FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with accelerated phase CML treated with the 140 mg once daily regimen, the median duration of MaHR and the median overall survival was not reached and the median PFS was 25 months.
Icelandic: Hjá sjúklingum með CML í hröðunarfasa sem fengu meðferð með 140 mg einu sinni á sólarhring náðust miðgildi MaHR og miðgildi heildarlifunar ekki og miðgildi lifunar án versnunar var 25 mánuðir.
English: In patients with lymphoid blast phase CML treated with the 140 mg once daily regimen, the median duration of MaHR was 5 months, the median PFS was 5 months, and the median overall survival was 11 months.
Icelandic: Hjá sjúklingum í eitilfrumufasa CML sem fengu meðferð með 140 mg einu sinni á sólarhring var miðgildi MaHR 5 mánuðir, miðgildi lifunar án versnunar var 5 mánuðir og miðgildi heildarlifunar var 11 mánuðir.
English: • Store the constituted oral suspension in a refrigerator (2°C - 8°C).
Icelandic: Geymdu blandaða mixtúru í kæli (2°C - 8°C).
English: Holding the syringe tip firmly into the bottle, turn the bottle with the syringe upside down.
Icelandic: Með sprautuendann vandlega í glasinu á að snúa glasinu þannig að sprautan sé á hvolfi.
English: within 60 months (95% CI)
Icelandic: innan 60 mánaða (95% CI)
English: Two-level dose reduction
Icelandic: Skammtar minnkaðir um tvö skammtaþrep
English: The cardiac adverse reactions of congestive heart failure/cardiac dysfunction, pericardial effusion, arrhythmias, palpitations, QT prolongation and myocardial infarction (including fatal) were reported in patients taking dasatinib.
Icelandic: Greint var frá hjartabilun/truflun á hjartastarfsemi, vökvasöfnun í gollurshúsi, hjartsláttaróreglu, hjartsláttarónotum, QT lengingu og hjartadrepi (þ.m.t. banvænu) hjá sjúklingum sem fengu dasatinib.
English: Active substances that may increase dasatinib plasma concentrations In vitro studies indicate that dasatinib is a CYP3A4 substrate.
Icelandic: Rannsóknir in vitro gefa til kynna að dasatinib sé hvarfefni CYP3A4.
English: Concentration data in 32 paediatric patients treated with the powder for oral suspension dose of 72 mg/m2 was pooled with data from the tablet for a population pharmacokinetic
Icelandic: Upplýsingar um þéttni hjá 32 börnum sem fengu mixtúru í skammtinum 72 mg/m2 voru sameinaðar upplýsingum úr greiningu á lyfjahvörfum fyrir töflur sem sýndu að útsetning fyrir mixtúru (mælt við meðalþéttni við jafnvægi [Cavgss]) við 72 mg/m2 var u.þ.b.
English: Uncommon blood creatine phosphokinase increased, gamma-glutamyltransferase increased Injury, poisoning, and procedural complications
Icelandic: Sjaldgæfar aukinn kreatínfosfókínasi í blóði, aukinn gamma-glútamýltransferasi Áverkar,eitranir og fylgikvillar aðgerðar
English: In paediatric patients with Ph+ ALL treated with dasatinib in combination with chemotherapy, CBCs should be performed prior to the start of each block of chemotherapy and as clinically indicated.
Icelandic: Hjá börnum með Ph+ ALL sem fá dasatinib ásamt krabbameinslyfjameðferð á að gera heildar blóðkornatalningu fyrir hverja lotu krabbameinslyfja og eins og við á klínískt.
English: SPRYCEL 70 mg film-coated tablets
Icelandic: SPRYCEL 70 mg filmuhúðaðar töflur
English: Major molecular response All patients
Icelandic: Meiriháttar litningasvörun Allir sjúklingar
English: Total prescribed dose (mL)
Icelandic: Ávísaður skammtur (ml)
English: A total of 46 dasatinib-treated patients had recurrent pleural effusions.
Icelandic: 46 sjúklingar á meðferð með dasatinib endurtekna vökvasöfnun í brjóstholi.
