FrancophonIA/ELRC3.0 huggingface dataset:
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-transportøre OAT1 eller OAT3 eller galdesalt-eksportpumpen (BSEP) in vitro.
English: Co-administration of Iclusig with a potent inhibitor of gastric acid secretion resulted in a minor reduction in ponatinib Cmax without a reduction in AUC0-∞.
Danish: Samtidig administration af Iclusig og en potent hæmmer af gastrisk syresekretion medførte en mindre reduktion af ponatinib-Cmax uden reduktion af AUC0-∞.
English: Depletion of lymphoid organs was observed in repeat-dose toxicity studies in rats and cynomolgus monkeys.
Danish: Svind af lymfoide organer blev observeret i toksicitetsstudier med gentagen dosering hos rotter og cynomolgus-aber.
English: The incidence of serious bleeding events was higher in patients with AP-CML, BP-CML and Ph+ ALL.
Danish: Forekomsten af alvorlige blødninger var højere hos patienter med AP-CML, BPCML og Ph+ ALL.
English: No clinically significant changes in the mean QTc interval (i.e., > 20 ms) from baseline were detected in the study.
Danish: Ingen klinisk signifikante ændringer i det gennemsnitlige QTc-interval (dvs. > 20 msek.)
English: The frequency of Grade 3 or 4 thrombocytopenia, neutropenia, and anaemia was higher in patients with AP-CML and BP-CML/Ph+ ALL than in patients with CP-CML (see Table 4).
Danish: Hyppigheden af grad 3 eller 4 trombocytopeni, neutropeni og anæmi var større hos patienter med AP-CML og BP-CML/Ph+ ALL end hos patienter med CP-CML (se tabel 4).
English: The frequency of these events is greater in patients with accelerated phase CML (AP-CML) or blast phase CML (BP-CML)/Ph+ ALL than in chronic phase CML (CP-CML).
Danish: Hyppigheden af disse bivirkninger er større hos patienter med CML i accelereret fase (AP-CML) eller CML i blastfase (BP-CML)/Ph+ ALL i blastfase end hos patienter med CML i kronisk fase (CP-CML).
English: • tissue swelling in eyelid or around the eyes, caused by excess fluid
Danish: • vævshævelse i øjenlåg eller omkring øjnene på grund af for meget væske
English: Table 7 Efficacy of Iclusig in resistant or intolerant advanced phase CML patients Accelerated Phase CML
Danish: Tabel 7 Effekt af Iclusig hos resistente eller intolerante CML-patienter i accelereret fase CML i accelereret fase
English: - gamma-glutamyltransferase
Danish: - gammaglutamyltransferase
English: Iclusig therapy should be prescribed by a doctor experienced in leukaemia treatment.
Danish: Iclusig-behandling skal ordineres af en læge med erfaring i behandling af patienter med leukæmi.
English: • increased blood level of bilirubin - the yellow breakdown substance of the blood pigment
Danish: • forhøjet niveau af bilirubin i blodet - det gulorange nedbrydningsprodukt af blodfarvestof
English: • clarithromycin, telithromycin, troleandomycin: medicines to treat bacterial infections.
Danish: • clarithromycin, telithromycin, troleandomycin: lægemidler, der bruges til at behandle bakterieinfektioner
English: Hyper-/hypoplastic changes of the chondrocytes in the physis were noted in repeat-dose toxicity studies in rats.
Danish: Hyper-/hypoplastiske ændringer i kondrocytterne i vækstpladen blev bemærket i toksicitetsstudier med gentagen dosering hos rotter.
English: Recurrence at 30 mg:
Danish: Recidiv ved 30 mg:
English: OTHER SPECIAL WARNING(S), IF NECESSARY Outer Carton:
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Ydre karton:
English: A single dose of 30 mg ponatinib was administered to patients with mild, moderate, or severe hepatic impairment and to healthy volunteers with normal hepatic function.
Danish: En enkelt dosis på 30 mg ponatinib blev administreret til patienter med let, moderat eller svært nedsat leverfunktion og til raske frivillige forsøgspersoner med normal leverfunktion.
English: • obstruction of the blood vessels in the eye, visual disturbance
Danish: • obstruktion af blodårer i øjet
English: Arterial and venous thrombosis and occlusions, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures have occurred in Iclusig-treated patients.
Danish: Arterielle og venøse tromboser og okklusioner, herunder letal myokardieinfarkt, apopleksi, stenose i de store hjernearterier, svær perifer karsygdom og behov for akut revaskulariserende indgreb, er forekommet hos patienter behandlet med Iclusig.
