FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 10 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 45 mg
Danish: Tabel 10 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: The median duration of treatment with Iclusig was 32.2 months in CP-CML patients, 19.4 months in AP-CML patients, and 2.9 months in BP-CML/Ph+ ALL patients.
Danish: Den mediane behandlingsvarighed med Iclusig var 32,2 måneder for patienter med CP-CML, 19,4 måneder for patienter med AP-CML og 2,9 måneder for patienter med BP-CML/Ph+ ALL.
English: Co-administration of a single 15 mg oral dose of Iclusig in the presence of ketoconazole (400 mg daily), a strong CYP3A inhibitor, resulted in modest increases in ponatinib systemic exposure, with ponatinib AUC0-∞ and Cmax values that were 78% and 47% higher, respectively, than those seen when ponatinib was administered alone.
Danish: Samtidig administration af en enkelt 15 mg oral dosis af Iclusig ved tilstedeværelsen af ketoconazol (400 mg dagligt), en stærk CYP3A-hæmmer, medførte mindre stigninger i systemisk eksponering for ponatinib, med ponatinib AUC0-∞- og Cmax-værdier, som var hhv. 78 % og 47 % højere end dem, som konstateredes, da ponatinib blev administreret alene.
English: • pain in skeletal system or neck
Danish: • smerter i knogler eller hals
English: The median time to MaHR in patients with AP-CML, BP-CML, and Ph+ ALL was 0.7 months (range: 0.4 to 5.8 months), 1.0 months (range: 0.4 to 3.7 months), and 0.7 months (range: 0.4 to 5.5 months),
Danish: Mediantiden til MaHR hos patienter med AP-CML og BP-CML/Ph+ ALL var hhv. 0,7 måneder (0,4-5,8 måneder), 1,0 måned (0,4-3,7 måneder) og 0,7 måned (0,4-5,5 måneder).
English: • sodium decrease in the blood
Danish: • nedsat natrium i blodet
English: • a 15 mg film-coated tablet and a 30 mg film-coated tablet to allow for dose adjustments.
Danish: • en 15 mg filmovertrukket tablet og en 30 mg filmovertrukket tablet til brug ved dosisjusteringer.
English: At the time of updated reporting with minimum follow-up for all ongoing patients of 64 months, the median duration of MaHR for AP-CML (median duration of treatment: 19.4 months) BP-CML (median duration of treatment: 2.9 months), and Ph+ ALL (median duration of treatment: 2.7 months) patients was estimated as 12.9 months (range: 1.2 to 68.4 months), 6.0 months (range: 1.8 to 59.6 months), and 3.2 months (range: 1.8 to 12.8 months), respectively.
Danish: På tidspunktet for den opdaterede rapportering med minimumopfølgning på 64 måneder for alle igangværende patienter estimeredes den mediane varighed af MaHR for patienter med AP-CML (median behandlingsvarighed: 19,4 måneder), BP-CML (median behandlingsvarighed: 2,9 måneder), og Ph+ ALL (median behandlingsvarighed: 2,7 måneder) til hhv. 12,9 måneder (1,2-68,4 måneder), 6,0 måneder (1,8-59,6 måneder) og 3,2 måneder (1,8-12,8 måneder).
English: Arterial occlusion adverse events were more frequent with increasing age and in patients with history of ischaemia, hypertension, diabetes, or hyperlipidaemia.
Danish: Bivirkninger i form af arteriel okklusion var hyppigere med stigende alder og hos patienter med iskæmi, hypertension, diabetes eller hyperlipidæmi i anamnesen.
English: • a liver or pancreas disorder or reduced kidney function.
Danish: • har en sygdom i leveren eller bugspytkirtlen eller nedsat nyrefunktion.
English: Retinal venous occlusions associated in some cases with permanent visual impairment or vision loss have occurred in Iclusig-treated patients.
Danish: Der er forekommet retinale venøse okklusioner, i nogle tilfælde forbundet med permanent nedsat syn eller synstab, hos Iclusig-behandlede patienter.