English: Digestive problems: loss of vital nutrients such as protein from your digestive tract, bowel obstruction, anal fistula (an abnormal opening from the anus to the skin around the anus), impairment of kidney function, diabetes
Icelandic: Meltingartruflanir: tap lífsnauðsynlegra næringarefna úr meltingarvegi, garnastífla, bakraufarfistill (óeðlileg opin rauf frá endaþarmsopi að húðinni umhverfis endaþarmsopið), skert nýrnastarfsemi, sykursýki
English: SPRYCEL 50 mg film-coated tablets EU/1/06/363/005
Icelandic: SPRYCEL 50 mg filmuhúðaðar töflur EU/1/06/363/005
English: SPRYCEL 70 mg: the film-coated tablet is white to off-white, biconvex, round with “BMS” debossed on one side and “524” on the other side.
Icelandic: SPRYCEL 70 mg filmuhúðaða taflan er hvít til beinhvít, kúpt á báðum hliðum, kringlótt með „BMS“ greypt í aðra hliðina og „524“ í hina.
English: CHR (advanced CML/Ph+ ALL): WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement.
Icelandic: CHR (langt gengið CML/Ph+ ALL): hvít blóðkorn ≤ ULN rannsóknarstofu, ANC ≥ 1.000/mm3, blóðflögur ≥ 100.000/mm3, hvorki kímfrumur né formerglingar í útæðablóði, kímfrumur í beinmerg ≤ 5%, < 5% merglingar og millimerglingar í útæðablóði < 20% blákyrningar (basophils) í útæðablóði og ekkert utan beinmergs.
English: SPRYCEL 140 mg: the film-coated tablet is white to off-white, biconvex, round with “BMS 140” debossed on one side and “857” on the other side.
Icelandic: SPRYCEL 140 mg filmuhúðaða taflan er hvít til beinhvít, kúpt á báðum hliðum, kringlótt með „BMS 140“ greypt í aðra hliðina og „857“ í hina.
English: Each film-coated tablet contains 20 mg dasatinib (as monohydrate).
Icelandic: Hver filmuhúðuð tafla inniheldur 20 mg dasatinib (sem einhýdrat).
English: Rare diabetes mellitus Psychiatric disorders
Icelandic: Mjög sjaldgæfar sykursýki Geðræn vandamál
English: Step 3: Remove the closure, insert the press-in bottle adapter (PIBA) into the bottle neck, and close the bottle tightly with the child-resistant closure.
Icelandic: (PIBA) inn í háls glassins og lokið glasinu vandlega með barnaöryggislokinu.
English: If you have accidentally taken too much SPRYCEL, talk to your doctor immediately.
Icelandic: Ef stærri skammtur af SPRYCEL en mælt er fyrir um er tekinn Hafa skal tafarlaust samband við lækninn ef fyrir slysni er tekið of mikið af SPRYCEL.
English: SPRYCEL 80 mg: the film-coated tablet is white to off-white, biconvex, triangular with “BMS 80” debossed on one side and “855” on the other side.
Icelandic: SPRYCEL 80 mg filmuhúðaða taflan er hvít til beinhvít, kúpt á báðum hliðum, þríhyrnd með „BMS 80“ greypt í aðra hliðina og „855“ í hina.
English: • Do not wash in a dishwasher.
Icelandic: Ekki setja í uppþvottavél.
English: After constitution
Icelandic: Eftir blöndun
English: SPRYCEL 80 mg film-coated tablets
Icelandic: SPRYCEL 80 mg filmuhúðaðar töflur
English: Median duration of treatment on dasatinib was 3 months with 7% of patients treated for > 24 months to date.
Icelandic: Miðgildi meðferðarlengdar með dasatinib var 3 mánuðir og voru 7% sjúklinganna meðhöndlaðir í > 24 mánuði.
