natgillin/translations-raw huggingface dataset:
Almindelig forhøjet blodbilirubin, forhøjet alkalisk fosfatase i blodet, forhøjet gammaglutamyltransferase
Common blood bilirubin increased, blood alkaline phosphatase increased, gamma-glutamyltransferase increased
Meget almindelig udslæt, tør hud, pruritus
Very common rash, dry skin, pruritus
Gastrointestinal blødning og subduralt hæmatom var de hyppigst rapporterede grad 3/4 blødningshændelser.
Gastrointestinal haemorrhage and subdural hematoma were the most commonly reported grade 3/4 bleeding events.
Resistent eller intolerant R/I Kohorte (N=203)
Resistant or Intolerant R/I Cohort (N=203)
Det sekundære effektendepunkt hos CP-CML var komplet hæmatologisk respons (CHR) og ”major” molekulært respons (MMR).
The secondary efficacy endpoints in CP-CML were complete haematological response (CHR) and major molecular response (MMR).
• hjerteanfald (blandt symptomerne er en pludselig fornemmelse af hurtigere puls, smerter i brystkassen, kortåndethed)
• heart attack (symptoms include: sudden feeling of increased heart rate, chest pain, breathlessness)
• kredsløbsproblemer (blandt symptomerne er: smerter i arme og ben, kulde i lemmernes ekstremiteter)
• blood circulation problems (symptoms include: pain in the legs or arms, coldness of the extremities of the limbs)
Der sås ingen virkning på parametre for hanrotters fertilitet.
There were no effects on male rat fertility parameters.
• mini-slagtilfælde
• mini stroke
Opnåede MMR på 45 mg (N=63)
Achieved MMR at 45 mg (N=63)
Den anbefalede startdosis er: Én 45 mg filmovertrukket tablet én gang dagligt.
The recommended starting dose is one 45 mg film-coated tablet once daily.
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.
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
Flasker med Iclusig 15 mg indeholder enten 30, 60 eller 180 filmovertrukne tabletter.
Bottles of Iclusig 15 mg contain either 30, 60 or 180 film-coated tablets.
Forekomsten af svære blødninger var højere hos patienter med AP-CML, BP-CML og Ph+ ALL.
The incidence of severe bleeding events was higher in patients with AP-CML, BP-CML and Ph+ ALL.
Behandlingen med Iclusig skal omgående afbrydes i tilfælde af tromboemboli.
Iclusig should be interrupted immediately in case of thromboembolism.
• 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.
• 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.
• Det skal overvejes at seponere Iclusig
• Iclusig discontinuation should be considered
• forhøjet niveau af bilirubin i blodet - det gulorange nedbrydningsprodukt af hæmoglobin
• increased blood level of bilirubin - the yellow breakdown substance of the blood pigment
Ikke almindelig cerebral arteriestenose, cerebral hæmoragi, intrakraniel hæmoragi, posteriort reversibelt encefalopati-syndrom *
Uncommon cerebral artery stenosis, cerebral haemorrhage, haemorrhage intracranial, posterior reversible encephalopathy syndrome *
4.2 vedrørende en vurdering af kardiovaskulær status inden start af behandling og pkt.
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.
I fase 2-forsøget forekom der alvorlige arterielle okklusive bivirkninger hos 20 % af patienterne (behandlingsrelateret hyppighed).
In the phase 2 trial, serious arterial occlusive adverse reactions occurred in 20% of patients (treatment-emergent frequencies).
Venøse tromboemboliske bivirkninger (behandlingsrelaterede hyppigheder) forekom hos 6 % af patienterne.
Venous thromboembolic reactions (treatment-emergent frequencies) occurred in 6% of patients.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/839/006 30 filmovertrukne tabletter
MARKETING AUTHORISATION NUMBER(S) EU/1/13/839/006 30 film-coated tablets
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).
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).
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,
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.
Flasker med Iclusig 30 mg indeholder 30 filmovertrukne tabletter.
Bottles of Iclusig 30 mg contain 30 film-coated tablets.
Opnåede MCyR med 45 mg (N=86)
Achieved MCyR at 45 mg (N=86)
Arteriel okklusion og venøs tromboemboli
Arterial occlusion and venous thromboembolism
Til standarddosis på 45 mg én gang dagligt findes der en 45 mg filmovertrukket tablet.
For the standard dose of 45 mg once daily, a 45 mg film-coated tablet is available.
Bivirkninger, der er rapporteret hos alle CML- og Ph+ ALL-patienter, er vist i tabel 4.