English: Co-administration of a single 45 mg dose of Iclusig in the presence of rifampin (600 mg daily), a strong CYP3A inducer, to 19 healthy volunteers, decreased the AUC0-∞ and Cmax of ponatinib by 62% and 42%, respectively, when compared to administration of ponatinib alone.
Danish: Samtidig administration af en enkelt dosis på 45 mg Iclusig ved tilstedeværelse af rifampin (600 mg dagligt), en potent CYP3A-induktor, til 19 raske frivillige forsøgspersoner nedsatte AUC0-∞ og Cmax af ponatinib med hhv. 62 % og 42 % sammenlignet med administration af ponatinib alene.
English: • troubling skin rashes involving blisters or peeling and spread across the body, and involving tiredness.
Danish: • problematisk hududslæt med blærer eller afskalning, som spreder sig over hele kroppen og ledsages af træthed.
English: Common blood bilirubin increased, blood alkaline phosphatase increased, gamma-glutamyltransferase increased
Danish: Almindelig forhøjet blodbilirubin, forhøjet alkalisk fosfatase i blodet, forhøjet gammaglutamyltransferase
English: Very common rash, dry skin, pruritus
Danish: Meget almindelig udslæt, tør hud, pruritus
English: Gastrointestinal haemorrhage and subdural hematoma were the most commonly reported grade 3/4 bleeding events.
Danish: Gastrointestinal blødning og subduralt hæmatom var de hyppigst rapporterede grad 3/4 blødningshændelser.
English: Resistant or Intolerant R/I Cohort (N=203)
Danish: Resistent eller intolerant R/I Kohorte (N=203)
English: The secondary efficacy endpoints in CP-CML 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: • heart attack (symptoms include: sudden feeling of increased heart rate, chest pain, breathlessness)
Danish: • hjerteanfald (blandt symptomerne er en pludselig fornemmelse af hurtigere puls, smerter i brystkassen, kortåndethed)
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 lemmernes ekstremiteter)
English: There were no effects on male rat fertility parameters.
Danish: Der sås ingen virkning på parametre for hanrotters fertilitet.
English: • mini stroke
Danish: • mini-slagtilfælde
English: Achieved MMR at 45 mg (N=63)
Danish: Opnåede MMR på 45 mg (N=63)
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 dagligt.
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
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: Bottles of Iclusig 15 mg contain either 30, 60 or 180 film-coated tablets.
Danish: Flasker med Iclusig 15 mg indeholder enten 30, 60 eller 180 filmovertrukne tabletter.
English: The incidence of severe bleeding events was higher in patients with AP-CML, BP-CML and Ph+ ALL.
Danish: Forekomsten af svære blødninger var højere hos patienter med AP-CML, BP-CML og Ph+ ALL.
English: Iclusig should be interrupted immediately in case of thromboembolism.
Danish: Behandlingen med Iclusig skal omgående afbrydes i tilfælde af tromboemboli.
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: • med 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 discontinuation should be considered
Danish: • Det skal overvejes at seponere Iclusig
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 hæmoglobin
English: Uncommon cerebral artery stenosis, cerebral haemorrhage, haemorrhage intracranial, posterior reversible encephalopathy syndrome *
Danish: Ikke almindelig cerebral arteriestenose, cerebral hæmoragi, intrakraniel hæmoragi, posteriort reversibelt encefalopati-syndrom *
English: See sections 4.2 for the assessment of cardiovascular status prior to start of therapy and 4.4 for situations where an alternative treatment may be considered.
Danish: 4.2 vedrørende en vurdering af kardiovaskulær status inden start af behandling og pkt.
English: In the phase 2 trial, serious arterial occlusive adverse reactions occurred in 20% of patients (treatment-emergent frequencies).
Danish: I fase 2-forsøget forekom der alvorlige arterielle okklusive bivirkninger hos 20 % af patienterne (behandlingsrelateret hyppighed).
English: Venous thromboembolic reactions (treatment-emergent frequencies) occurred in 6% of patients.
