FrancophonIA/ELRC3.0 huggingface dataset:
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 höfuðkúbu/heila).
English: Active substances that may increase imatinib plasma concentrations:
Icelandic: Virk efni sem geta aukið plasmaþéttni imatinibs:
English: ANC < 1.0 x 109/L and/or platelets < 50 x 109/L
Icelandic: ANC < 1,0 x 109/l og/eða blóðflögur < 50 x 10
English: Printing ink: shellac, black iron oxide (E172), propylene glycol, ammonia solution, potassium hydroxide.
Icelandic: Prentblek: gljálakk, svart járnoxíð (E172), própýlenglýkol, ammóníumlausn, kalíumhýdroxíð.
English: days 2, 3, 16, and 17
Icelandic: fresti x 6 skammtar)iii: dagar 2, 3, 16, og 17
English: For patients unable to swallow the film-coated tablets, the tablets may be dispersed in a glass of still water or apple juice.
Icelandic: Fyrir sjúklinga sem geta ekki kyngt töflunum má blanda innihaldi þeirra við glas venjulegu vatni eða eplasafa.
English: Black iron oxide (E172) Propylene glycol Ammonia solution Potassium hydroxide
Icelandic: Svart járnoxíð (E172) Própýlenglýkól Ammóníumlausn Kalíumhýdroxíð
English: The age of these patients ranged from 2 to 16 years and imatinib was given at dose 300 mg/m2 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: Your doctor will tell you exactly how many capsules of Imatinib Actavis to take.
Icelandic: Læknirinn ákveður nákvæmlega hve mörg hylki af Imatinib Actavis á að nota.
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+ mánuðir, miðað við þann tíma þegar upplýsingarnar voru birtar).
English: Imatinib inhibits signalling and proliferation of cells driven by dysregulated PDGFR and Abl kinase activity.
Icelandic: Imatinib hamlar frumuboðum og frumufjölgun sem knúin er áfram af PDGFR og Abl kinasa virkni sem ekki lætur að stjórn.
English: All patients achieved complete haematological response, complete cytogenetic response and/or complete molecular response.
Icelandic: Allir sjúklingar náðu heildarblóðsvörun, fullri litningasvörun og/eða fullri sameindasvörun.
English: 6-MP (75 mg/m2/day, PO): days 1-56
Icelandic: 6-MP (75 mg/m2/sólarhring, til inntöku): dagar 11-56
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 hvötum CYP3A4.
English: 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: Efni sem örva virkni CYP3A4 (t.d. dexametason, fenytoin, carbamazepin, rifampicin, fenobarbital, fosfenytoin, primidon eða Hypericum perforatum, einnig þekkt sem jóhannesarjurt) geta dregið marktækt úr útsetningu fyrir imatinibi, sem hugsanlega eykur líkur á meðferðarbresti.
English: Pleural effusion5, pharyngolaryngeal pain, pharyngitis
Icelandic: Fleiðruvökvi5, verkur í koki og barkakýli, kokbólga.
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 sjúklingum með GIST.
English: Oval-shape, 18.6x6.6 mm, biconvex dark yellow to brownish film-coated tablet, embossed with company logo on one side and “37” with score line on the other side.
Icelandic: Sporöskjulaga, 18,6x6,6 mm, tvíkúpt dökkgul til brúnleit filmuhúðuð tafla, merkt með merki fyrirtækisins á annarri hliðinni og „37“ með deiliskoru á hinni hliðinni.
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: 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.
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).
English: If you have any questions about how Imatinib Actavis works or why this medicine has been prescribed for you, ask your doctor.
Icelandic: Leitaðu til læknisins ef þú þarfnast frekari upplýsinga um hvernig Imatinib Actavis verkar eða hvers vegna lyfinu hefur verið ávísað handa þér.
English: - Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL).
