FrancophonIA/ELRC3.0 huggingface dataset:
English: 10) Musculoskeletal pain and related events were more commonly observed in patients with CML than in GIST patients.
Icelandic: Stoðkerfisverkir og annað því um líkt kom oftar fyrir hjá sjúklingum með CML en hjá
English: The paediatric patient received 400 mg/m2/daily, subsequently increased to 520 mg/m2/daily.
Icelandic: Barn fékk 400 mg/m² á sólarhring, sem síðan var aukið í 520 mg/m² á sólarhring.
English: Myelodysplastic/myeloproliferative diseases with PDGFR gene re-arrangements could be associated with high eosinophil levels.
Icelandic: Vera má að mergrangvaxtarsjúkdómar/mergfrumnafjölgunarsjúkdómar (MDS/MPD) með PDGFR endurröðun erfðavísa tengist miklum fjölda rauðkyrninga.
English: 9/l, repeat step 1 and resume imatinib at reduced dose of 300 mg.
Icelandic: 9/l skal endurtaka lið 1 og halda áfram með minni skammti af imatinibi, þ.e. 300 mg.
English: 8 g to 10 g (single dose): Vomiting and gastrointestinal pain have been reported.
Icelandic: 8 g til 10 g (stakur skammtur):
English: 7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
Icelandic: 7, ropi, sortusaur, vélindabólga, skinuholsvökvi, magasár, blóðug uppköst, varaþroti,
English: Patients with renal impairment should be given the minimum starting dose.
Icelandic: Nota á minnsta upphafsskammt handa sjúklingum með skerta nýrnastarfsemi.
English: Patients should be tested for HBV infection before initiating treatment with imatinib.
Icelandic: B veirusýkingu áður en meðferð með imatinib er hafin.
English: Out of 9 patients with chronic phase CML and cytogenetic data available, 4 (44 %) and 3 (33 %) achieved a complete and partial cytogenetic response, respectively, for a rate of MCyR of 77 %.
Icelandic: 4 (44 %) fullkomna litningasvörun og 3 (33 %) litningasvörun að hluta í sameinaða hlutfallinu 77 % fyrir meiriháttar litningasvörun (MCyR: major cytogenetic response).
English: There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Icelandic: Engar samanburðarrannsóknir sýna fram á klínískan ávinning í bráðafasa, svo sem bata á sjúkdómstengdum einkennum eða aukinni lifun.
English: Due to the possible occurrence of tumour lysis syndrome (TLS), correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of imatinib (see section 4.8).
Icelandic: Mælt er með að bætt sé úr klínískt marktækum vökvaskorti og að há þvagsýra sé meðhöndluð áður en meðferð er hafin með imatinibi vegna hugsanlegrar myndunar æxlislýsuheilkennis (tumour lysis syndrome) (sjá kafla 4.8).
English: 2/day, IV): days 1, 8 and 15 2/day bolus, IV): days 1 and 2 2/dose q12h x 4 doses, iv): Days 3 and 4 2, IM): day 4 G-CSF (5 μg/kg, SC): days 5-14 or until ANC > 1500 post nadir Triple IT therapy (age-adjusted): days 1 and 15 2/day, PO): days 1-7 and 15-21
Icelandic: ARA-C (3 g/m²/skammt á 12 klst. fresti x 4, i.v.): dagar 2 og 3 G-CSF (5 μg/kg, s.c.): dagar 4-13 eða þar til ANC > 1500 eftir lægsta gildi
English: PEG-ASP (2500 IUnits/m2, IM): day 4
Icelandic: L-ASP (6000 a.einingar/m², i.m.): dagur 44
English: The dose is 800 mg per day, to be taken as 1 capsule of 400 mg in the morning and 1 capsule of
Icelandic: Skammturinn er 800 mg á sólarhring, en þá er tekið 1 hylki sem inniheldur 400 mg að morgni og 1 hylki sem inniheldur 400 mg að kvöldi.
English: UNIQUE IDENTIFIER - 2D BARCODE {2D barcode carrying the unique identifier included.}
Icelandic: 17. EINKVÆMT AUÐKENNI - TVÍVÍTT STRIKAMERKI <Á pakkningunni er tvívítt strikamerki með einkvæmu auðkenni.>
English: Pruritus, face oedema, dry skin, erythema, alopecia, night sweats, photosensitivity
Icelandic: Kláði, andlitsbjúgur, húðþurrkur, hörundsroði, hárlos, nætursviti, ljósnæmis
English: This will help protect you from stomach problems when
Icelandic: Það hjálpar til við að vernda þig gegn magavandamálum þegar þú notar Imatinib medac.