Adverse reactions reported in all CML and Ph+ ALL patients are presented in Table 4.
Meget almindelig infektion i øvre luftveje Almindelig pneumoni, sepsis, folliculitis, cellulitis
Common pneumonia, sepsis, folliculitis, cellulitis
• 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.
• 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
I fase 2-forsøget (med en minimumopfølgning på 64 måneder) forekom der venøse tromboemboliske bivirkninger hos 6 % af patienterne (behandlingsrelateret hyppighed).
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).
• Iclusig skal genoptages med 30 mg efter bedring til ≤ grad 1 (< 3 × ULN) eller bedring til niveau før behandling Forekomst ved 30 mg:
• Iclusig should be resumed at 30 mg after recovery to ≤ Grade 1 (< 3 × ULN), or recovery to pre-treatment grade Occurrence at 30 mg:
Iclusig er indiceret til behandling af voksne patienter
Iclusig is indicated in adult patients with
Iclusig skal seponeres *IULN = laboratoriets øvre normalgrænse
Iclusig should be discontinued *IULN = institution upper limit of normal Hepatic toxicity
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).
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).
I fase 2-forsøget (med en minimumopfølgning på 64 måneder) forekom der arterielle okklusive bivirkninger hos 25 % af patienterne (behandlingsrelateret hyppighed).
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).
Det endokrine system Almindelig hypothyroidisme
Common hypothyroidism
Forekomst ved 30 mg:
Occurrence at 30 mg:
• hovedpine, forvirring, krampeanfald og synstab, som kan være symptomer på en hjernesygdom,
• headache, confusion, seizures, and loss of vision, which may be symptoms of a brain condition known as posterior reversible encephalopathy syndrome (PRES).
Iclusig kan medføre forhøjet ALAT, ASAT, bilirubin og alkalisk fosfatase.
Iclusig may result in elevation in ALT, AST, bilirubin, and alkaline phosphatase.
• infektion i øvre luftveje (kan forårsage åndenød)
• upper airway infection (may cause breathing difficulty)
Hæmatologisk responsrate ”Major”a (MaHR)
Cytogenetic Response Major (MCyR) a
• smerter i knogler, led, muskler, ryg, arme eller ben, muskelkramper
• pain in bones, joints, pain in muscles, back, arms or legs, muscle spasms
Almindelig hjerteinsufficiens, myokardieinfarkt, kongestiv hjerteinsufficiens, koronararteriesygdom, angina pectoris, perikardiel effusion, atrieflimren, nedsat ejektionsfraktion, akut koronarsyndrom, atrieflagren
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
• hududslæt, afskalning af huden, unormal fortykkelse af huden, hudrødme, blå mærker,
• skin rash, peeling of the skin, abnormal thickening of the skin, redness, bruising, skin pain,
Den kliniske relevans af disse fund for human fertilitet kendes ikke.
The clinical relevance of these findings to human fertility is unknown.
Iclusig 30 mg filmovertrukne tabletter er cirka 8 mm i diameter med "C7" på den ene side.
Iclusig 30 mg film-coated tablets are approximately 8 mm in diameter with "C7" on one side.
• lungebetændelse (kan forårsage åndenød)
• lung infection (may cause breathing difficulty)
• du får problemer med dit hjerte eller blodårer
• you develop heart or blood vessel problems.
Risikoen for arterielle okklusive hændelser er sandsynligvis dosisrelateret (se pkt.
The risk of arterial occlusive events is likely to be dose-related (see sections 4.2 and 5.1).
• blødning i maven (blandt symptomerne er mavesmerter, opkastning af blod)
• stomach bleeding (symptoms include: stomach pain, vomiting blood)
Forekomst ved 15 mg:
Occurrence at 15 mg:
• Iclusig skal pauseres og genoptages med 30 mg efter bedring til < grad 2
• Iclusig should be withheld and resumed at 30 mg after recovery to < Grade 2
Hyppigheden af tromboemboliske hændelser er højere hos patienter med Ph+ ALL eller BP-CML end hos patienter med AP-CML eller CPCML.
The incidence of thromboembolic events is higher in patients with Ph+ ALL or BP-CML than those with AP-CML or CP-CML.
