FrancophonIA/ELRC3.0 huggingface dataset:
English: In the phase 2 trial, 86 CP-CML patients achieved MCyR at a dose of 45 mg, 45 CP-CML patients achieved MCyR after a dose reduction to 30 mg, mostly for adverse events.
Danish: I fase 2-forsøget opnåede 86 CP-CML-patienter MCyR med en dosis på 45 mg, 45 CP-CML-patienter opnåede MCyR efter dosisreduktion til 30 mg, hovedsagelig på grund af bivirkninger.
English: A majority of these ongoing patients (82/110 patients; 75%) were reported to be receiving 15 mg at the last dose, while 24/110 patients (22%) were receiving 30 mg, and 4/110 (4%) were receiving 45 mg. At the time of study closure initiation (minimum follow-up of 64 months, and more than 3 years after the recommendation for prospective dose reduction), 99 CP-CML patients were ongoing and 77 (78%) of these patients received 15 mg as their last dose on study.
Danish: Størstedelen af disse igangværende patienter (82/110 patienter; 75 %) blev rapporteret at få 15 mg som seneste dosis, mens 24/110 patienter (22 %) fik 30 mg, og 4/110 (4 %) fik 45 mg. På det tidspunkt, hvor lukning af studiet blev påbegyndt (minimumopfølgning på 64 måneder og mere end 3 år efter anbefalingen om prospektiv dosisreduktion), var der 99 igangværende CP-CML-patienter, og 77 (78 %) af disse patienter fik 15 mg som deres seneste dosis i studiet.
English: In rats, treatment with ponatinib has shown effects on female fertility and male fertility was not affected (see section 5.3).
Danish: Hos rotter har behandling med ponatinib vist virkninger på fertiliteten hos hunner, mens fertiliteten hos hanner ikke blev påvirket (se pkt.
English: ≥ 12 month reduction at 30 mg 8 ≥ 18 month reduction at 30 mg 7 ≥ 24 month reduction at 30 mg 6 ≥ 36 month reduction at 30 mg 1 Any dose reduction to 15 mg ≥ 3 month reduction at 15 mg
Danish: Ingen dosisreduktion Udelukkende dosisreduktion til 30 mg ≥ 3 måneders reduktion til 30 mg ≥ 6 måneders reduktion til 30 mg ≥ 12 måneders reduktion til 30 mg ≥ 18 måneders reduktion til 30 mg ≥ 24 måneders reduktion til 30 mg ≥ 36 måneders reduktion til 30 mg Enhver dosisreduktion til 15 mg ≥ 3 måneders reduktion til 15 mg ≥ 6 måneders reduktion til 15 mg ≥ 12 måneders reduktion til 15 mg ≥ 18 måneders reduktion til 15 mg ≥ 24 måneders reduktion til 15 mg ≥ 36 måneders reduktion til 15 mg
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TILL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: • swollen, or red area of skin that feels hot and tender (cellulitis)
Danish: • hævede eller røde områder på huden, som føles varme og ømme (cellulitis)
English: In juvenile rats, mortality related to inflammatory effects was observed in animals treated with 3 mg/kg/day, and reductions in body weight gain were observed at doses of 0.75, 1.5 and 3 mg/kg/day during the pre-weaning and early post-weaning treatment phases.
Danish: Hos unge rotter blev der observeret mortalitet relateret til inflammatoriske virkninger hos dyr behandlet med 3 mg/kg/dag, og nedsat øgning af legemsvægt blev observeret ved doser på 0,75, 1,5 og 3 mg/kg/dag i behandlingsfaserne før fravænning og tidligt efter fravænning.
English: Ponatinib inhibits the activity of other clinically relevant kinases with IC50 values below 20 nM and has demonstrated cellular activity against RET, FLT3, and KIT and members of the FGFR, PDGFR, and VEGFR families of kinases.
Danish: Ponatinib hæmmer aktiviteten af andre klinisk relevante kinaser med IC50-værdier under 20 nM og har vist cellulær aktivitet mod RET, FLT3 og KIT og medlemmer af FGFR-, PDGFR- og VEGFRfamilier af kinaser.