English: An increased rate of opportunistic infections was observed with chronic imatinib treatment.
Icelandic: Við langvarandi meðferð með imatinibi sást aukning á tíðni tækifærissýkinga.
English: Dyspnoea, epistaxis, cough
Icelandic: Ristill, áblástur, nefkoksbólga, lungnabólga
English: Therapeutic indication
Icelandic: LYFJAGERÐARFRÆÐILEGAR UPPLÝSINGAR
English: The condition was reported to be reversible with the administration of systemic steroids, circulatory support measures and temporarily withholding imatinib.
Icelandic: Greint var frá því að þetta ástand gengi til baka þegar gefnir voru sterar til almennrar (systemic) verkunar, veitt var meðferð til að tryggja blóðrás og notkun imatinibs hætt tímabundið.
English: Renal failure chronic Reproductive system and breast disorders
Icelandic: Endurkoma (endurvirkjun) lifrarbólgu
English: CPM (300 mg/m2, IV): days 29-33
Icelandic: CPM (300 mg/m²/sólarhring, i.v.): dagar 22-26
English: MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5
Icelandic: MESNA (360 mg/m²/skammt á 3 klst. fresti, x 8 skammtar/sólarhring, i.v.):
English: Maintenance (8-week cycles) Cycle 5
Icelandic: Viðhaldsmeðferð (8-vikna lotur)
English: Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms
Icelandic: Handa- og fótaheilkenni (palmoplantar erythrodysesthesia syndrome)*, hornlagsskæningur (lichenoid keratosis)*, flatskæningur*, eitrunardreplos húðþekju*, lyfjaútbrot ásamt rauðkyrningageri og altækum einkennum
English: Imatinib medac contains lactose monohydrate
Icelandic: Imatinib medac inniheldur laktósaeinhýdrat
English: Psychiatric disorders
Icelandic: Innleiðing sjúkdómshlés
English: Paediatric population
Icelandic: Pabianickie Zakłady
English: Three (3) patients with HES and CEL associated with PDGFR gene re-arrangements were reported in 3 publications.
Icelandic: Í 3 birtum heimildum var greint var frá 3 sjúklingum með HES og CEL í tengslum við PDGFR endurröðun erfðavísa.
English: • Cough, having difficulty breathing or painful breathing (signs of lung problems).
Icelandic: Hósti, öndunarerfiðleikar eða sársaukafull öndun (einkenni lungnasjúkdóms).
English: No patient developed grade 4 thrombocytopenia.
Icelandic: Enginn sjúklingur fékk blóðflagnafæð af gráðu
English: GI tumour sites may have been the source of the GI bleeds (see section 4.4).
Icelandic: Staðsetning æxlis í maga og þörmum kann að hafa verið upptök maga- og þarmablæðinga (sjá kafla 4.4).
English: 9/l) and thrombocytopenias (platelet count < 50 x 10
Icelandic: 9/l) og blóðflagnafæðar (blóðflagnafjöldi < 50 x 10
English: • Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red
Icelandic: Húðfölvi, þreyta og mæði ásamt dökkleitu þvagi (einkenni of fárra rauðra blóðkorna).
English: VP-16 (100 mg/m 2, IV): days 29-33
Icelandic: VP-16 (100 mg/m²/sólarhring, i.v.): dagar 22-26
English: Active substances that may decrease imatinib plasma concentrations Substances that are inducers of CYP3A4 activity (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidone or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to imatinib, potentially increasing the risk of therapeutic failure.
Icelandic: Virk efni sem geta minnkað plasmaþéttni imatinibs Efni sem virkja CYP3A4 (t.d. dexametason, fenytoin, carbamazepin, rifampicin, fenobarbital, fosfenytoin, primidon eða Hypericum perforatum, einnig þekkt sem jóhannesarjurt [jónsmessurunni.
English: Pharmacokinetics in paediatric patients
Icelandic: Lyfjahvörf sjúklingahópa
English: Imatinib and its metabolites are not excreted via the kidney to a significant extent.
Icelandic: Imatinib og umbrotsefni þess skiljast ekki út um nýru í magni sem máli skiptir.
English: • Weight gain.
Icelandic: Þyngdartap.
English: Adverse reactions and their frequencies are reported in Table 1.
Icelandic: Aukaverkanir og tíðni þeirra, er tilgreind er í töflu
English: 5, pharyngolaryngeal pain, pharyngitis
Icelandic: 5, verkur í koki og barkakýli, kokbólga.