English: SPRYCEL 100 mg film-coated tablets EU/1/06/363/011
Icelandic: SPRYCEL 100 mg filmuhúðaðar töflur EU/1/06/363/011
English: EU/1/06/363/004 - 56 film-coated tablets (blisters) EU/1/06/363/007 - 60 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/001 - 60 film-coated tablets (bottle)
Icelandic: EU/1/06/363/004 - 56 filmuhúðaðar töflur (þynnupakkning) EU/1/06/363/007 - 60 x 1 filmuhúðuð tafla (stakskammta þynnupakkning) EU/1/06/363/001 - 60 filmuhúðaðar töflur (töfluglas)
English: Rates of MR4.5 over time were consistently higher in dasatinib-treated patients compared with imatinib-treated patients.
Icelandic: Tíðni MR4,5 eftir tíma er sýnd myndrænt á mynd 3. Tíðni MR4,5 var markviss hærri hjá sjúklingum sem fengu meðferð með dasatinib samanborið við sjúklinga sem fengu meðferð með imatinib.
English: Thereafter, treatment can be resumed as appropriate at a reduced dose depending on the initial severity of the adverse reaction.
Icelandic: Þá má hefja meðferð að nýju með minni skammti eins og við á eftir alvarleika aukaverkunarinnar.
English: Inflammation of the lungs
Icelandic: Vökvasöfnun í gollurshúsi Lungnabjúgur Blæðingar
English: SPRYCEL 140 mg film-coated tablets Each film-coated tablet contains 140 mg dasatinib (as monohydrate).
Icelandic: Hver filmuhúðuð tafla inniheldur 140 mg dasatinib (sem einhýdrat).
English: However, when antacids were administered 2 hours prior to a single dose of SPRYCEL, no relevant changes in dasatinib concentration or exposure were observed.
Icelandic: Samt sem áður komu engar marktækar breytingar á þéttni dasatinibs eða útsetningu eftir gjöf sýrubindandi lyfja 2 klst.
English: How to take SPRYCEL 4.
Icelandic: Virkni SPRYCEL í III.
English: Digestive problems: diarrhoea, feeling or being sick (nausea, vomiting) Skin, hair, eye, general: skin rash, fever, swelling around the face, hands and feet, headache, feeling tired or weak, bleeding
Icelandic: Húð, hár, augu og almennar aukaverkanir: útbrot, hiti, bjúgur í andliti, höndum og fótum, höfuðverkur, þreytu- eða máttleysistilfinning, blæðingar Verkir:
English: SPRYCEL 70 mg film-coated tablets dasatinib
Icelandic: SPRYCEL 70 mg filmuhúðaðar töflur dasatinib
English: In SPRYCEL-treated patients with newly diagnosed chronic phase CML who experienced grade 3 or 4 myelosuppression, recovery generally occurred following brief dose interruptions and/or reductions and permanent discontinuation of treatment occurred in 1.6% of patients after a minimum of 12 months follow-up.
Icelandic: Sjúklingar með nýlega greint CML í stöðugum fasa sem fengu SPRYCEL og mergbælingu af 3 eða 4. gráðu, náðu sér yfirleitt eftir stutt skammtahlé og/eða skammtalækkun.
English: EU/1/06/363/006 - 56 film-coated tablets (blisters) EU/1/06/363/009 - 60 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/003 - 60 film-coated tablets (bottle)
Icelandic: EU/1/06/363/006 - 56 filmuhúðaðar töflur (þynnupakkning) EU/1/06/363/009 - 60 x 1 filmuhúðuð tafla (stakskammta þynnupakkning) EU/1/06/363/003 - 60 filmuhúðaðar töflur (töfluglas)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
Icelandic: Lýsing á útliti SPRYCEL og pakkningastærðir
English: SPRYCEL 100 mg film-coated tablets
Icelandic: SPRYCEL 100 mg filmuhúðaðar töflur
English: Pericardial effusion Pulmonary oedema Haemorrhage Gastrointestinal bleeding a Phase 3 dose optimisation study results reported at the recommended starting dose of 140 mg once daily (n=304) population at 2 year final study follow up.
Icelandic: stigs rannsókn eftir 2 ára eftirfylgni úr hópi sem fékk ráðlagðan upphafsskammt 140 mg einu sinni á sólarhring (n=304).
