FrancophonIA/ELRC3.0 huggingface dataset:
English: • The active substance is imatinib (as mesilate).
Icelandic: Virka innihaldsefnið er imatinib (sem mesilat).
English: The starting dose is 400 mg, to be taken as 1 capsule of 400 mg once a day.
Icelandic: Upphafsskammturinn er 400 mg, en þá er tekið 1 hylki sem inniheldur 400 mg einu sinni á sólarhring.
English: There is no experience in children or adolescents with HES/CEL.
Icelandic: Engin reynsla er af notkun lyfsins hjá börnum eða unglingum með HES/CEL.
English: Study AIT07 was a multicentre, open-label, randomised, phase II/III study that included 128 patients (1 to < 18 years) treated with imatinib in combination with chemotherapy.
Icelandic: Rannsókn AIT07 var fjölsetra, opin, slembuð, II/III stigs rannsókn sem í tóku þátt 128 sjúklingar
English: Clinical studies in Ph+ ALL
Icelandic: á Ph+ ALL
English: The effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival.
Icelandic: Verkun imatinibs grundvallast á heildar blóð- og litningasvörun og lifun án versnunar sjúkdóms.
English: At a dose of 60 mg/kg, female rats had significant postimplantation foetal loss and a reduced number of live foetuses.
Icelandic: Hjá kvenkyns rottum komu fram marktækt fleiri fósturlát eftir hreiðrun og fækkun lifandi fóstra við 60 mg/kg skammta.
English: Ifosfamide (1.8 g/m2/day, IV): days 1-5
Icelandic: Ifosfamid (1,8 g/m²/sólarhring, i.v.): dagar 1-5
English: • Chronic myeloid leukaemia (CML) in blast crisis.
Icelandic: Kyrningabráðafasi (myeloid blast crisis):
English: Palpitations, tachycardia, cardiac failure congestive 3, pulmonary oedema
Icelandic: Hjartsláttarónot, hraðsláttur, hjartabilun 3, lungnabjúgur.
English: Pleuritic pain, pulmonary fibrosis, pulmonary hypertension, pulmonary haemorrhage
Icelandic: Fleiðruverkur, lungnatrefjun, lungnaháþrýstingur, lungnablæðing.
English: 9/l, repeat step 1 and resume imatinib at reduced dose of 260 mg/m
Icelandic: 9/l skal endurtaka lið 1 og halda áfram með minni skammti af imatinibi, þ.e. 260 mg
English: Methylprednisolone 40 mg intrathecal, day 1
Icelandic: Metylprednisolon 40 mg í mænuvökva, dag 1
English: • Rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, pustular eruption (signs of skin problems).
Icelandic: Útbrot, húðroði ásamt blöðrum á vörum, augum, húð eða í munni, húðflögnun, hiti, rauður eða fjólublár blettahúðþroti, kláði, sviði, útbrot með graftrarbólum (einkenni húðkvilla).
English: Haematological response criteria (all responses to be confirmed after ≥ 4 weeks): CHR:
Icelandic: Aftur í stöðugan fasa (RTC) Meiriháttar litningasvörun Fullkomin (Staðfest Að hluta Skilmerki blóðsvörunar (öll svörun skal staðfest eftir ≥ 4 vikur):
English: In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when imatinib is co-administered (see section 4.4).
Icelandic: Hjá sjúklingum sem gengist hafa undir skjaldkirtilsbrottnám og eru í meðferð með levotyroxini má vera að útsetning í plasma fyrir levotyroxini minnki við samhliða meðferð með imatinibi (sjá kafla 4.4).
English: Frequency categories are defined using the following convention: very common
Icelandic: Tíðniflokkar eru skilgreindir á eftirfarandi hátt:
English: In paediatric CML patients the most frequent toxicities observed were grade 3 or 4 cytopenias involving neutropenia, thrombocytopenia and anaemia.
