FrancophonIA/ELRC3.0 huggingface dataset:
English: What Tasigna looks like and contents of the pack Tasigna is supplied as hard capsules.
Danish: Tasigna leveres som hårde kapsler.
English: 40 hard capsules.
Danish: 40 hårde kapsler.
English: A black imprint is stamped on each hard capsule (“NVR/ABL”).
Danish: De hårde kapsler er præget med sort (”NVR/ABL”).
English: PVC/PVDC/Alu blisters
Danish: PVC/PVDC/Alu-blistere
English: Concomitant treatment with strong CYP3A4 inhibitors, including ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin, and telithromycin, should therefore be avoided (see section 4.4).
Danish: ketoconazol, itraconazol, voriconazol, ritonavir, clarithromycin og telithromycin, bør derfor undgås (se pkt.
English: No new events of progression to AP/BC were reported on-treatment since the 2-year analysis.
Danish: Der blev ikke rapporteret nye tilfælde af progression til accelereret fase/blastkrise under behandling efter 2-års-analysen.
English: Troponin increased, blood bilirubin unconjugated increased, blood insulin decreased, insulin C-peptide decreased, blood parathyroid hormone increased
Danish: Forhøjet troponin, forhøjet ukonjugeret bilirubin i blodet, nedsat insulin i blodet, nedsat insulin C-peptid, forhøjet parathyroideahormon i blodet
English: When to take Tasigna
Danish: Hvornår du skal tage Tasigna
English: If the prior dose was 300 mg twice daily in adult newly diagnosed patients with CML in the chronic phase, or 400 mg twice daily in adult patients with imatinib-resistant or intolerant CML in chronic or accelerated phase, 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.
Danish: Hvis den tidligere dosis var 300 mg 2 gange dagligt hos voksne patienter med nydiagnosticeret CML i den kroniske fase, eller 400 mg 2 gange dagligt hos voksne patienter med imatinib-resistent eller intolerant CML i kronisk eller accelereret fase, eller 230 mg/m2 gange dagligt i pædiatriske patienter, kan behandlingen genoptages ved 400 mg 1 gang dagligt hos voksne patienter, og 230 mg/m2 gang dagligt hos pædiatriske patienter, når toksiciteten er svundet.
English: CCyR rate by 24 months (includes patients who achieved CCyR at or before the 24 month time point as responders) was statistically higher for both the nilotinib 300 mg twice daily and 400 mg twice daily groups compared to the imatinib 400 mg once daily group.
Danish: CCyR-rate ved 24 måneder (inkluderer patienter, der opnåede CCyR ved eller før 24 måneders-tidspunktet, som respondenter) var statistisk signifikant højere for både gruppen, der fik nilotinib 300 mg 2 gange dagligt, og gruppen, der fik nilotinib 400 mg 2 gange dagligt, sammenlignet med gruppen, der fik imatinib 400 mg 1 gang dagligt.
English: Nervous system disorders Headache
Danish: Nervesystemet Hovedpine Meget almindelig
English: Eye pruritus, conjunctivitis, dry eye (including xerophthalmia)
Danish: Øjenkløe, konjunktivitis, tørre øjne (inklusive xeroftalmi)
English: Cardiac disorders (reported in 300 mg twice daily and/or 400 mg twice daily treatment arm of phase III study) Common:
Danish: Hjerte (rapporteret i fase III studie med behandlingsarm 300 mg 2 gange dagligt og/eller 400 mg 2 gange dagligt)
English: Pyrexia, chest pain (including non-cardiac chest pain), chest discomfort
Danish: Feber, brystsmerter (inklusive ikke-kardielle brystsmerter), ubehag i brystet
English: Uncommon:
Danish: Ikke-almindelig:
English: The following other side effects have been reported with frequency not known (cannot be estimated from the available data): - allergy (hypersensitivity to Tasigna) - memory loss, disturbed or depressed mood, lack of energy - oral thrush - skin cyst, thinning or thickening of the skin, thickening of the outermost layer of the skin, skin discolouration, hives, fungal infection of the feet
Danish: Følgende andre bivirkninger er observeret med hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data): - allergi (overfølsomhed over for Tasigna) - hukommelsestab, ændret eller nedsat humør, mangel på energi - svamp i munden - vabler, tyndere eller fortykket hud, fortykning af de yderste lag i huden, misfarvning af huden,
English: Ventricular dysfunction, pericarditis, ejection fraction decreased
Danish: Ventrikulær dysfunktion, perikarditis, nedsat uddrivningsfraktion
English: 18 <1 Very common
Danish: 18 <1 Meget almindelig
English: Black iron oxide (E172) n-Butyl alcohol Propylene glycol Dehydrated ethanol Isopropylalcohol Ammonium hydroxide
Danish: Jernoxid, sort (E 172) n-Butylalkohol Propylenglycol Vandfri alkohol Isopropylalkohol Ammoniumhydroxid
English: How much Tasigna to take
Danish: Så meget Tasigna skal du tage
English: 33 <1 Very common
Danish: 33 <1 Meget almindelig
English: Blood parathyroid hormone increased, blood insulin decreased, insulin C-peptide decreased, weight decreased
Danish: Forhøjet parathyroideahormon i blodet, nedsat insulin i blodet, nedsat insulin C-peptid, vægttab
English: 28 hard capsules.
