adult patients and at 230 mg/m once daily in paediatric patients once the toxicity has resolved.
Voksne patienter med nydiagnosticeret CML i kronisk fase ved 300 mg 2 gange dagligt og imatinib-resistente eller intolerante patienter med CML i kronisk fase ved 400 mg 2 gange dagligt
Adult patients with newly diagnosed chronic phase CML at 300 mg twice daily and imatinib-resistant or intolerant CML in chronic phase at 400 mg twice daily
ÆSKE MED ENKELTPAKNING (FOLDER) ÆSKE MED ENKELTPAKNING (KARTON)
CARTON OF UNIT PACK (WALLET) CARTON OF UNIT PACK (CARTON)
- 392 (14 pakninger med 28) hårde kapsler.
- 392 (14 packs of 28) hard capsules.
Tab af major molekylært respons (MMR=BCR-ABL/ABL ≤0,1 % IS) hos CML-patienter, som modtog nilotinib som første- eller andenlinje-behandling, eller bekræftet tab af MR4 (to konsekutive målinger med mindst 4 ugers mellemrum, som viser tab af MR4 (MR4=BCR-ABL/ABL ≤0,01% IS)) hos CML-patienter, som modtog nilotinib som andenlinje-behandling, skal medføre genoptagelse af behandlingen senest 4 uger efter tab af remission er blevet konstateret.
Loss of major molecular response (MMR=BCR-ABL/ABL ≤0.1%IS) in CML patients who received nilotinib as first- or second-line therapy, or confirmed loss of MR4 (two consecutive measures separated by at least 4 weeks showing loss of MR4 (MR4=BCR-ABL/ABL ≤0.01%IS)) in CML
laboratorieabnormaliteter), som rapporteres hos mindst 5 % af de voksne patienter, som blev behandlet med 300 mg nilotinib 2 gange dagligt i det randomiserede fase III studie, er vist i tabel 3.
Most frequently reported adverse reactions in Tasigna clinical studies Non-haematological adverse reactions (excluding laboratory abnormalities) that are reported in at least 5% of the adult patients treated with 300 mg of nilotinib twice daily in the randomised Phase III study are shown in Table 3.
Papilødem, korioretinopati, diplopi, fotofobi, hævede øjne, blefaritis, smerter i øjnene, allergisk konjunktivitis, okulær overfladesygdom
Papilloedema, chorioretinopathy, diplopia, photophobia, eye swelling, blepharitis, eye pain, conjunctivitis allergic, ocular surface disease Ear and labyrinth disorders Common:
Sjældne tilfælde af tumorlysesyndrom er blevet rapporteret for patienter behandlet med Tasigna.
Rare cases of tumour lysis syndrome have been reported in patients treated with Tasigna.
Tasigna 50 mg hårde kapsler nilotinib
Tasigna 50 mg hard capsules nilotinib
Tasigna 150 mg hårde kapsler nilotinib
Tasigna 150 mg hard capsules nilotinib
De estimerede rater af patienter, der var i live ved 72 måneder, var henholdsvis 91,6 %, 95,8 % og 91,4 % (HR=0,8934 og stratificeret log-rank p=0,7085 mellem nilotinib 300 mg 2 gange dagligt og imatinib, HR=0,4632 og stratificeret log-rank p=0,0314, mellem nilotinib 400 mg 2 gange dagligt og imatinib).
The estimated rates of patients alive at 72 months were 91.6%, 95.8% and 91.4%, respectively (HR=0.8934 and stratified log-rank p=0.7085 between nilotinib 300 mg twice daily and imatinib, HR=0.4632 and stratified log-rank p=0.0314 between nilotinib 400 mg twice daily and imatinib).
Sikkerheden og effekten af Tasigna hos pædiatriske patienter, fra 2 til < 18 år, med Philadelphiakromosom-positiv CML i kronisk fase er etableret (se pkt.
The safety and efficacy of Tasigna in paediatric patients with Philadelphia chromosome positive CML in chronic phase from 2 to less than 18 years of age have been established (see sections 4.8, 5.1 and 5.2).
Derfor bør samtidig administration af alternative lægemidler med mindre potentiale for CYP3A4-induktion vælges til patienter, der samtidig modtager nilotinib (se pkt.
Therefore, in patients receiving nilotinib, co-administration of alternative therapeutic agents with less potential for CYP3A4 induction should be selected (see section 4.5).