Icelandic: Hjá börnum með CML voru algengustu eiturverkanirnar sem sáust frumufæð af gráðu 3 eða 4 og var um að ræða daufkyrningafæð, blóðflagnafæð og blóðleysi.
English: Yellow iron oxide (E172) Titanium dioxide (E171) Red iron oxide (E172)
Icelandic: Gult járnoxíð (E172) Títantvíoxíð (E171) Rautt járnoxíð (E172)
English: Imatinib medac is also a treatment for adults for:
Icelandic: Imatinib medac er einnig til meðferðar hjá fullorðnum við:
English: Dose adjustment for adverse reactions in all indications in adults and paediatric patients
Icelandic: Skammtabreytingar vegna aukaverkana, á við um allar ábendingar, hjá börnum og fullorðnum
English: • paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in
Icelandic: Börnum með Ph+ CML í stöðugum (chronic) fasa eftir að meðferð með interferoni-alfa hefur ekki borið árangur, eða í hröðunarfasa (accelerated phase).
English: Imatinib should not be used during pregnancy unless clearly necessary.
Icelandic: Ekki má nota imatinib á meðgöngu nema brýna nauðsyn beri til.
English: What Imatinib medac looks like and contents of the pack Imatinib medac 100 mg hard capsules are gelatin capsules of size “3” with orange body and cap. Imatinib medac 400 mg hard capsules are gelatin capsules of size “00” with caramel body and cap. Imatinib medac 100 mg capsules are supplied in packs containing 60 capsules in blisters.
Icelandic: Lýsing á útliti Imatinib medac og pakkningastærðir Imatinib medac 100 mg hörð hylki eru gelatínhylki af stærð „3“ með appelsínugulum botni og loki.
English: The main circulating metabolite in humans is the N-demethylated piperazine derivative, which shows similar in vitro potency to the parent.
Icelandic: Aðalumbrotsefni í blóðrás manna er N-metýlsvipta piperazinafleiðan sem sýnir svipaða in vitro virkni og lyfið sjálft.
English: Imatinib medac 400 mg hard capsules Each hard capsule contains 50.072 mg lactose monohydrate.
Icelandic: Hvert hart hylki inniheldur 50,072 mg af laktósaeinhýdrati.
English: In the event of overdose, the patient should be observed and appropriate supportive treatment given.
Icelandic: Eigi ofskömmtun sér stað skal fylgjast með sjúklingnum og veita viðeigandi stuðningsmeðferð.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Icelandic: Sjúklingar með galaktósaóþol, Lapp laktasaskort eða vanfrásog glúkósagalaktósa, sem eru mjög sjaldgæfir arfgengir kvillar, skulu ekki nota lyfið.
English: Imatinib medac 100 mg hard capsules Each hard capsule contains 12.518 mg lactose monohydrate.
Icelandic: Hvert hart hylki inniheldur 12,518 mg af laktósaeinhýdrati.
English: Renal toxicity was observed in monkeys treated for 2 weeks, with focal mineralisation and dilation of the renal tubules and tubular nephrosis.
Icelandic: Eiturverkanir á nýru sáust hjá öpum sem fengu 2 vikna meðferð og var um að ræða staðbundna steinefnaútfellingu og útvíkkun á nýrnapíplum og drep í píplum.
English: Yellow iron oxide (E172) Titanium dioxide (E171) Red iron oxide (E172) Black iron oxide (E172)
Icelandic: Gult járnoxíð (E172) Títantvíoxíð (E171) Rautt járnoxíð (E172) Svart járnoxíð (E172)
English: : intravenous
Icelandic: Innleiðslumeðferð
English: Older people: Imatinib pharmacokinetics have not been studied in older people.
Icelandic: Lyfjahvörf imatinibs hafa ekki verið rannsökuð hjá öldruðum.
English: (24 h), day 1, and Ara-C 2 g/m i.v.