English: Concomitant use of ponatinib with anti-clotting agents should be approached with caution in patients who may be at risk of bleeding events (see “Myelosuppression” and “Haemorrhage”).
Danish: Forsigtighed anbefales ved samtidig brug af ponatinib og antikoagulerende medicin til patienter med risiko for blødningshændelser (se “Myelosuppression” og “Hæmoragi”).
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: • indinavir, nelfinavir, ritonavir, saquinavir: medicines to treat HIV infection.
Danish: • indinavir, nelfinavir, ritonavir, saquinavir: lægemidler, der bruges til at behandle
English: In these patients, alternative treatment options should also be considered before starting treatment with ponatinib.
Danish: Før behandling med ponatinib indledes hos disse patienter, skal alternative behandlingsmuligheder overvejes.
English: b CHR: WBC ≤ institutional ULN, ANC ≥1000/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 ≥ 1000/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 ekstramedulær involvering (herunder ingen hepatomegali eller splenomegali).
English: Vascular occlusive events occurred in 44 of these 132 patients.
Danish: Hos 44 ud af disse 132 patienter opstod der vaskulære okklusive bivirkninger.
English: • a 15 mg film-coated tablet to allow for dose adjustments.
Danish: • en 15 mg filmovertrukket tablet til brug ved dosisjusteringer.
English: • diarrhoea, vomiting, constipation, nausea
Danish: • diarré, opkastning, obstipation, kvalme
English: For a dose of 30 mg or 15 mg once daily, 15 mg film-coated tablets are available.
Danish: Til en dosis på 30 mg eller 15 mg én gang dagligt findes der 15 mg filmovertrukne tabletter.
English: Ponatinib Cmax was comparable in patients with mild hepatic impairment and healthy volunteers with normal hepatic function.
Danish: Ponatinib-Cmax var sammenlignelig hos patienter med let nedsat leverfunktion og raske frivillige forsøgspersoner med normal leverfunktion.
English: See sections 4.2 Assessment of cardiovascular status prior to start of therapy and 4.4 Situations where an alternative treatment may be considered.
Danish: 4.2 ”Vurdering af kardiovaskulær status inden start af behandling” og pkt.
English: PHARMACEUTICAL FORM AND CONTENTS 30 tablets
Danish: LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) 30 tabletter
English: A reduction in dose is therefore expected to reduce the risk of vascular occlusive events, however, the analysis suggested that there may be a ‘carry over' effect of higher doses such that it might take up to several months before a dose reduction manifests in risk reduction.
Danish: Imidlertid antyder analysen, at der kan være en ‘carry-over-effekt' af højere doser, så det kan tage flere måneder, før en dosisreduktion viser en risikoreduktion.
English: The median time to MaHR in patients with AP-CML, BP-CML, and Ph+ ALL was 21 days (range: 12 to 176 days), 29 days (range: 12 to 113 days), and 20 days (range: 11 to 168 days), respectively.
Danish: Den mediane tid til MaHR hos patienter med AP-CML og BP-CML/Ph+ ALL var hhv. 21 dage (mellem 12 og 176 dage), 29 dage (mellem 12 og 113 dage) og 20 dage (mellem 11 og 168 dage).
English: Iclusig may result in elevation in ALT, AST, bilirubin, and alkaline phosphatase.
Danish: Iclusig kan medføre forhøjelser i ALAT, ASAT, bilirubin og alkalisk fosfatase.
English: Ponatinib is not a substrate for the human organic anion transporting polypeptides OATP1B1, OATP1B3 and the organic cation transporters OCT-1.
Danish: Ponatinib er ikke et substrat for de humane organiske anion-transportpolypeptider OATP1B1, OATP1B3 og den organiske kation-transportør OCT-1.
English: • liver damage, jaundice (symptoms include: yellowing of the skin and eyes)
Danish: • leverskade, gulsot (blandt symptomer er: gulfarvning af hud og øjne)
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Iclusig in paediatric patients from 1 year to less than 18 years in CML and Ph+ ALL (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Iclusig til pædiatriske patienter fra 1 år til under 18 år hos CML og Ph+ ALL (se pkt.
English: • sulfasalazine: a medicine to treat severe bowel and rheumatic joint inflammation.
Danish: • sulfasalazin: et lægemiddel, der bruges til at behandle svær betændelse i tarme og reumatiske led
English: • colchicine: a medicine to treat gout attacks.