- alaninaminotransferase
alanine aminotransferase aspartate aminotransferase
Iclusig 15 mg filmovertrukne tabletter Iclusig 30 mg filmovertrukne tabletter Iclusig 45 mg filmovertrukne tabletter ponatinib
Iclusig 15 mg film-coated tablets Iclusig 30 mg film-coated tablets Iclusig 45 mg film-coated tablets ponatinib
Ikke almindelig myokardieiskæmi, ubehag i hjertet, iskæmisk kardiomyopati, koronararteriespasme, nedsat funktion af venstre ventrikel
Uncommon myocardial ischemia, cardiac discomfort, ischemic cardiomyopathy, arteriospasm coronary, left ventricular dysfunction,
• hjertesvigt (blandt symptomerne er svækkelse, træthed, hævede ben)
• heart failure (symptoms include: weakness, fatigue, swollen legs)
Seponering skal overvejes hos patienter, der udvikler alvorlig hjerteinsufficiens (se pkt.
Discontinuation of ponatinib should be considered in patients who develop serious heart failure (see sections 4.2 and 4.8).
Reaktivering af hepatitis B er beskrevet i forbindelse med behandling med BCRABL-tyrosinkinasehæmmere.
Hepatitis B reactivation has been reported in association with BCR-ABL TKIs.
Almindelig dehydrering, væskeretention, hypokalcæmi, hyperglykæmi, hyperuricæmi, hypofosfatæmi, hypertriglyceridæmi, hypokalæmi, vægttab, hyponatriæmi
Common dehydration, fluid retention, hypocalcaemia, hyperglycaemia, hyperuricaemia, hypophosphataemia, hypertriglyceridaemia, hypokalaemia, weight decreased, hyponatraemia
Flasken indeholder en forseglet plastdåse med et molekylær si-tørremiddel.
The bottle contains one sealed plastic canister containing a molecular sieve desiccant.
Alvorlige venøse tromboemboliske bivirkninger forekom hos 5 % af patienterne (behandlingsrelateret hyppighed) (se pkt.
Serious venous thromboembolic adverse reactions occurred in 5% of patients (treatment-emergent frequencies) (see section 4.8).
Almindelig kløende udslæt, eksfoliativt udslæt, erytem, alopeci, hudafskalning, nattesved, hyperhidrose, petekkier, ekkymose, hudsmerter, eksfoliativ dermatitis, hyperkeratose, hyperpigmentering af huden
Common rash pruritic, exfoliative rash, erythema, alopecia, skin exfoliation, night sweats, hyperhidrosis, petechia, ecchymosis, pain of skin, dermatitis exfoliative, hyperkeratosis, skin hyperpigmentation
Iclusig leveres i plastflasker hver indeholdende en dåse med et molekylær si-tørremiddel.
Iclusig is available in plastic bottles, each containing one canister of a molecular sieve desiccant.
Iclusig 45 mg filmovertrukne tabletter EU/1/13/839/003
Iclusig 45 mg film-coated tablets EU/1/13/839/003
Patienten skal overvåges for tegn på tromboemboli.
Monitoring for evidence of thromboembolism should be performed.
Flasken indeholder en forseglet dåse med et molekylær si-tørremiddel.
The bottle contains one sealed canister containing a molecular sieve desiccant.
• Iclusig skal seponeres
• Iclusig should be discontinued
• 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:
• 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:
Iclusig 15 mg filmovertrukne tabletter EU/1/13/839/001
Iclusig 15 mg film-coated tablets EU/1/13/839/001
Almindelig pancytopeni, febril neutropeni, nedsat leukocyttal, nedsat lymfocyttal
Common pancytopenia, febrile neutropenia, white blood cell count decreased, lymphocyte count decreased
• Iclusig skal pauseres og genoptages med 15 mg efter bedring til ≤ grad 1 eller bedring til niveau før behandling Forekomst ved 15 mg:
• Iclusig should be interrupted and resumed at 15 mg after recovery to ≤ Grade 1, or recovery to pretreatment grade Occurrence at 15 mg:
Meget almindelig Hypertension Almindelig perifer arteriel okklusionssygdom, perifer iskæmi, perifer arteriestenose, claudicatio intermittens, dyb venetrombose, hedeture, rødmen
Common peripheral arterial occlusive disease, peripheral ischaemia, peripheral artery stenosis, intermittent claudication, deep vein thrombosis, hot flush, flushing
• ubehagelig trykkende fornemmelse, følelse af opfyldning, klemmen eller smerte midt i brystet
• uncomfortable pressure, fullness, squeezing or pain in the centre of the chest (Angina pectoris) and chest pain not in connection with the heart
• 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.
• ever had or might now have a hepatitis B infection.