English: Table 9 Efficacy of Iclusig in resistant or intolerant Ph+ ALL patients Overall (N=32)
Danish: Tabel 9 Effekt af Iclusig hos resistente eller intolerante Ph+ ALL-patienter Generelt (N=32)
English: Overall arterial occlusive adverse reactions have occurred in 25% of Iclusig-treated patients from the phase 2 trial, with serious adverse reactions occurring in 20% of patients.
Danish: Generelt forekom arterielle okklusive bivirkninger hos 25 % af Iclusig-behandlede patienter fra fase 2-forsøget, og alvorlige bivirkninger forekom hos 20 % af patienterne.
English: Iclusig treatment should be temporarily interrupted if hypertension is not medically controlled.
Danish: Iclusig-behandlingen bør afbrydes midlertidigt, hvis hypertension ikke kan kontrolleres medicinsk.
English: Elevation of AST or ALT ≥ 3 × ULN concurrent with an elevation of bilirubin > 2 × ULN and alkaline phosphatase < 2 × ULN
Danish: Forhøjelse af ASAT eller ALAT ≥ 3 × ULN samtidig med forhøjelse af bilirubin > 2 × ULN og alkalisk fosfatase < 2 × ULN
English: • obstruction of the blood vessels in the eye
Danish: • obstruktion af blodårer i øjet
English: Adverse reactions such as lethargy, dizziness, and vision blurred have been associated with Iclusig.
Danish: Bivirkninger som f.eks. letargi, svimmelhed og sløret syn er blevet forbundet med Iclusig.
English: Iclusig has minor influence on the ability to drive and use machines.
Danish: Iclusig påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Lactose monohydrate Microcrystalline cellulose Sodium starch glycolate Colloidal anhydrous silica Magnesium stearate
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose Natriumstivelsesglycolat Kolloid vandfri silica Magnesiumstearat
English: Of 43 CP-CML patients, 31 CP-CML patients achieved a MCyR with a median duration of follow-up of 55.5 months (range: 1.7 to 91.4 months).
Danish: Ud af 43 patienter med CP-CML opnåede 31 patienter med CP-CML et MCyR med en median opfølgningsvarighed på 55,5 måneder (mellem 1,7 og 91,4 måneder).
English: The median time to onset of the first cardiovascular, cerebrovascular, and peripheral vascular arterial occlusive events was 351, 611, and 605 days, respectively.
Danish: Mediantiden til opståen af de første kardiovaskulære, cerebrovaskulære og perifere vaskulære arterielle hændelser var hhv. 351, 611 og 605 dage.
English: BCR-ABL mutation detected at entry, n (%)b None a* of 427 patients reporting prior TKI therapy with dasatinib or nilotinib b Of the patients with one or more BCR-ABL kinase domain mutations detected at entry, 37 unique mutations were detected.
Danish: BCR-ABL-mutation konstateret ved indtræden, n (%)b Ingen a* ud af 427 patienter der rapporterede tidligere TKI-behandling med dasatinib eller nilotinib b Blandt patienter med en eller flere BCR-ABL-kinase-domæne-mutationer konstateret ved indtræden i studiet blev der konstateret 37 unikke mutationer.
English: All patients were administered 45 mg of Iclusig once-daily with the possibility of dose de-escalations and dose interruptions followed by dose resumption and re-escalation.
Danish: Alle patienter fik 45 mg Iclusig én gang dagligt med muligheden for dosis-deeskaleringer og dosisafbrydelse efterfulgt af dosisgenoptagelse og -re-eskalering.
English: In a two-year carcinogenicity study in male and female rats, oral administration of ponatinib at 0.05, 0.1 and 0.2 mg/kg/day in males and at 0.2 and 0.4 mg/kg/day in females did not result in any tumorigenic effects.
Danish: I et toårigt karcinogenicitetsstudie hos han- og hunrotter medførte oral administration af ponatinibdoser på 0,05, 0,1 og 0,2 mg/kg/dag til hanner og af 0,2 og 0,4 mg/kg/dag til hunner ingen tumorigene virkninger.
English: For all patients in the phase 2 trial, the dose intensity-safety relationship indicated that there are significant increases in grade ≥ 3 adverse events (cardiac failure, arterial thrombosis, hypertension, thrombocytopenia, pancreatitis, neutropenia, rash, ALT increase, AST increase, lipase increase, myelosuppression, arthralgia) over the dose range of 15 to 45 mg once-daily.