Icelandic: 1 g/m² i.v. (24 klst.), dag 1, og Ara-C 2 g/m² i.v. (með 12 klst. millibili),
English: Concomitant use of rifampicin or other strong CYP3A4 inducers and imatinib should be avoided.
Icelandic: Forðast skal samhliða notkun imatinibs með rifampicini eða öðrum öflugum virkjum CYP3A4.
English: The starting dose is 100 mg, to be taken as 1 capsule of 100 mg once a day.
Icelandic: Upphafsskammturinn er 100 mg, en þá er tekið 1 hylki sem inniheldur 100 mg einu sinni á sólarhring.
English: All 65 FIP1L1-PDGFRα fusion kinase positive patients achieved a CHR sustained for months (range from 1+ to 44+ months censored at the time of the reporting).
Icelandic: FRα samrunakinasa-jákvæðir náðu CHR er stóð í marga mánuði (á bilinu 1+ til 44+ mánuði, miðað við þann tíma þegar upplýsingarnar voru birtar).
English: Reinduction block 1 (3 weeks)
Icelandic: Endurinnleiðsluhluti 1 (3 vikur)
English: The capsule shell for 400 mg capsule is composed of gelatine, yellow iron oxide (E172), titanium dioxide (E171), red iron oxide (E172) and black iron oxide (E172).
Icelandic: Hylkisskelin (á 400 mg hylkjunum) er samsett út gelatíni, gulu járnoxíði (E172), títantvíxoíði (E171), rauðu járnoxíði (E172) og svörtu járnoxíði (E172).
English: Imatinib was teratogenic in rats when administered during organogenesis at doses ≥ 100 mg/kg, approximately equal to the maximum clinical dose of 800 mg/day, based on body surface area.
Icelandic: Imatinib olli fósturskemmdum þegar það var gefið á tímabili líffæramyndunar hjá rottum við skammta ≥ 100 mg/kg sem er u.þ.b. jafnt stærsta ráðlögðum skammti, 800 mg/sólarhring, á grundvelli líkamsyfirborðs.
English: The age of these patients ranged from newborn to 14 years and imatinib was given at dose 50 mg daily or doses ranging from 400 to 520 mg/m daily.
Icelandic: Sjúklingarnir voru á aldrinum nýfæddir til 14 ára og fengu imatinib í skammtinum 50 mg á sólarhring eða í skömmtum á bilinu 400 til 520 mg/m² á sólarhring.
English: • Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in skull/brain).
Icelandic: Mikill höfuðverkur, máttleysi eða lömun í útlimum eða andliti, talerfiðleikar, skyndilegt meðvitundarleysi (einkenni um sjúkdóm í taugakerfinu svo sem blæðingar eða þroti innan
English: Patients with mild and moderate impairment of renal function appear to have a higher plasma exposure than patients with normal renal function.
Icelandic: Svo virðist sem útsetning fyrir imatinibi í plasma sé meiri hjá sjúklingum með vægt og í meðallagi skerta nýrnastarfsemi en hjá þeim sem eru með eðlilega nýrnastarfsemi.
English: The age of these patients ranged from 2 to 16 years and imatinib was given at dose 300 mg/m daily or doses ranging from 200 to 400 mg daily.
Icelandic: Sjúklingarnir voru á aldrinum 2 ára til 16 ára og fengu imatinib í skammtinum 300 mg/m² á sólarhring eða í skömmtum á bilinu 200 til 400 mg á sólarhring.
English: The mechanism and relevance of these findings in the rat carcinogenicity study for humans are not yet clarified.
Icelandic: Ekki hefur enn verið leitt í ljós hver sé orsök þessara niðurstaðna úr rannsóknum á krabbameinsvaldandi eiginleikum hjá rottum og ekki hefur heldur verið leitt í ljós hvort þær skipta máli fyrir menn.
English: Clinical studies in chronic myeloid leukaemia
Icelandic: Klínískar rannsóknir á langvarandi kyrningahvítblæði
English: • Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with your ovaries or womb).
