FrancophonIA/ELRC3.0 huggingface dataset:
English: Very common fatigue, asthenia, oedema peripheral, pyrexia, pain
Danish: Meget almindelig træthed, asteni, perifert ødem, pyreksi, smerter
English: Haematological Response Rate Majora (MaHR)
Danish: Hæmatologisk responsrate ”Major”a (MaHR)
English: Occurrence at 45 mg:
Danish: Forekomst ved 45 mg:
English: Achieved MCyR at 45 mg (N=87)
Danish: Opnåede MCyR med 45 mg (N=87)
English: Some patients experienced more than one type of event.
Danish: Nogle patienter oplevede mere end en type bivirkning.
English: In the phase 2 trial, serious arterial and venous occlusive adverse reactions occurred in 18% of patients (treatment-emergent frequencies).
Danish: I fase 2-forsøget forekom der alvorlige arterielle og venøse okklusive bivirkninger hos 18 % af patienterne (behandlingsrelateret hyppighed).
English: If you have been told by your doctor that you have an intolerance to milk sugar (lactose) contact your doctor before taking this medicine.
Danish: Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter (lactose).
English: What Iclusig contains
Danish: Iclusig indeholder
English: Based on the Kaplan-Meier estimates, 87% (95% CI: [78%-92%]) of CP-CML patients (median duration of treatment: 866 days) who achieved a MCyR and 66% (95% CI: [55%- 75%]) of CP-CML patients who achieved a MMR are projected to maintain that response at 24 months.
Danish: Baseret på Kaplan-Meier-estimater, anslås det, at 87 % (95 % CI: [78-92 %]) af de CP-CML-patienter (median behandlingsvarighed: 866 dage), som opnåede MCyR, og 66 % (95 % CI: [55-75 %]) af de CP-CML-patienter, som opnåede MMR, forventes at ville opretholde dette respons ved måned 24.
English: Caution is recommended when administering Iclusig to patients with severe hepatic impairment (see section 5.2).
Danish: Forsigtighed anbefales ved administration af Iclusig til patienter med svært nedsat leverfunktion (se pkt.
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 af ponatinib, med ponatinib AUC0-∞ og Cmax værdier, som var hhv. 78 % og 47 % højere end dem, som konstateredes, da ponatinib blev administreret alene.
English: In the phase 2 trial, arterial and venous occlusive adverse reactions have occurred in 23% of patients (treatment-emergent frequencies).
Danish: I fase 2-forsøget forekom der arterielle og venøse okklusive bivirkninger hos 23 % af patienterne (behandlingsrelateret hyppighed).
English: Iclusig 15 mg film-coated tablets Iclusig 45 mg film-coated tablets
Danish: Iclusig 15 mg filmovertrukne tabletter Iclusig 45 mg filmovertrukne tabletter ponatinib
English: • narrowing of the arteries in the brain
Danish: • forsnævring af pulsårer i hjernen
English: Thrombocytopenia (platelet count decreased)
Danish: Trombocytopeni (nedsat trombocyttal)
English: Iclusig has not been studied in patients with renal impairment.
Danish: Iclusig er ikke blevet undersøgt hos patienter med nedsat nyrefunktion.
English: • stomach bleeding (symptoms include: stomach pain, vomiting blood)
Danish: • maveblødning (blandt symptomerne er: mavesmerter, opkastning af blod)
English: Caution is recommended in when administering Iclusig to patients with estimated creatinine clearance of < 50 mL/min or end-stage renal disease (see section 4.2).
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 (se pkt.
English: Common cardiac failure, myocardial infarction, cardiac failure congestive, coronary artery disease, angina pectoris, pericardial effusion, atrial fibrillation, ejection fraction decreased
Danish: Almindelig hjerteinsufficiens, myokardieinfarkt, kongestiv hjerteinsufficiens, koronararteriesygdom, angina pectoris, perikardiel effusion, atrieflimren, nedsat ejektionsfraktion
English: Very common side effects (affects more than 1 per 10 users):
Danish: Meget almindelige bivirkninger (forekommer hos flere end 1 ud af 10 patienter):
English: • skin rash, itching, peeling of the skin, redness, bruising, skin pain, hair loss
Danish: • hududslæt, kløe, afskalning af huden, rødme, blå mærker, hudsmerter, hårtab
English: Important adverse reactions
Danish: Vigtige bivirkninger
English: A break in treatment or a decrease in dose may be required when lipase is increased.
Danish: Hvis lipasen er steget, kan det være nødvendigt at holde en pause i behandlingen eller reducere dosen.
English: A reduction of the starting dose of Iclusig in patients with hepatic impairment is not necessary (see sections 4.2 and 4.4).