Iclusig 30 mg filmovertrukne tabletter EU/1/13/839/006
Iclusig 30 mg film-coated tablets EU/1/13/839/006
Almindelig pancreatitis, forhøjet blodamylase, gastroesofageal reflukssygdom, stomatitis, dyspepsi, abdominal distension, abdominale gener, mundtørhed, gastrisk blødning
Common pancreatitis, blood amylase increased, gastrooesophageal reflux disease, stomatitis, dyspepsia, abdominal distension, abdominal discomfort, dry mouth, gastric haemorrhage
LÆGEMIDLETS NAVN Iclusig 30 mg filmovertrukne tabletter ponatinib
NAME OF THE MEDICINAL PRODUCT Iclusig 30 mg film-coated tablets ponatinib
• Iclusig skal pauseres og genoptages med 15 mg efter bedring til ANC ≥ 1,5 x 109/l og trombocyttal ≥ 75 x 109/l
• Iclusig should be withheld and resumed at 15 mg after recovery to ANC ≥ 1.5 x 109/L and platelet ≥ 75 x 109/L
Den kliniske relevans af dette fund for mennesker kendes ikke.
The clinical relevance of this finding for humans is not known.
• 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:
• 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:
Alvorlige bivirkninger (almindelige: kan forekomme hos 1 ud af 10 patienter):
Serious side effects (common: may affect up to 1 in 10 people):
• væske i brystkassen (kan forårsage åndenød)
• fluid in the thorax (may cause breathing difficulty)
LÆGEMIDLETS NAVN Iclusig 45 mg filmovertrukne tabletter ponatinib
NAME OF THE MEDICINAL PRODUCT Iclusig 45 mg film-coated tablets ponatinib
Hvis komplet hæmatologisk respons ikke er opnået efter 3 måneder (90 dage), skal seponering af ponatinib overvejes.
Discontinuing ponatinib should be considered if a complete haematologic response has not occurred by 3 months (90 days).
Flaske af højdensitetspolyethylen (HDPE) med skruelåg, der indeholder 30 filmovertrukne tabletter og en plastdåse med et tørremiddel (molekylær si).
High density polyethylene (HDPE) bottles with screw-top closures, containing 30 film-coated tablets, together with one plastic canister containing a molecular sieve desiccant.
• næseblod, problemer med stemmelyde, forhøjet blodtryk i lungekredsløbet
• nosebleed, difficulty producing voice sounds, hypertension in the lungs
Flaske af højdensitetspolyethylen (HDPE) med skruelåg, der indeholder enten 30, 60 eller 180 filmovertrukne tabletter og en plastdåse med et tørremiddel (molekylær si).
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.
- nedsat antal hvide blodlegemer, de såkaldte neutrofiler (blandt symptomerne er: øget tendens til betændelse)
• changes in blood levels: decreased number of red blood cells (symptoms include: weakness, dizziness, fatigue) decreased number of blood platelets (symptoms include: increased tendency to bleed or bruise) decreased number of white blood cells called neutrophilis (symptoms include: increase tendency of infection) increased level of the serum protein known as lipase
• blodprop i en dyb vene, pludselig blokering af en vene, blodprop i en blodåre i lungen (blandt symptomerne er: hedeture, rødmen, rødmen i ansigtet, åndenød)
• blood clot in a deep vein, sudden vein obstruction, blood clot in a blood vessel of the lung
Hvid, bikonveks, rund, filmovertrukket tablet, som er cirka 8 mm i diameter og præget med "C7" på den ene side.
White, biconvex, round film-coated tablet that is approximately 8 mm in diameter, with "C7" debossed on one side.
Meget almindelig hovedpine, svimmelhed Almindelig apopleksi, cerebralt infarkt, perifer neuropati, letargi, migræne, hyperæstesi, hypoæstesi, paraæstesi, transitorisk iskæmisk attak
Common cerebrovascular accident, cerebral infarction, neuropathy peripheral, lethargy, migraine, hyperaesthesia, hypoaesthesia, paraesthesia, transient ischaemic attack
Flaske af højdensitetspolyethylen (HDPE) med skruelåg, der indeholder enten 30 eller 90 filmovertrukne tabletter og en plastdåse med et tørremiddel (molekylær si).
High density polyethylene (HDPE) bottles with screw-top closures, containing either 30 or 90 film-coated tablets, together with one plastic canister containing a molecular sieve desiccant.