Danish: 28 hårde kapsler.
English: The concomitant administration of other medicinal products that induce CYP3A4 (e.g., phenytoin, carbamazepine, phenobarbital and St. John's Wort) is likewise likely to reduce exposure to nilotinib to a clinically relevant extent.
Danish: Samtidig administration af andre lægemidler, som inducerer CYP3A4 (f.eks. phenytoin, carbamazepin, phenobarbital og perikon), kan ligeledes sandsynligvis mindske eksponeringen for nilotinib i klinisk relevant grad.
English: Shock haemorrhagic, hypotension, thrombosis Respiratory, thoracic and mediastinal disorders Common:
Danish: Hæmoragisk shock, hypotension, trombose Luftveje, thorax og mediastinum Almindelig:
English: Of the patients who achieved HR, 53% (95% CI: 39% - 67%) were maintaining response at 24 months.
Danish: Af de patienter, som opnåede HR, var responset opretholdt hos 53 % (95 % CI: 39-67 %) ved måned 24.
English: However, patients with hepatic impairment should be treated with caution (see section 4.4).
Danish: Patienter med nedsat leverfunktion skal dog behandles med forsigtighed (se pkt.
English: Hypertensive crisis, peripheral arterial occlusive disease, intermittent claudication, arterial stenosis limb, haematoma, arteriosclerosis
Danish: Hypertensiv krise, perifer arteriel okklusiv sygdom, claudicatio intermittens, arteriestenose i ekstremitet, hæmatomer, arteriosklerose
English: Patients who re-initiate nilotinib therapy should have their BCR-ABL transcript levels monitored monthly until MMR 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 MMR retableres, og herefter hver 12. uge (se pkt.
English: Hypertension, flushing
Danish: Hypertension, rødmen
English: If you are told to discontinue Tasigna, your doctor will continue to carefully monitor your CML before, during and after you have discontinued Tasigna and may tell you to re-start Tasigna if your condition indicates that this is necessary.
Danish: Hvis du får at vide, at du skal holde op med at tage Tasigna, vil din læge fortsætte med at overvåge din CML nøje før, under og efter at du er holdt op med at tage Tasigna.
English: In adult patients with imatinib-resistant or intolerant CML in chronic phase and accelerated phase The data described below reflect exposure to nilotinib in 458 adult patients in an open-label multicentre Phase II study in 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: Hos voksne imatinib-resistente eller intolerante patienter med kronisk og accelereret CML De nedenfor beskrevne data afspejler 458 voksne patienters eksponering for nilotinib i et open-label-, multicenter fase II-studie hos imatinibresistente eller -intolerante CML-patienter i kronisk fase (CP) (n=321) eller accelereret fase (AP) (n=137).
English: Gastrointestinal haemorrhage, melaena, mouth ulceration, gastroesophageal reflux, stomatitis, oesophageal pain, dry mouth, gastritis, sensitivity of teeth
Danish: Gastrointestinal blødning, melæna, mundsår, gastroøsofageal reflux, stomatitis, smerter i øsofagus, mundtørhed, gastritis, følsomme tænder
English: Dyspnoea, dyspnoea exertional, epistaxis, cough, dysphonia
Danish: Dyspnø, funktionsdyspnø, epistaxis, hoste, dysfoni
English: In a Phase II clinical study with newly diagnosed adult patients with Ph+ CML in chronic phase (N=190), musculoskeletal symptoms were reported within a year of Tasigna discontinuation in 24.7% versus 16.3% within the previous year on nilotinib treatment.