Nilotinib 300 mg 2 gange dagligt (n = 282) Nilotinib 400 mg 2 gange dagligt (n = 281)
Nilotinib 300 mg twice daily (n = 282) Nilotinib 400 mg twice daily (n = 281)
Der blev observeret QTcF på over 500 msek.
QTcF exceeding 500 msec was observed in <1% of patients.
De hårde kapsler er lysegule.
The hard capsules are light yellow.
Sikkerhedsinformation fra to studier om behandlingsophør med nilotinib er også beskrevet.
Safety information from a Tasigna treatment discontinuation study in CML patients who have been treated with nilotinib as first-line therapy is also provided.
Immunsystemet Ikke kendt:
Febrile neutropenia Immune system disorders Not known:
Tasigna 50 mg hårde kapsler
Tasigna 50 mg hard capsules
Sådan skal du tage Tasigna
How to take Tasigna
Abdominal udspiling, abdominalt ubehag, dysgeusi, flatulens
Abdominal distension, abdomnial discomfort, dysgeusia, flatulence
Seponering af behandling hos voksne Ph+ CML-patienter i kronisk fase, som har været i behandling med nilotinib som førstelinjebehandling og som har opnået et vedvarende dybt molekylært respons I et enkeltarmet, ikke-blindet studie blev der rekrutteret 215 voksne patienter med Ph+ CML i kronisk fase, som havde fået nilotinib som førstelinjebehandling i ≥2 år og havde opnået MR4.5 målt ved BCR-ABL-testen MolecularMD MRDx Patienterne skulle fortsætte behandling med nilotinib i yderligere 52 uger (nilotinib-konsolideringsfase).
Treatment discontinuation in adult Ph+ CML patients in chronic phase who have been treated with nilotinib as first-line therapy and who have achieved a sustained deep molecular response In an open-label, single-arm study, 215 adult patients with Ph+ CML in chronic phase treated with nilotinib in first-line for ≥2 years who achieved MR4.5 as measured with the MolecularMD MRDx BCR-ABL test were enrolled to continue nilotinib treatment for additional 52 weeks (nilotinib consolidation phase).
Ekstremitets-s merter
Pain in extremity
Nogle bivirkninger er ikke almindelige (kan påvirke op til 1 ud af 100 patienter) - øget hudfølsomhed - tør i munden, ondt i halsen, sår i munden - smerter i brystet - smerter og hævede led (gigt) - øget appetit - opmærksomhedsforstyrrelse - kan ikke opnå eller opretholde rejsning - brystforstørrelse hos mænd - influenzalignende symptomer - lungebetændelse, bronkitis - urinvejsinfektion - herpes virus infektion - svamp i munden eller skeden - stivhed i muskler og led, hævede led - følelse af, at kropstemperaturen ændrer sig (inklusive svedeture, kuldefølelse) - følsomme tænder
Some side effects are uncommon (may affect up to 1 in 100 people) - increased skin sensitivity - dry mouth, sore throat, mouth sores - breast pain - painful and swollen joints (gout) - increased appetite - attention disorder - inability to achieve or maintain an erection - breast enlargement in men - flu-like symptoms - pneumonia, bronchitis - urinary tract infection - herpes virus infection - oral or vaginal thrush - muscle and joint stiffness, joint swelling - feeling body temperature change (including feeling hot, feeling cold) - sensitive teeth
No Observed Effect Level (NOEL) for unge rotter anses for at være 6 mg/kg/dag baseret på en reduktion i kropsvægt hos begge køn og en forsinket preputial seperation hos hanrotter (som kan skyldes vægtreduktionen).
Based on a reduction in body weight in both genders and a delayed preputial separation in males (which may be associated with the reduction in weight), the No-Observed-Effect-Level in juvenile rats was considered to be 6 mg/kg/day.
- 120 (3 pakninger med 40) hårde kapsler.
- 120 (3 packs of 40) hard capsules.
Dosering til pædiatriske Philadelphiakromosom-positive CML-patienter Dosering til pædiatriske patienter er individuelt tilpasset og er baseret på kropsoverfladeareal (mg/m Den anbefalede dosis af nilotinib er 230 mg/m2 gange dagligt, afrundet til nærmeste 50 mg dosis (til en maksimal enkeltdosis på 400 mg) (se tabel 1).