Danish: For alle patienter i fase 2-forsøget indicerede dosisstørrelses-sikkerhedsforholdet, at der er en signifikant stigning i grad ≥ 3 bivirkninger (hjerteinsufficiens, arterietrombose, hypertension, trombocytopeni, pancreatitis, neutropeni, udslæt, forhøjet ALAT, forhøjet ASAT, forhøjet lipase, myelosuppression, artralgi) over dosisområdet 15-45 mg én gang dagligt.
English: Tablet coating Talc
Danish: Tabletovertræk Talkum
English: b CHR: WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils < 5% in peripheral blood, No extramedullary involvement (including no hepatomegaly or splenomegaly).
Danish: b CHR: WBC ≤ institutionel ULN, ANC ≥ 1.000/mm3, trombocytter ≥ 100.000/mm3, ingen blaster eller promyelocytter i perifert blod, knoglemarvsblaster ≤ 5 %, < 5 % myelocytter plus metamyelocytter i perifert blod, basofilocytter < 5 % i perifert blod og ingen ekstramedullær involvering (herunder ingen hepatomegali eller splenomegali).
English: Cardiovascular status should continue to be monitored and medical and supportive therapy for conditions that contribute to cardiovascular risk should be optimised during treatment with ponatinib.
Danish: Den kardiovaskulære status skal fortsat overvåges, og medicinsk og understøttende behandling af tilstande, der øger den kardiovaskulære risiko, skal optimeres under behandlingen med ponatinib.
English: Ponatinib is not a substrate for the human organic anion transporting polypeptides OATP1B1, OATP1B3 and the organic cation transporter OCT-1.
Danish: Ponatinib er ikke et substrat for de humane organiske anion-transportpolypeptider OATP1B1, OATP1B3 og den organiske kation-transportør OCT-1.
English: The safety and efficacy of Iclusig in CML and Ph+ ALL patients who were resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy were evaluated in a single-arm, open-label, international, multicenter trial.
Danish: Iclusigs sikkerhed og effekt hos CML- og Ph+ ALL-patienter, som var resistente eller intolerante over for tidligere behandling med tyrosin-kinase-hæmmere (TKI), blev evalueret i et enkeltarmet, åbent, internationalt, multicenterforsøg.
English: Of the CP-CML patients previously treated with one, two, three or four prior TKIs, 75% (12/16), 68% (66/97), 44% (63/142), and 58% (7/12)) achieved a MCyR while on Iclusig, respectively.
Danish: Ud af de CP-CML-patienter, som tidligere blev behandlet med én, to, tre eller fire tidligere TKI'er, opnåede hhv.75 % (12/16), 68 % (66/97), 44 % (63/142) og 58 % (7/12) et MCyR under behandling med Iclusig.
English: changes in skin colour, hair loss
Danish: hudsmerter, farveændringer i huden, hårtab
English: • Iclusig should be interrupted and hepatic function should be monitored
Danish: • Iclusig skal pauseres og leverfunktionen monitoreres
English: Table 8 Efficacy of Iclusig in resistant or intolerant advanced phase CML patients Accelerated Phase CML
Danish: Tabel 8 Effekt af Iclusig hos resistente eller intolerante CML-patienter i accelereret fase CML i accelereret fase
English: c MCyR combines both complete (No detectable Ph+ cells) and partial (1% to 35% Ph+ cells)
Danish: c MCyR kombinerer både komplet (ingen Ph+ celler konstateret) og delvist (1 % til 35 % Ph+ celler)
English: • inflammation of hair follicles, swollen, red area of skin or underneath skin that feels hot and tender
Danish: • betændelse i hårsække, opsvulmet, rødt område på huden eller under huden, som føles varmt og ømt
English: Arterial occlusion
Danish: Arteriel okklusion
English: Database cutoff date 06 February 2017.
Danish: Database cut-off-dato: 6. februar 2017.
English: Carriers of HBV who require treatment with Iclusig should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Danish: Bærere af HBV, hvor behandling med Iclusig er nødvendig, skal overvåges tæt for tegn og symptomer på aktiv HBV-infektion i hele behandlingsperioden og i flere måneder efter behandlingsophør (se pkt.