Danish: Venøse tromboemboliske bivirkninger (behandlingsrelaterede hyppigheder) forekom hos 6 % af patienterne.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/839/006 30 film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/839/006 30 filmovertrukne tabletter
English: The frequency of Grade 3 or 4 thrombocytopenia, neutropenia, and anaemia was higher in patients with AP-CML and BPCML/Ph+ ALL than in patients with CP-CML (see Table 5).
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 5).
English: Also, post-hoc analyses to assess the relationship of shorter-term cytogenetic (MCyR) and molecular (MMR) response outcomes with longer-term outcomes of PFS and OS, maintenance of response (MCyR and MMR) after dose reductions, and PFS and OS by Arterial Occlusive Event status were conducted.
Danish: Der blev desuden udført post-hoc-analyser for at vurdere relationen mellem kortsigtet cytogenetisk respons (MCyR) og molekylært respons (MMR) og langsigtede resultater for PFS og OS,
English: Bottles of Iclusig 30 mg contain 30 film-coated tablets.
Danish: Flasker med Iclusig 30 mg indeholder 30 filmovertrukne tabletter.
English: Achieved MCyR at 45 mg (N=86)
Danish: Opnåede MCyR med 45 mg (N=86)
English: Arterial occlusion and venous thromboembolism
Danish: Arteriel okklusion og venøs tromboemboli
English: For the standard dose of 45 mg once daily, a 45 mg film-coated tablet is available.
Danish: Til standarddosis på 45 mg én gang dagligt findes der en 45 mg filmovertrukket tablet.
English: Adverse reactions reported in all CML and Ph+ ALL patients are presented in Table 4.
Danish: Bivirkninger, der er rapporteret hos alle CML- og Ph+ ALL-patienter, er vist i tabel 4.
English: Common pneumonia, sepsis, folliculitis, cellulitis
Danish: Meget almindelig infektion i øvre luftveje Almindelig pneumoni, sepsis, folliculitis, cellulitis
English: • chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation
Danish: • med kronisk myeloid leukæmi (CML) i kronisk fase, accelereret fase eller blastfase, der er resistente over for dasatinib eller nilotinib; der er intolerante over for dasatinib eller nilotinib, og til hvem videre behandling med imatinib ikke er klinisk relevant; eller som har T315I-mutationen.
English: In the phase 2 trial (with a minimum of 64 months follow-up), venous thromboembolic adverse reactions have occurred in 6% of patients (treatment-emergent frequencies).
Danish: I fase 2-forsøget (med en minimumopfølgning på 64 måneder) forekom der venøse tromboemboliske bivirkninger hos 6 % af patienterne (behandlingsrelateret hyppighed).
English: • Iclusig should be resumed at 30 mg after recovery to ≤ Grade 1 (< 3 × ULN), or recovery to pre-treatment grade Occurrence at 30 mg:
Danish: • Iclusig skal genoptages med 30 mg efter bedring til ≤ grad 1 (< 3 × ULN) eller bedring til niveau før behandling Forekomst ved 30 mg:
English: Iclusig is indicated in adult patients with
Danish: Iclusig er indiceret til behandling af voksne patienter
English: Iclusig should be discontinued *IULN = institution upper limit of normal Hepatic toxicity
Danish: Iclusig skal seponeres *IULN = laboratoriets øvre normalgrænse
English: The primary efficacy endpoint in AP-CML and BP-CML/Ph+ ALL was major haematological response (MaHR), defined as either a complete haematological response (CHR) or no evidence of leukaemia (NEL).
Danish: Det primære effektendepunkt hos AP-CML og BP-CML/Ph+ ALL var ”major” hæmatologisk respons (MaHR), defineret som enten komplet hæmatologisk respons (CHR) eller ingen tegn på leukæmi (NEL).
English: In the phase 2 trial (with a minimum of 64 months follow-up), arterial occlusive adverse reactions have occurred in 25% of patients (treatment-emergent frequencies).
Danish: I fase 2-forsøget (med en minimumopfølgning på 64 måneder) forekom der arterielle okklusive bivirkninger hos 25 % af patienterne (behandlingsrelateret hyppighed).