English: Efficacy of SPRYCEL was consistently demonstrated across different subgroups, including age, gender, and baseline Hasford score.
Icelandic: Virkni SPRYCEL sást alltaf hjá mismunandi undirflokkum, þ.m.t. aldur, kyn og Hasfordstig við upphaf meðferðar.
English: White to off-white, biconvex, triangular film-coated tablet with "BMS 80" debossed on one side and "855" on the other side.
Icelandic: Hvít til beinhvít, tvíkúpt, þríhyrnd filmuhúðuð tafla með „BMS 80“ greypt í aðra hliðina og „855“ í hina.
English: SPRYCEL 50 mg: the film-coated tablet is white to off-white, biconvex, oval with “BMS” debossed on one side and “528” on the other side.
Icelandic: SPRYCEL 50 mg filmuhúðaða taflan er hvít til beinhvít, kúpt á báðum hliðum, sporöskjulaga með „BMS“ greypt í aðra hliðina og „528“ í hina.
English: c Includes brain natriuretic peptide increased, ventricular dysfunction, left ventricular dysfunction, right ventricular dysfunction, cardiac failure, cardiac failure acute, cardiac failure chronic, cardiac failure congestive, cardiomyopathy, congestive cardiomyopathy, diastolic dysfunction, ejection fraction decreased and ventricular failure, left ventricular failure, right ventricular failure, and ventricular hypokinesia.
Icelandic: hjartabilun, bráð hjartabilun, langvinn hjartabilun, blóðríkishjartabilun (cardiac failure congestive), hjartavöðvakvilli, blóðríkishjartavöðvakvilli (congestive cardiomyopathy), þanbilstruflanir, minnkað útfall frá sleglum og sleglabilun, bilun í vinstri slegli, bilun í hægri slegli og vanhreyfni slegla.
English: If a pleural effusion is diagnosed, dasatinib should be interrupted until patient is examined, asymptomatic or has returned to baseline.
Icelandic: Ef vökvasöfnun í brjóstholi greinist skal gera hlé á dasatinibgjöf þar til sjúklingur hefur verið skoðaður, er einkennalaus eða eins og við upphaf meðferðar.
English: The frequency of grade 3 and 4 haematological abnormalities is presented in Table 8.
Icelandic: Tíðni óeðlilegra blóðgilda af 3. og 4. gráðu er sýnd í töflu
English: White to off-white, biconvex, oval film-coated tablet with "BMS 100" debossed on one side and "852" on the other side.
Icelandic: Hvít til beinhvít, tvíkúpt, sporöskjulaga filmuhúðuð tafla með „BMS 100“ greypt í aðra hliðina og „852“ í hina.
English: SPRYCEL contains the active substance dasatinib.
Icelandic: SPRYCEL inniheldur virka efnið dasatinib.
English: The dose for the use of powder for oral suspension in adult patients with accelerated, myeloid or lymphoid blast phase (advanced phase) CML or Ph+ ALL has not been determined.
Icelandic: Skammtur mixtúrunnar hefur ekki verið ákvarðaður hjá fullorðnum sjúklingum með CML eða Ph+ ALL í hröðunarfasa, kyrningabráðafasa eða eitilfrumubráðafasa (langt gengið).
English: SPRYCEL 100 mg: the film-coated tablet is white to off-white, biconvex, oval with “BMS 100” debossed on one side and “852” on the other side.
Icelandic: SPRYCEL 100 mg filmuhúðaða taflan er hvít til beinhvít, kúpt á báðum hliðum, sporöskjulaga með „BMS 100“ greypt í aðra hliðina og „852“ í hina.
English: Common gastrointestinal bleeding*, colitis (including neutropaenic colitis), gastritis, mucosal inflammation (including mucositis/stomatitis), dyspepsia, abdominal distension, constipation, oral soft tissue disorder
Icelandic: Algengar blæðingar í meltingarvegi*, ristilbólga (m.a. neutropenic colitis), magabólga, slímhimnubólga (m.a. slímbólga/munnbólga), meltingartruflunanir, þaninn kviður, hægðatregða, breytingar á mjúkvef í munni
English: The use of latex or nitrile gloves for appropriate disposal when handling tablets that are inadvertently crushed or broken is recommended, to minimise the risk of dermal exposure.