The recommended dose of nilotinib is 230 mg/m twice daily, rounded to the nearest 50 mg dose (to a maximum single dose of 400 mg) (see Table 1).
De estimerede rater af patienter uden progression til accelereret fase eller blastkrise inklusive klonal evolution ved 72 måneder var henholdsvis 98,7 %, 97,9 % og 93,2 % (HR=0,1626 og stratificeret log-rank p=0,0009 mellem nilotinib 300 mg 2 gange dagligt og imatinib 1 gang dagligt, HR=0,2848 og stratificeret log-rank p=0,0085 mellem nilotinib 400 mg 2 gange dagligt og imatinib 1 gang dagligt).
The estimated rates of patients free from progression to accelerated phase or blast crisis including clonal evolution at 72 months were 98.7%, 97.9% and 93.2%, respectively (HR=0.1626 and stratified log-rank p=0.0009 between nilotinib 300 mg twice daily and imatinib once daily, HR=0.2848 and stratified log-rank p=0.0085 between nilotinib 400 mg twice daily and imatinib once daily).
I alt 199 (35,2 %) af alle patienter var ikke evaluerbare for MMR ved 36 måneder (87 i nilotinib-gruppen, der fik 300 mg 2 gange dagligt og 112 i imatinib-gruppen) på grund af manglende/ikke evaluerbare PCR-vurderinger (n=17), atypiske transkriptioner ved baseline (n=7), eller ophør før 36-måneder (n=175).
A total of 199 (35.2%) of all patients were not evaluable for MMR at 36 months (87 in the nilotinib 300 mg twice daily group and 112 in the imatinib group) due to missing/unevaluable PCR assessments (n=17), atypical transcripts at baseline (n=7), or discontinuation prior to the 36-month time point (n=175).
(eosinofiler) i blodet - øget indhold i blodet af lipase eller amylase (funktionen af bugspytkirtlen) - øget indhold i blodet af bilirubin eller leverenzymer (leverfunktionen) - øget indhold af kreatinin eller urinstof (nyrefunktionen) i blodet - lavt eller højt indhold af insulin i blodet (hormon, der regulerer blodsukkeret) - lavt eller højt indhold af sukker eller højt fedt-indhold (herunder kolesterol) i blodet - øget indhold af parathyroideahormon (et hormon som regulerer indholdet af calcium og fosfor) i blodet - ændringer af proteiner (lavt antal af globuliner eller tilstedeværelse af paraprotein) i blodet - højt indhold af enzymer (alkalisk fosfatase, laktatdehydrogenase eller kreatininfosfokinase) i blodet - højt indhold af kalium, calcium, fosfor eller urinsyre i blodet - lavt indhold af magnesium, kalium, natrium, calcium eller fosfor i blodet
During Tasigna treatment, you may also have some abnormal blood test results such as: low level of blood cells (white cells, red cells, platelets) or haemoglobin increase in the number of platelets or white cells, or specific types of white cells (eosinophils) in the blood high blood level of lipase or amylase (pancreas function) high blood level of bilirubin or liver enzymes (liver function) high blood level of creatinine or urea (kidney function) low or high blood level of insulin (a hormone regulating blood sugar level) low or high level of sugar, or high level of fats (including cholesterol) in the blood high blood level of parathyroid hormone (a hormone regulating calcium and phosphorus level) change in blood proteins (low level of globulins or presence of paraprotein) high blood levels of enzymes (alkaline phosphatase, lactate dehydrogenase or creatine phosphokinase) high blood level of potassium, calcium, phosphorus or uric acid low blood level of magnesium, potassium, sodium, calcium, or phosphorus
Hvis kun CML-relaterede dødsfald tages i betragtning, var de estimerede rater for total overlevelse ved 72 måneder henholdsvis 97,7 %, 98,5 % og 93,9 % (HR=0,3694 og stratificeret log-rank p=0,0302 mellem nilotinib 300 mg 2 gange dagligt og imatinib, HR=0,2433 og stratificeret log-rank p=0,0061,mellem nilotinib 400 mg 2 gange dagligt og imatinib).
Considering only CML-related deaths as events, the estimated rates of overall survival at 72 months were 97.7%, 98.5% and 93.9%, respectively (HR=0.3694 and stratified log-rank p=0.0302 between nilotinib 300 mg twice daily and imatinib, HR=0.2433 and stratified log-rank p=0.0061 between nilotinib 400 mg twice daily and imatinib).