Icelandic: - fullorðnum sjúklingum með langt gengið rauðkyrningagersheilkenni (hypereosinophilic syndrome [HES]) og/eða langvarandi rauðkyrningahvítblæði (chronic eosinophilic leukaemia
English: VCR 1.3 g/m2 i.v., day 1; prednisolone 60 mg/m2 oral, days 1-5
Icelandic: Viðhaldsmeðferð VCR 1,3 g/m2 i.v., dag 1; Prednisolon 60 mg/m2 til inntöku, daga 1-5
English: If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop imatinib until ANC ≥ 1 x 109/L and platelets ≥ 20 x 109/L, then resume treatment at 200 mg/m2.
Icelandic: Ef frumufæð varir í 4 vikur og tengist enn ekki hvítblæði, skal hætta notkun imatinibs þar til ANC ≥ 1 x 109/l og blóðflögur ≥ 20 x 109/l.
English: Patients should be tested for HBV infection before initiating treatment with Imatinib Actavis.
Icelandic: B veirusýkingu áður en meðferð með Imatinib Actavis er hafin.
English: How to store Imatinib Actavis
Icelandic: Hvernig geyma á Imatinib Actavis
English: The most commonly reported (≥ 10%) drug-related adverse reactions in both settings were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash.
Icelandic: Algengustu (≥ 10%) lyfjatengdu aukaverkanirnar sem greint var frá hjá báðum hópunum voru væg ógleði, uppköst, niðurgangur, kviðverkir, þreyta, vöðvaþrautir, vöðvakrampar og útbrot.
English: Women of childbearing potential Women of childbearing potential must be advised to use effective contraception during treatment.
Icelandic: Ráðleggja verður konum á barneignaraldri að nota örugga getnaðarvörn meðan á meðferð stendur.
English: - Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood cells).
Icelandic: - Húðfölvi, þreyta og mæði ásamt dökkleitu þvagi (einkenni of fárra rauðra blóðkorna).
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 eða legi).
English: Pack sizes: The capsules are supplied in aluminium blister packs of 24, 48, 60, 96, 120 or 180 capsules.
Icelandic: Hylkin fást í álþynnupakkningum með 24, 48, 60, 96, 120 eða 180 hylkjum
English: and platelets ≥ 75 x 109/L.
Icelandic: 9/l og blóðflögur ≥ 20 x 109/l.
English: Target organs for neoplastic changes were the kidneys, urinary bladder, urethra, preputial and clitoral gland, small intestine, parathyroid glands, adrenal glands and nonglandular 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: 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 imatinibi.
English: Pack sizes: The capsules are supplied in aluminium blister packs of 30 or 90 capsules.
Icelandic: Hylkin fást í álþynnupakkningum með 30 eða 90 hylkjum.
English: VP-16 (100 mg/m2/day, IV): days 22-26
Icelandic: VP-16 (100 mg/m2/sólarhring, i.v.): dagar 22-26
English: Headache2
Icelandic: Höfuðverkur2
English: Pack sizes: The tablets are supplied in aluminium blister packs of 10, 30, 60 or 90 film-coated tablets.
Icelandic: Töflurnar fást í álþynnupakkningum með 10, 30, 60 eða 90 filmuhúðuðum töflum.
English: EU/1/13/825/003 24 capsules EU/1/13/825/004 48 capsules EU/1/13/825/019 60 capsules EU/1/13/825/005 96 capsules EU/1/13/825/006 120 capsules EU/1/13/825/007 180 capsules
Icelandic: EU/1/13/825/003 24 hylki EU/1/13/825/004 48 hylki EU/1/13/825/019 60 hylki EU/1/13/825/005 96 hylki EU/1/13/825/006 120 hylki EU/1/13/825/007 180 hylki
English: Other medicines and Imatinib Actavis
Icelandic: Notkun annarra lyfja samhliða Imatinib Actavis
English: How to take Imatinib Actavis
Icelandic: Hvernig nota á Imatinib Actavis
English: Hard capsule of size 3 with light yellow cap and light yellow body imprinted with “50 mg” in black ink.