Icelandic: Mælt með notkun latex eða nítríl hanska þegar farga þarf töflum á viðeigandi hátt sem óvart eru muldar eða brotnar.
English: SPRYCEL 50 mg film-coated tablets dasatinib
Icelandic: SPRYCEL 50 mg filmuhúðaðar töflur dasatinib
English: Each film-coated tablet contains 70 mg dasatinib (as monohydrate).
Icelandic: Hver filmuhúðuð tafla inniheldur 70 mg dasatinib (sem einhýdrat).
English: SPRYCEL 20 mg film-coated tablets
Icelandic: SPRYCEL 20 mg filmuhúðaðar töflur
English: SPRYCEL 50 mg film-coated tablets
Icelandic: SPRYCEL 50 mg filmuhúðaðar töflur
English: If you have accidentally taken too many tablets, talk to your doctor immediately.
Icelandic: Ef stærri skammtur af SPRYCEL en mælt er fyrir um er tekinn Hafa skal tafarlaust samband við lækninn ef of margar töflur hafa verið teknar fyrir slysni.
English: SPRYCEL will only be prescribed by a doctor with experience in treating leukaemia.
Icelandic: Aðeins læknir með reynslu í meðferð á hvítblæði ávísar SPRYCEL.
English: Rare cor pulmonale, myocarditis, acute coronary syndrome, cardiac arrest, electrocardiogram PR prolongation, coronary artery disease, pleuropericarditis
Icelandic: Mjög sjaldgæfar hægri hjartabilun (cor pulmonale), hjartavöðvabólga, brátt kransæðaheilkenni, hjartastopp, lenging PR-bils á hjartalínuriti, kransæðasjúkdómur, fleiðru- og gollursbólga
English: CHR: WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement.
Icelandic: CHR: hvít blóðkorn ≤ ULN rannsóknarstofu, ANC ≥ 1.000/mm3, blóðflögur ≥ 100.000/mm3, hvorki kímfrumur (blasts) né formerglingar (promyelocytes) í útæðablóði, kímfrumur í beinmerg ≤ 5%, < 5% merglingar og millimerglingar í útæðablóði < 20% blákyrningar (basophils) í útæðablóði og ekkert utan beinmergs.
English: Rare deep vein thrombosis, embolism, livedo reticularis
Icelandic: Mjög sjaldgæfar segamyndun í djúplægri bláæð, blóðreksstífla, marmarahúð (livedo reticulares)
English: Figure 4: Landmark plot for overall survival for dasatinib by BCR-ABL level (≤ 10% or > 10%) at 3 months in a phase 3 study of newly diagnosed patients with chronic phase CML
Icelandic: Mynd 4: Graf (landmark plot) sem sýnir heildarlifun fyrir dasatinib eftir BCR-ABL gildum (≤ 10 eða > 10%) eftir 3 mánuði í III.
English: The primary toxicities occurred in the gastrointestinal, haematopoietic, and lymphoid systems.
Icelandic: Fyrstu eiturverkanir komu fram í meltingarfærum, blóðmyndandi vefjum og eitlakerfi.
English: Additionally, in vitro and in vivo platelet assays suggest that SPRYCEL treatment reversibly affects platelet activation.
Icelandic: Auk þess bendir in vitro og in vivo greining á blóðflögum til þess að SPRYCEL hafi tímabundin áhrif á virkni blóðflagna.
English: Patients aged 65 years and older are more likely than younger patients to experience pleural effusion, dyspnoea, cough, pericardial effusion and congestive heart failure, and should be monitored closely.
Icelandic: Meiri líkur eru á vökvasöfnun í brjóstholi, mæði, hósta, vökvasöfnun í gollurshúsi og hjartabilun hjá sjúklingum 65 ára og eldri heldur en hjá þeim sem eru yngri og því skal fylgjast náið með þeim.