English: Other medicines and Imatinib medac
Icelandic: Notkun annarra lyfja samhliða Imatinib medac
English: The most commonly reported (≥ 10 %) treatment-related adverse reactions were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash.
Icelandic: Algengustu (≥ 10 %) meðferðartengdu aukaverkanirnar sem greint var frá voru væg ógleði, uppköst, niðurgangur, kviðverkir, þreyta, vöðvaþrautir, vöðvakrampar og útbrot.
English: Study AUS01
Icelandic: Rannsókn AUS01 Innleiðsluupprætingarmeðferð
English: Imatinib medac 400 mg hard capsules
Icelandic: Imatinib medac 400 mg hörð hylki
English: Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
Icelandic: Engar samanburðarrannsóknir hafa verið gerðar sem sýna fram á klínískan ávinning eða lengda lifun fyrir þessa sjúkdóma, nema hvað varðar nýgreint CML í stöðugum fasa.
English: Patients with severe renal impairment should be treated with caution.
Icelandic: Gæta skal varúðar við meðferð sjúklinga með alvarlega skerta nýrnastarfsemi.
English: Maintenance
Icelandic: UPPLÝSINGAR
English: Ara-C 2x 2 g/m i.v.
Icelandic: Ara-C 2 x 2 g/m² i.v. (3 klst., með 12 klst. millibili), dag 5
English: Clinical studies in HES/CEL
Icelandic: á HES/CEL
English: • Joint pain with swelling.
Icelandic: Liðverkir ásamt þrota.
English: *, interstitial lung disease*
Icelandic: *, millivefslungnasjúkdómur*.
English: Dose increases from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients with blast crisis may be considered in the absence of severe adverse drug reaction and severe non-leukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Icelandic: Íhuga má aukningu skammta úr 600 mg í mest 800 mg (gefið sem 400 mg tvisvar sinnum á sólarhring) hjá sjúklingum í bráðafasa, ef ekki koma fram alvarlegar aukaverkanir og ekki alvarleg daufkyrningafæð (neutropenia) eða blóðflagnafæð sem ekki tengjast hvítblæðinu, við eftirfarandi aðstæður:
English: (3 h), days 1-4; Mitoxantrone 10 mg/m i.v.
Icelandic: Ara-C 1.000 mg/m²/12 klst. i.v. (3 klst.), daga 1-4; Mitoxantron 10 mg/m² i.v. daga 3-5;
English: Methotrexate (5 g/m over 24 hours, IV): days 1 and 15 at hour 36, IV; 15 mg/m
Icelandic: Metótrexat (5 g/m² á 24 klst., i.v.): dagar 1 og 15
English: VCR 2 mg i.v.
Icelandic: Vincristin 2 mg i.v., daga 4, 11;
English: Some medicines can interfere with the effect of Imatinib medac when taken together.
Icelandic: Við samhliða notkun geta sum lyf haft áhrif á verkun Imatinib medac.
English: This medicine works by inhibiting the growth of abnormal cells in the diseases listed below.
Icelandic: Við neðangreinda sjúkdóma hemur þetta lyf vöxt óeðlilegra frumna.
English: Lymphoid blast crisis: a limited number of patients were enrolled in phase I studies (n = 10).
Icelandic: I stigs rannsóknir (n = 10).
English: Imatinib
Icelandic: Pabianice
English: In addition a further 24 patients with MDS/MPD were reported in 13 publications.
Icelandic: Í 13 birtum heimildum var greint frá 24 sjúklingum til viðbótar, sem voru með MDS/MPD.
English: Therapy should be initiated by a physician experienced in the treatment of patients with haematological malignancies and malignant sarcomas, as appropriate.
Icelandic: Læknir með reynslu í meðferð sjúklinga með illkynja blóðsjúkdóma eða illkynja sarkmein, eftir því sem við á, á að hefja meðferðina.
English: Common:
Icelandic: AST:
English: Liver function tests
Icelandic: Prófa á fyrir lifrarbólgu
English: • paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+)
Icelandic: Börnum með nýlega greint Fíladelfíulitnings (bcr-abl) jákvætt (Ph+) langvarandi kyrningahvítblæði (chronic myeloid leukaemia [CML]), þar sem beinmergsskipti eru ekki talin
English: 8) Some fatal cases of hepatic failure and of hepatic necrosis have been reported.