Danish: I et klinisk fase II-studie med nydiagnosticerede voksne patienter med Ph+ CML i kronisk fase (N=190) blev der rapporteret muskuloskeletale symptomer inden for et år efter seponering af Tasigna hos 24,7 % versus 16,3 % i det foregående år med behandling med nilotinib.
English: Tasigna 50 mg hard capsules Tasigna 200 mg hard capsules
Danish: Tasigna 50 mg hårde kapsler Tasigna 200 mg hårde kapsler
English: Component of a multipack comprising 14 cartons.
Danish: Delpakning af multipakning med 14 pakninger.
English: If clinically appropriate, re-escalation of the dose to the starting dose of 300 mg twice daily in adult newly diagnosed patients with CML in the chronic phase or to 400 mg twice daily in adult patients with imatinib-resistant or intolerant CML in chronic or accelerated phase 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 doseringen for startdosis til 300 mg 2 gange dagligt til nydiagnosticerede voksne patienter med CML i kronisk fase eller til 400 mg 2 gange dagligt til imatinib-resistente eller intolerante voksne patienter med kronisk eller accelereret CML, eller 230 mg/m2 gange dagligt hos pædiatriske patienter.
English: • Pack containing 120 (3 packs of 40) hard capsules.
Danish: • Pakning indeholdende 120 (3 pakninger med 40) hårde kapsler.
English: White to yellowish powder in red opaque hard gelatin capsules, size 1 with black axial imprint “NVR/BCR”.
Danish: Hvidt til gulligt pulver i røde uigennemsigtige hårde gelatinekapsler, størrelse 1 med ”NVR/BCR” præget medsort.
English: If a HMG-CoA reductase inhibitor (a lipid-lowering agent) is required, please refer to section 4.5 before initiating treatment since certain HMG-CoA reductase inhibitors are also metabolised by the CYP3A4 pathway.
Danish: 4.5 før behandlingsstart, da nogle HMG-CoA-reduktase-hæmmere også metaboliseres af CYP3A4-enzymsystemet.
English: INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Danish: KARTON MED DELPAKNINGER I MULTIPAKNING (UDEN BLÅ BOKS)
English: The hard capsule shell is composed of gelatin, titanium dioxide (E171), yellow iron oxide (E172) and, shellac (E904), dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and red iron oxide (E172) for stamping of the imprint.
Danish: Den hårde kapsel består af gelatine, titandioxid (E 171), gul jernoxid (E 172) og shellac (E 904), dehydreret alkohol, isopropylalkohol, butylalkohol, propylenglycol, stærk ammoniakopløsning, kaliumhydroxid og rød jernoxid (E 172) til prægning.
English: If the prior dose was 230 mg/m once daily, treatment should be discontinued.
Danish: Såfremt den tidligere dosis var 230 mg/m2 gange dagligt kan behandlingen genoptages med
English: The Kaplan-Meier (KM) estimated median time on nilotinib to regain MR4.0 and MR4.5 was 12.0 weeks (95% CI: 8.3, 12.7) and 13.1 weeks (95% CI: 12.4, 16.1), respectively.
Danish: Den estimerede Kaplan-Meier (KM) mediantid med nilotinib-behandling til genvinding af MR4.0 og MR4.5 var henholdsvis 12,0 uger (95 % CI: 8,3; 12,7) og 13,1 uger (95 % CI: 12,4; 16,1).
English: - 112 (4 packs of 28) hard capsules.
Danish: - 112 (4 pakninger med 28) hårde kapsler.
English: Imatinib 400 mg once daily (n = 283)
Danish: Imatinib 400 mg 1 gang dagligt (n = 283)
English: INTERMEDIATE WALLET OF MULTIPACK (WITHOUT BLUE BOX) INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Danish: FOLDER MED DELPAKNINGER I MULTIPAKNING (UDEN BLÅ BOKS) KARTON MED DELPAKNINGER I MULTIPAKNING (UDEN BLÅ BOKS)
English: The Kaplan-Meier (KM) estimated median time on nilotinib treatment to regain MMR and MR4.5 was 7.9 weeks (95% CI: 5.1, 8.0) and 13.1 weeks (95% CI: 12.3, 15.7), respectively.
Danish: Den estimerede Kaplan-Meier (KM) mediantid med nilotinib-behandling til genvinding af MMR og MR4.5 var henholdsvis 7,9 uger (95 % CI: 5,1; 8,0) og 13,1 uger (95 % CI: 12,3; 15,7).