English: At all post-dose time points on day 8, the mean changes from baseline in QTcF interval were 4 - 6 msec, with associated upper 95% confidence intervals < 7 msec. Of the 2,182 patients with resistance or intolerance to prior imatinib therapy who received SPRYCEL in clinical studies, 15 (1%) had QTc prolongation reported as an adverse reaction.
Icelandic: Á 8. degi var meðaltals breyting QTcF bils 4-6 msek miðað við upphafsgildi, mælt eftir lyfjatöku, efra 95% öryggisbil var < 7 msek.
English: Cytogenetic responsec (%)
Icelandic: Litningasvörunc (%)
English: Notably, 22% of patients reported a complete cytogenetic response (CCyR) in the dasatinib arm while only 8% achieved a CCyR in the imatinib arm. With longer treatment and follow-up (median of 24 months), MCyR was achieved in 53% of the dasatinib-treated patients (CCyR in 44%) and 33% of the imatinib-treated patients (CCyR in 18%) prior to crossover.
Icelandic: Við lengri meðferð og eftirfylgni (miðgildi 24 mánuðir) náðist meiriháttar litningasvörun hjá 53% þeirra sem fengu dasatinib (fullkomin litningasvörun hjá 44%) og 33% þeirra sem fengu imatinib (fullkomin litningasvörun hjá 18%) fyrir víxlun.
English: Laboratory test abnormalities Haematology
Icelandic: stigs klínískum rannsóknum varð meðaltalsbreyting
English: e Includes drug eruption, erythema, erythema multiforme, erythrosis, exfoliative rash, generalised erythema, genital rash, heat rash, milia, miliaria, pustular psoriaisis, rash, rash erythematous, rash follicular, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular, skin exfoliation, skin irritation, toxic skin eruption, urticaria vesiculosa, and vasculitic rash.
Icelandic: hitaútbrot, hyrnigrjón (milia), svitabólur, graftarbólusóri, útbrot, roðaútbrot (rash erythematous), útbrot í hárslíðri, útbreidd útbrot, dílaútbrot, dröfnuörðuútbrot (maculo-papular), örðu útbrot (papular), kláðaútbrot, graftarbólur, vessablöðruútbrot, húðflögnun, erting í húð, eitrunarútþot, vessablöðruofsakláði, æðabólguútbrot.
English: SPRYCEL 20 mg film-coated tablets dasatinib
Icelandic: SPRYCEL 20 mg filmuhúðaðar töflur dasatinib
English: White to off-white, biconvex, round film-coated tablet with "BMS" debossed on one side and "527" on the other side.
Icelandic: Hvít til beinhvít, tvíkúpt, kringlótt filmuhúðuð tafla með „BMS“ greypt í aðra hliðina og „527“ í hina.
English: NAME OF THE MARKETING AUTHORISATION HOLDER BRISTOL-MYERS SQUIBB PHARMA EEIG 3.
Icelandic: NAFN MARKAÐSLEYFISHAFA BRISTOL-MYERS SQUIBB PHARMA EEIG 3. FYRNINGARDAGSETNING EXP
English: If cytopaenia is unrelated to leukaemia, stop treatment until ANC ≥1.0 × 109/L and platelets ≥75 × 109/L and resume at the original starting dose or at a reduced dose.
Icelandic: Ef frumufæð tengist ekki hvítblæði, skal hætta meðferðinni þar til ANC ≥1,0 x 109/l og blóðflögur ≥75 x 109/l.
English: In patients with CML with resistance or intolerance to prior imatinib therapy, cytopaenias (thrombocytopaenia, neutropaenia, and anaemia) were a consistent finding.
Icelandic: Hjá sjúklingum með CML sem voru ónæmir fyrir eða þoldu ekki fyrri meðferð með imatinibi, var undantekningarlaust greint frá frumufæð (blóðflagnafæð, daufkyrningafæð og blóðleysi).
English: SPRYCEL is indicated for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.