(eosinofiler) i blodet - øget indhold i blodet af lipase eller amylase (funktionen af bugspytkirtlen) - øget indhold i blodet af bilirubin eller leverenzymer (leverfunktionen) - lavt eller højt indhold af insulin i blodet (hormon, der regulerer blodsukkeret) - lavt eller højt indhold af sukker eller højt fedt-indhold (herunder kolesterol) i blodet - øget indhold af parathyroideahormon (et hormon som regulerer indholdet af calcium og fosfor) i blodet - ændringer af proteiner (lavt antal af globuliner eller tilstedeværelse af paraprotein) i blodet - højt indhold af alkalisk fosfatase i blodet - højt indhold af kalium, calcium, fosfor eller unrinsyre i blodet - lavt indhold af kalium eller calcium i blodet
During Tasigna treatment, you may also have some abnormal blood test results such as: - low level of blood cells (white cells, red cells, platelets) or haemoglobin - increase in the number of platelets or white cells, or specific types of white cells (eosinophils) in the blood - high blood level of lipase or amylase (pancreas function) - high blood level of bilirubin or liver enzymes (liver function) - low or high blood level of insulin (a hormone regulating blood sugar level) - low or high level of sugar, or high level of fats (including cholesterol) in the blood - high blood level of parathyroid hormone (a hormone regulating calcium and phosphorus level) - change in blood proteins (low level of globulins or presence of paraprotein) - high blood level of alkaline phosphatase - high blood level of potassium, calcium, phosphorus or uric acid - low blood level of potassium or calcium
120 (3 pakninger med 40) hårde kapsler.
120 (3 packs of 40) hard capsules.
Titandioxid (E 171) Jernoxid, gul (E 172)
Titanium dioxide (E171) Yellow iron oxide (E172)
Nogle bivirkninger er almindelige (kan påvirke op til 1 ud af 10 patienter) - diarré, opkastning, mavesmerter, ubehag i maven efter måltider, luft i tarmene, hævelse eller opsvulmen af maven, forstoppelse - smerter i knoglerne, smerter i leddene, muskelspasmer, muskelsvaghed, smerter i armene eller benene, rygsmerter, smerte eller ubehag i siden af kroppen - infektioner i de øvre lufveje - tør hud, urenheder i huden, vorter, mindsket hudfølsomhed - tab af appetit, smagsforstyrrelser, vægtstigning - søvnløshed, angst, depression - natlige svedeture, stor svedafsondring
Some side effects are common (may affect up to 1 in 10 people) - diarrhoea, vomiting, abdominal pain, stomach discomfort after meals, flatulence, swelling or bloating of the abdomen, constipation - bone pain, pain in joints, muscle spasms, muscle weakness, pain in extremity, back pain, pain or discomfort in the side of the body - upper respiratory tract infections - dry skin, acne, wart, decreased skin sensitivity - loss of appetite, disturbed sense of taste, weight increase - insomnia, anxiety, depression - night sweats, excessive sweating
Nogle bivirkninger er meget almindelige (kan påvirke mere end 1 ud af 10 patienter) - hovedpine - træthed - muskelsmerte - kløe, udslæt - kvalme - hårtab - muskelskeletale smerter, muskelsmerter, smerter i arme og/eller ben, ledsmerter, knoglesmerter og ryg smerter efter ophør med behandlingen med Tasigna langsommere vækst hos børn og unge
Some side effects are very common (may affect more than 1 in 10 people) - headache - tiredness - muscle pain - itching, rash - nausea - hair loss - musculoskeletal pain, muscle pain, pain in extremity, pain in joints, bone pain and spinal pain upon discontinuing treatment with Tasigna - slowing of growth in children and adolescents
9/l og/eller trombocytter <10 x 10
9/l and/or platelet counts <10 x 10
Nogle bivirkninger er almindelige (kan påvirke op til 1 ud af 10 patienter) - infektioner i de øvre lufveje - ubehag i maven efter måltider, luft i tarmene, hævelse eller opsvulmen af maven - smerter i knoglerne, smerter i leddene, muskelspasmer, muskelsvaghed - smerter inklusive rygsmerter, nakkesmerter og smerter i lemmerne, smerte eller ubehag i siden af kroppen - tør hud, urenheder i huden, vorte, mindsket hudfølsomhed, nældefeber - tab af appetit, smagsforstyrrelser, vægtstigning eller vægttab - søvnløshed, depression, angst - natlige svedeture, stor svedafsondring - generel utilpashed - forstyrrelser af stemmen - næseblod - hyppig vandladning
Some side effects are common (may affect up to 1 in 10 people) - upper respiratory tract infections - stomach discomfort after meals, flatulence, swelling or bloating of the abdomen - bone pain, pain in joints, muscle spasms, muscle weakness - pain including back pain, neck pain and pain in extremity, pain or discomfort in the side of the body - dry skin, acne, wart, decreased skin sensitivity, hives - loss of appetite, disturbed sense of taste, weight decrease or increase - insomnia, depression, anxiety - night sweats, excessive sweating - generally feeling unwell - voice disorder - nose bleed - frequent urine output
De estimerede rater af patienter uden progression til accelereret fase eller blastkrise ved 72 måneder, var henholdsvis 99,3 %, 98,7 % og 95,2 % (HR=0,1599 og stratificeret log-rank p=0,0059 mellem nilotinib 300 mg 2 gange dagligt og imatinib 1 gang dagligt, HR=0,2457 og stratificeret log-rank p=0,0185 mellem nilotinib 400 mg 2 gange dagligt og imatinib 1 gang dagligt).