Icelandic: Grindarholsverkir stundum ásamt ógleði og uppköstum, ásamt óvæntum blæðingum frá leggöngum, sundl eða yfirlið vegna lækkaðs blóðþrýstings (einkenni sjúkdóms í eggjastokkum
English: A further 6 DFSP patients treated with imatinib were reported in 5 published case reports, their ages ranging from 18 months to 49 years.
Icelandic: Greint var frá 6 DFSP sjúklingum til viðbótar, á aldrinum 18 mánaða til 49 ára, sem fengu meðferð með imatinibi, í 5 birtum tilfellagreinum.
English: There have been post-marketing reports of spontaneous abortions and infant congenital anomalies from women who have taken imatinib.
Icelandic: Eftir markaðssetningu lyfsins hefur verið greint frá fósturlátum án þekktrar ástæðu (spontaneous abortion) og meðfæddum vansköpunum hjá konum á meðferð með Imatinib medac.
English: Five (5) patients with MDS/MPD associated with PDGFR gene re-arrangements were reported in 4 publications.
Icelandic: Í 4 birtum heimildum var greint frá 5 sjúklingum með MDS/MPD í tengslum við PDGFR endurröðun erfðavísa.
English: Theaterstr.
Icelandic: Heyrnarskerðing.
English: G-CSF (5 μg/kg, SC): days 5-14 or until ANC > 1500 post nadir Triple IT therapy (age-adjusted): days 1 and 15
Icelandic: G-CSF (5 μg/kg, s.c.): dagar 5-14 eða þar til ANC > 1500 eftir lægsta gildi Þreföld i.t. meðferð (aðlöguð að aldri): dagar 1 og 15
English: Five (5) patients with DFSP and PDGFR gene re-arrangements were reported in 3 publications.
Icelandic: Í 3 birtum heimildum var greint frá fimm (5) sjúklingum með DFSP og PDGFR endurröðun erfðavísa.
English: Acute respiratory failure
Icelandic: Bráð öndunarbilun
English: The capsule shell for 100 mg capsule is composed of gelatine, yellow iron oxide (E172), titanium dioxide (E171) and red iron oxide (E172).
Icelandic: Hylkisskelin (á 100 mg hylkjunum) er samsett út gelatíni, gulu járnoxíði (E172), títantvíxoíði (E171) og rauðu járnoxíði (E172).
English: Imatinib medac contains lactose.
Icelandic: Imatinib medac inniheldur laktósa.
English: When and how to take Imatinib medac • Take Imatinib medac with a meal.
Icelandic: Hvenær og hvernig á að nota Imatinib medac
English: There have been case reports of growth retardation occurring in children and pre-adolescents receiving imatinib.
Icelandic: Greint hefur verið frá vaxtarskerðingu hjá börnum og stálpuðum börnum (preadolecents) á meðferð með imatinibi.
English: • Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of
Icelandic: Ógleði ásamt lystarleysi, dökkleitt þvag, gul húð eða augu (einkenni lifrarsjúkdóms).
English: Reinduction block 2 (3 weeks)
Icelandic: Endurinnleiðsluhluti 2 (3 vikur)
English: Imatinib medac inhibits the growth of these cells in a certain subtype of these diseases.
Icelandic: Imatinib medac hamlar fjölgun þessara frumna hjá ákveðnum undirhópum sjúkdómanna.
English: Ara-C 40 mg intrathecal, days 1, 8, 15, 22;
Icelandic: Ara-C 40 mg í mænuvökva, daga 1, 8, 15, 22;
English: VCR (1.5 mg/m 2/day, IV): days 1, 29
Icelandic: VCR (1,5 mg/m², i.v.): dagar 1 og 29
English: In this study, 14 patients with HES/CEL were treated with 100 mg to 1,000 mg of imatinib daily.
Icelandic: 14 sjúklingar með HES/CEL meðferð með imatinibi 100 til 1.000 mg/sólarhring.