English: In patients with moderate or severe hepatic impairment, ponatinib Cmax and AUC0-∞ were lower and ponatinib plasma elimination half-life was longer in patients with mild, moderate, and severe hepatic impairment but not clinically significantly different than in healthy volunteers with normal hepatic function.
Danish: Hos patienter med moderat eller svært nedsat leverfunktion var ponatinib-Cmax og -AUC0-∞ lavere, og ponatinibs plasmaeliminationshalveringstid var længere hos patienter med let, moderat og svært nedsat leverfunktion, men ikke klinisk signifikant forskellig fra den hos raske frivillige forsøgspersoner med normal leverfunktion.
English: In a fertility study in male and female rats, female fertility parameters were reduced at dose levels corresponding to human clinical exposures.
Danish: I et fertilitetsstudie hos han- og hunrotter blev parametre for hunrotters fertilitet reduceret ved dosisniveauer svarende til humane kliniske eksponeringer.
English: Table 3 Recommended dose modifications for hepatic toxicity Elevation of liver transaminase > 3 × ULN*
Danish: Tabel 3 Anbefalede dosisjusteringer ved levertoksicitet Forhøjelse af leveraminotransferase > 3 × ULN*
English: Severe skin reactions (such as Stevens-Johnson Syndrome) have been reported with some BCR-ABL Tyrosine Kinase Inhibitors.
Danish: Der er rapporteret om svære kutane bivirkninger (som for eksempel Stevens-Johnson-syndrom) med visse BCR-ABL-tyrosinkinasehæmmere.
English: • blood clot in the main arteries carrying blood to the head or neck (carotid artery)
Danish: • blodprop i en af de store blodårer, der transporterer blod til hovedet eller halsen (halspulsårerne)
English: At therapeutic serum concentrations, ponatinib did not inhibit OATP1B1 or OATP1B3, OCT1 or OCT2, organic anion transporters OAT1 or OAT3, or bile salt export pump (BSEP) in vitro.
Danish: Ved terapeutiske serumkoncentrationer hæmmede ponatinib ikke OATP1B1 eller OATP1B3, OCT1 eller OCT2, organiske anion-transportører OAT1 eller OAT3 eller galdesalt-eksportpumpen (BSEP) in vitro.
English: The trial enrolled 449 patients of which 444 were eligible for analysis: 267 CP-CML patients (R/I Cohort: n=203, T315I Cohort: n=64), 83 AP-CML patients (R/I Cohort: n=65, T315I Cohort: n=18), 62 BP-CML (R/I Cohort: n=38, T315I Cohort: n=24), and 32 Ph+ ALL patients (R/I Cohort: n=10, T315I Cohort: n=22).
Danish: I forsøget blev der indrulleret 449 patienter, hvoraf 444 var egnede til analyse: 267 CP-CML-patienter (R/I kohorte: n=203, T315I kohorte: n=64), 83 AP-CML-patienter (R/I kohorte: n=65, T315I kohorte: n=18), 62 BP-CML, (R/I kohorte: n=38, T315I kohorte: n=24) og 32 Ph+ ALL-patienter (R/I kohorte: n=10, T315I kohorte: n=22).
English: In CP-CML patients who achieved MCyR, the median time to MCyR was 2.8 months (range: 1.6 to 11.3 months) and in patients who achieved MMR, the median time to MMR was 5.5 months (range: 1.8 to 55.5 months).
Danish: Hos CP-CML-patienter, som opnåede MCyR, var mediantiden til MCyR 2,8 måneder (1,6 til 11,3 måneder), og hos patienter, som opnåede MMR, var mediantiden til MMR 5,5 måneder (1,8 til 55,5 måneder).
English: *Reported using National Cancer Institute Common Terminology Criteria for Adverse Events version
Danish: *Rapporteret ved hjælp af National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0.
English: • blurred vision, dry eye, infection in the eye, visual disturbance
Danish: • sløret syn, tørre øjne, infektion i øjet, synsforstyrrelser
English: If decreased vision or blurred vision occurs, an ophthalmic examination (including fundoscopy) should be performed.
Danish: Hvis der forekommer nedsat syn eller sløret syn, skal der udføres en oftalmologisk undersøgelse (herunder oftalmoskopi).