Danish: Det er ikke nødvendigt at reducere startdosis af Iclusig hos patienter med nedsat leverfunktion (se pkt.
English: Very common abdominal pain, diarrhoea, vomiting, constipation, nausea, lipase increased
Danish: Meget almindelig abdominalsmerter, diarré, opkastning obstipation, kvalme, forhøjet lipase
English: • blurred vision, dry eye
Danish: • sløret syn, tørre øjne
English: • stroke (symptoms include: difficulty to speak or move, sleepiness, migraine, abnormal sensations)
Danish: • slagtilfælde (blandt symptomerne er: problemer med at tale eller bevæge sig, søvnighed,
English: Achieved MMR at 45 mg (N=63)
Danish: Opnåede MMR På 45 mg (N=63)
English: Common musculoskeletal pain, neck pain, musculoskeletal chest pain
Danish: Almindelig muskoloskeletale smerter, nakkesmerter, muskelskeletbrystsmerter
English: Interrupt Iclusig for serious or severe haemorrhage and evaluate.
Danish: I tilfælde af alvorlig eller svær hæmoragi skal Iclusig seponeres og patienten evalueres.
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: Common pancreatitis, blood amylase increased, gastrooesophageal reflux disease, stomatitis, dyspepsia, abdominal distension, abdominal discomfort, dry mouth
Danish: Almindelig pancreatitis, forhøjet blodamylase, gastroesofageal reflukssygdom, stomatitis, dyspepsi, abdominal distension, abdominale gener, mundtørhed
English: Iclusig is available in plastic bottles, each containing one canister of molecular sieve desiccant.
Danish: Iclusig leveres i plastflasker hver indeholdende en dåse med molekylær si-tørremiddel.
English: R/I Cohort (N=38)
Danish: R/I Kohorte (N=38)
English: White, biconvex, round film-coated tablet that is approximately 9 mm in diameter, with "AP4" debossed on one side.
Danish: Hvid, bikonveks, rund, filmovertrukket tablet, som er cirka 9 mm i diameter, præget med "AP4" på den ene side.
English: Table 8 Efficacy of Iclusig in resistant or intolerant Ph+ ALL patients Overall (N=32)
Danish: Tabel 8 Effekt af Iclusig hos resistente eller intolerante Ph+ ALL patienter
English: Phosphorus decreased
Danish: Nedsat fosfor
English: Uncommon myocardial ischemia, acute coronary syndrome, cardiac discomfort, ischemic cardiomyopathy, arteriospasm coronary, left ventricular dysfunction, atrial flutter
Danish: Ikke almindelig myokardieiskæmi, akut koronarsyndrom, ubehag i hjertet, iskæmisk kardiomyopati, koronararteriespasme, nedsat funktion af venstre ventrikel, atrieflagren
English: The bottle contains one sealed plastic canister containing molecular sieve desiccant.
Danish: Flasken indeholder en forseglet plastdåse med molekylær si-tørremiddel.
English: Uncommon retinal vein thrombosis, retinal vein occlusion, retinal artery occlusion, visual impairment
Danish: Ikke almindelig retinal venetrombose, retinal veneokklusion, retinal arterieokklusion, synsnedsættelse
English: Common pulmonary embolism, pleural effusion, epistaxis, dysphonia, pulmonary hypertension
Danish: Meget almindelig dyspnø, hoste Almindelig lungeemboli, pleuraeffusion, epistaxis, dysfoni, pulmonal hypertension
English: Common chills, influenza like illness, non-cardiac chest pain, mass, face oedema
Danish: Almindelig kulderystelser, influenzalignende sygdom, ikke-kardiale smerter i brystet, palpabel knude, ansigtsødem
English: White, biconvex, round film-coated tablet that is approximately 6 mm in diameter, with "A5" debossed on one side.
Danish: Hvid, bikonveks, rund, filmovertrukket tablet, som er cirka 6 mm i diameter, præget med "A5" på den ene side.
English: R/I Cohort (N=65)
Danish: R/I Kohorte (N=65)
English: • pain in muscles, skeletal system, neck or chest
Danish: • smerter i muskler, knogler, hals og bryst.
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: • kronisk myeloid leukæmi (CML) i kronisk fase, accelereret fase eller blastfase, der er resistent over for dasatinib eller nilotinib, der er intolerant over for dasatinib eller nilotinib, og til hvem videre behandling med imatinib ikke er klinisk relevant eller som har T315I-mutationen.
English: Women of childbearing age being treated with Iclusig should avoid becoming pregnant.