Danish: • colchicin: et lægemiddel, der bruges til at behandle podagra-anfald
English: • heart problems, problems of the blood vessels in the heart muscle, left sided chest pain, dysfunction of the left heart chamber
Danish: • hjerteproblemer, problemer med blodkarrene i hjertemusklen, smerter i venstre side af brystet,
English: In cynomolgus monkeys, systolic heart murmurs with no macroscopic or microscopic correlates were noted in individual animals treated with 5 and 45 mg/kg in the single dose toxicity study and at 1, 2.5 and 5 mg/kg in the 4-week repeat-dose toxicity study.
Danish: Hos cynomolgus-aber blev der bemærket systolisk hjertemislyd uden makroskopiske eller mikroskopiske korrelater hos individuelle dyr, der blev behandlet med 5 og 45 mg/kg i toksicitetsstudiet med enkeltdosis og med 1, 2,5 og 5 mg/kg i 4-ugers toksicitetsstudiet med gentagen dosering.
English: Iclusig treatment should be temporarily interrupted if hypertension is not medically controlled (see section 4.2).
Danish: Iclusig-behandling skal midlertidigt seponeres, hvis hypertension ikke kan kontrolleres medicinsk (se pkt.
English: Table 9 Vascular Occlusive First Adverse Events in CP-CML Patients who Achieved MCyR at 45 mg or 30 mg (data extraction 7 April 2014) Most Recent Dose at Onset of First Vascular Occlusive Event
Danish: Tabel 9 Første vaskulære okklusive bivirkning hos patienter med CP-CML, som opnåede MCyR med 45 mg eller 30 mg (dataekstraktion 7. april 2014) Seneste dosis ved opståen af første vaskulære okklusive bivirkning
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/839/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/839/001
English: Vascular occlusive adverse events were more frequent with increasing age and in patients with prior history of ischaemia, hypertension, diabetes, or hyperlipidaemia.
Danish: Bivirkninger i form af vaskulær okklusion var hyppigere med stigende alder og hos patienter med iskæmi, hypertension, diabetes eller hyperlipidæmi i anamnesen.
English: • lung infection, blood infection, inflammation of hair follicles
Danish: • lungebetændelse, blodforgiftning, betændelse i hårsække
English: Liver function abnormality
Danish: Abnorm leverfunktion
English: • blood circulation problems (symptoms include: pain in the legs or arms, coldness of the extremities of the limbs)
Danish: • kredsløbsproblemer (blandt symptomerne er: smerter i arme og ben, kulde i lemmenes ekstremiteter)
English: In cynomolgus monkeys, thyroid gland follicular atrophy mostly accompanied by a reduction in T3 levels and a tendency toward increased TSH levels were observed in the 4-week repeat-dose toxicity study in cynomolgus monkeys.
Danish: Hos cynomolgus-aber blev der observeret follikulær atrofi i glandula thyroidea ledsaget af en reduktion i T3-niveauer og en tendens til forhøjede TSH-niveauer i 4-ugers toksicitetsstudiet med gentagen dosering hos cynomolgus-aber.
English: Table 10 Maintenance of response in CP-CML patients who achieved MCyR or MMR at 45 mg dose (data extraction 7 April 2014) Achieved MCyR at 45 mg (N=87)
Danish: Tabel 10 Opretholdelse af respons hos patienter med CP-CML, som opnåede MCyR eller MMR med en dosis på 45 mg (dataekstraktion 7. april 2014) Opnåede MCyR på 45 mg (N=87)
English: Although renal excretion is not a major route of ponatinib elimination, the potential for moderate or severe renal impairment to affect hepatic elimination has not been determined (see section 4.2).
Danish: Selvom ponatinib ikke primært udskilles via nyrerne, er muligheden for, at moderat eller svært nedsat nyrefunktion vil påvirke udskillelsen via leveren ikke klarlagt (se pkt.
English: Alkaline phosphatase increased
Danish: Forhøjet alkalisk fosfatase
English: • increased blood levels of several liver enzymes called:
Danish: • forhøjede niveauer af flere leverenzymer, der kaldes:
English: Resistance in CP-CML was defined as failure to achieve either a complete haematological response (by 3 months), a minor cytogenetic response (by 6 months), or a major cytogenetic response (by 12 months) while on dasatinib or nilotinib.
Danish: Resistens hos CP-CML blev defineret som manglende komplet hæmatologisk respons (efter 3 måneder), ”minor” cytogenetisk respons (efter 6 måneder) eller ”major” cytogenetisk respons (efter 12 måneder) under behandling med dasatinib eller nilotinib.