English: 40 hard capsules
Danish: 40 hårde kapsler
English: Accelerated phase n=137
Danish: Accelereret CML n=137
English: Visual impairment, vision blurred, conjunctival haemorrhage, visual acuity reduced, eyelid oedema, photopsia, hyperaemia (scleral, conjunctival, ocular), eye irritation
Danish: Nedsat syn, sløret syn, konjunktival blødning, nedsat synsskarphed, øjenlågsødem, fotopsi, hyperæmi (skleral, konjunktival, okulær), øjenirritation
English: The KM estimated MMR and MR4.5 rates at 24 weeks of re-initiation were 98.8% (95% CI: 94.2, 99.9) and 90.9% (95% CI: 83.2, 96.0), respectively.
Danish: De estimerede KM MMR- og MR4.5-rater 24 uger efter genoptagelse var henholdsvis 98,8 % (95 % CI: 94,2; 99,9) og 90,9 % (95 % CI: 83,2; 96,0).
English: Haemoglobin decreased, blood amylase increased, blood alkaline phosphatase increased, gamma-glutamyltransferase increased, weight increased, blood insulin increased, globulins decreased
Danish: Nedsat hæmoglobin, forhøjet amylase i blodet, forhøjet alkalisk fosfatase i blodet, forhøjet gamma-glutamyltransferase, vægtøgning, forhøjet insulin i blodet, nedsatte globuliner
English: Erythema multiforme, urticaria, blister, dermal cyst, sebaceous hyperplasia, swelling face, skin atrophy, skin hypertrophy, skin exfoliation, skin hyperpigmentation, skin discolouration, hyperkeratosis, psoriasis Musculoskeletal and connective tissue disorders Common:
Danish: Erythema multiforme, urticaria, blærer, hudcyster, sebacøs hyperplasi, hævet ansigt, hudatrofi, hypertrofi af huden, afskalning af huden, hyperpigmentering af huden, misfarvninger af huden, hyperkeratose, psoriasis Knogler, led, muskler og bindevæv
English: White to yellowish powder in light yellow opaque hard gelatin capsules, size 0 with red axial imprint “NVR/TKI”.
Danish: Hvidt til gulligt pulver i lysegule, uigennemsigtige, hårde gelatinekapsler, størrelse 0 med ”NVR/TKI” præget med rødt.
English: Pulmonary oedema, pleural effusion, interstitial lung disease, pleuritic pain, pleurisy, pharyngolaryngeal pain, throat irritation
Danish: Lungeødem, pleural effusion, interstitiel lungesygdom, pleurasmerter, pleuritis, faryngolaryngeale smerter, halsirritation
English: PVC/PVDC/Alu [in carton] 392 hard capsules
Danish: PVC/PVDC/Alu [i karton] 392 hårde kapsler
English: Dehydration, increased appetite, gout, dyslipidaemia
Danish: Dehydrering, øget appetit, arthritis urica, dyslipidæmi
English: No episodes of torsade de pointes (transient or sustained) were observed.
Danish: Der blev ikke observeret nogen episoder med torsades de pointes (forbigående eller vedvarende).
English: By 6 years 79%; P < .0001
Danish: Ved 6 år 79%; p < 0,0001
English: Multipack: 120 (3 packs of 40) hard capsules.
Danish: Multipakning: 120 (3 pakninger med 40) hårde kapsler.
English: In a Phase II clinical study with adult patients with Ph+ CML in chronic phase on nilotinib treatment and previously treated with imatinib (N=126), musculoskeletal symptoms were reported within a year of discontinuation in 42.1% versus 14.3% within the previous year on nilotinib treatment.
Danish: I et klinisk fase II-studie med nydiagnosticerede voksne patienter med Ph+ CML i kronisk fase i nilotinib behandling, som tidligere har været behandlet med imatinib (N=126), blev der rapporteret muskuloskeletale symptomer inden for et år efter seponering af nilotinib hos 42,1 % versus 14,3 % i det foregående år med behandling med nilotinib.
English: 10 <1 Very common
Danish: 10 <1 Meget almindelig
English: The No-Observed-Effect-Level for the skin neoplastic lesions was 100 mg/kg/day, representing approximately 10 to 20 times the human exposure at the maximum approved dose of 800 mg/day (administered as 400 mg twice daily).
Danish: Dette svarer til ca. 10-20 gange den humane eksponering (baseret på AUC) ved den maksimale godkendte humane dosis på 800 mg/dag (administreret som 400 mg to gange dagligt).