Danish: • Råd om kontraception til mænd og kvinder Kvinder i den fertile alder, som behandles med Iclusig, bør undgå at blive gravide.
English: approximately 87% of the radioactive dose is recovered in the faeces and approximately 5% in the urine.
Danish: Efter oral enkeltdosis af [14C]-mærket ponatinib kunne ca. 87 % af den radioaktive dosis genfindes i fæces og ca. 5 % i urin.
English: The bottle contains one sealed canister containing molecular sieve desiccant.
Danish: Flasken indeholder en forseglet dåse med molekylær si-tørremiddel.
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: Substances that may increase ponatinib serum concentrations
Danish: Stoffer, der kan øge serumkoncentrationer af ponatinib
English: Arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatmentemergent frequencies) occurred in 9.6%, 7.3%, and 6.9% of Iclusig-treated patients, respectively.
Danish: Arterielle kardiovaskulære, cerebrovaskulære og perifere vaskulære okklusive bivirkninger forekom hos hhv. 9,6 %, 7,3 % og 6,9 % af Iclusig-behandlede patienter (behandlingsrelaterede hyppigheder).
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: • fluid in the thorax (may cause breathing difficulty), nosebleed, difficulty producing voice sounds,
Danish: • væske i brystkassen (kan forårsage åndenød), næseblod, problemer med stemmelyde, forhøjet blodtryk i lungekredsløbet
English: Uncommon poor peripheral circulation, splenic infarction, embolism venous, venous thrombosis
Danish: Ikke almindelig dårlig perifer blodgennemstrømning, miltinfarkt, veneemboli, venetrombose
English: The risk of vascular occlusive events is likely to be dose-related (see sections 4.2 and 5.1).
Danish: Risikoen for vaskulære okklusive hændelser er sandsynligvis dosisrelateret (se pkt.
English: Substances that may decrease ponatinib serum concentrations
Danish: Stoffer, der kan nedsætte serumkoncentrationer af ponatinib
English: Common dehydration, fluid retention, hypocalcaemia, hyperglycaemia, hyperuricaemia, hypophosphataemia, hypertriglyceridaemia, hypokalaemia, weight decreased
Danish: Meget almindelig nedsat appetit Almindelig dehydrering, væskeretention, hypokalcæmi, hyperglykæmi, hyperuricæmi, hypofosfatæmi, hypertriglyceridæmi, hypokalæmi, vægttab
English: In order to determine the optimal starting dose of Iclusig and characterise the safety and efficacy of Iclusig following dose reductions after achieving MCyR in patients with CP-CML, the MAH should conduct and submit the results of a doseranging study.
Danish: Indehaveren af markedsføringstilladelsen skal gennemføre og fremsende resultaterne af et dosisintervalstudie med henblik på at bestemme den optimale startdosis for Iclusig og for at beskrive sikkerheden og effekten af Iclusig efter dosisreduktion hos CP-CML-patienter, der har opnået MCyR.
English: (95% CI) a Primary endpoint for AP-CML and BP-CML/Ph+ ALL Cohorts was MaHR, which combines complete haematological responses and no evidence of leukaemia.
Danish: (95 % CI) a Primært endepunkt for AP-CML og BP-CML/Ph+ ALL-kohorter var MaHR, som kombinerer komplet respons og ingen tegn på leukæmi.
English: Common pancytopenia, febrile neutropenia, white blood cell count decreased
Danish: Almindelig pancytopeni, febril neutropeni, nedsat leukocyttal
English: Serious arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatment-emergent frequencies) occurred in 6.7%, 5.6%, and 5.1% of Iclusig treated patients, respectively.
Danish: Alvorlige arterielle kardiovaskulære, cerebrovaskulære og perifere vaskulære okklusive bivirkninger forekom hos hhv. 6,7 %, 5,6 % og 5,1 % af Iclusigbehandlede patienter (behandlingsrelaterede hyppigheder).
English: A benefit -risk consideration should guide a decision to restart Iclusig therapy (see sections 4.2 and 4.8).
Danish: En afvejning af fordele og risici skal være vejledende for beslutningen om at genoptage Iclusig-behandlingen (se pkt.