Icelandic: Hart hylki af stærð 3 með ljósgulan efri hluta og gulan neðri hluta merktan „50 mg“ með svörtu bleki.
English: Imatinib Actavis can help you to fight this condition.
Icelandic: Actavis getur hjálpað til í baráttunni við sjúkdóminn.
English: If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop imatinib until ANC ≥ 1 x 109/L and platelets ≥ 20 x 109/L, then resume treatment at 300 mg.
Icelandic: Ef frumufæð varir í 4 vikur og tengist enn ekki hvítblæði, skal hætta notkun imatinibs þar til ANC ≥ 1 x 109/l og blóðflögur ≥ 20 x 10
English: The suspension should be administered immediately after complete disintegration of the tablet(s).
Icelandic: Dreifuna skal gefa strax og taflan (töflurnar) hafa sundrast að fullu.
English: If you take more Imatinib Actavis than you should
Icelandic: Ef tekinn er stærri skammtur af Imatinib Actavis en mælt er fyrir um
English: (24 h), day 1, and Ara-C 2 g/m2 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: In newly diagnosed chronic phase CML grade 4 neutropenia (ANC < 0.5 x 109/L) and thrombocytopenia (platelet count < 10 x 109/L) were observed in 3.6% and < 1% of patients, respectively.
Icelandic: 4 (ANC < 0,5 x 109/l) hjá 3,6% sjúklinga og blóðflagnafæð (blóðflagnafjöldi < 10 x 109/l) hjá < 1% sjúklinga.
English: - Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection).
Icelandic: B sýkingar ef þú hefur áður verið með lifrarbólgu B (sýking í lifur).
English: VCR (1.5 mg/m2/day, IV): days 1, 8, and 15
Icelandic: VCR (1,5 mg/m2/sólarhring, i.v.): dagar 1, 8, og 15
English: - Feeling dizzy or weak.
Icelandic: - Sundl eða slappleiki.
English: Imatinib Actavis 50 mg hard capsules Imatinib Actavis 100 mg hard capsules Imatinib Actavis 400 mg hard capsules
Icelandic: Imatinib Actavis 50 mg hörð hylki Imatinib Actavis 100 mg hörð hylki Imatinib Actavis 400 mg hörð hylki
English: Elimination Based on the recovery of compound(s) after an oral 14C-labelled dose of imatinib, approximately 81%
Icelandic: Brotthvarf Á grundvelli endurheimtra efnasambanda eftir inntöku 14C-merkts skammts af imatinibi til inntöku,
English: What Imatinib Actavis looks like and contents of the pack
Icelandic: Lýsing á útliti Imatinib Actavis og pakkningastærðir
English: Not known (frequency cannot be estimated from the available data): - Combination of a widespread severe rash, feeling sick, fever, high level of certain white blood cells or yellow skin or eyes (signs of jaundice) with breathlessness, chest pain/discomfort, severely decreased urine output and feeling thirsty etc. (signs of a treatment-related allergic reaction).
Icelandic: - Sambland af útbreiddum alvarlegum útbrotum, ógleði, hita, miklu magni af ákveðnum hvítum blóðkornum eða gulnun húðar eða augna (einkenni gulu) ásamt mæði, verk/óþægindum fyrir brjósti, verulega minnkuðu þvagmagni og þorsta o.s.frv. (einkenni meðferðartengdra ofnæmisviðbragða).
English: The median duration of the neutropenic and thrombocytopenic episodes usually ranged from 2 to 3 weeks, and from 3 to 4 weeks, respectively.
Icelandic: Miðgildi þess tíma sem daufkyrningafæð stóð yfir var 2 til 3 vikur og 3 til 4 vikur fyrir blóðflagnafæð.