English: Common hypothyroidism
Danish: Det endokrine system Almindelig hypothyroidisme
English: Occurrence at 30 mg:
Danish: Forekomst ved 30 mg:
English: • headache, confusion, seizures, and loss of vision, which may be symptoms of a brain condition known as posterior reversible encephalopathy syndrome (PRES).
Danish: • hovedpine, forvirring, krampeanfald og synstab, som kan være symptomer på en hjernesygdom,
English: Iclusig may result in elevation in ALT, AST, bilirubin, and alkaline phosphatase.
Danish: Iclusig kan medføre forhøjet ALAT, ASAT, bilirubin og alkalisk fosfatase.
English: • upper airway infection (may cause breathing difficulty)
Danish: • infektion i øvre luftveje (kan forårsage åndenød)
English: Cytogenetic Response Major (MCyR) a
Danish: Hæmatologisk responsrate ”Major”a (MaHR)
English: • pain in bones, joints, pain in muscles, back, arms or legs, muscle spasms
Danish: • smerter i knogler, led, muskler, ryg, arme eller ben, muskelkramper
English: Common cardiac failure, myocardial infarction, cardiac failure congestive, coronary artery disease, angina pectoris, pericardial effusion, atrial fibrillation, ejection fraction decreased, acute coronary syndrome, atrial flutter
Danish: Almindelig hjerteinsufficiens, myokardieinfarkt, kongestiv hjerteinsufficiens, koronararteriesygdom, angina pectoris, perikardiel effusion, atrieflimren, nedsat ejektionsfraktion, akut koronarsyndrom, atrieflagren
English: • skin rash, peeling of the skin, abnormal thickening of the skin, redness, bruising, skin pain,
Danish: • hududslæt, afskalning af huden, unormal fortykkelse af huden, hudrødme, blå mærker,
English: The clinical relevance of these findings to human fertility is unknown.
Danish: Den kliniske relevans af disse fund for human fertilitet kendes ikke.
English: Iclusig 30 mg film-coated tablets are approximately 8 mm in diameter with "C7" on one side.
Danish: Iclusig 30 mg filmovertrukne tabletter er cirka 8 mm i diameter med "C7" på den ene side.
English: • lung infection (may cause breathing difficulty)
Danish: • lungebetændelse (kan forårsage åndenød)
English: • you develop heart or blood vessel problems.
Danish: • du får problemer med dit hjerte eller blodårer
English: The risk of arterial occlusive events is likely to be dose-related (see sections 4.2 and 5.1).
Danish: Risikoen for arterielle okklusive hændelser er sandsynligvis dosisrelateret (se pkt.
English: • stomach bleeding (symptoms include: stomach pain, vomiting blood)
Danish: • blødning i maven (blandt symptomerne er mavesmerter, opkastning af blod)
English: Occurrence at 15 mg:
Danish: Forekomst ved 15 mg:
English: • Iclusig should be withheld and resumed at 30 mg after recovery to < Grade 2
Danish: • Iclusig skal pauseres og genoptages med 30 mg efter bedring til < grad 2
English: The incidence of thromboembolic events is higher in patients with Ph+ ALL or BP-CML than those with AP-CML or CP-CML.
Danish: Hyppigheden af tromboemboliske hændelser er højere hos patienter med Ph+ ALL eller BP-CML end hos patienter med AP-CML eller CPCML.
English: alanine aminotransferase aspartate aminotransferase
Danish: - alaninaminotransferase
English: Iclusig 15 mg film-coated tablets Iclusig 30 mg film-coated tablets Iclusig 45 mg film-coated tablets ponatinib
Danish: Iclusig 15 mg filmovertrukne tabletter Iclusig 30 mg filmovertrukne tabletter Iclusig 45 mg filmovertrukne tabletter ponatinib
English: Uncommon myocardial ischemia, cardiac discomfort, ischemic cardiomyopathy, arteriospasm coronary, left ventricular dysfunction,
Danish: Ikke almindelig myokardieiskæmi, ubehag i hjertet, iskæmisk kardiomyopati, koronararteriespasme, nedsat funktion af venstre ventrikel
English: • heart failure (symptoms include: weakness, fatigue, swollen legs)
Danish: • hjertesvigt (blandt symptomerne er svækkelse, træthed, hævede ben)
English: Discontinuation of ponatinib should be considered in patients who develop serious heart failure (see sections 4.2 and 4.8).