English: • increased blood levels of liver and pancreatic enzymes:
Danish: • forhøjede niveauer af lever- og bugspytkirtelenzymer i blodet:
English: Serious side effects (common: affects 1 to 10 users in 100):
Danish: Alvorlige bivirkninger (almindelige: forekommer hos mellem1 og 10 ud af 100 patienter):
English: Very common bone pain, arthralgia, myalgia, pain in extremity, back pain, muscle spasms
Danish: Meget almindelig knoglesmerter, artralgi, myalgi, smerter i ekstremiteter, rygsmerter, muskelkramper
English: The MAH shall complete, within the stated timeframe, the below measures: Description
Danish: Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: NAME OF THE MEDICINAL PRODUCT Iclusig 15 mg film-coated tablets Ponatinib
Danish: LÆGEMIDLETS NAVN Iclusig 15 mg filmovertrukne tabletter Ponatinib
English: Uncommon cerebral artery stenosis
Danish: Ikke almindelig cerebral arteriestenose
English: Common cerebrovascular accident, cerebral infarction, neuropathy peripheral, lethargy, migraine, hyperaesthesia, hypoaesthesia, paraesthesia, transient ischaemic attack
Danish: Meget almindelig hovedpine, svimmelhed Almindelig cerebrovaskulær hændelse, cerebralt infarkt, perifer neuropati, letargi, migræne, hyperæstesi, hypoæstesi, paraæstesi, transitorisk iskæmisk attak
English: Very common anaemia, platelet count decreased, neutrophil count decreased
Danish: Meget almindelig anæmi, nedsat trombocyttal, nedsat neutrofiltal
English: Calcium decreased
Danish: Nedsat calcium
English: NAME OF THE MEDICINAL PRODUCT Iclusig 45 mg film-coated tablets Ponatinib
Danish: LÆGEMIDLETS NAVN Iclusig 45 mg filmovertrukne tabletter Ponatinib
English: Men receiving treatment with Iclusig are advised not to father a child during treatment.
Danish: Mænd, der behandles med Iclusig, frarådes at gøre kvinder gravide under behandlingen.
English: How to take Iclusig
Danish: Sådan skal du tage Iclusig
English: Consider discontinuation of ponatinib 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: Caution should be exercised and a reduction of the starting dose of Iclusig to 30 mg should be considered with concurrent use of strong CYP3A inhibitors such as clarithromycin, indinavir, itraconazole,
Danish: Der skal udvises forsigtighed, og reduktion af startdosis af Isclusig til 30 mg bør overvejes ved samtidig administration af potente CYP3A-hæmmere som f.eks. clarithromycin, indinavir, itraconazol, ketoconazol, nefazodon, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazol og grapefrugtjuice.
English: Each 15 mg film-coated tablet contains 15 mg ponatinib (as ponatinib hydrochloride).
Danish: Hver 15 mg filmovertrukket tablet indeholder 15 mg ponatinib (som ponatinibhydrochlorid).
English: Each film-coated tablet contains 120 mg of lactose monohydrate.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 120 mg lactosemonohydrat.
English: Haematological Response Rate
Danish: Hæmatologisk responsrate
English: NAME OF THE MEDICINAL PRODUCT Iclusig 15 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Iclusig 15 mg filmovertrukne tabletter
English: • Withhold Iclusig and resume at 30 mg after recovery to ≤ Grade 1
Danish: • Pausér Iclusig og genoptag med 30 mg efter bedring til ≤ grad
English: • dehydration
Danish: • væskemangel (dehydrering)
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof
English: NAME OF THE MEDICINAL PRODUCT Iclusig 45 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Iclusig 45 mg filmovertrukne tabletter
English: At doses of 30 mg or greater plasma steady state trough concentrations of ponatinib typically exceed 21 ng/mL (40 nM).
Danish: Ponatinib fremkaldte skrumpning af tumor og længere overlevelse hos mus med tumorer, som havde naturligt forekommende eller T315I-mutant BCR-ABL. Ved doser på 30 mg eller derover oversteg større plasma steady state minimumskoncentrationer af ponatinib typisk 21 ng/ml (40 nM).
English: Each 45 mg film-coated tablet contains 45 mg ponatinib (as ponatinib hydrochloride).
Danish: Hver 45 mg filmovertrukket tablet indeholder 45 mg ponatinib (som ponatinibhydrochlorid).
English: Common rash pruritic, exfoliative rash, erythema, alopecia, pruritis, skin exfoliation, night sweats, hyperhidrosis, petechia, ecchymosis, pain of skin, dermatitis exfoliative
Danish: Meget almindelig udslæt, tør hud Almindelig kløende udslæt, eksfoliativt udslæt, erytem, alopeci, pruritus, hudafskalning, nattesved, hyperhidrose, petekkier, ekkymose, hudsmerter, eksfoliativ dermatitis
English: • breathing difficulties
Danish: • åndenød
English: Ponatinib inhibits the tyrosine kinase activity of ABL and T315I mutant ABL with IC50 values of 0.4 and 2.0 nM, respectively.