Icelandic: 8 Greint hefur verið frá nokkrum tilvikum um banvæna lifrarbólgu og lifrardrep.
English: imatinib treatment induces a rapid response in newly diagnosed paediatric CML patients with a CHR of 78 % after 8 weeks of therapy.
Icelandic: Meðferð með imatinibi leiðir til skjótrar svörunar hjá nýlega greindum börnum með CML og eftir 8 vikna meðferð hafði náðst fullkomin blóðsvörun (complete haematological response:
English: Mild
Icelandic: Alvarleg
English: Dose increases from 340 mg/m daily to 570 mg/m daily (not to exceed the total dose of 800 mg) may be considered in the absence of severe adverse drug reaction and severe non-leukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Icelandic: Íhuga má aukningu skammta úr 340 mg/m² daglega í 570 mg/m² daglega (þó má ekki fara yfir heildarskammtinn 800 mg) ef ekki koma fram alvarlegar aukaverkanir og ekki alvarleg daufkyrningafæð (neutropenia) eða blóðflagnafæð sem ekki tengjast hvítblæðinu, við eftirfarandi aðstæður:
English: 1800 mg to 3200 mg (as high as 3200 mg daily for 6 days): Weakness, myalgia, increased creatine phosphokinase, increased bilirubin, gastrointestinal pain.
Icelandic: 1800 mg til 3200 mg (allt að 3200 mg á sólarhring í 6 daga):
English: Three of the partial responders were subsequently rendered disease free by surgery.
Icelandic: Hjá 3 sjúklinganna sem sýndu svörun að hluta til tókst síðan að vinna bug á sjúkdómnum með skurðaðgerð.
English: CPM (250 mg/m2/dose q12h x 4 doses, IV): days 3 and 4
Icelandic: Doxorubicin 50 mg/m² i.v. (24 klst.), dag 4;
English: days 3-5;
Icelandic: Lota 5
English: Consolidation block 2 (3 weeks)
Icelandic: Upprætingarhluti 2 (3 vikur)
English: Triple IT therapy (age-adjusted): days 1 and 22 2/day, IV): days 22-26 2/day, IV): days 22-26 2/day, IV): days 22-26 G-CSF (5 μg/kg, SC): days 27-36 or until ANC > 1500 post nadir 2, q12h, IV): days 43, 44 2, IM): day 44
Icelandic: G-CSF (5 μg/kg, s.c.): dagar 27-36 eða þar til ANC > 1500 eftir lægsta gildi ARA-C (3 g/m², á 12 klst. fresti, i.v.): dagar 43 og 44
English: Consolidation block 1 (3 weeks)
Icelandic: Upprætingarhluti 1 (3 vikur)
English: • Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (eg.
Icelandic: Ógleði, mæði, óreglulegur hjartsláttur, skýjað þvag, þreyta og/eða óþægindi í liðum í tengslum við óeðlilegar niðurstöður úr rannsóknum (t.d. mikið magn kalíums, þvagsýru og kalsíums og
English: MTX 1.5 g/m i.v.
Icelandic: MTX 1,5 g/m² i.v. (24 klst.), dag 1;
English: ANC < 1.0 x 10
Icelandic: ANC < 1,0 x 10 9/l og/eða blóðflögur < 50 x 10
English: Teratogenic effects included exencephaly or encephalocele, absent/reduced frontal and absent parietal bones.
Icelandic: Fósturskemmdirnar eru útheili (exencephaly) eða heilahaull, vöntun/minnkun á ennisbeini og vöntun á hvirfilbeini.
English: Posology for DFSP in adult patients The recommended dose of imatinib is 800 mg/day for patients with DFSP.
Icelandic: Ráðlagður skammtur af imatinibi er 800 mg/sólarhring fyrir sjúklinga með DFSP.
English: (24 h), day 4; DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/m i.v.
Icelandic: DEX 40 mg/sólarhring daga 1-4 og 11-14, til skiptis við MTX 1 g/m² i.v. (24 klst.), dag 1, Ara-C 1 g/m² i.v. (2 klst., með 12 klst. millibili), daga 2-3 (samtals 8 meðferðarlotur)
English: • Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of
Icelandic: Miklir kviðverkir, blóðug uppköst, blóðugar hægðir eða blóð í þvagi, svartar hægðir (einkenni
English: Myeloid blast crisis: 260 patients with myeloid blast crisis were enrolled.
Icelandic: 260 sjúklingar með kyrningabráðafasa tóku þátt í rannsókninni.
English: • Pain or swelling in your abdomen, flatulence, heartburn or constipation.