English: Table 11 Maintenance of response in CP-CML patients who achieved MCyR or MMR at 45 mg dose (data extraction 6 February 2017) Achieved MCyR at 45 mg (N=86)
Danish: Tabel 11 Opretholdelse af respons hos patienter med CP-CML, som opnåede MCyR eller MMR med en dosis på 45 mg (dataekstraktion 6. februar 2017) Opnåede MCyR på 45 mg (N=86)
English: • heart problems, left sided chest pain, dysfunction of the left heart chamber
Danish: • hjerteproblemer, smerter i venstre side af brystet, funktionsfejl i venstre hjertekammer
English: Not known aneurysms and artery dissections
Danish: Ikke kendt aneurismer og arterielle dissektioner
English: Vascular occlusive events occurred in 44 of these 131 patients.
Danish: Hos 44 ud af disse 131 patienter opstod der vaskulære okklusive bivirkninger.
English: The adverse reactions described in this section were identified in a single-arm, open-label, international, multicenter trial in 449 CML and Ph+ ALL patients who were resistant or intolerant to prior TKI therapy including those with a BCR-ABL T315I mutation.
Danish: Bivirkningerne, der er beskrevet i dette punkt, blev identificeret i et enkeltarmet, åbent, internationalt, multicenterforsøg med 449 patienter med CML og Ph+ ALL, der var resistente eller intolerante overfor tidligere TKI-behandling, herunder personer med en BCR-ABL T315I-mutation.
English: Patients were assigned to one of six cohorts based on disease phase (CP-CML; AP-CML; or BPCML/Ph+ ALL), resistance or intolerance (R/I) to dasatinib or nilotinib, and the presence of the T315I mutation.
Danish: Patienter blev fordelt i én af seks kohorter baseret på sygdomsfase (CP-CML, AP-CML eller BP-CML/Ph+ ALL), resistens og intolerans (R/I) over for dasatinib eller nilotinib og tilstedeværelsen af T315I-mutation.
English: A brain condition called posterior reversible encephalopathy syndrome (PRES) has been reported in patients treated with ponatinib.
Danish: Der er indberettet tilfælde af en hjernesygdom, som kaldes posteriort reversibelt encefalopati-syndrom (PRES), hos patienter, der fik ponatinib.
English: Arterial occlusions, including fatal myocardial infarction, stroke, retinal arterial occlusions associated in some cases with permanent visual impairment or vision loss, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, renal artery stenosis (associated with worsening, labile or treatment-resistant hypertension), and the need for urgent revascularization procedures have occurred in Iclusig-treated patients.
Danish: Arterielle okklusioner, herunder dødeligt myokardieinfarkt, apopleksi, retinale arterielle okklusioner, der i visse tilfælde var forbundet med permanent synsnedsættelse eller synstab, stenose i de store hjernearterier, svær perifer karsygdom, nyrearteriestenose (forbundet med forværret, labil eller behandlingsresistent hypertension) og behov for akut revaskulariserende indgreb, er forekommet hos patienter behandlet med Iclusig.
English: • indinavir, nelfinavir, ritonavir, saquinavir: medicines to treat HIV infection.
Danish: • indinavir, nelfinavir, ritonavir, saquinavir: lægemidler, der bruges til at behandle hiv-infektion
English: Hypertension may contribute to risk of arterial thrombotic events, including renal artery stenosis.
Danish: Hypertension kan øge risikoen for arterielle trombotiske hændelser, herunder nyrearteriestenose.
English: Symptoms may include sudden onset of severe headache, confusion, seizures, and vision changes.
Danish: Symptomerne kan for eksempel være pludselig kraftig hovedpine, forvirring, krampeanfald og synsændringer.
English: Hypertension may contribute to risk of arterial occlusive events.
Danish: Hypertension kan øge risikoen for arterielle okklusive hændelser.
English: Severe haemorrhage, including fatalities, occurred in Iclusig-treated patients.
Danish: Svær hæmoragi, herunder dødelige tilfælde, er forekommet hos Iclusig-behandlede patienter.
English: If diagnosed, interrupt Iclusig treatment and resume treatment only once the event is resolved and if the benefit of continued treatment outweighs the risk of PRES.
Danish: Behandlingen må først genoptages, når tilstanden er afhjulpet, og hvis fordelene ved at fortsætte behandlingen opvejer risikoen for PRES.