English: VCR (1.5 mg/m2/day, IV): days 1, 8 and 15
Icelandic: VCR (1,5 mg/m2/sólarhring, i.v.): dagar 1, 8 og 15
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: - If you are a woman who is pregnant or might get pregnant and are trying to open the capsules, you should handle the contents with caution in order to avoid skin-eye contact or inhalation.
Icelandic: - Þungaðar konur og konur sem geta orðið þungaðar eiga, þegar þær opna hylkin, að meðhöndla innihaldið af varúð til þess að forðast snertingu við húð og augu sem og innöndun.
English: Hard capsule of size 00 with orange opaque colour cap and body imprinted with “400 mg” in black ink.
Icelandic: Hart hylki af stærð 00 með ógagnsæjan appelsínugulan efri hluta og neðri hluta merktan „400 mg“ með svörtu bleki.
English: If your daily dose is 800 mg (8 tablets), you should take 4 tablets in the morning and 4 tablets in the evening.
Icelandic: Ef dagsskammturinn er 800 mg (8 töflur) skalt þú taka 4 töflur að morgni og 4 töflur að kvöldi.
English: This may be a sign of damage to blood vessels known as thrombotic microangiopathy (TMA).
Icelandic: Þetta geta verið einkenni um skemmdir í æðum sem kallast segaöræðakvilli.
English: Induction therapy I DEX 10 mg/m2 oral, days 1-5; VCR 2 mg i.v., days 6, 13, 20; daunorubicin 45 mg/m2 i.v., days 6-7, 13-14
Icelandic: VCR 2 mg i.v., daga 6, 13, 20; Daunorubicin 45 mg/m2 i.v., daga 6-7, 13-14
English: Round, 9.2 mm in diameter, biconvex dark yellow to brownish film-coated tablet, embossed with company logo on one side and “36” with score line on the other side.
Icelandic: Kringlótt, 9,2 mm í þvermál, tvíkúpt, dökkgul til brúnleit filmuhúðuð tafla, merkt með merki fyrirtækisins á annarri hliðinni og „36“ með deiliskoru á hinni hliðinni.
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 væga og miðlungi alvarlega skerðingu á nýrnastarfsemi en hjá þeim sem eru með eðlilega nýrnastarfsemi.
English: ANC < 0.5 x 10
Icelandic: 4 (ANC < 0,5 x 109/l)
English: CPM (300 mg/m2/day, IV): days 22-26
Icelandic: CPM (300 mg/m2/sólarhring, i.v.): dagar 22-26
English: Five (5) patients with DFSP and PDGFR gene re-arrangements were reported in 3 publications.
Icelandic: Í 3 birtum heimildum var greint frá 5 sjúklingum með DFSP og PDGFR endurröðun erfðavísa.
English: CPM (250 mg/m2/dose q12h x 4 doses, iv): Days 3 and 4
Icelandic: ARA-C (3 g/m2/skammt á 12 klst. fresti x 4, i.v.): dagar 2 og 3
English: In the event of recurrence of ANC < 1.0 x 109/L and/or platelets < 50 x 109/L, repeat step 1 and resume imatinib at reduced dose of 260 mg/m2.
Icelandic: < 50 x 109/l, skal endurtaka lið 1 og halda áfram með minni skammti af imatinibi, þ.e. 260 mg/m2.
English: Pack containing either 10, 30, 60, or 90 capsules.
Icelandic: 10, 30, 60 eða 90 hylki
English: Remission induction DEX 10 mg/m2 oral, days 6-7, 13-16; VCR 1 mg i.v., days 7, 14; IDA 8 mg/m2 i.v.
Icelandic: DEX 10 mg/m2 til inntöku, daga 6-7, 13-16; VCR 1 mg i.v., daga 7, 14;
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 altækrar (systemic) verkunar, veitt var meðferð til að tryggja blóðrás og notkun imatinibs hætt tímabundið.