English: Breast-feeding should be stopped during treatment with Iclusig.
Danish: Amning skal ophøre under behandlingen med Iclusig.
English: Resistance in AP-CML and BP-CML/Ph+ ALL was defined as failure to achieve either a major haematological response (AP-CML by 3 months, BP-CML/Ph+ ALL by 1 month), loss of major haematological response (at any time), or development of kinase domain mutation in the absence of a major haematological response while on dasatinib or nilotinib.
Danish: Resistens hos AP-CML og BP-CML/Ph+ ALL blev defineret som enten manglende ”major” hæmatologisk respons (AP-CML efter 3 måneder, BP-CML/Ph+ ALL efter 1 måned), tab af ”major” hæmatologisk respons (på et hvilket som helst tidspunkt) eller udvikling af kinase-domæne-mutation i fravær af hæmatologisk respons under behandling med dasatinib eller nilotinib.
English: The secondary efficacy endpoints in CPCML were complete haematological response (CHR) and major molecular response (MMR).
Danish: Det sekundære effektendepunkt hos CP-CML var komplet hæmatologisk respons (CHR) og ”major” molekulært respons (MMR).
English: Ponatinib is mainly eliminated via faeces.
Danish: Ponatinib udskilles primært via fæces.
English: See the package leaflet for further information.
Danish: Se yderligere oplysninger i indlægssedlen.
English: - aspartate aminotransferase
Danish: - aspartataminotransferase
English: • tissue swelling in face caused by excess fluid
Danish: • hævelse i ansigtet på grund af for meget væske
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
English: Iclusig 45 mg film-coated tablets are approximately 9 mm in diameter with "AP4" on one side.
Danish: Iclusig 45 mg filmovertrukne tabletter er cirka 9 mm i diameter med "AP4" på den ene side.
English: PHARMACEUTICAL FORM AND CONTENTS 60 tablets
Danish: LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) 60 tabletter
English: • rash, dry skin
Danish: • udslæt, tør hud
English: Recurrence at 15 mg:
Danish: Recidiv ved 15 mg:
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 blev også observeret misdannelser af blødt væv og skelet ved maternelle ikke-toksiske doseringer.
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:
English: The recommended starting dose is one 45 mg film-coated tablet once daily.
Danish: Den anbefalede startdosis er: Én 45 mg filmovertrukket tablet én gang daglig
English: Adverse reactions reported in all CML and Ph+ ALL patients are presented in Table 3.
Danish: Bivirkninger, der er rapporteret hos alle CML- og Ph+ ALL-patienter, er vist i tabel 3.
English: Iclusig 15 mg film-coated tablets are approximately 6 mm in diameter with "A5" on one side.
Danish: Iclusig 15 mg filmovertrukne tabletter er cirka 6 mm i diameter med "A5" på den ene side.
English: Vascular occlusion
Danish: Vaskulær okklusion
English: At the time of updated reporting with minimum follow-up for all ongoing patients of 27 months, the median duration of MaHR for AP-CML (median duration of treatment: 590 days), BP-CML (median duration of treatment: 89 days), and Ph+ ALL (median duration of treatment: 81 days) patients was estimated as 13.1 months (range: 1.2 to 35.8+ months), 6.1 months (range: 1.8 to 31.8+ months), and 3.3 months (range: 1.8 to 13.0 months), respectively.
Danish: På tidspunktet for den opdaterede rapportering med minimumopfølgning på 27 måneder for alle igangværende patienter estimeredes den mediane varighed af MaHR for patienter med AP-CML (median behandlingsvarighed: 590 dage), BP-CML (median behandlingsvarighed: 89 dage), og Ph+ ALL (median behandlingsvarighed: 81 dage) til hhv. 13,1 måneder (1,2-35,8+ måneder), 6,1 måneder (1,8-31,8+ måneder) og 3,3 måneder (1,8-13,0 måneder).
English: • mini stroke, cerebral infarction
Danish: • mini-slagtilfælde, blodprop i hjernen
English: Anaemia (Hgb decreased)
Danish: Anæmi (nedsat Hgb)
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 hurtigt voksende, umodne lymfatiske blodlegemer i blodet og knoglemarven, hvor blodlegemer dannes.
English: High density polyethylene (HDPE) bottles with screw-top closures, containing either 60 or 180 film-coated tablets, together with one plastic canister containing molecular sieve desiccant.
Danish: Højdensitets polyethylen (HDPE) flasker med skruelåg, der indeholder enten 60 eller 180 filmovertrukne tabletter, og en plastdåse med molekylær si-tørremiddel.