Icelandic: Kviðverkir eða þaninn kviður, vindgangur, brjóstsviði eða hægðatregða.
English: Laboratory test abnormalities
Icelandic: Afbrigðileg rannsóknarstofupróf
English: Immune system disorders
Icelandic: Laktósaeinhýdrat Magnesíumsterat
English: Cases of liver injury, including hepatic failure and hepatic necrosis, have been observed with imatinib.
Icelandic: Komið hafa fram tilvik lifrarskemmda, þar með talið lifrarbilunar og lifrardreps í tengslum við notkun imatinibs.
English: • Severely decreased urine output, feeling thirsty (signs of kidney problems).
Icelandic: Mikil minnkun þvagmyndunar, þorsti (einkenni nýrnasjúkdóms).
English: There are no controlled trials in paediatric patients with DFSP.
Icelandic: Ekki hafa verið gerðar neinar samanburðarrannsóknir hjá börnum með DFSP.
English: • Feeling dizzy or weak.
Icelandic: Sundl eða slappleiki.
English: Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric Hepatobiliary disorders
Icelandic: Garnastífla/teppa í meltingarvegi*, garnarof*, sarpbólga*, GAVE (víkkun lítilla blóðæða í neðsta hluta magans [gastric antral vascular ectasia])*.
English: Liver dysfunction
Icelandic: Endurvirkjun lifrarbólgu
English: Additionally, improvements in symptomatology and other organ dysfunction abnormalities were reported by the investigators in the case reports.
Icelandic: Í tilvikagreinunum greindu rannsakendur að auki frá bata hvað varðar einkenni og aðra óeðlilega vanstarfsemi líffæra.
English: Hepatic insufficiency: Imatinib is mainly metabolised through the liver.
Icelandic: Imatinib umbrotnar einkum í lifur.
English: • Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or
Icelandic: Útferð úr auga ásamt kláða, roða og þrota (tárubólga), aukin táramyndun eða þokusýn.
English: Gastrointestinal haemorrhage
Icelandic: Skel hylkisins Gelatín
English: Moderate
Icelandic: Forklínískt
English: Remission induction DEX 10 mg/m oral, days 6-7, 13-16; i.v.
Icelandic: Daunorubicin 30 mg/m² i.v., daga 1-3, 15-16;
English: 2/day PO): days 1-5; 29-33 6-MP (75 mg/m 2/day, PO): days 8-28 Methotrexate (20 mg/m 2/week, PO): days 8, 15, 22
Icelandic: DEX 10 mg/m² til inntöku, daga 6-7, 13-16; IDA 8 mg/m² i.v. (0,5 klst.), daga 7, 8, 14, 15; Ara-C 60 mg/m² i.v., daga 22-25, 29-32
English: Imatinib medac inhibits the growth of these cells.
Icelandic: Imatinib medac hamlar fjölgun þessara frumna.
English: Treatment was discontinued permanently because of liver laboratory abnormalities in less than 1 % of CML patients.
Icelandic: Hjá innan við 1 % sjúklinga með CML þurfti að hætta meðferð alveg vegna breytinga á lifrargildum.
English: Table 3 Chemotherapy regimen used in combination with imatinib
Icelandic: Tafla 3 Krabbameinslyfjameðferð samhliða imatinibi
English: Patients will be carefully checked by their doctor for signs of this infection before treatment is started.
Icelandic: Áður en meðferð er hafin mun læknirinn skoða sjúklinga vandlega með tilliti til
English: Fluid retention
Icelandic: Upprætingarmeðferð
English: 6400 mg (single dose): One case reported in the literature of one patient who experienced nausea, vomiting, abdominal pain, pyrexia, facial swelling, decreased neutrophil count, increased transaminases.
Icelandic: Greint hefur verið frá einu tilviki í heimildum um einn sjúkling sem fann fyrir ógleði, uppköstum, kviðverkjum, hita, þrota í andliti og greindist með fækkun daufkyrninga og transaminasahækkun.
English: Migraine, somnolence, syncope, peripheral neuropathy, memory impairment, sciatica, restless leg syndrome, tremor, cerebral haemorrhage
Icelandic: Brjóstastækkun hjá körlum, ristruflanir, miklar tíðablæðingar, óreglulegar tíðablæðingar, truflanir á kynlífi, sárar geirvörtur, brjóstastækkun, pungbjúgur.
English: (24 h), day 1; Etoposide 250 mg/m i.v.