English: Haemoglobin decreased, blood amylase increased, blood alkaline phosphatase increased, gamma-glutamyltransferase increased, blood creatinine phosphokinase increased, weight decreased, weight increased, blood insulin increased, globulins decreased
Danish: Nedsat hæmoglobin, forhøjet blodamylase, forhøjet alkalisk fosfatase i blodet, forhøjet gamma-glutamyltransferase, forhøjet kreatininfosfokinase i blodet, vægttab, vægtøgning, forhøjet blodinsulin, nedsatte globuliner
English: By 3 years
Danish: Ved 3 år
English: Renal failure, haematuria, urinary incontinence, chromaturia Reproductive system and breast disorders Uncommon:
Danish: Nyresvigt, hæmaturi, urininkontinens, kromaturi Det reproduktive system og mammae Ikke almindelig:
English: • Multipacks containing 112 (4 packs of 28) hard capsules, 120 (3 packs of 40) hard capsules or
Danish: • Multipakninger indeholdende 112 (4 pakninger med 28) hårde kapsler, 120 (3 pakninger med
English: Multipack: 392 (14 packs of 28) hard capsules.
Danish: Multipakning: 392 (14 pakninger med 28) hårde kapsler.
English: 28 hard capsules
Danish: 28 hårde kapsler
English: Use in adults - The recommended dose is 800 mg per day.
Danish: - Den anbefalede dosis er 800 mg dagligt.
English: The hard capsule shell is composed of gelatin, titanium dioxide (E171), red and yellow iron oxide (E172) and, shellac, black iron oxide (E172), n-butyl alcohol, propylene glycol, dehydrated ethanol, isopropylalcohol and ammoniumhydroxide for stamping of the imprint.
Danish: Den hårde kapsel består af gelatine, titandioxid (E 171), rød og gul jernoxid (E 172) samt shellac, sort jernoxid (E 172), n-butylalkohol, propylenglycol, dehydreret alkohol, isopropylalkohol og ammoniumhydroxid til prægning.
English: Erythema multiforme, erythema nodosum, skin ulcer, palmar-plantar erythrodysaesthesia syndrome, petechiae, photosensitivity, blister, dermal cysts, sebaceous hyperplasia, skin atrophy, skin discolouration, skin exfoliation, skin hyperpigmentation, skin hypertrophy, hyperkeratosis, psoriasis
Danish: Erythema multiforme, erythema nodosum, hudsår, palmoplantar erytrodysæstesisyndrom, petekkier, fotosensibilitet, blærer, hudcyster, sebacøs hyperplasi, hudatrofi, misfarvninger af huden, afskalning af huden, hyperpigmentering af huden, hypertrofi af huden, hyperkeratose, psoriasis Knogler, led, muskler og bindevæv
English: In patients for whom CYP3A4 inducers are indicated, alternative agents with less enzyme induction potential should be selected.
Danish: Man bør vælge alternative stoffer med mindre enzyminduktionspotentiale hos patienter, for hvem CYP3A4-inducere er indiceret.
English: Of the patients who achieved MCyR, 63% (95% CI: 45% - 80%) were maintaining response at 24 months.
Danish: Af de patienter, som opnåede MCyR, var responset opretholdt hos 63 % (95 % CI: 45-80 %) ved måned 24.
English: Paediatric patients with newly diagnosed CML in chronic phase at 230 mg/m twice daily and imatinib-resistant or intolerant CML in chronic phase at 230 mg/m twice daily
Danish: Pædiatriske patienter med nydiagnosticeret CML i kronisk fase ved 230 mg/m 2 gange dagligt og imatinib-resistent eller intolerant CML i kronisk fase ved 230 mg/m2 gange dagligt
English: Of the patients who achieved MCyR, 77% (95% CI: 70% - 84%) were maintaining response at 24 months.
Danish: Af de patienter, som opnåede MCyR, var responset opretholdt hos 77 % (95 % CI: 70-84 %) ved måned 24.
English: Nilotinib 300 mg twice daily (n = 282) Nilotinib 400 mg twice daily (n = 281) Imatinib 400 mg once daily (n = 283)
Danish: Nilotinib 300 mg 2 gange dagligt (n = 282) Nilotinib 400 mg 2 gange dagligt (n = 281) Imatinib 400 mg 1 gang dagligt (n = 283)
English: Component of a multipack comprising 3 cartons.
Danish: Delpakning af multipakning med 3 pakninger.