Danish: Seponering skal overvejes hos patienter, der udvikler alvorlig hjerteinsufficiens (se pkt.
English: Hepatitis B reactivation has been reported in association with BCR-ABL TKIs.
Danish: Reaktivering af hepatitis B er beskrevet i forbindelse med behandling med BCRABL-tyrosinkinasehæmmere.
English: Common dehydration, fluid retention, hypocalcaemia, hyperglycaemia, hyperuricaemia, hypophosphataemia, hypertriglyceridaemia, hypokalaemia, weight decreased, hyponatraemia
Danish: Almindelig dehydrering, væskeretention, hypokalcæmi, hyperglykæmi, hyperuricæmi, hypofosfatæmi, hypertriglyceridæmi, hypokalæmi, vægttab, hyponatriæmi
English: The bottle contains one sealed plastic canister containing a molecular sieve desiccant.
Danish: Flasken indeholder en forseglet plastdåse med et molekylær si-tørremiddel.
English: Serious venous thromboembolic adverse reactions occurred in 5% of patients (treatment-emergent frequencies) (see section 4.8).
Danish: Alvorlige venøse tromboemboliske bivirkninger forekom hos 5 % af patienterne (behandlingsrelateret hyppighed) (se pkt.
English: Common rash pruritic, exfoliative rash, erythema, alopecia, skin exfoliation, night sweats, hyperhidrosis, petechia, ecchymosis, pain of skin, dermatitis exfoliative, hyperkeratosis, skin hyperpigmentation
Danish: Almindelig kløende udslæt, eksfoliativt udslæt, erytem, alopeci, hudafskalning, nattesved, hyperhidrose, petekkier, ekkymose, hudsmerter, eksfoliativ dermatitis, hyperkeratose, hyperpigmentering af huden
English: Iclusig is available in plastic bottles, each containing one canister of a molecular sieve desiccant.
Danish: Iclusig leveres i plastflasker hver indeholdende en dåse med et molekylær si-tørremiddel.
English: Iclusig 45 mg film-coated tablets EU/1/13/839/003
Danish: Iclusig 45 mg filmovertrukne tabletter EU/1/13/839/003
English: Monitoring for evidence of thromboembolism should be performed.
Danish: Patienten skal overvåges for tegn på tromboemboli.
English: The bottle contains one sealed canister containing a molecular sieve desiccant.
Danish: Flasken indeholder en forseglet dåse med et molekylær si-tørremiddel.
English: • Iclusig should be discontinued
Danish: • Iclusig skal seponeres
English: • Iclusig should be withheld and resumed at the same dose after recovery to ANC ≥ 1.5 x 109/L and platelet ≥ 75 x 109/L Recurrence at 45 mg:
Danish: • Iclusig skal pauseres og genoptages med den samme dosis efter bedring til ANC ≥ 1,5 x 109/l og trombocyttal ≥ 75 x 109/l Recidiv ved 45 mg:
English: Iclusig 15 mg film-coated tablets EU/1/13/839/001
Danish: Iclusig 15 mg filmovertrukne tabletter EU/1/13/839/001
English: Common pancytopenia, febrile neutropenia, white blood cell count decreased, lymphocyte count decreased
Danish: Almindelig pancytopeni, febril neutropeni, nedsat leukocyttal, nedsat lymfocyttal
English: • Iclusig should be interrupted and resumed at 15 mg after recovery to ≤ Grade 1, or recovery to pretreatment grade Occurrence at 15 mg:
Danish: • Iclusig skal pauseres og genoptages med 15 mg efter bedring til ≤ grad 1 eller bedring til niveau før behandling Forekomst ved 15 mg:
English: Common peripheral arterial occlusive disease, peripheral ischaemia, peripheral artery stenosis, intermittent claudication, deep vein thrombosis, hot flush, flushing
Danish: Meget almindelig Hypertension Almindelig perifer arteriel okklusionssygdom, perifer iskæmi, perifer arteriestenose, claudicatio intermittens, dyb venetrombose, hedeture, rødmen
English: • uncomfortable pressure, fullness, squeezing or pain in the centre of the chest (Angina pectoris) and chest pain not in connection with the heart
Danish: • ubehagelig trykkende fornemmelse, følelse af opfyldning, klemmen eller smerte midt i brystet
English: • ever had or might now have a hepatitis B infection.