Danish: Ponatinib hæmmer tyrosin-kinase-aktiviteten af ABL og T315I-mutant ABL med IC50 værdier på hhv. 0,4 og 2,0 nM. I cellulære assays var ponatinib i stand til at overvinde imatinib-, dasatinib- og nilotinib-resistens medieret af BCR-ABL-kinase-domæne-mutationer.
English: • Withhold Iclusig and resume at 30 mg after recovery to
Danish: • Pausér Iclusig og genoptag med 30 mg efter bedring til
English: • pancreas inflammation.
Danish: • betændelse i bugspytkirtlen.
English: Serious venous occlusive reactions (treatment-emergent frequencies) occurred in 4.5% of patients (see section 4.8).
Danish: Alvorlige venøse okklusive bivirkninger forekom hos 4,5 % af patienterne (behandlingsrelateret hyppighed) (se pkt.
English: How to store Iclusig Keep this medicine out of the sight and reach of children.
Danish: Opbevar dette lægemiddel utilgængeligt for børn.
English: Uncommon side effects (affects 1 to 10 users in 1,000):
Danish: Ikke almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 1.000 patienter):
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 15 mg of ponatinib (as hydrochloride).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 15 mg ponatinib (som hydrochlorid).
English: • Withhold Iclusig and resume at 15 mg after recovery to
Danish: • Pausér Iclusig og genoptag med 15 mg efter bedring til
English: AST increased
Danish: Forhøjet ALAT
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 45 mg of ponatinib (as hydrochloride).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 45 mg ponatinib (som hydrochlorid).
English: T315I Cohort (N=64)
Danish: T315I Kohorte (N=64)
English: Venous occlusive reactions (treatment-emergent frequencies) occurred in 5.0% of patients.
Danish: Venøse okklusive bivirkninger forekom hos 5,0 % af patienter (behandlingsrelateret hyppighed).
English: • fluid retention
Danish: • væskeretention
English: Sodium decreased
Danish: Nedsat natrium
English: Leukopenia (WBC decreased)
Danish: Leukopeni (nedsat leukocyttal)
English: T315I Cohort (N=18)
Danish: T315I Kohorte (N=18)
English: Serious venous occlusive reactions (treatment-emergent frequencies) occurred in 4.5% of patients.
Danish: Alvorlige venøse okklusive bivirkninger forekom hos 4,5 % af patienterne (behandlingsrelateret hyppighed).
English: • a history of bleeding issues
Danish: • har haft en blodprop
English: Common side effects (affects 1 to 10 users in 100):
Danish: Almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 100 patienter):
English: T315I Cohort (N=22)
Danish: T315I kohorte (N=22)
English: Common vision blurred, dry eye, periorbital oedema, eyelid oedema
Danish: Almindelig sløret syn, tørre øjne, periorbitalt ødem, øjenlågsødem
English: T315I Cohort (N=24)
Danish: T315I Kohorte (N=24)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 15 mg ponatinib (as hydrochloride).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 15 mg ponatinib (som hydrochlorid).
English: Each film-coated tablet contains 40 mg of lactose monohydrate.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 40 mg lactosemonohydrat.
English: • insomnia
Danish: • søvnløshed
English: Key elements of the Healthcare Professional Brochure:
Danish: Informationspakken til læger skal indeholde følgende vigtige punkter:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 45 mg ponatinib (as hydrochloride).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 45 mg ponatinib (som hydrochlorid).
English: No Dose Reduction Dose reduction to 30 mg only ≥ 90 day reduction at 30 mg ≥ 180 day reduction at 30 mg ≥ 360 day reduction at 30 mg Any dose reduction to 15 mg ≥ 90 day reduction at 15 mg ≥ 180 day reduction at 15 mg ≥ 360 day reduction at 15 mg
Danish: ≥ 360 dages reduktion med 15 mg
English: (95% CI) a Primary endpoint for CP-CML Cohorts was MCyR, which combines both complete (No detectable Ph+
Danish: (95 % CI) a Primære endepunkt for CP-CML-kohorter var MCyR, som kombinerer både komplet (ingen konstaterede Ph+ celler) og delvist (1 % til 35 % Ph+ celler) cytogenetisk respons.
English: ANC ≥ 1.5 x 109/L and platelet ≥ 75 x 109/L
Danish: • Pausér Iclusig og genoptag med 15 mg efter bedring til ANC ≥ 1,5 x 109/l og trombocyttal ≥ 75 x 109/l
English: What Iclusig looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: What Iclusig is and what it is used for What you need to know before you take Iclusig How to take Iclusig
Danish: Det skal du vide, før du begynder at bruge Iclusig Sådan skal du tage Iclusig Bivirkninger