English: Nilotinib 300 mg twice daily n=282
Danish: Nilotinib 300 mg 2 gange dagligt n=282
English: Haematoma, peripheral artery stenosis Respiratory, thoracic and mediastinal disorders Common:
Danish: Hæmatomer, perifer arteriestenose Luftveje, thorax og mediastinum Almindelig:
English: Gastrointestinal ulcer perforation, retroperitoneal haemorrhage, haematemesis, gastric ulcer, oesophagitis ulcerative, subileus, enterocolitis, haemorrhoids, hiatus hernia, rectal haemorrhage, gingivitis Hepatobiliary disorders
Danish: Perforation af gastrointestinal ulcus, retroperitoneal blødning, hæmatemese, ventrikelulcus, ulcerativ øsofagit, subileus, enterocolitis, hæmorroider, spiserørsbrok, rektalblødning, tandkødsbetændelse
English: Chronic phase (n=321)
Danish: Kronisk CML (n=321)
English: palpitations (sensation of rapid heartbeat), fainting, blue discolouration of the lips, tongue or skin (signs of heart disorders) - difficulty breathing or painful breathing, cough, wheezing with or without fever, swelling of the feet or legs (signs of lung disorders) - fever, easy bruising or unexplained bleeding, severe or frequent infections, unexplained weakness (signs of blood disorders)
Danish: hjertebanken, besvimelse, blåfarvning af læberne, tungen eller huden (tegn på hjertesygdom) - besvær eller smerter ved vejtrækning, hoste, pibende vejrtrækning med eller uden feber, hævede fødder eller ben (tegn på lungesygdom) - feber, let til blå mærker eller uforklarlig blødning, hyppige infektioner, uforklarlig svaghed
English: Grade
Danish: Asteni
English: Tasigna 200 mg hard capsules
Danish: Tasigna 200 mg hårde kapsler
English: How Tasigna works
Danish: Sådan virker Tasigna
English: Of the patients who achieved CCyR, 85% (95% CI: 78% - 93%) were maintaining response at 24 months.
Danish: Af de patienter, som nåede CCyR, var responset opretholdt hos 85 % (95 % CI: 78-93 %) ved måned 24.
English: • Unit packs containing 28 hard capsules (7 daily blisters, each containing 4 hard capsules) or
Danish: • Enkeltpakninger indeholdende 28 hårde kapsler (7 dags blisterkort, hver indeholdende 4 hårde kapsler) eller 40 hårde kapsler (5 blisterkort, hver indeholdende 8 hårde kapsler).
English: Tasigna 150 mg hard capsules
Danish: Tasigna 150 mg hårde kapsler
English: Reproductive toxicity and fertility studies
Danish: Reproduktions- og udviklingstoksicitetsstudier
English: Hyperuricaemia, hypoglycaemia, appetite disorder Psychiatric disorders
Danish: Hyperurikæmi, hypoglykæmi, spiseforstyrrelse Psykiske forstyrrelser
English: Treatment discontinuation in adult CML patients in chronic phase who have achieved a sustained deep molecular response on nilotinib treatment following prior imatinib therapy In an open-label, single-arm study, 163 adult patients with Ph+ CML in chronic phase taking tyrosine kinase inhibitors (TKIs) for ≥3 years (imatinib as initial TKI therapy for more than 4 weeks without documented MR4.5 on imatinib at the time of switch to nilotinib, then switched to nilotinib for at least two years), and who achieved MR4.5 on nilotinib treatment as measured with the MolecularMD MRDx BCR-ABL test were enrolled to continue nilotinib treatment for additional 52 weeks (nilotinib consolidation phase).
Danish: Seponering af behandling hos voksne CML-patienter i kronisk fase, som har opnået et vedvarende dybt molekylært respons på nilotinib behandling efter tidligere behandling med imatinib Et enkeltarmet, ikke-blindet studie omfattede 163 voksne patienter med Ph+ CML i kronisk fase, som blev behandlede med tyrosinkinase-hæmmere (TKIs) i ≥3 år (imatinib som førstelinje TKI behandling i mere end 4 uger uden dokumenteret MR4.5 på imatinib ved tidspunktet for skift til nilotinib, fulgt af skift til nilotinib i mindst 2 år), og som opnåede MR4.5 ved behandling med nilotinib målt ved BCR-ABL-testen MolecularMD MRDx.
English: PA/Alu/PVC/Alu [in wallet] 112 hard capsules
Danish: PA/Alu/PVC/Alu [i folder] 112 hårde kapsler