English: • narrowing of the blood vessels, poor blood circulation
Danish: • forsnævring af blodkarrene, dårligt kredsløb
English: High density polyethylene (HDPE) bottles with screw-top closures, containing either 30 or 90 film-coated tablets, together with one plastic canister containing molecular sieve desiccant.
Danish: Højdensitets polyethylen (HDPE) flasker med skruelåg, der indeholder enten 30 eller 90 filmovertrukne tabletter, og en plastdåse med molekylær si-tørremiddel.
English: Some patients experienced more than 1 type of event.
Danish: Nogle patienter oplevede mere end én type bivirkning.
English: Close clinical surveillance is recommended when ponatinib is administered with these medicinal products.
Danish: Når ponatinib administreres sammen med disse lægemidler, anbefales nøje klinisk overvågning.
English: • heartburn caused by reflux of stomach juices, inflammation in the mouth, abdominal swelling or discomfort or indigestion, dry mouth
Danish: • halsbrand, som skyldes refluks af mavesaft, betændelse i munden, oppustet mave eller mavegener, mundtørhed
English: Dry flaky skin was observed in toxicity studies in rats.
Danish: Tør, skællende hud blev observeret i studier hos rotter.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/839/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/839/003
English: Defined as a ≤0.1% ratio of BCR-ABL to ABL transcripts on the International Scale (IS) (ie, ≤0.1% BCR-ABLIS; patients must have the b2a2/b3a2 (p210) transcript), in peripheral blood measured by quantitative reverse transcriptase polymerase chain reaction (qRT PCR).
Danish: Defineret som et ≤0,1 % forhold af BCR-ABL til ABL-transkripter på den internationale skala (IS) (dvs. ≤0,1 % BCR-ABLIS; patienter skal have b2a2/b3a2- (p210)
English: Other medicines and Iclusig
Danish: Brug af anden medicin sammen med Iclusig
English: • heart failure (symptoms include: weakness, fatigue, swollen legs)
Danish: • hjertesvigt (blandt symptomerne er: svækkelse, træthed, hævede ben)
English: For the standard dose of 45 mg once daily, a 45 mg film-coated tablet is available.
Danish: Til standard dosis på 45 mg én gang dagligt findes der en 45 mg filmovertrukket tablet.
English: Caution is recommended when administering Iclusig to patients with estimated creatinine clearance of < 50 mL/min, or end-stage renal disease.
Danish: Det anbefales at være forsigtig med at give Iclusig til patienter med estimeret kreatinin-clearance på < 50 ml/min eller med nyresygdom i terminalstadiet.
English: Common pneumonia, sepsis, folliculitis
Danish: Meget almindelig infektion i øvre luftveje Almindelig pneumoni, sepsis, folliculitis
English: c MCyR combines both complete (No detectable Ph+ cells) and partial (1% to 35% Ph+ cells) cytogenetic responses.
Danish: c MCyR kombinerer både fuldstændigt (ingen Ph+ celler konstateret) og delvist (1 % til 35 % Ph+ celler) cytogenetisk respons.
English: Pancreatitis and serum lipase
Danish: Pancreatitis og serumlipase
English: • Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
Danish: • Philadelphiakromosom positiv akut lymfoblastær leukæmi (Ph+ ALL), der er resistente over for dasatinib, der er intolerante over for dasatinib, og til hvem videre behandling med imatinib ikke er klinisk relevant eller som har T315I-mutationen.
English: Iclusig contains lactose
Danish: Iclusig indeholder lactose
English: Do not swallow the desiccant canister contained in the bottle.
Danish: Du må ikke synke den dåse med tørremiddel, der er i flasken.
English: No specific studies have been performed to evaluate the effects of gender, age, race, and body weight on ponatinib pharmacokinetics.
Danish: Reelle faktorer, der påvirker ponatinibs farmakokinetik Der er udført nogle specifikke studier for at vurdere virkningerne af køn, alder, race og legemsvægt på ponatinibs farmakokinetik.
English: Duration of use
Danish: Behandlingsvarighed
English: Substances that may have their serum concentrations altered by ponatinib
Danish: Stoffer, hvis serumkoncentrationer kan ændres af ponatinib
English: Achieved MCyR at 30 mg (N=45)
Danish: Opnåede MCyR med 30 mg (N=45)
English: • pain in bones, joints, back, arms or legs, muscle spasms
Danish: • smerter i knogler, led, ryg, arme eller ben, muskelkramper