• Iclusig skal pauseres og genoptages med 30 mg efter bedring til ≤ grad 1 (< 1,5 x IULN)
• Iclusig should be withheld and resumed at 30 mg after recovery to ≤ Grade 1 (< 1.5 x IULN) Occurrence at 30 mg:
Iclusig 45 mg filmovertrukne tabletter
Iclusig 45 mg film-coated tablets
Hvid, bikonveks, rund, filmovertrukket tablet, som er cirka 9 mm i diameter og præget med "AP4" på den ene side.
White, biconvex, round film-coated tablet that is approximately 9 mm in diameter, with “AP4” debossed on one side.
(stoffet, der farver blodet) (blandt symptomerne er mørkfarvet urin)
(symptoms include: dark amber urine)
• har haft nyrearteriestenose (forsnævring af blodkarrene til en eller begge nyrer)
• a history of renal artery stenosis (narrowing of the blood vessels to one or both kidneys)
• Iclusig skal pauseres og genoptages med 15 mg efter bedring til ≤ grad 1 (< 1,5 x IULN)
• Iclusig should be withheld and resumed at 15 mg after recovery to ≤ Grade 1 (< 1.5 x IULN) Occurrence at 15 mg:
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.
Ponatinib inhibits the tyrosine kinase activity of ABL and T315I mutant ABL with IC50 values of 0.4 and 2.0 nM, respectively.
Iclusig 30 mg filmovertrukne tabletter
Iclusig 30 mg film-coated tablets
Arterielle kardiovaskulære, cerebrovaskulære og perifere vaskulære okklusive bivirkninger forekom hos hhv. 13 %, 9 % og 11 % af Iclusig-behandlede patienter (behandlingsrelaterede hyppigheder).
Arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatment-emergent frequencies) occurred in 13%, 9%, and 11% of Iclusig-treated patients, respectively.
Hvid, bikonveks, rund, filmovertrukket tablet, som er cirka 6 mm i diameter og præget med "A5" på den ene side.
White, biconvex, round film-coated tablet that is approximately 6 mm in diameter, with "A5" debossed on one side.
Ikke almindelig dårlig perifer blodgennemstrømning, miltinfarkt, veneemboli, venetrombose, hypertensiv krise, nyrearteriestenose
Uncommon poor peripheral circulation, splenic infarction, embolism venous, venous thrombosis, hypertensive crisis, renal artery stenosis
20 % af patienterne med CP-CML, 11 % med AP-CML, 15 % med BP-CML og 9 % med Ph+ ALL seponerede behandlingen på grund af bivirkninger efter en minimumopfølgning på 64 måneder.
After a minimum follow-up of 64 months, the rates of adverse reactions resulting in discontinuation were 20% in CP-CML, 11% in AP-CML, 15% in BP-CML and 9% in Ph+ ALL.
• forstoppelse
• palpitation
Iclusig skal seponeres
How to store Iclusig
Alvorlige arterielle kardiovaskulære, cerebrovaskulære og perifere vaskulære okklusive bivirkninger forekom hos hhv. 10 %, 7 % og 9 % af Iclusig-behandlede patienter (behandlingsrelaterede hyppigheder).
Serious arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatment-emergent frequencies) occurred in 10%, 7%, and 9% of Iclusig treated patients, respectively.
• udslæt, tør hud, kløe
• rash, dry skin, itching
Iclusig 15 mg filmovertrukne tabletter
Iclusig 15 mg film-coated tablets
R/I Kohorte (N=65)
Cohort (N=65)
Ikke almindelige bivirkninger (kan forekomme hos 1 ud af 100 patienter):
Uncommon side effects (may affect up to 1 in 100 people):
• Iclusig skal pauseres og genoptages med 15 mg efter bedring til ≤ grad 2
• Iclusig should be withheld and resumed at 15 mg after recovery to < Grade 2
Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 120 mg lactosemonohydrat.
Each film-coated tablet contains 120 mg of lactose monohydrate.
I tilfælde af alvorlig eller svær hæmoragi skal Iclusig seponeres og patienten evalueres.
Iclusig should be interrupted and patients evaluated for serious or severe haemorrhage.
Alvorlige arterielle kardiovaskulære, cerebrovaskulære og perifere vaskulære okklusive bivirkninger forekom hos hhv. 10 %, 7 % og 9 % af de Iclusig-behandlede patienter (behandlingsrelaterede hyppigheder) (se pkt.
Serious arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatment-emergent frequencies) occurred in 10%, 7%, and 9% of Iclusig treated patients, respectively (see section 4.8).
- gammaglutamyltransferase
amylase alkaline phosphatase gamma-glutamyltransferase