English: Target organs for neoplastic changes were the kidneys, urinary bladder, urethra, preputial and clitoral gland, small intestine, parathyroid glands, adrenal glands and non-glandular stomach.
Icelandic: Marklíffæri hvað æxlisbreytingar varðar voru nýru, þvagblaðra, þvagrás, forhúðar- og snípkirtill (preputial and clitoral gland), mjógirni, kalkkirtlar, nýrnahettur og kirtlafrír hluti maga.
English: This is because Imatinib medac could cause hepatitis B to become active again, which can be fatal in some cases.
Icelandic: Þetta er vegna þess að Imatinib medac gæti endurvirkjað lifrarbólgu
English: The liver was a target organ in rats and dogs.
Icelandic: Marklíffærið hjá rottum og hundum var lifrin.
English: VCR 2 mg i.v., days 6, 13, 20; Daunorubicin 45 mg/m i.v., days 6-7, 13-14
Icelandic: Daunorubicin 45 mg/m² i.v., daga 6-7, 13-14
English: Imatinib medac is indicated for the treatment of
Icelandic: Imatinib medac er ætlað til meðferðar hjá:
English: Methylprednisolone 40 mg intrathecal, days 1, 8, 15, 22
Icelandic: Metylprednisolon 40 mg í mænuvökva, daga 1, 8, 15, 22
English: Each 400 mg hard capsule of Imatinib medac contains 400 mg imatinib (as mesilate).
Icelandic: Hvert 400 mg hart hylki af Imatinib medac inniheldur 400 mg af imatinibi (sem mesilat).
English: 3) On a patient-year basis, cardiac events including congestive heart failure were more commonly observed in patients with transformed CML than in patients with chronic CML.
Icelandic: 3 Á grundvelli sjúklingsára tengdust hjartaatvik, þ.m.t. hjartabilun, oftar sjúklingum með umbreytt (transformed) CML en sjúklingum með langvarandi CML.
English: Pleural effusion
Icelandic: Tafla yfir aukaverkanir
English: Common: Uncommon: Rare:
Icelandic: Mjög sjaldgæfar:
English: 5) Pleural effusion was reported more commonly in patients with GIST and in patients with transformed CML (CML-AP and CML-BC) than in patients with chronic CML.
Icelandic: CML (CML-AP og CML-BC) en hjá sjúklingum með langvarandi CML.
English: Partial
Icelandic: Verkunarháttur
English: Imatinib medac 100 mg hard capsules Imatinib medac 400 mg hard capsules
Icelandic: Imatinib medac 100 mg hörð hylki Imatinib medac 400 mg hörð hylki
English: • Imatinib medac is not recommended during pregnancy unless clearly necessary as it may harm your baby.
Icelandic: Ekki er ráðlagt að nota Imatinib medac á meðgöngu nema brýna nauðsyn beri til því það getur skaðað fóstrið.
English: As cardiac adverse events have been reported uncommonly with imatinib, a careful assessment of the benefit/risk of imatinib therapy should be considered in the HES/CEL population before treatment initiation.
Icelandic: Vegna þess að greint hefur verið frá sjaldgæfum tilvikum um aukaverkanir á hjarta, í tengslum við imatinib, skal leggja ítarlegt mat á hlutfall áhættu og ávinnings hvað varðar sjúklinga með HES/CEL, áður en meðferð með imatinibi hefst.
English: All patients achieved complete haematological response, cytogenetic response and/or clinical response.
Icelandic: Allir sjúklingar náðu fullkominni blóðsvörun, litningasvörun og/eða klínískri svörun.
English: Intensification block 2 (9 weeks)
Icelandic: Eflingarhluti 2 (9 vikur)
English: Cataract, glaucoma, papilloedema
Icelandic: Brjóstverkur, lasleiki.
English: Increased blood urea nitrogen (BUN) and creatinine were observed in several of these animals.