English: • problems of the blood vessels in the heart muscle
Danish: • problemer med blodkarrene i hjertet
English: Table 7 Efficacy of Iclusig in resistant or intolerant chronic phase CML patients Overall (N=267)
Danish: Tabel 7 Effekt af Iclusig hos resistente og intolerante CML-patienter i kronisk fase Generelt (N=267)
English: For a dose of 30 mg or 15 mg once daily, 15 mg and 30 mg film-coated tablets are available.
Danish: Til en dosis på 30 mg eller 15 mg én gang dagligt findes der 15 mg og 30 mg filmovertrukne tabletter.
English: Based on the Kaplan-Meier estimates, 82% (95% CI: [74%-88%]) of CP-CML (median duration of treatment: 32.2 months) patients who achieved a MCyR are projected to maintain that response at 48 months and 61% (95% CI: [51%- 70%]) of CP-CML patients who achieved a MMR are projected to maintain that response at 36 months.
Danish: Baseret på Kaplan-Meier-estimater anslås det, at 82 % (95 % CI: [74-88 %]) af de CP-CML-patienter (median behandlingsvarighed 32,2 måneder), som opnåede MCyR, kan forventes at ville opretholde dette respons ved måned 48, og 61 % (95 % CI: [51-70 %]) af de CP-CML-patienter, som opnåede MMR, kan forventes at ville opretholde dette respons ved måned 36.
English: Monitoring for evidence of arterial occlusion should be performed and if decreased vision or blurred vision occurs, an ophthalmic examination (including fundoscopy) should be performed.
Danish: Patienten skal overvåges for tegn på arteriel okklusion, og hvis der forekommer nedsat syn eller sløret syn, skal der udføres en oftalmologisk undersøgelse (herunder oftalmoskopi).
English: • or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall
Danish: • har eller har haft et aneurisme (udvidelse og svækkelse af en blodårevæg) eller en rift i en blodårevæg
English: ALT=alanine aminotransferase, ANC=absolute neutrophil count, AST=aspartate aminotransferase, Hgb=haemoglobin, WBC=white blood cell count.
Danish: ALAT = alaninaminotransferase, ANC = absolut neutrofiltal, ASAT = aspartataminotransferase, Hgb = hæmoglobin, WBC = leukocyttal.
English: In a study in rats, diffuse corneal edema with neutrophilic cell infiltration, and hyperplastic changes in the lenticular epithelium suggestive of a mild phototoxic reaction were observed in animals treated with 5 and 10 mg/kg ponatinib.
Danish: I et studie med rotter blev der observeret diffus corneaødem med neutrofilcelleinfiltration og hyperplastiske forandringer i linseepitelet, hvilket tyder på en mild fototoksisk reaktion hos dyr, behandlet med 5 og 10 mg/kg ponatinib.
English: • Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL): a type of leukaemia involving too many immature white blood cells in the blood and blood forming bone marrow.
Danish: • Philadelphiakromosom positiv akut lymfoblastær leukæmi (Ph+ ALL): en type leukæmi med for mange umodne hvide blodlegemer i blodet og knoglemarven, hvor blodlegemer dannes.
English: Multiple foetal soft tissue and skeletal alterations were also observed at maternal nontoxic dosages.
Danish: Der blev også observeret flere ændringer i fostres bløde væv og skelet ved maternelle ikke-toksiske doseringer.
English: • renal artery stenosis (narrowing of the blood vessels to one or both kidneys)
Danish: • nyrearteriestenose (forsnævring af blodkarrene til en eller begge nyrer)
English: Post-marketing cases of Posterior Reversible Encephalopathy Syndrome (PRES) have been reported in Iclusig-treated patients.
Danish: Efter markedsføringen er derrapporteret om tilfælde af posteriort reversibelt encefalopati-syndrom (PRES) hos patienter, der fik behandling med Iclusig.
English: The median dose intensity was 28 mg/day in CP-CML patients or, 63% of the expected 45 mg dose; median dose intensity was greater in advanced disease states (32 mg/day in the AP-CML patients and 44 mg/day in the BP CML/Ph+ ALL patients).
Danish: Mediandosis var 28 mg/dag hos patienter med CP-CML eller 63 % af den forventede dosis på 45 mg; mediandosis var højere ved fremskredne sygdomsstadier (32 mg/dag hos patienter med AP-CML og 44 mg/dag hos patienter med BP-CML/Ph+ALL).