English: Excipients
Icelandic: Forklínískt
English: Rash pustular, contusion, sweating increased, urticaria, ecchymosis, increased tendency to bruise, hypotrichosis, skin hypopigmentation, dermatitis exfoliative, onychoclasis, folliculitis, petechiae, psoriasis, purpura, skin hyperpigmentation, bullous eruptions
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, blöðruútsláttur.
English: Some medicines can interfere with the effect of Imatinib Actavis when taken together.
Icelandic: Við samhliða notkun geta sum lyf haft áhrif á verkun Imatinib Actavis.
English: - Numb or cold toes and fingers (signs of Raynaud's syndrome).
Icelandic: - Dofi eða kuldi í tám og fingrum (einkenni æðakrampaheilkennis).
English: Palpitations, tachycardia, cardiac failure congestive3, pulmonary oedema
Icelandic: Hjartsláttarónot, hraðsláttur, hjartabilun3, lungnabjúgur.
English: The dose is 800 mg per day (8 tablets), to be taken as 4 tablets in the morning and 4 tablets in the evening.
Icelandic: Skammturinn er 800 mg á sólarhring (8 töflur), en þá eru teknar 4 töflur að morgni og 4 töflur að kvöldi).
English: Shellac Glaze-45% Black iron oxide (E172) Propylene glycol Ammonium Hydroxide 28%
Icelandic: Svart járnoxíð (E172) Própýlenglýkól Ammóníumhýdroxíð 28%
English: EU/1/13/825/015 10 tablets EU/1/13/825/016 30 tablets EU/1/13/825/017 60 tablets EU/1/13/825/018 90 tablets
Icelandic: EU/1/13/825/015 10 töflur EU/1/13/825/016 30 töflur EU/1/13/825/017 60 töflur EU/1/13/825/018 90 töflur
English: 8 to 10 g (single dose): Vomiting and gastrointestinal pain have been reported.
Icelandic: 8 til 10 g (stakur skammtur):
English: Clinical studies in DFSP 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 imatinibi 800 mg á sólarhring.
English: Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people): - Chest pain, irregular heart rhythm (signs of heart problems).
Icelandic: Sjaldgæfar (geta komið fyrir hjá allt að 1 af hverjum 100 einstaklingum) eða mjög sjaldgæfar (geta komið fyrir hjá allt að 1 af hverjum 1.000 einstaklingum):
English: EU/1/13/825/008 10 tablets EU/1/13/825/009 20 tablets EU/1/13/825/010 30 tablets EU/1/13/825/011 60 tablets EU/1/13/825/012 90 tablets EU/1/13/825/013 120 tablets EU/1/13/825/014 180 tablets
Icelandic: EU/1/13/825/008 10 töflur EU/1/13/825/009 20 töflur EU/1/13/825/010 30 töflur EU/1/13/825/011 60 töflur EU/1/13/825/012 90 töflur EU/1/13/825/013 120 töflur EU/1/13/825/014 180 töflur
English: Days 2, 3, 16, and 17
Icelandic: fresti x 6 skammtar)iii: dagar 2, 3, 16 og 17
English: - Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision.
Icelandic: - Útferð úr auga ásamt kláða, roða og þrota (tárubólga), aukin táramyndun eða þokusýn.
English: Cellulose microcrystalline Copovidone
Icelandic: Töflukjarni Örkristallaður sellulósi Kópóvídón
English: Increased blood urea nitrogen (BUN) and creatinine were observed in several of these animals.
Icelandic: Hækkað blóðnitur (BUN) og hækkað kreatínín sást í nokkrum dýranna.
English: The starting dose is 400 mg, to be taken as 8 capsules once a day.
Icelandic: Upphafsskammturinn er 400 mg, en þá eru tekin 8 hylki einu sinni á sólarhring.
English: Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
Icelandic: Munnbólga, munnsæri, blæðing í meltingarfærum7, ropi, sortusaur, vélindabólga, skinuholsvökvi, magasár, blóðug uppköst, varaþroti, kyngingartregða, brisbólga.