Icelandic: Hækkað blóðnitur (BUN) og hækkað kreatinin sást í nokkrum dýranna.
English: Rash pustular, contusion, sweating increased, urticaria, ecchymosis, increased tendency to bruise, hypotrichosis, skin hypopigmentation, dermatitis exfoliative, onychoclasis, folliculitis, petechiae, psoriasis, purpura, skin hyperpigmentation,
Icelandic: Bóluútbrot, mar, aukin svitamyndun, ofsakláði, flekkblæðingar, mar af minna tilefni en áður, gisið hár, vanlitun í húð, skinnflagningsbólga, brotnar neglur, hársekksbólga, depilblæðingar, sóri, purpuri, oflitun í húð,
English: Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m
Icelandic: Hröðunarfasi CML og bráðafasi, hjá börnum, (upphafsskammtur 340 mg/m²)
English: G-CSF (5 μg/kg, SC): days 4-13 or until ANC > 1500 post nadir
Icelandic: G-CSF (5 μg/kg, s.c.): dagar 27-36 eða þar til ANC > 1500 eftir lægsta
English: Isolated cases of imatinib overdose have been reported spontaneously and in the literature.
Icelandic: Greint hefur verið frá einstökum tilvikum um ofskömmtun imatinibs með almennum aukaverkanatilkynningum og í rituðum heimildum.
English: 9/l, repeat step 1 and resume imatinib at reduced dose of 400 mg.
Icelandic: 9/l skal endurtaka lið 1 og halda áfram með minni skammti af imatinibi, þ.e. 400 mg.
English: Intensification block 1 (9 weeks)
Icelandic: Eflingarhluti 1 (9 vikur)
English: Positive genotoxic effects were obtained for imatinib in an in vitro mammalian cell assay (Chinese hamster ovary) for clastogenicity (chromosome aberration) in the presence of metabolic activation at a concentration of 125 μg/ml.Two intermediates of the manufacturing process, which are also present in the final product, are positive for mutagenesis in the Ames assay.
Icelandic: Staðfest var í in vitro spendýrafrumuprófi fyrir imatinib að það hefur eiturverkanir á erfðaefni (eggjastokkar kínahamstra) hvað varðar litningaskemmdir við örvuð umbrot (metabolic activation) við þéttni sem er 125 µg/ml.
English: (n = 5), 340 mg/m2/day (n = 7) and 570 mg/m 2/day (n = 5).
Icelandic: Sjúklingar fengu imatinib í skömmtunum 260 mg/m²/sólarhring (n = 5), 340 mg/m²/sólarhring (n = 9), 440 mg/m²/sólarhring (n = 7) og 570 mg/m²/sólarhring (n = 5).
English: One phase II, open label, multicentre clinical trial (study B2225) was conducted including 12 patients with DFSP treated with imatinib 800 mg daily.
Icelandic: Fram fór ein opin, fjölsetra, II. stigs klínísk rannsókn (rannsókn B2225) sem í tóku þátt 12 sjúklingar með DFSP, sem fengu meðferð með 800 mg af imatinibi á sólarhring.
English: Each 100 mg hard capsule of Imatinib medac contains 100 mg imatinib (as mesilate).
Icelandic: Hvert 100 mg hart hylki af Imatinib medac inniheldur 100 mg af imatinibi (sem mesilat).
English: Transformed CML is the stage of the disease after its progression from chronic phase to accelerated phase (AP) or blast crisis (BC).
Icelandic: Umbreytt CML er stig sjúkdómsins eftir versnun hans úr stöðugum fasa yfir í
English: Women of childbearing potential Women of childbearing potential must be advised to use effective contraception during treatment.
Icelandic: Ráðleggja skal konum á barneignaraldri að nota örugga getnaðarvörn meðan á meðferð stendur.