Danish: • nogensinde har været eller måske er smittet med hepatitis B. Dette er fordi Iclusig kan forårsage, at hepatitis B bliver aktiv igen, hvilket undertiden kan være dødeligt.
English: Iclusig 30 mg film-coated tablets EU/1/13/839/006
Danish: Iclusig 30 mg filmovertrukne tabletter EU/1/13/839/006
English: Common pancreatitis, blood amylase increased, gastrooesophageal reflux disease, stomatitis, dyspepsia, abdominal distension, abdominal discomfort, dry mouth, gastric haemorrhage
Danish: Almindelig pancreatitis, forhøjet blodamylase, gastroesofageal reflukssygdom, stomatitis, dyspepsi, abdominal distension, abdominale gener, mundtørhed, gastrisk blødning
English: NAME OF THE MEDICINAL PRODUCT Iclusig 30 mg film-coated tablets ponatinib
Danish: LÆGEMIDLETS NAVN Iclusig 30 mg filmovertrukne tabletter ponatinib
English: • Iclusig should be withheld and resumed at 15 mg after recovery to ANC ≥ 1.5 x 109/L and platelet ≥ 75 x 109/L
Danish: • Iclusig skal pauseres og genoptages med 15 mg efter bedring til ANC ≥ 1,5 x 109/l og trombocyttal ≥ 75 x 109/l
English: The clinical relevance of this finding for humans is not known.
Danish: Den kliniske relevans af dette fund for mennesker kendes ikke.
English: • Iclusig should be withheld and resumed at 30 mg after recovery to ANC ≥ 1.5 x 109/L and platelet ≥ 75 x 109/L Recurrence at 30 mg:
Danish: • Iclusig skal pauseres og genoptages med 30 mg efter bedring til ANC ≥ 1,5 x 109/l og trombocyttal ≥ 75 x 109/l Recidiv ved 30 mg:
English: Serious side effects (common: may affect up to 1 in 10 people):
Danish: Alvorlige bivirkninger (almindelige: kan forekomme hos 1 ud af 10 patienter):
English: • fluid in the thorax (may cause breathing difficulty)
Danish: • væske i brystkassen (kan forårsage åndenød)
English: NAME OF THE MEDICINAL PRODUCT Iclusig 45 mg film-coated tablets ponatinib
Danish: LÆGEMIDLETS NAVN Iclusig 45 mg filmovertrukne tabletter ponatinib
English: Discontinuing ponatinib should be considered if a complete haematologic response has not occurred by 3 months (90 days).
Danish: Hvis komplet hæmatologisk respons ikke er opnået efter 3 måneder (90 dage), skal seponering af ponatinib overvejes.
English: High density polyethylene (HDPE) bottles with screw-top closures, containing 30 film-coated tablets, together with one plastic canister containing a molecular sieve desiccant.
Danish: Flaske af højdensitetspolyethylen (HDPE) med skruelåg, der indeholder 30 filmovertrukne tabletter og en plastdåse med et tørremiddel (molekylær si).
English: • nosebleed, difficulty producing voice sounds, hypertension in the lungs
Danish: • næseblod, problemer med stemmelyde, forhøjet blodtryk i lungekredsløbet
English: High density polyethylene (HDPE) bottles with screw-top closures, containing either 30, 60 or 180 film-coated tablets, together with one plastic canister containing a molecular sieve desiccant.
Danish: Flaske af højdensitetspolyethylen (HDPE) med skruelåg, der indeholder enten 30, 60 eller 180 filmovertrukne tabletter og en plastdåse med et tørremiddel (molekylær si).