English: Dose adjustment for adverse reactions
Icelandic: Skammtabreytingar vegna aukaverkana
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 imatinib vegna hugsanlegrar myndunar æxlislýsuheilkennis (tumour lysis syndrome) (sjá kafla 4.8).
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 (væga, meðlungi alvarlega eða alvarlega skerðingu).
English: days 3-5; MTX 15 mg intrathecal, day 1; methylprednisolone 40 mg intrathecal, day 1
Icelandic: MTX 15 mg í mænuvökva, dag 1; Metylprednisolon 40 mg í mænuvökva, dag 1
English: There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Icelandic: Engar klínískar samanburðarrannsóknir sýna fram á klínískan ávinning, svo sem bata á sjúkdómstengdum einkennum eða aukinni lifun.
English: Imatinib Actavis 100 mg film-coated tablets EU/1/13/825/008
Icelandic: Imatinib Actavis 100 mg filmuhúðaðar töflur EU/1/13/825/008
English: (0.5 h), days 7, 8, 14, 15; CP 500 mg/m2 i.v.
Icelandic: IDA 8 mg/m2 i.v. (0,5 klst.), daga 7, 8, 14, 15; CP 500 mg/m2 i.v.(1 klst.) dag 1;
English: Imatinib Actavis 400 mg film-coated tablets EU/1/13/825/015
Icelandic: Imatinib Actavis 400 mg filmuhúðaðar töflur EU/1/13/825/015
English: The dose is 800 mg per day (2 capsules), to be taken as one capsule in the morning and a second capsule in the evening.
Icelandic: Skammturinn er 800 mg á sólarhring (tvö hylki) sem er tekinn er sem eitt hylki að morgni og annað hylki að kvöldi).
English: G-CSF = granulocyte colony stimulating factor, VP-16 = etoposide, MTX = methotrexate, IV = intravenous, SC = subcutaneous, IT = intrathecal, PO = oral, IM = intramuscular, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethane sulfonate sodium, iii= or until MTX level is < 0.1 µM, q6h = every 6 hours, Gy= Gray
Icelandic: VCR (1,5 mg/m2/sólarhring, i.v.): dagar 1 og 29 DEX (6 mg/m2/sólarhring, til inntöku): dagar 1-5; 29-33 6-MP (75 mg/m2/sólarhring, til inntöku): dagar 1-56 Metótrexat (20 mg/m2/viku, til inntöku): dagar 1, 8, 15, 22, 29, 36, 43 og 50 G-CSF = kyrningavaxtarþáttur (granulocyte colony stimulating factor), VP-16 = etoposid, MTX = metótrexat, i.v. = í bláæð, s.c. = undir húð, i.t. = í mænuvökva, i.m. = í vöðva, ARA-C = cytarabin, CPM = cyclofosfamid, VCR = vincristin, DEX = dexametason, DAUN = daunorubicin, 6-MP = 6mercaptopurin, E.coli L-ASP = L-asparaginasi, PEG-ASP = PEG asparaginasi, MESNA= 2-mercaptoetan sulfonat natríum, iii= eða þar til MTX þéttni er < 0,1 µM, Gy= Gray
English: The usual starting dose is 600 mg to be taken as 6 tablets once a day.
Icelandic: Venjulegur upphafsskammtur er 600 mg sem er tekinn sem 6 töflur einu sinni á dag.
English: Muscle spasm and cramps, musculoskeletal pain including myalgia9, arthralgia, bone pain10
Icelandic: Vöðvakippir og krampar, stoðkerfisverkir þar með taldir vöðvaverkir9, liðverkir og beinverkir.10
English: This leaflet was last revised in Other source of information
Icelandic: Þessi fylgiseðill var síðast uppfærður <{MM/ÁÁÁÁ}> <í {mánuður ÁÁÁÁ}>.