English: Dizziness, paraesthesia, taste disturbance, hypoaesthesia
Icelandic: Ógleði, niðurgangur, uppköst, meltingartruflun, kviðverkir
English: Imatinib medac is also a treatment for children and adolescents for:
Icelandic: Imatinib medac er einnig til meðferðar hjá börnum og unglingum við:
English: Haematological response Complete haematological response (CHR)
Icelandic: Blóðsvörun Fullkomin blóðsvörun (CHR)
English: What Imatinib medac contains
Icelandic: Imatinib medac inniheldur
English: Flushing, haemorrhage
Icelandic: Æxlunarfæri og brjóst
English: The recommended dose of imatinib is 100 mg/day for patients with HES/CEL.
Icelandic: Ráðlagður skammtur af imatinibi er 100 mg/sólarhring handa sjúklingum með HES/CEL.
English: Liver dysfunction classification:
Icelandic: Skert lifrarstarfsemi:
English: Evaluation by a cardiology specialist, performance of an echocardiogram and determination of serum troponin should therefore be considered in patients with HES/CEL, and in patients with MDS/MPD associated with high eosinophil levels before imatinib is administered.
Icelandic: á troponini í sermi hjá sjúklingum með HES/CEL og hjá sjúklingum með MDS/MPD sem tengjast miklum fjölda rauðkyrninga, áður en meðferð með imatinibi hefst.
English: Acute febrile neutrophilic dermatosis (Sweet's syndrome), nail discolouration, angioneurotic oedema, rash vesicular, erythema multiforme, leucocytoclastic vasculitis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis
Icelandic: Bráð daufkyrningahúðsótt með sótthita (Sweets heilkenni), mislitun nagla, ofsabjúgur, útbrot með blöðrum, regnbogaroðaþot, ofnæmisæðabólga, Stevens-Johnson heilkenni, bráð almenn bóluútbrot (AGEP).
English: All patients achieved complete haematological response, complete cytogenetic response and/or complete molecular response.
Icelandic: Allir sjúklingar náðu fullkominni blóðsvörun, fullkominni litningasvörun og/eða fullkominni sameindasvörun.
English: • Anorexia, weight loss or a disturbed sense of taste.
Icelandic: Lystarleysi, þyngdartap eða breytingar á bragðskyni.
English: • Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a
Icelandic: B sýkingar ef þú hefur áður verið með lifrarbólgu B (sýking í lifur).
English: Imatinib medac 100 mg hard capsules Size “3” hard capsules with orange body and cap. Imatinib medac 400 mg hard capsules Size “00” hard capsules with caramel body and cap.
Icelandic: Imatinib medac 100 mg hörð hylki Hörð hylki af stærð „3“ með appelsínugulum botni og loki.
English: Concomitant use of imatinib and medicinal products that induce CYP3A4 (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to imatinib, potentially increasing the risk of therapeutic failure.
Icelandic: Samhliða notkun imatinibs og lyfja sem virkja CYP3A4 (t.d. dexametason, fenytoin, carbamazepin, rifampicin, fenobarbital eða Hypericum perforatum, einnig þekkt sem jóhannesarjurt [jónsmessurunni.
English: Organ function impairment
Icelandic: Skert líffærastarfsemi
English: Clinical cases of hypothyroidism have been reported in thyroidectomy patients undergoing levothyroxine replacement during treatment with imatinib (see section 4.5).
Icelandic: Greint hefur verið frá klínískum tilvikum um skjaldvakabrest hjá sjúklingum sem gengist hafa undir skjaldkirtilsbrottnám og eru í uppbótarmeðferð með levotyroxini samhliða meðferð með imatinibi (sjá kafla 4.5).
English: In patients with hepatic dysfunction (mild, moderate or severe), peripheral blood counts and liver enzymes should be carefully monitored (see sections 4.2, 4.8 and 5.2).
Icelandic: Fylgjast skal vandlega með blóðhag og lifrarensímum (sjá kafla 4.2, 4.8 og 5.2) hjá sjúklingum með skerta lifrarstarfsemi (vægt, í meðallagi eða alvarlega skerta).