The estimated rates of patients free from progression to accelerated phase or blast crisis at 72 months were 99.3%, 98.7% and 95.2%, respectively (HR=0.1599 and stratified log-rank p=0.0059 between nilotinib 300 mg twice daily and imatinib once daily, HR=0.2457 and stratified log-rank p=0.0185 between nilotinib 400 mg twice daily and imatinib once daily).
Nogle bivirkninger er meget almindelige (kan påvirke mere end 1 ud af 10 patienter) - diarré - hovedpine - træthed, mangel på energi - muskelsmerte - kløe, udslæt - kvalme - mavesmerter - forstoppelse - opkastning - hårtab - muskelskeletale smerter, muskelsmerter, smerter i arme og/eller ben, ledsmerter, knoglesmerter og rygsmerter efter ophør med behandlingen med Tasigna - langsommere vækst hos børn og unge
Some side effects are very common (may affect more than 1 in 10 people) - diarrhoea - headache - tiredness, lack of energy - muscle pain - itching, rash - nausea - abdominal pain - constipation - vomiting - hair loss - musculoskeletal pain, muscle pain, pain in extremity, pain in joints, bone pain and spinal pain upon discontinuing treatment with Tasigna - slowing of growth in children and adolescents
Dosering til voksne Philadelphiakromosom-positive CML-patienter Den anbefalede dosis er: - 300 mg 2 gange dagligt til patienter med nydiagnosticeret CML i kronisk fase.
Posology for Philadelphia chromosome positive CML adult patients The recommended dose is: - 300 mg twice daily in newly diagnosed patients with CML in the chronic phase, - 400 mg twice daily in patients with chronic or accelerated phase CML with resistance or intolerance to prior therapy.
Imatinib 400 mg 1 gang dagligt n=283
Imatinib 400 mg once daily n=283
I fase III-studiet med patienter med nydiagnosticeret CML i kronisk fase, som behandledes med 300 mg imatinib to gange dagligt, var den gennemsnitlige ændring fra baseline i QTcF-intervallet ved steady state 6 msek.
In the Phase III study in patients with newly diagnosed CML in chronic phase receiving 300 mg nilotinib twice daily, the change from baseline in mean time-averaged QTcF interval at steady state was 6 msec. No patient had a QTcF >480 msec. No episodes of torsade de pointes were observed.
Hvidt til gulligt pulver i hård gelatinekapsel med rød, uigennemsigtig øverste del og lysegul, uigennemsigtig nederste del, størrelse 4 med ”NVR/ABL” præget med sort på øverste del. Tasigna 200 mg hårde kapsler
White to yellowish powder in hard gelatin capsule with red opaque cap and light yellow opaque body, size 4 with black radial imprint “NVR/ABL” on cap.