Icelandic: Etoposid 250 mg/m² i.v. (1 klst.) daga 4-5;
English: Improvements were reported in cardiac, nervous, skin/subcutaneous tissue, respiratory/thoracic/mediastinal, musculoskeletal/connective tissue/vascular, and gastrointestinal organ systems.
Icelandic: Greint var frá ávinningi hvað varðar hjarta, taugar, húð/undirhúð, öndunarfæri/brjósthol/miðmæti, stoðkerfi/stoðvef/æðar og meltingarfæri.
English: i.v., days 1-3, 15-16; VCR 2 mg total dose i.v., days 1, 8, 15, 22;
Icelandic: VCR 2 mg heildarskammtur i.v., daga 1, 8, 15, 22; CP 750 mg/m² i.v., daga 1, 8;
English: Imatinib medac 400 mg hard capsules Capsule content
Icelandic: Imatinib medac 400 mg hörð hylki Innihald hylkis
English: Imatinib medac 100 mg hard capsules Capsule content
Icelandic: Imatinib medac 100 mg hörð hylki Innihald hylkis
English: • Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL).
Icelandic: Rauðkyrningagersheilkenni (HES) og/eða langvarandi rauðkyrningahvítblæði (CEL).
English: Imatinib medac will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.
Icelandic: Einungis læknir með reynslu af lyfjum til meðferðar við blóðkrabbameinum eða æxlum mun ávísa Imatinib medac.
English: What you need to know before you take Imatinib medac
Icelandic: Ef gleymist að taka Imatinib medac
English: Musculoskeletal and connective tissue disorders Very common: Muscle spasm and cramps, musculoskeletal pain including myalgia
Icelandic: Vöðvakippir og krampar, stoðkerfisverkir þar með taldir vöðvaverkir
English: Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry
Icelandic: Háþrýstingur, margúll, innanbastsmargúll, kaldir útlimir, lágþrýstingur,
English: INFORMATION IN BRAILLE Imatinib medac 100 mg
Icelandic: Imatinib medac 100 mg hörð hylki imatinib medac GmbH
English: • Itching.
Icelandic: B sýkingu.
English: Methotrexate (5 g/m over 24 hours, IV): day 1 Leucovorin (75 mg/m at hour 36, IV; 15 mg/m
Icelandic: Leucovorin (75 mg/m² á 36. klst. i.v.; 15 mg/m² i.v. eða til inntöku á 6 klst. fresti x 6 skammtar) iii: dagar 2 og 3
English: Crospovidone (type A) Lactose monohydrate Magnesium stearate
Icelandic: Crospovidon (tegund A)
English: • Chronic renal failure.
Icelandic: ANC = heildardaufkyrningafjöldi.
English: • Bruising.
Icelandic: Munnangur.
English: Biotransformation
Icelandic: Lífefnafræði
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 100 mg of imatinib (as mesilate).
Icelandic: Hvert hart hylki inniheldur 100 mg af imatinibi (sem mesilat).
English: CP 200 mg/m i.v., days 3-5; MTX 15 mg intrathecal, day 1
Icelandic: Ara-C 75 mg/m² i.v. (1 klst.), daga 1-5; VM26 60 mg/m² i.v. (1 klst.), daga 1-5
English: BATCH NUMBER Lot:
Icelandic: 13. LOTUNÚMER Lotunr.
English: Renal insufficiency: Patients with renal dysfunction or on dialysis should be given the minimum recommended dose of 400 mg daily as starting dose.
Icelandic: Nota skal minnsta ráðlagðan upphafsskammt, þ.e. 400 mg á sólarhring, handa sjúklingum með skerta nýrnastarfsemi eða í skilunarmeðferð.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 400 mg of imatinib (as mesilate).
Icelandic: Hvert hart hylki inniheldur 400 mg af imatinibi (sem mesilat).
English: VCR (1.5 mg/m 2/day, IV): days 1, 8, and 15 DAUN (45 mg/m 2/day bolus, IV): days 1 and 2
Icelandic: DAUN (45 mg/m²/sólarhring í einum skammti [bolus], i.v.): dagar 1 og 2 CPM (250 mg/m²/skammt á 12 klst. fresti x 4 skammtar, i.v.): dagar 3 og 4 PEG-ASP (2500 a.einingar/m², i.m.): dagur 4
English: ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3
Icelandic: ARA-C (3 g/m², á 12 klst. fresti, i.v.): dagar 43 og 44 L-ASP (6000 a.einingar/m², i.m.): dagur 44
English: Biochemistry
Icelandic: Vökvasöfnun