Icelandic: SPRYCEL er ætlað til meðferðar hjá börnum með: nýlega greint Ph+ CML í stöðugum fasa (Ph+ CML-CP) eða Ph+ CML-CP sem eru ónæm fyrir eða þola ekki fyrri meðferð þ.m.t. meðferð með imatinibi. nýgreint Ph+ brátt eitilfrumukrabbamein (acute lymphoblastic leukaemia (ALL)) ásamt krabbameinslyfjameðferð.
English: Survival (%; Kaplan-Meier estimates) Progression-Free 1 year 2 year Overall 1 year 2 year
Icelandic: 1 ár 2 ár Heildar 1 ár 2 ár
English: SPRYCEL powder for oral suspension is to be constituted as follows: Note: If you have to constitute more than one bottle, complete one bottle at a time.
Icelandic: Ef þú þarft að blanda fleiri en eitt glas skaltu klára að blanda eitt glas í einu.
English: Not known interstitial lung disease
Icelandic: Tíðni ekki þekkt gáttatif/gáttaflökt
English: There were no discontinuations of SPRYCEL therapy due to these biochemical laboratory parameters.
Icelandic: 1%. Í engu tilviki var meðferð með SPRYCEL hætt vegna þessara lífefnagilda.
English: Rare hyperthyroidism, thyroiditis Metabolism and nutrition disorders
Icelandic: Mjög sjaldgæfa ofvirkni skjaldkirtils, skjaldkirtilsbólga Efnaskipti og næring
English: Febrile neutropaenia Nausea
Icelandic: CCyRb Meiriháttar sameindasvörunc
English: White to off-white, biconvex, round film-coated tablet with "BMS" debossed on one side and "524" on the other side.
Icelandic: Hvít til beinhvít, tvíkúpt, kringlótt filmuhúðuð tafla með „BMS“ greypt í aðra hliðina og „524“ í hina.
English: In the Phase II paediatric study, 1 newly diagnosed patient and 2 imatinib-resistant or intolerant patients progressed to blast phase CML.
Icelandic: Í II. stigs rannsókninni hjá börnum ágerðist sjúkdómurinn í CML í bráðafasa hjá 1 nýgreindum sjúklingi og 2 sjúklingum ónæmum fyrir eða sem þoldu ekki imatinib.
English: SPRYCEL 50 mg film-coated tablets Each film-coated tablet contains 50 mg dasatinib (as monohydrate).
Icelandic: Hver filmuhúðuð tafla inniheldur 50 mg dasatinib (sem einhýdrat).
English: SPRYCEL 80 mg film-coated tablets Each film-coated tablet contains 80 mg dasatinib (as monohydrate).
Icelandic: Hver filmuhúðuð tafla inniheldur 80 mg dasatinib (sem einhýdrat).
English: EU/1/06/363/015 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/014 - 30 film-coated tablets (bottle)
Icelandic: EU/1/06/363/015 - 30 x 1 filmuhúðuð tafla (stakskammta þynnupakkning) EU/1/06/363/014 - 30 filmuhúðaðar töflur (töfluglas)
English: Common arthralgia, myalgia, muscular weakness, musculoskeletal stiffness, muscle spasm Uncommon rhabdomyolysis, osteonecrosis, muscle inflammation, tendonitis, arthritis
Icelandic: Algengar liðverkur, vöðvaverkur, vöðvamáttleysi, stífleiki í stoðkerfi, vöðvakrampi
English: Make sure bottle adapter is firmly pressed.
Icelandic: Gangið úr skugga um að millistyk kið á glasinu sé vel fast.
English: EU/1/06/363/011 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/010 - 30 film-coated tablets (bottle)
Icelandic: EU/1/06/363/011 - 30 x 1 filmuhúðuð tafla (stakskammta þynnupakkning) EU/1/06/363/010 - 30 filmuhúðaðar töflur (töfluglas)
English: Haematology parameters Neutropaenia Thrombocytopaenia Anaemia a Phase 3 dose optimisation study results reported at 2 year study follow up.
Icelandic: Langtímavirkni SPRYCEL í III. stigs skammtarannsókn (dose optimisation study):