Øjenlågsødem, fotopsi, konjunktival blødning, hyperæmi (skleral, konjunktival, okulær)
Eyelid oedema, photopsia, conjunctival haemorrhage, hyperaemia (scleral, conjunctival, ocular)
I alt 322 (38,1 %) af alle patienter var ikke evaluerbare for MMR efter 60 måneder (99 i nilotinib 300 mg to gange dagligt gruppen, 93 i nilotinib 400 mg to gange dagligt gruppen og 130 i imatinib-gruppen) på grund af manglende / ikke evaluerbare PCR-vurderinger (n=9), atypiske transkripter ved baseline (n=8) eller seponering forud for 60-måneders tidspunktet (n=305).
A total of 322 (38.1%) of all patients were not evaluable for MMR at 60 months (99 in the nilotinib 300 mg twice daily group, 93 in the nilotinib 400 mg twice daily group and 130 in the imatinib group) due to missing/unevaluable PCR assessments (n=9), atypical transcripts at baseline (n=8) or discontinuation prior to the 60-month time point (n=305).
Delpakning af multipakning med 4 pakninger.
Component of a multipack comprising 4 cartons.
Multipakning: 112 (4 pakninger med 28) hårde kapsler.
Multipack: 112 (4 packs of 28) hard capsules.
10 % af patienterne seponerede Tasigna på grund af bivirkninger.
Discontinuation due to adverse drug reactions was observed in 10% of patients.
• Multipakninger indeholdende 112 (4 pakninger med 28) hårde kapsler.
• Multipacks containing 112 (4 packs of 28) hard capsules.
I alt 395 (46,7 %) af alle patienter var ikke evaluerbare for MMR efter 72 måneder (130 i nilotinib 300 mg to gange dagligt gruppen, 110 i nilotinib 400 mg to gange dagligt gruppen og 155 i imatinib-gruppen) på grund af manglende / ikke evaluerbare PCR-vurderinger (n=25), atypiske transkripter ved baseline (n=8) eller seponering forud for 72-måneders tidspunktet (n=362).
A total of 395 (46.7%) of all patients were not evaluable for MMR at 72 months (130 in the nilotinib 300 mg twice daily group, 110 in the nilotinib 400 mg twice daily group and 155 in the imatinib group) due to missing/unevaluable PCR assessments (n=25), atypical transcripts at baseline (n=8) or discontinuation prior to the 72-month time point (n=362).
PVC/PVDC/Alu [i karton] 40 hårde kapsler
PVC/PVDC/Alu [in carton] 40 hard capsules
Nedsat uddrivningsfraktion, perikardiel effusion, perikarditis, diastolisk dysfunktion, ventresidig grenblok Vaskulære sygdomme Almindelig:
Ejection fraction decrease, pericardial effusion, pericarditis, diastolic dysfunction, left bundle branch block
CML-AP n=137 Grad 3-4
CMLAP n=137 Grade
De fleste af patienterne havde et langt forløb med CML med ekstensiv forudgående behandling med andre antineoplastiske stoffer, inkl.
The majority of patients had a long history of CML that included extensive prior treatment with other antineoplastic agents, including imatinib, hydroxyurea, interferon, and some had even failed organ transplant (Table 11).
PVC/PVDC/Alu [i karton] 120 hårde kapsler
PVC/PVDC/Alu [in carton] 120 hard capsules
CML-C P n=321 Grad
CMLCP n=321 Grade
PVC/PVDC/Alu [i karton] 112 hårde kapsler
PVC/PVDC/Alu [in carton] 112 hard capsules
Almindelig 6
1 Common
BCR-ABL kinase-domæne-mutationstest skal udføres hos patienter, der ikke kan opretholde MMR 3 måneder efter genoptagelse af behandlingen.
For patients who fail to achieve MMR after three months of treatment re-initiation, BCR-ABL kinase domain mutation testing should be performed.
Det kan overvejes at seponere behandling af egnede voksne Philadelphiakromosom-positive (Ph+) CML-patienter i kronisk fase, som er blevet behandlet med 300 mg nilotinib to gange dagligt i mindst 3 år, hvis et dybt molekylært respons har været opretholdt i mindst et år umiddelbart før seponering af behandlingen.
Adult Philadelphia chromosome positive CML patients in chronic phase who have been treated with nilotinib as first-line therapy and who achieved a sustained deep molecular response (MR4.5) Discontinuation of treatment may be considered in eligible adult Philadelphia chromosome positive (Ph+) CML patients in chronic phase who have been treated with nilotinib at 300 mg twice daily for a minimum of 3 years if a deep molecular response is sustained for a minimum of one year immediately prior to discontinuation of therapy.